FLEET FOR CHILDREN- sodium phosphate, dibasic, heptahydrate, 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]

SPL UNCLASSIFIED SECTION

Drug Facts

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 after 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.

Directions

Single Daily Dosage

Do not use more unless directed by a doctor. See Warnings
children 5 to 11 years	One bottle or as directed by a doctor
children 2 to under 5 years	one-half bottle (see below)
children under 2 years	DO NOT USE

One-half bottle preparation: Unscrew cap and remove 2 tablespoons of liquid with a measuring spoon. Replace cap and follow DIRECTIONS on back of carton.

 

Other Information

Sodium Content 2.2 g

Inactive Ingredients

benzalkonium chloride, disodium EDTA, purified water

Questions?

C.B. Fleet Co., Inc.

4615 Murray Place

Lynchburg, VA 24502

U.S.A.

PRINCIPAL DISPLAY PANEL

Fleet
ready-to-use
enema for children.

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0132-0565
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 PHOSPHATE, DIBASIC, HEPTAHYDRATE	3.5 g  in 66 mL
SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW) (PHOSPHATE ION - UNII:NK08V8K8HR)	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: 0132-0565-40	66 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product	11/15/2009

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Export only		11/15/2009

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