Label: FLEET- bisacodyl enema

  • NDC Code(s): 0132-0703-36
  • Packager: C.B. Fleet Company, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 18, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each 30 mL delivered dose)  

  • Purpose

    Bisacodyl 10 mg .............Stimulant laxative/ bowel cleanser

  • Uses

    • for relief of fecal impaction
    • for relief of occasional constipation
    • for removal of residue after barium administration

    This product usually produces a bowel movement in 5 to 20 minutes.

  • Warnings

    For rectal use only.

    Do not use

    when abdominal pain, nausea, or vomiting are present unless directed by a doctor.

    Ask a doctor before using this product if you

    • have a sudden change in bowel habits lasting more than 2 weeks
    • already used a laxative for more than 1 week

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

    Stop use and ask a doctor if you have

          • rectal bleeding

          • no bowel movement within 20 minutes of using this product.

    These symptoms may indicate a serious condition.

    If pregnant or breast-feeding,

    ask a health professional before use. 

    Keep out of reach of children.

    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

    • store at temperatures not above 86˚ F (30˚ C)

  • Inactive ingredients

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

  • Questions?

    or www.fleetlabs.com

    Tamper Evident: bottle sealed for safety. If bottle wrapper with fleet emblem is torn, damaged or missing, do not use.

  • PRINCIPAL DISPLAY PANEL

    Fleet
    Laxative
    bisacodyl
    Enema

    PRINCIPAL DISPLAY PANEL Fleet Laxative bisacodyl Enema

  • 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 DrugM00705/10/2002
    Labeler - C.B. Fleet Company, Inc. (003119054)
    Establishment
    NameAddressID/FEIBusiness Operations
    C.B. Fleet Company, Inc.003119054manufacture(0132-0703)
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