DOCUSATE SODIUM- docusate sodium capsule, gelatin coated
Marc Glassman, Inc.

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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314 - Docusate Sodium

Active ingredient

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

■ fail to have a bowel movement occur after use

Pregnancy/Breastfeeding

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children

Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

■ Adults and children 12 years and over: take 1 to 3 capsules, preferably at bedtime

■ Children 2 to under 12 years of age: take 1 capsule at bedtime

■ Children under 2 years of age: ask a doctor

Other information

each capsule contains: sodium 5mg

store at room temperature 15°-30°C (59°-86°F)

Inactive ingredients

FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, gelatin, glycerin, polyethylene glycol 400, purified water, sorbitol

Principal Display Panel

Docusate Sodium

DOCUSATE SODIUM
docusate sodium capsule, gelatin coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:68998-314
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 (UNII: 2G86QN327L)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
SORBITOL (UNII: 506T60A25R)

Product Characteristics
Color	red	Score	no score
Shape	OVAL	Size	8mm
Flavor		Imprint Code	SCU1
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:68998-314-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	12/23/2014	09/30/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part334	12/23/2014	09/30/2023

Labeler - Marc Glassman, Inc. (094487477)

Revised: 12/2016

Document Id: a7657585-f04d-41be-9e7c-91044068fa7b

Set id: 526db2dd-ad57-4dc7-ac44-1c5c9ee4536e

Version: 5

Effective Time: 20161228

Marc Glassman, Inc.