Label: BISACODY ENTERIC COATED- bisacodyl tablet, coated

  • NDC Code(s): 36800-190-25
  • Packager: TOP CARE (Topco Associates LLC)
  • 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 06/14

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

  • Active ingredient (in each tablet)

     Bisacodyl USP 5 mg

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  • Purpose

     Stimulant laxative

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  • Use

    • for temporary relief of occasional constipation and irregularity
    • this product generally produces a bowel movement in 6 to 12 hours
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  • Warnings

    Do not use

    if you cannot swallow without chewing.

    Ask a doctor before use if you have

    • stomach pain, nausea or vomiting
    • a sudden change in bowel habits that lasts more than 2 weeks

    When using this product

    • do not chew or crush tablet(s)
    • do not use within 1 hour after taking an antacid or milk
    • it may cause stomach discomfort, faintness and cramps

    Stop use and ask a doctor if

    • you have rectal bleeding or no bowel movement after using this product. These could be signs of a serious condition.
    • you need to use a laxative for more than 1 week

    If pregnancy or breast-feeding,

     ask a health professions before use.

    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

    • take with a glass of water
     adults and children 12 yers of age and over   take 1 to 3 tablets in a single daily dose 
     children 6 to under 12 years of age  take 1 tablet in a single daily dose
     children under 6 years of age  ask a doctor
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  • Other information

    •  store between 20º-25ºC (68º-77ºF)
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  • Inactive ingredients

    acacia, anhydrous calcium sulfate, anhydrous lactose, carnauba wax, colloidal silicon dioxide, corn starch, D&C yellow #10 aluminum lake, FD&C yellow #6 aluminum lake, gelatin, iron oxide, iron oxide black, iron oxide yellow (iron oxide ochre), magnesium stearate, microcrystalline cellulose, polyethylene glycol (PEG) 400, polyvinyl acetate phthalate, povidone, shellac, sodium starch glycolate, stearic acid, sugar, talc, and titanium dioxide

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  • Questions or comments?

    Cal toll free 1-888-423-0139

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  • Principal Display Panel

    OVERNIGHT RELIEF

    Laxative Tablets

    Bisacodyl, USP 5 mg

    • Gentle, predictable, overnight relief from constipation

    COMPARE TO DULCOLAX® active ingredient*

    Enteric Coated Tablets

    *This product is not manufactured or distributed by Boehringer Ingelheim Pharmaceuticals, Inc.,distributor of Dulcolax® Laxative.

    TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING.

    KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

    DISTRIBUTED BY TOPCO ASSOCIATES LLC

    ELK GROVE VILLAGE, IL  60077

    QUESTIONS? 1-888-423-0139

    topcare@topco.com

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  • Product Label

    Bisacodyl 5 mg

    Top Care Laxative Tablet

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  • INGREDIENTS AND APPEARANCE
    BISACODY  ENTERIC COATED
    bisacodyl tablet, coated
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:36800-190
    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  
    CALCIUM SULFATE ANHYDROUS  
    ANHYDROUS LACTOSE  
    CARNAUBA WAX  
    SILICON DIOXIDE  
    STARCH, CORN  
    D&C YELLOW NO. 10  
    FD&C YELLOW NO. 6  
    GELATIN  
    MAGNESIUM STEARATE  
    CELLULOSE, MICROCRYSTALLINE  
    SHELLAC  
    SODIUM STARCH GLYCOLATE TYPE A POTATO  
    STEARIC ACID  
    TALC  
    TITANIUM DIOXIDE  
    Polyvinyl Acetate Phthalate  
    SUCROSE  
    POVIDONES  
    FERRIC OXIDE RED  
    FERRIC OXIDE YELLOW  
    FERROSOFERRIC OXIDE  
    POLYETHYLENE GLYCOLS  
    Product Characteristics
    Color ORANGE Score no score
    Shape ROUND Size 6mm
    Flavor Imprint Code TCL003
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:36800-190-25 1 in 1 CARTON
    1 25 in 1 BLISTER PACK
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH NOT FINAL part334 01/10/2013
    Labeler - TOP CARE (Topco Associates LLC) (006935977)
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