Luvira by Sterling-Knight Pharmaceuticals, LLC LUVIRA capsule

Luvira by

Drug Labeling and Warnings

Luvira by is a Prescription medication manufactured, distributed, or labeled by Sterling-Knight Pharmaceuticals, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DESCRIPTION

Luvira is an orally administered prescription omega-3-acid ethyl ester 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 probiotic 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.
69336-351-90

STORAGE

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 35190
Rev. 0619-1

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

LUVIRA 
luvira capsule

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 69336-351
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OMEGA-3-ACID ETHYL ESTERS (UNII: D87YGH4Z0Q) (OMEGA-3 FATTY ACIDS - UNII:71M78END5S)	OMEGA-3-ACID ETHYL ESTERS	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: 69336-351-90	90 in 1 BOTTLE; Type 0: Not a Combination Product	11/07/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		11/07/2019

Labeler - Sterling-Knight Pharmaceuticals, LLC (079556942)

Establishment
Name	Address	ID/FEI	Business Operations
Sterling-Knight Pharmaceuticals, LLC		079556942	manufacture(69336-351)