Label: DULCOLAX- bisacodyl suppository

  • 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 February 1, 2011

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

View All Sections
  • Drug Facts

    Active ingredient (in each suppository)Purpose
    Bisacodyl USP 10 mg .................................... 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

    Ask a doctor before use if you have

    • stomach pain, nausea or vomiting
    • a sudden change in bowel habits that lasts more than 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 no bowel movement after using this product. These could be signs of a serious condition.
    • you need to use a laxative for more than 1 week

    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

    adults and children 12 years of age and over1 suppository in a single daily dose. Peel open plastic. Insert suppository well into rectum, pointed end first. Retain about 15 to 20 minutes.
    children 6 to under 12 years of age1/2 suppository in a single daily dose
    children under 2 years of ageask a doctor
  • Other information

    • do not store above 30°C (86°F)
  • Inactive ingredient

    hydrogenated vegetable oil

  • PRINCIPAL DISPLAY PANEL

    Dulcolax (bisacodyl USP) Laxative Suppositories

    10 mg

    NDC 54868-3155-1

    image of package label

  • INGREDIENTS AND APPEARANCE
    DULCOLAX 
    bisacodyl suppository
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54868-3155(NDC:0597-0052)
    Route of AdministrationRECTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    bisacodyl (UNII: 10X0709Y6I) (bisacodyl - UNII:10X0709Y6I) bisacodyl10 mg
    Inactive Ingredients
    Ingredient NameStrength
    HYDROGENATED COCONUT OIL (UNII: JY81OXM1OM)  
    HYDROGENATED PALM KERNEL OIL (UNII: FM8D1RE2VP)  
    Product Characteristics
    ColorWHITEScore    
    ShapeBULLETSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54868-3155-14 in 1 CARTON
    14 in 1 BLISTER PACK
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33403/17/2011
    Labeler - Physicians Total Care, Inc. (194123980)
    Establishment
    NameAddressID/FEIBusiness Operations
    Physicians Total Care, Inc.194123980relabel
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!