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Dulcolax by Boehringer Ingelheim Pharmaceuticals, Inc.

Dosage form: capsule, liquid filled
Ingredients: docusate sodium 100mg
Labeler: Boehringer Ingelheim Pharmaceuticals, Inc.
NDC Code: 0597-0016

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 
docusate sodium capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0597-0016
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
docusate sodium (docusate) docusate sodium100 mg
Inactive Ingredients
Ingredient NameStrength
FD&C RED NO. 40 
FD&C YELLOW NO. 6 
GELATIN 
GLYCERIN 
HYPROMELLOSES 
POLYETHYLENE GLYCOLS 
PROPYLENE GLYCOL 
WATER 
TITANIUM DIOXIDE 
SORBITOL 
SORBITAN 
MANNITOL 
ISOPROPYL ALCOHOL 
Product Characteristics
ColorREDScoreno score
ShapeOVALSize10mm
FlavorImprint CodeDulcolax
Contains    
Packaging
#Item CodePackage Description
1NDC:0597-0016-011 BOTTLE in 1 CARTON
1100 CAPSULE, LIQUID FILLED in 1 BOTTLE
2NDC:0597-0016-181 BOTTLE in 1 CARTON
2180 CAPSULE, LIQUID FILLED in 1 BOTTLE
3NDC:0597-0016-261 BOTTLE in 1 CARTON
325 CAPSULE, LIQUID FILLED in 1 BOTTLE
4NDC:0597-0016-501 BOTTLE in 1 CARTON
450 CAPSULE, LIQUID FILLED in 1 BOTTLE
5NDC:0597-0016-551 BOTTLE in 1 CARTON
530 CAPSULE, LIQUID FILLED in 1 BOTTLE
6NDC:0597-0016-561 BOTTLE in 1 CARTON
610 CAPSULE, LIQUID FILLED in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33410/01/2002
Labeler - Boehringer Ingelheim Pharmaceuticals, Inc. (603175944)
Registrant - Boehringer Ingelheim Pharmaceuticals, Inc. (603175944)

Revised: 04/2016
 
Boehringer Ingelheim Pharmaceuticals, Inc.

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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