POLYETHYLENE GLYCOL 3350 NF

POLYETHYLENE GLYCOL 3350 NF is an FDA drug label for the active ingredient POLYETHYLENE GLYCOL 3350 manufactured by SUNRISE PHARMACEUTICAL, INC 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 20200122.

Generic: POLYETHYLENE GLYCOL 3350

Manufacturer: SUNRISE PHARMACEUTICAL, INC

Product Type: HUMAN OTC DRUG

Route: ORAL

Dosage Form:

NDC: 11534-180

Application: ANDA206105

Effective: 20200122

Active Ingredients: Active ingredient (in each dose) Polyethylene Glycol 3350, 17 g (cap filled to line)

Indications & Usage

Use relieves occasional constipation (irregularity) generally produces a bowel movement in 1 to 3 days

Dosage & Administration

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 (clear section in cap) adults and children 17 years of age and older: ○ fill to top of clear section 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

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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