{"adverse_reactions":["ADVERSE REACTIONS: Allergic sensitization has been reported following both oral and parenteral administration of folic acid."],"boxed_warning":["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.","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 ® Enhance is contraindicated in patients with a known hypersensitivity to any of the ingredients."],"description":["DESCRIPTION: PRENATE® Enhance is a prescription prenatal vitamin that contains 400 mg of DHA and advanced calcium. Each dark purple softgel is imprinted with “N” on one side and blank on the other. OTHER INGREDIENTS: Beeswax, palm shortening, and soy lecithin, Gelatin capsule (FD+C Blue #1, FD+C Red #40, gelatin, glycerin, purified water, sorbitol, and titanium dioxide). Prenante Enhance Supplement Facts Panel"],"dosage_and_administration":["DOSAGE AND ADMINISTRATION: One softgel daily, or as directed by a physician."],"effective_time":"20260414","how_supplied":["HOW SUPPLIED: Bottles of 30 softgels (75854-309-30). 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":"4f71b301-7c6e-8329-e063-6394a90ae519","indications_and_usage":["INDICATIONS: PRENATE ® Enhance 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. PRENATE ® Enhance can also be beneficial in improving the nutritional status of women prior to conception."],"openfda":{"brand_name":["PRENATE Enhance"],"generic_name":["ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, FOLIC ACID, PYRIDOXINE HYDROCHLORIDE, CYANOCOBALAMIN, BIOTIN, CALCIUM CARBONATE, FERROUS FUMARATE, MAGNESIUM OXIDE, LACTIC ACID AND DOCONEXENT"],"is_original_packager":[true],"manufacturer_name":["Avion Pharmaceuticals, LLC"],"nui":["N0000193618","M0001797","M0022797","N0000175952","M0022794","N0000175951"],"package_ndc":["75854-309-30"],"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":["75854-309"],"product_type":["HUMAN PRESCRIPTION DRUG"],"route":["ORAL"],"spl_id":["4f71b301-7c6e-8329-e063-6394a90ae519"],"spl_set_id":["cf10de09-6ed5-4a66-84fa-2da4f668bbe6"],"substance_name":["ASCORBIC ACID","CHOLECALCIFEROL",".ALPHA.-TOCOPHEROL ACETATE, DL-","FOLIC ACID","PYRIDOXINE HYDROCHLORIDE","CYANOCOBALAMIN","BIOTIN","CALCIUM CARBONATE","FERROUS FUMARATE","POTASSIUM IODIDE","MAGNESIUM OXIDE","DOCONEXENT"],"unii":["PQ6CK8PD0R","1C6V77QF41","WR1WPI7EW8","935E97BOY8","68Y4CF58BV","P6YC3EG204","6SO6U10H04","H0G9379FGK","R5L488RY0Q","1C4QK22F9J","3A3U0GI71G","ZAD9OKH9JC"],"upc":["0375854309303"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 30 Softgel label 75854-309-30 PRENATE ® Enhance Rx postnatal vitamin with probiotics and DHA, 25 mcg Vitamin D and chelated iron Rx Only Dietary Supplement 30 Softgels Prenate Enhance Bottle Label"],"precautions":["PRECAUTIONS: Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where Vitamin B12 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":"cf10de09-6ed5-4a66-84fa-2da4f668bbe6","spl_product_data_elements":["PRENATE Enhance ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, folic acid, pyridoxine hydrochloride, cyanocobalamin, biotin, calcium carbonate, ferrous fumarate, magnesium oxide, lactic acid and doconexent GELATIN GLYCERIN LECITHIN, SOYBEAN BEESWAX CORN OIL WATER FD&C RED NO. 40 TITANIUM DIOXIDE FD&C BLUE NO. 1 ASCORBIC ACID ASCORBIC ACID CHOLECALCIFEROL CHOLECALCIFEROL .ALPHA.-TOCOPHEROL ACETATE, DL- .ALPHA.-TOCOPHEROL, DL- FOLIC ACID FOLIC ACID PYRIDOXINE HYDROCHLORIDE PYRIDOXINE CYANOCOBALAMIN CYANOCOBALAMIN BIOTIN BIOTIN CALCIUM CARBONATE CALCIUM CATION FERROUS FUMARATE FERROUS CATION POTASSIUM IODIDE IODIDE ION MAGNESIUM OXIDE MAGNESIUM CATION DOCONEXENT DOCONEXENT dark purple N"],"spl_unclassified_section":["Rx postnatal vitamin with 400 mg DHA, 25 mcg Vitamin D and chelated iron Rx Only Dietary Supplement","MANUFACTURED FOR: Avion Pharmaceuticals, LLC Alpharetta, GA 30005 1-888-61-AVION L-0174 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"],"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.] KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN."],"version":"7"}