{"abuse":["Abuse"],"adverse_reactions":["ADVERSE REACTIONS Allergic sensibilization has been reported following both oral and parenteral administration of folic acid. Paresthesia and somnolense have been reported with pyridoxine. Mild transient diarrhea, polycithemia vera, itching transitory axanthema and feeling of swelling of entire body have been associated with cobalamine. There are occasional reports of hypersensitivity reactions (rash, pruitis, 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 hypersensivity to any of the ingredients. Calcium supplementation is contraindicated in those with hpercalcemia. Conditions causing hypercalcemia include sarcoidosis, hyperparathyroidism, hypervitaminosis D. Vitamin D in contraindicated in those with hypercalcemia and those with evidence of Vitamin D toxiticy."],"controlled_substance":["Controlled Substance"],"dependence":["Dependence"],"description":["DESCRIPTION Each oval white coated tablet contains folacin (as folic acid USP) 1.6mg hydroxocabalamin (B12), 425mcg pyridoxine (B6) 25 mg calcium (as calcium carbonate) 600mg, cholecalciferol (D3) 400IU, policosanol 5mg. Calafol ® Rx tablets do not contain sugar, lactose or dyes."],"dosage_and_administration":["DOSAGE AND ADMINISTRATION Usual adult dose is one tablet twice daily, with food, not to exceed 2 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 latter 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 phenyton and folic acid may result in decreased phenyton effectiveness. Concomitant intake of H 2 blockers and prolon-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 latter 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 phenyton and folic acid may result in decreased phenyton effectiveness. Concomitant intake of H 2 blockers and prolon-pump-inhibitors with calcium decrease the absorption of calcium salts."],"effective_time":"20110309","general_precautions":["General Folic acid when administered as a single agent in doses above 0.1 mg daily may obscure pernicious anemia in that homatological remission can occur while neurological manifestations remain progressive. Pregnant women and nursing mothers should avoid using supplemental doses of vitamin D higher than FDA amounts. Supplemental calcium taken without food may increase the risk of kidney stones. Patient taking warfarin should exercise caution when using Calafol Rx. Calafol Rx supplementation should be stopped before surgery. Patients with hemophilia should avoid taking Calafol."],"geriatric_use":["Geriatric Use"],"how_supplied":["HOW SUPPLIED Calafol ® Rx is supplied as an oval white coated tablet. Each tablet is debossed with AP 99 on the scored side. Calafol ® Rx is supplied in bottles of 90 tablets (NDC 0722-7065-90). Keep out of reach of children. Dispense in a light, light resistant container. Store at controlled room temperature 20-25 C (68-77 F). Protect from light and moisture."],"id":"5b913335-c966-4032-9dbf-0a5774d86f31","indications_and_usage":["INDICATIONS AND USAGE Calafol ® 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 or eligible for hormone replacement therapies) patients 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 defects in the developing fetus, (ii) reduce circulating plasma homocysteine levels and (iii) reduce the toxic side effects of low dose methotrexate without decreasing its effectiveness."],"information_for_patients":["Information for Patients Calafol ® Rx tablets are a 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 7065 CL"],"pediatric_use":["Pediatric Use The safety and effectiveness of Calafol ® Rx in pediatric patients have not been established."],"precautions":["PRECAUTIONS General Folic acid when administered as a single agent in doses above 0.1 mg daily may obscure pernicious anemia in that homatological remission can occur while neurological manifestations remain progressive. Pregnant women and nursing mothers should avoid using supplemental doses of vitamin D higher than FDA amounts. Supplemental calcium taken without food may increase the risk of kidney stones. Patient taking warfarin should exercise caution when using Calafol Rx. Calafol Rx supplementation should be stopped before surgery. Patients with hemophilia should avoid taking Calafol. Information for Patients Calafol ® Rx tablets are a 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 latter 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 phenyton and folic acid may result in decreased phenyton effectiveness. Concomitant intake of H 2 blockers and prolon-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 Calafol ® Rx in pediatric patients have not been established. Geriatric Use"],"pregnancy":["Pregnancy Teratogenic Effects Nonteratogenic Effects"],"set_id":"5b913335-c966-4032-9dbf-0a5774d86f31","spl_product_data_elements":["CALAFOL RX FOLIC ACID, PYRIDOXINE, CYANOCOBALAMIN, CALCIUM, AND POLYCOSANOL FOLIC ACID FOLIC ACID PYRIDOXINE PYRIDOXINE CYANOCOBALAMIN CYANOCOBALAMIN CALCIUM CARBONATE CALCIUM ERICERUS PELA POLYCOSANOL ERICERUS PELA POLYCOSANOL CHOLECALCIFEROL CHOLECALCIFEROL CELLULOSE, MICROCRYSTALLINE CROSCARMELLOSE SODIUM SILICON DIOXIDE MAGNESIUM STEARATE Modified AP;99"],"teratogenic_effects":["Teratogenic Effects"],"version":"1","warnings":["WARNINGS"]}