FDA Label for Omega-3-acid Ethyl Esters

View Indications, Usage & Precautions

Omega-3-acid Ethyl Esters Product Label

The following document was submitted to the FDA by the labeler of this product International Brand Management Inc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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.


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




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