Label: FLEET- bisacodyl tablet 

  • Label RSS
  • NDC Code(s): 0132-0704-02
  • Packager: C.B. Fleet Company, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 01/13

If you are a consumer or patient please visit this version.

  • Active Ingredient (in each tablet)

    Bisacodyl 5 mg.......................Stimulant Laxative

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  • Use

    For relief of occasional constipation.

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  • Warnings

    May cause abdominal discomfort, faintness and cramps.


    If pregnant or breast-feeding
    , ask a health professional before use.


    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
    Swallow tablets whole. It is important that you do not chew or crush. Do not give to children under 6 years of age, or to persons who cannot swallow without chewing, unless directed by a doctor.

    Do not take within 1 hour after taking an antacid, milk or milk products.


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  • Stop using this product and consult a doctor if you

    • have rectal bleeding
    • have no bowel movement after use

    These symptoms may indicate a serious condition.

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  • Keep out of reach of children

    In case of overdose, get medical help or contact a Poison Control Center right away.

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  • Directions

    Single Daily Dosage

    adults and children 12 years and over
    1 - 3 tablets
    children 6 to under 12 years
    1 tablet
    children under 6 years
    ask a doctor
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  • Other Information

    • this product generally produces bowel movement in 6-12 hours
    • each tablet is imprinted with "TCL 0003" for identification
    • store at temperatures not above 86F (30C)
    • do not use if foil imprinted with "Bisacodyl 5mg Laxative Tablet" is broken or missing
    • consult Physicians' Desk Reference for complete professional labeling
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  • Inactive Ingredients

    acacia, anhydrous lactose, beeswax, calcium sulfate, carnauba wax, collodial silicon dioxide, corn starch, DandC yellow 10 lake, FDandC yellow 6 lake, gelatin, magnesium stearate, microcrystalline cellulose, pharmaceutical glaze, polyvinyl acetate phthalate, povidone, sodium starch glycolate, stearic acid, sucrose, talc, titanium dioxide

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  • Questions?

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

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  • INGREDIENTS AND APPEARANCE
    FLEET 
    bisacodyl tablet
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:0132-0704
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Bisacodyl (Bisacodyl) Bisacodyl 5 mg
    Inactive Ingredients
    Ingredient Name Strength
    ACACIA  
    ANHYDROUS LACTOSE  
    YELLOW WAX  
    CALCIUM SULFATE  
    CARNAUBA WAX  
    SILICON DIOXIDE  
    STARCH, CORN  
    D&C YELLOW NO. 10  
    FD&C YELLOW NO. 6  
    GELATIN  
    MAGNESIUM STEARATE  
    CELLULOSE, MICROCRYSTALLINE  
    SHELLAC  
    POVIDONE  
    SODIUM STARCH GLYCOLATE TYPE A POTATO  
    STEARIC ACID  
    SUCROSE  
    TALC  
    TITANIUM DIOXIDE  
    Product Characteristics
    Color orange Score no score
    Shape ROUND Size 24mm
    Flavor Imprint Code TCL003
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0132-0704-02 25 in 1 CARTON
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part334 06/05/2002
    Labeler - C.B. Fleet Company, Inc. (003119054)
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