DOK- docusate sodium capsule 
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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Active ingredient

Drug Facts

Active Ingredient (in each softgel)

Docusate Sodium, USP, 100 mg

Purpose

Stool Softener

Keep Out of Reach of Children

Keep out of reach of children.

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

This package is intended for institutional use only. In case of overdose, get medical help or contact a Poison Control Center right away.

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 one 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 or if you fail to have a bowel movement after use.

If pregnant or breast-feeding ask a health professional before use.

Directions

Adults and children over 12 years of age, take 2 softgels, preferably at bedtime

children 6 to 12 years of age take 1 softgel at bedtime

Inactive ingredients

FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol, purified water and sorbitol special

Storage

Store at 20 - 25 C (68 - 77 F); excursions permitted to 15 - 30 C (59-86 F). [See USP Controlled Room Temperature]

Other Information

Each softgel contains: sodium 5 mg

For use as a Stool Softener in Treating & Avoiding Constipation

Distributed by

Major Pharmaceuticals

31778 Enterprise Drive

Livonia, MI 48150 USA

MFGD By Banner Pharmacaps, Inc., NC 27265

Questions? Adverse Drug Event

Call (800) 616-2471

DOK 100 mg

Docusate Sodium Softgels, USP

10 Softgel Capsules

Repackaged by Cardinal Health

Zanesville, OH 43701

L34321500311

Package/Label Principal Display Panel

DOK 100 MG.

Docusate Sodium Softgels, USP

10 Softgel Capsules

bag label
DOK 
docusate sodium capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55154-0667(NDC:0904-2244)
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
ShapeCAPSULESize13mm
FlavorImprint Code P51
Contains    
Packaging
#Item CodePackage Description
1NDC:55154-0667-010 in 1 BAG
11 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Unapproved drug other06/06/2011
Labeler - Cardinal Health (188557102)
Establishment
NameAddressID/FEIBusiness Operations
Cardinal Health188557102REPACK(55154-0667)

Revised: 07/2012
 
Cardinal Health