Pyridoxine (Vitamin B6) Tablets

Pronunciation: peer-i-DOX-een
Generic Name: Pyridoxine (Vitamin B6)
Brand Name: Generic only. No brands available.
Pyridoxine (Vitamin B6) is used for:

Treating or preventing low levels of pyridoxine (vitamin B6). It may also be used for other conditions as determined by your doctor.

Pyridoxine (Vitamin B6) is a vitamin. It works by increasing the blood levels of pyridoxine (vitamin B6).

Do NOT use Pyridoxine (Vitamin B6) if: you are allergic to any ingredient in Pyridoxine (Vitamin B6)

Contact your doctor or health care provider right away if any of these apply to you.

Before using Pyridoxine (Vitamin B6):

Some medical conditions may interact with Pyridoxine (Vitamin B6). Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement if you have allergies to medicines, foods, or other substances

Some MEDICINES MAY INTERACT with Pyridoxine (Vitamin B6). Tell your health care provider if you are taking any other medicines, especially any of the following:

Hydantoins (eg, phenytoin) or levodopa because effectiveness may be decreased by Pyridoxine (Vitamin B6)

This may not be a complete list of all interactions that may occur. Ask your health care provider if Pyridoxine (Vitamin B6) may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Pyridoxine (Vitamin B6):

Use Pyridoxine (Vitamin B6) as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Pyridoxine (Vitamin B6) may be taken with or without food. If you miss a dose of Pyridoxine (Vitamin B6) and you are taking it regularly, take it as soon as possible. If several hours have passed or if it is nearing time for the next dose, do not double the dose to catch up, unless advised by your health care provider. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Pyridoxine (Vitamin B6).

Important safety information: Pyridoxine (Vitamin B6) may cause drowsiness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Pyridoxine (Vitamin B6). Using Pyridoxine (Vitamin B6) alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks. Do not take large doses of vitamins (megadoses or megavitamin therapy) unless directed to by your doctor. Pyridoxine (Vitamin B6) contains pyridoxine (vitamin B 6). Before you begin taking any new prescription or nonprescription medicine, read the ingredients to see if it also contains pyridoxine. If it does or if you are uncertain, contact your doctor or pharmacist. If you are taking 200 mg per day or more of Pyridoxine (Vitamin B6) regularly, do not suddenly stop taking Pyridoxine (Vitamin B6) without checking with your doctor. PREGNANCY and BREAST-FEEDING: If you become pregnant while taking Pyridoxine (Vitamin B6), discuss with your doctor the benefits and risks of using Pyridoxine (Vitamin B6) during pregnancy. Pyridoxine (Vitamin B6) is excreted in breast milk. If you are or will be breast-feeding while you are using Pyridoxine (Vitamin B6), check with your doctor or pharmacist to discuss the risks to your baby. Possible side effects of Pyridoxine (Vitamin B6):

All medicines may cause side effects, but many people have no, or minor, side effects. When used in small doses, no COMMON side effects have been reported with this product. Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); decreased sensation of touch, temperature, or vibration; loss of coordination; numbness of the feet or around the mouth; numbness or tingling of the skin.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Pyridoxine (Vitamin B6) side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include loss of coordination; numbness of the hands and feet.

Proper storage of Pyridoxine (Vitamin B6):

Store Pyridoxine (Vitamin B6) at room temperature, between 59 and 86 degrees F (15 and 30 degrees C), in a tightly closed container. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Pyridoxine (Vitamin B6) out of the reach of children and away from pets.

General information: If you have any questions about Pyridoxine (Vitamin B6), please talk with your doctor, pharmacist, or other health care provider. Pyridoxine (Vitamin B6) is to be used only by the patient for whom it is prescribed. Do not share it with other people. If your symptoms do not improve or if they become worse, check with your doctor. Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Pyridoxine (Vitamin B6). If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012 Database Edition 12.1.1.002 Copyright © 2012 Wolters Kluwer Health, Inc. More Pyridoxine (Vitamin B6) resources Pyridoxine (Vitamin B6) Side Effects (in more detail) Pyridoxine (Vitamin B6) Dosage Pyridoxine (Vitamin B6) Use in Pregnancy & Breastfeeding Pyridoxine (Vitamin B6) Drug Interactions Pyridoxine (Vitamin B6) Support Group 1 Review for Pyridoxine (Vitamin B6) - Add your own review/rating Compare Pyridoxine (Vitamin B6) with other medications Anemia Dietary Supplementation Drug Induced Vitamin/Mineral Deficiency Nausea/Vomiting Seizures

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pyridoxine

Generic Name: pyridoxine (vitamin B6) (PIR ih DOX een)
Brand names: Vitamin B6, Vitelle Nestrex

What is pyridoxine?

Pyridoxine is vitamin B6. Vitamins are naturally occurring substances necessary for many processes in the body. Pyridoxine is important in the breakdown of protein, fats, and carbohydrates from foods into products needed by the body.

Pyridoxine is used to treat or prevent vitamin B6 deficiency. It is also used to treat a certain type of anemia (lack of red blood cells). Pyridoxine injection is used to treat some types of seizure in babies.

Pyridoxine taken by mouth (oral) is available without a prescription. Injectable pyridoxine must be given by a healthcare professional.

Pyridoxine may also be used for purposes not listed in this medication guide.

What is the most important information I should know about pyridoxine? You should not use pyridoxine if you have ever had an allergic reaction to it.

Ask a doctor or pharmacist before taking pyridoxine if you have any medical conditions, if you take other medications or herbal products, or if you are allergic to any drugs or foods.

Before you receive injectable pyridoxine, tell your doctor if you have kidney disease or heart disease. Pyridoxine is only part of a complete program of treatment that may also include a special diet. It is very important to follow the diet plan created for you by your doctor or nutrition counselor. You should become very familiar with the list of foods you should eat or avoid to help control your condition. What should I discuss with my healthcare provider before taking pyridoxine? You should not use pyridoxine if you have ever had an allergic reaction to it.

Ask a doctor or pharmacist if it is safe for you to take this medicine if:

you have any other medical conditions;

you take other medications or herbal products; or

you are allergic to any drugs or foods.

To make sure you can safely receive injectable pyridoxine, tell your doctor if you have heart disease or kidney disease. FDA pregnancy category A. Pyridoxine is not expected to harm an unborn baby. Your pyridoxine dose needs may be different during pregnancy. Do not take pyridoxine without medical advice if you are pregnant or plan to become pregnant. Pyridoxine can pass into breast milk. Your dose needs may be different while you are nursing. High doses of this medication may harm a nursing baby. Do not take pyridoxine without medical advice if you are breast-feeding a baby. How should I take pyridoxine?

Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

Injectable pyridoxine is injected into a muscle. You may be shown how to use injections at home. Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of used needles and syringes.

Never use more than the recommended dose of pyridoxine.

The recommended dietary allowance of pyridoxine increases with age. Follow your healthcare provider's instructions. You may also consult the National Academy of Sciences "Dietary Reference Intake" or the U.S. Department of Agriculture's "Dietary Reference Intake" (formerly "Recommended Daily Allowances" or RDA) listings for more information.

Pyridoxine is only part of a complete program of treatment that may also include a special diet. It is very important to follow the diet plan created for you by your doctor or nutrition counselor. You should become very familiar with the list of foods you should eat or avoid to help control your condition. Store at room temperature away from moisture and heat.

See also: Pyridoxine dosage (in more detail)

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose? Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include severe forms of some of the side effects listed in this medication guide.

What should I avoid while taking pyridoxine?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Pyridoxine side effects Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have a serious side effect such as:

decreased sensation to touch, temperature, and vibration;

loss of balance or coordination;

numbness in your feet or around your mouth;

clumsiness in your hands; or

feeling tired.

Less serious side effects may include:

nausea;

headache;

drowsiness; or

mild numbness or tingling.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Pyridoxine Dosing Information

Usual Adult Dose for Drug Induced Vitamin/Mineral Deficiency:

Drug Induced Neuritis:
Cycloserine: 100 to 300 mg/day orally in divided doses.
Isoniazid or penicillamine: 100 to 200 mg/day orally for 3 weeks or 25 to 100 mg/day for prophylaxis.
Oral contraceptives: 25 to 30 mg/day orally.
Acute Intoxication:
Hydralazine: 25 mg/kg. One-third of the dose should be administered IM and the remainder administered as an IV infusion over 3 hours.
Isoniazid: 1 to 4 grams IV as a first dose, then 1 g IM every 30 minutes until the total required dose has been administered (given with other anticonvulsants as needed). The total dose administered should equal the amount of isoniazid ingested.
Mushroom ingestion (genus Gyromitra): 25 mg/kg IV infused over 15 to 30 minutes. Repeat as needed to a maximum total daily dose of 15 to 20 g.

Usual Adult Dose for Dietary Supplement:

Pyridoxine Deficiency:
10 to 25 mg/day orally, IM, or IV for 3 weeks followed by 2 to 5 mg/day from a multivitamin product.

Usual Adult Dose for Anemia:

Sideroblastic, hereditary: 200 to 600 mg orally daily. If adequate response obtained, dose may be decreased to 30 to 50 mg orally daily.
If therapeutic response is not obtained after 1 to 2 months of pyridoxine therapy, a different therapy should be considered.

Usual Adult Dose for Nausea/Vomiting:

Nausea and vomiting of Pregnancy:
25 mg orally every 8 hours.

Usual Pediatric Dose for Drug Induced Vitamin/Mineral Deficiency:

Drug Induced Neuritis (cycloserine, isoniazid, hydralazine, penicillamine) :
Treatment: 10 to 50 mg/day.
Prophylaxis: 1 to 2 mg/kg/day
Acute Intoxication:
Hydralazine: 25 mg/kg: One-third of the dose should be administered IM and the remainder administered as an IV infusion over 3 hours.
Isoniazid: Acute ingestion of known amount: Initial: A total dose of pyridoxine equal to the amount of isoniazid ingested (maximum dose: 70 mg/kg, up to 5 g); administer at a rate of 0.5 to 1 g/minute until seizures stop or the maximum initial dose has been administered; may repeat every 5 to 10 minutes as needed to control persistent seizure activity and/or CNS toxicity. If seizures stop prior to the administration of the calculated initial dose, infuse the remaining pyridoxine over 4 to 6 hours. Acute ingestion of unknown amount: Initial: 70 mg/kg (maximum dose: 5 g); administer at a rate of 0.5 to 1 g/minute; may repeat every 5 to 10 minutes as needed to control persistent seizure activity and/or CNS toxicity.
Mushroom ingestion (genus Gyromitra): 25 mg/kg IV. Repeat as needed up to a maximum total dose of 15 to 20 g.

Usual Pediatric Dose for Dietary Supplement:

Pyridoxine Deficiency:
5 to 25 mg/day orally, IM, or IV for 3 weeks followed by 1.5 to 2.5 mg/day from a multivitamin product.

Usual Pediatric Dose for Seizures:

Pyridoxine-dependent seizures:
10 to 100 mg PO, IM, or IV initially, followed by 2 to 100 mg orally daily.

What other drugs will affect pyridoxine?

There may be other drugs that can interact with pyridoxine. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More pyridoxine resources Pyridoxine Side Effects (in more detail) Pyridoxine Dosage Pyridoxine Use in Pregnancy & Breastfeeding Pyridoxine Drug Interactions Pyridoxine Support Group 1 Review for Pyridoxine - Add your own review/rating pyridoxine Oral, Injection Advanced Consumer (Micromedex) - Includes Dosage Information Pyridoxine Hydrochloride Monograph (AHFS DI) Compare pyridoxine with other medications Anemia Dietary Supplementation Drug Induced Vitamin/Mineral Deficiency Nausea/Vomiting Seizures Where can I get more information? Your pharmacist can provide more information about pyridoxine.

See also: pyridoxine side effects (in more detail)

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High Potency Multi B Complex

Dosage Form: FOR ANIMAL USE ONLY
HIGH POTENCY VITAMIN B COMPLEX INDICATIONS

For use as a supplement source of B complex vitamins in cattle, swine and sheep.

Precautions

Allergic-type reactions following the injection of products containing thiamine have been reported. Administer with caution and keep treated animals under close observation.

High Potency Multi B Complex Dosage and Administration

Inject intramuscularly. May be administered subcutaneously or intravenously if recommended by your veterinarian. The following are suggested dosages, depending on the condition of the animal and the desired response.

Adult Cattle--1 to 2 mL per 100 pounds body weight.
Calves, Swine and Sheep--5 mL per 100 pounds of body weight.

May be repeated daily, if indicated.

TAKE TIME OBSERVE LABEL DIRECTIONS

COMPOSITION

Each mL of sterile aqueous solution contains:

Thiamine Hydrochloride (B1) . . . . . . . . . . . . . 100 mg
Riboflavin (B2) . . . . . . . . . . . . . . . . . . . . . . . . .5 mg
  (as Riboflavin 5'--Phosphate Sodium)
Niacinamide . . . . . . . . . . . . . . . . . . . . . . . . .100 mg
Pyridoxine Hydrochloride (B6) . . . . . . . . . . . . . 10 mg
d-Panthenol . . . . . . . . . . . . . . . . . . . . . . . . . .10 mg
Cyanocobalamin (B12) . . . . . . . . . . . . . . . . .100 mcg
With Citric Acid and Benzyl Alcohol 1.5% v/v (preservative)

Store at controlled room temperature between 15o and 30oC (59o-86oF)

Protect from light

High Potency Multi B Complex 
cyanocobalamin, niacinamide, dexpanthenol, p yridoxine hydrochloride, riboflavin 5 phosphate sodium, thiamine hydrochloride  injection Product Information Product Type OTC ANIMAL DRUG NDC Product Code (Source) 58005-606 Route of Administration INTRAMUSCULAR, SUBCUTANEOUS, INTRAVENOUS DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CYANOCOBALAMIN (CYANOCOBALAMIN) CYANOCOBALAMIN 100 ug  in 1 mL NIACINAMIDE (NIACINAMIDE) NIACINAMIDE 100 mg  in 1 mL DEXPANTHENOL (DEXPANTHENOL) DEXPANTHENOL 10 mg  in 1 mL PYRIDOXINE HYDROCHLORIDE (PYRIDOXINE) PYRIDOXINE HYDROCHLORIDE 10 mg  in 1 mL RIBOFLAVIN 5'-PHOSPHATE SODIUM (RIBOFLAVIN) RIBOFLAVIN 5'-PHOSPHATE SODIUM 5 mg  in 1 mL THIAMINE HYDROCHLORIDE (THIAMINE) THIAMINE HYDROCHLORIDE 100 mg  in 1 mL Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains          Packaging # NDC Package Description Multilevel Packaging 1 58005-606-04 100 mL In 1 VIAL None 2 58005-606-05 250 mL In 1 VIAL None 3 58005-606-06 500 mL In 1 VIAL None
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 07/01/1996
Labeler - Sparhawk Laboratories, Inc. (958829558) Revised: 08/2010Sparhawk Laboratories, Inc.

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pyridoxine Oral, Injection

pir-i-DOX-een

Commonly used brand name(s)

In the U.S.

Aminoxin Pyri-500 Rodex Vitabee 6

Available Dosage Forms:

Injectable Solution Tablet Capsule Tablet, Extended Release Tablet, Enteric Coated

Therapeutic Class: Nutritive Agent

Pharmacologic Class: Vitamin B

Uses For pyridoxine

Vitamins are compounds that you must have for growth and health. They are needed in small amounts only and are usually available in the foods that you eat. Pyridoxine (vitamin B 6) is necessary for normal breakdown of proteins, carbohydrates, and fats.

Some conditions may increase your need for pyridoxine. These include:

Alcoholism Burns Diarrhea Dialysis Heart disease Intestinal problems Liver disease Overactive thyroid Stress, long-term illness, or serious injury Surgical removal of stomach

In addition, infants receiving unfortified formulas such as evaporated milk may need additional pyridoxine.

Increased need for pyridoxine should be determined by your health care professional.

Lack of pyridoxine may lead to anemia (weak blood), nerve damage, seizures, skin problems, and sores in the mouth. Your doctor may treat these problems by prescribing pyridoxine for you.

Claims that pyridoxine is effective for treatment of acne and other skin problems, alcohol intoxication, asthma, hemorrhoids, kidney stones, mental problems, migraine headaches, morning sickness, and menstrual problems, or to stimulate appetite or milk production have not been proven.

Injectable pyridoxine is given by or under the supervision of a health care professional. Other forms of pyridoxine are available without a prescription.

Importance of Diet

For good health, it is important that you eat a balanced and varied diet. Follow carefully any diet program your health care professional may recommend. For your specific dietary vitamin and/or mineral needs, ask your health care professional for a list of appropriate foods. If you think that you are not getting enough vitamins and/or minerals in your diet, you may choose to take a dietary supplement.

Pyridoxine is found in various foods, including meats, bananas, lima beans, egg yolks, peanuts, and whole-grain cereals. Pyridoxine is not lost from food during ordinary cooking, although some other forms of vitamin B 6 are.

Vitamins alone will not take the place of a good diet and will not provide energy. Your body also needs other substances found in food such as protein, minerals, carbohydrates, and fat. Vitamins themselves often cannot work without the presence of other foods.

The daily amount of pyridoxine needed is defined in several different ways.

For U.S.— Recommended Dietary Allowances (RDAs) are the amount of vitamins and minerals needed to provide for adequate nutrition in most healthy persons. RDAs for a given nutrient may vary depending on a person's age, sex, and physical condition (e.g., pregnancy). Daily Values (DVs) are used on food and dietary supplement labels to indicate the percent of the recommended daily amount of each nutrient that a serving provides. DV replaces the previous designation of United States Recommended Daily Allowances (USRDAs). For Canada— Recommended Nutrient Intakes (RNIs) are used to determine the amounts of vitamins, minerals, and protein needed to provide adequate nutrition and lessen the risk of chronic disease.

