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DOK by Major Pharmaceuticals

Dosage form: tablet, film coated
Ingredients: DOCUSATE SODIUM 100mg
Labeler: Major Pharmaceuticals
NDC Code: 0904-2244

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 tablet)

Docusate Sodium 100mg

Purpose

Stool Softener

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

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
  • you fail to have a bowel movement after use

If pregnant or breast-feeding

ask a healthcare professional before use

Keep out of reach of childrenIn case of overdose, get medical help or contact a Poison Control Center right away.

Directions
 Adults and children 12 years of age: Take 2 softgels, preferably at bedtime
 Children 6 to 12 years of age Take 1 softgel at bedtime

Other information
  • Each softgel contains:  sodium 5mg
  • Store at 20º - 25ºC (68º - 77ºF); excursions permitted to 15º - 30ºC (59º - 86ºF).  [See USP Controlled Room Temperature]

Inactive ingredients

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

Questions or comments? (800) 616-2471

PRINCIPAL DISPLAY PANEL DOK (DOCUSATE SODIUM) SOFTGELS, USP 100MG

 

DOK 
docusate sodium tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)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 
AMMONIUM LAURETH-5 SULFATE 
1-PROPOXY-2-PROPANOL 
WATER 
SORBITOL 
Product Characteristics
ColorWHITEScore2 pieces
ShapeROUND (Round Biconvex) Size11mm
FlavorImprint CodeGPI;S1
Contains    
Packaging
#Item CodePackage Description
1NDC:0904-2244-61100 TABLET, FILM COATED (100 TABLET) in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart33404/21/2011
Labeler - Major Pharmaceuticals (191427277)

 
Major Pharmaceuticals

Medically reviewed on Jul 16, 2018

See Also

Further information

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

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