DOK- docusate sodium tablet, film coated 
Cardinal Health

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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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.

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

edible ink, 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

L34321501214

Package/Label Principal Display Panel

DOK 100 MG.

Docusate Sodium Softgels, USP

10 Softgel Capsules

bag label
DOK 
docusate sodium tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55154-0667(NDC:0904-2244)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM100 mg
Inactive Ingredients
Ingredient NameStrength
FD&C RED NO. 40 (UNII: WZB9127XOA)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
Product Characteristics
ColorWHITEScore2 pieces
ShapeROUND (Round Biconvex) Size11mm
FlavorImprint Code GPI;S1
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55154-0667-010 in 1 BAG06/06/201108/31/2017
11 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33406/06/201108/31/2017
Labeler - Cardinal Health (188557102)
Establishment
NameAddressID/FEIBusiness Operations
Cardinal Health188557102REPACK(55154-0667)

Revised: 3/2018
 
Cardinal Health