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Luvira

Generic name: omega-3-acid ethyl ester
Dosage form: capsule
Drug class: Nutraceutical products

Medically reviewed by Drugs.com. Last updated on Jan 1, 2020.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:69336-349
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OMEGA-3 FATTY ACIDS (OMEGA-3 FATTY ACIDS) OMEGA-3 FATTY ACIDS 1220 mg
12-HYDROXYEICOSAPENTAENOIC ACID, (12R)- (12-HYDROXYEICOSAPENTAENOIC ACID, (12R)-) 12-HYDROXYEICOSAPENTAENOIC ACID, (12R)- 465 mg
4,7,10,13,16,19-DOCOSAHEXAENOIC ACID, (4E,7E,10E,13E,16E,19E)- (4,7,10,13,16,19-DOCOSAHEXAENOIC ACID, (4E,7E,10E,13E,16E,19E)-) 4,7,10,13,16,19-DOCOSAHEXAENOIC ACID, (4E,7E,10E,13E,16E,19E)- 375 mg
Inactive Ingredients
Ingredient Name Strength
GELATIN
GLYCERIN
Product Characteristics
Color yellow Score no score
Shape capsule Size 78mm
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description
1 NDC:69336-349-90 90 CAPSULE in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 01/17/2020
Labeler - Sterling-Knight Pharmaceuticals, LLC (079556942)
Establishment
Name Address ID/FEI Operations
Sterling-Knight Pharmaceuticals, LLC 079556942 manufacture(69336-349)
Sterling-Knight Pharmaceuticals, LLC

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