Label: WOMENS GENTLE LAXATIVE- bisacodyl tablet, delayed release

  • NDC Code(s): 72476-960-25
  • Packager: RETAIL BUSINESS SERVICES, LLC
  • 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 May 2, 2023

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  • Drug Facts

  • Active Ingredient (in each softgel)

    Bisacodyl (USP) 5 mg

  • Purpose

    Stimulant laxative

  • Uses

    • for temporary relief of occasional constipation and irregularity
    • this product generally produces 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)
    • it may cause stomach discomfort, faintness and cramps
    • do not use within 1 hour after taking an antacid or milk

    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 1(800)222-1222

  • Directions

    adults and children 12 years and over1 to 3 tablets in a single daily dose
    children 6 to under 12 years of age1 tablet in a single daily dose
    children under 6 years of ageask a doctor

  • Other Information

    • store at 20-25°C (68-77°F)
    • protect from excessive humidity
  • Inactive ingredients

    dextrose monohydrate, D&C Red #27, FD&C Blue #1, hypromellose, lactose monohydrate, lecithin, magnesium stearate, maltodextrin, methacrylic acid copolymer, methyl cellulose, pregelatinized starch, silica, sodium bicarbonate, sodium lauryl sulfate, talc, titanium dioxide, triacetin, triethyl citrate

  • Questions or comments?

    1-888-333-9792

  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel

    Carton

    Women Lax 25 ct

  • INGREDIENTS AND APPEARANCE
    WOMENS GENTLE LAXATIVE 
    bisacodyl tablet, delayed release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72476-960
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BISACODYL (UNII: 10X0709Y6I) (DEACETYLBISACODYL - UNII:R09078E41Y) BISACODYL5 mg
    Inactive Ingredients
    Ingredient NameStrength
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    AMMONIUM ACRYLOYL DIMETHYLTAURATE/METHACRYLATE, DIMETHYLACRYLAMIDE AND METHACRYLIC ACID COPOLYMER, PPG-3 GLYCERYL TRIACRYLATE CROSSLINKED (100000 MW) (UNII: WR7H9IW2XX)  
    HYDROXYMETHYL CELLULOSE (UNII: 273FM27VK1)  
    STARCH, POTATO (UNII: 8I089SAH3T)  
    SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIACETIN (UNII: XHX3C3X673)  
    TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
    DEXTROSE MONOHYDRATE (UNII: LX22YL083G)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Product Characteristics
    ColorpinkScoreno score
    ShapeROUNDSize6mm
    FlavorImprint Code F
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72476-960-251 in 1 CARTON08/03/2022
    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 not finalpart33408/03/2022
    Labeler - RETAIL BUSINESS SERVICES, LLC (967989935)
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