sodium phosphate, dibasic and sodium phosphate, monobasic

FDA Drug Profile — Fleet, Pedia-Lax

Drug Details

Generic Name
sodium phosphate, dibasic and sodium phosphate, monobasic
Brand Names
Fleet, Pedia-Lax
Application Number
M007
Sponsor
C.B. Fleet Company, Inc.
NDC Codes
3
Dosage Forms
ENEMA
Routes
RECTAL
Active Ingredients
SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE, SODIUM PHOSPHATE, MONOBASIC

Indications and Usage

Use for relief of occasional constipation. This product usually produces a bowel movement in 1 to 5 minutes.

Warnings

Warnings For rectal use only. Using more than one enema in 24 hours can be harmful. Do not use • for more than 3 days • if you have kidney disease • if you have heart problems • if you are dehydrated • when abdominal pain, nausea, or vomiting are present unless directed by a doctor Ask a doctor before using this product if you • are 55 years of age or older • are on a sodium-restricted diet • have a sudden change in bowel habits lasting more than 2 weeks • already used a laxative for more than 1 week Stop use and ask a doctor if you have • rectal bleeding • no bowel movement or no liquid comes out of the rectum after 30 minutes • symptoms of dehydration [feeling thirsty, dizziness, vomiting, urinating less often than normal] These symptoms may indicate a serious condition. If pregnant or breast-feeding , ask a health professional before use. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.