Label: BISACODYL ENTERIC 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 24, 2017

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

  • ACTIVE INGREDIENT

    Bisacodyl 5mg

  • 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

    Pregnancy/Breastfeeding

    ask a health professions 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.

  • PURPOSE

    Stimulant laxative

  • INDICATIONS & USAGE

    -relieves occasional constipation and irregularity

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

  • 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

  • KEEP OUT OF REACH OF CHILDREN

    -store at 25 degrees C (77 degrees F) excursions permitted between 15 degrees-30 degrees C (59 degrees-86 degrees F)

    -use by expiration date on package

    -protect from excessive humidity

  • INACTIVE INGREDIENT


    acacia, bees wax, calcium sulfate, carnauba wax, cellulose, corn starch, D&C Yellow No. 10 lake, FD&C Yellow No. 6 lake, gelatin, lactose, magnesium stearate, pharmaceutical glaze, polyvinyl acetate phthalate, silica gel, sodium starch glycolate, stearinc acid, sugar, talc, titanium dioxide.

  • PRINCIPAL DISPLAY PANEL

    085

  • INGREDIENTS AND APPEARANCE
    BISACODYL ENTERIC 
    bisacodyl enteric tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61919-085(NDC:0904-7927)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BISACODYL (UNII: 10X0709Y6I) (DEACETYLBISACODYL - UNII:R09078E41Y) BISACODYL5 mg
    Inactive Ingredients
    Ingredient NameStrength
    CALCIUM SULFATE ANHYDROUS (UNII: E934B3V59H)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    AMMONIUM NONOXYNOL-4 SULFATE (UNII: 9HIA70O4J0)  
    SHELLAC (UNII: 46N107B71O)  
    ACACIA (UNII: 5C5403N26O)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    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)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TALC (UNII: 7SEV7J4R1U)  
    POLYVINYL ACETATE PHTHALATE (UNII: 58QVG85GW3)  
    ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColororangeScoreno score
    ShapeROUNDSize6mm
    FlavorImprint Code 5
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61919-085-6060 in 1 BOTTLE; Type 0: Not a Combination Product02/24/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33402/24/2017
    Labeler - DIRECT RX (079254320)
    Registrant - DIRECT RX (079254320)
    Establishment
    NameAddressID/FEIBusiness Operations
    DIRECT RX079254320repack(61919-085)