DULCOLAX STOOL SOFTENER- docusate sodium capsule, liquid filled

Dulcolax Stool Softener by

Drug Labeling and Warnings

Dulcolax Stool Softener 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® Stool Softener

Drug Facts

Active ingredient (in each capsule)

Docusate sodium (USP) 100 mg

Purpose

Stool softener laxative

Use

● for relief of occasional constipation and irregularity

● this product generally produces bowel movement in 12 to 72 hours

Warnings

Do not use

● if you are presently taking mineral oil, unless told to do so by a doctor

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

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.

Directions

take with a glass of water

adults and children 12 years of age and over       1 to 3 capsules daily. This dose may be taken as a single daily dose or in divided doses.

children 2 to under 12 years of age                         1 capsule daily

children under 2 years of age                               ask a doctor

Other information

● each capsule contains: sodium 6 mg

● 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 ingredients

FD&C red no. 40, FD&C yellow no. 6, gelatin, glycerin, mannitol, pharmaceutical ink, polyethylene glycol 400, propylene glycol, sorbitan, sorbitol, water

Questions?

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

PRINCIPAL DISPLAY PANEL

Dulcolax
Docusate sodium (USP) 100 mg/ Stool Softener Laxative
STOOL SOFTENER
Stimulant –Free
50
Liquid Gels
Sugar Free

INGREDIENTS AND APPEARANCE

DULCOLAX STOOL SOFTENER 
docusate sodium capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41167-0220
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)
MANNITOL (UNII: 3OWL53L36A)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SORBITAN (UNII: 6O92ICV9RU)
SORBITOL (UNII: 506T60A25R)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	RED	Score	no score
Shape	OVAL	Size	10mm
Flavor		Imprint Code	DE;100
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41167-0220-5	1 in 1 CARTON	11/22/2017
1		10 in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 41167-0220-4	1 in 1 CARTON	11/17/2017
2		100 in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC: 41167-0220-2	1 in 1 CARTON	10/15/2018
3		25 in 1 BOTTLE; Type 0: Not a Combination Product
4	NDC: 41167-0220-3	1 in 1 CARTON	12/05/2017
4		50 in 1 BOTTLE; Type 0: Not a Combination Product
5	NDC: 41167-0220-9	1 in 1 CARTON	10/15/2018
5		30 in 1 BOTTLE; Type 0: Not a Combination Product
6	NDC: 41167-0220-6	1 in 1 CARTON	10/15/2018
6		180 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	11/17/2017

Labeler - Chattem, Inc. (003336013)