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.

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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 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 age take 1 softgel daily
children under 2 years ask 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 Type HUMAN OTC DRUG Item Code (Source) NDC:16103-399
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
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
Color red (Two-toned- white and clear red) Score no score
Shape OVAL Size 12mm
Flavor Imprint Code SCU2
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:16103-399-08 100 in 1 BOTTLE; Type 0: Not a Combination Product 03/01/2016
2 NDC:16103-399-11 1000 in 1 BOTTLE; Type 0: Not a Combination Product 03/01/2016
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part334 03/01/2016
Labeler - Pharbest Pharmaceuticals, Inc. (557054835)
Registrant - Pharbest Pharmaceuticals, Inc (557054835)
Establishment
Name Address ID/FEI Business Operations
Pharbest Pharmaceuticals, Inc 557054835 repack(16103-399) , relabel(16103-399)
Establishment
Name Address ID/FEI Business Operations
SWISSCAPS Romania srl 565466997 manufacture(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.