MAJOR DOK DOCUSATE SODIUM - docusate sodium capsule, liquid filled
Major Pharmaceuticals

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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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)

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

Major DOK Stool Softener 100 mg 1000 count

Docusate Sodium 100 mg 1000 count

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	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DOCUSATE SODIUM (DOCUSATE)	DOCUSATE SODIUM	100 mg

Inactive Ingredients
Ingredient Name	Strength
FD&C RED NO. 40
FD&C YELLOW NO. 6
GELATIN
GLYCERIN
POLYETHYLENE GLYCOLS
PROPYLENE GLYCOL
WATER
SORBITOL

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

Packaging
#	Item Code	Package Description	Multilevel Packaging
1	NDC:0904-7889-59	100 CAPSULE, LIQUID FILLED (100 CAPSULE) in 1 BOTTLE	None
2	NDC:0904-7889-80	1000 CAPSULE, LIQUID FILLED (1000 CAPSULE) in 1 BOTTLE, PLASTIC	None

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

Labeler - Major Pharmaceuticals (191427277)

Revised: 08/2012 Major Pharmaceuticals