Label: LAXATIVE- bisacodyl tablet, coated

  • 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 10/14

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 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 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

    • 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, 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?

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

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  • Principal Display Panel

    Laxative Tablets

    Bisacodyl, 5 mg

    Gentle, Predictable Overnight Relief From Constipation

    Enteric coated tablets

    Compare to the active ingredient in: Dulcolax®*

    *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: fred's Inc.

    4300 NEW GETWELL RD, MEMPHIS, TN 38118

    www.fredsinc.com

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  • Product Label

    Bisacodyl 5 mg

    Fred's Laxative tablets

     

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  • INGREDIENTS AND APPEARANCE
    LAXATIVE 
    bisacodyl tablet, coated
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:55315-190
    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  
    ALUMINUM OXIDE  
    GELATIN  
    FERRIC OXIDE RED  
    FERROSOFERRIC OXIDE  
    FERRIC OXIDE YELLOW  
    MAGNESIUM STEARATE  
    CELLULOSE, MICROCRYSTALLINE  
    POLYETHYLENE GLYCOL 400  
    Polyvinyl Acetate Phthalate  
    POVIDONES  
    SHELLAC  
    SODIUM STARCH GLYCOLATE TYPE A CORN  
    STEARIC ACID  
    TALC  
    TITANIUM DIOXIDE  
    SUCROSE  
    Product Characteristics
    Color ORANGE, YELLOW 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:55315-190-03 1 in 1 CARTON
    1 25 in 1 BLISTER PACK; Combination Product Type = C112160
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH NOT FINAL part334 07/08/2010
    Labeler - Freds Inc (005866116)
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