DULCOLAX (BISACODYL) SUPPOSITORY [PHYSICIANS TOTAL CARE, INC.]

  • Home
  • DULCOLAX (BISACODYL) SUPPOSITORY [PHYSICIANS TOTAL CARE, INC.]

DULCOLAX (BISACODYL) SUPPOSITORY [PHYSICIANS TOTAL CARE, INC.]
PDF | XML
NDC 54868-3155-1
Set ID 1bf775a9-bd9e-41a6-acef-9a3795fbf25c
Category HUMAN OTC DRUG LABEL
Packager Physicians Total Care, Inc.
Generic Name
Product Class
Product Number
Application Number PART334
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

Related Drugs

Search DailyMed Drugs