STOOL SOFTENER DOCUSATE SODIUM 50 MG- docusate sodium capsule, liquid filled
PuraVation Pharmaceuticals Inc

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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STOOL SOFTENER DOCUSATE SODIUM 50mg, Capsule, liquid filled

Drug Facts

Active ingredient (in each softgel)

Docusate Sodium 50 mg

Purpose

Stool softener

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
vomiting
noticed 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 a bowel movement after use of a laxative. These could be signs of a serious condition.
you need to use a stool softener 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 only by mouth. Doses may be taken as a single daily dose or in divided doses.

Adults and children 12 years of ages and over	take 1 to 6 softgels daily
Children 2 and under 12 years of age	take 1 to 3 softgels daily
children under 2 years of age	ask a doctor

Other information

each softgel contains: sodium 3 mg VERY LOW SODIUM
store at 15°-30°C (59°-86°F)
Keep tightly closed.

Inactive ingredients

citric acid, D&C red #33, FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol, purified water, sorbitol special, white edible ink

Manufactured by:
Humanwell PuraCap Pharmaceutical (Wuhan) Ltd.
Wuhan, Hubei
430206, China

PRINCIPAL DISPLAY PANEL - 30 SOFTGEL CAROTN

STOOL SOFTENER

NDC 76270-116-20

Compare to the active ingredient in Colace® 50 mg®

50 MG DOCUSATE SODIUM PER SOFTGEL

Stimulant freeGentle & effectiveComfortable relief of constipation

30 Softgels 50 mg

PRINCIPAL DISPLAY PANEL - Carton Label

PRINCIPAL DISPLAY PANEL - 100 SOFTGEL CAROTN

STOOL SOFTENER

NDC 76270-116-24

Compare to the active ingredient in Colace® 50 mg*

50 MG DOCUSATE SODIUM PER SOFTGEL

Stimulant freeGentle & effectiveComfortable relief of constipation

100 Softgels 50 mg

PRINCIPAL DISPLAY PANEL - Carton Label

STOOL SOFTENER DOCUSATE SODIUM 50 MG
docusate sodium capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:76270-116
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG)	DOCUSATE SODIUM	50 mg

Ingredient Name	Strength
Inactive Ingredients
FD&C RED NO. 40 (UNII: WZB9127XOA)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)

Product Characteristics
Color	red (clear)	Score	no score
Shape	CAPSULE (OVAL)	Size	13mm
Flavor		Imprint Code	PC20
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:76270-116-20	1 in 1 CARTON	11/12/2013	02/10/2017
1		30 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2	NDC:76270-116-24	1 in 1 CARTON	11/12/2013	02/10/2017
2		100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part334	11/12/2013	02/10/2017

Labeler - PuraVation Pharmaceuticals Inc (968385034)

Revised: 2/2017

Document Id: f944a24c-17c1-4b69-8f78-372f958cb34c

Set id: b207efe1-6314-415f-806c-10213406343f

Version: 2

Effective Time: 20170210

PuraVation Pharmaceuticals Inc