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

Drug Facts

Active ingredient (in each suppository)Purpose
Bisacodyl (USP) 10 mg .................................... Stimulant 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. Peel open plastic. Insert suppository well into rectum, pointed end first. Retain about 15 to 20 minutes.
children 6 to under 12 years of age1/2 suppository in a single daily dose
children under 6 years of ageask a doctor

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. © 2016, BI Pharmaceuticals, Inc. All rights reserved.

Dulcolax® 10 mg Suppository Carton
NDC: 0597-0052-28

dulcolax-suppositories-carton
DULCOLAX 
bisacodyl suppository
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0597-0052
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:0597-0052-164 in 1 CARTON04/01/200210/29/2021
14 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:0597-0052-287 in 1 CARTON04/01/200210/29/2021
24 in 1 BLISTER PACK; Type 0: Not a Combination Product
3NDC:0597-0052-341 in 1 CARTON04/01/200210/29/2021
34 in 1 BLISTER PACK; Type 0: Not a Combination Product
4NDC:0597-0052-382 in 1 CARTON04/01/200210/29/2021
44 in 1 BLISTER PACK; Type 0: Not a Combination Product
5NDC:0597-0052-441 in 1 CARTON04/01/200210/29/2021
51 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 finalpart33404/01/200210/29/2021
Labeler - Boehringer Ingelheim Pharmaceuticals, Inc. (603175944)
Registrant - Boehringer Ingelheim Pharmaceuticals, Inc. (603175944)

Revised: 10/2021
Document Id: fbab0415-cc0c-48cf-b3da-21b5b9be665f
Set id: b9959929-204f-496e-8cb6-493eee2d5777
Version: 5
Effective Time: 20211029
 
Boehringer Ingelheim Pharmaceuticals, Inc.