Label: ENTERIC COATED STIMULANT LAXATIVE- bisacodyl tablet, delayed release

  • NDC Code(s): 0536-3381-01, 0536-3381-10
  • Packager: RUGBY LABORATORIES INC
  • Category: HUMAN OTC DRUG LABEL

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 July 15, 2020

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  • ACTIVE INGREDIENT

    ACTIVE INGREDIENT
    In each tablet: Bisacodyl 5mg

  • INACTIVE INGREDIENT

    Acadia, Anhydrous Calcium Sulfate, Anhydrous Lactose, Carnauba Wax, Colloidal Silicon Dioxide, Corn Starch, D&C Yellow #10 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 Phthalates, Povidone, Shellac, Sodium Starch Glycolate, Stearic Acid, Sugar, Talc, Titanium Dioxide

  • PURPOSE

    PURPOSE
    Stimulant Laxative

  • INDICATIONS & USAGE

    INDICATIONS & USAGE
    Uses: relieves occasional constipation and irregularity - this product generally produces a bowel movement in 6 to 12 hours

  • DOSAGE & ADMINISTRATION

    DOSAGE & ADMINISTRATION

    • adults and children 12 years and over: take 1 to 3 tablets in a single daily dose
    • children 6 to under 12 years: take 1 tablet in a single daily dose
    • children under 6 years: ask a doctor

  • KEEP OUT OF REACH OF CHILDREN

  • 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.

  • WARNINGS

    WARNINGS
    Warning: 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 two ...

    Warning: 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 two weeks.

    When using this product: Do not chew or crush tablet(s); Do not use within 1 hour after taking an antacid or milk; Do not use this product if you have stomach discomfort, faintness or cramps.

  • PRINCIPAL DISPLAY PANEL

    1000CT

  • INGREDIENTS AND APPEARANCE
    ENTERIC COATED STIMULANT LAXATIVE 
    bisacodyl tablet, delayed release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-3381
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BISACODYL (UNII: 10X0709Y6I) (DEACETYLBISACODYL - UNII:R09078E41Y) BISACODYL5 mg
    Inactive Ingredients
    Ingredient NameStrength
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    SHELLAC (UNII: 46N107B71O)  
    ACACIA (UNII: 5C5403N26O)  
    CALCIUM SULFATE ANHYDROUS (UNII: E934B3V59H)  
    ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYVINYL ACETATE PHTHALATE (UNII: 58QVG85GW3)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SUCROSE (UNII: C151H8M554)  
    TALC (UNII: 7SEV7J4R1U)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    GELATIN (UNII: 2G86QN327L)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    POVIDONE (UNII: FZ989GH94E)  
    Product Characteristics
    ColororangeScoreno score
    ShapeROUNDSize6mm
    FlavorImprint Code TCL;003
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0536-3381-01100 in 1 BOX; Type 0: Not a Combination Product09/22/2012
    2NDC:0536-3381-101000 in 1 BOTTLE; Type 0: Not a Combination Product09/22/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33409/22/2012
    Labeler - RUGBY LABORATORIES INC (079246066)
    Registrant - TIME CAP LABS, INC (037052099)
    Establishment
    NameAddressID/FEIBusiness Operations
    TIME CAP LABORATORIES, INC.037052099manufacture(0536-3381)