Polyethylene Glycol

POLYETHYLENE GLYCOL ORAL HUMAN OTC DRUG

Polyethylene Glycol is an FDA drug label for the active ingredient POLYETHYLENE GLYCOL manufactured by BluePoint Laboratories 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 20210920.

Generic name
POLYETHYLENE GLYCOL
Manufacturer
BluePoint Laboratories
Product type
HUMAN OTC DRUG
Route
ORAL
Dosage form
N/A
NDC
68001-505
Application
ANDA091077
Label effective
20210920

Active ingredients

ACTIVE INGREDIENT 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. 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

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.