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DOK by Major Pharmaceuticals

Medically reviewed on February 12, 2018

Dosage form: capsule
Ingredients: DOCUSATE SODIUM 100mg
Labeler: Major Pharmaceuticals
NDC Code: 0904-6457

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.

Drug Facts

Active ingredient (in each softgel)

Docusate Sodium 100 mg

Purpose

Stool softener laxative

Uses
  • relieves occasional constipation (irregularity)
  • generally produces bowel movement in 12 to 72 hours

Warnings

Do not use

if you are presently taking mineral oil, unless told to do so by a doctor.

Ask a doctor before use if you have
  • stomach pain
  • nausea
  • vomiting
  • noticed a sudden change in bowel habits that last over 2 weeks

Stop use and ask a doctor if
  • you have rectal bleeding or fail to have a bowel movement after use of a laxative. These could be a signs of a serious condition.
  • you need to use a laxative for more than 1 week

If pregnant or breast-feeding,

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
  • take only by mouth. Doses may be taken as a single daily dose or in divided doses.
adults and children 12 years and overtake 1 to 3 softgels daily.
children 2 to under 12 years of agetake 1 softgel daily
children under 2 years ask a doctor

Other information
  • each softgel contains: sodium 6 mg
  • store at 25ºC (77ºF);excursions permitted between 15-30ºC (59-86ºF)

Inactive ingredients

edible ink, FD&C Red #40, FD&C Yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol*, purified water sorbitan, sorbitol

*contains one or more of these ingredients

Questions or comments?

 Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

Compare to the active ingredient in Colace® Regular Strength Stool Softener**

DOK™ 100 mg

Docusate sodium

Stool Softener Laxative

For Use as a Stool Softener in Treating & Avoiding Constipation

Softgels

**This product is not manufactured or distributed bt Purdue Products L.P., distributor of Colace® Regular Strength Stool Softener.

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

Distributed by:

Major® Pharmaceuticals

17177 N Laurel Park Drive, Suite 233

Livonia, MI 48152

Product Label

MAJOR Stool Softener Laxative

DOK 
docusate sodium capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-6457
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 
SORBITAN 
POLYETHYLENE GLYCOLS 
PROPYLENE GLYCOL 
WATER 
SORBITOL 
GLYCERIN 
MEDIUM-CHAIN TRIGLYCERIDES 
Product Characteristics
ColorORANGEScoreno score
ShapeOVALSize12mm
FlavorImprint CodeP51;S77;SCU1
Contains    
Packaging
#Item CodePackage Description
1NDC:0904-6457-60100 CAPSULE in 1 BOTTLE, PLASTIC
2NDC:0904-6457-801000 CAPSULE in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart33402/28/2015
Labeler - Major Pharmaceuticals (191427277)

 
Major Pharmaceuticals

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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