DOCUSATE SODIUM capsule, liquid filled

Docusate Sodium by

Drug Labeling and Warnings

Docusate Sodium by is a Otc medication manufactured, distributed, or labeled by NCS HealthCare of KY, Inc dba Vangard Labs. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient (in each softgel)

Docusate Sodium 100mg

Purpose

Stool softener

Uses

• for the 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 breastfeeding

ask a health care 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

• adults and children over 12 years of age: take 1 to 3 softgels preferably at bedtime
  
• children 6- 12 years of age: take 1 softgel at bedtime

Other information

• each softgel contains: sodium 6mg
• store at controlled room temperature 15o - 30o C (59o- 86o F)
• *This product is not manufactured or distributed by Purdue Pharma L.P., owner of the registered trademark Colace®

Inactive Ingredients

edible ink, FDandC Red #40, FDandC Yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol, purified water and sorbitol special.

Questions or comments?

Adverse Drug Event Call: (800)-616-2471)

PRINCIPAL DISPLAY PANEL

Distributed by : Major Pharmaceuticals, 31778 Enterprise Drive, Livonia, MI 48150, U.S.A.

Rev. 2/09

Principal Display Panel

 

INGREDIENTS AND APPEARANCE

DOCUSATE SODIUM 
docusate sodium capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0615-0585(NDC:0904-7889)
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
FD&C RED NO. 40 (UNII: WZB9127XOA)
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)

Product Characteristics
Color	ORANGE (ORANGE)	Score	no score
Shape	OVAL (OVAL)	Size	13mm
Flavor		Imprint Code	P51
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0615-0585-30	6 in 1 BOX, UNIT-DOSE
1		5 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 0615-0585-05	15 in 1 BLISTER PACK; Type 0: Not a Combination Product
3	NDC: 0615-0585-31	31 in 1 BLISTER PACK; Type 0: Not a Combination Product
4	NDC: 0615-0585-39	30 in 1 BLISTER PACK; 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	04/23/2010

Labeler - NCS HealthCare of KY, Inc dba Vangard Labs (050052943)

Establishment
Name	Address	ID/FEI	Business Operations
NCS HealthCare of KY, Inc dba Vangard Labs		050052943	REPACK(0615-0585)