Label: THE MEDICINE SHOPPE GENTLE LAXATIVE- bisacodyl tablet

  • NDC Code(s): 49614-131-63
  • Packager: The Medicine Shoppe International
  • 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 02/12

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

  • Active ingredient(s)

    Bisacodyl USP 5 mg

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  • Purpose

    Stimulant Laxative

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  • Use(s)

    • for temporary relief of occasional constipation and irregularity
    • this product generally produces 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)
    • it may cause stomach discomfort, faintness or cramps
    • do not use within 1 hour after taking an antacid or milk

    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 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: sodium less than 0.5mg
    • store at 20°-25°C (68°-77°F)
    • protect from excessive humidity
    • TAMPER EVIDENT: Blister packaged for your protection. Do not use if individual seals are broken
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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, magnesium stearate, microcrystalline cellulose, polyethylene glycol (PEG) 400, polyvinyl acetate phthalate, povidone, shellac, sodium starch glycolate, stearic acid, sugar, talc, titanium dioxide.


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  • Principal Display Panel

    The Medicine Shoppe

    Gentle Laxative

    Overnight Relief of Constipation and Irregularity

    *Compare to the active ingredient of Dulcolax®

    LAXATIVE

    Bisacodyl USP, 5 mg

    25 Coated Tablets

     

    CIN 1796986

    Distributed By:

    The Medicine Shoppe International, Inc.

    Earth City MO 63045

    www.medicineshoppe.com

    A Cardinal Health Company

    Questions? 1-800-325-1397

    Medicine Shoppe Gentle Laxative 25ct
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  • INGREDIENTS AND APPEARANCE
    THE MEDICINE SHOPPE GENTLE LAXATIVE 
    bisacodyl tablet
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:49614-131
    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  
    FERROSOFERRIC OXIDE  
    FERRIC OXIDE YELLOW  
    MAGNESIUM STEARATE  
    CELLULOSE, MICROCRYSTALLINE  
    POLYETHYLENE GLYCOL 400  
    POLYVINYL ACETATE PHTHALATE  
    POVIDONE  
    SHELLAC  
    SODIUM STARCH GLYCOLATE TYPE A POTATO  
    STEARIC ACID  
    SUCROSE  
    TALC  
    TITANIUM DIOXIDE  
    Product Characteristics
    Color ORANGE Score no score
    Shape ROUND Size 6mm
    Flavor Imprint Code TCL;003
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:49614-131-63 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 10/14/2011
    Labeler - The Medicine Shoppe International (071997654)
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