FLEET- bisacodyl enema 
C.B. Fleet Company, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

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

Stop use and ask a doctor if you have

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

Inactive ingredients

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

Questions?

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

Fleet Bisacodyl Enema Carton

FLEET 
bisacodyl enema
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0132-0703
Route of AdministrationRECTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BISACODYL (UNII: 10X0709Y6I) (DEACETYLBISACODYL - UNII:R09078E41Y) BISACODYL10 mg  in 30 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0132-0703-3637 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product05/10/2002
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33405/10/2002
Labeler - C.B. Fleet Company, Inc. (003119054)
Establishment
NameAddressID/FEIBusiness Operations
C.B. Fleet Company, Inc.003119054manufacture(0132-0703)

Revised: 9/2017
Document Id: 36be417e-8635-49a0-930e-12d1d4b86dcf
Set id: 324e61eb-8f6b-48d7-85c2-b1b5642691c9
Version: 4
Effective Time: 20170928
 
C.B. Fleet Company, Inc.