Zyvana by Sterling-Knight Pharmaceuticals, LLC ZYVANA capsule

Zyvana by

Drug Labeling and Warnings

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

Drug Details [pdf]

DESCRIPTION

Zyvana is an orally administered prescription dietary supplement formulation.

Zyvana should be administered under the supervision of a licensed medical practitioner.

Other Ingredients: Soybean Oil, Gelatin (bovine), Garlic Powder, Glycerin, Lecithin, Beeswax, Purified Water, Titanium Dioxide, FD&C Yellow #5.

INDICATIONS AND USAGE

Zyvana is an orally administered prescription dietary supplement formulation for the 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.Zyvana 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 Zyvana is 2 capsules per day.The daily dose may be taken as a single dose of 2 capsules or 1 capsule twice daily.

HOW SUPPLIED SECTION

Zyvana is supplied as yellow softgel capsule printed with 405 dispensed in white HDPE plastic bottles of 60ct. 69336-405-60

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 dietary supplement product shall be pursuant to state statutes as applicable. This is not an Orange Book product. This product may be administered under a physician’s supervision. There are no implied or explicit claims on therapeutic equivalence.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Manufactured for:

Sterling-Knight Pharmaceuticals, LLC

Ripley, MS 38663 

Item 40560

Rev. 0920-1

INGREDIENTS AND APPEARANCE

ZYVANA 
zyvana capsule

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 69336-405
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R)	ASCORBIC ACID	527 mg
CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41)	CHOLECALCIFEROL	0.041 mg
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z)	PYRIDOXINE	12 mg
ZINC GLUCONATE (UNII: U6WSN5SQ1Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC GLUCONATE	23 mg
SELENIUM (UNII: H6241UJ22B) (SELENIUM - UNII:H6241UJ22B)	SELENIUM	0.097 mg

Inactive Ingredients
Ingredient Name	Strength
SOYBEAN OIL (UNII: 241ATL177A)
GELATIN (UNII: 2G86QN327L)
GARLIC (UNII: V1V998DC17)
GLYCERIN (UNII: PDC6A3C0OX)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
PEG-8 BEESWAX (UNII: 3C1QUF1TIR)
WATER (UNII: 059QF0KO0R)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

Product Characteristics
Color	yellow (softgel capsule)	Score	4 pieces
Shape	capsule	Size	14mm
Flavor		Imprint Code	405
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69336-405-60	60 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	02/22/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		02/22/2021

Labeler - Sterling-Knight Pharmaceuticals, LLC (079556942)