{"adverse_reactions":["ADVERSE REACTIONS Adverse reactions with iron therapy may include constipation, diarrhea, nausea, vomiting, dark stools and abdominal pain. Adverse reactions with iron therapy are usually transient. 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 Ferrex™ 150 Forte Plus is contraindicated in patients with a known hypersensitivity to any of the components of this product. Hemochromatosis and hemosiderosis are contraindications to the use of this product."],"description":["DESCRIPTION Each Ferrex™ 150 Forte Plus Capsule contains: Elemental Iron: (as Sumalate® Sumalate® (ferrous asparto glycinate) is a registered trademark of Albion International, Inc., Clearfield, Utah and is licensed exclusively to Breckenridge Pharmaceutical, Inc., for certain iron products. ) 50 mg (as Polysaccharide Complex) 100 mg Succinic Acid 50 mg Vitamin C Ascorbic Acid (as Calcium Ascorbate) 60 mg Threonic Acid (as Calcium Threonate) 0.8 mg Folic Acid, USP 1 mg Vitamin B 12 (Cyanocobalamin) 25 mcg Inactive Ingredients: Citric Acid, Croscarmellose Sodium, Crospovidone, Dicalcium Phosphate, FD&C Blue No.1 Lake, FD&C Red No.40 Lake, Gelatin, Microcrystalline Cellulose, Polyethylene Glycol, Polyvinylpyrrolidone, Silica, Stearic Acid and Titanium Dioxide."],"description_table":["
Elemental Iron:
(as Sumalate®Sumalate® (ferrous asparto glycinate) is a registered trademark of Albion International, Inc., Clearfield, Utah and is licensed exclusively to Breckenridge Pharmaceutical, Inc., for certain iron products.) 50 mg
(as Polysaccharide Complex) 100 mg
Succinic Acid 50 mg
Vitamin C
Ascorbic Acid (as Calcium Ascorbate) 60 mg
Threonic Acid (as Calcium Threonate) 0.8 mg
Folic Acid, USP 1 mg
Vitamin B12 (Cyanocobalamin) 25 mcg
"],"dosage_and_administration":["DOSAGE AND ADMINISTRATION Usual adult dosage is 1 capsule daily, or as directed by a physician."],"effective_time":"20110309","general_precautions":["General Do not exceed recommended dose. The type of anemia and the underlying cause or causes should be determined before starting with Ferrex™ 150 Forte Plus. 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. Folic Acid in doses above 0.1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations remain progressive. Pernicious anemia should be excluded before using this product since folic acid may mask the symptoms of pernicious anemia."],"geriatric_use":["Geriatric Use Clinical studies on this product have not been performed in subjects aged 65 and over to determine whether elderly subjects respond differently from younger subjects. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy."],"how_supplied":["HOW SUPPLIED Ferrex™ 150 Forte Plus capsules are available as a white/red capsule, imprinted B 798. Supplied in bottles of 90 capsules, NDC 51991-798-90. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. IN CASE OF ACCIDENTAL OVERDOSE, SEEK PROFESSIONAL ASSISTANCE OR CONTACT A POISON CONTROL CENTER IMMEDIATELY. Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F). See USP Controlled Room Temperature. Protect from light and moisture. Dispense in a tight, light-resistant container with a child-resistant closure as defined in the USP/NF."],"id":"6d5483ec-bdb8-458e-8a0a-4df92025c7bc","indications_and_usage":["INDICATIONS AND USAGE Ferrex 150™ Forte Plus is indicated for the dietary management of iron deficiencies and/or nutritional megaloblastic anemias."],"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 - 90 Capsule Bottle Label Breckenridge Pharmaceutical, Inc. NDC 51991-798-90 Ferrex ™ 150 Forte Plus Capsules Rx Only 90 CAPSULES PRINCIPAL DISPLAY PANEL - 90 Capsule Bottle Label"],"pediatric_use":["Pediatric Use Safety and effectiveness in pediatric patients have not been established."],"precautions":["PRECAUTIONS General Do not exceed recommended dose. The type of anemia and the underlying cause or causes should be determined before starting with Ferrex™ 150 Forte Plus. 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. Folic Acid in doses above 0.1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations remain progressive. Pernicious anemia should be excluded before using this product since folic acid may mask the symptoms of pernicious anemia. Pediatric Use Safety and effectiveness in pediatric patients have not been established. Geriatric Use Clinical studies on this product have not been performed in subjects aged 65 and over to determine whether elderly subjects respond differently from younger subjects. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. If pregnant, or planning to become pregnant or are currently breast-feeding please contact your physician, or health-care provider before using or continuing use."],"pregnancy":["If pregnant, or planning to become pregnant or are currently breast-feeding please contact your physician, or health-care provider before using or continuing use."],"set_id":"511979f5-794a-4c8d-89f4-8bbf50ec827e","spl_product_data_elements":["Ferrex 150 Forte Plus IRON, SUCCINIC ACID, CALCIUM ASCORBATE, CALCIUM THREONATE, FOLIC ACID, and CYANOCOBALAMIN IRON IRON SUCCINIC ACID SUCCINIC ACID CALCIUM ASCORBATE CALCIUM ASCORBATE CALCIUM THREONATE CALCIUM THREONATE FOLIC ACID FOLIC ACID CYANOCOBALAMIN CYANOCOBALAMIN Citric Acid Monohydrate Croscarmellose Sodium Crospovidone Anhydrous Dibasic Calcium Phosphate FD&C Blue No. 1 FD&C Red No. 40 Aluminum Oxide Gelatin Cellulose, Microcrystalline Polyethylene Glycol Povidone K30 Silicon Dioxide Stearic Acid Titanium Dioxide White/Red B;798"],"spl_unclassified_section":["Rx Only","All prescription substitutions using this product shall be pursuant to state statutes as applicable. This is not an Orange Book product. *U.S. Patent Nos. 5,516,925; 6,716,814 Other U.S. patents pending. Manufactured by: Contract Pharmacal Corp. Hauppauge, NY 11788 USA Distributed by: Breckenridge Pharmaceutical, Inc. Boca Raton, FL 33487 Rx Only Rev. 11/09"],"storage_and_handling":["Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F). See USP Controlled Room Temperature. Protect from light and moisture. Dispense in a tight, light-resistant container with a child-resistant closure as defined in the USP/NF."],"version":"1","warnings":["WARNINGS 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. Folic Acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where Vitamin B 12 is deficient."]}