Normal daily recommended intakes for pyridoxine are generally defined as follows:

Infants and children— Birth to 3 years of age: 0.3 to 1 milligram (mg). 4 to 6 years of age: 1.1 mg. 7 to 10 years of age: 1.4 mg. Adolescent and adult males—1.7 to 2 mg. Adolescent and adult females—1.4 to 1.6 mg. Pregnant females—2.2 mg. Breast-feeding females—2.1 mg. Before Using pyridoxine

If you are taking this dietary supplement without a prescription, carefully read and follow any precautions on the label. For this supplement, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to pyridoxine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Problems in children have not been reported with intake of normal daily recommended amounts.

Geriatric

Problems in older adults have not been reported with intake of normal daily recommended amounts.

Breast Feeding

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this dietary supplement, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this dietary supplement with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Altretamine Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Proper Use of pyridoxine Dosing

The dose of pyridoxine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of pyridoxine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For oral dosage forms (capsules, tablets, oral solution): To prevent deficiency, the amount taken by mouth is based on normal daily recommended intakes: Adult and teenage males—1.7 to 2 milligrams (mg) per day. Adult and teenage females—1.4 to 1.6 mg per day. Pregnant females—2.2 mg per day. Breast-feeding females—2.1 mg per day. Children 7 to 10 years of age—1.4 mg per day. Children 4 to 6 years of age—1.1 mg per day. Children birth to 3 years of age—0.3 to 1 mg per day. To treat deficiency: Adults, teenagers, and children—Treatment dose is determined by prescriber for each individual based on the severity of deficiency.

To use the extended-release capsule form of this dietary supplement:

Swallow the capsule whole. Do not crush, break, or chew before swallowing. If the capsule is too large to swallow, you may mix the contents of the capsule with jam or jelly and swallow without chewing.

To use the extended-release tablet form of this dietary supplement:

Swallow the tablet whole. Do not crush, break, or chew before swallowing. Missed Dose

If you miss a dose of pyridoxine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

pyridoxine Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

With large doses Clumsiness numbness of hands or feet

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: pyridoxine Oral, Injection side effects (in more detail)

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More pyridoxine Oral, Injection resources Pyridoxine Oral, Injection Side Effects (in more detail) Pyridoxine Oral, Injection Use in Pregnancy & Breastfeeding Pyridoxine Oral, Injection Drug Interactions Pyridoxine Oral, Injection Support Group 1 Review for Pyridoxine Oral, Injection - Add your own review/rating Compare pyridoxine Oral, Injection with other medications Anemia Dietary Supplementation Drug Induced Vitamin/Mineral Deficiency Nausea/Vomiting Seizures

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Nephrocaps

ascorbic acid, thiamine, riboflavin, niacin, pyridoxine, folic acid, cyanocobalamin, biotin and pantothenic acid
Dosage Form: capsule, liquid filled
Nephrocaps® - DIALYSIS/STRESS Vitamin Supplement Nephrocaps Description

Nephrocaps® are opaque black oval softgels imprinted “n”. These softgels provide water-soluble vitamins.

Each softgel contains:

Vitamin C (ascorbic acid)…………………………..100 mg

Thiamine (as thiamine mononitrate).........................1.5 mg

Riboflavin.................................................................1.7 mg

Niacin (as niacinamide).............................................20 mg

Vitamin B6 (as pyridoxine HCl)...............................10 mg

Folate (folic acid)........................................................1 mg

Vitamin B12 (as cyanocobalamin)............................6 mcg

Biotin......................................................................150 mcg

Pantothenic Acid (as calcium pantothenate)………..5 mg

Indications and Usage for Nephrocaps

 In the wasting syndrome in chronic renal failure; uremia; impaired metabolic functions of the kidney and to maintain levels when dietary intake of vitamins is inadequate or excretion or loss is excessive. Also, highly effective as a stress vitamin. 

Precautions

Folic acid may mask the symptoms of pernicious anemia in that hematologic remission may occur while neurologic manifestations remain progressive. 

Nephrocaps Dosage and Administration

One softgel daily, or as directed by a physician. If on dialysis, take after treatment. 

Storage

Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F). Keep container tightly closed and protected from heat and moisture.

To report a serious adverse event or obtain product information contact 1-800-343-9497.

Keep out of reach of children. How is Nephrocaps Supplied

Nephrocaps® (Dialysis/Stress Vitamin Supplement) are supplied in bottles with 30 (NDC 0256-0185-04) or 90 (NDC 0256-0185-05) softgels.

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

NDC 0256-0185-05

Rx Only

Nephrocaps®
DIALYSIS/STRESS
Vitamin Supplement

Each Softgel Contains: Vitamin C 100 mg, folate 1 mg, niacin 20 mg, thiamine 1.5 mg, riboflavin 1.7 mg, Vitamin B-6 10 mg, Vitamin B-12 6 mcg, pantothenic acid 5 mg and biotin 150 mcg.

90 SOFTGELS

Fleming Pharmaceuticals
St. Louis, MO 63026

Mfg. for Fleming Pharmaceuticals.

Lot No.

Exp. Date

L225 Rev.0909

Bottle Label - 90 Softgels

Nephrocaps 
ascorbic acid, folic acid, niacin, thiamine, riboflavin, pyridoxine, cyanocobalamin, pantothenic acid, biotin  capsule, liquid filled Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0256-0185 Route of Administration ORAL DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ASCORBIC ACID (ASCORBIC ACID) ASCORBIC ACID 100 mg THIAMINE (THIAMINE) THIAMINE 1.5 mg RIBOFLAVIN (RIBOFLAVIN) RIBOFLAVIN 1.7 mg NIACIN (NIACIN) NIACIN 20 mg PYRIDOXINE (PYRIDOXINE) PYRIDOXINE 10 mg FOLIC ACID (FOLIC ACID) FOLIC ACID 1 mg CYANOCOBALAMIN (CYANOCOBALAMIN) CYANOCOBALAMIN 6 ug BIOTIN (BIOTIN) BIOTIN 150 ug PANTOTHENIC ACID (PANTOTHENIC ACID) PANTOTHENIC ACID 5 mg Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found Product Characteristics Color BLACK (White imprint) Score no score Shape CAPSULE (Oval) Size 13mm Flavor Imprint Code n Contains          Packaging # NDC Package Description Multilevel Packaging 1 0256-0185-05 90 CAPSULE In 1 BOTTLE None 2 0256-0185-04 30 CAPSULE In 1 BOTTLE None 3 0256-0185-08 12 BOTTLE In 1 TRAY contains a BOTTLE 3 5 CAPSULE In 1 BOTTLE This package is contained within the TRAY (0256-0185-08)
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Unapproved drug other 02/01/1993
Labeler - Fleming & Company, Pharmaceuticals (006491351) Establishment Name Address ID/FEI Operations CATALENT PHARMA SOLUTIONS, INC. 051762268 MANUFACTURE Revised: 09/2010Fleming & Company, Pharmaceuticals
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Aminoxin

Generic Name: pyridoxine (Oral route, Injection route)

pir-i-DOX-een

Commonly used brand name(s)

In the U.S.

Aminoxin Pyri-500 Rodex Vitabee 6

Available Dosage Forms:

Injectable Solution Tablet Capsule Tablet, Extended Release Tablet, Enteric Coated

Therapeutic Class: Nutritive Agent

Pharmacologic Class: Vitamin B

Uses For Aminoxin

Vitamins are compounds that you must have for growth and health. They are needed in small amounts only and are usually available in the foods that you eat. Pyridoxine (vitamin B 6) is necessary for normal breakdown of proteins, carbohydrates, and fats.

Some conditions may increase your need for pyridoxine. These include:

Alcoholism Burns Diarrhea Dialysis Heart disease Intestinal problems Liver disease Overactive thyroid Stress, long-term illness, or serious injury Surgical removal of stomach

In addition, infants receiving unfortified formulas such as evaporated milk may need additional pyridoxine.

Increased need for pyridoxine should be determined by your health care professional.

Lack of pyridoxine may lead to anemia (weak blood), nerve damage, seizures, skin problems, and sores in the mouth. Your doctor may treat these problems by prescribing pyridoxine for you.

Claims that pyridoxine is effective for treatment of acne and other skin problems, alcohol intoxication, asthma, hemorrhoids, kidney stones, mental problems, migraine headaches, morning sickness, and menstrual problems, or to stimulate appetite or milk production have not been proven.

Injectable pyridoxine is given by or under the supervision of a health care professional. Other forms of pyridoxine are available without a prescription.

Importance of Diet

For good health, it is important that you eat a balanced and varied diet. Follow carefully any diet program your health care professional may recommend. For your specific dietary vitamin and/or mineral needs, ask your health care professional for a list of appropriate foods. If you think that you are not getting enough vitamins and/or minerals in your diet, you may choose to take a dietary supplement.

Pyridoxine is found in various foods, including meats, bananas, lima beans, egg yolks, peanuts, and whole-grain cereals. Pyridoxine is not lost from food during ordinary cooking, although some other forms of vitamin B 6 are.

Vitamins alone will not take the place of a good diet and will not provide energy. Your body also needs other substances found in food such as protein, minerals, carbohydrates, and fat. Vitamins themselves often cannot work without the presence of other foods.

The daily amount of pyridoxine needed is defined in several different ways.

For U.S.— Recommended Dietary Allowances (RDAs) are the amount of vitamins and minerals needed to provide for adequate nutrition in most healthy persons. RDAs for a given nutrient may vary depending on a person's age, sex, and physical condition (e.g., pregnancy). Daily Values (DVs) are used on food and dietary supplement labels to indicate the percent of the recommended daily amount of each nutrient that a serving provides. DV replaces the previous designation of United States Recommended Daily Allowances (USRDAs). For Canada— Recommended Nutrient Intakes (RNIs) are used to determine the amounts of vitamins, minerals, and protein needed to provide adequate nutrition and lessen the risk of chronic disease.

Normal daily recommended intakes for pyridoxine are generally defined as follows:

Infants and children— Birth to 3 years of age: 0.3 to 1 milligram (mg). 4 to 6 years of age: 1.1 mg. 7 to 10 years of age: 1.4 mg. Adolescent and adult males—1.7 to 2 mg. Adolescent and adult females—1.4 to 1.6 mg. Pregnant females—2.2 mg. Breast-feeding females—2.1 mg. Before Using Aminoxin

If you are taking this dietary supplement without a prescription, carefully read and follow any precautions on the label. For this supplement, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Problems in children have not been reported with intake of normal daily recommended amounts.

Geriatric

Problems in older adults have not been reported with intake of normal daily recommended amounts.

Breast Feeding

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this dietary supplement, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this dietary supplement with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Altretamine Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Proper Use of pyridoxine

This section provides information on the proper use of a number of products that contain pyridoxine. It may not be specific to Aminoxin. Please read with care.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For oral dosage forms (capsules, tablets, oral solution): To prevent deficiency, the amount taken by mouth is based on normal daily recommended intakes: Adult and teenage males—1.7 to 2 milligrams (mg) per day. Adult and teenage females—1.4 to 1.6 mg per day. Pregnant females—2.2 mg per day. Breast-feeding females—2.1 mg per day. Children 7 to 10 years of age—1.4 mg per day. Children 4 to 6 years of age—1.1 mg per day. Children birth to 3 years of age—0.3 to 1 mg per day. To treat deficiency: Adults, teenagers, and children—Treatment dose is determined by prescriber for each individual based on the severity of deficiency.

To use the extended-release capsule form of this dietary supplement:

Swallow the capsule whole. Do not crush, break, or chew before swallowing. If the capsule is too large to swallow, you may mix the contents of the capsule with jam or jelly and swallow without chewing.

To use the extended-release tablet form of this dietary supplement:

Swallow the tablet whole. Do not crush, break, or chew before swallowing. Missed Dose

If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Aminoxin Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

With large doses Clumsiness numbness of hands or feet

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Aminoxin side effects (in more detail)

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

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Taron-Prex Prenatal

Dosage Form: capsule
Taron™-Prex Prenatal with DHA CAP
Rx Prenatal Vitamin

Rx Only

Taron-Prex Prenatal Description

Taron™-Prex Prenatal with DHA capsules are a prescription prenatal/postnatal multivitamin/mineral softgel capsule with fish oil-based DHA. Each softgel capsule is oblong, maroon and imprinted with "T543" in white ink.

1.2 mg Folic Acid and 265 mg DHA (key omega-3 fatty acid from purified fish oil) Essential vitamins and minerals Gentle stool softener Each softgel capsule contains: * From approximately 350 mg of Omegas derived from approximately 380 mg of purified fish oil. Vitamin C (ascorbic acid, USP) 25 mg   Calcium (tribasic calcium phosphate, NF) 160 mg   Iron (ferrous fumarate, USP) 30 mg   Vitamin D3 (cholecalciferol, USP) 170 IU   Vitamin E (d-alpha tocopherol, USP) 30 IU   Vitamin B6 (pyridoxine hydrochloride, USP) 25 mg   Folic Acid, USP 1.2 mg   DHA (Docosahexaenoic Acid) 265 mg* Docusate Sodium, USP not more than 55 mg  

Inactive Ingredients: Gelatin, Soybean Oil, Glycerin, Purified Water, Lecithin, Yellow Bees Wax, Natural Orange Flavor, FD&C Red #40, Titanium Dioxide, Ethyl Vanillin, FD&C Yellow #6, FD&C Blue #1.

INDICATIONS

Taron™-Prex Prenatal with DHA capsules are indicated to provide vitamin/mineral and fish-based DHA supplementation throughout pregnancy, during the postnatal period for both lactating and non-lactating mothers, and throughout the childbearing years. Taron™-Prex Prenatal with DHA may be useful in improving the nutritional status of women prior to conception.

Contraindications

Taron™-Prex Prenatal with DHA capsules are contraindicated in patients with a known Hypersensitivity to any of the ingredients, including fish or fish oil. Do not take this product if you are presently taking mineral oil, unless directed by a doctor.

Warning

Ingestion of more than 3 grams of omega-3 fatty acids such as DHA) per day has been shown to have potential antithrombotic effects, including an increased bleeding time and International Normalized Ratio (INR). Administration of omega-3 fatty acids should be avoided in patients taking anticoagulants and in those known to have an inherited or acquired predisposition to bleeding.

WARNING

Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. KEEP THIS PRODUCT OUT OF THE REACH OF CHILDREN. In case of accidental overdose, call a doctor or poison control center immediately.

THIS PRODUCT CONTAINS SOY AND FISH OIL.

PRECAUTION

Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias here vitamin B12 is deficient. Folic acid in doses above 0.1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations remain progressive.

Adverse Reactions

Allergic sensitization has been reported following both oral and parenteral administration of folic acid.

CAUTION

Exercise caution to ensure that the prescribed dosage of DHA does not exceed 1 gram (1000 mg) per day.

Taron-Prex Prenatal Dosage and Administration

Before, during and/or after pregnancy, one softgel capsule daily or as prescribed by a physician.

How is Taron-Prex Prenatal Supplied

Bottles of 30 softgel capsules

NDC 13811-543-30

STORAGE

Store at 20°-25°C (68°-77°F), excursions permitted to 15°-30°C (59°- 86°F) [See USP controlled room temperature].

KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN.

Call your doctor about side effects. You may report side effects by calling 888 9 TRIGEN (888-987-4436).

Rx Only

All prescriptions using this product shall be pursuant to state statutes as applicable. This is not an Orange Book product. There are no implied or explicit claims on therapeutic equivalence.

Manufactured For:
TRIGEN Laboratories, Inc.
Sayreville, NJ 08872
www.trigenlab.com

Rev. 06/11

PRINCIPAL DISPLAY PANEL - 30 Capsule Label

NDC 13811-543-30

Rx Only

Taron™-Prex Prenatal
with DHA CAP

RX PRENATAL VITAMIN

1.2 mg Folic Acid and 265 mg DHA
(key omega-3 fatty acid) Essential vitamins and minerals Gentle stool softener

30 CAPSULES

TRIGEN
LABORATORIES

TARON-PREX  PRENATAL
ascorbic acid, tribasic calcium phosphate, iron, cholecalciferol, alpha-tocopherol, pyridoxine hydrochloride, folic acid, doconexent, and docusate sodium  capsule Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 13811-543 Route of Administration ORAL DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Ascorbic Acid (Ascorbic Acid) Ascorbic Acid 25 mg Tribasic Calcium Phosphate (Calcium Cation) Tribasic Calcium Phosphate 160 mg Iron (Iron) Iron 30 mg Cholecalciferol (Cholecalciferol) Cholecalciferol 170 [iU] Alpha-Tocopherol (Alpha-Tocopherol) Alpha-Tocopherol 30 [iU] Pyridoxine Hydrochloride (Pyridoxine) Pyridoxine Hydrochloride 25 mg Folic Acid (Folic Acid) Folic Acid 1.2 mg Doconexent (Doconexent) Doconexent 265 mg Docusate Sodium (Docusate) Docusate Sodium 55 mg Inactive Ingredients Ingredient Name Strength Gelatin   Soybean Oil   Glycerin   Water   Yellow Wax   FD&C Red No. 40   Titanium Dioxide   Ethyl Vanillin   FD&C Yellow No. 6   FD&C Blue No. 1   Product Characteristics Color RED (maroon) Score no score Shape CAPSULE (oblong) Size 20mm Flavor ORANGE Imprint Code T543 Contains          Packaging # NDC Package Description Multilevel Packaging 1 13811-543-30 30 CAPSULE In 1 BOTTLE None
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Unapproved drug other 12/01/2009
Labeler - TRIGEN Laboratories, Inc. (830479668) Revised: 09/2011TRIGEN Laboratories, Inc.

