Label: BISACODYL suppository

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 December 8, 2009

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  • ACTIVE INGREDIENT

    Bisacodyl, 10 mg

  • PURPOSE

    Stimulant Laxative

  • USES

    • For relief of occasional constipation
    • This product generally produces bowel movement in 15 minutes to 1 hour
  • WARNINGS

    For rectal use only. May cause abdominal discomfort, faintness, rectal burning, and mild cramps.

    Do not use

    • more than one per day
    • for a period of longer than one week unless directed by a doctor
    • laxative products when abdominal pain, nausea, or vomiting are present unless directed by a doctor
    • if seal under product lid is torn, damaged, or open

    Ask a doctor before use

    • if you have noticed a sudden change in bowel habits that persist over a period of two weeks
    • if you are pregnant or nursing a baby




    Stop use and ask a doctor

    if you have rectal bleeding or fail to have a bowel movement after using a laxative. This may indicate a serious condition.



    Keep out of reach of children

    If swallowed, get medical help or contact a Poison Control Center right away.

  • DIRECTIONS

    Adults and children 12
    years of age and older
    		Children 6 to 12 years
    		Children under 6
    One suppository once
    daily
    		1/2 suppository once
    daily
    		Ask a doctor.



    • Detach one suppository from the strip and remove from foil
    • Carefully insert one suppository well into the rectum
    • Do not use more than once per day
  • SPL UNCLASSIFIED SECTION


  • OTHER INFORMATION

    • Store at room temperature: 15°- 30° C (59° - 86° F). Do not exceed 30° C (86° F).
    • Individually sealed for your protection. Do not use if foil is torn or open.
  • INACTIVE INGREDIENT

    hydrogenated vegetable oil
  • QUESTIONS


  • PACKAGE INFORMATION

    CVS pharmacy

    NDC 50730-1004-0
    Compare to the active
    ingredient in Dulcolax®
    NEW!

    Gentle
    LAXATIVE
    SUPPOSITORIES
    Bisacodyl USP

    GUARANTEED RELIEF
    Gentle Yet Effective

    4 Suppositories (10mg each)

    Comfort Shaped

    Distributed by CVS Pharmacy, Inc. One CVS Drive
    Woonsocket, RI 02895 ©CVS/pharmacy
    www.cvs.com  1-800-shop-CVS

    This product is not manufactured or distributed by Boehringer Ingelhem
    Consumer Healthcare, owner of the registered trademark Dulcolax®.

    box
  • INGREDIENTS AND APPEARANCE
    BISACODYL 
    bisacodyl suppository
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50730-1004
    Route of AdministrationRECTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    bisacodyl (UNII: 10X0709Y6I) (bisacodyl - UNII:10X0709Y6I) bisacodyl10 mg
    Inactive Ingredients
    Ingredient NameStrength
    fat, hard (UNII: 8334LX7S21)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50730-1004-04 in 1 BOX
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33401/01/2009
    Labeler - H and P Industries, Inc. dba Triad Group (050259597)
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