DOCUSATE SODIUM- docusate sodium capsule 
NCS HealthCare of KY, Inc dba Vangard Labs

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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Active ingredient(s)

Docustae Sodium

Purpose

Stool Softener

Use(s)

-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 more 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 aperiod of 2 weeks

Stop use and ask a doctor if

-you have rectal bleeding

-you fail to have a bowel movement after use

Pregnancy/Breastfeeding

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

-adults and children 12 years of age and over: take 1 softgel daily or as directed by a doctor

-children under 12 years of age: take as directed by a doctor

Other information

-each softgel contains: sodium 15mg

-do not use if imprinted safety seal under cap is broken or missing

Storage

-store at controlled room temperature 15 degrees-30 degrees C (59 degrees - 86 degrees F)

Inactive ingredients

FD&C Red #40, gelatin glycerin, polyethylene glycol, propylene glycol, purified water and sorbitol special. May also contain: citric acid USP anhydrous, D&C Yellow#10, FD&C Yellow #6, ethyl vanillin, methyparaben and proplyaraben.

Questions

ADVERSE DRUG EVENT CALL: (800) 616-2471

Distributed by: Major Pharmaceuticals

31778 Enterprise Drive

Livonia, MI 48150, USA

M-58                                Rev. 2/09

Reorder No: 700208        PLD-8

Lot No.   U1082                L15MJ100

Exp. Date  06/12

Principal Display Panel

Docusate Sodium Softgel Caps

250mg

Docusate Sodium Softgels capsules 250mg

Principal Display Panel

Docusate Sodium Softgel Capsules

100mg

Docusate Sodium Softgel Capsules 100mg
DOCUSATE SODIUM 
docusate sodium capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0615-0586(NDC:0904-7891)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DOCUSATE SODIUM (DOCUSATE) DOCUSATE SODIUM250 mg
Product Characteristics
ColorRED (Orange) Scoreno score
ShapeCAPSULESize21mm
FlavorImprint Code P20
Contains    
Packaging
#Item CodePackage Description
1NDC:0615-0586-3930 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart33407/01/2010
DOCUSATE SODIUM 
docusate sodium capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0615-0585(NDC:0904-7889)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DOCUSATE SODIUM (DOCUSATE) DOCUSATE SODIUM100 mg
Product Characteristics
ColorRED (Orange) Scoreno score
ShapeOVALSize13mm
FlavorImprint Code P;51
Contains    
Packaging
#Item CodePackage Description
1NDC:0615-0585-0515 in 1 BLISTER PACK
2NDC:0615-0585-3131 in 1 BLISTER PACK
3NDC:0615-0585-3930 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart33407/01/2010
Labeler - NCS HealthCare of KY, Inc dba Vangard Labs (050052943)
Establishment
NameAddressID/FEIBusiness Operations
NCS HealthCare of KY, Inc dba Vangard Labs050052943RELABEL, REPACK

Revised: 07/2010
Document Id: c549c2bc-edb4-4a3f-b854-fcdfbf6de1ae
Set id: a753c56b-17c0-4451-9d4f-ba359de3af22
Version: 1
Effective Time: 20100714
 
NCS HealthCare of KY, Inc dba Vangard Labs