polyethylene glycol-3350 and electrolytes with Flavor Pack

FDA Drug Profile — GaviLyte - C TM

Drug Details

Generic Name
polyethylene glycol-3350 and electrolytes with Flavor Pack
Brand Names
GaviLyte - C TM
Application Number
ANDA090186
Sponsor
Lupin Pharmaceuticals,Inc.
NDC Codes
1
Dosage Forms
POWDER, FOR SOLUTION
Routes
ORAL
Active Ingredients
POLYETHYLENE GLYCOL 3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE, SODIUM SULFATE ANHYDROUS

Indications and Usage

INDICATIONS AND USAGE GaviLyte- C with flavor pack is indicated for bowel cleansing prior to colonoscopy or barium enema X-ray examination.

Warnings

WARNINGS Flavor pack is for use only in combination with the contents of the accompanying 4 liter container. No other additional ingredients (e.g., flavorings) should be added to the solution. GaviLyte- C with flavor pack should be used with caution in patients with severe ulcerative colitis.