STOOL SOFTENER GENTLE RELIEF- 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 GENTEL RELIEF (Docusate Sodium) capsule, liquid filled

Drug Facts

Active ingredient (in each softgel)

Docusate Sodium 100 mg

Purpose

Stool softener

Uses

for 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 currently taking mineral oil, unless directed by a doctor
when abdominal pain, nausea, or vomiting are present
for longer than 1 week, unless directed by a doctor

Ask a doctor before use if you notice a sudden change in bowel habits that persists over a period of 2 weeks.

Stop use and ask a doctor if

you have rectal bleeding
you fail to have a bowel movement after use

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 with a glass of water

Adults and children 12 years of age and over	take 1 to 3 softgels daily. This dose may be taken as a single daily dose or in divided doses
Children 2 and under 12 years of age	take 1 softgel daily
children under 2 years of age	ask a doctor

Other information

each softgel contains: sodium 6 mg
store at controlled room temperature 15°-30°C (59°-86°F)
do not use if imprinted safety seal under cap is broken or missing

Inactive ingredients

FD&C Red # 40, FD&C Yellow #6, gelatin, glycerin, polyethylene glycol, sorbitol special, purified water

Questions or comments? Call toll free: 1-800-833-6278

PRINCIPAL DISPLAY PANEL

STOOL SOFTENER

Gentle Relief

Provides safe, gentle relief of constipation

Docusate Sodium 100 mg

Softens stool
Provides gentle relief

100 SOFT FELS

Compare to the active ingredient in DULCOLAX®

PRINCIPAL DISPLAY PANEL - Shipping Label

STOOL SOFTENER GENTLE RELIEF
docusate sodium capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:76270-101
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG)	DOCUSATE SODIUM	100 mg

Ingredient Name	Strength
Inactive Ingredients
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:76270-101-24	1 in 1 CARTON	04/15/2013	12/30/2016
1		100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2	NDC:76270-101-27	1 in 1 CARTON	04/15/2013	12/30/2016
2		250 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	04/15/2013	12/30/2016

Labeler - PuraVation Pharmaceuticals Inc (968385034)

Name	Address	ID/FEI	Business Operations
Establishment
Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.		421293287	MANUFACTURE(76270-101) , ANALYSIS(76270-101)

Revised: 12/2016

Document Id: b25d71d5-5bad-48a0-ba75-926ce394ea9c

Set id: 04a94233-bd2d-477f-b397-f7da59334dbb

Version: 2

Effective Time: 20161230

PuraVation Pharmaceuticals Inc