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Zyvana

Generic Name: ascorbic acid, cholecalciferol, pyridoxine hydrochloride, zinc gluconate and selenium
Dosage Form: capsule

Medically reviewed by Drugs.com. Last updated on Feb 1, 2021.

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 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 for Zyvana

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.

Zyvana 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

Zyvana
Zyvana capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:69336-405
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ASCORBIC ACID (ASCORBIC ACID) ASCORBIC ACID 527 mg
CHOLECALCIFEROL (CHOLECALCIFEROL) CHOLECALCIFEROL 0.041 mg
PYRIDOXINE HYDROCHLORIDE (PYRIDOXINE) PYRIDOXINE 12 mg
ZINC GLUCONATE (ZINC CATION) ZINC GLUCONATE 23 mg
SELENIUM (SELENIUM) SELENIUM 0.097 mg
Inactive Ingredients
Ingredient Name Strength
SOYBEAN OIL
GELATIN
GARLIC
GLYCERIN
LECITHIN, SOYBEAN
PEG-8 BEESWAX
WATER
TITANIUM DIOXIDE
FD&C YELLOW NO. 5
Product Characteristics
Color yellow (softgel capsule) Score 4 pieces
Shape capsule Size 14mm
Flavor Imprint Code 405
Contains
Packaging
# Item Code Package Description
1 NDC:69336-405-60 60 CAPSULE in 1 BOTTLE, PLASTIC
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)
Sterling-Knight Pharmaceuticals, LLC