Label: GENTLE LAXATIVE STIMULANT LAXATIVE- bisacodyl tablet, coated

  • NDC Code(s): 63868-908-25
  • Packager: QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 8, 2023

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  • 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. (1-800-222-1222).

  • 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 at 20-25ºC (68º-77ºF)
    •
    Protect from excessive humidity
  • 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?

    1-866-467-2748

  • Principal Display Panel

    NDC# 63868-908-25

    *Compare to the Active Ingredient in Dulcolax®

    Gentle Laxative

    Relieves Constipation & Irregularity

    Bisacodyl, USP 5 mg

    Relieves Constipation And Irregularity Overnight

    Comfort-Coated Tablets For Gentle, Predictable Constipation Relief

    25 TABLETS

    100% QC SATISFACTION GURANTEED

    *This product is not manufactured or distributed by Boehringer Ingelheim Pharmaceuticals, Inc., the owner of the registered trademark Dulcolax®.

    TAMPER EVIDENT: DO NOT USE IF any individual unit is broken or open.

    Distributed by C.D.M.A., Inc.

    43157 W. Nine Mile

    Novi, MI 48376-0995

    www.qualitychoice.com

    Questions: 248-449-9300

  • Product Label

    QC(CDMA) Gentle Laxative Bisacodyl USP 5mg

    QC(CDMA) Gentle Laxative

  • INGREDIENTS AND APPEARANCE
    GENTLE LAXATIVE  STIMULANT LAXATIVE
    bisacodyl tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-908
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BISACODYL (UNII: 10X0709Y6I) (DEACETYLBISACODYL - UNII:R09078E41Y) BISACODYL5 mg
    Inactive Ingredients
    Ingredient NameStrength
    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, UNSPECIFIED (UNII: 2G86QN327L)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    Polyvinyl Acetate Phthalate (UNII: 58QVG85GW3)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    SHELLAC (UNII: 46N107B71O)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SUCROSE (UNII: C151H8M554)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorORANGEScoreno score
    ShapeROUNDSize6mm
    FlavorImprint Code RP116
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63868-908-251 in 1 CARTON04/19/2019
    125 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00704/19/2019
    Labeler - QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION) (011920774)
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