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MultiVit with Fluoride Chewable Tablets

Dosage Form: chewable tablets
Multi-Vitamin With Fluoride Chewable Tablets
Rx Only *Daily Value not established Supplement Facts Serving Size: 1 Chewable Tablet Amount Per Tablet % Daily Value Adults & children 4 years or more Vitamin A ................................. 2500 IU 50% Vitamin C ................................... 60 mg 100% Vitamin D .................................. 400 IU 100% Vitamin E .................................... 15 IU 50% Thiamin (B1) .......................... 1.05 mg 70% Riboflavin (B2) ......................... 1.2 mg 71% Niacin ..................................... 13.5 mg 68% Vitamin (B6) ........................... 1.05 mg 53% Folate ........................................ 0.3 mg 75% Vitamin B12 ............................ 4.5 mcg 75% Fluoride (as sodium fluoride) ... 1.0 mg *

Active ingredient for Caries Prophylaxis: Fluoride as Sodium Fluoride.

Other ingredients: Artificial grape flavor, ascorbic acid, butylated hydroxyl toluene, cholecalciferol, citric acid, compressible sugar, DL-alpha Tocopherol, D&C Red # 7 calcium lake, FD&C Blue #1 aluminum lake, folic acid, gelatin, magnesium stearate, maltodextrin, mannitol, medium chain triglycerides, methyl cellulose, mono- and di-glycerides, niacinamide, povidone, pyridoxine, riboflavin, silicon dioxide, sodium ascorbate, sodium citrate, starches, sucralose, thiamine, vitamin A acetate, vitamin B12 and vitamin E acetate.

CLINICAL PHARMACOLOGY

It is well established that fluoridation of the water supply (1 ppm fluoride) during the period of tooth development leads to a significant decrease in the incidence of dental caries.

Multi-vitamin with Fluoride Chewable Tablets provide sodium fluoride and ten essential vitamins in a chewable tablet. Because the tablets are chewable, they provide a topical as well as systemic source of fluoride.

Hydroxyapatite is the principal crystal for all calcified tissue in the human body. The fluoride ion reacts with the hydroxyapatite in the tooth as it is formed to produce the more caries-resistant crystal, fluorapatite. The reaction may be expressed by the equation:

Ca10(PO4)6(OH)2 + 2F-  —————> Ca10(PO4)6F2 + 2OH-

(Hydroxyapatite)                                   (Fluorapatite)

Three stages of fluoride deposition in tooth enamel can be distinguished:

1. Small amounts (reflecting the low levels of fluoride in tissue fluids) are incorporated into the enamel crystals while they are being formed.

2.  After enamel has been laid down, fluoride deposition continues in the surface enamel.  Diffusion of fluoride from the surface inward is apparently restricted.

3.  After eruption, the surface enamel acquires fluoride from the water, food, supplementary fluoride and smaller amounts from saliva.

INDICATIONS AND USAGE

Supplementation of the diet with ten essential vitamins.

Supplementation of the diet with fluoride for caries prophylaxis.

See Dosage and Administration.

Multi-vitamin with Fluoride Chewable Tablets supply significant amounts of Vitamins A, C, D, E, thiamin, riboflavin, niacin, vitamin B6, vitamin B12, and folate to supplement the diet, and to help assure that nutritional deficiencies of these vitamins will not develop. Thus, in a single easy-to-use preparation, children obtain ten essential vitamins and the important mineral, fluoride.

The American Academy of Pediatrics recommends that children up to age 16, in areas where drinking water contains less than optimal levels of fluoride, receive daily fluoride supplementation.

Children using Multi-vitamin with fluoride Chewable Tablets regularly should receive semiannual dental examinations. The regular brushing of teeth and attention to good oral hygiene practices are also essential.

WARNINGS

As in the case of all medications, keep out of the reach of children.

Should be chewed. This product, as all chewable tablets, is not recommended for children under age 4 due to risk of choking.

PRECAUTIONS

The suggested dose of Multi-vitamin with Fluoride Chewable Tablets should not be exceeded, since dental fluorosis may result from continued ingestion of large amounts of fluoride.

Before prescribing Multi-vitamin with Fluoride Chewable Tablets, read these Important Considerations When Using Dosage Schedule found in Dosage and Administration.

If fluoride level is unknown, drinking water should be tested for fluoride content before supplements are prescribed. For testing of fluoride content, contact the local or state health department. All sources of fluoride should be evaluated with a thorough fluoride history. Patient exposure to multiple water sources can make proper prescribing complex. Ingestion of higher than recommended levels of fluoride by children has been associated with an increase in mild dental fluorosis in developing, unerupted teeth. Fluoride supplements require long-term compliance on a daily basis. ADVERSE REACTIONS

Allergic rash and other idiosyncrasies have been rarely reported.

DOSAGE AND ADMINISTRATION *1.0 ppm = 1 mg / liter **2.2 mg Sodium Fluoride contains 1mg fluoride ion. Fluoride Ion Level in Drinking Water (ppm)* AGE <0.3 ppm 0.3-0.6 ppm >0.6 ppm 4-6 years 0.50 mg / day**
(1/2 tablet) 0.25 mg / day
(1/4 tablet) None 6-16 years 1.0 mg / day
(1 tablet) 0.50 mg / day
(1/2 tablet) None HOW SUPPLIED

Multi-vitamin 1 mg Sodium Fluoride Tablets: grape flavored, round, purple, debossed “BP 815”, available in 100 ct. bottle, NDC 64376-815-01.

Multi-vitamin 0.5 mg Sodium Fluoride Tablets: cherry flavored, square, red, debossed “BP 814”, available in 100 ct. bottle, NDC 64376-814-01.

Multi-vitamin 0.25 mg Sodium Fluoride Tablets: orange flavored, round, orange, debossed “BP 813”, available in 100 ct. bottle, NDC 64376-813-01.

Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C -30°C (59°-86°F) [See USP Controlled Room Temperature].

Manufactured for:
Boca Pharmacal, Inc.
Coral Springs, FL 33065
www.bocapharmacal.com
1-800-354-8460 Iss. 07/11

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

[Rev 13]

MULTI-VITAMIN 
vitamin a, vitamin d, thiamine, riboflavin, niacin, pyridoxine, folic acid, fluoride ion, ascorbic acid, alpha-tocopherol-acetate-dl, cyanocobalamin  tablet, chewable Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 64376-815 Route of Administration ORAL DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength VITAMIN A (VITAMIN A) VITAMIN A 2500 [iU] VITAMIN D (VITAMIN D) VITAMIN D 400 [iU] THIAMINE (THIAMINE) THIAMINE 1.05 mg RIBOFLAVIN (RIBOFLAVIN) RIBOFLAVIN 1.2 mg NIACIN (NIACIN) NIACIN 13.5 mg PYRIDOXINE (PYRIDOXINE) PYRIDOXINE 1.05 mg FOLIC ACID (FOLIC ACID) FOLIC ACID 0.3 mg FLUORIDE ION (FLUORIDE ION) FLUORIDE ION 1.0 mg ASCORBIC ACID (ASCORBIC ACID) ASCORBIC ACID 60 mg .ALPHA.-TOCOPHEROL ACETATE, DL- (.ALPHA.-TOCOPHEROL ACETATE, DL-) .ALPHA.-TOCOPHEROL ACETATE, DL- 15 [iU] CYANOCOBALAMIN (CYANOCOBALAMIN) CYANOCOBALAMIN 4.5 ug Inactive Ingredients Ingredient Name Strength SODIUM CITRATE   CHOLECALCIFEROL   CYANOCOBALAMIN   FD&C BLUE NO. 1   FOLIC ACID   GELATIN   STARCH, CORN   MAGNESIUM STEARATE   MANNITOL   NIACINAMIDE   POVIDONE   PYRIDOXINE   GRAPE   RIBOFLAVIN   SILICON DIOXIDE   SODIUM ASCORBATE   THIAMINE   VITAMIN A ACETATE   ALPHA-TOCOPHEROL ACETATE   D&C RED NO. 7   ASCORBIC ACID   SUCRALOSE   BUTYLATED HYDROXYTOLUENE   CITRIC ACID MONOHYDRATE   .ALPHA.-TOCOPHEROL, DL-   MALTODEXTRIN   MEDIUM-CHAIN TRIGLYCERIDES   SUCROSE   GLYCERYL MONOSTEARATE   METHYLCELLULOSE (1500 CPS)   Product Characteristics Color PURPLE Score no score Shape ROUND (Biconvex) Size 13mm Flavor GRAPE Imprint Code BP;815 Contains          Packaging # NDC Package Description Multilevel Packaging 1 64376-815-01 100 TABLET In 1 BOTTLE None
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Unapproved drug other 09/06/2011
Labeler - Boca Pharmacal, Inc (170266089) Registrant - Boca Pharmacal, Inc (170266089) Establishment Name Address ID/FEI Operations Cispharma, Inc 833171445 MANUFACTURE Revised: 09/2011Boca Pharmacal, Inc

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Multi Vitamin with Fluoride

Dosage Form: tablet, chewable
Unknown Title

Multi-Vitamin With Fluoride Chewable Tablets
Rx Only

*Daily Value not established Supplement Facts Serving Size: 1 Chewable Tablet Amount Per Tablet % Daily Value Adults & children 4 years or more Vitamin A .................................. 2500 IU 50% Vitamin C ..................................... 60 mg 100% Vitamin D .................................... 400 IU 100% Vitamin E ...................................... 15 IU 50% Thiamin (B1) ............................ 1.05 mg 70% Riboflavin (B2) ........................... 1.2 mg 71% Niacin ....................................... 13.5 mg 68% Vitamin (B6) ............................. 1.05 mg 53% Folate ......................................... 0.3 mg 75% Vitamin B12 .............................. 4.5 mcg 75% Fluoride (as sodium fluoride) ... 0.25 mg *

Active ingredient for Caries Prophylaxis: Fluoride as Sodium Fluoride.

Other ingredients: Ascorbic acid, butylated hydroxyl toluene, cholecalciferol, citric acid, compressible sugar, DL-alpha Tocopherol, FD&C yellow #6 aluminum lake, folic acid, gelatin, magnesium stearate, maltodextrin, mannitol, medium chain triglycerides, methyl cellulose, mono- and di-glycerides, niacinamide, orange flavor, povidone, pyridoxine, riboflavin, silicon dioxide, sodium ascorbate, sodium citrate, starches, sucralose, thiamine, vitamin A acetate, vitamin B12 and vitamin E acetate.

CLINICAL PHARMACOLOGY

It is well established that fluoridation of the water supply (1 ppm fluoride) during the period of tooth development leads to a significant decrease in the incidence of dental caries.

Multi-vitamin with Fluoride Chewable Tablets provide sodium fluoride and ten essential vitamins in a chewable tablet. Because the tablets are chewable, they provide a topical as well as systemic source of fluoride.

Hydroxyapatite is the principal crystal for all calcified tissue in the human body. The fluoride ion reacts with the hydroxyapatite in the tooth as it is formed to produce the more caries-resistant crystal, fluorapatite. The reaction may be expressed by the equation:

Ca10(PO4)6(OH)2 + 2F-  —————> Ca10(PO4)6F2 + 2OH-

(Hydroxyapatite)                                   (Fluorapatite)

Three stages of fluoride deposition in tooth enamel can be distinguished:

1. Small amounts (reflecting the low levels of fluoride in tissue fluids) are incorporated into the enamel crystals while they are being formed.

2. After enamel has been laid down, fluoride deposition continues in the surface enamel. Diffusion of fluoride from the surface inward is apparently restricted.

3. After eruption, the surface enamel acquires fluoride from the water, food, supplementary fluoride and smaller amounts from saliva.

INDICATIONS AND USAGE

Supplementation of the diet with ten essential vitamins.

Supplementation of the diet with fluoride for caries prophylaxis.

See Dosage and Administration.

Multi-vitamin with Fluoride Chewable Tablets supply significant amounts of Vitamins A, C, D, E, thiamin, riboflavin, niacin, vitamin B6, vitamin B12, and folate to supplement the diet, and to help assure that nutritional deficiencies of these vitamins will not develop. Thus, in a single easy-to-use preparation, children obtain ten essential vitamins and the important mineral, fluoride.

The American Academy of Pediatrics recommends that children up to age 16, in areas where drinking water contains less than optimal levels of fluoride, receive daily fluoride supplementation.

Children using Multi-vitamin with fluoride Chewable Tablets regularly should receive semiannual dental examinations. The regular brushing of teeth and attention to good oral hygiene practices are also essential.

WARNINGS

As in the case of all medications, keep out of the reach of children.

Should be chewed. This product, as all chewable tablets, is not recommended for children under age 4 due to risk of choking.

PRECAUTIONS

The suggested dose of Multi-vitamin with Fluoride Chewable Tablets should not be exceeded, since dental fluorosis may result from continued ingestion of large amounts of fluoride.

Before prescribing Multi-vitamin with Fluoride Chewable Tablets, read these Important Considerations When Using Dosage Schedule found in Dosage and Administration.

If fluoride level is unknown, drinking water should be tested for fluoride content before supplements are prescribed. For testing of fluoride content, contact the local or state health department. All sources of fluoride should be evaluated with a thorough fluoride history. Patient exposure to multiple water sources can make proper prescribing complex. Ingestion of higher than recommended levels of fluoride by children has been associated with an increase in mild dental fluorosis in developing, unerupted teeth. Fluoride supplements require long-term compliance on a daily basis. ADVERSE REACTIONS

Allergic rash and other idiosyncrasies have been rarely reported.

DOSAGE AND ADMINISTRATION *1.0 ppm = 1 mg / liter **2.2 mg Sodium Fluoride contains 1mg fluoride ion. Fluoride Ion Level in Drinking Water (ppm)* AGE <0.3 ppm 0.3-0.6 ppm >0.6 ppm 4-6 years 0.50 mg / day**(2 tablets) 0.25 mg / day(1 tablet) None 6-16 years 1.0 mg / day(4 tablets) 0.50 mg / day(2 tablets) None HOW SUPPLIED

Multi-vitamin 1 mg Sodium Fluoride Tablets: grape flavored, round, purple, debossed “BP 815”, available in 100 ct. bottle, NDC 64376-815-01.

Multi-vitamin 0.5 mg Sodium Fluoride Tablets: cherry flavored, square, red, debossed “BP 814”, available in 100 ct. bottle, NDC 64376-814-01.

Multi-vitamin 0.25 mg Sodium Fluoride Tablets: orange flavored, round, orange, debossed “BP 813”, available in 100 ct. bottle, NDC 64376-813-01.

Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C -30°C (59°-86°F) [See USP Controlled Room Temperature].

Manufactured for: Boca Pharmacal, Inc.
Coral Springs, FL 33065 www.bocapharmacal.com

1-800-354-8460 Iss. 08/11

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

[Rev 18]

MULTI-VITAMIN WITH FLUORIDE 
vitamin a, vitamin d, thiamine, riboflavin, niacin, pyridoxine, folic acid, fluoride ion, ascorbic acid, .alpha.-tocopherol-acetate-dl, cyanocobalamin  tablet, chewable Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 64376-813 Route of Administration ORAL DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength VITAMIN A (VITAMIN A) VITAMIN A 2500 [iU] VITAMIN D (VITAMIN D) VITAMIN D 400 [iU] THIAMINE (THIAMINE) THIAMINE 1.05 mg RIBOFLAVIN (RIBOFLAVIN) RIBOFLAVIN 1.2 mg NIACIN (NIACIN) NIACIN 13.5 mg PYRIDOXINE (PYRIDOXINE) PYRIDOXINE 1.05 mg FOLIC ACID (FOLIC ACID) FOLIC ACID 0.3 mg FLUORIDE ION (FLUORIDE ION) FLUORIDE ION 0.25 mg ASCORBIC ACID (ASCORBIC ACID) ASCORBIC ACID 60 mg .ALPHA.-TOCOPHEROL ACETATE, DL- (.ALPHA.-TOCOPHEROL ACETATE, DL-) .ALPHA.-TOCOPHEROL ACETATE, DL- 15 [iU] CYANOCOBALAMIN (CYANOCOBALAMIN) CYANOCOBALAMIN 4.5 ug Inactive Ingredients Ingredient Name Strength MALTODEXTRIN   CHOLECALCIFEROL   CYANOCOBALAMIN   FD&C YELLOW NO. 6   FOLIC ACID   GELATIN   MEDIUM-CHAIN TRIGLYCERIDES   MAGNESIUM STEARATE   MANNITOL   NIACINAMIDE   POVIDONE   .ALPHA.-TOCOPHEROL ACETATE   .ALPHA.-TOCOPHEROL, DL-   RIBOFLAVIN   SILICON DIOXIDE   CITRIC ACID MONOHYDRATE   THIAMINE   VITAMIN A ACETATE   ASCORBIC ACID   GLYCERYL MONOSTEARATE   BUTYLATED HYDROXYTOLUENE   SUCROSE   PYRIDOXINE   SODIUM ASCORBATE   SODIUM CITRATE   STARCH, CORN   SUCRALOSE   ORANGE   CELLULOSE, MICROCRYSTALLINE   Product Characteristics Color ORANGE Score no score Shape ROUND (Flat) Size 13mm Flavor ORANGE Imprint Code BP;813 Contains          Packaging # NDC Package Description Multilevel Packaging 1 64376-813-01 100 TABLET In 1 BOTTLE None
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Unapproved drug other 12/28/2011
Labeler - Boca Pharmacal, Inc (170266089) Registrant - Boca Pharmacal, Inc (170266089) Establishment Name Address ID/FEI Operations Cispharma, Inc 833171445 MANUFACTURE Revised: 01/2012Boca Pharmacal, Inc

Read More:

PreNexa

ascorbic acid, tribasic calcium phosphate, ferrous fumarate, cholecalciferol, alpha-tocopherol, pyridoxine hydrochloride, folic acid, doconexent and docusate sodium
Dosage Form: capsule, gelatin coated
PreNexa® Capsules

Rx only

Rx Prenatal Vitamin with plant-Based DHA

1.2 mg Folic Acid and 300 mg DHA (key omega-3 fatty acid) Essential vitamins and minerals Gentle stool softener PreNexa Description

PreNexa® Capsules are a prescription prenatal/postnatal multivitamin/mineral softgel capsule with plant-based DHA. Each softgel capsule is brown in color, opaque, and imprinted with "PreNexa".

