FLEET FOR CHILDREN- sodium phosphate, dibasic and sodium phosphate, monobasic enema

Fleet for Children by

Drug Labeling and Warnings

Fleet for Children by is a Otc medication manufactured, distributed, or labeled by C.B. Fleet Company, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient (in each 59-mL delivered dose)

Monobasic Sodium Phosphate 9.5 g.................Laxative / Bowel Cleanser

Dibasic Sodium Phosphate 3.5 g......................Laxative / Bowel Cleanser

Use

For relief of occasional constipation or bowel cleansing before rectal examinations.

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.

Keep out of reach of children

In case of overdose or accidental ingestion, get medical help right away.

Other Information

Sodium Content 2.2 g

Inactive Ingredients

benzalkonium chloride, disodium EDTA, purified water

Questions?

C.B. Fleet Co., Inc.

Lynchburg, VA 24502

U.S.A.

PRINCIPAL DISPLAY PANEL

Directions

• children 5 to 11 years: One bottle or as directed by a doctor
• children 2 to under 5 years: One-half bottle
• children under 2 years: DO NOT USE

 

INGREDIENTS AND APPEARANCE

FLEET FOR CHILDREN 
sodium phosphate, dibasic and sodium phosphate, monobasic enema

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0132-0529
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
EDETATE DISODIUM (UNII: 7FLD91C86K)
WATER (UNII: 059QF0KO0R)
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0132-0529-20	66 mL in 1 BOTTLE, WITH APPLICATOR

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
export only		08/02/2007

Labeler - C.B. Fleet Company, Inc. (003119054)

Establishment
Name	Address	ID/FEI	Business Operations
C.B. Fleet Company, Inc.		003119054	manufacture(0132-0529)