DOK EXTRA STRENGTH STOOL SOFTENER by Major Pharmaceuticals Drug Facts

DOK EXTRA STRENGTH STOOL SOFTENER by

Drug Labeling and Warnings

DOK EXTRA STRENGTH STOOL SOFTENER by is a Otc medication manufactured, distributed, or labeled by Major Pharmaceuticals. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

 

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG)	DOCUSATE SODIUM	250 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	CAPSULE	Size	20mm
Flavor		Imprint Code	P20
Contains

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

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
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

34390-5

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

Version: 2

Effective Time: 20181220