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Luvira Package Insert

Status:
Prescription (Rx) Facts
Strength:
1220 mg, 465 mg, 375 mg
Drug class:
Active ingredients:
Similar drugs:

Source: FDA drug labeling via NLM DailyMed · About this document

Prescribing information (package insert) - 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

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.

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 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

About this document

Source: FDA drug labeling via NLM DailyMed · View the label on DailyMed

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The information on this site does not replace the advice of a doctor or pharmacist.

Drug information for Luvira

Rx or OTC
Prescription (Rx)?
  • This drug is available only with a prescription from a licensed healthcare provider.
  • Rx
Drug class Omega-3 Fatty Acid
Active ingredients Omega-3 fatty acids 1220 mg, 12-Hydroxyeicosapentaenoic acid, (12r)- 465 mg, 4,7,10,13,16,19-Docosahexaenoic acid, (4e,7e,10e,13e,16e,19e)- 375 mg
Dosage form Capsule
Route Oral
Marketing status not in the current FDA NDC Directory
Company (applicant) Sterling-Knight Pharmaceuticals, LLC
FDA approval UNAPPROVED DRUG OTHERUnapproved drug
Manufacturers 1 labelers list this drug on DailyMed
Packages (NDC)
Package
1220 mg, 465 mg, 375 mg – 90 in 1 bottle NDC 69336-349-90

Source: FDA drug labeling via NLM DailyMed, data as of October 31, 2026. FDA data (DailyMed, Orange Book, Drug Shortages, enforcement reports). Not a substitute for the advice of a doctor or pharmacist.