laxative
laxative is an FDA drug label for the active ingredient POLYETHYLENE GLYCOL 3350 manufactured by Rite Aid Corporation 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 20230210.
Generic: POLYETHYLENE GLYCOL 3350
Manufacturer: Rite Aid Corporation
Product Type: HUMAN OTC DRUG
Route: ORAL
Dosage Form:
NDC: 11822-1199
Application: ANDA090685
Effective: 20230210
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 (white section in cap) • adults and children 17 years of age and older: • use once a day • fill to top of white 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 • 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 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 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 (1-800-222-1222).
Adverse Reactions
Not available.
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