STOOL SOFTENER- docusate sodium 100mg 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 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.

Overdose warning

In case of overdose, get medical help or contact a Posion Control Center right away.

Directions

• take with a glass of water -see Overdose warning

• adults and children 12 years of age and over:

  1 to 3 softgels daily. This dose may be taken as a single daily dose

  or in divided doses

• children 2 to under 12 years of age: 1 softgel daily
• children under 2 years of age: ask a doctor

Other information

• each softgel contains: sodium 5mg
• store at room temperature 15°-30° C (59°-86° F). Protect from excessive humidity
• contains FD&C Yellow No. 6

Inactive Ingredients

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

Questions or comments?

Call toll free: 1-855-215-8180

PRINCIPAL DISPLAY PANEL

PuraVation Stool Softener

Docusate Sodium - 100 mg EACH

100 SOFTGELS

NDC: 51013-819-01

INGREDIENTS AND APPEARANCE

STOOL SOFTENER 
docusate sodium 100mg capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51013-819
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, UNSPECIFIED (UNII: 2G86QN327L)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SORBITOL (UNII: 506T60A25R)
FD&C RED NO. 40 (UNII: WZB9127XOA)
WATER (UNII: 059QF0KO0R)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
GLYCERIN (UNII: PDC6A3C0OX)

Product Characteristics
Color	red (clear red)	Score	no score
Shape	OVAL	Size	13mm
Flavor		Imprint Code	PC1
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51013-819-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	11/30/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M007	11/30/2024

Labeler - PuraCap Pharmaceutical LLC (962106329)

Establishment
Name	Address	ID/FEI	Business Operations
Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd		421293287	manufacture(51013-819)