DULCOLAX- docusate sodium capsule, liquid filled 
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.

----------

Dulcolax®
Stool Softener (docusate sodium USP 100mg)

Drug Facts

Active ingredient (in each liquid gel)Purpose
Docusate sodium 100mgStool softener laxative

Use

  • for temporary relief of occasional constipation and irregularity
  • this product generally produces bowel movement in 12 to 72 hours

Warnings

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

Ask a doctor or pharmacist before use if you are presently taking mineral oil

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 and over1 to 3 liquid gels daily. This dose may be taken as a single daily dose or in divided doses.
children 2 to under 12 years of age1 liquid gel daily
children under 2 years of ageask a doctor

Other information

  • each liquid gel contains: sodium 6mg
  • store at 20-25°C (68-77°F)
  • protect from excessive humidity
  • do not use this product if the safety seal under the cap is torn or missing

Inactive ingredients

FD&C Red #40, FD&C Yellow #6, gelatin, glycerin, hypromellose, isopropyl alcohol, mannitol, polyethylene glycol 400, propylene glycol, sorbitan, sorbitol, titanium dioxide, water

Questions? Call toll-free 1-888-285-9159 (English/Spanish) Or visit www.DULCOLAX.com

Dist: Boehringer Ingelheim Consumer Health Care Products Division of Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT 06877. Copyright © 2014, Boehringer Ingelheim Pharmaceuticals, Inc. All rights reserved.

Dulcolax® Stool Softener Carton
NDC: 0597-0016-26

dulcolax-stool-softener-carton
DULCOLAX 
docusate sodium capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0597-0016
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
docusate sodium (UNII: F05Q2T2JA0) (docusate - UNII:M7P27195AG) docusate sodium100 mg
Inactive Ingredients
Ingredient NameStrength
FD&C RED NO. 40 (UNII: WZB9127XOA)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
GELATIN (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
SORBITOL (UNII: 506T60A25R)  
SORBITAN (UNII: 6O92ICV9RU)  
MANNITOL (UNII: 3OWL53L36A)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
Product Characteristics
ColorREDScoreno score
ShapeOVALSize10mm
FlavorImprint Code Dulcolax
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0597-0016-011 in 1 CARTON10/01/200210/29/2021
1100 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:0597-0016-181 in 1 CARTON10/01/200210/29/2021
2180 in 1 BOTTLE; Type 0: Not a Combination Product
3NDC:0597-0016-261 in 1 CARTON02/01/201310/29/2021
325 in 1 BOTTLE; Type 0: Not a Combination Product
4NDC:0597-0016-501 in 1 CARTON10/01/200210/29/2021
450 in 1 BOTTLE; Type 0: Not a Combination Product
5NDC:0597-0016-551 in 1 CARTON10/01/200210/29/2021
530 in 1 BOTTLE; Type 0: Not a Combination Product
6NDC:0597-0016-561 in 1 CARTON10/01/200210/29/2021
610 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33410/01/200210/29/2021
Labeler - Boehringer Ingelheim Pharmaceuticals, Inc. (603175944)
Registrant - Boehringer Ingelheim Pharmaceuticals, Inc. (603175944)

Revised: 11/2021
Document Id: 33f9070e-241e-4795-a3af-7fc0f26fbabe
Set id: 19a67966-be6c-409b-bbbe-33b0b8b65d65
Version: 5
Effective Time: 20211104
 
Boehringer Ingelheim Pharmaceuticals, Inc.