Label: BISACODYL- bisacodyl enteric coated 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 February 28, 2013

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

  • Active ingredient(s)

     Bisacodyl 5mg

  • Purpose

     Stimulant laxative

  • Use(s)

     -relieves occasional constipation and irregularity

     -this product generally produces bowel movement in 6 to 12 hours

  • Warnings

    Do not use

     Do not use if you cannot swallow without chewing

    Ask a doctor before use if

     -you have a sudden change in bowel habits that lasts more than 2 weeks

    -stomach pain, nausea or vomiting

    When using this product

     -do not use within 1 hour after taking an antacid or milk

    -do not chew or crush tablet(s)

    -you may have stomach discomfort, faintness or cramps

    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

    If pregnant or breastfeeding

     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 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

     -store at 25ºC (77º F) excursions permitted between 15º-30º C (59º-86º 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 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 phthalate, povidone, shellac, sodium starch glycolate, stearic acid, sugar, talc, titanium dioxide.

  • Questions

     To Report Adverse Drug Event call: (800) 616-2471

  • Principal Display Panel

     Bisacodyl Enteric Coated Tabs, USP 5mg

    Bisacodyl Enteric Coated Tabs, USP 5mg

  • INGREDIENTS AND APPEARANCE
    BISACODYL 
    bisacodyl enteric coated tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0615-0598(NDC:0904-7927)
    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)  
    ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    GELATIN (UNII: 2G86QN327L)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    Polyvinyl Acetate Phthalate (UNII: 58QVG85GW3)  
    SHELLAC (UNII: 46N107B71O)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    SUCROSE (UNII: C151H8M554)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    LACTOSE (UNII: J2B2A4N98G)  
    CALCIUM SULFATE ANHYDROUS (UNII: E934B3V59H)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    POVIDONES (UNII: FZ989GH94E)  
    Product Characteristics
    ColorORANGEScoreno score
    ShapeROUNDSize6mm
    FlavorImprint Code 5
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0615-0598-3930 in 1 BLISTER PACK
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart33409/02/1993
    Labeler - NCS HealthCare of KY, Inc dba Vangard Labs (050052943)
    Establishment
    NameAddressID/FEIBusiness Operations
    NCS HealthCare of KY, Inc dba Vangard Labs050052943RELABEL(0615-0598) , REPACK(0615-0598)