{"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 CalciFolic-D TM Wafer. 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 CalciFolic-D TM Wafer is contraindicated in patients with hypersensitivity to any of its components. Calcium and Vitamin D supplementation is contraindicated in those with hypercalcenia or conditions thay may lead to hypercalcenia 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 CalciFolic-D 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)........................................... 1342mg Vitamin D 3 (Cholecalciferol) ............................................................ 300IU Magnesium (Magnesium Oxide) ...................................................... 50mg Boron (Boron Amino Acid Chelate) ................................................ 250mcg 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, Plasdone, Natural Chocolate Flavor, Magnesium Stearate, Acacia Gum, Silicon Dioxide. Nutrition Information: Each wafer contains 8 calories and 2 grams of carbohydrates."],"dosage_and_administration":["DOSAGE AND ADMINISTRATION Chew one wafer twice daily or as prescribed by 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 levodepa. Therefore, CalciFolic-D 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 levodepa. Therefore, CalciFolic-D 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, round shaped wafer, debossed on scored side with \"EV0068\", plain on the other side. CalciFolic-D TM Wafers are supplied in bottles of 60 wafers, NDC 0542-0068-60 Store at room temperature, 15-30 o C (69-86 o F). Protect from light and moisture."],"id":"08e570f8-d0f4-4fe2-8615-5cd980c6f64d","indications_and_usage":["INDICATIONS AND USAGE CalciFolic-D 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 osteoporosis. CalciFolic-D TM 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 B 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 CalciFolic-D 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 health."],"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 7060 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 CalciFolic-D 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 health. Laboratory Tests Interactions Drug Interactions As little as 5 mg of pyridoxine (Vitamin B 6 ) daily can decrease the efficacy of levodepa. Therefore, CalciFolic-D 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":"08e570f8-d0f4-4fe2-8615-5cd980c6f64d","spl_product_data_elements":["Calcifolic D Oil and Water Soluble Vitamins and Minerals FOLIC ACID FOLIC ACID CYANOCOBALAMIN CO-57 CYANOCOBALAMIN CO-57 CHOLECALCIFEROL CHOLECALCIFEROL PYRIDOXINE PYRIDOXINE CALCIUM CARBONATE CALCIUM MAGNESIUM OXIDE MAGNESIUM OXIDE BORON BORON FRUCTOSE COCOA CROSPOVIDONE ACACIA COCOA STEARIC ACID SILICON DIOXIDE MAGNESIUM STEARATE Brown mottled EV;0068"],"teratogenic_effects":["Teratogenic Effects"],"version":"1","warnings":["WARNINGS Keep this and all medications out of the reach of childre."]}