Label: UNIT DOSE BISACODYL- bisacodyl tablet, delayed release

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 9, 2024

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  • Active ingredient (in each tablet)

    Bisacodyl 5 mg

    Enteric Coated Tablets

  • Purpose

    Stimulant laxative

  • Uses

    •
    relieves occasional constipation and irregularity
    •
    this product generally produces bowel movement in 6 to 12 hours
  • Warnings

    This Unit Dose package is not child resistant and is Intended for Institutional Use Only. If pregnant or breast-feeding, 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.

    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 2 weeks

    When using this product

    •
    do not chew or crush tablet(s)
    •
    do not use within 1 hour after taking an antacid or milk
    •
    you may have stomach discomfort, faintness or cramps

    Stop use and ask a doctor if

    •
    have rectal bleeding or fail to have a bowel movement after use of a laxative. These may be signs of a serious condition.
    •
    you need to use a laxative for more than 1 week

    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 (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
    •
    avoid excessive humidity
  • Inactive ingredients

    acacia, ammonium hydroxide, calcium carbonate, carnauba wax, colloidal anhydrous silica, corn starch, D&C yellow #10 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, iron oxide black, lactose anhydrous, magnesium stearate, methylparaben, polydextrose, polyethylene glycol, polyvinyl acetate phthalate, povidone, propylene glycol, propylparaben, shellac glaze, simethicone, sodium alginate, sodium benzoate, sodium bicarbonate, stearic acid, sucrose, talc, titanium dioxide, triacetin, triethyl citrate

  • Questions or comments?

    (800) 616-2471

    Distributed By:

    MAJOR® PHARMACEUTICALS

    17177 N Laurel Park Drive, Suite 233

    Livonia, MI 48152 USA

    Distributed By:

    Cardinal Health

    Dublin, OH 43017

    L5071915-11223

    L5071915-21223

  • Principal Display Panel

    Bisacodyl 5 mg

    Enteric Coated Tablets

    10 Tablets

    Bag Label
  • INGREDIENTS AND APPEARANCE
    UNIT DOSE BISACODYL 
    bisacodyl tablet, delayed release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55154-6897(NDC:0904-6407)
    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 CARBONATE (UNII: H0G9379FGK)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POLYDEXTROSE (UNII: VH2XOU12IE)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    Polyvinyl Acetate Phthalate (UNII: 58QVG85GW3)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    SHELLAC (UNII: 46N107B71O)  
    SODIUM ALGINATE (UNII: C269C4G2ZQ)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SUCROSE (UNII: C151H8M554)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIACETIN (UNII: XHX3C3X673)  
    TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
    Product Characteristics
    ColorORANGEScoreno score
    ShapeROUNDSize6mm
    FlavorImprint Code 5
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55154-6897-010 in 1 BAG03/25/2002
    11 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00703/25/2002
    Labeler - Cardinal Health 107, LLC (118546603)
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