Label: WOMANS LAXATIVE- bisacodyl tablet, coated

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by 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 March 20, 2013

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  • Active ingredient (in each enteric coated tablet)

     Bisacodyl 5mg

  • Purpose

     Stimulant laxative

  • Use

    • for relief of occasional constipation and irregularity. This product generally produces bowel movement within 8 to 12 hours if taken at bedtime or within 6 hours if taken before breakfast.
  • Warnings

    Do not use

    • if you are currently taking mineral oil, unless directed by a doctor
    • when abdominal pain, nausea, or vomiting are present
    • for longer than 1 week, unless directed by a doctor. Prolonged or continued use of this product can lead to laxative dependency and loss of normal bowel function. Serious side effects from prolonged use or overdose can occur

    Caution

    • do not chew or crush
    • do not give to children under 6 years of age or to persons who cannot swallow without chewing
    • do not take this product within 1 hour after taking an antacid and/or milk
    • this product may cause abdominal discomfort, faintness, rectal burning, and mild cramps

    Ask a doctor before use if

    • you notice a sudden change in bowel habits that persists over a period of 2 weeks.

    Stop use and ask a doctor if

    • you have rectal bleeding
    • you fail to have a bowel movement after use of a laxative

    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

    • do not take more than 3 tablets daily 
     adults and children 12 years of age and older take 1-3 tablets in a single dose once daily
     children 6 to under 12 years of age take 1 tablet daily
     children under 6 years of age consult a doctor
  • Other information

    • each tablet contains: calcium 15 mg/tablet
    • store at 15º-30ºC (59º-86ºF)
    • keep in a dry place
    • *This product is not manufactured or distributed by Schering-Plough, owner of the registered trademark Correctol®.
  • 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 (PEG) 400, povidone, shellac, sodium starch glycolate, stearic acid, sugar, talc, titanium dioxide, and triacetin

  • Principal Display Panel

     Woman's Laxative Tablets

    Stimulant Laxative for gentle, dependable overnight relief

    Bisacodyl, 5 mg Tablets

    *Compare to Correctol® Active ingredient

    Call toll free 1-877-753-3935

    TAMPER EVIDENT

    USE ONLY IF BLISTERS ARE INTACT.

  • PRODUCT LABEL

    BISACODYL, 5 MG

    WOMANS LAXATIVE TABLETS

     

  • INGREDIENTS AND APPEARANCE
    WOMANS LAXATIVE 
    bisacodyl tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37012-120
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BISACODYL (UNII: 10X0709Y6I) (BISACODYL - UNII:10X0709Y6I) 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)  
    POVIDONES (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:37012-120-302 in 1 CARTON
    115 in 1 BLISTER PACK
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart33407/09/2010
    Labeler - Shopko Stores Operating Co., LLC. (023252638)
    Registrant - P and L Development of New York Corporation (800014821)
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