{"abuse":["Abuse"],"adverse_reactions":["ADVERSE REACTIONS Allergic sensibilization has been reported following both oral and parenteral administration of folic acid. Paresthesia and somnolence have been reported with pyridoxine. Mild transient diarrhea, polycythemia vera, itching transitory exanthema and feeling of swelling of entire body have been associated with cobalamins. There are occasional reports of hypersensivity reactions (rash, pruritis, urticaria) in those receiving parenteral hydroxocobalamin and possibly oral hydroxocobalamin. Calcium carbonate may cause gastrointestinal side reactions such as constipation, bloating, gas and flatulence."],"carcinogenesis_and_mutagenesis_and_impairment_of_fertility":["Carcinogenesis, Mutagenesis, Impairment of Fertility"],"clinical_pharmacology":["CLINICAL PHARMACOLOGY"],"contraindications":["CONTRAINDICATIONS This product is contraindicated in patients with a known hypersensitivity to any of the ingredients. Calcium supplementation is contraindicated in those with hypercalcemia. Conditions causing hypercalcemia include sarcoidosis, hyperparathyroidism, hypervitaminosis D. Vitamin D is contraindicated in those with hypercalcemia and in those with evidence of vitamin D toxicity."],"controlled_substance":["Controlled Substance"],"dependence":["Dependence"],"description":["DESCRIPTION Each oval white coated tablet contains folacin (as folic acid USP) 1.6mg hydroxocobalamin (B 12a ) 425 mcg, pyridoxine (B 6 ) 25mg, calcium (as calcium carbonate) 400mg. cholecalciferol (D 3 ) 400 IU. Calafox ® Rx tablets do not contain sugar, lactose or dyes."],"dosage_and_administration":["DOSAGE AND ADMINISTRATION Usual adult dose is one tablet once or twice daily, with food, not to exceed 3 tablets in 24 hours."],"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 Pyridoxine supplements should not be given to patients receiving levodopa, because the action of the taller drug is antagonized by pyridoxine. However, this vitamin may be used concurrently in patients receiving a preparation containing both carbidopa and levodopa. Concurrent use of phenytoin and folic acid may result in decreased phenytoin effectiveness. Concomitant intake of H 2 blockers and proton-pump-inhibitors with calcium decrease the absorption of calcium salts. Drug/Laboratory Test Interactions","Drug Interactions Pyridoxine supplements should not be given to patients receiving levodopa, because the action of the taller drug is antagonized by pyridoxine. However, this vitamin may be used concurrently in patients receiving a preparation containing both carbidopa and levodopa. Concurrent use of phenytoin and folic acid may result in decreased phenytoin effectiveness. Concomitant intake of H 2 blockers and proton-pump-inhibitors with calcium decrease the absorption of calcium salts."],"effective_time":"20110308","general_precautions":["General Folic acid when administered as a single agent in doses above 0.1mg daily may obscure pernicious anemia in that hematological remission can occur while neurological manifestations remain progressive. Pregnant women and nursing mothers should avoid using supplemental doses of vitamin D higher than ROA amounts. Supplemental calcium taken without food may increase the risk of kidney stones."],"geriatric_use":["Geriatric Use"],"how_supplied":["HOW SUPPLIED Calafox® Rx is supplied as an oval white coated tablet. Each tablet is debossed with \"AP 90\" on the scored side. Calafox ® Rx is supplied in bottles of 90 tablets (NDC 88220-0090-90). Keep Out of Reach of Children. Dispense in a tight, light-resistant container. STORAGE: Store at controlled room temperature. 20-25 o C (68-77 o F). Protect from light and moisture."],"id":"7267ec0a-b0ef-44bf-ac06-4014d03b334d","indications_and_usage":["INDICATIONS AND USAGE Calafox ® Rx tablets are indicated for the distinctive nutritional requirements of individuals under a physician's treatment with or at risk for: cardiovascular disease, cerebrovascular disease, osteoporosis, micronutrient deficiencies associated with inflammatory bowel disease and dementia with particular emphasis on menopausal patients (including those patients treated with uterine fibroids, and patients with endometriosis. Folic Acid Supplementation: The supplemental use of folacin (folic acid) may be indicated in patients with increased requirements of this vitamin. Folic acid administration may (i) reduce the risk of neural tube defewcts in the developing fetus, (ii) reduce the toxic side effects of low dose methotrexate without decreasing its effectiveness."],"information_for_patients":["Information for Patients Calafox ® Rx tablets area medical food, for use only under the direction and supervision of a licensed physician."],"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 6775 cl"],"pediatric_use":["Pediatric Use The safety and effectiveness of Calafox ® Rx in pediatric patients have not been established."],"precautions":["PRECAUTIONS General Folic acid when administered as a single agent in doses above 0.1mg daily may obscure pernicious anemia in that hematological remission can occur while neurological manifestations remain progressive. Pregnant women and nursing mothers should avoid using supplemental doses of vitamin D higher than ROA amounts. Supplemental calcium taken without food may increase the risk of kidney stones. Information for Patients Calafox ® Rx tablets area medical food, for use only under the direction and supervision of a licensed physician. Laboratory Tests Interactions Drug Interactions Pyridoxine supplements should not be given to patients receiving levodopa, because the action of the taller drug is antagonized by pyridoxine. However, this vitamin may be used concurrently in patients receiving a preparation containing both carbidopa and levodopa. Concurrent use of phenytoin and folic acid may result in decreased phenytoin effectiveness. Concomitant intake of H 2 blockers and proton-pump-inhibitors with calcium decrease the absorption of calcium salts. Drug/Laboratory Test Interactions Carcinogenesis, Mutagenesis, Impairment of Fertility Pregnancy Teratogenic Effects Nonteratogenic Effects Labor and Delivery Nursing Mothers Pediatric Use The safety and effectiveness of Calafox ® Rx in pediatric patients have not been established. Geriatric Use"],"pregnancy":["Pregnancy Teratogenic Effects Nonteratogenic Effects"],"set_id":"7267ec0a-b0ef-44bf-ac06-4014d03b334d","spl_product_data_elements":["Calafol Rx Oil and Water Soluble Vitamins PYRIDOXINE PYRIDOXINE FOLIC ACID FOLIC ACID CYANOCOBALAMIN CYANOCOBALAMIN CALCIUM CALCIUM CHOLECALCIFEROL CHOLECALCIFEROL CELLULOSE, MICROCRYSTALLINE CROSCARMELLOSE SODIUM SILICON DIOXIDE MAGNESIUM STEARATE Modified oval AP;90;"],"teratogenic_effects":["Teratogenic Effects"],"version":"1","warnings":["WARNINGS"]}