Label: WOMENS LAXATIVE ENTERIC COATED- bisacodyl tablet, coated

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 11, 2024

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    In each tablet: Bisacodyl 5mg

  • PURPOSE

    Stimulant Laxative

  • INDICATIONS & USAGE

    • relieves occasional constipation and irregularity
    • this product generally produces bowel movement in 6 to 12 hours

  • WARNINGS

    Warnings

  • DO NOT USE

    Do not useif you cannot swallow without chewing

  • ASK DOCTOR

    Ask a doctor before use if you have

    • stomach pain, nausea or vomiting
    • a sudden change in bowel habits that lasts more than two weeks

  • WHEN USING

    When using this product

    • do not chew or crush tablet(s)
    • do not use within 1 hour after taking an antacid or milk
    • you may have stomach discomfort, faintness or cramps
  • STOP USE

    Stop use and ask a doctor if

    • you have rectal bleeding or fail to have a bowel movement after use of a laxative. These could be signs of a serious condition.
    • you need to use a laxative for more than 1 week
  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding,ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    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).

  • DOSAGE & ADMINISTRATION

    • take with a glass of water

    adults and children 12 years 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:magnesium 5mg
    • store at 25°C (77F) excursions permitted between 15° - 30°C (59° - 86°F)
    • use by expiration date on package
      • protect from excessive humidity
  • INACTIVE INGREDIENTS

    Acacia, Anhydrous Calcium Sulfate, Anhydrous Lactose, Carnauba Wax, Colloidal Silicon Dioxide, Corn Starch, D&C Red #27 Aluminum Lake, FD&C Blue #2 Aluminum Lake, FD&C Yellow #6 Aluminum Lake, Gelatin, Iron Oxide, Iron Oxide Black, Iron Oxide Yellow (Iron Oxide Ochre), Magnesium Stearate,Microcrystalline Cellulose, Polyethylene Glycol (PEG) 400, Polyvinyl Acetate Phthalate, Povidone,Shellac, Sodium Starch Glycolate, Stearic Acid, Sugar, Talc, Titanium Dioxide

  • QUESTIONS

  • PRINCIPAL DISPLAY PANEL

    25ct

  • INGREDIENTS AND APPEARANCE
    WOMENS LAXATIVE ENTERIC COATED 
    bisacodyl tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0570
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BISACODYL (UNII: 10X0709Y6I) (DEACETYLBISACODYL - UNII:R09078E41Y) BISACODYL5 mg
    Inactive Ingredients
    Ingredient NameStrength
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    POVIDONE (UNII: FZ989GH94E)  
    SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
    POLYVINYL ACETATE PHTHALATE (UNII: 58QVG85GW3)  
    RAW SUGAR (UNII: 8M707QY5GH)  
    ACACIA (UNII: 5C5403N26O)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    GELATIN (UNII: 2G86QN327L)  
    FERROUS OXIDE (UNII: G7036X8B5H)  
    CALCIUM SULFATE ANHYDROUS (UNII: E934B3V59H)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    SHELLAC (UNII: 46N107B71O)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorpinkScoreno score
    ShapeROUNDSize5mm
    FlavorImprint Code TCL
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70000-0570-11 in 1 CARTON07/24/2020
    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 DrugM00707/24/2020
    Labeler - CARDINAL HEALTH (063997360)
    Registrant - TIME CAP LABORATORIES, INC. (037005209)
    Establishment
    NameAddressID/FEIBusiness Operations
    TIME CAP LABORATORIES, INC037052099manufacture(70000-0570)