Each softgel capsule contains:

Vitamin C (ascorbic acid, USP) 28 mg Calcium (tribasic calcium phosphate, NF) 160 mg Iron (ferrous fumarate, USP) 26 mg Vitamin D3 (cholecalciferol, USP) 400 IU Vitamin E (d-alpha tocopherol, USP) 30 IU Vitamin B6 (pyridoxine hydrochloride, USP) 25 mg Folic Acid, USP 1.2 mg DHA (docosahexaenoic acid, contained in the oil derived from microalgae) 300 mg Docusate Sodium, USP 55 mg

Inactive Ingredients: Ethyl vanillin, FD&C blue #1, FD&C red #40, FD&C yellow #6, gelatin, glycerin, lecithin, palm kernel oil, sodium benzoate, soybean oil, sunflower oil, titanium dioxide, yellow beeswax, water and white ink (ammonium hydroxide, isopropyl alcohol, n-butyl alcohol, propylene glycol, shellac glaze in SD-45 alcohol, simethicone, titanium dioxide).

Contains: Soy

INDICATIONS

PreNexa® Capsules are indicated to provide vitamin/mineral and plant-based DHA supplementation throughout pregnancy, during the postnatal period for both lactating and non-lactating mothers, and throughout the childbearing years. PreNexa® may be useful in improving the nutritional status of women prior to conception.

Contraindications

PreNexa® Capsules are contraindicated in patients with a known hypersensitivity to any of the ingredients. Do not take this product if you are presently taking mineral oil, unless directed by a doctor.

WARNING

Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. KEEP THIS PRODUCT OUT OF THE REACH OF CHILDREN. In case of accidental overdose, call a doctor or poison control center immediately.

Warning

Ingestion of more than 3 grams of omega-3 fatty acids (such as DHA) per day has been shown to have potential antithrombotic effects, including an increased bleeding time and International Normalized Ratio (INR). Administration of omega-3 fatty acids should be avoided in patients taking anticoagulants and in those known to have an inherited or acquired predisposition to bleeding.

PRECAUTION

Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B12 is deficient. Folic acid in doses above 1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress.

Adverse Reactions

Allergic sensitization has been reported following both oral and parenteral administration of folic acid.

CAUTION

Exercise caution to ensure that the prescribed dosage of DHA does not exceed 1 gram (1000 mg) per day.

PreNexa Dosage and Administration

Before, during and/or after pregnancy, one softgel capsule daily or as directed by a physician.

How is PreNexa Supplied

Bottles of 30 softgel capsules (NDC 0245-0177-30).

KEEP THIS AND ALL DRUGS OUT OF REACH OF CHILDREN.

Store at 20-25°C (68-77°F). [See USP Controlled Room Temperature.]

Distributed by:
UPSHER-SMITH LABORATORIES, INC.
Minneapolis, MN 55447
MADE IN CANADA

1-800-654-2299 www.upsher-smith.com
US Patents 5,407,957; 5,492,938; 6,977,167. Other US Patents Pending.

104067-01
Revised 0110

PRINCIPAL DISPLAY PANEL - Capsule Label

Newly
Formulated

NDC 0245-0177-30
Rx ONLY

DAILY-CAPSULE
PreNexa®
Rx PRENATAL VITAMIN WITH PLANT-BASED DHA

ONCE-DAILY
DHA
PLANT-BASED

ESSENTIAL VITAMINS,
MINERALS AND DHA
WITH A GENTLE
STOOL SOFTENER

30 SOFTGEL CAPSULES

UPSHER-SMITH

PreNexa 
ascorbic acid, tribasic calcium phosphate, ferrous fumarate, cholecalciferol, alpha tocopherol, pyridoxine hydrochloride, folic acid, doconexent, and docusate sodium  capsule, gelatin coated Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0245-0177 Route of Administration ORAL DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Ascorbic Acid (Ascorbic Acid) Ascorbic Acid 28 mg tribasic calcium phosphate (calcium cation) tribasic calcium phosphate 160 mg ferrous fumarate (iron) ferrous fumarate 26 mg cholecalciferol (cholecalciferol) cholecalciferol 400 [iU] alpha-tocopherol (alpha-tocopherol) alpha-tocopherol 30 [iU] pyridoxine hydrochloride (pyridoxine) pyridoxine hydrochloride 25 mg folic acid (folic acid) folic acid 1.2 mg doconexent (doconexent) doconexent 300 mg docusate sodium (docusate) docusate sodium 55 mg Inactive Ingredients Ingredient Name Strength ethyl vanillin   FD&C BLUE NO. 1   FD&C RED NO. 40   FD&C YELLOW NO. 6   gelatin   glycerin   lecithin, soybean   palm kernel oil   sodium benzoate   soybean oil   sunflower oil   titanium dioxide   wax, yellow   water   ammonia   isopropyl alcohol   butyl alcohol   propylene glycol   DIMETHICONE   Product Characteristics Color BROWN Score no score Shape CAPSULE Size 24mm Flavor Imprint Code PreNexa Contains          Packaging # NDC Package Description Multilevel Packaging 1 0245-0177-66 5 BLISTER PACK In 1 CARTON contains a BLISTER PACK 1 1 CAPSULE In 1 BLISTER PACK This package is contained within the CARTON (0245-0177-66) 2 0245-0177-30 30 CAPSULE In 1 BOTTLE None
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date UNAPPROVED DRUG OTHER 01/27/2010
Labeler - Upsher-Smith Laboratories, Inc. (047251004) Establishment Name Address ID/FEI Operations Upsher-Smith Laboratories, Inc. 047251004 ANALYSIS Establishment Name Address ID/FEI Operations Accucaps Industries Limited 248441727 ANALYSIS, MANUFACTURE Revised: 11/2009Upsher-Smith Laboratories, Inc. More PreNexa resources PreNexa Side Effects (in more detail) PreNexa Use in Pregnancy & Breastfeeding PreNexa Drug Interactions PreNexa Support Group 2 Reviews for PreNexa - Add your own review/rating PreNexa Concise Consumer Information (Cerner Multum) PreNexa MedFacts Consumer Leaflet (Wolters Kluwer) Cal-Nate MedFacts Consumer Leaflet (Wolters Kluwer) CareNatal DHA MedFacts Consumer Leaflet (Wolters Kluwer) CitraNatal 90 DHA MedFacts Consumer Leaflet (Wolters Kluwer) Duet DHA with Ferrazone MedFacts Consumer Leaflet (Wolters Kluwer) Folbecal MedFacts Consumer Leaflet (Wolters Kluwer) Gesticare DHA MedFacts Consumer Leaflet (Wolters Kluwer) MultiNatal Plus MedFacts Consumer Leaflet (Wolters Kluwer) Multifol Plus Concise Consumer Information (Cerner Multum) Neevo Caplets MedFacts Consumer Leaflet (Wolters Kluwer) Neevo DHA MedFacts Consumer Leaflet (Wolters Kluwer) OB Complete 400 MedFacts Consumer Leaflet (Wolters Kluwer) Prenate Elite tablets Prenate Elite MedFacts Consumer Leaflet (Wolters Kluwer) PrimaCare Advantage MedFacts Consumer Leaflet (Wolters Kluwer) PrimaCare ONE capsules PrimaCare One MedFacts Consumer Leaflet (Wolters Kluwer) Se-Natal 19 Chewable Tablets MedFacts Consumer Leaflet (Wolters Kluwer) Triveen-One MedFacts Consumer Leaflet (Wolters Kluwer) Ultra NatalCare MedFacts Consumer Leaflet (Wolters Kluwer) Vitafol-One MedFacts Consumer Leaflet (Wolters Kluwer) Compare PreNexa with other medications Vitamin/Mineral Supplementation during Pregnancy/Lactation

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Zatean-CH

calcium citrate, iron, cholecalciferol, .alpha.-tocopherol acetate, dl-, pyridoxine hydrochloride, folic acid, docusate sodium and doconexent
Dosage Form: capsule
Zatean™-CH
Softgel Capsule

Rx Only

Zatean-CH Description

Zatean™-CH is an orally administered prenatal prescription vitamin. Zatean™-CH is a purple, oblong soft gelatin capsule imprinted with "T583".

Each capsule contains the following Ingredients: * Folates– including reduced folates, are variant forms of Vitamin B9, or Folic Acid. † Derived from at least 281.7 mg omega-3s from at least 396.8 mg purified fish oil. Calcium (Calcium citrate) 100 mg Iron (Carbonyl iron) 27 mg Vitamin D3 (Cholecalciferol) 400 IU Vitamin E (dl-alpha tocopheryl acetate) 30 IU Vitamin B6 (Pyridoxine HCl) 25 mg Folate* 1 mg Docusate Sodium 50 mg Docosahexaenoic Acid (DHA) 250 mg† Inactive Ingredients

Lecithin, Soybean Oil, Yellow Beeswax, Natural Creamy Orange Flavor, Gelatin, Glycerin, Titanium Dioxide, FD&C Red #40, FD&C Blue #1, Ethyl Vanillin, Purified Water, and other trace excipients.

INDICATIONS

Zatean™-CH is a multivitamin/mineral prescription drug indicated for use in improving the nutritional status of women prior to conception, throughout pregnancy, and in the postnatal period for both lactating and nonlactating mothers.

Contraindications

This product is contraindicated in patients with a known hypersensitivity to any of the ingredients, including fish or fish oil.

Warnings

Daily ingestion of more than 3 g per day of omega-3 fatty acids (ALA, EPA, and DHA) from fish oils may have potential antithrombotic activities, or effects, and may increase bleeding times. Administration of omega-3 fatty acids - including DHA, should be avoided in patients with inherited or acquired bleeding diatheses, including those taking anticoagulants.

WARNING

Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of reach of children. In case of accidental overdose, call a doctor or poison control center immediately.

This product contains fish oil and soy products.

CAUTION

Exercise caution to ensure that the prescribed dosage of DHA does not exceed 1 gram (1000 mg) per day.

Precautions General

Folates (including folic acid and reduced folates), when administered as a single agent in doses above 0.1 mg daily, may obscure the detection of B12 deficiency (specifically, the administration of folic acid may reverse the hematological manifestations of B12 deficiency, including pernicious anemia, while not addressing the neurological manifestations). Reduced folates may be less likely than folic acid to mask vitamin B12 deficiency. Folate therapy alone is inadequate for the treatment of B12 deficiency.

PATIENT INFORMATION

Zatean™-CH is a prescription prenatal vitamin for use only under medical supervision and direction.

INTERACTIONS Drugs which may interact with folate include First generation anticonvulsants: High dose folic acid may result in decreased serum levels for first generation anticonvulsants (carbamazepine, fosphenytoin, phenytoin, phenobarbital, primidone, valproic acid, valproate). This may possibly reduce the effectiveness of first generation anticonvulsants and/or increase the frequency of seizures in susceptible patients. Caution should be used when prescribing folates among patients who are receiving treatment with first generation anticonvulsants. Second-generation anticonvulsants: Information on the effect of second-generation anticonvulsants (including, but not limited to, lamotrigine) on folate levels is limited and cannot be ruled out. Capecitabine: Folinic acid (5-formyltetrahydrofolate) may increase the toxicity of capecitabine. Cholestyramine: Reduces folic acid absorption and reduces serum folate levels. Colestipol: Reduces folic acid absorption and reduces serum folate levels. Colchicine: Colchicine may decrease folate plasma levels. L-dopa: L-dopa may decrease folate plasma levels. Cycloserine: Reduces folic acid absorption and reduces serum folate levels. Dihydrofolate Reductase Inhibitors (DHFRI): DHFRIs block the conversion of folic acid to its active forms, and lower plasma and red blood cell folate levels. DHFRIs include aminopterin, methotrexate, pyrimethamine, triamterene, and trimethoprim. Caution should be exercised when using folate with folate antagonists. Patients, typically, should not be given folate simultaneously with a folate antagonist, for the purpose of reducing or preventing clinical toxicity, as the therapeutic effect of the antagonist may be nullified. Fluoxetine: Fluoxetine exerts a noncompetitive inhibition of the 5-methyltetrahydrofolate active transport in the intestine. Isotretinoin: Reduced folate levels have occurred in some patients taking isotretinoin. Nonsteroidal Anti-inflammatory Drugs (NSAIDs): NSAIDs have been shown to inhibit some folate dependent enzymes in laboratory experiments. NSAIDs include ibuprofen, naproxen, indomethacin and sulindac. Oral Contraceptives: Serum folate levels may be depressed by oral contraceptive therapy. Methylprednisolone: Reduced serum folate levels have been noted after treatment with methylprednisolone. Pancreatic Enzymes, including, but not limited to pancreatin and pancrelipase: Reduced folate levels have occurred in some patients taking pancreatic extracts. Pentamidine: Reduced folate levels have been seen with prolonged intravenous pentamidine. Smoking and Alcohol: Reduced serum folate levels have been noted. Sulfasalazine: Inhibits the absorption and metabolism of folic acid. Metformin treatment in patients with type 2 diabetes decreases serum folate. Warfarin can produce significant impairment in folate status after a 6-month therapy. Folate may enhance the toxicity of fluorouracil. Concurrent administration of chloramphenicol and folate in folate-deficient patients may result in antagonism of the haematopoietic response to folate. Caution should be exercised with the concomitant use of folate and trimethoprim-sulfamethoxazole for the acute treatment of Pneumocystis carinii pneumonia in patients with HIV infection as it is associated with increased rates of treatment failure and mortality in a placebo controlled study. Drugs which may interact with pyridoxine hydrochloride include

Pyridoxine hydrochloride should not be given to patients receiving the drug levodopa, because the action of levodopa is antagonized by pyridoxine hydrochloride. However, pyridoxine hydrochloride may be used concurrently in patients receiving a preparation containing both carbidopa and levodopa.

Adverse Reactions

Allergic sensitization has been reported following both oral and parenteral administration of folic acid, as well as possibly the use of other forms of folates - including reduced folates.

Zatean-CH Dosage and Administration

One capsule daily or as directed by a physician.

How is Zatean-CH Supplied

Zatean™-CH is supplied in bottles of 30 capsules each.

NDC 13811-583-30

STORAGE

Store at controlled room temperature 15°-30°C (59°-86°F). [See USP]. Contact with moisture can discolor or erode the capsule.

Call your doctor about side effects. You may report side effects by calling 888 9 TRIGEN (888-987-4436).

KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN.

All prescriptions using this product shall be pursuant to state statutes as applicable. This is not an Orange Book product. There are no implied or explicit claims on therapeutic equivalence.

Rx Only

Manufactured For:
TRIGEN Laboratories, Inc., Sayreville, NJ 08872
www.trigenlab.com

MADE IN CANADA

Rev. 10/10

PRINCIPAL DISPLAY PANEL - 30 Capsule Bottle Label

NDC 13811-583-30

Rx Only

Zatean™-CH
Softgel Capsule

30 CAPSULES

TRIGEN
LABORATORIES

Zatean-CH 
calcium citrate, iron, cholecalciferol, .alpha.-tocopherol acetate, dl-, pyridoxine hydrochloride, folic acid, docusate sodium, and doconexent  capsule Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 13811-583 Route of Administration ORAL DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Calcium Citrate (Calcium Cation) Calcium Citrate 100 mg Iron (Iron) Iron 27 mg Cholecalciferol (Cholecalciferol) Cholecalciferol 400 [iU] .Alpha.-Tocopherol Acetate, DL- (.Alpha.-Tocopherol Acetate, DL-) .Alpha.-Tocopherol Acetate, DL- 30 [iU] Pyridoxine Hydrochloride (Pyridoxine) Pyridoxine Hydrochloride 25 mg Folic Acid (Folic Acid) Folic Acid 1 mg Docusate Sodium (Docusate) Docusate Sodium 50 mg Doconexent (Doconexent) Doconexent 250 mg Inactive Ingredients Ingredient Name Strength Soybean Oil   Yellow Wax   Gelatin   Glycerin   Titanium Dioxide   FD&C Red No. 40   FD&C Blue No. 1   Ethyl Vanillin   Water   Product Characteristics Color PURPLE Score no score Shape CAPSULE (oblong) Size 25mm Flavor ORANGE (Creamy Orange) Imprint Code T583 Contains          Packaging # NDC Package Description Multilevel Packaging 1 13811-583-30 30 CAPSULE In 1 BOTTLE None
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Unapproved drug other 11/01/2010
Labeler - TRIGEN Laboratories, Inc. (830479668) Revised: 09/2011TRIGEN Laboratories, Inc. More Zatean-CH resources Zatean-CH Side Effects (in more detail) Zatean-CH Use in Pregnancy & Breastfeeding Zatean-CH Drug Interactions Zatean-CH Support Group 0 Reviews for Zatean-CH - Add your own review/rating Zatean-CH Concise Consumer Information (Cerner Multum) Cal-Nate MedFacts Consumer Leaflet (Wolters Kluwer) CareNatal DHA MedFacts Consumer Leaflet (Wolters Kluwer) CitraNatal 90 DHA MedFacts Consumer Leaflet (Wolters Kluwer) Duet DHA with Ferrazone MedFacts Consumer Leaflet (Wolters Kluwer) Folbecal MedFacts Consumer Leaflet (Wolters Kluwer) Gesticare DHA MedFacts Consumer Leaflet (Wolters Kluwer) MultiNatal Plus MedFacts Consumer Leaflet (Wolters Kluwer) Multifol Plus Concise Consumer Information (Cerner Multum) Neevo Caplets MedFacts Consumer Leaflet (Wolters Kluwer) Neevo DHA MedFacts Consumer Leaflet (Wolters Kluwer) OB Complete 400 MedFacts Consumer Leaflet (Wolters Kluwer) PreNexa MedFacts Consumer Leaflet (Wolters Kluwer) Prenate Elite tablets Prenate Elite MedFacts Consumer Leaflet (Wolters Kluwer) PrimaCare Advantage MedFacts Consumer Leaflet (Wolters Kluwer) PrimaCare ONE capsules PrimaCare One MedFacts Consumer Leaflet (Wolters Kluwer) Se-Natal 19 Chewable Tablets MedFacts Consumer Leaflet (Wolters Kluwer) Triveen-One MedFacts Consumer Leaflet (Wolters Kluwer) Ultra NatalCare MedFacts Consumer Leaflet (Wolters Kluwer) Vitafol-One MedFacts Consumer Leaflet (Wolters Kluwer) Compare Zatean-CH with other medications Vitamin/Mineral Supplementation during Pregnancy/Lactation

Read More:

Inatal Ultra

prenatal multivitamin
Dosage Form: tablet, coated
Inatal Ultra

Prenatal Multivitamin/
Multimineral Tablets
63044-154-63

Rx Only

WARNING: Accidental overdose of iron-containing prod-Ucts is a leading cause of fatal poisoning in children under 6. Keep this product out of the reach of children. In case of accidental overdose, call a doctor or poison control center immediately. DESCRIPTION:

Inatal Ultra is a white, dye free, oval oil-and-water-soluble multivitamin/multimineral tablet with calcium citrate and carbonyl iron.

