DOSAGE & ADMINISTRATION SECTION.


DOSAGE ADMINISTRATION. Suggested use is capsules taken orally once daily or as prescribed by licensed medical practitioner.

HEALTH CLAIM SECTION.


ADVERSE REACTIONS. Allergic sensitization has been reported following both oral and parenteral administration of folic acid. You may report side effects by calling 1-800-519-8334 or the FDA by calling 1-800-FDA-1088.

HOW SUPPLIED SECTION.


HOW SUPPLIED HEALTH CLAIM:. Matervia Capsules are available in 60-count bottles NDC 72835-660-01Dispensed by Prescription+ This product is prescription-folate with or without other dietary ingredients that due to increased folate levels increased risk associated with masking of B12 deficiency (pernicious anemia) requires administration under the care of licensed medical practitioner (61 FR 8760).This product may be administered only under physicians supervision and all prescriptions using this product shall be pursuant to state statutes as applicable. The ingredients, indication or claims of this product are not to be construed to be drug claims.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.


PACKAGE LABEL. Matervia NDC 72835-660-01The label for Matervia is shown below:. Matervia Label.

SAFE HANDLING WARNING SECTION.


STORAGE AND HANDLNG. Store Matervia at room temperature. Avoid excessive heat, light, and moisture.StatementsThese statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.How SuppliedMatervia capsules are available in 60 count bottles. 72835-550-01Manufactured for:V2 Pharma, LLC103 Main StreetHudson, MI 49247.

STATEMENT OF IDENTITY SECTION.


HEALTH CLAIM. Matervia Capsules Prenatal/PostnatalDispensed By Prescription+Serving Size: CapsulesServings per Container: 30Other ingredients: Microcrystalline Cellulose (USP)Vegetable Capsule (cellulose, purified water). Matervia Supplement Facts.

WARNINGS SECTION.


WARNING AND PRECAUTIONS. WARNING: Accidental overdose of iron-containing products is leading cause of fatal poisoning in children under 6. KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN. In case of accidental overdose, call doctor or poison control center immediately.CONTRAINDICATIONS: Matervia is contraindicated in patients with known hypersensitivity to any of the ingredients. Do not take this product if you are presently taking mineral oil, unless directed by doctor.PRECAUTION:Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin is deficient. Folic acid in doses above mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress. Matervia should only be used under the direction and supervision of licensed medical practitioner.