{"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, polycythermia vora, itching, transitory exantherma and the feeling of swealling of the entire body has been associated with cyanacobalamin."],"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 Folacin (Folic Acid USP) 2.5mg. Pyridoxine (B 6 25mg. and Cyanacobalamin (B 12 ) 1 mg. Other ingredients are: Dibasic Calciium Phosphate, Microcrystalline Cellulose, Opadry II Flesh # Y-22-13577, Crospovidone, Croscarmellose Sodium, Magnesium Stearate, and I/H Polymer Solution. Folbalin TM tablets do not contain sugar, lactose or dye."],"dosage_and_administration":["DOSAGE AND ADMINISTRATION Usual adult dose is one tablet 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 should not be given to patients receiving the drug levodopa, because the action of levodopa is antagonized by pyridoxine. However, pyridoxine may be used concurrently in patients receiving a preparation containing both carbidopa and levodopa. Concurrent use of pheytoin and folacin (follic acid) may result in decreased phenytoin effectiveness. Drug/Laboratory Test Interactions","Drug Interactions Pyridoxine should not be given to patients receiving the drug levodopa, because the action of levodopa is antagonized by pyridoxine. However, pyridoxine may be used concurrently in patients receiving a preparation containing both carbidopa and levodopa. Concurrent use of pheytoin and folacin (follic acid) may result in decreased phenytoin effectiveness."],"effective_time":"20110315","general_precautions":["General"],"geriatric_use":["Geriatric Use"],"how_supplied":["HOW SUPPLIED Folbalin TM tablets are available as a round coated peach colored tablet debossed with a \"2\" on one side of the tablet. Suppluied in bottles of 90 tablets. 12593-040-90 Store at 25 o C (77 o F); excursions permitted to 15 o -30 o C (59 o -86 o F). See USP controlled room temperature. Protect from light and moisture. Dispense in original light-resistant container with child-resistant closure. All prescription substitutions using this product shall be pursuant to state statutes as applicable. This is not an Orange Book Product."],"id":"fe97caab-1508-4153-9a9b-e5693639027c","indications_and_usage":["INDICATIONS AND USAGE Folbalin TM tablets are indicated for the distinct nutritional requirements of individuals under a physician's treatment for vitamin deficiencies."],"information_for_patients":["Information for Patients Folbalin TM 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 6925 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 manifestation remain progressive. The 1 mg of cynocobalamin contained in Folbalin TM has been shown to provide an adequate amount of cynocobalamin to address this precaution. General Information for Patients Folbalin TM tablets are a medical food, for use only under the direction and supervision of a licensed physician. Laboratory Tests Interactions Drug Interactions Pyridoxine should not be given to patients receiving the drug levodopa, because the action of levodopa is antagonized by pyridoxine. However, pyridoxine may be used concurrently in patients receiving a preparation containing both carbidopa and levodopa. Concurrent use of pheytoin and folacin (follic 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":"fe97caab-1508-4153-9a9b-e5693639027c","spl_product_data_elements":["FOLBALIN Folic Acid, Pyridoxine, and Cyanocobolamine FOLIC ACID FOLIC ACID PYRIDOXINE HYDROCHLORIDE PYRIDOXINE CYANOCOBALAMIN CO-57 CYANOCOBALAMIN CO-57 CELLULOSE, MICROCRYSTALLINE DIBASIC CALCIUM PHOSPHATE DIHYDRATE CROSCARMELLOSE SODIUM CROSPOVIDONE MAGNESIUM STEARATE Peach 2"],"teratogenic_effects":["Teratogenic Effects"],"version":"1","warnings":["WARNINGS KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN. IN CASE OF ACCIDENTAL OVERDOSE, SEEK PROFESSIONAL ASSISTANCE OR CONTACT A POISON CONTROL CENTER IMMEDIATELY."]}