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

Drug Label Information

Updated November 3, 2023

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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 over                   1 to 3 tablets in a single daily dose

    children 6 to under 12 years of age                         1 tablet 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)

    ● protect from excessive humidity

  • Inactive ingredients

    acacia gum, ammonium hydroxide, beeswax, carnauba wax, corn starch, D&C red #30 aluminum lake, D&C yellow #10 aluminum lake, glycerin, glyceryl monostearate, iron oxides, lactose monohydrate, magnesium stearate, methacrylic acid ethyl acrylate copolymer, methylparaben, modified starch, polyethylene glycol 6000, polysorbate 80, povidone, propylene glycol, propylparaben, shellac, sodium benzoate, sucrose, talc, titanium dioxide, triethyl citrate

  • 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
    ACACIA (UNII: 5C5403N26O)  
    AMMONIA (UNII: 5138Q19F1X)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    SHELLAC (UNII: 46N107B71O)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SUCROSE (UNII: C151H8M554)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
    METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER (UNII: NX76LV5T8J)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    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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