{"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."],"clinical_pharmacology":["CLINICAL PHARMACOLOGY Iron is an essential component in the formation of hemoglobin. Adequate amounts of iron are necessary for effective erythropoiesis. Iron also serves as a cofactor of several essential enzymes, including cytochromes that are involved in electron transport. Folic acid is required for nucleoprotein synthesis and the maintenance of normal erythropoiesis. Folic acid is converted in the liver and plasma to its metabolically active form, tetrahydrofolic acid, by dihydrofolate reductase. Vitamin B 12 is required for the maintenance of normal erythropoiesis, nucleoprotein and myelin synthesis, cell reproduction and normal growth. Intrinsic factor, a glycoprotein secreted by the gastric mucosa, is required for active absorption of Vitamin B 12 from the gastrointestinal tract."],"contraindications":["CONTRAINDICATIONS This product is contraindicated in patients with a known hypersensitivity to any of the ingredients. Hemochromatosis and hemosiderosis are contra indications to iron therapy."],"description":["DESCRIPTION Se-Vate 21/7 Tablets for oral administration to provide 28-day iron supplement therapy. Each red film-coated tablet contains: Iron Ferrous Asparto Glycinate (elemental iron) 70 mg Ferrous Fumarate (elemental iron) 81 mg Succinic acid 150 mg Vitamin C (Ascorbic Acid) 140mg Vitamin C Complex Vitamin C Complex is a pharmaceutical grade material consisting of calcium ascorbate and calcium threonate. Ascorbic Acid (as calcium ascorbate) 60 mg Threonic Acid (as calcium threonate) 0.8 mg Folic Acid, USP 1 mg Vitamin B 12 (cyanocobalamin) 10 mcg"],"description_table":["
Iron
Ferrous Asparto Glycinate (elemental iron) 70 mg
Ferrous Fumarate (elemental iron) 81 mg
Succinic acid 150 mg
Vitamin C (Ascorbic Acid) 140mg
Vitamin C ComplexVitamin C Complex is a pharmaceutical grade material consisting of calcium ascorbate and calcium threonate.
Ascorbic Acid (as calcium ascorbate) 60 mg
Threonic Acid (as calcium threonate) 0.8 mg
Folic Acid, USP 1 mg
Vitamin B12 (cyanocobalamin) 10 mcg
"],"dosage_and_administration":["DOSAGE AND ADMINISTRATION Usual adult dose is 1 tablet daily, or as directed by a physician. Se-Vate 21/7 supplies a 28-day course of iron therapy that consists of 21 red active tablets and 7 blue absorption period tablets. Take 1 red tablet daily for 21 days, followed by 1 blue tablet daily for 7 days. After 28 tablets have been taken, a new course may be started if prescribed."],"effective_time":"20120730","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 Se-Vate 21/7 Tablets. 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 Clinical studies on this product have not been performed in sufficient numbers of 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 Se-Vate 21/7 Tablets are available in 4 blister cards of 7 tablets (NDC 13925-070-28) containing 28 capsule shaped tablets (21 red tablets and 7 blue tablets). The red film-coated tablets are debossed \"MVC-003\". The blue film-coated tablets are debossed \"MVC-004\"."],"id":"3ee3c787-6499-4f9c-8f6a-e89878d8893a","inactive_ingredient":["Inactive Ingredients: Aspartic Acid, Cellulose, Citric Acid, Croscarmellose Sodium, Dicalcium Phosphate, FD&C Red 40, FD&C Yellow #6, Hydroxy Propyl MethylCellulose, Magnesium Stearate, Magnesium Trisillicate, Sorbic Acid, Stearic Acid. Each blue film-coated tablet contains 150 mg of succinic acid and the following inactive ingredients: Dicalcium Phosphate, Cellulose, Stearic Acid, Croscarmellose Sodium, Magnesium Stearate, Magnesium Trisillicate, Hydroxy Propyl MethylCellulose, FD&C Blue #1."],"indications_and_usage":["INDICATIONS AND USAGE For the treatment of all anemias responsive to oral iron therapy, such as hypochromic anemia associated with pregnancy, chronic or acute blood loss, dietary restriction, metabolic disease and post-surgical convalescence."],"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: R x Only NDC 13925- 070 -28 ONCE DAILY Se-Vate 21/7 Tablets Iron supplement 28 tablets SETON PHARMACEUTICALS Carton label"],"pediatric_use":["Pediatric Use Safety and effectiveness in pediatric patients have not been established."],"precautions":["PRECAUTIONS"],"set_id":"3ee3c787-6499-4f9c-8f6a-e89878d8893a","spl_product_data_elements":["Se-Vate 21/7 FERROUS ASPARTO GLYCINATE, FERROUS FUMARATE, SUCCINIC ACID, ASCORBIC ACID, CALCIUM ASCORBATE, CALCIUM THREONATE, FOLIC ACID and CYANOCOBALAMIN Se-Vate 21/7 FERROUS ASPARTO GLYCINATE, FERROUS FUMARATE, SUCCINIC ACID, ASCORBIC ACID, CALCIUM ASCORBATE, CALCIUM THREONATE, FOLIC ACID and CYANOCOBALAMIN FERROUS ASPARTO GLYCINATE FERROUS CATION FERROUS FUMARATE FERROUS CATION SUCCINIC ACID SUCCINIC ACID ASCORBIC ACID ASCORBIC ACID CALCIUM ASCORBATE ASCORBIC ACID CALCIUM THREONATE CALCIUM CATION FOLIC ACID FOLIC ACID CYANOCOBALAMIN CYANOCOBALAMIN ASPARTIC ACID POWDERED CELLULOSE CITRIC ACID MONOHYDRATE CROSCARMELLOSE SODIUM CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS FD&C RED NO. 40 FD&C YELLOW NO. 6 HYPROMELLOSES MAGNESIUM STEARATE MAGNESIUM TRISILICATE SORBIC ACID STEARIC ACID MVC003 Se-Vate 21/7 MULTI-VITAMIN/MINERAL SUPPLEMENT CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS POWDERED CELLULOSE STEARIC ACID CROSCARMELLOSE SODIUM MAGNESIUM STEARATE MAGNESIUM TRISILICATE HYDROXYPROPYL CELLULOSE FD&C BLUE NO. 1 SUCCINIC ACID MVC004"],"spl_unclassified_section":["R x Only","Folic Acid Folic acid in doses above 1.0 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.","Call your doctor about side effects. You may report side effects to FDA at 1-800-FDA-1088. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN R x Only Manufactured For: Seton Pharmaceuticals Manasquan, NJ 08736 1-800-510-3401 08/12 SETON PHARMACEUTICALS"],"storage_and_handling":["Storage: Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. Avoid excessive heat 40°C (104°F). Avoid freezing."],"version":"1","warnings":["WARNINGS Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where Vitamin B 12 is deficient."]}