Each tablet contains:

Vitamin A* . . . . . . . . . . . . . . . . . . . . . . . 2700 I.U.

Vitamin C (Ascorbic Acid) . . . . . . . . . . . . . . 120 mg

Calcium (Calcium Citrate) . . . . . . . . . . . . . 200 mg

Elemental Iron (Carbonyl Iron) . . . . . . . . . . . 90 mg

Vitamin D3 (Cholecalciferol) . . . . . . . . . . . . 400 I.U.

Vitamin E (dl-Alpha Tocopheryl Acetate) . . . . . 30 I.U.

Vitamin B1 (Thiamine Mononitrate) . . . . . . . . . 3 mg

Vitamin B2 (Riboflavin) . . . . . . . . . . . . . . . . 3.4 mg

Niacinamide . . . . . . . . . . . . . . . . . . . . . . . . 20 mg

Vitamin B6 (Pyridoxine HCI) . . . . . . . . . . . . . 20 mg

Folic Acid . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 mg

Vitamin B12 (Cyanocobalamin) . . . . . . . . . . 12 mcg

Iodine (Potassium Iodide) . . . . . . . . . . . . . 150 mcg

Zinc (Zinc Oxide) . . . . . . . . . . . . . . . . . . . . . 25 mg

Copper (Cupric Oxide) . . . . . . . . . . . . . . . . . 2 mg

Docusate Sodium . . . . . . . . . . . . . . . . . . . . 50 mg

*Input as Vitamin A palmitate and beta carotene.

INDICATIONS:

Inatal Ultra ® is a multivitamin/multimineral nutritional supplement indicated for use in improving the nutritional status of women throughout pregnancy and in the postnatal period for both lactating and nonlactating mothers. Ultra NatalCare® can also be beneficial in improving the nutritional status of women prior to conception.

CONTRAINDICATIONS:

This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.

WARNINGS:

Folic Acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B12 is deficient.

NOTICE: Contact with moisture may produce surface discoloration or erosion of the tablet.

PRECAUTIONS:

Folic acid in doses above 0.1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress.

ADVERSE REACTIONS:

Allergic sensitization has been reported following both oral and parenteral administration of folic acid.

PEDIATRIC USE:

Safety and effectiveness in pediatric patients have not been established.

GERIATRIC USE:

Clinical studies on this product have not been performed in sufficient numbers of subjects aged 65 and over to determine whether elderly subjects respond differently from younger subjects. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy.

DOSAGE AND ADMINISTRATION:

One tablet daily or as directed by a physician.

HOW SUPPLIED:

NDC 63044-154-63 Unit Dose Packs containing 10 tablets per card.

Store at controlled room temperature 15°-30°C (59°-86°F).

KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN.

Manufactured for
Nnodum Pharmaceutical
Cincinnati, Ohio 45229

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Inatal Ultra 
Inatal Ultra  tablet, coated Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 63044-154 Route of Administration ORAL DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength VITAMIN A (VITAMIN A) VITAMIN A 2700 [iU] ASCORBIC ACID (ASCORBIC ACID) ASCORBIC ACID 120 mg CALCIUM CITRATE (CALCIUM) CALCIUM CITRATE 200 mg IRON PENTACARBONYL (IRON) IRON PENTACARBONYL 90 mg CHOLECALCIFEROL (CHOLECALCIFEROL) CHOLECALCIFEROL 400 [iU] ALPHA-TOCOPHEROL ACETATE (ALPHA-TOCOPHEROL) ALPHA-TOCOPHEROL ACETATE 30 [iU] THIAMINE MONONITRATE (THIAMINE) THIAMINE MONONITRATE 3 mg RIBOFLAVIN (RIBOFLAVIN) RIBOFLAVIN 3.4 mg NIACINAMIDE (NIACINAMIDE) NIACINAMIDE 20 mg PYRIDOXINE HYDROCHLORIDE (PYRIDOXINE) PYRIDOXINE HYDROCHLORIDE 20 mg FOLIC ACID (FOLIC ACID) FOLIC ACID 1 mg CYANOCOBALAMIN (CYANOCOBALAMIN) CYANOCOBALAMIN 12 ug POTASSIUM IODIDE (POTASSIUM CATION) POTASSIUM IODIDE 150 ug ZINC OXIDE (ZINC) ZINC OXIDE 25 mg CUPRIC OXIDE (COPPER) CUPRIC OXIDE 2 mg DOCUSATE SODIUM (DOCUSATE) DOCUSATE SODIUM 50 mg Inactive Ingredients Ingredient Name Strength CROSCARMELLOSE SODIUM   MAGNESIUM STEARATE   POLYETHYLENE GLYCOL   CELLULOSE, MICROCRYSTALLINE   MINERAL OIL   SODIUM LAURYL SULFATE   STEARIC ACID   TITANIUM DIOXIDE   VANILLIN   Product Characteristics Color WHITE (dye-free) Score 2 pieces Shape OVAL Size 10mm Flavor Imprint Code cpc43 Contains          Packaging # NDC Package Description Multilevel Packaging 1 63044-154-63 10 BLISTER PACK In 1 BOX, UNIT-DOSE contains a BLISTER PACK 1 10 TABLET In 1 BLISTER PACK This package is contained within the BOX, UNIT-DOSE (63044-154-63) 2 63044-154-01 100 TABLET In 1 BOTTLE None
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Unapproved drug other 06/20/2005
Labeler - Nnodum Pharmaceuticals (960457273) Revised: 10/2009Nnodum Pharmaceuticals
More Inatal Ultra resources Inatal Ultra Side Effects (in more detail) Inatal Ultra Dosage Inatal Ultra Use in Pregnancy & Breastfeeding Inatal Ultra Drug Interactions Inatal Ultra Support Group 0 Reviews for Inatal Ultra - Add your own review/rating Inatal Ultra Concise Consumer Information (Cerner Multum) Cal-Nate MedFacts Consumer Leaflet (Wolters Kluwer) CareNatal DHA MedFacts Consumer Leaflet (Wolters Kluwer) CitraNatal 90 DHA MedFacts Consumer Leaflet (Wolters Kluwer) Duet DHA with Ferrazone MedFacts Consumer Leaflet (Wolters Kluwer) Folbecal MedFacts Consumer Leaflet (Wolters Kluwer) Gesticare DHA MedFacts Consumer Leaflet (Wolters Kluwer) MultiNatal Plus MedFacts Consumer Leaflet (Wolters Kluwer) Multifol Plus Concise Consumer Information (Cerner Multum) Neevo Caplets MedFacts Consumer Leaflet (Wolters Kluwer) Neevo DHA MedFacts Consumer Leaflet (Wolters Kluwer) OB Complete 400 MedFacts Consumer Leaflet (Wolters Kluwer) PreNexa MedFacts Consumer Leaflet (Wolters Kluwer) Prenate Elite tablets Prenate Elite MedFacts Consumer Leaflet (Wolters Kluwer) PrimaCare Advantage MedFacts Consumer Leaflet (Wolters Kluwer) PrimaCare ONE capsules PrimaCare One MedFacts Consumer Leaflet (Wolters Kluwer) Se-Natal 19 Chewable Tablets MedFacts Consumer Leaflet (Wolters Kluwer) Triveen-One MedFacts Consumer Leaflet (Wolters Kluwer) Ultra NatalCare MedFacts Consumer Leaflet (Wolters Kluwer) Vitafol-One MedFacts Consumer Leaflet (Wolters Kluwer) Compare Inatal Ultra with other medications Vitamin/Mineral Supplementation during Pregnancy/Lactation

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Vitamin B Complex/Vitamin C/Vitamin D/Biotin/Folic Acid/Zinc

Pronunciation: VYE-ta-min B/VYE-ta-min C/VYE-ta-min D/BYE-oh-tin/FOE-lik AS-id/zink
Generic Name: Vitamin B Complex/Vitamin C/Vitamin D/Biotin/Folic Acid/Zinc
Brand Name: Vital-D Rx
Vitamin B Complex/Vitamin C/Vitamin D/Biotin/Folic Acid/Zinc is used for:

Treating or preventing a lack of certain vitamins, folic acid, or zinc. It may also be used for other conditions as determined by your doctor.

Vitamin B Complex/Vitamin C/Vitamin D/Biotin/Folic Acid/Zinc is a vitamin, zinc, and folic acid combination. It works by providing vitamins, zinc, and folic acid to the body to help meet nutritional requirements.

Do NOT use Vitamin B Complex/Vitamin C/Vitamin D/Biotin/Folic Acid/Zinc if: you are allergic to any ingredient in Vitamin B Complex/Vitamin C/Vitamin D/Biotin/Folic Acid/Zinc

Contact your doctor or health care provider right away if any of these apply to you.

Before using Vitamin B Complex/Vitamin C/Vitamin D/Biotin/Folic Acid/Zinc:

Some medical conditions may interact with Vitamin B Complex/Vitamin C/Vitamin D/Biotin/Folic Acid/Zinc. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement if you have allergies to medicines, foods, or other substances (including soy) if you have anemia (eg, pernicious anemia)

Some MEDICINES MAY INTERACT with Vitamin B Complex/Vitamin C/Vitamin D/Biotin/Folic Acid/Zinc. Tell your health care provider if you are taking any other medicines, especially any of the following:

Fluorouracil because the risk of its side effects may be increased by Vitamin B Complex/Vitamin C/Vitamin D/Biotin/Folic Acid/Zinc Hydantoins (eg, phenytoin) because their effectiveness may be decreased by Vitamin B Complex/Vitamin C/Vitamin D/Biotin/Folic Acid/Zinc

This may not be a complete list of all interactions that may occur. Ask your health care provider if Vitamin B Complex/Vitamin C/Vitamin D/Biotin/Folic Acid/Zinc may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Vitamin B Complex/Vitamin C/Vitamin D/Biotin/Folic Acid/Zinc:

Use Vitamin B Complex/Vitamin C/Vitamin D/Biotin/Folic Acid/Zinc as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Take Vitamin B Complex/Vitamin C/Vitamin D/Biotin/Folic Acid/Zinc by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation. Take Vitamin B Complex/Vitamin C/Vitamin D/Biotin/Folic Acid/Zinc with a full glass of water (8 oz/240 mL) Many medicines (eg, used for infection, high blood pressure, immune, low blood platelet levels, osteoporosis, thyroid problems) should not be taken at the same time as Vitamin B Complex/Vitamin C/Vitamin D/Biotin/Folic Acid/Zinc; their effectiveness may be decreased. Ask your doctor or pharmacist if your dose of Vitamin B Complex/Vitamin C/Vitamin D/Biotin/Folic Acid/Zinc should be separated from your dose of any of your other medicines. If you miss a dose of Vitamin B Complex/Vitamin C/Vitamin D/Biotin/Folic Acid/Zinc, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Vitamin B Complex/Vitamin C/Vitamin D/Biotin/Folic Acid/Zinc.

Important safety information: Do NOT take more than the recommended dose without checking with your doctor. Do not take large doses of vitamins (megadoses or megavitamin therapy) while you use Vitamin B Complex/Vitamin C/Vitamin D/Biotin/Folic Acid/Zinc unless your doctor tells you to. Tell your doctor or dentist that you take Vitamin B Complex/Vitamin C/Vitamin D/Biotin/Folic Acid/Zinc before you receive any medical or dental care, emergency care, or surgery. Vitamin B Complex/Vitamin C/Vitamin D/Biotin/Folic Acid/Zinc has pyridoxine (vitamin B6) and folic acid in it. Before you start any medicine, check the label to see if it has pyridoxine or folic acid in it too. If it does or if you are not sure, check with your doctor or pharmacist. PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Vitamin B Complex/Vitamin C/Vitamin D/Biotin/Folic Acid/Zinc while you are pregnant. It is not known if Vitamin B Complex/Vitamin C/Vitamin D/Biotin/Folic Acid/Zinc is found in breast milk. If you are or will be breast-feeding while you are using Vitamin B Complex/Vitamin C/Vitamin D/Biotin/Folic Acid/Zinc, check with your doctor. Discuss any possible risks to your baby. Possible side effects of Vitamin B Complex/Vitamin C/Vitamin D/Biotin/Folic Acid/Zinc:

All medicines may cause side effects, but many people have no, or minor, side effects. No COMMON side effects have been reported with Vitamin B Complex/Vitamin C/Vitamin D/Biotin/Folic Acid/Zinc. Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue).

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include confusion; decreased coordination; mental or mood changes; numbness or tingling of the hands or feet.

Proper storage of Vitamin B Complex/Vitamin C/Vitamin D/Biotin/Folic Acid/Zinc:

Store Vitamin B Complex/Vitamin C/Vitamin D/Biotin/Folic Acid/Zinc at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Vitamin B Complex/Vitamin C/Vitamin D/Biotin/Folic Acid/Zinc out of the reach of children and away from pets.

General information: If you have any questions about Vitamin B Complex/Vitamin C/Vitamin D/Biotin/Folic Acid/Zinc, please talk with your doctor, pharmacist, or other health care provider. Vitamin B Complex/Vitamin C/Vitamin D/Biotin/Folic Acid/Zinc is to be used only by the patient for whom it is prescribed. Do not share it with other people. If your symptoms do not improve or if they become worse, check with your doctor. Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Vitamin B Complex/Vitamin C/Vitamin D/Biotin/Folic Acid/Zinc. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012 Database Edition 12.1.1.002 Copyright © 2012 Wolters Kluwer Health, Inc. More Vitamin B Complex/Vitamin C/Vitamin D/Biotin/Folic Acid/Zinc resources Vitamin B Complex/Vitamin C/Vitamin D/Biotin/Folic Acid/Zinc Use in Pregnancy & BreastfeedingVitamin B Complex/Vitamin C/Vitamin D/Biotin/Folic Acid/Zinc Drug InteractionsVitamin B Complex/Vitamin C/Vitamin D/Biotin/Folic Acid/Zinc Support Group4 Reviews for Vitamin B Complex/Vitamin C/Vitamin D/Biotin/Folic Acid/Zinc - Add your own review/rating Compare Vitamin B Complex/Vitamin C/Vitamin D/Biotin/Folic Acid/Zinc with other medications Vitamin/Mineral Supplementation and Deficiency

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Multi Vitamin Infusion Pediatric

Dosage Form: injection, powder, lyophilized, for solution
M.V.I. Pediatric®
Multi-Vitamin for Infusion

For dilution in intravenous

infusions only.

Rx only

Multi Vitamin Infusion Pediatric Description

M.V.I. Pediatric® is a lyophilized, sterile powder intended for reconstitution and dilution in intravenous infusions. Each 5 mL of reconstituted product provides:

Ascorbic acid (vitamin C)………………………………………………………………………80 mg

Vitamin A* (retinol)………………………………………………………………………..0.7 mg (a)

Ergocalciferol*

(vitamin D)………………………………………………………………………………10 mcg (b)

Thiamine (vitamin B1)

(as the hydrochloride)………………………………………………………………………..1.2 mg

Riboflavin (vitamin B2) (as riboflavin-

5-phosphate sodium)…………………………………………………………………………...1.4 mg

Pyridoxine (vitamin B6)

(as the hydrochloride)………………………………………………………………………….1 mg

Niacinamide…………………………………………………………………………………….17 mg

Dexpanthenol

(d-pantothenyl alcohol)………………………………………………………………………...5 mg

Vitamin E* (dl-alpha

tocopheryl acetate)…………………………………………………………………………7 mg (c)

Biotin…………………………………………………………………………………………..20 mcg

Folic acid……………………………………………………………………………………..140 mcg

Cyanocobalamin

(vitamin B12)………………………………………………………………………………….1 mcg

Phytonadione*

(vitamin K1)………………………………………………………………………………...200 mcg

with 375 mg mannitol; sodium hydroxide for pH adjustment; 50 mg polysorbate 80; 0.8 mg polysorbate 20; 58 mcg butylated hydroxytoluene; 14 mcg butylated hydroxyanisole.

*Oil-soluble vitamins A, D, E and K1 water-solubilized with polysorbate 80.

(a) 0.7 mg vitamin A equals 2,300 USP units.

(b) 10 mcg ergocalciferol equals 400 USP units.

(c) 7 mg vitamin E equals 7 USP units.

Multivitamin Formula for Intravenous Infusion: M.V.I. Pediatric® (Multi- Vitamin for Infusion) provides a combination of important oil-soluble and water-soluble vitamins, formulated especially for incorporation into intravenous infusions after reconstitution. Through special processing techniques, the liposoluble vitamins A, D, E and K1 have been water solubilized with polysorbate 80, permitting intravenous administration of these vitamins.

Indications and Usage for Multi Vitamin Infusion Pediatric

This formulation is indicated as daily multivitamin maintenance dosage for infants and children up to 11 years of age receiving parenteral nutrition.

It is also indicated in other situations where administration by the intravenous route is required. Such situations include surgery, extensive burns, fractures and other trauma, severe infectious diseases, and comatose states, which may provoke a "stress" situation with profound alterations in the body’s metabolic demands and consequent tissue depletion of nutrients.

