The following Structured Product Label (SPL) was submitted to the FDA by Sterling-knight Pharmaceuticals, Llc for the product Zyvana (NDC 69336-405). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding description, indications and usage, warnings and precautions:, dosage and administration, how supplied section, storage, reserved for professional recommendation, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Zyvana is an orally administered prescription dietary supplement formulation.
Zyvana should be administered under the supervision of a licensed medical practitioner.
Supplement (Supplement)
Other Ingredients: Soybean Oil, Gelatin (bovine), Garlic Powder, Glycerin, Lecithin, Beeswax, Purified Water, Titanium Dioxide, FD&C Yellow #5.
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.
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.
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.
Zyvana is supplied as yellow softgel capsule printed with 405 dispensed in white HDPE plastic bottles of 60ct. 69336-405-60
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.
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.
Manufactured for:
Sterling-Knight Pharmaceuticals, LLC
Ripley, MS 38663
Item 40560
Rev. 0920-1
Label (Label)
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