DOCUSATE SODIUM- docusate sodium 100mg 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

Purpose

Stool softener

Uses

Warnings

Do not use if you are presently taking mineral oil, unless told to do so by a doctor

Ask a doctor before use if you have

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

Stop use and ask a doctor if

  • you have rectal bleeding or fail to have bowel movement after use of a laxative. These could be signs of a serious condition.
  • 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. (1-800-222-1222)

Directions

adults and children 12 years and over                 take 1-3 softgels daily
children 2 to under 12 years of agetake 1 softgel daily
children under 2 yearsask a doctor

Other information

keep tightly closed.

Inactive ingredients

D&C Red #33, edible ink, FD&C Red #40, FD&C Yellow #6, gelatin, glycerin, polyethylene glycol, purified water, sorbitol special, titanium dioxide 

Questions?

Adverse drug event call: (866) 562-2756 Mon-Fri 8 AM to 4 PM

NDC 16103-0399-11

PHARBEST

*Compare to the active ingredient of Colace®

Docusate

Sodium

Stool Softener

1000 SOFTGELS

100 mg each

Pharbest Docusate Sodium 100 mg Softgel Product Label

DOCUSATE SODIUM 
docusate sodium 100mg capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:16103-399
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, UNSPECIFIED (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
Colorred (Two-toned- white and clear red) Scoreno score
ShapeOVALSize12mm
FlavorImprint Code SCU2
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:16103-399-08100 in 1 BOTTLE; Type 0: Not a Combination Product03/01/2016
2NDC:16103-399-111000 in 1 BOTTLE; Type 0: Not a Combination Product03/01/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33403/01/2016
Labeler - Pharbest Pharmaceuticals, Inc. (557054835)
Registrant - Pharbest Pharmaceuticals, Inc (557054835)
Establishment
NameAddressID/FEIBusiness Operations
Pharbest Pharmaceuticals, Inc557054835repack(16103-399) , relabel(16103-399)
Establishment
NameAddressID/FEIBusiness Operations
SWISSCAPS Romania srl565466997manufacture(16103-399)

Revised: 3/2016
Document Id: dbd83e29-1de7-4407-87b9-dfe9207ec088
Set id: 025e03e0-e273-47ed-87f7-98e388abe047
Version: 1
Effective Time: 20160301
 
Pharbest Pharmaceuticals, Inc.