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Dulcolax by Boehringer Ingelheim Pharmaceuticals, Inc.

Dosage form: gel
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

Drug Facts
Active ingredient (in each liquid gel)Purpose
Docusate sodium 100 mg.............................................................................................................................Stool 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 15–30°C (59-86°F°)
  • protect from excessive humidity

Inactive ingredients

FD&C Red #40, FD&C Yellow #6, gelatin,glycerin, hypromellose, polyethylene glycol, propylene glycol, purified water, sorbitol special, titanium dioxide

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

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

DULCOLAX 
docusate sodium gel
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 
Product Characteristics
ColorREDScore    
ShapeOVALSize10mm
FlavorImprint CodeDulcolax
Contains    
Packaging
#Item CodePackage Description
1NDC:0597-0016-01100 GEL in 1 BOTTLE
2NDC:0597-0016-252 BOTTLE in 1 CARTON
2100 GEL in 1 BOTTLE
3NDC:0597-0016-2625 GEL in 1 BOTTLE
4NDC:0597-0016-5050 GEL in 1 BOTTLE
5NDC:0597-0016-5530 GEL in 1 BOTTLE
6NDC:0597-0016-5610 GEL 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)
Establishment
NameAddressID/FEIOperations
Banner Pharmacaps Inc945494508MANUFACTURE(0597-0016)

Revised: 05/2014
 
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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