Fleet by C.B. Fleet Company, Inc. FLEET- bisacodyl 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 30-mL delivered dose)

Bisacodyl 10 mg, Stimulant Laxative / Bowel Cleanser

Use

Use for relief of occasional constipation or bowel cleansing before rectal examinations

Warnings

For rectal use only

This product may cause abdominal discomfort, faintness, rectal burning, and mild cramps

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 within 20 minutes of enema use

These symptoms may indicate a serious condition.

Keep out of reach of children

Keept 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)

• adults and children 12 years and over: 1 bottle per day
• children under 12 years: DO NOT USE

Other information

• this product generally produces a bowel movement in 5-20 minutes
• store at temperatures not above 86F (30C)
• For complete professional use warnings and precautions, consult the Reference Safety Information on our website
• BOTTLE SEALED FOR SAFETY. IF BOTTLE WRAPPER WITH FLEET EMBLEM IS TORN, DAMAGED OR MISSING, DO NOT USE

Inactive ingredients

carbomer 934P, glycerin, methylparaben, octoxynol-9, propylparaben, purified water, sodium hydroxide

Questions?

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

FLEET 
bisacodyl enema

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0132-0703
Route of Administration	RECTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BISACODYL (UNII: 10X0709Y6I) (DEACETYLBISACODYL - UNII:R09078E41Y)	BISACODYL	10 mg  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31)
GLYCERIN (UNII: PDC6A3C0OX)
METHYLPARABEN (UNII: A2I8C7HI9T)
OCTOXYNOL 9 (UNII: 7JPC6Y25QS)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0132-0703-36	37 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product	05/10/2002

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	05/10/2002

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

Establishment
Name	Address	ID/FEI	Business Operations
C.B. Fleet Company, Inc.		003119054	manufacture(0132-0703)