{"adverse_reactions":["ADVERSE REACTIONS Adverse reactions with iron therapy may include GI irritation, constipation, diarrhea, nausea, vomiting, and dark stools. 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."],"clinical_pharmacology":["CLINICAL PHARMACOLOGY Oral iron is absorbed most efficiently when administered between meals. Iron is critical for normal hemoglobin synthesis to maintain oxygen transport, energy production and proper function of cells. Adequate amounts of iron are necessary for effective erythropoiesis. Iron also serves as a cofactor of several essential enzymes, including cytochromes, which are involved in electron transport. Folic acid is required for nucleoprotein synthesis and the maintenance of normal erythropoiesis. Folic acid is the precursor of tetrahydrofolic acid, which is involved as a cofactor for transformylation reactions in the biosynthesis of purines and thymidylates of nucleic acids. Deficiency of folic acid may account for the defective deoxyribonucleic acid (DNA) synthesis that leads to megaloblast formation and megaloblastic macrocytic anemias. Vitamin B 12 is essential to growth, cell reproduction, hematopoiesis, nucleic acid, and myelin synthesis. Deficiency may result in megaloblastic anemia or pernicious anemia."],"contraindications":["CONTRAINDICATIONS Hypersensitivity to any of the ingredients. Hemolytic anemia, hemochromatosis, and hemosiderosis are contraindications to iron therapy."],"description":["DESCRIPTION FerraPlus 90 is a dark grey, oval, film-coated tablet, debossed \"TL012\". Each dark grey film-coated tablet for oral administration contains: Docusate Sodium 50 mg Folic Acid 1 mg Iron (Carbonyl iron) 90 mg Vitamin B 12 (Cyanocobalamin) 12 mcg Vitamin C (Ascorbic acid) 120 mg Inactive Ingredients Microcrystalline Cellulose, Di Calcium Phosphate, TriPotassium Citrate, Sodium Carboxymethyl Cellulose, Acacia, Povidone K30, Croscarmellose Sodium, Fumed Silica, Stearic Acid, Magnesium Stearate, Citric Acid, Dextrin, Dextrose, Lecithin, and Sodium Citrate."],"description_table":["
Docusate Sodium 50 mg
Folic Acid 1 mg
Iron (Carbonyl iron) 90 mg
Vitamin B12 (Cyanocobalamin) 12 mcg
Vitamin C (Ascorbic acid) 120 mg
"],"dosage_and_administration":["DOSAGE AND ADMINISTRATION One tablet daily or as directed by a physician."],"drug_interactions":["DRUG INTERACTIONS Prescriber should be aware of a number of iron/drug interactions, including antacids, tetracyclines, or fluoroquinolones."],"effective_time":"20131212","general_precautions":["General Take 2 hours after meals. Do not exceed recommended dose. Discontinue use if symptoms of intolerance appear. The type of anemia and underlying cause or causes should be determined before starting therapy with FerraPlus 90 tablets. Ensure Hgb, Hct, reticulocyte count are determined before starting therapy and periodically thereafter during prolonged treatment. Periodically review therapy to determine if it needs to be continued without change or if a dose change is indicated."],"geriatric_use":["Geriatric Use Dosing for elderly patients should be cautious. Due to the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy, dosing should start at the lower end of the dosing range."],"how_supplied":["HOW SUPPLIED FerraPlus 90 is packaged in bottles of 90 tablets. NDC 13811-012-90 Dispense in a tight container with a child-resistant closure. STORAGE Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP controlled room temperature]."],"id":"4cb12a85-cdc5-4bcc-84e3-d8a54315daf3","inactive_ingredient":["Inactive Ingredients Microcrystalline Cellulose, Di Calcium Phosphate, TriPotassium Citrate, Sodium Carboxymethyl Cellulose, Acacia, Povidone K30, Croscarmellose Sodium, Fumed Silica, Stearic Acid, Magnesium Stearate, Citric Acid, Dextrin, Dextrose, Lecithin, and Sodium Citrate."],"indications_and_usage":["INDICATIONS AND USAGE FerraPlus 90 is indicated for the treatment of all anemias that are responsive to oral iron therapy. These include: hypochromic anemia associated with pregnancy, chronic and/or acute blood loss, metabolic disease, post-surgical convalescence, and dietary needs."],"openfda":{},"overdosage":["OVERDOSAGE"],"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 90 mg Tablet Bottle NDC 13811-012-90 R x Only FerraPlus 90 Tablets WITH 90 MG CARBONYL IRON 90 COATED TABLETS TRIGEN LABORATORIES PRINCIPAL DISPLAY PANEL - 90 mg Tablet Bottle"],"pediatric_use":["Pediatric Use Safety and effectiveness in pediatric patients have not been established."],"precautions":["PRECAUTIONS General Take 2 hours after meals. Do not exceed recommended dose. Discontinue use if symptoms of intolerance appear. The type of anemia and underlying cause or causes should be determined before starting therapy with FerraPlus 90 tablets. Ensure Hgb, Hct, reticulocyte count are determined before starting therapy and periodically thereafter during prolonged treatment. Periodically review therapy to determine if it needs to be continued without change or if a dose change is indicated. Folic Acid 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 these products since folic acid may mask the symptoms of pernicious anemia. Pediatric Use Safety and effectiveness in pediatric patients have not been established. Geriatric Use Dosing for elderly patients should be cautious. Due to the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy, dosing should start at the lower end of the dosing range."],"set_id":"b044e461-0da3-4b7c-ab6e-e1b7792fa94b","spl_product_data_elements":["FerraPlus 90 Docusate Sodium, Folic Acid, Iron, Cyanocobalamin, and Ascorbic acid Docusate Sodium Docusate Folic Acid Folic Acid Iron Iron Cyanocobalamin Cyanocobalamin Ascorbic acid Ascorbic acid Cellulose, Microcrystalline Anhydrous Dibasic Calcium Phosphate Potassium Citrate Anhydrous Carboxymethylcellulose Sodium Acacia Povidone K30 Croscarmellose Sodium Silicon Dioxide Stearic Acid Magnesium Stearate Citric Acid Monohydrate Icodextrin Dextrose Sodium Citrate dark grey TL012"],"spl_unclassified_section":["R x Only","Symptoms abdominal pain, metabolic acidosis, anuria, CNS damage, coma, convulsions, death, dehydration, diffuse vascular congestion, hepatic cirrhosis, hypotension, hypothermia, lethargy, nausea, vomiting, diarrhea, tarry stools, melena, hematemesis, tachycardia, hyperglycemia, drowsiness, pallor, cyanosis, lassitude, seizures, and shock.","NOTICE Contact with moisture can discolor or erode the tablet. Do not chew tablet.","KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN. R x Only Call your doctor about side effects. You may report side effects by calling 888 9 TRIGEN (888-987-4436). All prescriptions using this product shall be pursuant to state statutes as applicable. This is not an Orange Book product. There are no implied or explicit claims on therapeutic equivalence. Manufactured For: TRIGEN Laboratories, Inc. Sayreville, NJ 08872 www.trigenlab.com Rev. 07/11"],"storage_and_handling":["STORAGE Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP controlled room temperature]."],"version":"2","warnings":["WARNING Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B 12 is deficient."]}