MAJOR DOK DOCUSATE SODIUM- docusate sodium capsule, liquid filled

MAJOR DOK Docusate Sodium by

Drug Labeling and Warnings

MAJOR DOK Docusate Sodium by is a Otc medication manufactured, distributed, or labeled by Major Pharmaceuticals. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient (in each softgel)

Docusate Sodium 100mg

Purpose

Stool softener

Uses

• for the 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 1 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 breastfeeding

ask a health care 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

• adults and children over 12 years of age: take 1 to 3 softgels preferably at bedtime
  
• children 6- 12 years of age: take 1 softgel at bedtime

Other information

• each softgel contains: sodium 6mg
• store at controlled room temperature 15o - 30o C (59o- 86o F)
• do not use if imprinted safety seal under cap is broken or missing.
• *This product is not manufactured or distributed by Purdue Pharma L.P., owner of the registered trademark Colace®

Inactive Ingredients

edible ink, FDandC Red #40, FDandC Yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol, purified water and sorbitol special.

Questions or comments?

Adverse Drug Event Call: (800)-616-2471)

PRINCIPAL DISPLAY PANEL

MAJOR® DOK™ 100 mg Docusate Sodium

For use as a stool softener in treating & avoiding constipation

*Compare to the active ingredient in COLACE®

Product Labeling

Docusate Sodium 100 mg 1000 count

 

INGREDIENTS AND APPEARANCE

MAJOR DOK DOCUSATE SODIUM 
docusate sodium capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0904-7889
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG)	DOCUSATE SODIUM	100 mg

Inactive Ingredients
Ingredient Name	Strength
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)

Product Characteristics
Color	ORANGE (ORANGE)	Score	no score
Shape	OVAL (OVAL)	Size	13mm
Flavor		Imprint Code	P51
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0904-7889-59	100 in 1 BOTTLE; Type 0: Not a Combination Product	04/23/2010	12/30/2021
2	NDC: 0904-7889-60	100 in 1 BOTTLE; Type 0: Not a Combination Product	04/23/2010	12/30/2021
3	NDC: 0904-7889-80	1000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/23/2010	12/30/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part334	04/23/2010	12/30/2021

Labeler - Major Pharmaceuticals (191427277)