DOCUSATE SODIUM - docusate sodium  capsule 
Pharbest Pharmaceuticals, 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.


Drug Facts

Active ingredient (in each softgel)

Docusate sodium 100 mg


Stool softener



Do not use

  • when abdominal pain, nausea, or vomiting are present
  • for more than one week unless directed by a doctor

Ask a doctor before use if you

  • are taking mineral oil
  • have noticed a sudden change in bowel habits that last over 2 weeks

Stop use and ask a doctor if

  • you have no bowel movement after 3 days
  • you have rectal bleeding
These could be signs of a serious condition

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.


adults and children over 12 years                        
take 1-2 softgels daily until first bowel movement; 1 softgel daily thereafter
children 6 to 12 years
take 1 softgel daily
children under 6 years
consult a doctor

Other information

Inactive ingredients: D&C yellow #10, FD&C red #40, gelatin, glycerin, ink white, polyethylene glycol, sorbitol, propylene glycol.


Adverse drug event call: (866) 562-2756

Principal Display Panel

*Compare to the active ingredient of Colace®

Docusate Sodium

Stool Softener


100 mg each

Image of Docusate label

docusate sodium capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:16103-384
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 Yellow No. 10 (UNII: 35SW5USQ3G)  
FD&C Red No. 40 (UNII: WZB9127XOA)  
Gelatin (UNII: 2G86QN327L)  
Glycerin (UNII: PDC6A3C0OX)  
Polyethylene Glycol (UNII: 3WJQ0SDW1A)  
Propylene Glycol (UNII: 6DC9Q167V3)  
Sorbitol (UNII: 506T60A25R)  
Product Characteristics
Colorred (Two-toned- white and clear red) Scoreno score
FlavorImprint Code 51A
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:16103-384-08100 in 1 BOTTLE
2NDC:16103-384-111000 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33401/22/2007
Labeler - Pharbest Pharmaceuticals, Inc. (557054835)
NameAddressID/FEIBusiness Operations
Pharbest Pharmaceuticals, Inc557054835repack
NameAddressID/FEIBusiness Operations
Accucaps Industries Ltd.248441727manufacture

Revised: 7/2010
Document Id: 53890faa-599b-4959-9eb4-f141abb61a1a
Set id: 64a4d802-0c72-46ce-9c1d-d01947523669
Version: 1
Effective Time: 20100706
Pharbest Pharmaceuticals, Inc.