STOOL SOFTENER- docusate sodium 100 mg capsule, liquid filled

Stool Softener by

Drug Labeling and Warnings

Stool Softener by is a Otc medication manufactured, distributed, or labeled by GERITREX LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient (in each softgel)

Docusate Sodium 100 mg

Purpose

Stool softener laxative

Uses

• relieves occasional constipation (irregularity)
• 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
• vomitting
• notice a sudden change in bowel habits that lasts over 2 weeks

Stop use and ask a doctor if

• you have rectal bleeding or fail to have bowel movement after use of laxative. These could be signs of 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 accidental overdose, get medical help or contact a Poison Control Center right away

Directions

take only by mouth. Doses may be taken as a single daily does 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: ask a doctor

Other Information

• each softgel contains: sodium 6 mg
• store at 25°C (77°F); excursions premitted between 15-30°C (59-86°F)

Inactive ingredients

D&C red #33, editable ink, FD&C blue #1*, FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol*, purified water, sorbitan, sorbitol, titanium dioxide
*contains one or more of these ingredients.

Questions or comments?

Call 1-800-736-3437

Label

INGREDIENTS AND APPEARANCE

STOOL SOFTENER 
docusate sodium 100 mg capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54162-943
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
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
GELATIN (UNII: 2G86QN327L)
WATER (UNII: 059QF0KO0R)
SORBITAN (UNII: 6O92ICV9RU)
SORBITOL (UNII: 506T60A25R)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	red, white	Score	no score
Shape	OVAL	Size	8mm
Flavor		Imprint Code	D1;P10;SCU2
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54162-943-00	100 in 1 BOX; Type 0: Not a Combination Product	10/01/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	10/01/2018

Labeler - GERITREX LLC (112796248)

Establishment
Name	Address	ID/FEI	Business Operations
GERITREX LLC		112796248	manufacture(54162-943)