Label: BISACODYL- bisacodyl suppository

  • NDC Code(s): 0904-7142-12, 0904-7142-60
  • Packager: Major Pharmaceuticals
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated December 8, 2023

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  • Active ingredient (in each suppository)

    Bisacodyl USP, 10mg

  • Purpose

    Stimulant Laxative

  • Uses

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

    For rectal use only

    Do not use

    • more than once per day
    • for a period longer than one week unless directed by a doctor
    • laxative products when abdominal pain, nausia, or vomiting are present unless directed a doctor

    Ask a Doctor before using any laxative if you have

    • notice a sudden change in bowel habits that lasts more than 2 weeks

    When using this product

    • may cause stomach discomfort, faintness, 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 a laxative. 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

    Adults and children 12 years of age and over - One suppository once daily

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

    Children under 6 - Ask a doctor

    • Detach one suppository from the strip and remove the foil
    • Carefully insert one suppository well into the rectum, pointed end first
    • Do not use more than once per day
    • Retain about 15 to 20 minutes

  • Other information

    • Storage temperature not to exceed 30ºC (86ºF)
    • Indiviually sealed for your protection. Do not use if foil is torn or open.
  • Inactive ingredients

    hydrogenated vegetable oil

  • Questions or comments?

    (800) 616-2471

  • Major Bisacodyl Suppositories

    Major Bisacodyl 12

    Major_Bisacodyl_12.jpg

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

    Bisacodyl Suppositories 12ct

    Distributed by

    Major Pharmaceuticals

    Livonia, MI 48152

  • INGREDIENTS AND APPEARANCE
    BISACODYL  
    bisacodyl suppository
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-7142
    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:0904-7142-122 in 1 CARTON05/05/2021
    16 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:0904-7142-60100 in 1 CARTON05/05/202110/31/2023
    21 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00705/05/2021
    Labeler - Major Pharmaceuticals (191427277)
    Registrant - DSC Laboratories, Inc. (097807374)
    Establishment
    NameAddressID/FEIBusiness Operations
    DSC Laboratories, Inc.097807374manufacture(0904-7142)
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