Health Claim
Matervia Capsules - Prenatal/Postnatal
Dispensed By Prescription†
Serving Size: 2 Capsules
Servings per Container: 30
Other ingredients: Microcrystalline Cellulose (USP)
Vegetable Capsule (cellulose, purified water)
Matervia Capsule
FDA Label NDC 72835-660
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by V2 Pharma Llc for the product Matervia (NDC 72835-660). 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 health claim, description, warning and precautions, adverse reactions, dosage & administration, how supplied health claim:, storage and handlng, package label, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Description
Matervia is an orally administered prescription vitamin formulation for the clinical dietary management of suboptimal nutritional status
in patients where advanced folate supplementation is required and nutritional supplementation in physiologically stressful conditions for maintenance of good health is needed.
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.
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.
Dosage & Administration
Suggested use is 2 capsules taken orally once daily or as prescribed by a licensed medical practitioner.
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.
Storage And Handlng
Store Matervia at room temperature. Avoid excessive heat, light, and moisture.
Statements
These 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 Supplied
Matervia capsules are available in 60 count bottles. 72835-550-01
Manufactured for:
V2 Pharma, LLC
103 W Main Street
Hudson, MI 49247
Package Label
Matervia NDC 72835-660-01
The label for Matervia is shown below:
* Please review the disclaimer below.
