WOMENS LAXATIVE (BISACODYL) TABLET, COATED [TOP CARE (TOPCO ASSOCIATES LLC)]

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WOMENS LAXATIVE (BISACODYL) TABLET, COATED [TOP CARE (TOPCO ASSOCIATES LLC)]
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NDC 36800-120-03
Set ID c634329b-56b8-4043-8270-40c0358f255b
Category HUMAN OTC DRUG LABEL
Packager TOP CARE (Topco Associates LLC)
Generic Name
Product Class
Product Number
Application Number PART334
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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
    • within 1 hour after taking an antacid or milk

    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 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.

  • 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

    • each tablet contains: calcium 15 mg
    • store between 20-25ºC (68-77ºF)
  • 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, povidone, shellac, sodium starch glycolate, stearic acid, sugar, talc, titanium dioxide, triacetin

  • Questions or comments?

    Call toll free 1-888-423-0139

  • Principal Display Panel

    COMPARE TO CORRECTOL® LAXATIVE ACTIVE INGREDIENT*

    Women's Gentle Laxative

    BISACODYL, 5 mg • STIMULANT LAXATIVE

    • Gentle, Predictable, Overnight Relief from Constipation

    ENTERIC COATED TABLETS

    GLUTEN FREE

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

    ELK GROVE VILLAGE, IL  60007

    topcare@topco.com

  • Product Label

    Bisacodyl USP 5 mg

    TOPCARE HEALTH Women's Gentle Laxative

  • INGREDIENTS AND APPEARANCE
    WOMENS LAXATIVE 
    bisacodyl tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-120
    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)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    HYPROMELLOSE PHTHALATE (24% PHTHALATE, 55 CST) (UNII: 87Y6436BKR)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    KAOLIN (UNII: 24H4NWX5CO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    POVIDONE (UNII: FZ989GH94E)  
    SHELLAC (UNII: 46N107B71O)  
    SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SUCROSE (UNII: C151H8M554)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIACETIN (UNII: XHX3C3X673)  
    Product Characteristics
    ColorPINKScoreno score
    ShapeROUNDSize11mm
    FlavorImprint Code TCL057
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:36800-120-032 in 1 CARTON05/31/201312/30/2022
    115 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart33405/31/201312/30/2022
    Labeler - TOP CARE (Topco Associates LLC) (006935977)
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