Label: BISACODYL ENTERIC COATED- bisacodyl tablet, coated 

  • NDC Code(s): 0904-7927-17, 0904-7927-60, 0904-7927-61, 0904-7927-80
  • Packager: Major Pharmaceuticals
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 07/12

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

  • Active ingredient(s)

     Bisacodyl 5mg

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  • Purpose

     Stimulant laxative

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  • Use(s)

     -relieves occasional constipation and irregularity

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

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  • 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.

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  • 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

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  • Other information

     -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

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  • Storage
  • 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.

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  • Questions

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

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  • Principal Display Panel

     Bisacodyl Enteric Coated Tabs, USP 5mg

    Bisacodyl 5 mg EC Tabs

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  • INGREDIENTS AND APPEARANCE
    BISACODYL  ENTERIC COATED
    bisacodyl tablet, coated
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:0904-7927
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    BISACODYL (BISACODYL) BISACODYL 5 mg
    Inactive Ingredients
    Ingredient Name Strength
    ACACIA  
    CALCIUM SULFATE ANHYDROUS  
    ANHYDROUS LACTOSE  
    CARNAUBA WAX  
    SILICON DIOXIDE  
    STARCH, CORN  
    D&C YELLOW NO. 10  
    FD&C YELLOW NO. 6  
    GELATIN  
    MAGNESIUM STEARATE  
    CELLULOSE, MICROCRYSTALLINE  
    AMMONIUM NONOXYNOL-4 SULFATE  
    SHELLAC  
    SODIUM STARCH GLYCOLATE TYPE A POTATO  
    STEARIC ACID  
    TALC  
    TITANIUM DIOXIDE  
    Polyvinyl Acetate Phthalate  
    Product Characteristics
    Color ORANGE Score no score
    Shape ROUND Size 6mm
    Flavor Imprint Code 5
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0904-7927-17 25 in 1 BLISTER PACK
    2 NDC:0904-7927-60 100 in 1 BOTTLE
    3 NDC:0904-7927-61 100 in 1 BOX, UNIT-DOSE
    4 NDC:0904-7927-80 1000 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH NOT FINAL part334 10/24/2008
    Labeler - Major Pharmaceuticals (191427277)
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