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]

ACTIVE INGREDIENT

Drug Facts

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

INDICATIONS & USAGE

Use

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

WARNINGS

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.

DOSAGE & ADMINISTRATION

Directions

• adults and children 12 years of age and over: 1 suppository in a single daily dose. Peel open plastic. Insert suppository well into rectum, pointed end first. Retain about 15 to 20 minutes.
• children 6 to under 12 years of age: 1/2 suppository in a single daily dose
• children under 6 years of age: ask a doctor

STORAGE AND HANDLING

Other information

• store at 20-25°C (68-77°F)

INACTIVE INGREDIENT

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. © 2016, BI Pharmaceuticals, Inc. All rights reserved.

PRINCIPAL DISPLAY PANEL

Dulcolax® 10 mg Suppository Carton
NDC: 0597-0052-28

INGREDIENTS AND APPEARANCE

DULCOLAX 
bisacodyl suppository

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0597-0052
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: 0597-0052-16	4 in 1 CARTON	04/01/2002
1		4 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 0597-0052-28	7 in 1 CARTON	04/01/2002
2		4 in 1 BLISTER PACK; Type 0: Not a Combination Product
3	NDC: 0597-0052-34	1 in 1 CARTON	04/01/2002
3		4 in 1 BLISTER PACK; Type 0: Not a Combination Product
4	NDC: 0597-0052-38	2 in 1 CARTON	04/01/2002
4		4 in 1 BLISTER PACK; Type 0: Not a Combination Product
5	NDC: 0597-0052-44	1 in 1 CARTON	04/01/2002
5		1 in 1 BLISTER PACK; 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	04/01/2002

Labeler - Boehringer Ingelheim Pharmaceuticals, Inc. (603175944)

Registrant - Boehringer Ingelheim Pharmaceuticals, Inc. (603175944)