Docusate Sodium by Olds Softgels Inc. DOCUSATE SODIUM tablet

Docusate Sodium by

Drug Labeling and Warnings

Docusate Sodium by is a Otc medication manufactured, distributed, or labeled by Olds Softgels Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Docusate Sodium 50%

PURPOSE

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

Keep out of reach of children.

INDICATIONS & USAGE

Olds SoftGels Inc

DOSAGE & ADMINISTRATION

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

WARNINGS

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

INACTIVE INGREDIENT

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DOCUSATE SODIUM 
docusate sodium tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69160-002
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
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
Color	white	Score	no score
Shape	OVAL	Size	18mm
Flavor		Imprint Code	401
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69160-002-01	18000 in 1 BOX; Type 0: Not a Combination Product	05/19/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	05/19/2015

Labeler - Olds Softgels Inc. (202822235)

Establishment
Name	Address	ID/FEI	Business Operations
Olds Softgels Inc.		202822235	manufacture(69160-002) , label(69160-002) , pack(69160-002)