Description
Each capsule contains 1 gram of
Omega-3 acid ethyl esters liquid
concentrate consisting of at least
900 mg of Omega-3 acid ethyl esters.
Omega-3-acid Ethyl Esters
FDA Label NDC 69837-170
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by International Brand Management Inc for the product Omega-3-acid Ethyl Esters (NDC 69837-170). 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 description, dosage forms & strengths, storage and handling, dosage & administration, 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
Dosage Forms & Strengths
Each capsule provides:
Etcosapentaenoic acid (EPA)
ethyl ester: 465 mg
Docosahexaeonic acid (DHA) ethyl
ester: 375 mg
Storage And Handling
Store in tight, light-resistant containers
at 25C (77F); excursions permitted
to 15-30C (59-86F)(see USP
Controlled Room Temperature).
Protect from light. Do not freeze.
Keep out of reach of children.
Dispense in a tight, light-resistant
container (see USP).
Dosage & Administration
Usual dosage:
See package insert for full prescribing
information.
Swallow capsules whole.
Package Label.Principal Display Panel
Copy Of Label (Omega1 Rx)
* Please review the disclaimer below.
