{"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 ESSENTIAL ® is contraindicated in patients with a known hypersensitivity to any of the ingredients."],"description":["DESCRIPTION: PRENATE ESSENTIAL® is a prescription prenatal/postnatal multivitamin/mineral/essential fatty acid softgel. Each softgel is dark green in color, opaque, and imprinted with “Prenate” on one side and blank on the other. PRENATE ESSENTIAL® contains fish oil and soy. Prenate Essential Supplement Facts Panel OTHER INGREDIENTS: Capsule gelatin (gelatin, sorbitol, glycerin, purified water, turmeric, and sodium copper chlorophyllin), soy lecithin, white beeswax and soybean oil."],"dosage_and_administration":["DOSAGE AND ADMINISTRATION: Before, during and/or after pregnancy, one softgel daily or as directed by a physician."],"effective_time":"20260612","how_supplied":["HOW SUPPLIED: Bottles of 30 softgels (75854-313-30). 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":"5413d54f-f790-2d5c-e063-6294a90a7460","inactive_ingredient":["OTHER INGREDIENTS: Capsule gelatin (gelatin, sorbitol, glycerin, purified water, turmeric, and sodium copper chlorophyllin), soy lecithin, white beeswax and soybean oil."],"indications_and_usage":["INDICATIONS: PRENATE ESSENTIAL ® 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 Essential"],"generic_name":["ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, LEVOMEFOLATE CALCIUM, CYANOCOBALAMIN, BIOTIN, CALCIUM FORMATE, FERROUS ASPARTO GLYCINATE, POTASSIUM IODIDE, MAGNESIUM OXIDE, DOCONEXENT AND ICOSAPENT"],"is_original_packager":[true],"manufacturer_name":["Avion Pharmaceuticals, LLC"],"nui":["N0000193618","M0001797","M0022797","N0000175952","M0022794","N0000175951"],"package_ndc":["75854-313-30"],"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":["75854-313"],"product_type":["HUMAN PRESCRIPTION DRUG"],"route":["ORAL"],"spl_id":["5413d54f-f790-2d5c-e063-6294a90a7460"],"spl_set_id":["e5acfb2a-0959-4542-9b4c-790be194d581"],"substance_name":["ICOSAPENT","ASCORBIC ACID","CHOLECALCIFEROL",".ALPHA.-TOCOPHEROL ACETATE, DL-","PYRIDOXINE HYDROCHLORIDE","FOLIC ACID","LEVOMEFOLATE CALCIUM","CYANOCOBALAMIN","BIOTIN","CALCIUM FORMATE","FERROUS ASPARTO GLYCINATE","POTASSIUM IODIDE","MAGNESIUM OXIDE","DOCONEXENT"],"unii":["AAN7QOV9EA","PQ6CK8PD0R","1C6V77QF41","WR1WPI7EW8","68Y4CF58BV","935E97BOY8","A9R10K3F2F","P6YC3EG204","6SO6U10H04","NP3JD65NPY","H7426RGB3L","1C4QK22F9J","3A3U0GI71G","ZAD9OKH9JC"]},"package_label_principal_display_panel":["PACKAGE LABEL.PRINCIPAL DISPLAY PANEL 75854-313-30 PRENATE ESSENTIAL ® Rx only Dietary Supplement • Key vitamins, minerals, and DHA support nutrition GLUTEN FREE Rx Only Dietary Supplement 30 Softgels Prenate Essential 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."],"set_id":"e5acfb2a-0959-4542-9b4c-790be194d581","spl_product_data_elements":["Prenate Essential ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, pyridoxine hydrochloride, folic acid, levomefolate calcium, cyanocobalamin, biotin, calcium formate, ferrous asparto glycinate, potassium iodide, magnesium oxide, doconexent and icosapent ICOSAPENT ICOSAPENT GELATIN GLYCERIN LECITHIN, SOYBEAN BEESWAX WATER SOYBEAN OIL SORBITOL SODIUM COPPER CHLOROPHYLLIN TURMERIC ASCORBIC ACID ASCORBIC ACID CHOLECALCIFEROL CHOLECALCIFEROL .ALPHA.-TOCOPHEROL ACETATE, DL- .ALPHA.-TOCOPHEROL, DL- PYRIDOXINE HYDROCHLORIDE PYRIDOXINE FOLIC ACID FOLIC ACID LEVOMEFOLATE CALCIUM LEVOMEFOLIC ACID CYANOCOBALAMIN CYANOCOBALAMIN BIOTIN BIOTIN CALCIUM FORMATE CALCIUM CATION FERROUS ASPARTO GLYCINATE FERROUS CATION POTASSIUM IODIDE IODIDE ION MAGNESIUM OXIDE MAGNESIUM CATION DOCONEXENT DOCONEXENT opaque Prenate"],"spl_unclassified_section":["Rx Only Dietary Supplement","MANUFACTURED FOR: Avion Pharmaceuticals, LLC Atlanta, GA 30005 1-888-61-AVION L-0448 Rev. 0525-01 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":["STORAGE: Store at 20° - 25°C (68° - 77°F); excursions permitted to 15° - 30°C (59° - 86°F) [See USP Controlled Room Temperature.]"],"version":"8","warnings":["WARNING: Ingestion of more than 3 grams of omega-3 fatty acids (such as DHA) per day has been shown to have potential antithrombotic effects, including an increased bleeding time and International Normalized Ratio (INR). Administration of omega-3 fatty acids should be avoided in patients taking anticoagulants and in those known to have an inherited or acquired predisposition to bleeding."]}