DULCOLAX- bisacodyl tablet, coated 
Boehringer Ingelheim Pharmaceuticals, Inc.

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.

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Dulcolax ®
Bisacodyl (USP) 5 mg Tablets/Stimulant Laxative

Drug Facts

Active ingredient (in each tablet)Purpose
Bisacodyl (USP) 5 mgStimulant laxative

Use

  • for temporary 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
  • 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.

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

Other information

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? 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.

Dulcolax® 25 Tablets Carton

dulcolax-25-tablets-carton

Dulcolax® 8 Tablets Carton

dulcolax-8-tablets-carton
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)

Revised: 12/2018
Document Id: 7e3d2ba1-1ea6-62e3-d82d-a0f19a906bb3
Set id: 8527ae95-fdfd-4b62-9f56-598c2656aeb6
Version: 3
Effective Time: 20181219
 
Boehringer Ingelheim Pharmaceuticals, Inc.