Luvira Capsules Omega-3-acid Dietary Supplement Dispense by Prescription

Manufacturer
Sterling-Knight Pharmaceuticals, LLC
Effective date
2020-01-28
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 20:32:05

Label at a glance#

ProductLuvira
Active ingredientOMEGA-3 FATTY ACIDS, 12-HYDROXYEICOSAPENTAENOIC ACID, (12R)-, 4,7,10,13,16,19-DOCOSAHEXAENOIC ACID, (4E,7E,10E,13E,16E,19E)-
Label structure7 sections

Indications and uses

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.

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.

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 ...

Label contents#

Full prescribing information#

DESCRIPTION

DESCRIPTION SECTION

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

INDICATIONS & USAGE SECTION

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:

WARNINGS AND PRECAUTIONS SECTION

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.

DOSAGE AND ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

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 SUPPLIED

HOW SUPPLIED SECTION

Luvira is supplied as clear yellowish Softgel capsule dispensed in white HDPE plastic bottles of 90ct.
69336-349-90

STORAGE AND HANDLING

STORAGE AND HANDLING SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LUVIRALUVIRA

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
OMEGA-3 FATTY ACIDS Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ef9a935e-31b7-402c-a66c-716cdfe4f126Product name920241218
115c5bd2-98e1-4a98-8292-90803ca7e851Product name120220127

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69336-349-902022-01-28C16284748780-1d6a99b39-8707-a426-e053-dadaa90af4c2Luvira Capsules Omega-3-acid Dietary Supplement Dispense by Prescription

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69336-349-90Luvira90 in 1 BOTTLECAPSULE902

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69336-349LUVIRA CAPSULE [STERLING-KNIGHT PHARMACEUTICALS, LLC]2Legacy NDC, 1 package rows20200129_9f38aea7-4e56-42fc-99d6-c964a9f26205.zip

Products#

Every source-derived product name is available through these pages.

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69336-34969336-349-90

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
baf70922-8fa4-491d-bd45-f0f985def69e9f38aea7-4e56-42fc-99d6-c964a9f262052020-01-28WarningsExact identifier
spl id: baf70922-8fa4-491d-bd45-f0f985def69e
spl set id: 9f38aea7-4e56-42fc-99d6-c964a9f26205

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.