STOOL SOFTENER- docusate sodium capsule, liquid filled

STOOL SOFTENER by

Drug Labeling and Warnings

STOOL SOFTENER by is a Otc medication manufactured, distributed, or labeled by PuraCap Pharmaceutical LLC, Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each softgel)

Docusate sodium 250 mg

Purpose

Stool softener laxative

Uses

• for the prevention of dry, hard stools
• for relief of occasional constipation
• this product generally produces a bowel movement within 12 to 72 hours

Warnings

Do not use

if you are presently taking mineral oil, unless directed by a doctor.

Ask a doctor before use if you have

• stomach pain
• nausea
• vomiting
• noticed a sudden change in bowel habits that last over 2 weeks

Stop use and ask a doctor if

• you have rectal bleeding or fail to have a bowel movement after use of a laxative. 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: take 1 softgel daily or as directed by a doctor
• children under 12 years of age: ask a doctor

Other information

• each softgel contains:sodium 15 mg
• store at 20º-25ºC (68º-77ºF); excursions permitted between 15º-30ºC (59º-86ºF)

Inactive ingredients

anhydrous citric acid, FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol, purified water, sorbitol sorbitan solution, and white edible ink

Questions or comments?

Call toll free: 1-855-215-8180

Principal Display Panel

STOOL SOFTENER

DOCUSATE SODIUM 250mg 100 SOFTGELS

Compare to the active ingredient in COLACE®

NDC: 51013-194-24

INGREDIENTS AND APPEARANCE

STOOL SOFTENER 
docusate sodium capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51013-194
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG)	DOCUSATE SODIUM	250 mg

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
SORBITAN (UNII: 6O92ICV9RU)

Product Characteristics
Color	red (clear)	Score	no score
Shape	capsule (oval)	Size	20mm
Flavor		Imprint Code	P4
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51013-194-24	100 in 1 BOTTLE; Type 0: Not a Combination Product	07/14/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	07/14/2017

Labeler - PuraCap Pharmaceutical LLC (962106329)

Establishment
Name	Address	ID/FEI	Business Operations
Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.		421293287	manufacture(51013-194) , analysis(51013-194)