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polyethylene glycol-3350
Dosage Form: powder, for solution
Gavilax (Polyethylene Glycol 3350, Powder for Oral Solution) DESCRIPTION

Drug Facts

Active Ingredient (in each dose)…………………     Purpose

Polyethylene Glycol 3350, 17 g (cap filled to line).......Laxative


relieves occasional constipation (irregularity)

generally produces a bowel movement in 1 to 3 days


Allergy alert: Do not use if you are allergic to polyethylene glycol

Do not use if you have kidney disease, except under the advice and supervision of a doctor

Ask a doctor before use if you have

nausea, vomiting or abdominal pain

a sudden change in bowel habits that lasts over 2 weeks

irritable bowel syndrome

Ask a doctor or pharmacist before use if you are taking a prescription drug

When using this product you may have loose, watery, more frequent stools

Stop use and ask a doctor if

you have rectal bleeding or your nausea, bloating, cramping or abdominal pain gets worse. These may be signs of a serious condition.

you get diarrhea

you need to use a laxative for longer than 1 week

side effects occur.

Drug Facts (continued)

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.


do not take more than directed unless advised by your doctor

the bottle top is a measuring cap marked to contain 17 grams of powder when filled to the indicated line.

adults and children 17 years of age and older:

fill to top of line in cap which is marked to indicate the correct dose (17 g)

stir and dissolve in any 4 to 8 ounces of beverage (cold, hot or room temperature) then drink

use once a day

use no more than 7 days

children 16 years of age or under: ask a doctor

Other Information

store at 20° - 25°C (68°– 77°F)

tamper-evident: do not use if printed foil seal under cap is missing, open or broken

Inactive Ingredients           none

Questions or comments?


polyethylene glycol-3350  powder, for solution Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 43386-312 Route of Administration ORAL DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength POLYETHYLENE GLYCOL 3350 (POLYETHYLENE GLYCOL 3350) POLYETHYLENE GLYCOL 3350 17 g Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found Product Characteristics Color WHITE Score      Shape Size Flavor Imprint Code Contains          Packaging # NDC Package Description Multilevel Packaging 1 43386-312-08 14 DOSE PACK In 1 BOTTLE None 2 43386-312-14 30 DOSE PACK In 1 BOTTLE None
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA091077 10/09/2009
Labeler - GAVIS Pharmaceuticals, LLC (829838551) Contact Address Telephone Number Email Address Anu Radha Subramanian Address: 400 Campus Drive City, State, Zip: Somerset, NJ, 08873 Country: USA ++1908-603-6080 Registrant - Novel Laboratories, Inc. (793518643) Establishment Name Address ID/FEI Operations Novel Laboratories, Inc. 793518643 manufacture, repack, MANUFACTURE, ANALYSIS, ANALYSIS Establishment Name Address ID/FEI Operations Dow Chemical Company 801038019 api manufacture, MANUFACTURE Revised: 10/2009GAVIS Pharmaceuticals, LLC
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