Label: DULCOLAX LAXATIVE- bisacodyl suppository

  • NDC Code(s): 41167-0210-1, 41167-0210-2, 41167-0210-3, 41167-0210-5
  • Packager: Chattem, Inc.
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated November 3, 2023

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  • SPL UNCLASSIFIED SECTION

    Dulcolax®

    Medicated Laxative Suppositories

    Drug Facts

  • Active ingredient (in each suppository)

    Bisacodyl (USP) 10 mg

  • Purpose

    Stimulant laxative

  • Use

    • for 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  
    • noticed 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 fail to have a 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.

    In case of overdose, get medical help or contact a Poison Control Center right away.

  • Directions  

    adults and children 12 years of age and over       1 suppository in a single daily dose. Peel open plastic. Insert suppository into rectum, pointed end first. Retain about 15 to 20 minutes.

    children 6 to under 12 years of age                         ½ suppository in a single daily dose

    children under 6 years of age                               ask a doctor

  • Other information

    • do not use if individual blister unit is open or torn
    • store at 20°-25°C (68°-77°F)  
  • Inactive ingredient

    hard fat

  • Questions?

    Call 1-866-844-2798 or visit www.Dulcolax.com

    Keep carton as it contains important product information.

  • PRINCIPAL DISPLAY PANEL

    Dulcolax
    Bisacodyl (USP) 10 mg Suppository/ Stimulant Laxative
    MEDICATED LAXATIVE SUPPOSITORY
    4
    COMFORT SHAPED
    SUPPOSITORIES
    DO NOT SWALLOW

    PRINCIPAL DISPLAY PANEL Dulcolax Bisacodyl (USP) 10 mg Suppository/ Stimulant Laxative MEDICATED LAXATIVE SUPPOSITORY 4 COMFORT SHAPED SUPPOSITORIES DO NOT SWALLOW

  • INGREDIENTS AND APPEARANCE
    DULCOLAX LAXATIVE 
    bisacodyl suppository
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41167-0210
    Route of AdministrationRECTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BISACODYL (UNII: 10X0709Y6I) (DEACETYLBISACODYL - UNII:R09078E41Y) BISACODYL10 mg
    Inactive Ingredients
    Ingredient NameStrength
    FAT, HARD (UNII: 8334LX7S21)  
    Product Characteristics
    ColorwhiteScore    
    ShapeBULLETSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41167-0210-34 in 1 CARTON06/04/2019
    14 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:41167-0210-57 in 1 CARTON06/04/2019
    24 in 1 BLISTER PACK; Type 0: Not a Combination Product
    3NDC:41167-0210-11 in 1 CARTON06/04/2019
    34 in 1 BLISTER PACK; Type 0: Not a Combination Product
    4NDC:41167-0210-22 in 1 CARTON06/04/2019
    44 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)06/04/2019
    Labeler - Chattem, Inc. (003336013)
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