FDA Label for Luvira
View Indications, Usage & Precautions
Luvira Product Label
The following document was submitted to the FDA by the labeler of this product Sterling-knight Pharmaceuticals, Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
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.