Label: GENTLE LAXATIVE FOR WOMEN STIMULANT LAXATIVE- bisacodyl tablet 

  • Label RSS
  • NDC Code(s): 41520-120-30
  • Packager: Care One (American Sales Company)
  • 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 07/14

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

  • Active ingredient (in each enteric 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 hat 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 pregnant or breast-feeding,

     ask a health professional 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 years 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

    • each tablet contains: calcium 15 mg
    • store between 20º-25ºC (68º-77ºF) 
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  • Inactive ingredients

    acacia, calcium sulfate anhydrous, carnauba wax, colloidal silicon dioxide, corn starch, D&C red # 7 calcium lake, hypromellose phthalate, iron oxide, iron oxide black, iron oxide yellow, kaolin, magnesium stearate, microcrystalline cellulose, polyethylene glycol (PEG) 400, povidone, shellac, sodium starch glycolate, stearic acid, sugar, talc, titanium dioxide, and triacetin

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  • ​Questions or Comments?

     Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

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  • Principal Display Panel

    Compare to the active ingredient in CORRECTOL® *

    Gentle Laxative for Women

    For gentle, dependable overnight relief 

    Stimulant Laxative

    Bisacodyl 5 mg

    Tablets

    *This product is not manufactured or distributed by MSD Consumer Care Inc., distributor of Correctol®.

    DISTRIBUTED BY FOODHOLD U.S.A., LLC

    LANDOVER, MD 20785

    1-877-846-9949

    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.

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  • Product Label

    Bisacodyl 5 mg

    Care One Gentle Laxative For Women

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  • INGREDIENTS AND APPEARANCE
    GENTLE LAXATIVE FOR WOMEN  STIMULANT LAXATIVE
    bisacodyl tablet
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:41520-120
    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  
    CARNAUBA WAX  
    SILICON DIOXIDE  
    STARCH, CORN  
    D&C RED NO. 7  
    HYPROMELLOSE PHTHALATE (24% PHTHALATE, 55 CST)  
    FERRIC OXIDE RED  
    FERROSOFERRIC OXIDE  
    FERRIC OXIDE YELLOW  
    KAOLIN  
    MAGNESIUM STEARATE  
    CELLULOSE, MICROCRYSTALLINE  
    POLYETHYLENE GLYCOL 400  
    POVIDONES  
    SHELLAC  
    SODIUM STARCH GLYCOLATE TYPE A CORN  
    STEARIC ACID  
    SUCROSE  
    TALC  
    TITANIUM DIOXIDE  
    TRIACETIN  
    Product Characteristics
    Color PINK Score no score
    Shape ROUND Size 11mm
    Flavor Imprint Code TCL057
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:41520-120-30 2 in 1 CARTON
    1 15 in 1 BLISTER PACK
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH NOT FINAL part334 07/15/2010
    Labeler - Care One (American Sales Company) (809183973)
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