{"abuse":["Abuse"],"adverse_reactions":["ADVERSE REACTIONS Adverse reactions have been reported with specific vitamins and minerals, but generally at levels substantially higher than those in CalciFol TM . However, allergic and/or idiosyncratic reactions to vitamins even at lower potencies or any ingredient are possible."],"carcinogenesis_and_mutagenesis_and_impairment_of_fertility":["Carcinogenesis, Mutagenesis, Impairment of Fertility"],"clinical_pharmacology":["CLINICAL PHARMACOLOGY"],"contraindications":["CONTRAINDICATIONS CalciFol TM Wafer is contraindicated in patients with hypersensivity to any of its components. CalciFol is contraindicated in those hypersensitive to any components contained therein. Calcium and Vitamin D supplementation is contraindicated in those with hypercalcemia or conditions that may lead to hypercalcemia and those who form calcium containing stones are generally advised not to take supplemental calcium. Concomitant use of iron and calcium may inhibit the absorption of iron. Concomitant use of quinolones or tetracycline with calcium may decrease the absorption of these medications. Folic acid is contraindicated in patients with untreated and uncomplicated pernicious anemia, and in those with anaphylatic sensitivity to folic acid. The use of folic acid doses above 1 miligram/day may precipitate or axacerbate the neurological damage of Vitamin B 12 deficiency. High doses of folic acid may result in decreased serum levels of the anticonvulsant drugs; carbamazapine, fosphenytoin, phenytoin, phenobarbitol, and valproic acid."],"controlled_substance":["Controlled Substance"],"dependence":["Dependence"],"description":["DESCRIPTION CalciFol TM Wafer is a Chewable Calcium and Folic Acid Formula with Vitamin D, Magnesium and other nutrients for the maintenance and support of special dietary needs of any individual where supplementation with the ingredients contained within would prove beneficial including: premenopausal, menopausal and postmenopausal patients pertaining to the loss of calcium or calcium deficit, as well as cardiovascular wellness managed through dietary therapy. Each chocolate-flavored chewable wafer contains: Active ingredients Calcium Carbonate (Elemental 500mg) ........................................ 1342 mg Vitamin D 3 (Cholecalciferol) ........................................................ 300 IU Magnesium (Magnesium Oxide) .................................................. 50 mg Boron (Boron Amino Acid Chelate) ............................................ 250 mcg Folic Acid .................................................................................. 1.0 mg Vitamin B 6 (Pyridoxine HCI) .................................................... 10 mg Vitamin B 12 (Cyanocobalamin) ................................................. 125 mcg Inactive Ingredients: Fructose, Natural Cocoa Dutch Chocolate, Stearic Acid, Plasdont. Natural ChocoIate Flavor, Magnesium Stearate, Acacia Gum. Silicon Dioxide"],"dosage_and_administration":["DOSAGE AND ADMINISTRATION Usual adult dosage is one chewable wafer daily or as prescribed y a physician."],"drug_abuse_and_dependence":["DRUG ABUSE AND DEPENDENCE Controlled Substance Abuse Dependence"],"drug_and_or_laboratory_test_interactions":["Drug/Laboratory Test Interactions"],"drug_interactions":["Interactions Drug Interactions As little as 5 mg of Pyridoxine (Vitamin B 6 ) daily can decrease the efficacy of Levodopa in the treatment of Parkinsonism. Therefore, CalciFol TM Wafer is not recommended for patients undergoing such therapy. Drug/Laboratory Test Interactions","Drug Interactions As little as 5 mg of Pyridoxine (Vitamin B 6 ) daily can decrease the efficacy of Levodopa in the treatment of Parkinsonism. Therefore, CalciFol TM Wafer is