Folyra Tablet
FDA Label NDC 85477-523

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Oncora Pharma, Llc for the product Folyra (NDC 85477-523). 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 description, indications and usage, contraindications, precautions, warnings, adverse reactions, dosage and administration, how supplied, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Description

→ Indications And Usage

→ Contraindications

→ Precautions

→ Warnings

→ Adverse Reactions

→ Dosage And Administration

→ How Supplied

→ Storage

→ Principal Display Panel

Description

Folyra is a prescription multivitamin/multimineral dietary supplement.

SUPPLEMENT FACTS
Servingsize Amount per serving:		1tablet % Daily Value
Vitamin A (as Beta-Carotene)	300 mcg RAE	33%
Vitamin C (as Ascorbic Acid)	60mg	67%
Vitamin D (as Cholecalciferol)	10mcg	50%
Vitamin E (as di-Alpha Tocopherol Acetate)	4.5 mg (10 IU)	33%
Vitamin 86 (as Pyrldoxine HCI)	26mg	1529%
Biotin	0.280mg	933%
Folate	1.67 mg □FE	418%
(from Folic Acid)	0.67 mg □FE
(from 5 Methyl Tetrahydrotolate Calcium Salt)	1 mg DFE
Vitamin 812 (as Cyanocobalamin)	0.013 mg	542%
Calcium (as Calcium Carbonate)	80 mg	6%
Magnesium (as Magnesium Oxide)	25mg	6%
Ferrochel""	20mg	111mg
Iodine (as Potassium Iodide)	0.150mg	100%
Other Ingredients: Microcrystalline Cellulose, Maltodextrin, Croscarmellose Sodium, Silcon Dioxide, Stearic Acid, Magnesium Stearate, FiIm Coating (Hydroxypropyl Methylcellulose, Polyethylene Glycol, Titanium Dioxide, FD&C Blue# 1

Indications And Usage

Folyra is a prescription multivitamin/multimineral dietary supplement indicated for the clinical dietary management of patients with suboptimal nutritional status requiring supplementation of folate and B vitamins, under physician supervision.

Contraindications

Folyra is contraindicated in patients with a known hypersensitivity to any of the ingredients.

Precautions

Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where Vitamin B12 deficiency is present. Folic acid in doses above 1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress.

Warnings

WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6 years of age. KEEP THIS PRODUCT OUT OF REACH OF CHILDREN. In case of accidental overdose, call a doctor or poison control center immediately.

Adverse Reactions

Allergic sensitization has been reported following both oral and parenteral administration of folic acid. Call your doctor for medical advice about adverse reactions. To report suspected adverse reactions or obtain product information, contact Oncora Pharma at 888-321-2821.

Dosage And Administration

One tablet orally once or twice daily or as directed by a physician.

How Supplied

Folyra is supplied as tan, oblong tablets in bottles of 30 (NDC 85477-523-30).

Storage

STORAGE: Store at 20-25°C (68-77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Avoid excessive heat, light, and moisture.

Principal Display Panel

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