DOK- docusate sodium tablet, film coated
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 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 children

In 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) SOFTGELS, USP 100MG

DOK
docusate sodium tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0904-2244
Route of Administration	ORAL

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

Ingredient Name	Strength
Inactive Ingredients
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
AMMONIUM LAURETH-5 SULFATE (UNII: 43ZIH89I48)
1-PROPOXY-2-PROPANOL (UNII: 152BY1743W)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)

Product Characteristics
Color	WHITE	Score	2 pieces
Shape	ROUND (Round Biconvex)	Size	11mm
Flavor		Imprint Code	GPI;S1
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0904-2244-61	100 in 1 BLISTER PACK; Type 0: Not a Combination Product	04/21/2011	12/31/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part334	04/21/2011	12/31/2018

Labeler - Major Pharmaceuticals (191427277)

Revised: 12/2019

Document Id: 07ed0d89-9d76-4ed5-8d0e-6f002243966e

Set id: 9ac7514b-fa72-46be-b932-ca69fe7ae07b

Version: 3

Effective Time: 20191213

Major Pharmaceuticals