{"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 PIXIE ® is contraindicated in patients with a known hypersensitivity to any of the ingredients."],"description":["Rx Only Dietary Supplement DESCRIPTION: PRENATE PIXIE ® is a prescription prenatal/postnatal multivitamin/mineral/essential fatty acid softgel. Each softgel is purple in color, opaque, and imprinted with “PIX”. Prenate Pixie ® contains no ingredient made from gluten-containing grain (wheat, barley, or rye) Supplement Facts Panel PRENATE PIXIE ® contains fish oil and soy. OTHER INGREDIENTS : Beeswax, palm shortening and soy lecithin. Capsule (caramel, FD&C blue #1, FD&C red #40, gelatin, glycerin, purified water and titanium dioxide)."],"dosage_and_administration":["DOSAGE AND ADMINISTRATION: Before, during and/or after pregnancy, one softgel daily or as directed by a physician."],"effective_time":"20250514","how_supplied":["HOW SUPPLIED: Bottles of 30 softgels (75854-0316-30). 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":"3518fe22-c02c-a014-e063-6394a90a4ef1","inactive_ingredient":["PRENATE PIXIE ® contains fish oil and soy. OTHER INGREDIENTS : Beeswax, palm shortening and soy lecithin. Capsule (caramel, FD&C blue #1, FD&C red #40, gelatin, glycerin, purified water and titanium dioxide)."],"indications_and_usage":["INDICATIONS: PRENATE PIXIE ® 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 Pixie"],"generic_name":["ASCORBIC ACID, BIOTIN, CHOLECALCIFEROL, CYANOCOBALAMIN, LEVOMEFOLATE CALCIUM, FOLIC ACID, FERROUS ASPARTO GLYCINATE, POTASSIUM IODIDE, PYRIDOXINE HYDROCHLORIDE, .ALPHA.-TOCOPHEROL ACETATE, DL-, DOCOSAHEXAENOIC ACID, AND BLUEBERRY"],"is_original_packager":[true],"manufacturer_name":["Avion Pharmaceuticals, LLC"],"nui":["N0000193618","M0001797","M0022797","N0000175952","M0022794","N0000175951"],"package_ndc":["75854-316-30"],"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":["75854-316"],"product_type":["HUMAN PRESCRIPTION DRUG"],"route":["ORAL"],"spl_id":["3518fe22-c02c-a014-e063-6394a90a4ef1"],"spl_set_id":["fe0a737e-4f28-40d8-b4a7-090edf86a823"],"substance_name":["ASCORBIC ACID","BIOTIN","CHOLECALCIFEROL","CYANOCOBALAMIN","FOLIC ACID","FERROUS ASPARTO GLYCINATE","POTASSIUM IODIDE","PYRIDOXINE HYDROCHLORIDE",".ALPHA.-TOCOPHEROL ACETATE, DL-","BLUEBERRY","DOCOSAHEXAENOIC ACID","LEVOMEFOLATE CALCIUM"],"unii":["PQ6CK8PD0R","6SO6U10H04","1C6V77QF41","P6YC3EG204","935E97BOY8","H7426RGB3L","1C4QK22F9J","68Y4CF58BV","WR1WPI7EW8","253RUG1X1A","ZAD9OKH9JC","A9R10K3F2F"]},"package_label_principal_display_panel":["75854-0316-30 Prenate pixie® Robust Rx Prenatal Vitamin with 11 concentrated nutrients and minerals in a tiny softgel package SUGAR FREE GLUTEN FREE LACTOSE FREE Rx Only Dietary Supplement 30 Softgels 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":"fe0a737e-4f28-40d8-b4a7-090edf86a823","spl_product_data_elements":["Prenate Pixie ascorbic acid, biotin, cholecalciferol, cyanocobalamin, levomefolate calcium, folic acid, ferrous asparto glycinate, potassium iodide, pyridoxine hydrochloride, .alpha.-tocopherol acetate, dl-, Docosahexaenoic acid, and blueberry GLYCERIN LECITHIN, SOYBEAN WATER TITANIUM DIOXIDE FD&C RED NO. 40 CARAMEL FD&C BLUE NO. 1 GELATIN BEESWAX PALM SHORTENING ASCORBIC ACID ASCORBIC ACID BIOTIN BIOTIN CHOLECALCIFEROL CHOLECALCIFEROL CYANOCOBALAMIN CYANOCOBALAMIN FOLIC ACID FOLIC ACID FERROUS ASPARTO GLYCINATE FERROUS CATION POTASSIUM IODIDE IODIDE ION PYRIDOXINE HYDROCHLORIDE PYRIDOXINE .ALPHA.-TOCOPHEROL ACETATE, DL- .ALPHA.-TOCOPHEROL, DL- BLUEBERRY BLUEBERRY DOCOSAHEXAENOIC ACID DOCONEXENT LEVOMEFOLATE CALCIUM LEVOMEFOLIC ACID PIX"],"spl_unclassified_section":["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. 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. MANUFACTURED FOR: Avion Pharmaceuticals, LLC Alpharetta, Georgia 30005 1-888-61-AVION L-0244 Rev. 0325-03"],"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":"12"}