Docusate Sodium
FDA Label NDC 69160-002

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Olds Softgels Inc. for the product Docusate Sodium (NDC 69160-002). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, otc - keep out of reach of children, indications & usage, dosage & administration, warnings, inactive ingredient, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Docusate Sodium 50%

Otc - 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. 

Otc - 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

Package Label.Principal Display Panel

Label Image (Capture)

Label Image (Capture)

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