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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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 
docusate sodium capsule, gelatin coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68998-314
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM100 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorREDScoreno score
ShapeOVALSize8mm
FlavorImprint Code SCU1
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68998-314-01100 in 1 BOTTLE; Type 0: Not a Combination Product12/23/2014
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart33412/23/2014
Labeler - Marc Glassman, Inc. (094487477)

Revised: 12/2016
Document Id: 25bb7c23-df45-4aef-809a-d28c798185f6
Set id: 526db2dd-ad57-4dc7-ac44-1c5c9ee4536e
Version: 4
Effective Time: 20161228
 
Marc Glassman, Inc.