{"adverse_reactions":["ADVERSE REACTIONS: Allergic sensitization has been reported following both oral and parenteral administration of folic acid."],"boxed_warning":["WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of reach of children. In case of accidental overdose, call a doctor or poison control center immediately."],"contraindications":["CONTRAINDICATIONS: FeRiva FA ® is contraindicated in patients with a known hypersensitivity to any of the ingredients. Hemochromatosis and hemosiderosis are contraindicated to iron therapy."],"description":["DESCRIPTION: FeRiva FA ® is a prescription iron supplement. FeRiva FA ® is a red gel capsule. Facts"],"dosage_and_administration":["DOSAGE AND ADMINISTRATION: Adults, one (1) capsule daily, with or without food, or as prescribed by your healthcare provider. Do not administer to children under the age of 12."],"effective_time":"20230926","how_supplied":["HOW SUPPLIED: In child-resistant bottles of 30 capsules (75854-319-30). The listed product number is not a National Drug Code, but has instead been formatted to comply with standard industry practice for pharmacy computer systems."],"id":"05b67438-745f-4bea-86c8-9337e1f05075","inactive_ingredient":["OTHER INGREDIENTS: Silicon dioxide and magnesium stearate. Gel capsule: (bovine gelatin, titanium dioxide, FD&C blue #1 and FD&C red #40)."],"indications_and_usage":["INDICATIONS: FeRiva FA ® is a multivitamin/multimineral dietary supplement indicated for use in improving the nutritional status of patients with iron deficiency."],"openfda":{},"package_label_principal_display_panel":["PACKAGE LABEL.PRINCIPAL DISPLAY PANEL 75854-0319-30 FeRivaFA ™ Iron Supplement 30 Capsules Rx Only Avion PHARMACEUTICALS fa"],"pediatric_use":["PEDIATRIC USE: Safety and effectiveness have not been studied in pediatric patients."],"precautions":["PRECAUTIONS: 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 1.0 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress. While prescribing this nutritional supplement for pregnant women, nursing mothers or for women prior to conception, their medical condition and other drugs, herbs and/or supplements consumption should be considered."],"recent_major_changes":[""],"set_id":"47e3ae30-64ac-462c-95eb-2e29506d9a7b","spl_product_data_elements":["FeRiva FA ferrous bisglycinate, ferrous asparto glycinate, ferrous fumarate, ascorbic acid, folic acid, cyanocobalamin, biotin, cupric oxide and docusate sodium SILICON DIOXIDE MAGNESIUM STEARATE GELATIN TITANIUM DIOXIDE FD&C BLUE NO. 1 FD&C RED NO. 40 FERROUS BISGLYCINATE FERROUS CATION FERROUS ASPARTO GLYCINATE FERROUS CATION FERROUS FUMARATE FERROUS CATION ASCORBIC ACID ASCORBIC ACID FOLIC ACID FOLIC ACID CYANOCOBALAMIN CYANOCOBALAMIN BIOTIN BIOTIN CUPRIC OXIDE CUPRIC CATION DOCUSATE SODIUM DOCUSATE"],"spl_unclassified_section":["Iron Supplement Rx Only Dietary Supplement","MANUFACTURED FOR: Avion Pharmaceuticals, LLC Alpharetta, GA 30022 1-888-61-AVION Rev. 0915-01 Sumalate ® is a registered trademark of Albion Laboratories, Inc., covered by one or more claims of U.S. Patent Nos. 6,716,814, 8,007,846, and 8,425,956. Ferrochel ® is a registered trademark of Albion Laboratories, Inc. covered by U.S. Patents 6,716,814 & 7,838,042. 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. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN."],"storage_and_handling":["STORAGE: Store at 20° - 25°C (68° - 77°F); excursions permitted to 15° - 30°C (59° - 86°F) [See USP Controlled Room Temperature.]"],"version":"7"}