T
Dosage Form: tablet, chewable
Topco Complete Acid Reducer plus Antacid Drug Facts
Active ingredient (in each chewable tablet)
Famotidine 10 mg
Calcium carbonate 800 mg
Magnesium hydroxide 165 mg
Purpose
Acid reducer
Antacid
Uses
relieves heartburn associated with acid indigestion and sour stomach
Warnings
Allergy alert: Do not use if you are allergic to famotidine or other acid reducers
Do not use
if you have trouble or pain swallowing food, vomiting with blood, or bloody or black stools. These may be signs of a serious condition. See your doctor.
with other acid reducers
Ask a doctor before use if you have
had heartburn over 3 months. This may be a sign of a more serious condition.
heartburn with lightheadedness, sweating, or dizziness
chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness
frequent chest pain
frequent wheezing, particularly with heartburn
unexplained weight loss
nausea or vomiting
stomach pain
Ask a doctor or pharmacist before use if you are
presently taking a prescription drug. Antacids may interact with certain prescription drugs.
Stop use and ask a doctor if
your heartburn continues or worsens
you need to take this product for more than 14 days
If pregnant or breast-feeding,
ask a health professional before use.
Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center right away.
Directions
adults and children 12 years and over:
do not swallow tablet whole: chew completely
to relieve symptoms, chew 1 tablet before swallowing
do not use more than 2 chewable tablets in 24 hours
children under 12 years: ask a doctor
Other information
each tablet contains: calcium 320 mg; magnesium 65 mg
Phenylketonurics: Contains Phenylalanine 2.2 mg per tablet
read the directions and warnings before use
read the bottle label. It contains important information.
store at 20°-25°C (68°-77°F)
protect from moisture
Inactive ingredients
aspartame, D&C red no. 7 calcium, dextrates, FD&C blue no. 1 lake, FD&C red no. 40 lake, flavor, glyceryl monostearate, lactose anhydrous, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyacrylate dispersion, polysorbate 80, povidone, pregelatinized starch, sodium starch glycolate, talc
Questions or comments?
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Dual Action
Complete
Famotidine 10 mg/Calcium Carbonate 800 mg/Magnesium Hydroxide 165 mg Tablets
Acid Reducer plus Antacid
Just One Tablet
Relieves Heartburn Due to Acid Indigestion
Berry Flavor
Actual Size
Compare to Pepcid® Complete active ingredients
Complete Acid Reducer plus Antacid Label
TOPCARE COMPLETE
famotidine, calcium carbonate and magnesium hydroxide tablet, chewable
Product Information
Product Type
HUMAN OTC DRUG
NDC Product Code (Source)
36800-321
Route of Administration
ORAL
DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name
Basis of Strength
Strength
FAMOTIDINE (FAMOTIDINE)
FAMOTIDINE
10 mg
MAGNESIUM HYDROXIDE (MAGNESIUM HYDROXIDE)
MAGNESIUM HYDROXIDE
165 mg
CALCIUM CARBONATE (CARBONATE ION)
CALCIUM CARBONATE
800 mg
Inactive Ingredients
Ingredient Name
Strength
No Inactive Ingredients Found
Product Characteristics
Color
PINK (mottled)
Score
no score
Shape
ROUND (bi-layered)
Size
17mm
Flavor
BERRY
Imprint Code
L321
Contains
Packaging
#
NDC
Package Description
Multilevel Packaging
1
36800-321-63
25 TABLET In 1 BOTTLE
None
2
36800-321-71
50 TABLET In 1 BOTTLE
None
3
36800-321-09
65 TABLET In 1 BOTTLE
None
Marketing Information
Marketing Category
Application Number or Monograph Citation
Marketing Start Date
Marketing End Date
ANDA
ANDA077355
08/05/2008
Labeler - Topco Associates LLC (006935977)
Revised: 05/2009Topco Associates LLC
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