ZYVANA- zyvana capsule 
Sterling-Knight Pharmaceuticals, LLC

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.

----------

Zyvana Capsules
Multi-Balanced Daily Immune Support
Dietary Supplement
Dispense by Prescription

DESCRIPTION

Zyvana is an orally administered prescription dietary supplement formulation.

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

supplement

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

label

ZYVANA 
zyvana capsule
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:69336-405
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID527 mg
CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL0.041 mg
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE12 mg
ZINC GLUCONATE (UNII: U6WSN5SQ1Z) (ZINC CATION - UNII:13S1S8SF37) ZINC GLUCONATE23 mg
SELENIUM (UNII: H6241UJ22B) (SELENIUM - UNII:H6241UJ22B) SELENIUM0.097 mg
Inactive Ingredients
Ingredient NameStrength
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
Coloryellow (softgel capsule) Score4 pieces
ShapecapsuleSize14mm
FlavorImprint Code 405
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69336-405-6060 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/22/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other02/22/2021
Labeler - Sterling-Knight Pharmaceuticals, LLC (079556942)

Revised: 2/2021
Document Id: 4504b136-174a-43dd-b19f-caaf1102a39a
Set id: a43bbbcf-520c-4e31-b8b8-84924cdfe7dc
Version: 1
Effective Time: 20210222
 
Sterling-Knight Pharmaceuticals, LLC