InstaLax Polyethylene Glycol 3350

FDA Drug Profile — Polyethylene Glycol 3350

Drug Details

Generic Name
InstaLax Polyethylene Glycol 3350
Brand Names
Polyethylene Glycol 3350
Application Number
ANDA203928
Sponsor
Sun Pharmaceutical Industries, Inc.
NDC Codes
1
Dosage Forms
POWDER, FOR SOLUTION
Routes
ORAL
Active Ingredients
POLYETHYLENE GLYCOL 3350

Indications and Usage

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

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 the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.