DOCUSATE SODIUM 250MG- docusate sodium capsule 
Olds Softgels 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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ACTIVE INGREDIENT

Docusate Sodium 250 mg

IMPORTANT

This is a bulk shipment, intended for further processing only. It is not to be used in its present condition and it should be repackaged immediately and labeled strictly in conformance with the Federal Food, Drug and Cosmetic Act and other pertinent government regulations. 

Keep out of reach of children.

Olds SoftGels Inc

All complaints or claims for allowances of any kind must be made within 10 days after receipt of goods.

All complaints or claims for allowances of any kind must be made within 10 days after receipt of goods.

INACTIVE INGREDIENTS

Red No. 40

Granular FD and C

Yellow No.6

Granular

Gelatin

Glycerin USP 99 Percent

Polyethylene

Glycol 400 USP PEG 400

Propylene glycol

Purified water

Sorbitol special GC

LABELPACKAGE LABEL

DOCUSATE SODIUM 250MG 
docusate sodium capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69160-003
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM250 mg
Inactive Ingredients
Ingredient NameStrength
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
GELATIN (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
SORBITAN (UNII: 6O92ICV9RU)  
SORBITOL (UNII: 506T60A25R)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
Product Characteristics
Colorred (40) , yellow (6) Scoreno score
ShapeOVALSize23mm
FlavorImprint Code GC425
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69160-003-017000 in 1 BOX; Type 0: Not a Combination Product05/18/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33405/18/2016
Labeler - Olds Softgels Inc. (202822235)
Establishment
NameAddressID/FEIBusiness Operations
Olds Softgels Inc.202822235manufacture(69160-003)

Revised: 4/2020
Document Id: a2521c80-c652-64a1-e053-2a95a90afd9e
Set id: 3324cde5-69be-1e89-e054-00144ff8d46c
Version: 2
Effective Time: 20200402
 
Olds Softgels Inc.