DULCOLAX- docusate sodium capsule, liquid filled

Dulcolax by

Drug Labeling and Warnings

Dulcolax by is a Otc medication manufactured, distributed, or labeled by Boehringer Ingelheim Pharmaceuticals, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Drug Facts

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

INDICATIONS & USAGE

Use

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

WARNINGS

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.

DOSAGE & ADMINISTRATION

Directions 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

STORAGE AND HANDLING

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 INGREDIENT

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.

PRINCIPAL DISPLAY PANEL

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

INGREDIENTS AND APPEARANCE

DULCOLAX 
docusate sodium capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0597-0016
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
docusate sodium (UNII: F05Q2T2JA0) (docusate - UNII:M7P27195AG)	docusate sodium	100 mg

Inactive Ingredients
Ingredient Name	Strength
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
HYPROMELLOSES (UNII: 3NXW29V3WO)
POLYETHYLENE GLYCOLS (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
Color	RED	Score	no score
Shape	OVAL	Size	10mm
Flavor		Imprint Code	Dulcolax
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0597-0016-01	1 in 1 CARTON	10/01/2002
1		100 in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 0597-0016-18	1 in 1 CARTON	10/01/2002
2		180 in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC: 0597-0016-26	1 in 1 CARTON	02/01/2013
3		25 in 1 BOTTLE; Type 0: Not a Combination Product
4	NDC: 0597-0016-50	1 in 1 CARTON	10/01/2002
4		50 in 1 BOTTLE; Type 0: Not a Combination Product
5	NDC: 0597-0016-55	1 in 1 CARTON	10/01/2002
5		30 in 1 BOTTLE; Type 0: Not a Combination Product
6	NDC: 0597-0016-56	1 in 1 CARTON	10/01/2002
6		10 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	10/01/2002

Labeler - Boehringer Ingelheim Pharmaceuticals, Inc. (603175944)

Registrant - Boehringer Ingelheim Pharmaceuticals, Inc. (603175944)