Matervia

Matervia
SPL v1
SPL
SPL Set ID a918e273-4742-4417-8ae5-88d3870011f0
Route
ORAL
Published
Effective Date 2025-06-16
Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Ascorbic Acid (125 mg) Cholecalciferol (20 ug) Pyridoxal 5-phosphate (1.4 mg) Folic Acid (2.5 mg) Methylcobalamin (1000 ug) Ferrous Bisglycinate (200 mg) Iodide Ion (13 mg)
Inactive Ingredients
Microcrystalline Cellulose Hypromellose, Unspecified

Identifiers & Packaging

Marketing Status
UNAPPROVED DRUG OTHER Active Since 2025-06-11

Description

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)

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

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.


Medication Information

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

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.

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.

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)

Package Label

Matervia NDC 72835-660-01

The label for Matervia is shown below:

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

Dosage & Administration

Suggested use is 2 capsules taken orally once daily or as prescribed by a licensed medical practitioner.

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.

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.


Structured Label Content

Description (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.

Health Claim (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)

Package Label (PACKAGE LABEL)

Matervia NDC 72835-660-01

The label for Matervia is shown below:

Adverse Reactions (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.

Storage and Handlng (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

Dosage & Administration (DOSAGE & ADMINISTRATION)

Suggested use is 2 capsules taken orally once daily or as prescribed by a licensed medical practitioner.

Warning and 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.

How Supplied Health Claim: (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.


Advanced Ingredient Data


Raw Label Data

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