The physician should not await the development of clinical signs of vitamin deficiency before initiating vitamin therapy.

M.V.I. Pediatric® (reconstituted and administered in intravenous fluids under proper dilution) contributes intake of these necessary vitamins toward maintaining the body’s normal resistance and repair processes.

Patients with multiple vitamin deficiencies or with markedly increased requirements may be given multiples of the daily dosage for two or more days as indicated by the clinical status. Blood vitamin concentrations should be monitored to ensure maintenance of adequate levels, particularly in patients receiving parenteral multivitamins as their sole source of vitamins for long periods of time.

Contraindications

Known hypersensitivity to any of the vitamins or excipients in this product or a pre-existing hypervitaminosis.

Allergic reaction has been known to occur following intravenous administration of thiamine and vitamin K. The formulation is contraindicated prior to blood sampling for detection of megaloblastic anemia, as the folic acid and cyanocobalamin in the vitamin solution can mask serum deficits.

Warnings

WARNING: This product contains aluminum that may be toxic. Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired. Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions, which contain aluminum.

Research indicates that patients with impaired kidney function, including premature neonates, who receive parenteral levels of aluminum at greater than 4 to 5 mcg/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration.

Precautions

General: Caution should be exercised when administering this multivitamin formulation to patients on warfarin sodium-type anticoagulant therapy. In such patients, vitamin K may antagonize the hypoprothrombinemic response to anticoagulant drugs. Therefore, periodic monitoring of prothrombin time is essential in determining the appropriate dosage of anticoagulant therapy.

Adequate blood levels of vitamin E are achieved when M.V.I. Pediatric® is given to infants at the recommended dosage. Larger doses or supplementation with oral or parenteral vitamin E are not recommended because elevated blood levels of vitamin E may result.

Studies have shown that vitamin A may adhere to plastic, resulting in inadequate vitamin A administration in the doses recommended with M.V.I. Pediatric®. Additional vitamin A supplementation may be required, especially in low birth weight infants.

Where long-standing specific vitamin deficiencies exist, it may be necessary to add therapeutic amounts of specific vitamins to supplement the maintenance vitamins provided in M.V.I. Pediatric®.

In patients receiving parenteral multivitamins, blood vitamin concentrations should be periodically monitored to determine if vitamin deficiencies or excesses are developing.

Polysorbates have been associated with the E -Ferol syndrome (thrombocytopenia, renal dysfunction, hepatomegaly, cholestasis, ascites, hypotension, and metabolic acidosis) in low birth weight infants.

M.V.I. Pediatric® should be aseptically transferred to the infusion fluid.

Drug-Drug Interactions

Physical Incompatibilities: M.V.I. Pediatric® is not physically compatible with alkaline solutions or moderately alkaline drugs such as Diamox (Acetazolamide), Diuril Intravenous Sodium (Chlorothiazide sodium), Aminophylline or sodium bicarbonate.

M.V.I. Pediatric® is not physically compatible with ampicillin and it may not be physically compatible with ACHROMYCIN (tetracycline HCl). It has also been reported that folic acid is unstable in the presence of calcium salts such as calcium gluconate. Direct addition of M.V.I. Pediatric® to intravenous fat emulsions is not recommended. Consult appropriate references for listings of physical compatibility of solutions and drugs with the vitamin infusion. In such circumstances, admixture or Y-site administration with vitamin solutions should be avoided.

Several vitamins have been reported to decrease the activity of certain antibiotics. Thiamine, riboflavin, pyridoxine, niacinamide, and ascorbic acid have been reported to decrease the antibiotic activity of erythromycin, kanamycin, streptomycin, doxycycline, and lincomycin. Bleomycin is inactivated in vitro by ascorbic acid and riboflavin.

Some of the vitamins in M.V.I. Pediatric® may react with vitamin K bisulfite or sodium bisulfite; if bisulfite solutions are necessary, patients should be monitored for vitamin A and thiamine deficiencies.

Clinical Interactions: A number of interactions between vitamins and drugs have been reported which may affect the metabolism of either agent. The following are examples of these types of interactions.

Folic acid may lower the serum concentration of phenytoin resulting in increased seizure frequency. Conversely, phenytoin may decrease serum folic acid concentrations and, therefore, should be avoided in pregnancy. Folic acid may decrease the patient's response to methotrexate therapy.

Pyridoxine may decrease the efficacy of levodopa by increasing its metabolism. Concomitant administration of hydralazine or isoniazid may increase pyridoxine requirements.

In patients with pernicious anemia, the hematologic response to vitamin B12 therapy may be inhibited by concomitant administration of chloramphenicol.

Vitamin K may antagonize the hypoprothrombinemic effect of oral anticoagulants (see bolded statement).

Consult appropriate references for additional specific vitamin-drug interactions.

Drug-Laboratory Test Interactions:

Ascorbic acid in the urine may cause false negative urine glucose determinations.

Carcinogenesis, Mutagenesis, and Impairment of Fertility:

Carcinogenicity studies have not been performed.

Adverse Reactions

There have been rare reports of anaphylactic reactions following parenteral multivitamin administration. Rare reports of anaphylactoid reactions have also been reported after large intravenous doses of thiamine. The risk, however, is negligible if thiamine is coadministered with other vitamins in the B group. There have been no reports of fatal anaphylactoid reactions associated with M.V.I. Pediatric®.

There have been rare reports of the following types of reactions:

Dermatologic - rash, erythema, pruritus

CNS - headache, dizziness, agitation, anxiety

Ophthalmic -diplopia

Allergic - urticaria, shortness of breath, wheezing, and angioedema

Overdosage

The possibility of hypervitaminosis A or D should be borne in mind. Clinical manifestations of hypervitaminosis A have been reported in patients with renal failure receiving 1.5 mg/day retinol. Therefore, vitamin A supplementation of renal failure patients should be undertaken with caution.

Multi Vitamin Infusion Pediatric Dosage and Administration

The single dose vial of M.V.I. Pediatric® is reconstituted by adding 5 mL of Sterile Water for Injection USP, Dextrose Injection USP 5%, or Sodium Chloride Injection to the 10 mL vial.

The vial may be swirled gently after the addition of the water to hasten reconstitution. Use of this product is restricted to a suitable work area, such as a laminar flow hood. The reconstituted solution is ready within three minutes for immediate use. The withdrawal of container contents should be accomplished without delay. However, should this not be possible, a maximum time of 4 hours from initial closure entry is permitted to complete fluid transfer operations. The amount to be administered should be added to appropriate intravenous infusion fluids (see below).

The reconstituted M.V.I. Pediatric® should not be given as a direct, undiluted intravenous injection as it may give rise to dizziness, faintness and possible tissue irritation.

For a single dose, 5 mL of reconstituted M.V.I. Pediatric® should be added directly to not less than 100 mL of intravenous dextrose, saline or similar infusion solutions.

Infants weighing less than 1 kg: The daily dose is 30% (1.5 mL) of a single full dose (5 mL). Do not exceed this daily dose.

Infants weighing 1 to 3 kg: The daily dose is 65% (3.25 mL) of a single full dose (5 mL). Multiples of this recommended dose should not be given to infants weighing less than 3 kg. A supplemental vitamin A may be required for low birth weight infants.

Infants and children weighing 3 kg or more up to 11 years of age: The daily dose is 5 mL unless there is clinical or laboratory evidence for increasing or decreasing the dosage.

DISCARD ANY UNUSED PORTION.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

After M.V.I. Pediatric® is reconstituted it should be immediately diluted into the intravenous solution. The resulting solution should be administered immediately. Some of the vitamins in this product, particularly vitamins A and D and riboflavin, are light-sensitive and exposure to light should be minimized.

How is Multi Vitamin Infusion Pediatric Supplied

M.V.I. Pediatric® is available as:

NDC 61703-421-53, Single Dose Vial, Boxes of 10.

Store under refrigeration, 2 to 8°C (36 to 46°F).

Revised: August, 2007

 

005036

Manufactured for:

Hospira, Inc.

Lake Forest, IL 60045 USA            EN-1593

RL-2156
Multi Vitamin Infusion Pediatric 
ascorbic acid, retinol, ergocalciferol, thiamine hydrochloride, riboflavin 5-phosphate sodium, pyridoxine hydrochloride, niacinamide, dexpanthenol, alpha-tocopherol acetate, biotin, folic acid, cyanocobalamin, and phytonadione  injection, powder, lyophilized, for solution Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 61703-421 Route of Administration INTRAVENOUS DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ASCORBIC ACID (ASCORBIC ACID) ASCORBIC ACID 80 mg  in 5 mL RETINOL (RETINOL) RETINOL 0.7 mg  in 5 mL ERGOCALCIFEROL (ERGOCALCIFEROL) ERGOCALCIFEROL 10 ug  in 5 mL THIAMINE HYDROCHLORIDE (THIAMINE) THIAMINE HYDROCHLORIDE 1.2 mg  in 5 mL RIBOFLAVIN 5'-PHOSPHATE SODIUM (RIBOFLAVIN) RIBOFLAVIN 5'-PHOSPHATE SODIUM 1.4 mg  in 5 mL PYRIDOXINE HYDROCHLORIDE (PYRIDOXINE) PYRIDOXINE HYDROCHLORIDE 1 mg  in 5 mL NIACINAMIDE (NIACINAMIDE) NIACINAMIDE 17 mg  in 5 mL DEXPANTHENOL (DEXPANTHENOL) DEXPANTHENOL 5 mg  in 5 mL ALPHA-TOCOPHEROL ACETATE (ALPHA-TOCOPHEROL) ALPHA-TOCOPHEROL ACETATE 7 mg  in 5 mL BIOTIN (BIOTIN) BIOTIN 20 ug  in 5 mL FOLIC ACID (FOLIC ACID) FOLIC ACID 140 ug  in 5 mL CYANOCOBALAMIN (CYANOCOBALAMIN) CYANOCOBALAMIN 1 ug  in 5 mL PHYTONADIONE (PHYTONADIONE) PHYTONADIONE 200 ug  in 5 mL Inactive Ingredients Ingredient Name Strength MANNITOL 375 mg  in 5 mL SODIUM HYDROXIDE   POLYSORBATE 80 50 mg  in 5 mL POLYSORBATE 20 0.8 mg  in 5 mL BUTYLATED HYDROXYTOLUENE 58 ug  in 5 mL BUTYLATED HYDROXYANISOLE 14 ug  in 5 mL Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains          Packaging # NDC Package Description Multilevel Packaging 1 61703-421-53 10 VIAL In 1 BOX contains a VIAL, SINGLE-DOSE 1 5 mL In 1 VIAL, SINGLE-DOSE This package is contained within the BOX (61703-421-53)
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA018920 11/02/2011
Labeler - Hospira Worldwide, Inc. (141588017) Revised: 12/2011Hospira Worldwide, Inc.

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Iron/Vitamin B Complex/Vitamin C/Folic Acid Caplets

Pronunciation: VYE-ta-min/FOE-lik AS-id/EYE-urn
Generic Name: Vitamin B Complex/Vitamin C/Folic Acid/
Brand Name: Examples include Foli-Iron and I-Fol Plus

Accidental overdose of products that contain iron is a leading cause of fatal poisoning in children younger than 6 years old. Keep this and all medicines out of the reach of children. In case of accidental ingestion, call the poison control center or a doctor at once.

Iron/Vitamin B Complex/Vitamin C/Folic Acid Caplets are used for:

Preventing and treating low iron levels in the body. It may also be used for other conditions as determined by your doctor.

Iron/Vitamin B Complex/Vitamin C/Folic Acid Caplets are an iron, vitamin, and folic acid combination. It works by providing iron, vitamins, and folic acid to the body.

Do NOT use Iron/Vitamin B Complex/Vitamin C/Folic Acid Caplets if: you are allergic to any ingredient in Iron/Vitamin B Complex/Vitamin C/Folic Acid Caplets you have high levels of iron in the blood (eg, hemochromatosis, hemosiderosis) you have pernicious anemia

Contact your doctor or health care provider right away if any of these apply to you.

Before using Iron/Vitamin B Complex/Vitamin C/Folic Acid Caplets:

Some medical conditions may interact with Iron/Vitamin B Complex/Vitamin C/Folic Acid Caplets. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement if you have allergies to medicines, foods, or other substances if you have any other type of anemia (eg, hemolytic anemia) if you have stomach or bowel problems (eg, Crohn disease, inflammation, ulcer), metabolism problems, the blood disease porphyria, or other blood problems (eg, thalassemia) if you have a bleeding problem, have had multiple blood transfusions, or are receiving dialysis

Some MEDICINES MAY INTERACT with Iron/Vitamin B Complex/Vitamin C/Folic Acid Caplets. Tell your health care provider if you are taking any other medicines, especially any of the following:

Fluorouracil because the risk of its side effects may be increased by Iron/Vitamin B Complex/Vitamin C/Folic Acid Caplets Doxycycline, hydantoins (eg, phenytoin), mycophenolate, penicillamine, or thyroid hormones (eg, levothyroxine) because their effectiveness may be decreased by Iron/Vitamin B Complex/Vitamin C/Folic Acid Caplets

This may not be a complete list of all interactions that may occur. Ask your health care provider if Iron/Vitamin B Complex/Vitamin C/Folic Acid Caplets may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Iron/Vitamin B Complex/Vitamin C/Folic Acid Caplets:

Use Iron/Vitamin B Complex/Vitamin C/Folic Acid Caplets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Take Iron/Vitamin B Complex/Vitamin C/Folic Acid Caplets by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation. If you also take bisphosphonates (eg, alendronate), cefdinir, methyldopa, a quinolone antibiotic (eg, ciprofloxacin), or a tetracycline antibiotic (eg, minocycline), ask your doctor or pharmacist how to take it with Iron/Vitamin B Complex/Vitamin C/Folic Acid Caplets. If you miss a dose of Iron/Vitamin B Complex/Vitamin C/Folic Acid Caplets, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Iron/Vitamin B Complex/Vitamin C/Folic Acid Caplets.

Important safety information: Do not take more than the recommended dose without checking with your doctor. Do not take large doses of vitamins (megadoses or megavitamin therapy) while you use Iron/Vitamin B Complex/Vitamin C/Folic Acid Caplets unless your doctor tells you to. Iron/Vitamin B Complex/Vitamin C/Folic Acid Caplets has pyridoxine (vitamin B6), folic acid, and iron in it. Before you start any new medicine, check the label to see if it also has pyridoxine, folic acid, or iron in it too. If it does or if you are not sure, check with your doctor or pharmacist. Iron/Vitamin B Complex/Vitamin C/Folic Acid Caplets may interfere with certain lab tests, such as tests used to check for blood in the stool. Be sure your doctor and lab personnel know you are taking Iron/Vitamin B Complex/Vitamin C/Folic Acid Caplets. Iron/Vitamin B Complex/Vitamin C/Folic Acid Caplets should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed. PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Iron/Vitamin B Complex/Vitamin C/Folic Acid Caplets while you are pregnant. Iron/Vitamin B Complex/Vitamin C/Folic Acid Caplets are found in breast milk. If you are or will be breast-feeding while you use Iron/Vitamin B Complex/Vitamin C/Folic Acid Caplets, check with your doctor. Discuss any possible risks to your baby. Possible side effects of Iron/Vitamin B Complex/Vitamin C/Folic Acid Caplets:

All medicines may cause side effects, but many people have no, or minor side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; dark or green stools; diarrhea; nausea; stomach pain; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); black, tarry, or bloody stools; severe or persistent stomach pain.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include black, tarry, or bloody stools; blue or unusually pale skin; drowsiness or dizziness; fast heartbeat; increased thirst or urination; seizures; severe or persistent nausea, vomiting, diarrhea, or stomach pain; sluggishness; vomiting blood; weakness.

Proper storage of Iron/Vitamin B Complex/Vitamin C/Folic Acid Caplets:

Store Iron/Vitamin B Complex/Vitamin C/Folic Acid Caplets at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Iron/Vitamin B Complex/Vitamin C/Folic Acid Caplets out of the reach of children and away from pets.

General information: If you have any questions about Iron/Vitamin B Complex/Vitamin C/Folic Acid Caplets, please talk with your doctor, pharmacist, or other health care provider. Iron/Vitamin B Complex/Vitamin C/Folic Acid Caplets are to be used only by the patient for whom it is prescribed. Do not share it with other people. If your symptoms do not improve or if they become worse, check with your doctor. Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Iron/Vitamin B Complex/Vitamin C/Folic Acid Caplets. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012 Database Edition 12.1.1.002 Copyright © 2012 Wolters Kluwer Health, Inc. More Iron/Vitamin B Complex/Vitamin C/Folic Acid resources Iron/Vitamin B Complex/Vitamin C/Folic Acid Use in Pregnancy & BreastfeedingIron/Vitamin B Complex/Vitamin C/Folic Acid Drug InteractionsIron/Vitamin B Complex/Vitamin C/Folic Acid Support Group4 Reviews for Iron/Vitamin B Complex/Vitamin C/Folic Acid - Add your own review/rating Compare Iron/Vitamin B Complex/Vitamin C/Folic Acid with other medications Vitamin/Mineral Supplementation and Deficiency

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Vitamin B Complex/Vitamin C/Folic Acid/Iron/Zinc

Pronunciation: VYE-ta-min/FOE-lik AS-id/EYE-urn/zink
Generic Name: Vitamin B Complex/Vitamin C/Folic Acid/Iron/Zinc
Brand Name: Corvite 150

Accidental overdose of products that contain iron is a leading cause of fatal poisoning in children younger than 6 years old. Keep this and all medicines out of the reach of children. In case of accidental ingestion, call the poison control center or a doctor at once.

Vitamin B Complex/Vitamin C/Folic Acid/Iron/Zinc is used for:

Preventing and treating certain types of anemia (eg, caused by low blood iron levels, poor nutrition). It may also be used for other conditions as determined by your doctor.

