DULCOLAX- bisacodyl suppository

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]

DESCRIPTION

Drug Facts

• Active ingredient (in each suppository): Purpose
• Bisacodyl (USP) 10 mg: Stimulant laxative

Use

• for temporary relief of occasional constipation and irregularity
• this product generally produces bowel movement in 15 minutes to 1 hour

Warnings

For rectal use only

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

When using this product it may cause stomach discomfort, faintness, rectal burning and mild cramps

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. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

adults and children 12 years of age and over	1 suppository in a single daily dose. See consumer leaflet for proper, safe use of the applicator.
children 6 to under 12 years of age	Ask a doctor. Applicator not for use in children under 12 years of age.
children under 6 years of age

Other information

• store at 20°-25°C (68°-77°F)

Inactive ingredient hard fat

Questions? call 1-888-285-9159 (English/Spanish), M – F, 8:30 – 5 EST, or visit www.Dulcolax.com

Distributed by: Boehringer Ingelheim (BI) Consumer Health Care Products Division of BI Pharmaceuticals, Inc., Ridgefield, CT 06877. Product of Italy. Manufactured in Italy. © 2015, Boehringer Ingelheim Pharmaceuticals, Inc. All rights reserved.

PRINCIPAL DISPLAY PANEL

Carton - Dulcolax Suppositories with DulcoGlide Applicators

INGREDIENTS AND APPEARANCE

DULCOLAX 
bisacodyl suppository

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0597-0162
Route of Administration	RECTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BISACODYL (UNII: 10X0709Y6I) (DEACETYLBISACODYL - UNII:R09078E41Y)	BISACODYL	10 mg

Inactive Ingredients
Ingredient Name	Strength
FAT, HARD (UNII: 8334LX7S21)

Product Characteristics
Color	WHITE	Score
Shape	BULLET	Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0597-0162-03	1 in 1 CARTON	08/05/2013
1		5 in 1 BLISTER PACK; Type 1: Convenience Kit of Co-Package

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	08/05/2013

Labeler - Boehringer Ingelheim Pharmaceuticals, Inc. (603175944)

Registrant - Boehringer Ingelheim Pharmaceuticals, Inc. (603175944)