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DOK by Major Pharmaceuticals

Medically reviewed on June 14, 2018

Dosage form: capsule, liquid filled
Ingredients: DOCUSATE SODIUM 100mg
Labeler: Major Pharmaceuticals
NDC Code: 0904-6455

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.

Major 44-655

Active ingredient (in each liquid-filled capsule)

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 lasts 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 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 (1-800-222-1222) right away.

Directions
  • take with a glass of water
  • take only by mouth. Doses may be taken as a single daily dose or in divided doses.
 adults and children 12 years and over take 1 to 3 capsules daily
 children 2 to under 12 years take 1 capsule daily
 children under 2 years ask a doctor


Other information
  • each capsule contains: sodium 6 mg Very Low Sodium
  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • protect from excessive humidity
  • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
  • see end flap for expiration date and lot number

Inactive ingredients

anhydrous citric acid, edible white ink, FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol, purified water, sorbitol

Questions or comments?

(800) 616-2471

Principal Display Panel

NDC 0904-6455-61

MAJOR®
PHARMACEUTICALS

Unit Dose

DOK
(Docusate Sodium)

Stool Softener Laxative

100 mg

100 SOFTGELS

This Unit Dose package is not child resistant and
is Intended for Institutional Use Only.

50844         REV0218C65512

Distributed by MAJOR® PHARMACEUTICALS
17177 N Laurel Park Drive, Suite 233
Livonia, MI 48152 USA           M-17
Rev. 02/18                                           Re-order No. 301872

Product of China
Packaged and Quality Assured in the USA

Major 44-655

DOK 
docusate sodium capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-6455
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, UNSPECIFIED 
GLYCERIN 
POLYETHYLENE GLYCOL, UNSPECIFIED 
PROPYLENE GLYCOL 
SORBITOL 
WATER 
ANHYDROUS CITRIC ACID 
Product Characteristics
ColorORANGEScoreno score
ShapeOVALSize13mm
FlavorImprint Code655
Contains    
Packaging
#Item CodePackage Description
1NDC:0904-6455-6110 BLISTER PACK in 1 PACKAGE
110 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart33403/01/2015
Labeler - Major Pharmaceuticals (191427277)
Establishment
NameAddressID/FEIOperations
Humanwell Puracap Pharmaceuticals (Wuhan) Co., Ltd421293287API MANUFACTURE(0904-6455)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.038154464PACK(0904-6455)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867837PACK(0904-6455)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.967626305PACK(0904-6455)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.868734088PACK(0904-6455)

 
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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