Label: DULCOLAX SIMULANT LAXATIVE- bisacodyl tablet, film coated

  • NDC Code(s): 41167-0101-0, 41167-0101-1, 41167-0101-2, 41167-0101-3, view more
    41167-0101-4, 41167-0101-5, 41167-0101-6, 41167-0101-7
  • Packager: Chattem, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated April 1, 2025

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  • SPL UNCLASSIFIED SECTION

    Dulcolax®

    Stimulant Laxative Tablets

    Drug Facts

  • Active ingredient (in each tablet)

    Bisacodyl (USP) 5 mg

  • Purpose

    Stimulant laxative

  • Use

    ● for relief of occasional constipation and irregularity

    ● this product generally produces bowel movement in 6 to 12 hours

  • Warnings

    Do not use

    ● if you cannot swallow without chewing

    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 and cramps

    ● do not chew or crush tablet(s)

    ● do not use within 1 hour after taking an antacid or milk

    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

    ● Take with a glass of water
    adults and children 12 years of age and overstart with 1 tablet/day. If needed, increase to 2 or 3 tablets a day in a single daily dose.
    children 6 to under 12 years of age1 tablet per day
    children under 6 years of ageask a doctor
  • Other information

    ● store at 20°-25°C (68°-77°F)

    ● protect from excessive humidity

  • Inactive ingredients

    glycerol monostearate, hypromellose, iron oxides, lactose, macrogol 6000, magnesium stearate, methacrylic acid - ethyl acrylate copolymer, polysorbate 80, pregelatinized maize starch, stearic acid, triethyl citrate, water

  • Questions?

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

    Keep carton as it contains important product information.

  • PRINCIPAL DISPLAY PANEL

    OVERNIGHT RELIEF
    Dulcolax
    LAXATIVE
    25 comfort coated Tablets

    PRINCIPAL DISPLAY PANEL OVERNIGHT RELIEF Dulcolax LAXATIVE 25 comfort coated Tablets

  • INGREDIENTS AND APPEARANCE
    DULCOLAX SIMULANT LAXATIVE 
    bisacodyl tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41167-0101
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BISACODYL (UNII: 10X0709Y6I) (DEACETYLBISACODYL - UNII:R09078E41Y) BISACODYL5 mg
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    LACTOSE (UNII: J2B2A4N98G)  
    POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER (UNII: NX76LV5T8J)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColororangeScoreno score
    ShapeROUNDSize5mm
    FlavorImprint Code 12
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41167-0101-01 in 1 CARTON02/12/2021
    18 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:41167-0101-11 in 1 CARTON02/12/2021
    210 in 1 BLISTER PACK; Type 0: Not a Combination Product
    3NDC:41167-0101-21 in 1 CARTON02/12/2021
    325 in 1 BLISTER PACK; Type 0: Not a Combination Product
    4NDC:41167-0101-32 in 1 CARTON02/12/2021
    425 in 1 BLISTER PACK; Type 0: Not a Combination Product
    5NDC:41167-0101-44 in 1 CARTON02/12/2021
    525 in 1 BLISTER PACK; Type 0: Not a Combination Product
    6NDC:41167-0101-58 in 1 CARTON02/12/2021
    625 in 1 BLISTER PACK; Type 0: Not a Combination Product
    7NDC:41167-0101-63 in 1 CARTON02/12/2021
    710 in 1 BLISTER PACK; Type 0: Not a Combination Product
    8NDC:41167-0101-71 in 1 CARTON06/01/2022
    86 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)02/12/2021
    Labeler - Chattem, Inc. (003336013)
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