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 - Shipping Label

DOCUSATE SODIUM CAPSULES, 50 mg

Quantity : 20000 Capsules
NDC. No : 53345-015-01

IMPORTANT:

Inspect immediate upon receipt.
This is a bulk shipment intended for further processing only.
Protect from heat, humidity, and light. Do not refrigerate.

CAUTION : "FOR FURTHER MANUFACTURING, PROCESSING OR REPACKING"

Shipping Label

DOCUSATE SODIUM 50 MG
docusate sodium capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:53345-015
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 GLYCOL, UNSPECIFIED (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
Packaging
1	NDC:53345-015-01	1 in 1 BOX	11/12/2013
1		20000 in 1 BAG; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M007	11/12/2013

Labeler - Humanwell PuraCap Pharmaceutical (Wuhan), Ltd. (421293287)

Name	Address	ID/FEI	Business Operations
Establishment
Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.		421293287	manufacture(53345-015)

DOCUSATE SODIUM 50mg, Capsule, liquid filled