{"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 administrationis a prenatal/postnatal iron supplement that is a round, copper colored tablet with \"NxFE\" embossed on one side. table"],"dosage_and_administration":["DOSAGE AND ADMINISTRATION: One softgel daily, or as directed by a physician."],"effective_time":"20250108","how_supplied":["HOW SUPPLIED: Bottles of 30 tablets (75854-321-30). 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":"4d353856-ca49-47ab-8acb-ea21b1444d8e","inactive_ingredient":["OTHER INGREDIENTS: Croscarmellose sodium, dicalcium phosphate, magnesium stearate, microcrystalline cellulose, silicon dioxide, stearic acid. Coating contains: HPMC, triacetin, titanium dioxide, Candurin® Orange (FD&C Blue #1, FD&C Red #40, FD&C Yellow #6). 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":{},"package_label_principal_display_panel":["​Rx Only Dietary Supplement 75854-321-30 30 Tablets Sugar Free Lactose Free Niferex ​TM www.niferexrx.com tablets Ni"],"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."],"recent_major_changes":[""],"set_id":"899f97fb-85f1-4e78-9708-b916a1646129","spl_product_data_elements":["Niferex ferrous asparto glycinate, iron, ascorbic acid, folic acid, cyanocobalamin, zinc, succinic acid, and intrinsic factor CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS CELLULOSE, MICROCRYSTALLINE CROSCARMELLOSE SODIUM MAGNESIUM STEARATE SILICON DIOXIDE FERROUS ASPARTO GLYCINATE FERROUS CATION IRON DEXTRAN FERRIC CATION ASCORBIC ACID ASCORBIC ACID LEVOMEFOLIC ACID LEVOMEFOLIC ACID FOLIC ACID FOLIC ACID CYANOCOBALAMIN CYANOCOBALAMIN ZINC ZINC SUCCINIC ACID SUCCINIC ACID INTRINSIC FACTOR INTRINSIC FACTOR copper colored NxFE"],"spl_unclassified_section":["Rx Only Dietary Supplement","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. MANUFACTURED FOR: Avion Pharmaceuticals, LLC Alpharetta, GA 30005 1-888-61-AVION Rev. 0119-01 AV-428 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."],"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.] KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN."],"version":"7"}