Label: BISACODYL ENTERIC COATED- bisacodyl 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 December 23, 2019

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  • 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

    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.

  • 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

    Repackaged by Aphena Pharma Solutions - TN.
    See Repackaging Information for available configurations.
    Aphena Pharma Solutions - TN
  • Storage

     -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 ingredients

    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.

  • Questions

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

  • Repackaging Information

    Please reference the Product Characteristics section listed below for a description of individual tablets or capsules. This drug product has been received by Aphena Pharma - TN in a manufacturer or distributor packaged configuration and repackaged in full compliance with all applicable cGMP regulations. The package configurations available from Aphena are listed below:

    Count4mg
    0467544-655-04
    0667544-655-06

    Store between 20°-25°C (68°-77°F). See USP Controlled Room Temperature. Dispense in a tight light-resistant container as defined by USP. Keep this and all drugs out of the reach of children.

    Repackaged by:
    Aphena Pharma Solutions - TN
    Cookeville, TN 38506

    20130612AW

  • PRINCIPAL DISPLAY PANEL - 5mg

    NDC 67544-655 - Bisacodyl 5mg
    Bottle Label 5mg

  • INGREDIENTS AND APPEARANCE
    BISACODYL  ENTERIC COATED
    bisacodyl tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67544-655(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
    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, UNSPECIFIED (UNII: 2G86QN327L)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    AMMONIUM NONOXYNOL-4 SULFATE (UNII: 9HIA70O4J0)  
    SHELLAC (UNII: 46N107B71O)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Polyvinyl Acetate Phthalate (UNII: 58QVG85GW3)  
    Product Characteristics
    ColorORANGEScoreno score
    ShapeROUNDSize6mm
    FlavorImprint Code 5
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67544-655-0404 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/30/2010
    2NDC:67544-655-0606 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/29/2010
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart33410/24/2008
    Labeler - Aphena Pharma Solutions - Tennessee, LLC (128385585)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aphena Pharma Solutions - Tennessee, LLC128385585Repack(67544-655)
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