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

STOOL SOFTENER DOCUSATE SODIUM 50 MG by

Drug Labeling and Warnings

STOOL SOFTENER DOCUSATE SODIUM 50 MG 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 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 and over:

  take 1 to 6 softgels daily

• Children 2 to under 12 years of age:

  take 1 to 3 softgels daily

• children under 2 years:

  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 - 30ct

STOOL SOFTENERNDC: 51013-111-20

Compare to the active ingredient in Colace® 50 mg

50 MG DOCUSATE SODIUM PER SOFTGEL 30 Softgels

PRINCIPAL DISPLAY PANEL - 100ct

STOOL SOFTENER NDC: 51013-111-24

Compare to the active ingredient in Colace® 50 mg

50 MG DOCUSATE SODIUM PER SOFTGEL 100 Softgels

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51013-111
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51013-111-20	1 in 1 CARTON	08/22/2014
1		30 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2	NDC: 51013-111-24	1 in 1 CARTON	08/22/2014
2		100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	08/22/2014

Labeler - PuraCap Pharmaceutical LLC (962106329)

Establishment
Name	Address	ID/FEI	Business Operations
Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.		421293287	analysis(51013-111) , manufacture(51013-111)