{"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 MINI ® is contraindicated in patients with a known hypersensitivity to any of the ingredients."],"description":["DESCRIPTION: PRENATE MINI® is a prescription prenatal/postnatal multivitamin/mineral/essential fatty acid softgel. Each oval softgel is teal green in color and imprinted with “Mini”. Contains no ingredient made from a gluten containing grain (wheat, barley or rye). Contains fish oil and soy. Prenate Mini Supplement Facts Panel"],"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 (75854-0315-30). 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":"5413b731-3365-6419-e063-6394a90ab88f","inactive_ingredient":["OTHER INGREDIENTS: Beeswax, bovine gelatin, FD&C Blue #1, FD&C Yellow #5, fish (tuna) oil, glycerin, purified water, soy lecithin, titanium dioxide and vegetable shortening."],"indications_and_usage":["INDICATIONS: PRENATE MINI ® 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 Mini"],"generic_name":["ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, LEVOMEFOLATE CALCIUM, CYANOCOBALAMIN, BIOTIN, CALCIUM CARBONATE, FERROUS ASPARTO GLYCINATE, IRON, POTASSIUM IODIDE, MAGNESIUM OXIDE, DOCONEXENT AND LOWBUSH BLUEBERRY"],"is_original_packager":[true],"manufacturer_name":["Avion Pharmaceuticals, LLC"],"nui":["N0000193618","M0001797","M0022797","N0000175952","M0022794","N0000175951"],"package_ndc":["75854-315-30"],"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":["75854-315"],"product_type":["HUMAN PRESCRIPTION DRUG"],"route":["ORAL"],"spl_id":["5413b731-3365-6419-e063-6394a90ab88f"],"spl_set_id":["8ab766c2-d554-4141-92b2-fbe038e80c9f"],"substance_name":["BIOTIN","CALCIUM CARBONATE","FERROUS ASPARTO GLYCINATE","IRON","POTASSIUM IODIDE","MAGNESIUM OXIDE","DOCONEXENT","LOWBUSH BLUEBERRY","LEVOMEFOLATE CALCIUM","ASCORBIC ACID","CHOLECALCIFEROL",".ALPHA.-TOCOPHEROL ACETATE, DL-","PYRIDOXINE HYDROCHLORIDE","FOLIC ACID","CYANOCOBALAMIN"],"unii":["6SO6U10H04","H0G9379FGK","H7426RGB3L","E1UOL152H7","1C4QK22F9J","3A3U0GI71G","ZAD9OKH9JC","A9R10K3F2F","PQ6CK8PD0R","1C6V77QF41","WR1WPI7EW8","68Y4CF58BV","935E97BOY8","P6YC3EG204"]},"package_label_principal_display_panel":["PACKAGE LABEL.PRINCIPAL DISPLAY PANEL 75854-0315-30 Rx Only Dietary Supplement Prenate mini ® A small, easy-to-swallow softgel with complete prenatal nutrition support, including 350 mg of DHA 30 Softgels SUGAR FREE GLUTEN FREE LACTOSE FREE Avion PHARMACEUTICALS Prenate Mini 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. This product contains FD&C Yellow No. 5 (tartrazine) which may cause allergic-type reactions (including bronchial asthma) in certain susceptible persons. Although the overall incidence of FD&C Yellow No. 5 (tartrazine) sensitivity in the general population is low, it is frequently seen in patients who also have aspirin hypersensitivity."],"set_id":"8ab766c2-d554-4141-92b2-fbe038e80c9f","spl_product_data_elements":["Prenate Mini ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, pyridoxine hydrochloride, folic acid, levomefolate calcium, cyanocobalamin, biotin, calcium carbonate, ferrous asparto glycinate, iron, potassium iodide, magnesium oxide, doconexent and lowbush blueberry BIOTIN BIOTIN CALCIUM CARBONATE CALCIUM CATION FERROUS ASPARTO GLYCINATE FERROUS CATION IRON IRON POTASSIUM IODIDE IODIDE ION MAGNESIUM OXIDE MAGNESIUM CATION DOCONEXENT DOCONEXENT LOWBUSH BLUEBERRY ICOSAPENT LEVOMEFOLATE CALCIUM LEVOMEFOLIC ACID FISH OIL GELATIN TYPE B BOVINE (150 BLOOM) GLYCERIN LECITHIN, SOYBEAN BEESWAX WATER CORN OIL FD&C BLUE NO. 1 TITANIUM DIOXIDE FD&C YELLOW NO. 5 ASCORBIC ACID ASCORBIC ACID CHOLECALCIFEROL CHOLECALCIFEROL .ALPHA.-TOCOPHEROL ACETATE, DL- .ALPHA.-TOCOPHEROL, DL- PYRIDOXINE HYDROCHLORIDE PYRIDOXINE FOLIC ACID FOLIC ACID CYANOCOBALAMIN CYANOCOBALAMIN teal green Mini"],"spl_unclassified_section":["Rx Only Dietary Supplement","MANUFACTURED FOR: Avion Pharmaceuticals, LLC Alpharetta, GA 30005 1-888-61-AVION L-0245 Rev. 0325-03 Sumalate ® is a registered trademark of Albion Laboratories,Inc., covered by one or more claims of U.S. Patent Nos. 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":"15"}