Label: FLEET- bisacodyl enema

  • NDC Code(s): 0132-0703-36
  • Packager: C.B. Fleet Company, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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.

Drug Label Information

Updated September 28, 2017

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  • 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

    Fleet Bisacodyl Enema Carton

  • INGREDIENTS AND APPEARANCE
    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)
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