DULCOLAX- bisacodyl suppository 
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) 10 mg Suppository/Stimulant Laxative
Medicated Laxative Suppository
with DulcoGlide™Applicators

Drug Facts

Active ingredient (in each suppository)Purpose
Bisacodyl (USP) 10 mgStimulant laxative

Use

  • for temporary 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
  • 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 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. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

adults and children 12 years of age and over1 suppository in a single daily dose. See consumer leaflet for proper, safe use of the applicator.
children 6 to under 12 years of ageAsk a doctor. Applicator not for use in children under 12 years of age.
children under 6 years of age

Other information

  • store at 20°-25°C (68°-77°F)

Inactive ingredient hard fat

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 Italy. © 2015, Boehringer Ingelheim Pharmaceuticals, Inc. All rights reserved.

Carton - Dulcolax Suppositories with DulcoGlide Applicators

dulcoease-suppository-carton
DULCOLAX 
bisacodyl suppository
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0597-0162
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:0597-0162-031 in 1 CARTON08/05/201310/29/2021
15 in 1 BLISTER PACK; Type 1: Convenience Kit of Co-Package
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33408/05/201310/29/2021
Labeler - Boehringer Ingelheim Pharmaceuticals, Inc. (603175944)
Registrant - Boehringer Ingelheim Pharmaceuticals, Inc. (603175944)

Revised: 10/2021
Document Id: b0528a9d-1356-4d07-8331-4750c0ef1f23
Set id: 8459ee71-64eb-daba-d73d-b6ee37b945d1
Version: 4
Effective Time: 20211029
 
Boehringer Ingelheim Pharmaceuticals, Inc.