ADVERSE REACTIONS SECTION.

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.

CONTRAINDICATIONS SECTION.

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

DESCRIPTION SECTION.

DESCRIPTION. Folyra is prescription multivitamin/multimineral dietary supplement.SUPPLEMENT FACTSServingsizeAmount per serving:1tablet% Daily Value Vitamin (as Beta-Carotene)300 mcg RAE33%Vitamin (as Ascorbic Acid)60mg67%Vitamin (as Cholecalciferol)10mcg50%Vitamin (as di-Alpha Tocopherol Acetate)4.5 mg (10 IU)33%Vitamin 86 (as Pyrldoxine HCI)26mg1529%Biotin0.280mg933%Folate1.67 mg FE418%(from Folic Acid)0.67 mg FE(from Methyl Tetrahydrotolate Calcium Salt)1 mg DFEVitamin 812 (as Cyanocobalamin)0.013 mg542%Calcium (as Calcium Carbonate)80 mg6%Magnesium (as Magnesium Oxide)25mg6%Ferrochel20mg111mgIodine (as Potassium Iodide)0.150mg100%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.

DOSAGE & ADMINISTRATION SECTION.

DOSAGE AND ADMINISTRATION. One tablet orally once or twice daily or as directed by physician.

HOW SUPPLIED SECTION.

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

INDICATIONS & USAGE SECTION.

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

PRECAUTIONS SECTION.

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 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress.

STORAGE AND HANDLING SECTION.

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

WARNINGS SECTION.

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