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Docusate Sodium 250mg

Medically reviewed on May 18, 2018

Dosage form: capsule
Ingredients: DOCUSATE SODIUM 250mg
Labeler: Olds Softgels Inc.
NDC Code: 69160-003

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.

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

PACKAGE LABEL

DOCUSATE SODIUM 250MG 
docusate sodium capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69160-003
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DOCUSATE SODIUM (DOCUSATE) DOCUSATE SODIUM250 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
Colorred (40) , yellow (6) Scoreno score
ShapeOVALSize23mm
FlavorImprint CodeGC425
Contains    
Packaging
#Item CodePackage Description
1NDC:69160-003-017000 CAPSULE in 1 BOX
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/FEIOperations
Olds Softgels Inc.202822235manufacture(69160-003)

 
Olds Softgels Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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