DOCUSATE SODIUM capsule, liquid filled

DOCUSATE SODIUM by

Drug Labeling and Warnings

DOCUSATE SODIUM by is a Otc medication manufactured, distributed, or labeled by Dolgencorp, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each softgel)

Docusate Sodium 100 mg 

Purpose

Stool Softner 

Uses

• relieves occasional constipation (irregularity)
• this product generally produces a bowel movement within 12 to 72 hours

WARNINGS

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
• vomittiong
• a sudden change in bowel habits that lasts more than 2 weeks

Stop use and ask a doctor if

• you have rectal bleeding ot no bowel movement after use of a laxative. These could be signs of a serious condition.
• yo need to use a stool softener laxative for more than 1 week

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding,ask a health professional before use

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.  In case of overdose, get medical help or contact a Poison Control Center right away.1(800)222-1222

Directions

Take only by mouth. Doses may be taken as a single daily dose or in divided doses.

Adults and children 12 years and over : take 1-3 softgels daily.

Children 2 to under 12 years of age :  take 1 softgel daily.

Children under 2 years of age: ask a doctor

Other information

• Store at 25°C  (77°F), excursions permitted between 15°-30°C (59°-86°F)
• Keep tightly closed.

Inactive ingredients

gelatin, glycerin, polyethylene glycol-400, povidone, propylene glycol, purified water, sorbitol solution, titanium dioxide.

Questions or comments?

1-888-309-9030

PRINCIPAL DISPLAY PANEL

DGTM Health

Compare to the active ingredient of Colace®*

STOOL SOFTENER CLEAR

DOCUSATE SODIUM 100 mg

Relieves constipation

Gentle Relief

Stimulant-Free
Dye-Free

100 Softgels

* This product is not manufactured or distributed by Purdue Products L.P., owner of the registered trademark Colace.

INGREDIENTS AND APPEARANCE

DOCUSATE SODIUM 
docusate sodium capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55910-223
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
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
POVIDONE K30 (UNII: U725QWY32X)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	white (Transparent Softgels appear slightly Yellow)	Score	no score
Shape	OVAL	Size	12mm
Flavor		Imprint Code	S50
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55910-223-10	1 in 1 CARTON	05/21/2019
1		100 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	05/21/2019

Labeler - Dolgencorp, Inc. (068331990)

Registrant - Spirit Pharmaceuticals LLC (179621011)

Establishment
Name	Address	ID/FEI	Business Operations
MEDGEL PVT LTD		677385498	manufacture(55910-223)