Label: BISACODYL- bisacodyl suppository

  • NDC Code(s): 69842-816-04, 69842-816-08, 69842-816-16
  • Packager: CVS Pharmacy
  • 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 November 3, 2021

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

  • Active ingredient (in each suppository)

    Bisacodyl USP 10mg

  • Purpose

    Stimulant Laxative

  • Use

    • 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 last over a period 2 weeks

    When using this product

    it 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 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 right away.

  • Directions

    • detach one suppository from the strip
    • remove wrapper berore inserting into rectum

    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 years of age - do not use

  • Other information

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

    hydrogenated vegetable oil

  • CVS Bisacodyl Suppositories

    CVS Bisacodyl 8ct

    CVSBisacodyl8ct.jpg

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

    Bisacodyl Suppositories 8ct

    Distributed by

    CVS Pharmacy

    One CVS Drive

    Woonsocket, RI 02895

  • INGREDIENTS AND APPEARANCE
    BISACODYL  
    bisacodyl suppository
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-816
    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:69842-816-041 in 1 CARTON04/14/2021
    14 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:69842-816-082 in 1 CARTON04/14/2021
    24 in 1 BLISTER PACK; Type 0: Not a Combination Product
    3NDC:69842-816-164 in 1 CARTON04/14/2021
    34 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 finalpart33404/14/2021
    Labeler - CVS Pharmacy (062312574)
    Registrant - DSC Laboratories, Inc. (097807374)
    Establishment
    NameAddressID/FEIBusiness Operations
    DSC Laboratories, Inc.097807374manufacture(69842-816)