DULCOLAX LAXATIVE- bisacodyl suppository

Dulcolax Laxative by

Drug Labeling and Warnings

Dulcolax Laxative by is a Otc medication manufactured, distributed, or labeled by Chattem, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Dulcolax®

Medicated Laxative Suppositories

Drug Facts

Active ingredient (in each suppository)

Bisacodyl (USP) 10 mg

Purpose

Stimulant laxative

Use

• for 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  
  
• noticed 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 fail to have a 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  

adults and children 12 years of age and over       1 suppository in a single daily dose. Peel open plastic. Insert suppository into rectum, pointed end first. Retain about 15 to 20 minutes.

children 6 to under 12 years of age                         ½ suppository in a single daily dose

children under 6 years of age                               ask a doctor

Other information

• do not use if individual blister unit is open or torn
  
• store at 20°-25°C (68°-77°F)  

Inactive ingredient

hard fat

Questions?

Call 1-866-844-2798 or visit www.Dulcolax.com

Keep carton as it contains important product information.

PRINCIPAL DISPLAY PANEL

Dulcolax
Bisacodyl (USP) 10 mg Suppository/ Stimulant Laxative
MEDICATED LAXATIVE SUPPOSITORY
4
COMFORT SHAPED
SUPPOSITORIES
DO NOT SWALLOW

INGREDIENTS AND APPEARANCE

DULCOLAX LAXATIVE 
bisacodyl suppository

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41167-0210
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: 41167-0210-3	4 in 1 CARTON	06/04/2019
1		4 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 41167-0210-5	7 in 1 CARTON	06/04/2019
2		4 in 1 BLISTER PACK; Type 0: Not a Combination Product
3	NDC: 41167-0210-1	1 in 1 CARTON	06/04/2019
3		4 in 1 BLISTER PACK; Type 0: Not a Combination Product
4	NDC: 41167-0210-2	2 in 1 CARTON	06/04/2019
4		4 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	06/04/2019

Labeler - Chattem, Inc. (003336013)