Label: LUVIRA capsule
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Contains inactivated NDC Code(s)
NDC Code(s): 69336-349-90 - Packager: Sterling-Knight Pharmaceuticals, LLC
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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.
Drug Label Information
Updated January 28, 2020
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
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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.
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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.
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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
- HOW SUPPLIED
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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 - PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
LUVIRA
luvira capsuleProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69336-349 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OMEGA-3 FATTY ACIDS (UNII: 71M78END5S) (OMEGA-3 FATTY ACIDS - UNII:71M78END5S) OMEGA-3 FATTY ACIDS 1220 mg 12-HYDROXYEICOSAPENTAENOIC ACID, (12R)- (UNII: 78P2ZC128S) (12-HYDROXYEICOSAPENTAENOIC ACID, (12R)- - UNII:78P2ZC128S) 12-HYDROXYEICOSAPENTAENOIC ACID, (12R)- 465 mg 4,7,10,13,16,19-DOCOSAHEXAENOIC ACID, (4E,7E,10E,13E,16E,19E)- (UNII: ZR7NX0Z98X) (4,7,10,13,16,19-DOCOSAHEXAENOIC ACID, (4E,7E,10E,13E,16E,19E)- - UNII:ZR7NX0Z98X) 4,7,10,13,16,19-DOCOSAHEXAENOIC ACID, (4E,7E,10E,13E,16E,19E)- 375 mg Inactive Ingredients Ingredient Name Strength GELATIN (UNII: 2G86QN327L) GLYCERIN (UNII: PDC6A3C0OX) Product Characteristics Color yellow Score no score Shape capsule Size 78mm Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69336-349-90 90 in 1 BOTTLE; Type 0: Not a Combination Product 01/17/2020 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 Business Operations Sterling-Knight Pharmaceuticals, LLC 079556942 manufacture(69336-349)
