Label: BISACODYL- bisacodyl suppository

  • Category: HUMAN OTC DRUG LABEL

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 March 8, 2012

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  • ACTIVE INGREDIENT (in each suppository)

    Bisacodyl USP, 10 mg

  • PURPOSE

    Laxative

  • USES

    For the relief of occasional constipation. Bowel movement is generally produced in 15 minutes to 1 hour.

  • WARNINGS

    For rectal use only

    Do not use
    laxative products for a period longer than one week unless directed by a doctor

    Ask a doctor before use if you have
    • abdominal pain, nausea or vomiting
    • a sudden change in bowel habits that lasts longer than 2 weeks

    Stop use and ask a doctor
    if rectal bleeding occurs or you fail to have a bowel movement after using a laxative. This may indicate a serious condition.

  • IF PREGNANT OR BREAST FEEDING,

    ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN SECTION

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

  • DIRECTIONS

    • Remove foil. Insert suppository well into rectum touching the bowel wall. Retain about 15 to 20 minutes.
         Direction Chart
    • In the presence of anal fissures or hemorrhoids, suppositories should be coated at the tip with petroleum jelly.

  • OTHER INFORMATION

    Store at room temperature

  • INACTIVE INGREDIENT

    hydrogenated vegetable oil

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    NDC 37205-102-53
    LEADER®
    BISACODYL SUPPOSITORIES
    LAXATIVE
    FOR PROMPT RELIEF OF CONSTIPATION
    12 BISACODYL SUPPOSITORIES 10 MG EACH
    Compare to Dulcolax® active ingredient*
    Satisfaction Guaranteed

    Unit Carton
  • INGREDIENTS AND APPEARANCE
    BISACODYL  
    bisacodyl suppository
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37205-102
    Route of AdministrationRECTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Bisacodyl (UNII: 10X0709Y6I) (Bisacodyl - UNII:10X0709Y6I) Bisacodyl10 mg
    Inactive Ingredients
    Ingredient NameStrength
    Hydrogenated Palm Kernel Oil (UNII: FM8D1RE2VP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:37205-102-5312 in 1 CARTON
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33409/10/1997
    Labeler - CARDINAL HEALTH, INC. (097537435)
    Registrant - G&W Laboratories, Inc. (001271188)
    Establishment
    NameAddressID/FEIBusiness Operations
    G&W Laboratories, Inc.001271188MANUFACTURE
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