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Docusate Sodium by Olds Softgels Inc.

Dosage form: tablet
Ingredients: DOCUSATE SODIUM 100mg
Labeler: Olds Softgels Inc.
NDC Code: 69160-002

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.

Docusate Sodium 50%

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.

INGREDIENTS: docusate sodium 50% in PEG 400 FD&C red #40 granular, FD&C yellow #6 granular, gelatin, glycerin, polyethylene glycol 400 USP (PEG 400) propylene glycol, purified water, sorbitol special GC

DOCUSATE SODIUM 
docusate sodium tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69160-002
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DOCUSATE SODIUM (DOCUSATE) DOCUSATE SODIUM100 mg
Inactive Ingredients
Ingredient NameStrength
POLYETHYLENE GLYCOL 400 
PROPYLENE GLYCOL 
GELATIN 
GLYCERIN 
WATER 
SORBITAN 
SORBITOL 
FD&C RED NO. 40 
FD&C YELLOW NO. 6 
Product Characteristics
ColorwhiteScoreno score
ShapeOVALSize18mm
FlavorImprint Code401
Contains    
Packaging
#Item CodePackage Description
1NDC:69160-002-0118000 TABLET in 1 BOX
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33405/19/2015
Labeler - Olds Softgels Inc. (202822235)
Establishment
NameAddressID/FEIOperations
Olds Softgels Inc.202822235manufacture(69160-002)

 
Olds Softgels Inc.

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Medically reviewed on May 21, 2018

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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