{"abuse":["Abuse"],"adverse_reactions":["ADVERSE REACTIONS Allergic sensitization has been reported following both oral and parenteral administration of folic acid."],"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."],"controlled_substance":["Controlled Substance"],"dependence":["Dependence"],"description":["DESCRIPTION Folplex™ tablets are intended for oral administration. Each Tablet Contains : 2.2 mg folic acid, 25 mg Vitamin B 6 and 1 mg Vitamin B 12 . INACTIVE INGREDIENTS : Dibasic Calcium Phosphate, Microcrystalline Cellulose, Modified Cellulose Gum, Crospovidone, Magnesium Stearate, Hypromellose, Titanium Dioxide, Polydextrose, Triacetin, Polyethylene Glycol, Iron Oxide Red, Iron Oxide Yellow."],"dosage_and_administration":["DOSAGE AND ADMINISTRATION Adults - 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 Drug/Laboratory Test Interactions","Drug Interactions"],"effective_time":"20110316","general_precautions":["General"],"geriatric_use":["Geriatric Use"],"how_supplied":["HOW SUPPLIED Folplex™ tablets are peach color coated oval-shaped tablets. Each tablet is imprinted with B 352 on the scored side and plain on the other side. Folplex™ tablets are available in bottles of 100 tablets. NDC 51991-352-01 All prescription substitutions using this product shall be pursuant to state statutes as applicable. This is not an Orange Book product."],"id":"83a89e75-0a3a-466c-96b9-23841356c469","indications_and_usage":["INDICATIONS AND USAGE Folplex™ tablets are indicated for nutritional support and folic acid supplementation."],"information_for_patients":["Information for Patients"],"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 7047 CL"],"pediatric_use":["Pediatric Use Safety and effectiveness in pediatric patients have not been established."],"precautions":["PRECAUTIONS Folic acid in doses above 0.1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations remain progressive. General Information for Patients Laboratory Tests Interactions Drug Interactions Drug/Laboratory Test Interactions Carcinogenesis, Mutagenesis, Impairment of Fertility Pregnancy Teratogenic Effects Nonteratogenic Effects Labor and Delivery Nursing Mothers Pediatric Use Safety and effectiveness in pediatric patients have not been established. Geriatric Use"],"pregnancy":["Pregnancy Teratogenic Effects Nonteratogenic Effects"],"set_id":"83a89e75-0a3a-466c-96b9-23841356c469","spl_product_data_elements":["FOLPLEX WATER SOLUBLE VITAMINS FOLIC ACID FOLIC ACID PYRIDOXINE HYDROCHLORIDE PYRIDOXINE CYANOCOBALAMIN CO-57 CYANOCOBALAMIN CO-57 CELLULOSE, MICROCRYSTALLINE ANHYDROUS DIBASIC CALCIUM PHOSPHATE CROSCARMELLOSE SODIUM CROSPOVIDONE MAGNESIUM STEARATE PEACH B;352"],"teratogenic_effects":["Teratogenic Effects"],"version":"1","warnings":["WARNINGS The administration of folic acid alone is inadequate for the treatment of pernicious anemia and other megaloblastic anemias caused by Vitamin B 12 deficiency Keep this and all medications out of the reach of children. In case of accidental overdose, seek professional assistance or contact a poison control center immediately. Dispense in a tight, light-resistant container with a child-resistant closure, as defined in USP/NF. Store at 25°C (77°F); excursions permitted to 15° - 30°C (59° - 86°F). See USP Controlled Room Temperature. Protect from light and moisture."]}