Label: BISACODYL- bisacodyl suppository

  • NDC Code(s): 70000-0573-1, 70000-0573-2
  • Packager: Cardinal Health
  • 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 June 17, 2021

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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 not finalpart33405/19/2021
    Labeler - Cardinal Health (063997360)
    Registrant - DSC Laboratories, Inc. (097807374)
    Establishment
    NameAddressID/FEIBusiness Operations
    DSC Laboratories, Inc.097807374manufacture(70000-0573)
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