Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED HEALTH CLAIM: Matervia Capsules are available in 60-count bottles NDC 72835-660-01 Dispensed by Prescription† † This product is a 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 a licensed medical practitioner (61 FR 8760). This product may be administered only under a physician’s 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 Matervia NDC 72835-660-01 The label for Matervia is shown below: Matervia Label
- HOW SUPPLIED HEALTH CLAIM: Matervia Capsules are available in 60-count bottles NDC 72835-660-01 Dispensed by Prescription† † This product is a 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 a licensed medical practitioner (61 FR 8760). This product may be administered only under a physician’s 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 Matervia NDC 72835-660-01 The label for Matervia is shown below: Matervia Label
Overview
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Dosage & Administration
DOSAGE & ADMINISTRATION Suggested use is 2 capsules taken orally once daily or as prescribed by a licensed medical practitioner.
Warnings & Precautions
WARNING AND PRECAUTIONS WARNING: Accidental overdose of iron-containing products is a 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 a doctor or poison control center immediately. CONTRAINDICATIONS: Matervia is contraindicated in patients with a known hypersensitivity to any of the ingredients. Do not take this product if you are presently taking mineral oil, unless directed by a doctor. PRECAUTION: Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B is deficient. Folic acid in doses above 1 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 a licensed medical practitioner.
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