DOCUSATE SODIUM- docusate sodium capsule

Docusate Sodium by

Drug Labeling and Warnings

Docusate Sodium by is a Otc medication manufactured, distributed, or labeled by Pharbest Pharmaceuticals, Inc., Pharbest Pharmaceuticals, Inc, Accucaps Industries Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each softgel)

Docusate sodium 100 mg

Purpose

Stool softener

Uses

• prevents/relieves dry hard stool
• results usually occurs 1 to 3 days after the first dose
  

Warnings

Do not use

• when abdominal pain, nausea, or vomiting are present
• for more than one week unless directed by a doctor
  

Ask a doctor before use if you

• are taking mineral oil
• have noticed a sudden change in bowel habits that last over 2 weeks
  

Stop use and ask a doctor if

• you have no bowel movement after 3 days
• you have rectal bleeding

These could be signs of a serious condition

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

• do not exceed recommended dose

• adults and children over 12 years: take 1-2 softgels daily until first bowel movement; 1 softgel daily thereafter
• children 6 to 12 years: take 1 softgel daily
• children under 6 years: consult a doctor

Other information

• Tamper Evident: Do not use if safety seal under cap is broken or missing
• store at room temperature 15o to 30oC (59o to 86oF)
• protect from moisture
  

Inactive ingredients: D&C yellow #10, FD&C red #40, gelatin, glycerin, ink white, polyethylene glycol, sorbitol, propylene glycol.

Questions?

Adverse drug event call: (866) 562-2756

Principal Display Panel

*Compare to the active ingredient of Colace®

Docusate Sodium

Stool Softener

1000 SOFTGELS

100 mg each

INGREDIENTS AND APPEARANCE

DOCUSATE SODIUM 
docusate sodium capsule

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 16103-384
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
D&C Yellow No. 10 (UNII: 35SW5USQ3G)
FD&C Red No. 40 (UNII: WZB9127XOA)
Gelatin (UNII: 2G86QN327L)
Glycerin (UNII: PDC6A3C0OX)
Polyethylene Glycol (UNII: 3WJQ0SDW1A)
Propylene Glycol (UNII: 6DC9Q167V3)
Sorbitol (UNII: 506T60A25R)

Product Characteristics
Color	red (Two-toned- white and clear red)	Score	no score
Shape	OVAL	Size	5mm
Flavor		Imprint Code	51A
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 16103-384-08	100 in 1 BOTTLE
2	NDC: 16103-384-11	1000 in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	01/22/2007

Labeler - Pharbest Pharmaceuticals, Inc. (557054835)

Establishment
Name	Address	ID/FEI	Business Operations
Pharbest Pharmaceuticals, Inc		557054835	repack

Establishment
Name	Address	ID/FEI	Business Operations
Accucaps Industries Ltd.		248441727	manufacture