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GAVILAX POLYETHYLENE GLYCOL 510G 1 BOTTLE

Generic: Polyethylene Glycol 3350

NDC:43386-0312-14

Manufacturer:Lupin Pharmaceuticals,Inc.

Strength:17 g/17g

Dosage Form:POWDER, FOR SOLUTION

Route:ORAL

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Drug Information

Identification

Generic Name

Polyethylene Glycol 3350

Brand Name

GAVILAX

Labeler / Distributor

Lupin Pharmaceuticals,Inc.

Product Type

HUMAN OTC DRUG

Administration

Dosage Form

POWDER, FOR SOLUTION

Route of Administration

ORAL

FDA Application Number

ANDA091077

Active Ingredients

Ingredient	Strength
POLYETHYLENE GLYCOL 3350	17 g/17g

Pharmacological Class

Osmotic Activity [MoA]Osmotic LaxativeStimulation Large Intestine Fluid/Electrolyte Secretion [PE]

Data sourced from openFDA / DailyMed. For full prescribing information, consult the drug label.

Wholesale compliance resources

DSCSA T2 documents DSCSA compliance resource hub

Drug Resources

Polyethylene glycol 3350 Drug Page NDC 43386-0312-14 Lookup

Clinical Drug Information

Indications & Usage

Directions 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: use once a day 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 do not combine with starch-based thickeners used for difficulty swallowing ensure that the powder is fully dissolved before drinking do not drink if there are any clumps do not use 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, printed with "SEALED for YOUR PROTECTION" is missing, open or broken

Warnings

WARNINGS 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

Dosage & Administration

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 If pregnant or breast-feeding, ask a health professional before use.

Clinical data sourced from openFDA drug labeling. For complete prescribing information, consult the full drug label.