{"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 DHA ® is contraindicated in patients with a known hypersensitivity to any of the ingredients."],"description":["DESCRIPTION: PRENATE DHA® is a prescription prenatal/postnatal multivitamin/mineral/essential fatty acid softgel. Each softgel is blue in color, opaque, and imprinted with “DHA” on one side and blank on the other. PRENATE DHA® can also be beneficial in improving the nutritional status of women prior to conception. PRENATE DHA ® contains fish oil and soy. OTHER INGREDIENTS: Gelatin capsule (FD&C Blue #1, FD&C Red #3, gelatin, glycerin, purified water, sorbitol and titanium dioxide), beeswax, soy lecithin, and soybean oil. Prenate DHA SF Panel"],"dosage_and_administration":["DOSAGE AND ADMINISTRATION: Before, during and/or after pregnancy, one softgel daily or as directed by a physician."],"effective_time":"20260417","how_supplied":["HOW SUPPLIED: Bottles of 30 softgels (75854-312-30). 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":"4faa7802-74fa-e413-e063-6394a90a9a49","indications_and_usage":["INDICATIONS: PRENATE DHA ® 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 DHA"],"generic_name":["ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL, DL-, FOLIC ACID, LEVOMEFOLATE CALCIUM, PYRIDOXINE HYDROCHLORIDE, CYANOCOBALAMIN, CALCIUM FORMATE, FERROUS ASPARTO GLYCINATE, MAGNESIUM OXIDE AND DOCONEXENT"],"is_original_packager":[true],"manufacturer_name":["Avion Pharmaceuticals, LLC"],"nui":["N0000193618","M0001797","M0022797","N0000175952","M0022794","N0000175951"],"package_ndc":["75854-312-30"],"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":["75854-312"],"product_type":["HUMAN PRESCRIPTION DRUG"],"route":["ORAL"],"spl_id":["4faa7802-74fa-e413-e063-6394a90a9a49"],"spl_set_id":["8f2eca71-9a82-4a19-9206-36a04b865fe1"],"substance_name":["LEVOMEFOLATE CALCIUM","ASCORBIC ACID","CHOLECALCIFEROL",".ALPHA.-TOCOPHEROL, DL-","FOLIC ACID","PYRIDOXINE HYDROCHLORIDE","CYANOCOBALAMIN","CALCIUM FORMATE","FERROUS ASPARTO GLYCINATE","MAGNESIUM OXIDE","DOCONEXENT"],"unii":["A9R10K3F2F","PQ6CK8PD0R","1C6V77QF41","7QWA1RIO01","935E97BOY8","68Y4CF58BV","P6YC3EG204","NP3JD65NPY","H7426RGB3L","3A3U0GI71G","ZAD9OKH9JC"]},"package_label_principal_display_panel":["PACKAGE LABEL.PRINCIPAL DISPLAY PANEL 75854-312-30 Prenate DHA ® Rx prenatal vitamin & DHA Key vitamins, minerals, and DHA support nutrition GLUTEN FREE Rx Only Dietary Supplement 30 Softgels Prenate DHA 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":"8f2eca71-9a82-4a19-9206-36a04b865fe1","spl_product_data_elements":["PRENATE DHA ascorbic acid, cholecalciferol, .alpha.-tocopherol, dl-, folic acid, levomefolate calcium, pyridoxine hydrochloride, cyanocobalamin, calcium formate, ferrous asparto glycinate, magnesium oxide and doconexent LEVOMEFOLATE CALCIUM LEVOMEFOLIC ACID GLYCERIN GELATIN LECITHIN, SOYBEAN SOYBEAN OIL BEESWAX WATER FD&C BLUE NO. 1 TITANIUM DIOXIDE FD&C RED NO. 3 ASCORBIC ACID ASCORBIC ACID CHOLECALCIFEROL CHOLECALCIFEROL .ALPHA.-TOCOPHEROL, DL- .ALPHA.-TOCOPHEROL, DL- FOLIC ACID FOLIC ACID PYRIDOXINE HYDROCHLORIDE PYRIDOXINE CYANOCOBALAMIN CYANOCOBALAMIN CALCIUM FORMATE CALCIUM CATION FERROUS ASPARTO GLYCINATE FERROUS CATION MAGNESIUM OXIDE MAGNESIUM CATION DOCONEXENT DOCONEXENT SORBITOL opaque 301"],"spl_unclassified_section":["Rx Only Dietary Supplement","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. 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.","MANUFACTURED FOR: Avion Pharmaceuticals, LLC Alpharetta, Georgia 30005 1-888-61-AVION L-0176 Rev 0325-02"],"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":"9","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."]}