DOCUSATE SODIUM capsule, gelatin coated

Docusate Sodium by

Drug Labeling and Warnings

Docusate Sodium by is a Otc medication manufactured, distributed, or labeled by Marc Glassman, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

DOCUSATE SODIUM 
docusate sodium capsule, gelatin coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68998-314
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
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

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

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part334	12/23/2014

Labeler - Marc Glassman, Inc. (094487477)