Luvira
FDA Label NDC 69336-349

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Sterling-knight Pharmaceuticals, Llc for the product Luvira (NDC 69336-349). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding description, indications and usage, warnings and precautions:, dosage and administration, how supplied, storage and handling, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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

* Please review the disclaimer below.