Vitamin B Complex/Vitamin C/Folic Acid/Iron/Zinc is a vitamin, mineral, folic acid, and iron combination. It works by providing vitamins, minerals, folic acid, and iron to the body.

Do NOT use Vitamin B Complex/Vitamin C/Folic Acid/Iron/Zinc if: you are allergic to any ingredient in Vitamin B Complex/Vitamin C/Folic Acid/Iron/Zinc you have high levels of iron in the blood (eg, hemochromatosis, hemosiderosis)

Contact your doctor or health care provider right away if any of these apply to you.

Before using Vitamin B Complex/Vitamin C/Folic Acid/Iron/Zinc:

Some medical conditions may interact with Vitamin B Complex/Vitamin C/Folic Acid/Iron/Zinc. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement if you have allergies to medicines, foods, or other substances if you have any other type of anemia (eg, pernicious anemia) if you have stomach or bowel problems (eg, inflammation, Crohn disease, ulcer), metabolism problems, the blood disease porphyria, or a blood disease (eg, thalassemia) if you have a bleeding problem, have had multiple blood transfusions, or are receiving dialysis

Some MEDICINES MAY INTERACT with Vitamin B Complex/Vitamin C/Folic Acid/Iron/Zinc. Tell your health care provider if you are taking any other medicines, especially any of the following:

Fluorouracil because the risk of its side effects may be increased by Vitamin B Complex/Vitamin C/Folic Acid/Iron/Zinc Doxycycline, hydantoins (eg, phenytoin), mycophenolate, penicillamine, or thyroid hormones (eg, levothyroxine) because their effectiveness may be decreased by Vitamin B Complex/Vitamin C/Folic Acid/Iron/Zinc.

This may not be a complete list of all interactions that may occur. Ask your health care provider if Vitamin B Complex/Vitamin C/Folic Acid/Iron/Zinc may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Vitamin B Complex/Vitamin C/Folic Acid/Iron/Zinc:

Use Vitamin B Complex/Vitamin C/Folic Acid/Iron/Zinc as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Take Vitamin B Complex/Vitamin C/Folic Acid/Iron/Zinc by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation. If you also take bisphosphonates (eg, alendronate), cefdinir, methyldopa, a quinolone antibiotic (eg, ciprofloxacin), or a tetracycline antibiotic (eg, minocycline), ask your doctor or pharmacist how to take it with Vitamin B Complex/Vitamin C/Folic Acid/Iron/Zinc. If you miss a dose of Vitamin B Complex/Vitamin C/Folic Acid/Iron/Zinc, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Vitamin B Complex/Vitamin C/Folic Acid/Iron/Zinc.

Important safety information: Do not take more than the recommended dose without checking with your doctor. Do not take large doses of vitamins (megadoses or megavitamin therapy) while you use Vitamin B Complex/Vitamin C/Folic Acid/Iron/Zinc unless your doctor tells you to. Vitamin B Complex/Vitamin C/Folic Acid/Iron/Zinc has pyridoxine (vitamin B6), folic acid, iron, and zinc in it. Before you start any new medicine, check the label to see if it also has pyridoxine, folic acid, iron, or zinc in it. If it does or if you are not sure, check with your doctor or pharmacist. Vitamin B Complex/Vitamin C/Folic Acid/Iron/Zinc may interfere with certain lab tests, such as tests used to check for blood in the stool. Be sure your doctor and lab personnel know you are taking Vitamin B Complex/Vitamin C/Folic Acid/Iron/Zinc. Vitamin B Complex/Vitamin C/Folic Acid/Iron/Zinc should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed. PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Vitamin B Complex/Vitamin C/Folic Acid/Iron/Zinc while you are pregnant. Vitamin B Complex/Vitamin C/Folic Acid/Iron/Zinc is found in breast milk. If you are or will be breast-feeding while you use Vitamin B Complex/Vitamin C/Folic Acid/Iron/Zinc, check with your doctor. Discuss any possible risks to your baby. Possible side effects of Vitamin B Complex/Vitamin C/Folic Acid/Iron/Zinc:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; dark or green stools; diarrhea; nausea; stomach pain; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); black, tarry, or bloody stools; severe or persistent stomach pain.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch .

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include black, tarry, or bloody stools; blue or unusually pale skin; drowsiness or dizziness; fast heartbeat; increased thirst or urination; seizures; severe or persistent nausea, vomiting, diarrhea, or stomach pain; sluggishness; vomiting blood; weakness.

Proper storage of Vitamin B Complex/Vitamin C/Folic Acid/Iron/Zinc:

Store Vitamin B Complex/Vitamin C/Folic Acid/Iron/Zinc at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Vitamin B Complex/Vitamin C/Folic Acid/Iron/Zinc out of the reach of children and away from pets.

General information: If you have any questions about Vitamin B Complex/Vitamin C/Folic Acid/Iron/Zinc, please talk with your doctor, pharmacist, or other health care provider. Vitamin B Complex/Vitamin C/Folic Acid/Iron/Zinc is to be used only by the patient for whom it is prescribed. Do not share it with other people. If your symptoms do not improve or if they become worse, check with your doctor. Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Vitamin B Complex/Vitamin C/Folic Acid/Iron/Zinc. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012 Database Edition 12.1.1.002 Copyright © 2012 Wolters Kluwer Health, Inc. More Vitamin B Complex/Vitamin C/Folic Acid/Iron/Zinc resources Vitamin B Complex/Vitamin C/Folic Acid/Iron/Zinc Use in Pregnancy & Breastfeeding Vitamin B Complex/Vitamin C/Folic Acid/Iron/Zinc Drug Interactions Vitamin B Complex/Vitamin C/Folic Acid/Iron/Zinc Support Group 4 Reviews for Vitamin B Complex/Vitamin C/Folic Acid/Iron/Zinc - Add your own review/rating Compare Vitamin B Complex/Vitamin C/Folic Acid/Iron/Zinc with other medications Vitamin/Mineral Supplementation and Deficiency

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Multivitamins with Folic Acid/Iron/Docusate

Pronunciation: MUL-ti-VYE-ta-mins/FOE-lik AS-id/EYE-urn/DOK-ue-sate
Generic Name: Multivitamins with Folic Acid/Iron/Docusate
Brand Name: Examples include Nephron FA and Ferro-Plex Hematinic

Accidental overdose of products that contain iron is a leading cause of fatal poisoning in children younger than 6 years old. Keep this and all medicines out of the reach of children. In case of accidental ingestion, call a doctor or poison control center right away.

Multivitamins with Folic Acid/Iron/Docusate is used for:

Treating or preventing low levels of vitamins, folic acid, and iron in the body. It may also be used for other conditions as determined by your doctor.

Multivitamins with Folic Acid/Iron/Docusate is a vitamin, folic acid, iron, and stool softener combination. It works by providing extra vitamins, folic acid, and iron to the body when you need more than what you get in your diet. The stool softener helps prevent constipation that may occur with iron products.

Do NOT use Multivitamins with Folic Acid/Iron/Docusate if: you are allergic to any ingredient in Multivitamins with Folic Acid/Iron/Docusate you have certain iron metabolism problems (eg, hemosiderosis, hemochromatosis) or high levels of iron in your blood

Contact your doctor or health care provider right away if any of these apply to you.

Before using Multivitamins with Folic Acid/Iron/Docusate:

Some medical conditions may interact with Multivitamins with Folic Acid/Iron/Docusate. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement if you have allergies to medicines, foods, or other substances if you have bowel problems (eg, colitis, Crohn disease, diverticulitis), certain blood disorders (eg, hemolytic or pernicious anemia, porphyria cutanea tarda, thalassemia), glucose-6-phosphate-dehydrogenase (G6PD) deficiency, or a peptic ulcer if you have had multiple blood transfusions

Some MEDICINES MAY INTERACT with Multivitamins with Folic Acid/Iron/Docusate. Tell your health care provider if you are taking any other medicines, especially any of the following:

Fluorouracil because the risk of its side effects may be increased by Multivitamins with Folic Acid/Iron/Docusate Cephalosporin antibiotics (eg, cephalexin), eltrombopag, hydantoins (eg, phenytoin), methyldopa, mycophenolate, penicillamine, quinolone antibiotics (eg, ciprofloxacin), tetracycline antibiotics (eg, doxycycline), or thyroid hormones (eg, levothyroxine) because their effectiveness may be decreased by Multivitamins with Folic Acid/Iron/Docusate

This may not be a complete list of all interactions that may occur. Ask your health care provider if Multivitamins with Folic Acid/Iron/Docusate may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Multivitamins with Folic Acid/Iron/Docusate:

Use Multivitamins with Folic Acid/Iron/Docusate as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Take Multivitamins with Folic Acid/Iron/Docusate by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation. Take Multivitamins with Folic Acid/Iron/Docusate with a full glass of water (8 oz/240 mL). Do not take an antacid within 1 hour before or 2 hours after you take Multivitamins with Folic Acid/Iron/Docusate. Avoid taking Multivitamins with Folic Acid/Iron/Docusate with dairy products; they may interfere with the absorption of the iron in Multivitamins with Folic Acid/Iron/Docusate. If you miss a dose of Multivitamins with Folic Acid/Iron/Docusate, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Multivitamins with Folic Acid/Iron/Docusate.

Important safety information: Do not take large doses of vitamins while you use Multivitamins with Folic Acid/Iron/Docusate unless your doctor tells you to. Multivitamins with Folic Acid/Iron/Docusate may discolor the stools. This is normal and not a cause for concern. Multivitamins with Folic Acid/Iron/Docusate has iron in it. Iron overdose is a leading cause of fatal poisoning in children younger than 6 years old. In case of an overdose, call a doctor or poison control center right away. Multivitamins with Folic Acid/Iron/Docusate has pyridoxine (vitamin B6), folic acid, and iron in it. Before you start any medicine, check the label to see if it has pyridoxine (vitamin B6), folic acid, or iron in it too. If it does or if you are not sure, check with your doctor or pharmacist. PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Multivitamins with Folic Acid/Iron/Docusate while you are pregnant. It is not known if Multivitamins with Folic Acid/Iron/Docusate is found in breast milk. If you are or will be breast-feeding while you use Multivitamins with Folic Acid/Iron/Docusate, check with your doctor. Discuss any possible risks to your baby. Possible side effects of Multivitamins with Folic Acid/Iron/Docusate:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; dark or discolored stools; diarrhea; nausea; stomach upset; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); black, tarry stools; blood in the vomit; persistent nausea, vomiting, or diarrhea; stomach pain or cramping.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include black, tarry stools; blood in the vomit; diarrhea; headache; nausea; vomiting.

Proper storage of Multivitamins with Folic Acid/Iron/Docusate:

Store Multivitamins with Folic Acid/Iron/Docusate at room temperature. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Multivitamins with Folic Acid/Iron/Docusate out of the reach of children and away from pets.

General information: If you have any questions about Multivitamins with Folic Acid/Iron/Docusate, please talk with your doctor, pharmacist, or other health care provider. Multivitamins with Folic Acid/Iron/Docusate is to be used only by the patient for whom it is prescribed. Do not share it with other people. If your symptoms do not improve or if they become worse, check with your doctor. Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Multivitamins with Folic Acid/Iron/Docusate. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012 Database Edition 12.1.1.002 Copyright © 2012 Wolters Kluwer Health, Inc. More Multivitamins with Folic Acid/Iron/Docusate resources Multivitamins with Folic Acid/Iron/Docusate Use in Pregnancy & Breastfeeding Drug Images Multivitamins with Folic Acid/Iron/Docusate Drug Interactions Multivitamins with Folic Acid/Iron/Docusate Support Group 11 Reviews for Multivitamins with Folic Acid/Iron/Docusate - Add your own review/rating Compare Multivitamins with Folic Acid/Iron/Docusate with other medications Anemia Vitamin/Mineral Supplementation and Deficiency

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Prenatal Multivitamin without Vitamin A with Minerals, Iron, L-methylfolate, Folic Acid, and DHA

Pronunciation: pree-NATE-al muhl-tee-VYE-ta-min/VYE-ta-min A/MIN-er-als/EYE-urn/el-METH-il-FOE-late/FOE-lik AS-id
Generic Name: Prenatal Multivitamin without Vitamin A with Minerals, Iron, L-methylfolate, Folic Acid, and DHA
Brand Name: Examples include Prenate DHA and Neevo DHA

Accidental overdose of products that contain iron is a leading cause of fatal poisoning in children younger than 6 years old. Keep this and all medicines out of the reach of children. In case of accidental ingestion, call the poison control center or doctor at once.

Prenatal Multivitamin without Vitamin A with Minerals, Iron, L-methylfolate, Folic Acid, and DHA is used for:

Treating or preventing a lack of vitamins or minerals before, during, and after pregnancy and while breast-feeding. It may also be used for other conditions as determined by your doctor.

Prenatal Multivitamin without Vitamin A with Minerals, Iron, L-methylfolate, Folic Acid, and DHA is a vitamin, mineral, iron, folic acid, and docosahexaenoic acid (DHA) combination. It works by providing vitamins and minerals to the body to help meet nutritional requirements.

Do NOT use Prenatal Multivitamin without Vitamin A with Minerals, Iron, L-methylfolate, Folic Acid, and DHA if: you are allergic to any ingredient in Prenatal Multivitamin without Vitamin A with Minerals, Iron, L-methylfolate, Folic Acid, and DHA you have hemochromatosis (a disorder of iron metabolism) or high levels of iron in your blood you are taking an anticoagulant (eg, warfarin)

Contact your doctor or health care provider right away if any of these apply to you.

Before using Prenatal Multivitamin without Vitamin A with Minerals, Iron, L-methylfolate, Folic Acid, and DHA: if you are pregnant, planning to become pregnant, or are breast-feeding if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement if you have allergies to medicines, foods, or other substances, including soy, fish, or fish oil if you have stomach or intestinal problems (eg, colitis, Crohn disease, diverticulitis), pernicious anemia or other blood problems (eg, anemia, porphyria), bleeding problems (eg, hemophilia), peptic ulcer, or kidney stones if you have had multiple blood transfusions

Some MEDICINES MAY INTERACT with Prenatal Multivitamin without Vitamin A with Minerals, Iron, L-methylfolate, Folic Acid, and DHA. Tell your health care provider if you are taking any other medicines, especially any of the following:

Oral anticoagulants (eg, warfarin) because the risk of bleeding may be increased by Prenatal Multivitamin without Vitamin A with Minerals, Iron, L-methylfolate, Folic Acid, and DHA Fluorouracil because the risk of its side effects may be increased by Prenatal Multivitamin without Vitamin A with Minerals, Iron, L-methylfolate, Folic Acid, and DHA Doxycycline, hydantoins (eg, phenytoin), levodopa, penicillamine, or thyroid hormones (eg, levothyroxine) because their effectiveness may be decreased by Prenatal Multivitamin without Vitamin A with Minerals, Iron, L-methylfolate, Folic Acid, and DHA

This may not be a complete list of all interactions that may occur. Ask your health care provider if Prenatal Multivitamin without Vitamin A with Minerals, Iron, L-methylfolate, Folic Acid, and DHA may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Prenatal Multivitamin without Vitamin A with Minerals, Iron, L-methylfolate, Folic Acid, and DHA:

Use Prenatal Multivitamin without Vitamin A with Minerals, Iron, L-methylfolate, Folic Acid, and DHA as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Take Prenatal Multivitamin without Vitamin A with Minerals, Iron, L-methylfolate, Folic Acid, and DHA by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation. Take Prenatal Multivitamin without Vitamin A with Minerals, Iron, L-methylfolate, Folic Acid, and DHA by mouth with a full glass of water (8 oz/240 mL). Do not take an antacid within 1 hour before or 2 hours after you take Prenatal Multivitamin without Vitamin A with Minerals, Iron, L-methylfolate, Folic Acid, and DHA. Avoid taking Prenatal Multivitamin without Vitamin A with Minerals, Iron, L-methylfolate, Folic Acid, and DHA with dairy products; they may interfere with the absorption of the iron in Prenatal Multivitamin without Vitamin A with Minerals, Iron, L-methylfolate, Folic Acid, and DHA. Many medicines (eg, used for infection, blood pressure, low blood platelet levels, osteoporosis, thyroid problems) should not be taken at the same time as Prenatal Multivitamin without Vitamin A with Minerals, Iron, L-methylfolate, Folic Acid, and DHA; their effectiveness may be decreased. Ask your doctor or pharmacist if your dose of Prenatal Multivitamin without Vitamin A with Minerals, Iron, L-methylfolate, Folic Acid, and DHA should be separated from your dose of any of your other medicines. If you miss a dose of Prenatal Multivitamin without Vitamin A with Minerals, Iron, L-methylfolate, Folic Acid, and DHA, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Prenatal Multivitamin without Vitamin A with Minerals, Iron, L-methylfolate, Folic Acid, and DHA.

