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

Fleet by

Drug Labeling and Warnings

Fleet 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 118-mL delivered dose)

Monobasic Sodium Phosphate 19 g.................Laxative / Bowel Cleanser

Dibasic Sodium Phosphate 7 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 you

• are on a sodium-restricted diet
• have kidney diseaseare pregnant or nursing a baby

Ask a doctor before using any laxative if you:

• have abdominal pain, nausea, or vomiting
• have a sudden change in bowel habits lasting more than 2 weeks
• have already used a laxative for more than 1 week

Stop using this product and consult a doctor if you

• have rectal bleeding
• have 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

• Adults and children 12 years and over: One Bottle
• Children 2 to 11 years: Use Fleet Enema for Children
• Children under 2 years: Do Not Use

Other Information

Sodium Content 4.4 g

Inactive Ingredients

benzalkonium chloride, disodium EDTA, purified water

Questions?

C.B. Fleet Co., Inc.

Lynchburg, VA 24502

U.S.A.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

FLEET 
sodium phosphate, dibasic and sodium phosphate, monobasic enema

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0132-0546
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	7 g  in 133 mL
SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW) (PHOSPHATE ION - UNII:NK08V8K8HR, SODIUM CATION - UNII:LYR4M0NH37)	SODIUM PHOSPHATE, MONOBASIC	19 g  in 133 mL

Inactive Ingredients
Ingredient Name	Strength
EDETATE DISODIUM (UNII: 7FLD91C86K)
WATER (UNII: 059QF0KO0R)
BENZETHONIUM CHLORIDE (UNII: PH41D05744)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0132-0546-40	133 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
export only		01/01/2016

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

Establishment
Name	Address	ID/FEI	Business Operations
C.B. Fleet Company, Inc.		003119054	manufacture(0132-0546)