Package insert / prescribing information
Generic name: omega-3-acid ethyl ester
Dosage form: capsule
Drug class: Nutraceutical products
Medically reviewed by Drugs.com. Last updated on Dec 22, 2022.
Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. Read further information about unapproved drugs.
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Luvira Description
Luvira is an orally administered prescription omega-3-acid dietary supplement formulation for the clinical dietary management of suboptimal nutritional status in patients where advanced supplementation is required and nutritional supplementation in physiologically stressful conditions for maintenance of good health is needed.
Luvira should be administered under the supervision of a licensed medical practitioner.
SUPPLEMENT FACTS
Serving Size: 1 Capsule
Servings Per Container:90
Amount Per Serving%Daily Value
Total Omega-3-Acid 1220mg*
Eicosapentaenoic acid (EPA) 465 mg
Docosahexaenoic acid(DHA) 375 mg
*Daily values not established
Other Ingredients: Gelatin (bovine), glycerin, de-ionized water.
Indications and Usage for Luvira
Luvira is an orally administered prescription omega-3-acid formulation for the clinical dietary management of suboptimal nutritional status in patients where advanced supplementation is required and nutritional supplementation in physiologically stressful conditions for maintenance of good health is needed.
WARNINGS AND PRECAUTIONS:
This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.
Luvira should only be used under the direction and supervision of a licensed medical practitioner. Use with caution in patients that may have a medical condition, are pregnant, lactating, trying to conceive, under the age of 18, or taking medications.
Luvira Dosage and Administration
The usual dose of Luvira is 3 - 4 capsules per day.
The daily dose may be taken as a single dose of 3 - 4 capsules or 1 – 2 capsules twice daily with or without food.
How is Luvira Supplied
Luvira is supplied as clear yellowish Softgel capsule dispensed in white HDPE plastic bottles of 90ct.
69336-349-90
STORAGE AND HANDLING
Store at controlled room temperature 15°-30°C (59°F-86°F). Keep in cool dry place. Call your doctor about side effects. You may report side effects to FDA at 1-800-FDA-1088. KEEP THIS OUT OF THE REACH OF CHILDREN.
Reserved for Professional Recommendation
All prescriptions using this product shall be pursuant to state statutes as applicable. This is not an Orange Book product. This product may be administered only under a physician’s supervision. There are no implied or explicit claims on therapeutic equivalence.
Manufactured for:
Sterling-Knight Pharmaceuticals, LLC
Ripley, MS 38663
Item 34990
Rev. 0620-1
Luvira Luvira capsule |
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Labeler - Sterling-Knight Pharmaceuticals, LLC (079556942) |
Establishment | |||
Name | Address | ID/FEI | Operations |
Sterling-Knight Pharmaceuticals, LLC | 079556942 | manufacture(69336-349) |
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