DOK EXTRA STRENGTH STOOL SOFTENER- 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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Drug Facts

Active ingredient (in each softgel)

Docusate Sodium 250mg

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 taking mineral oil, unless directed by a doctor
when abdominal pain, nausea, or vomiting are present
for more 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 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 and over: take 1 softgel daily or as directed by a doctor
children under 12 years of age: take as directed by a doctor

Other information

each softgel contains sodium 15mg
store at controlled room temperature 15o - 30o C (59o- 86o F)
do not use if imprinted safety seal under cap is broken or missing

Inactive Ingredients

edible white ink, FD&C Red No# 40, FD&C Yellow No. 6, gelatin, glycerin, polyethylene glycol, propylene glycol, purified wter, sorbitol special.

Questions or comments?

Adverse Drug Event Call: (800) 616-2471

Product Labeling

MAJOR DOK™

Docusate Sodium 250 mg

Extra Strength Stool Softener

For use as a Stool Softener in treating & Avoiding Constipation

Distributed by:

Major Pharmaceuticals

31778 Enterprise Drive

Livonia, MI 48150, USA

Major DOK Docusate Sodium 250 mg

Docusate Sodium 250 mg

DOK EXTRA STRENGTH STOOL SOFTENER
docusate sodium capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0904-7891
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG)	DOCUSATE SODIUM	250 mg

Ingredient Name	Strength
Inactive Ingredients
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	CAPSULE	Size	20mm
Flavor		Imprint Code	P20
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0904-7891-59	100 in 1 BOTTLE; Type 0: Not a Combination Product	08/27/2002	12/31/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part334	08/27/2002	12/31/2019

Labeler - Major Pharmaceuticals (191427277)

Revised: 12/2018

Document Id: b9eaaa09-9808-428d-8bb4-0c37371bce96

Set id: 6763caec-4cd9-4f0c-8723-ada8526adf91

Version: 2

Effective Time: 20181220

Major Pharmaceuticals