{"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 : Niferex® is contraindicated in patients with a known hypersensitivity to any of the ingredients."],"description":["DESCRIPTION: Niferex® for oral administration is an iron supplement that is an oval, copper colored, coated tablet with \"344\" embossed on one side. table"],"dosage_and_administration":["DOSAGE AND ADMINISTRATION: One tablet daily, or as directed by a physician."],"effective_time":"20250408","how_supplied":["HOW SUPPLIED: Bottles of 30 tablets (75854-344-30). The listed product number is not a National Drug Code. Instead, Avion Pharmaceuticals has assigned a product code formatted according to standard industry practice to meet the formatting requirements of pharmacy and healthcare insurance computer systems."],"id":"7eb0b406-c408-4c8e-aab2-495564b1a2ef","inactive_ingredient":["OTHER INGREDIENTS: Discalcium phosphate dihydrate, microcrystalline cellulose, croscarmellose sodium, stearic acid, silicon dioxide, magnesium stearate. Coating contains: Candurin® Orange (FD&C Blue #1, FD&C Red #40, FD&C Yellow #6), HPMC, titanium dioxide and triacetin. This product contains FD&C Yellow #6."],"indications_and_usage":["INDICATIONS: Niferex® is a multivitamin/multimineral dietary supplement indicated for use in improving the nutritional status of patients with iron deficiency."],"openfda":{"brand_name":["Niferex"],"generic_name":["FERROUS ASPARTO GLYCINATE, IRON, ASCORBIC ACID, FOLIC ACID, CYANOCOBALAMIN, ZINC, AND SUCCINIC ACID"],"is_original_packager":[true],"manufacturer_name":["Avion Pharmaceuticals, LLC"],"nui":["N0000193618","M0001797","M0022794","N0000175951"],"package_ndc":["75854-344-30"],"pharm_class_cs":["Ascorbic Acid [CS]","Vitamin B 12 [CS]"],"pharm_class_epc":["Vitamin C [EPC]","Vitamin B12 [EPC]"],"product_ndc":["75854-344"],"product_type":["HUMAN PRESCRIPTION DRUG"],"route":["ORAL"],"spl_id":["7eb0b406-c408-4c8e-aab2-495564b1a2ef"],"spl_set_id":["a38ff367-983b-42db-ae5e-c9f75f7ace13"],"substance_name":["FERROUS ASPARTO GLYCINATE","ASCORBIC ACID","LEVOMEFOLATE GLUCOSAMINE","FOLIC ACID","CYANOCOBALAMIN","ZINC","SUCCINIC ACID"],"unii":["H7426RGB3L","PQ6CK8PD0R","Q65PL71Q1A","935E97BOY8","P6YC3EG204","J41CSQ7QDS","AB6MNQ6J6L"]},"package_label_principal_display_panel":["75854-344-30 ​Rx Only Dietary Supplement 30 Tablets Sugar Free Lactose Free Niferex ​® Tablets (ferrous asparto glycinate) www.niferex.com Niferex-label"],"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."],"set_id":"a38ff367-983b-42db-ae5e-c9f75f7ace13","spl_product_data_elements":["Niferex ferrous asparto glycinate, iron, ascorbic acid, folic acid, cyanocobalamin, zinc, and succinic acid CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE CELLULOSE, MICROCRYSTALLINE CROSCARMELLOSE SODIUM MAGNESIUM STEARATE STEARIC ACID SILICON DIOXIDE FERROUS ASPARTO GLYCINATE FERROUS CATION ASCORBIC ACID ASCORBIC ACID LEVOMEFOLATE GLUCOSAMINE LEVOMEFOLATE GLUCOSAMINE FOLIC ACID FOLIC ACID CYANOCOBALAMIN CYANOCOBALAMIN ZINC ZINC SUCCINIC ACID SUCCINIC ACID FD&C BLUE NO. 1 FD&C RED NO. 40 FD&C YELLOW NO. 6 HYDROXYPROPYL METHYLCELLULOSE TITANIUM DIOXIDE TRIACETIN copper colored 344"],"spl_unclassified_section":["Rx Only Dietary Supplement","THESE STATEMENTS HAVE NOT BEEN EVALUATED BY THE FOOD AND DRUG ADMINISTRATION. THIS PRODUCT IS NOT INTENDED TO DIAGNOSE, TREAT, CURE OR INTENDED TO DIAGNOSE, PREVENT ANY DISEASE. KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN. MANUFACTURED FOR: Avion Pharmaceuticals, LLC Alpharetta, GA 30005 1-888-61-AVION L-0437 Rev. 0924-01 Quatrefolic® is a registered trademark of Gnosis, SpA. Covered by one or more claims of U.S. Patent #7,947,662 CAS #1181972-37-1 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."],"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"}