Health Claim:
Folvitra - Vitamin D3 and Folic Acid Tablets
Folvitra Tablet
FDA Label NDC 85622-004
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Blue Heron Pharmaceuticals, Llc for the product Folvitra (NDC 85622-004). 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:, warnings:, dosage:, precautions:, storage:, label:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Description:
Folvitra Multivitamin Capsules are clear capsules dispensed in plastic bottles of 30 ct.
85622-0004-30
Reserved for Professional Recommendation
Folvitra is an orally administered prescription folate product for the dietary management of patients with unique nutritional needs requiring increased folate levels and Vitamin D supplementation due to Vitamin D deficiency.
Folvitra Tablets should be administered under the supervision of a licensed medical practitioner.
This listed product is not a National Drug Code, but instead has merely been formatted to comply with standard industry practice for pharmacy and insurance computer systems.
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.
All prescriptions using this product shall be pursuant to state statutes as applicable. This is not an Orange Book product. This product may be administered only under a physician’s supervision. There are no implied or explicit claims on therapeutic equivalence.
Manufactured for:
Blue Heron Pharmaceuticals
Lutz, FL 33559
Warnings:
This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.
Folvitra Tablets should only be used under the direction and supervision of a licensed medical practitioner. Use with caution in patients that may have a medical condition, are pregnant, lactating, trying to conceive, under the age of 18, or taking medications.
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.
Tell your doctor if you have: kidney problems, thyroid disease. This medication should be used as directed during pregnancy or while breast-feeding. Consult your doctor about the risks and benefits.
Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B12 is deficient. Folic acid in doses above 0.1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress.
Dosage:
Usual adult dose is 1 tablet by mouth daily once daily, or as prescribed by a licensed medical practitioner.
Precautions:
CONTRAINDICATIONS
This product is contraindicated in patients with known hypersensitivity to any of the ingredients.
PRECAUTIONS
This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.
ADVERSE REACTIONS
Allergic sensitizations have been reported following oral administration of folic acid. Consult your physician immediately if adverse side effects occur.
KEEP OUT OF THE REACH OF CHILDREN.
Storage:
Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature.] Protect from light and moisture.
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