{"adverse_reactions":["ADVERSE REACTIONS: Allergic sensitization has been reported following both oral and parenteral administration of folic acid."],"boxed_warning":["WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of reach of children. In case of accidental overdose, call a doctor or poison control center immediately."],"contraindications":["CONTRAINDICATIONS: PRENATE ELITE ® is contraindicated in patients with a known hypersensitivity to any of the ingredients."],"description":["DESCRIPTION: PRENATE ELITE ® is a white, oval, oil- and water-soluble, multivitamin/multimineral, film-coated tablet debossed with “PN” on one side and blank on the other. Contains no ingredient made from gluten-containing grain (wheat, barley, or rye). Prenate Elite Supplement Facts Panel"],"dosage_and_administration":["DOSAGE AND ADMINISTRATION: Before, during and/or after pregnancy, one tablet daily or as directed by a physician."],"effective_time":"20260612","how_supplied":["HOW SUPPLIED: Bottles of 30 tablets (75854-314-30). The listed product number is not a National Drug Code. Instead, Avion Pharmaceuticals has assigned a product code formatted according to standard industry practice to meet the formatting requirements of pharmacy and healthcare insurance computer systems."],"id":"5413f02a-91aa-8623-e063-6394a90a56bc","inactive_ingredient":["OTHER INGREDIENTS: Croscarmellose Sodium, Magnesium Stearate, Microcrystalline Cellulose, Silicon Dioxide, Stearic Acid. Film Coating (Hypromellose, Titanium Dioxide,Triacetin)."],"indications_and_usage":["INDICATIONS: PRENATE ELITE ® is a multivitamin/multimineral fatty acid dietary supplement indicated for use in improving the nutritional status of women throughout pregnancy and in the postnatal period for both lactating and nonlactating mothers."],"openfda":{"brand_name":["Prenate Elite"],"generic_name":[".BETA.-CAROTENE, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, THIAMINE MONONITRATE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, LEVOMEFOLATE CALCIUM, CALCIUM FORMATE, FERROUS ASPARTO GLYCINATE, CYANOCOBALAMIN, BIOTIN, POTASSIUM IODIDE, MAGNESIUM OXIDE, ZINC OXIDE AND CUPRIC OXIDE"],"is_original_packager":[true],"manufacturer_name":["Avion Pharmaceuticals, LLC"],"nui":["N0000193618","M0001797","M0022797","N0000175952","M0022794","N0000175951"],"package_ndc":["75854-314-30"],"pharm_class_cs":["Ascorbic Acid [CS]","Vitamin D [CS]","Vitamin B 12 [CS]"],"pharm_class_epc":["Vitamin C [EPC]","Vitamin D [EPC]","Vitamin B12 [EPC]"],"product_ndc":["75854-314"],"product_type":["HUMAN PRESCRIPTION DRUG"],"route":["ORAL"],"spl_id":["5413f02a-91aa-8623-e063-6394a90a56bc"],"spl_set_id":["9b79c950-4312-4a53-9e36-fb8e00b053df"],"substance_name":[".BETA.-CAROTENE","ASCORBIC ACID","CHOLECALCIFEROL",".ALPHA.-TOCOPHEROL ACETATE, DL-","THIAMINE MONONITRATE","RIBOFLAVIN","NIACINAMIDE","PYRIDOXINE HYDROCHLORIDE","FOLIC ACID","LEVOMEFOLATE CALCIUM","CALCIUM FORMATE","FERROUS ASPARTO GLYCINATE","CYANOCOBALAMIN","BIOTIN","POTASSIUM IODIDE","MAGNESIUM OXIDE","ZINC OXIDE","CUPRIC OXIDE"],"unii":["PQ6CK8PD0R","1C6V77QF41","WR1WPI7EW8","8K0I04919X","TLM2976OFR","25X51I8RD4","68Y4CF58BV","935E97BOY8","A9R10K3F2F","NP3JD65NPY","H7426RGB3L","P6YC3EG204","6SO6U10H04","1C4QK22F9J","3A3U0GI71G","SOI2LOH54Z","V1XJQ704R4"],"upc":["0375854314307"]},"package_label_principal_display_panel":["PACKAGE LABEL.PRINCIPAL DISPLAY PANEL 75854-314-30 Prenate Elite ® PRENATAL VITAMINS-FILM-COATED TABLETS GLUTEN FREE Rx Only Dietary Supplement 30 Tablets Prenate Elite Bottle Label"],"precautions":["PRECAUTIONS: Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where Vitamin B 12 is deficient. Folic acid in doses above 1.0 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress. Biotin levels higher than the recommended daily allowance may cause interference with some laboratory tests, including cardiovascular diagnostic test (e.g. troponin) and hormone tests, and may lead to incorrect test results. Tell your healthcare provider about all prescription and over-the-counter medicines, vitamins, and dietary supplements that you take, including biotin."],"set_id":"9b79c950-4312-4a53-9e36-fb8e00b053df","spl_product_data_elements":["Prenate Elite .beta.-carotene, ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, levomefolate calcium, calcium formate, ferrous asparto glycinate, cyanocobalamin, biotin, potassium iodide, magnesium oxide, zinc oxide and cupric oxide MICROCRYSTALLINE CELLULOSE SILICON DIOXIDE CROSCARMELLOSE SODIUM STEARIC ACID MAGNESIUM STEARATE HYPROMELLOSES TRIACETIN TITANIUM DIOXIDE .BETA.-CAROTENE .BETA.-CAROTENE ASCORBIC ACID ASCORBIC ACID CHOLECALCIFEROL CHOLECALCIFEROL .ALPHA.-TOCOPHEROL ACETATE, DL- .ALPHA.-TOCOPHEROL, DL- THIAMINE MONONITRATE THIAMINE ION THIAMINE RIBOFLAVIN RIBOFLAVIN NIACINAMIDE NIACINAMIDE PYRIDOXINE HYDROCHLORIDE PYRIDOXINE FOLIC ACID FOLIC ACID LEVOMEFOLATE CALCIUM LEVOMEFOLIC ACID CALCIUM FORMATE CALCIUM CATION FERROUS ASPARTO GLYCINATE FERROUS CATION CYANOCOBALAMIN CYANOCOBALAMIN BIOTIN BIOTIN POTASSIUM IODIDE IODIDE ION MAGNESIUM OXIDE MAGNESIUM CATION ZINC OXIDE ZINC CATION CUPRIC OXIDE CUPRIC CATION PN"],"spl_unclassified_section":["Rx Only Dietary Supplement","MANUFACTURED FOR: Avion Pharmaceuticals, LLC Alpharetta, Georgia 30005 1-888-61-AVION L-0307 Rev. 0325-03 Formical ® is a registered trademark of Nephro-Tech 1, LLC, covered by one or more claims of U.S. Patent No. 6,528,542. Sumalate ® is a registered trademark of Albion Laboratories, Inc., covered by one or more claims of U.S. Patent Nos. 5,516,925, 6,716,814, 8,007,846, and 8,425,956. PRENATE ® is a registered trademark of Avion Pharmaceuticals, LLC. All rights reserved. THESE STATEMENTS HAVE NOT BEEN EVALUATED BY THE FOOD AND DRUG ADMINISTRATION. THIS PRODUCT IS NOT INTENDED TO DIAGNOSE, TREAT, CURE OR PREVENT ANY DISEASE. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN."],"storage_and_handling":["Store at 20° - 25°C (68° - 77°F); excursions permitted to 15° - 30°C (59° - 86°F) [See USP Controlled Room Temperature.]"],"version":"8"}