Label: DULCOLAX- bisacodyl tablet, coated

  • NDC Code(s): 0597-0012-00, 0597-0012-11, 0597-0012-26, 0597-0012-37, view more
    0597-0012-38, 0597-0012-50, 0597-0012-58, 0597-0012-59, 0597-0340-48, 0597-0340-54, 0597-0340-64, 0597-0340-70, 0597-0340-71, 0597-0340-72, 0597-0340-82, 0597-0340-97
  • Packager: Boehringer Ingelheim Pharmaceuticals, Inc.
  • 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 December 19, 2018

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

  • ACTIVE INGREDIENT

    Drug Facts

    Active ingredient (in each tablet)Purpose
    Bisacodyl (USP) 5 mgStimulant laxative
  • INDICATIONS & USAGE

    Use

    • for temporary relief of occasional constipation and irregularity
    • this product generally produces bowel movement in 6 to 12 hours
  • WARNINGS

    Warnings

    Do not use if you cannot swallow without chewing

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

  • DOSAGE & ADMINISTRATION

    Directions take with a glass of water

    adults and children 12 years of age and over1 to 3 tablets in a single daily dose
    children 6 to under 12 years of age1 tablet in a single daily dose
    children under 6 years of ageask a doctor
  • STORAGE AND HANDLING

    Other information

    • store at 20-25°C (68-77°F
    • protect from excessive humidity
  • INACTIVE INGREDIENT

    Inactive ingredients acacia gum, ammonium hydroxide, beeswax, carnauba wax, D&C Yellow #10 aluminum lake, D&C Red #30 aluminum lake, glycerin, glyceryl monostearate, iron oxide, lactose monohydrate, magnesium stearate, methacrylic acid ethyl acrylate copolymer, methyl paraben, modified corn starch, polyethylene glycol 6000, polysorbate 80, povidone, propyl paraben, shellac, sodium benzoate, sucrose, talc, titanium dioxide, triethyl citrate

  • QUESTIONS

    Questions? call 1-888-285-9159 (English/Spanish), M – F, 8:30 – 5 EST, or visit www.Dulcolax.com

    Distributed by: Boehringer Ingelheim (BI) Consumer Health Care Products Division of BI Pharmaceuticals, Inc., Ridgefield, CT 06877. Product of Italy. Manufactured in Mexico. © 2016, BI Pharmaceuticals, Inc. All rights reserved.

  • PRINCIPAL DISPLAY PANEL

    Dulcolax® 25 Tablets Carton

    dulcolax-25-tablets-carton
  • PRINCIPAL DISPLAY PANEL

    Dulcolax® 8 Tablets Carton

    dulcolax-8-tablets-carton
  • INGREDIENTS AND APPEARANCE
    DULCOLAX 
    bisacodyl tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0597-0012
    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)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (UNII: NX76LV5T8J)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    SHELLAC (UNII: 46N107B71O)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SUCROSE (UNII: C151H8M554)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    Product Characteristics
    ColorORANGEScoreno score
    ShapeROUNDSize5mm
    FlavorImprint Code BI;12
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0597-0012-261 in 1 CARTON10/01/2001
    125 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:0597-0012-111 in 1 CARTON10/01/2001
    210 in 1 BLISTER PACK; Type 0: Not a Combination Product
    3NDC:0597-0012-586 in 1 CARTON10/01/2001
    325 in 1 BLISTER PACK; Type 0: Not a Combination Product
    4NDC:0597-0012-598 in 1 CARTON10/01/2001
    425 in 1 BLISTER PACK; Type 0: Not a Combination Product
    5NDC:0597-0012-502 in 1 CARTON10/01/2001
    525 in 1 BLISTER PACK; Type 0: Not a Combination Product
    6NDC:0597-0012-381 in 1 CARTON10/01/2001
    68 in 1 BLISTER PACK; Type 0: Not a Combination Product
    7NDC:0597-0012-004 in 1 CARTON10/01/2001
    725 in 1 BLISTER PACK; Type 0: Not a Combination Product
    8NDC:0597-0012-372 in 1 CARTON10/01/2001
    815 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33410/01/2001
    DULCOLAX 
    bisacodyl tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0597-0340
    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)  
    MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE) (UNII: 461P5CJN6T)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (UNII: NX76LV5T8J)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    SHELLAC (UNII: 46N107B71O)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SUCROSE (UNII: C151H8M554)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    Product Characteristics
    ColorORANGEScoreno score
    ShapeROUNDSize5mm
    FlavorImprint Code BI;12
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0597-0340-481 in 1 CARTON08/01/2013
    125 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:0597-0340-711 in 1 CARTON08/01/2013
    210 in 1 BLISTER PACK; Type 0: Not a Combination Product
    3NDC:0597-0340-646 in 1 CARTON08/01/2013
    325 in 1 BLISTER PACK; Type 0: Not a Combination Product
    4NDC:0597-0340-978 in 1 CARTON08/01/2013
    425 in 1 BLISTER PACK; Type 0: Not a Combination Product
    5NDC:0597-0340-542 in 1 CARTON08/01/2013
    525 in 1 BLISTER PACK; Type 0: Not a Combination Product
    6NDC:0597-0340-821 in 1 CARTON08/01/2013
    68 in 1 BLISTER PACK; Type 0: Not a Combination Product
    7NDC:0597-0340-704 in 1 CARTON08/01/2013
    725 in 1 BLISTER PACK; Type 0: Not a Combination Product
    8NDC:0597-0340-722 in 1 CARTON08/01/2013
    815 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33408/01/2013
    Labeler - Boehringer Ingelheim Pharmaceuticals, Inc. (603175944)
    Registrant - Boehringer Ingelheim Pharmaceuticals, Inc. (603175944)