WOMANS LAXATIVE (BISACODYL) TABLET, COATED [HEALTHY ACCENTS (DZA BRANDS, LLC)]

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WOMANS LAXATIVE (BISACODYL) TABLET, COATED [HEALTHY ACCENTS (DZA BRANDS, LLC)]
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NDC 55316-174-65
Set ID 5dc02d4c-563b-483a-af15-47d2ef4868f5
Category HUMAN OTC DRUG LABEL
Packager Healthy Accents (DZA Brands, 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.

    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 may 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 older 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 20º-25ºC (68º-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, polythylene glycol (PEG 400), povidone, shellac, sodium starch glycolate, stearic acid, sugar, talc, titanium dioxide, triacetin

  • Questions or comments?

    Call toll free 1-866-322-2439

  • Principal Display Panel

    woman’s laxative

    bisacodyl, 5 mg

    stimulant laxative for gentle, dependable overnight relief

    compare to Correctol® active ingredient*

    coated tablets

    Distributed by: DZA Brands, LLC

    Salisbury, NC  28147

    Scarborough, ME  04074

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

    For product questions or concerns contact us at 1-866-322-2439. 

    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.

  • Package Label

    Bisacodyl 5 mg

    Healthy Accents Woman's Laxative Tablets

  • INGREDIENTS AND APPEARANCE
    WOMANS LAXATIVE 
    bisacodyl tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55316-174
    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)  
    FERROUS OXIDE (UNII: G7036X8B5H)  
    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
    ShapeROUNDSize10mm
    FlavorImprint Code TCL057
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55316-174-652 in 1 CARTON09/13/201012/31/2021
    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 FINALpart33409/13/201012/31/2021
    Labeler - Healthy Accents (DZA Brands, LLC) (090322194)
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