Label: FLEET FOR CHILDREN- sodium phosphate, dibasic and sodium phosphate, monobasic enema
- NDC Code(s): 0132-0555-20
- Packager: C.B. Fleet Company, Inc.
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated November 12, 2021
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active Ingredient (in each 59-mL delivered dose)
- Purpose
- Use
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Warnings
Using more than one enema in 24 hours can be harmful.
Ask a doctor before using this product if the child
- is on a sodium-restricted diet
- has kidney disease
Ask a doctor before using any laxative if the child has:
- abdominal pain, nausea, or vomiting
- a sudden change in bowel habits lasting more than 2 weeks
- already used a laxative for more than 1 week
Stop use and consult a doctor if the child has
- rectal bleeding
- no bowel movement ater the enema is given
These symptoms may indicate a serious condition.
- is on a sodium-restricted diet
- Keep out of reach of children
- Inactive Ingredients
- Questions?
- Directions
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
FLEET FOR CHILDREN
sodium phosphate, dibasic and sodium phosphate, monobasic enemaProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0132-0555 Route of Administration RECTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE (UNII: 70WT22SF4B) (PHOSPHATE ION - UNII:NK08V8K8HR, SODIUM CATION - UNII:LYR4M0NH37) SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE 3.5 g in 66 mL SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW) (PHOSPHATE ION - UNII:NK08V8K8HR, SODIUM CATION - UNII:LYR4M0NH37) SODIUM PHOSPHATE, MONOBASIC 9.5 g in 66 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) EDETATE DISODIUM (UNII: 7FLD91C86K) BENZETHONIUM CHLORIDE (UNII: PH41D05744) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0132-0555-20 66 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product 01/01/1980 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Export only 01/01/1980 Labeler - C.B. Fleet Company, Inc. (003119054) Establishment Name Address ID/FEI Business Operations C.B. Fleet Company, Inc. 003119054 manufacture(0132-0555)