DOCUSATE SODIUM - docusate sodium  capsule, liquid filled 
SDA Laboratories, 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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Drug Facts

Active ingredient (in each softgel)

Docusate sodium 100 mg


Purpose

Stool softener

Uses

Warnings


Do not use

if you are currently taking mineral oil, unless directed by a doctor

Ask a doctor before use if you have

  • stomach pain, nausea or vomiting
  • have noticed a sudden change in bowel habits that lasts over 2 weeks

Stop use and ask a doctor if

  • you have rectal bleeding
  • you fail to have a bowel movement after use
  • you need to use a stool softener laxative for more than 1 week

If pregnant or breast-feeding,

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 12 years and over                        
take 1 to 3 softgels daily
children 2 to under 12 years of age
take 1 softgel daily
children under 2 years
ask a doctor

Other information

Inactive ingredients: D&C red #33,Edible ink, FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol, sorbitol special


Questions?

Adverse drug event call (800) 687-0176

Principal Display Panel

Image of Docusate label
DOCUSATE SODIUM 
docusate sodium capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66424-030
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
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
GELATIN (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SORBITOL (UNII: 506T60A25R)  
Product Characteristics
Colorred (Two toned- white and clear red) Scoreno score
ShapeOVALSize5mm
FlavorImprint Code 51A
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:66424-030-01100 in 1 BOTTLE
2NDC:66424-030-101000 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33409/15/2010
Labeler - SDA Laboratories, Inc. (948067889)
Registrant - Pharbest Pharmaceuticals, Inc. (557054835)
Establishment
NameAddressID/FEIBusiness Operations
Pharbest Pharmaceuticals, Inc557054835repack

Revised: 11/2011
Document Id: c7bb68e7-5479-467d-9fc0-fdf5a459486a
Set id: d9480871-7671-450c-b7da-79ece4649c6c
Version: 1
Effective Time: 20111116
 
SDA Laboratories, Inc.