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Gentle Laxative (Care One (American Sales Company))

Available Formats

Dosage Form Package Information Links
TABLET, COATED 1 BLISTER PACK in 1 CARTON (41520-019-25) > 25 TABLET, COATED in 1 BLISTER PACK Label Information

Complete Gentle Laxative Information

  • Active ingredient (in each tablet)

    Bisacodyl USP 5 mg


  • Purpose

    Stimulant laxative


  • Use

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

  • 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 professional before use.

    Keep out of reach of children.

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


  • 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

  • Other information

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

  • 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


  • Questions or comments?

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


  • Principal Display Panel

    Compare to the Active Ingredient of Dulcolax® Laxative

    Gentle Laxative

    Bisacodyl 5 mg

    GENTLE YET EFFECTIVE STIMULANT LAXATIVE

    TABLETS

    Enteric Coated

    *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 Foodhold U.S.A., LLC

    LANDOVER, MD 20785

    1-877-846-9949


  • Product Label

    Bisacodyl USP 5 mg

    CareOne Gentle Laxative


  • INGREDIENTS AND APPEARANCE
    GENTLE LAXATIVE  STIMULANT LAXATIVE
    bisacodyl tablet, coated
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:41520-019
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    BISACODYL (UNII: 10X0709Y6I) (BISACODYL - UNII:10X0709Y6I) BISACODYL 5 mg
    Inactive Ingredients
    Ingredient Name Strength
    ACACIA (UNII: 5C5403N26O)  
    CALCIUM SULFATE ANHYDROUS (UNII: E934B3V59H)  
    ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    GELATIN (UNII: 2G86QN327L)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    SHELLAC (UNII: 46N107B71O)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Polyvinyl Acetate Phthalate (UNII: 58QVG85GW3)  
    SUCROSE (UNII: C151H8M554)  
    POVIDONE (UNII: FZ989GH94E)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    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:41520-019-25 1 in 1 CARTON 09/30/2010
    1 25 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH NOT FINAL part334 09/30/2010
    Labeler - Care One (American Sales Company) (809183973)