Important safety information: Do not exceed the recommended dose or take Prenatal Multivitamin without Vitamin A with Minerals, Iron, L-methylfolate, Folic Acid, and DHA for longer than prescribed without checking with your doctor. Do not take large doses of vitamins while you use Prenatal Multivitamin without Vitamin A with Minerals, Iron, L-methylfolate, Folic Acid, and DHA unless your doctor tells you to. Prenatal Multivitamin without Vitamin A with Minerals, Iron, L-methylfolate, Folic Acid, and DHA has pyridoxine (vitamin B6) in it. Before you start any new medicine, check the label to see if it has pyridoxine (vitamin B6) in it too. If it does or if you are not sure, check with your doctor or pharmacist. Some brands of Prenatal Multivitamin without Vitamin A with Minerals, Iron, L-methylfolate, Folic Acid, and DHA may contain fish oil or soy. If you have had an allergic reaction to fish, fish oil, or soy, ask your pharmacist if your brand contains fish oil or soy. Prenatal Multivitamin without Vitamin A with Minerals, Iron, L-methylfolate, Folic Acid, and DHA may darken the stools. This is normal and not a cause for concern. Prenatal Multivitamin without Vitamin A with Minerals, Iron, L-methylfolate, Folic Acid, and DHA has iron in it. Iron overdose is a leading cause of fatal poisoning in children younger than 6 years old. In case of an overdose, call a doctor or poison control center right away. Prenatal Multivitamin without Vitamin A with Minerals, Iron, L-methylfolate, Folic Acid, and DHA may interfere with certain lab tests, including tests used to check for blood in the stool. Be sure your doctor and lab personnel know you are taking Prenatal Multivitamin without Vitamin A with Minerals, Iron, L-methylfolate, Folic Acid, and DHA. PREGNANCY and BREAST-FEEDING: Prenatal Multivitamin without Vitamin A with Minerals, Iron, L-methylfolate, Folic Acid, and DHA is intended for use during pregnancy and breast-feeding. If you are or will be breast-feeding while you use Prenatal Multivitamin without Vitamin A with Minerals, Iron, L-methylfolate, Folic Acid, and DHA, check with your doctor. Possible side effects of Prenatal Multivitamin without Vitamin A with Minerals, Iron, L-methylfolate, Folic Acid, and DHA:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; dark or discolored stools; diarrhea; nausea; stomach upset; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); black, tarry stools; blood or streaks of blood in the stools; stomach pain or cramping.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include black, tarry stools; chest pain; loss of balance; seizure; severe nausea, vomiting, diarrhea, or stomach pain; shortness of breath; sluggishness; trouble breathing; unusual tiredness or weakness; unusually pale skin; weak pulse.

Proper storage of Prenatal Multivitamin without Vitamin A with Minerals, Iron, L-methylfolate, Folic Acid, and DHA:

Store Prenatal Multivitamin without Vitamin A with Minerals, Iron, L-methylfolate, Folic Acid, and DHA at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Prenatal Multivitamin without Vitamin A with Minerals, Iron, L-methylfolate, Folic Acid, and DHA out of the reach of children and away from pets.

General information: If you have any questions about Prenatal Multivitamin without Vitamin A with Minerals, Iron, L-methylfolate, Folic Acid, and DHA, please talk with your doctor, pharmacist, or other health care provider. Prenatal Multivitamin without Vitamin A with Minerals, Iron, L-methylfolate, Folic Acid, and DHA is to be used only by the patient for whom it is prescribed. Do not share it with other people. If your symptoms do not improve or if they become worse, check with your doctor. Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Prenatal Multivitamin without Vitamin A with Minerals, Iron, L-methylfolate, Folic Acid, and DHA. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012 Database Edition 12.1.1.002 Copyright © 2012 Wolters Kluwer Health, Inc. More Prenatal Multivitamin without Vitamin A with Minerals, Iron, L-methylfolate, Folic Acid, and DHA resources Prenatal Multivitamin without Vitamin A with Minerals, Iron, L-methylfolate, Folic Acid, and DHA Use in Pregnancy & Breastfeeding Drug Images Prenatal Multivitamin without Vitamin A with Minerals, Iron, L-methylfolate, Folic Acid, and DHA Drug Interactions Prenatal Multivitamin without Vitamin A with Minerals, Iron, L-methylfolate, Folic Acid, and DHA Support Group 21 Reviews for Prenatal Multivitamin without Vitamin A with Minerals, Iron, L-methylfolate, Folic Acid, and DHA - Add your own review/rating Compare Prenatal Multivitamin without Vitamin A with Minerals, Iron, L-methylfolate, Folic Acid, and DHA with other medications Vitamin/Mineral Supplementation during Pregnancy/Lactation

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Integra Plus

Pronunciation: FER-us FUE-ma-rate/PAHL-ee-SAAK-ah-ride EYE-urn/FOE-lik AS-id/VYE-ta-min B/VYE-ta-min C/BYE-oh-tin
Generic Name: Ferrous Fumarate/Polysaccharide Iron Complex/Folic Acid/Vitamin B Complex/Vitamin C/Biotin
Brand Name: Integra Plus

Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children younger than 6 years of age. Keep this product out of the reach of children. In case of accidental overdose, call a doctor or poison control center immediately.

Integra Plus is used for:

Treating anemia caused by low levels of iron or folate in the blood. It is also used as a stress vitamin. It may also be used for other conditions as determined by your doctor.

Integra Plus is a vitamin, folic acid, and iron combination. It works by providing vitamins, folic acid, and iron to the body to help meet nutritional requirements.

Do NOT use Integra Plus if: you are allergic to any ingredient in Integra Plus you have high levels of iron in your blood (eg, hemochromatosis, hemosiderosis) you have hemolytic anemia or pernicious anemia

Contact your doctor or health care provider right away if any of these apply to you.

Before using Integra Plus:

Some medical conditions may interact with Integra Plus. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement if you have allergies to medicines, foods, or other substances if you have any other type of anemia if you have stomach or bowel problems (eg, Crohn disease, diverticulitis, ulcerative colitis, peptic ulcer), the blood disease porphyria, or other blood problems (eg, thalassemia) if you have a bleeding problem or have had multiple blood transfusions

Some MEDICINES MAY INTERACT with Integra Plus. Tell your health care provider if you are taking any other medicines, especially any of the following:

Fluorouracil because the risk of its side effects may be increased by Integra Plus Doxycycline, hydantoins (eg, phenytoin), penicillamine, or thyroid hormones (eg, levothyroxine) because their effectiveness may be decreased by Integra Plus

This may not be a complete list of all interactions that may occur. Ask your health care provider if Integra Plus may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Integra Plus:

Use Integra Plus as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Take Integra Plus by mouth on an empty stomach at least 1 hour before or 2 hours after eating. If stomach upset occurs, take with food to reduce stomach irritation. Do not take an antacid within 1 hour before or 2 hours after you take Integra Plus. If you also take a bisphosphonate (eg, alendronate), a cephalosporin (eg, cefdinir), eltrombopag, methyldopa, penicillamine, a quinolone (eg, ciprofloxacin), or a tetracycline (eg, doxycycline), check with your doctor about how to take it with Integra Plus. If you miss a dose of Integra Plus, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Integra Plus.

Important safety information: Do not take more than the recommended dose without checking with your doctor. Do not take large doses of vitamins (megadoses or megavitamin therapy) unless directed by your doctor. Integra Plus has pyridoxine (vitamin B6), folic acid, and iron in it. Before you begin taking any new prescription or nonprescription medicine, read the ingredients to see if it has pyridoxine, folic acid, or iron in it too. If it does or if you are not sure, check with your doctor or pharmacist. Integra Plus has iron in it. Iron overdose is a leading cause of fatal poisoning in children younger than 6 years of age. In case of an overdose, call a doctor or poison control center right away. Integra Plus may darken the stools. This is normal and not cause for concern. Integra Plus may interfere with certain lab tests. Be sure your doctor and lab personnel know you are taking Integra Plus. Lab tests, including hematocrit, hemoglobin levels, and blood iron levels, may be performed while you use Integra Plus. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments. Integra Plus should not be used in CHILDREN younger than 12 years old; safety and effectiveness in these children have not been confirmed. PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Integra Plus while you are pregnant. If you are or will be breast-feeding while you use Integra Plus, check with your doctor. Discuss any possible risks to your baby. Possible side effects of Integra Plus:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; diarrhea; loss of appetite; nausea; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); black, tarry stools; numbness or tingling of the skin; severe or persistent stomach pain or cramping.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Integra Plus side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center ( http://www.aapcc.org), or emergency room immediately. Symptoms may include black, tarry, or bloody stools; blue or unusually pale skin; coma; drowsiness or dizziness; fast heartbeat; increased thirst or urination; loss of balance; seizures; severe or persistent nausea, vomiting, or diarrhea; sluggishness; vomiting blood; weakness.

Proper storage of Integra Plus:

Store Integra Plus at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Integra Plus out of the reach of children and away from pets.

General information: If you have any questions about Integra Plus, please talk with your doctor, pharmacist, or other health care provider. Integra Plus is to be used only by the patient for whom it is prescribed. Do not share it with other people. If your symptoms do not improve or if they become worse, check with your doctor. Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Integra Plus. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012 Database Edition 12.1.1.002 Copyright © 2012 Wolters Kluwer Health, Inc. More Integra Plus resources Integra Plus Side Effects (in more detail) Integra Plus Use in Pregnancy & Breastfeeding Integra Plus Drug Interactions Integra Plus Support Group 0 Reviews for Integra Plus - Add your own review/rating Integra Plus Prescribing Information (FDA) multivitamin with iron Concise Consumer Information (Cerner Multum) Allbee-C 800 with Iron Concise Consumer Information (Cerner Multum) Ferotrin Prescribing Information (FDA) Ferralet 90 Prescribing Information (FDA) Ferrex 150 Forte Prescribing Information (FDA) Ferrex 150 Forte Plus Prescribing Information (FDA) Ferrex 28 Prescribing Information (FDA) FerroGels Forte Prescribing Information (FDA) Hematogen Forte Prescribing Information (FDA) Integra F Prescribing Information (FDA) Irospan 24/6 Prescribing Information (FDA) NovaFerrum Prescribing Information (FDA) Tricon Prescribing Information (FDA) Compare Integra Plus with other medications Anemia Vitamin/Mineral Supplementation and Deficiency

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Prenatal Multivitamin and Minerals with Iron, Folic Acid, and L-Methylfolate Caplets

Pronunciation: pree-NATE-al muhl-tee-VYE-ta-min/MIN-er-als/EYE-urn/FOE-lik AS-id/meth-ill-FOE-late
Generic Name: Prenatal Multivitamin and Minerals with Iron, Folic Acid, and L-Methylfolate
Brand Name: Neevo

Accidental overdose of products that contain iron is a leading cause of fatal poisoning in children younger than 6 years old. Keep this and all medicines out of the reach of children. In case of accidental ingestion, call the poison control center or doctor at once.

Prenatal Multivitamin and Minerals with Iron, Folic Acid, and L-Methylfolate Caplets are used for:

Dietary management of a lack of vitamins, minerals, iron, and folic acid during pregnancy. Prenatal Multivitamin and Minerals with Iron, Folic Acid, and L-Methylfolate Caplets are used for certain patients who face intermediate- to high-risk pregnancies and are unable to metabolize or absorb folic acid. It may also be used for other certain conditions as determined by your doctor.

Prenatal Multivitamin and Minerals with Iron, Folic Acid, and L-Methylfolate Caplets are a vitamin, mineral, iron, and folic acid combination. It provides vitamins and minerals to the body to help meet nutritional requirements.

Do NOT use Prenatal Multivitamin and Minerals with Iron, Folic Acid, and L-Methylfolate Caplets if: you are allergic to any ingredient in Prenatal Multivitamin and Minerals with Iron, Folic Acid, and L-Methylfolate Caplets you have high levels of iron in your body (eg, hemosiderosis, hemochromatosis)

Contact your doctor or health care provider right away if any of these apply to you.

Before using Prenatal Multivitamin and Minerals with Iron, Folic Acid, and L-Methylfolate Caplets:

Some medical conditions may interact with Prenatal Multivitamin and Minerals with Iron, Folic Acid, and L-Methylfolate Caplets. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement if you have allergies to medicines, foods, or other substances if you have bowel problems (eg, colitis, Crohn disease, diverticulitis), blood problems (eg, anemia, porphyria, thalassemia), bleeding problems (eg, hemophilia), a peptic ulcer, or kidney stones if you have had multiple blood transfusions

Some MEDICINES MAY INTERACT with Prenatal Multivitamin and Minerals with Iron, Folic Acid, and L-Methylfolate Caplets. Tell your health care provider if you are taking any other medicines, especially any of the following:

Oral anticoagulants (eg, warfarin) because the risk of bleeding may be increased by Prenatal Multivitamin and Minerals with Iron, Folic Acid, and L-Methylfolate Caplets Cation exchange resins (eg, sodium polystyrene sulfonate) because severe side effects may occur Fluorouracil because its actions and the risk of its side effects may be increased by Prenatal Multivitamin and Minerals with Iron, Folic Acid, and L-Methylfolate Caplets Doxycycline, hydantoins (eg, phenytoin), levodopa, mycophenolate, penicillamine, or thyroid hormones (eg, levothyroxine) because their effectiveness may be decreased by Prenatal Multivitamin and Minerals with Iron, Folic Acid, and L-Methylfolate Caplets

This may not be a complete list of all interactions that may occur. Ask your health care provider if Prenatal Multivitamin and Minerals with Iron, Folic Acid, and L-Methylfolate Caplets may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Prenatal Multivitamin and Minerals with Iron, Folic Acid, and L-Methylfolate Caplets:

Use Prenatal Multivitamin and Minerals with Iron, Folic Acid, and L-Methylfolate Caplets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Take Prenatal Multivitamin and Minerals with Iron, Folic Acid, and L-Methylfolate Caplets by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation. Take Prenatal Multivitamin and Minerals with Iron, Folic Acid, and L-Methylfolate Caplets with a full glass of water (8 oz/240 mL). Avoid taking Prenatal Multivitamin and Minerals with Iron, Folic Acid, and L-Methylfolate Caplets with dairy products; they may interfere with the absorption of the iron in Prenatal Multivitamin and Minerals with Iron, Folic Acid, and L-Methylfolate Caplets. If you also take an antacid, ask your doctor or pharmacist how to take it with Prenatal Multivitamin and Minerals with Iron, Folic Acid, and L-Methylfolate Caplets. Many medicines (eg, used for infection, blood pressure, cancer, immune system suppression, low blood platelets, osteoporosis, thyroid problems) should not be taken at the same time as Prenatal Multivitamin and Minerals with Iron, Folic Acid, and L-Methylfolate Caplets because their effectiveness may be decreased. Ask your doctor or pharmacist if your dose of Prenatal Multivitamin and Minerals with Iron, Folic Acid, and L-Methylfolate Caplets should be separated from your dose of any of your other medicines. Taking Prenatal Multivitamin and Minerals with Iron, Folic Acid, and L-Methylfolate Caplets at the same time each day will help you remember to take it. Take Prenatal Multivitamin and Minerals with Iron, Folic Acid, and L-Methylfolate Caplets on a regular schedule to get the most benefit from it. If you miss a dose of Prenatal Multivitamin and Minerals with Iron, Folic Acid, and L-Methylfolate Caplets, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Prenatal Multivitamin and Minerals with Iron, Folic Acid, and L-Methylfolate Caplets.

Important safety information: Do not take large doses of vitamins while you take Prenatal Multivitamin and Minerals with Iron, Folic Acid, and L-Methylfolate Caplets unless your doctor tells you to. Prenatal Multivitamin and Minerals with Iron, Folic Acid, and L-Methylfolate Caplets may darken the stools. This is normal and not a cause for concern. Prenatal Multivitamin and Minerals with Iron, Folic Acid, and L-Methylfolate Caplets has pyridoxine (vitamin B6) and folic acid in it. Before you start any new medicine, check the label to see if it has pyridoxine (vitamin B6) or folic acid in it too. If it does or if you are not sure, check with your doctor or pharmacist. Prenatal Multivitamin and Minerals with Iron, Folic Acid, and L-Methylfolate Caplets has iron in it. Iron overdose is a leading cause of fatal poisoning in CHILDREN younger than 6 years of age. Keep this product out of the reach of children. In case of accidental overdose, call a doctor or poison control center immediately. PREGNANCY and BREAST-FEEDING: Prenatal Multivitamin and Minerals with Iron, Folic Acid, and L-Methylfolate Caplets are intended for use during pregnancy. If you are or will be breast-feeding while you take Prenatal Multivitamin and Minerals with Iron, Folic Acid, and L-Methylfolate Caplets, check with your doctor. Possible side effects of Prenatal Multivitamin and Minerals with Iron, Folic Acid, and L-Methylfolate Caplets:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; dark or discolored stools; diarrhea; headache; nausea; stomach upset; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); black, bloody, or tarry stools; burning, numbness, or tingling; severe drowsiness; stomach pain or cramping.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include black, tarry stools; chest pain; lack of feeling alert; loss of balance; seizure; severe nausea, vomiting, diarrhea, or stomach pain; shortness of breath; sluggishness; trouble breathing; unusual tiredness or weakness; unusually pale skin; weak pulse.

Proper storage of Prenatal Multivitamin and Minerals with Iron, Folic Acid, and L-Methylfolate Caplets:

Store Prenatal Multivitamin and Minerals with Iron, Folic Acid, and L-Methylfolate Caplets at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Prenatal Multivitamin and Minerals with Iron, Folic Acid, and L-Methylfolate Caplets out of the reach of children and away from pets.

General information: If you have any questions about Prenatal Multivitamin and Minerals with Iron, Folic Acid, and L-Methylfolate Caplets, please talk with your doctor, pharmacist, or other health care provider. Prenatal Multivitamin and Minerals with Iron, Folic Acid, and L-Methylfolate Caplets are to be used only by the patient for whom it is prescribed. Do not share it with other people. If your symptoms do not improve or if they become worse, check with your doctor. Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Prenatal Multivitamin and Minerals with Iron, Folic Acid, and L-Methylfolate Caplets. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012 Database Edition 12.1.1.002 Copyright © 2012 Wolters Kluwer Health, Inc. More Prenatal Multivitamin and Minerals with Iron, Folic Acid, and L-Methylfolate resources Prenatal Multivitamin and Minerals with Iron, Folic Acid, and L-Methylfolate Use in Pregnancy & Breastfeeding Drug Images Prenatal Multivitamin and Minerals with Iron, Folic Acid, and L-Methylfolate Drug Interactions Prenatal Multivitamin and Minerals with Iron, Folic Acid, and L-Methylfolate Support Group 21 Reviews for Prenatal Multivitamin and Minerals with Iron, Folic Acid, and L-Methylfolate - Add your own review/rating Compare Prenatal Multivitamin and Minerals with Iron, Folic Acid, and L-Methylfolate with other medications Vitamin/Mineral Supplementation during Pregnancy/Lactation

Read More:

Prenatal Multivitamin and Minerals with Iron, Folic Acid, and L-Methylfolate Caplets

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