{"abuse":["Abuse"],"adverse_reactions":["ADVERSE REACTIONS Allergic sensitization has been reported following both oral and parenteral administration of folacin (folic acid). Paresthesia and somnolence have been reported with pyridoxine. Mild transient diarrhea, polycythemia vera, itching transitory exanthema, and the feeling of swelling of the entire body has been associated with cyanocobalamin."],"carcinogenesis_and_mutagenesis_and_impairment_of_fertility":["Carcinogenesis, Mutagenesis, Impairment of Fertility"],"clinical_pharmacology":["CLINICAL PHARMACOLOGY"],"contraindications":["CONTRAINDICATIONS Known hypersensitivity to any of the components in the product is a contraindication."],"controlled_substance":["Controlled Substance"],"dependence":["Dependence"],"description":["DESCRIPTION Each round coated peach colored tablet contains: Active Ingredients: Folacin (Folic Acid)....................... 2.5 mg Pyridoxine (B 6 ) ............................. 25 mg Cyanocobalamin (B 12 ) .................. 2 mg Inactive Ingredients: Dibasic Calcium Phosphate, Microcrystalline Cellulose, Opadry II Flesh # Y-22-13577, Croscarmellose Sodium, Magnesium Stearate, Hydroxypropyl Methylcellulose. FOLTX ® tablets do not contain sugar, lactose, or dye."],"dosage_and_administration":["DOSAGE AND ADMINISTRATION Usual adult dose is one to two tablets daily or as directed 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 Pyridoxine supplements should not be given to patients receiving levodopa, because the action of the latter drug is antagonized by pyridoxine. However, pyridoxine may be used concurrently in patients receiving a preparation containing both carbidopa and levodopa. Concurrent use of phenytoin and folacin (folic acid) may result in decreased phenytoin effectiveness. 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, pyridoxine may be used concurrently in patients receiving a preparation containing both carbidopa and levodopa. Concurrent use of phenytoin and folacin (folic acid) may result in decreased phenytoin effectiveness."],"effective_time":"20110316","general_precautions":["General"],"geriatric_use":["Geriatric Use"],"how_supplied":["HOW SUPPLIED Available as a round coated peach colored tablet. Debossed with \"PAL\" on one side and a ♥ (heart shape) on the other. Supplied in bottles of 90 tablets. Store at controlled room temperature between 59 o ·86 o F (15 o -30 o C). Protect from light and moisture. Dispense in original light-resistant container with child-resistant closure. NDC# 00525-0906-90"],"id":"b6758e33-bb3b-4fda-8c34-ef72bf9c27cd","indications_and_usage":["INDICATIONS AND USAGE FOLTX ® tablets are indicated for the distinct nutritional requirements of individuals under physician's treatment for hyperhomocysteinemia, homocystinuria, or nutrient malabsorption; with particular emphasis for individuals with or at risk for: cardiovascular disease, cerebrovascular disease, peripheral vascular disease, atherosclerotic vascular disease, neurological disorders, renal disease, and vitamin B12 deficiency."],"information_for_patients":["Information for Patients FOLTX ® 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 6795 CL"],"pediatric_use":["Pediatric Use"],"precautions":["PRECAUTIONS Folacin (folic acid) when administered as a single agent in doses above 0.1mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations remain progressive. The 2 mgs of cyanocobalamin contained in FOLTX ® has been shown to provide an adequate amount of cyanocobalamin to address this precaution.' General Information for Patients FOLTX ® 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, pyridoxine may be used concurrently in patients receiving a preparation containing both carbidopa and levodopa. Concurrent use of phenytoin and folacin (folic acid) may result in decreased phenytoin effectiveness. Drug/Laboratory Test Interactions Carcinogenesis, Mutagenesis, Impairment of Fertility Pregnancy Teratogenic Effects Nonteratogenic Effects Labor and Delivery Nursing Mothers Pediatric Use Geriatric Use"],"pregnancy":["Pregnancy Teratogenic Effects Nonteratogenic Effects"],"set_id":"b6758e33-bb3b-4fda-8c34-ef72bf9c27cd","spl_product_data_elements":["FOLTX WATER SOLUBLE VITAMINS FOLIC ACID FOLIC ACID PYRIDOXINE HYDROCHLORIDE PYRIDOXINE CYANOCOBALAMIN CO-57 CYANOCOBALAMIN CO-57 CELLULOSE, MICROCRYSTALLINE DIBASIC CALCIUM PHOSPHATE DIHYDRATE CROSCARMELLOSE SODIUM CROSPOVIDONE MAGNESIUM STEARATE PAL"],"teratogenic_effects":["Teratogenic Effects"],"version":"1","warnings":["WARNINGS"]}