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Dulcolax

Boehringer Ingelheim Pharmaceuticals, Inc.
Boehringer Ingelheim Pharmaceuticals, Inc.

Dulcolax® Stool Softener




FULL PRESCRIBING INFORMATION

Active ingredient (in each liquid gel) Purpose
Docusate sodium 100 mg............................................................................................................................. Stool softener laxative

Purpose

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

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.

take with a glass of water

adults and children 12 years and over 1 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 age 1 liquid gel daily
children under 2 years of age ask a doctor
  • each liquid gel contains: sodium 6mg
  • store at 15–30°C (59-86°F°)
  • protect from excessive humidity

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

Dulcolax

Docusate sodium GEL

Product Information

Product Type Human otc drug label Item Code (Source) NDC:0597-0016
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
DOCUSATE SODIUM DOCUSATE 100 mg

Inactive Ingredients

Ingredient Name Strength
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

Color Size Imprint Code Shape
RED 10 mm Dulcolax OVAL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0597-0016-01 100 in 1 BOTTLE
2 100 in 1 BOTTLE
3 NDC:0597-0016-26 25 in 1 BOTTLE
4 NDC:0597-0016-50 50 in 1 BOTTLE
5 NDC:0597-0016-55 30 in 1 BOTTLE
6 NDC:0597-0016-56 10 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part334 2002-10-01


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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