polyethylene glycol 3350, sodium chloride, sodium bicarbonate, potassium chloride

FDA Drug Profile — PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride

Drug Details

Generic Name
polyethylene glycol 3350, sodium chloride, sodium bicarbonate, potassium chloride
Brand Names
PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride
Application Number
NDA019797
Sponsor
Affordable Pharmaceuticals, LLC
NDC Codes
1
Dosage Forms
POWDER, FOR SOLUTION
Routes
ORAL
Active Ingredients
POLYETHYLENE GLYCOL 3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE

Indications and Usage

1 INDICATIONS AND USAGE PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution is indicated for bowel cleansing prior to colonoscopy in adults and pediatric patients aged 6 months or greater. PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution is a combination of PEG 3350, an osmotic laxative, and electrolytes indicated for cleansing of the colon in preparation for colonoscopy in adults and pediatric patients aged 6 months or greater ( 1 )