not recommended for patients undergoing such therapy."],"effective_time":"20110310","general_precautions":["General"],"geriatric_use":["Geriatric Use"],"how_supplied":["HOW SUPPLIED Brown-mottled, pillow shape, wafer, scored on both sides, debossed on one side with \"EV 0066\" supplied in bottles of 30 wafers. NDC 0642-0066-30 Store at room temperature, 15-30 o C (69-86 o F). Protect from light and moisture."],"id":"c006d774-e3e5-4724-9676-1aad2efe1a62","indications_and_usage":["INDICATIONS AND USAGE CalciFol TM Wafer is indicated, in addition to diet to help satisfy the distinctive nutritional requirements of individuals under the supervision of a physician for the treatment of calcium deficiency, skeletal weakness and pre and post osteoporosis. CalciFol Wafer supplementation may be beneficial to individuals who have an insufficient dietary intake of the nutrients contained therein. Calcium and Vitamin D supplementation may be useful in both preventing and treating osteoporosis. Vitamin D supplementation may be beneficial to those who are institutionalized and/or have reduced exposure to sunlight. Folic acid, Vitamin B 6 and Vitamin 12 may help reduce the risk of cardiovascular disease by lowering blood levels of homocysteine. If dietary intake of calcium is inadequate patients currently taking bisphosphonates for treatment of osteoporosis should be instructed to take calcium and vitamin D daily (CalciFolic-D TM )"],"information_for_patients":["Information for Patients CalciFol TM Wafer is a medical food for use only under the direction and supervision of a licensed physician. Total intakes of greater than 2,000 mg of calcium provide no added benefit to bone healt."],"labor_and_delivery":["Labor and Delivery"],"laboratory_tests":["Laboratory Tests"],"nonteratogenic_effects":["Nonteratogenic Effects"],"nursing_mothers":["Nursing Mothers"],"openfda":{},"overdosage":["OVERDOSAGE"],"package_label_principal_display_panel":["PACKAGE/LABEL PRINCIPAL DISPLAY PANEL Container Label 6783 CL"],"pediatric_use":["Pediatric Use Not recommended for pediatric use."],"precautions":["PRECAUTIONS Folic acid, especially in doses above 0.1 mg daily, may obscure pernicious anemia, in that hematologic remission may occur while neurological manifestations remain progressive. General Information for Patients CalciFol TM Wafer is a medical food for use only under the direction and supervision of a licensed physician. Total intakes of greater than 2,000 mg of calcium provide no added benefit to bone healt. Laboratory Tests Interactions Drug Interactions As little as 5 mg of Pyridoxine (Vitamin B 6 ) daily can decrease the efficacy of Levodopa in the treatment of Parkinsonism. Therefore, CalciFol TM Wafer is not recommended for patients undergoing such therapy. Drug/Laboratory Test Interactions Carcinogenesis, Mutagenesis, Impairment of Fertility Pregnancy Shall only be administered under the supervision of a physician. Teratogenic Effects Nonteratogenic Effects Labor and Delivery Nursing Mothers Pediatric Use Not recommended for pediatric use. Geriatric Use"],"pregnancy":["Pregnancy Shall only be administered under the supervision of a physician. Teratogenic Effects Nonteratogenic Effects"],"set_id":"c006d774-e3e5-4724-9676-1aad2efe1a62","spl_product_data_elements":["Calcifol Chewable Oil and Water Soluble Vitamins and Minerals FOLIC ACID FOLIC ACID CHOLECALCIFEROL CHOLECALCIFEROL PYRIDOXINE PYRIDOXINE CYANOCOBALAMIN CO-57 CYANOCOBALAMIN CO-57 CALCIUM CARBONATE CALCIUM MAGNESIUM OXIDE MAGNESIUM OXIDE BORON BORON FRUCTOSE COCOA CROSPOVIDONE ACACIA COCOA STEARIC ACID SILICON DIOXIDE MAGNESIUM STEARATE Brown mottled EV;0066"],"teratogenic_effects":["Teratogenic Effects"],"version":"1","warnings":["WARNINGS KEEP OUT OF THE REACH OF CHILDREN."]}