Label: BISACODYL- bisacodyl suppository

  • NDC Code(s): 70000-0573-1, 70000-0573-2
  • Packager: Cardinal Health
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 12, 2024

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  • Active ingredient (in each suppository)

    Bisacodyl USP, 10mg

  • Purpose

    Stimulant Laxative

  • Uses

    • for temporary relief of occasional constipation
    • this product generally produces bowel movement in 15 minutes to 1 hour
  • Warnings

    For rectal use only.

    Do not use unless directed by a doctor

    • if abdominal pain, nausea or vomiting are present
    • for longer than 1 week

    Ask a Doctor before use if you have

    noticed a sudden change in bowel habits that lasts over a perios of 2 weeks

    When using this product

    it may cause abdominal discomfort, faitness, rectal burning and mild cramps

    Stop use and ask a doctor if

    you have rectal bleeding or fail to have a bowel movement after using this product. These may indicate a serious condition.

    If pregnant or breast feeding,

    ask a health professional before use.

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

  • Directions

    • detach one suppository from the strip
    • remove wrapper before inserting into rectum
    • carefully insert one suppository well into the rectum, pointed end first
    • retain about 15 to 20 minutes

    adults and children 12 years of age and over - 1 suppository once daily

    children 6 to under 12 years of age - 1/2 suppository once daily

    children under 6 - do not use

  • Other information

    • Store at room remperature do not to exceed 30ºC (86ºF)
    • Lot No. & Exp. Date: see wrapper or box
  • Inactive ingredients

    hydrogenated vegetable oil

  • Questions or comments?

    (800) 492-5988

  • Leader Bisacodyl Suppositories

    LeaderBisSupp.jpg

    Leader Bisacodyl Suppositories

    The product package shown above represents a sample of that currently in use. Additional packaging may also be available.

    Bisacodyl Suppositories

    Distributed by

    Major Pharmaceuticals

    Livonia, MI 48152

  • INGREDIENTS AND APPEARANCE
    BISACODYL  
    bisacodyl suppository
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0573
    Route of AdministrationRECTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BISACODYL (UNII: 10X0709Y6I) (DEACETYLBISACODYL - UNII:R09078E41Y) BISACODYL10 mg
    Inactive Ingredients
    Ingredient NameStrength
    HYDROGENATED PALM KERNEL OIL (UNII: FM8D1RE2VP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70000-0573-24 in 1 CARTON05/19/2021
    14 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:70000-0573-11 in 1 CARTON05/19/2021
    24 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00705/19/2021
    Labeler - Cardinal Health (063997360)
    Registrant - DSC Laboratories, Inc. (097807374)
    Establishment
    NameAddressID/FEIBusiness Operations
    DSC Laboratories, Inc.097807374manufacture(70000-0573)
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