GAVILAX

GAVILAX is an FDA drug label for the active ingredient POLYETHYLENE GLYCOL 3350 manufactured by Proficient Rx LP administered by ORAL. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20220601.

Generic: POLYETHYLENE GLYCOL 3350

Manufacturer: Proficient Rx LP

Product Type: HUMAN OTC DRUG

Route: ORAL

Dosage Form:

NDC: 63187-368

Application: ANDA091077

Effective: 20220601

Active Ingredients: Active Ingredient Polyethylene Glycol 3350, 17 g (cap filled to line)

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: • 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

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.

Contraindications

Not available.

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

Adverse Reactions

Not available.

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