Fleet by C.B. Fleet Company, Inc. FLEET- enema 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, Saline Laxative
Dibasic Sodium Phosphate 7 g, Saline Laxative

Use

For relief of occasional constipation

Warnings

For rectal use only.

Dosage warning:

Using more than one enema in 24 hours can be harmful. Do not use without asking a doctor:

• for more than 3 days
• if you have kidney disease
• if you have heart problems
• if you are dehydrated

Ask a doctor before using this product if you

• are 55 years or older
• are on a sodium-restricted diet

Ask a doctor before using any laxative if you have

• 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 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 or 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

Keep out of reach of children to prevent accidental ingestion.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Single Daily Dosage (per 24 hours).

Do not use more unless directed by a doctor. See Warnings.

Do not use if taking another sodium phosphates product.

• adults and children 12 years and over: 1 bottle per day
• children 2 to 11 years: Use Fleet Pedia-Lax Enema
• children under 2 years: DO NOT USE

Other Information

• each 118-mL delivered dose contains: sodium 4.4 g
• additional liquids by mouth are recommended while taking this product
• this product generally produces a bowel movement in 1-5 minutes
• BOTTLE SEALED FOR SAFETY. IF BOTTLE WRAPPER WITH FLEET EMBLEM IS TORN, DAMAGED OR MISSING, DO NOT USE.
• for complete professional use warnings and precautions, consult the Reference Safety Information on our website

Inactive Ingredients

benzalkonium chloride, disodium EDTA, purified water

Questions?

1-866-255-6960 or www.fleetlabs.com

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

FLEET 
enema enema

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0132-0119
Route of Administration	RECTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW) (SODIUM CATION - UNII:LYR4M0NH37)	SODIUM PHOSPHATE, MONOBASIC	19 g  in 133 mL
SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74) (SODIUM CATION - UNII:LYR4M0NH37)	SODIUM PHOSPHATE, DIBASIC	7 g  in 133 mL

Inactive Ingredients
Ingredient Name	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
EDETATE DISODIUM (UNII: 7FLD91C86K)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0132-0119-46	133 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product	05/26/2011

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	05/26/2011

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

Establishment
Name	Address	ID/FEI	Business Operations
C.B. Fleet Company, Inc.		003119054	manufacture(0132-0119)