{"adverse_reactions":["ADVERSE REACTIONS Allergic sensitization has been reported following both oral and parenteral administration of folic acid. Adverse reactions with iron therapy may include constipation, diarrhea, nausea, vomiting, dark stools and abdominal pain. Adverse reactions with iron therapy are usually transient. Carbonyl iron based products may decrease the absorption of medicines. Talk to your doctor or pharmacist before taking carbonyl products. You should call your doctor for medical advice about serious adverse events. To report adverse side effects or to obtain product information, contact CarWin Pharmaceutical Associates, LLC at 1-985-288-5122."],"boxed_warning":["WARNING: ACCIDENTAL OVERDOSE OF IRON-CONTAINING PRODUCTS IS A LEADING CAUSE OF FATAL POISONING IN CHILDREN UNDER 6 YEARS OF AGE."],"contraindications":["CONTRAINDICATIONS NuFera™ is contraindicated in patients with a known hypersensitivity to any of the ingredients. Hemochromatosis and hemosiderosis are contraindicated to iron therapy."],"dosage_and_administration":["DIRECTIONS One tablet daily with or without food or as prescribed by your healthcare provider."],"effective_time":"20151222","general_precautions":["General Do not exceed recommended dose. The type of anemia and the underlying cause or causes should be determined before starting therapy with NuFera™. Since the anemia may be a result of a systemic disturbance, such as recurrent blood loss, the underlying cause or causes should be corrected, if possible."],"geriatric_use":["GERIATRIC USE In general, dose selection in elderly population should be cautious and start at the lower end of the dosing range."],"how_supplied":["HOW SUPPLIED NuFera™ is available as red oblong tablets with imprint \"265\" in child-resistant bottles containing 30 tablets (15370-265-30) and in a 3ct professional sample (15370-265-03)."],"id":"c5222dfd-a466-4b73-b103-c3ebf8f7777c","indications_and_usage":["INDICATIONS NuFera™ is a multivitamin and mineral dietary supplement indicated for use in improving the nutritional status of patients with iron deficiency."],"openfda":{},"overdosage":["OVERDOSAGE The clinical course of acute iron overdosage can be variable. Initial symptoms may include abdominal pain, nausea, vomiting, diarrhea, tarry stools melena, hematemesis, hypotension, tachycardia, metabolic acidosis, hyperglycemia, dehydration, drowsiness, pallor, cyanosis, lassitude, seizures, shock and coma."],"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 30 Tablet Bottle Label 15370-265-30 Nu FERA ™ IRON SUPPLEMENT 125 mg CARBONYL IRON Rx 30 Tablets See attached labeling for complete product information. Rev. 11/2015 PRINCIPAL DISPLAY PANEL - 30 Tablet Bottle Label"],"pediatric_use":["PEDIATRIC USE Safety and effectiveness in pediatric population have not been established."],"precautions":["PRECAUTIONS Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where Vitamin B 12 is deficient. Folic acid in doses above 0.1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress.","PRECAUTIONS General Do not exceed recommended dose. The type of anemia and the underlying cause or causes should be determined before starting therapy with NuFera™. Since the anemia may be a result of a systemic disturbance, such as recurrent blood loss, the underlying cause or causes should be corrected, if possible. PEDIATRIC USE Safety and effectiveness in pediatric population have not been established. GERIATRIC USE In general, dose selection in elderly population should be cautious and start at the lower end of the dosing range."],"set_id":"8b7a7851-d0a4-4efc-a141-dcffeda8d1cf","spl_product_data_elements":["NuFera ASCORBIC ACID, CHOLECALCIFEROL, PYRIDOXINE HYDROCHLORIDE, LEVOMEFOLATE MAGNESIUM, FOLIC ACID, CYANOCOBALAMIN, and IRON PENTACARBONYL ASCORBIC ACID ASCORBIC ACID CHOLECALCIFEROL CHOLECALCIFEROL PYRIDOXINE HYDROCHLORIDE PYRIDOXINE LEVOMEFOLATE MAGNESIUM LEVOMEFOLIC ACID FOLIC ACID FOLIC ACID CYANOCOBALAMIN CYANOCOBALAMIN IRON PENTACARBONYL FERROUS CATION CELLULOSE, MICROCRYSTALLINE STARCH, CORN CALCIUM CARBONATE DOCUSATE SODIUM HYPROMELLOSES KERACYANIN POLYVINYL ALCOHOL TRIACETIN TALC TITANIUM DIOXIDE SILICON DIOXIDE CROSCARMELLOSE SODIUM HYDROXYPROPYL CELLULOSE (TYPE H) MAGNESIUM STEARATE STEARIC ACID 265"],"spl_unclassified_section":["Supplement Facts Serving Size: 1 Tablet Servings per container: 30 Amount per serving %DV Percent Daily Value Vitamin C (as ascorbic acid) 170 mg 283% Vitamin D 3 (as cholecalciferol) 1000 IU 250% Vitamin B 6 (as pyridoxine HCl) 15 mg 750% Folate (630 mcg of L-methylfolate magnesium, molar equivalent to 600 mcg of L-methylfolic acid; and 400 mcg of folic acid) 1 mg 250% Vitamin B 12 (as cyanocobalamin) 16 mcg 267% Iron (as carbonyl iron) 125 mg 694%","INACTIVE INGREDIENTS: Microcrystalline Cellulose, Pregelatinized Starch, Calcium Carbonate, Docusate Sodium, Red Coating (Hydroxypropyl Methylcellulose, Anthocyanin Extract Powder, Polyvinyl Alcohol, Triacetin, TALC, Titanium Dioxide), Silicon Dioxide, Croscarmellose Sodium, Hydroxypropyl Cellulose, Magnesium Stearate, Stearic Acid, Fumed Silica.","KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. 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. TAMPER EVIDENT: Do not use if seal is broken or missing.","Manufactured for: CarWin Pharmaceutical Associates, LLC Slidell, LA 70461 MADE IN CANADA Rx CW-250-SB-02 Rev. 11/15"],"spl_unclassified_section_table":["
Supplement Facts
Serving Size: 1 Tablet Servings per container: 30
Amount per serving %DVPercent Daily Value
Vitamin C (as ascorbic acid) 170 mg 283%
Vitamin D3 (as cholecalciferol) 1000 IU 250%
Vitamin B6 (as pyridoxine HCl) 15 mg 750%
Folate (630 mcg of L-methylfolate magnesium, molar equivalent to 600 mcg of L-methylfolic acid; and 400 mcg of folic acid) 1 mg 250%
Vitamin B12 (as cyanocobalamin) 16 mcg 267%
Iron (as carbonyl iron) 125 mg 694%
"],"storage_and_handling":["STORAGE Store at 20°-25°C (68°-77°F); excursions permitted to at 15°-30°C (59°-86°F) [see USP]. Protect from light and moisture and avoid excessive heat. Dispense in a tight, light resistant container as defined by the USP using a child-resistant closure."],"version":"1"}