Label: BISACODYL- bisacodyl suppository

  • NDC Code(s): 0904-7142-12, 0904-7142-60
  • Packager: Major Pharmaceuticals
  • 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 May 5, 2021

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

  • 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 CARTON05/05/2021
    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 not finalpart33405/05/2021
    Labeler - Major Pharmaceuticals (191427277)
    Registrant - DSC Laboratories, Inc. (097807374)
    Establishment
    NameAddressID/FEIBusiness Operations
    DSC Laboratories, Inc.097807374manufacture(0904-7142)