DOK- docusate sodium tablet 
Cardinal Health

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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Drug Facts

Active ingredient

Drug Facts

Active Ingredient (in each softgel)

Docusate Sodium 100 mg

Purpose

Stool softener

Keep Out of Reach of Children

Keep out of reach of children. In case of overdose, get medical help or contact a Poison

Control Center right away.

Uses

■ for prevention of dry, hard stools

■ for relief of occasional constipation

This product generally produces a bowel movement within 12 to 72 hours.

Warnings

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 breast-feeding, ask a health care professional before use.

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

Inactive ingredients

edible ink, FD&C Red #40, FD&C Yellow #6, gelatin,

glycerin, polyethylene glycol, propylene glycol, purified water and sorbitol special.

Questions?

Adverse Drug Event Call: (800) 616-2471

 Other Information

each softgel contains: sodium 6 mg

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

*Compare to the active ingredient in COLACE®

*This product is not manufactured or distributed by Purdue Pharma L.P., owner of the

registered trademark Colace®.

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

Rev. 2/09

PLD-B

L09MJ1000

DOK™

100 MG

(Docusate Sodium) Stool Softener

For Use as a Stool Softener in Treating & Avoiding Constipation

MAJOR®

Cardinal Health

Zanesville, OH 43701

OI81860410

Package/Label Principal Display Panel

DOK Softgels

(Docusate Sodium)

100 mg

blister

Package/Label Principal Display Panel

DOK Softgels

(Docusate Sodium)

100 mg

Stool Softener

QTY 30

carton
DOK 
dok tablet
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:55154-1346(NDC:0904-7889)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DOCUSATE SODIUM (DOCUSATE) DOCUSATE SODIUM100 mg
Inactive Ingredients
Ingredient NameStrength
FD&C RED NO. 40 
FD&C YELLOW NO. 6 
GELATIN 
GLYCERIN 
POLYETHYLENE GLYCOL 3350 
PROPYLENE GLYCOL 
WATER 
SORBITOL 
Product Characteristics
ColorORANGEScoreno score
ShapeCAPSULESize12mm
FlavorImprint Code P51
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55154-1346-96 in 1 CARTON
15 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Unapproved drug other06/03/2011
Labeler - Cardinal Health (188557102)
Establishment
NameAddressID/FEIBusiness Operations
Cardinal Health188557102REPACK

Revised: 6/2011
 
Cardinal Health