Description
Metavex™ is a prescription folic acid–containing dietary supplement intended to support metabolic health. Each tablet contains a combination of vitamins, minerals, and botanical ingredients formulated to provide nutritional support.
Metavex Tablet
FDA Label NDC 85477-503
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Oncora Pharma, Llc for the product Metavex (NDC 85477-503). 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, contraindications, warnings, precautions, dosage and administration, how supplied, display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Indications And Usage
Metavex™ is indicated as a prescription dietary supplement for the dietary management of individuals with metabolic health needs where folic acid supplementation is appropriate.
Administration:
Take two (2) tablets daily with a 12-ounce glass of water, or as directed by a licensed healthcare practitioner.
Contraindications
Metavex™ is contraindicated in patients with known hypersensitivity to any of its components.
Warnings
Metavex™ should be administered under the supervision of a licensed medical practitioner.
Patients should not exceed the recommended dosage.
If adverse reactions occur, discontinue use and consult a healthcare professional.
Precautions
Folic Acid and Vitamin B12 Deficiency:
Folic acid administered alone may be inappropriate for the treatment of pernicious anemia or other megaloblastic anemias where vitamin B12 deficiency is present. Doses of folic acid greater than 0.1 mg daily may mask hematologic signs of pernicious anemia while neurological manifestations continue to progress.
Patients with underlying medical conditions or those taking other medications should consult their healthcare provider prior to use.
Dosage And Administration
Take two (2) tablets daily with a 12-ounce glass of water, or as directed by a licensed healthcare practitioner.
How Supplied
Metavex™ is supplied as tan, oval tablets in bottles of 30 tablets.
NDC 85477-503-30
Display Panel
Metavex Pdp (Metavex 1)Metavex™ 
METABOLIC HEALTH
Prescription Folic Acid-Containing
Dietary Supplement
30 Tablets
Dispensed by Prescription
Distributed by:
Oncora Pharma
Dallas, TX 75228
NDC 85477-503-30
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