{"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 This product is contraindicated in patients with a known hypersensitivity to any of the ingredients."],"description":["DESCRIPTION PNV-Omega is a prescription prenatal/postnatal dietary supplement softgel capsule that contains multivitamins and minerals along with essential fatty acids. Each softgel is green in color, opaque and imprinted with “332” on one side. Supplement Facts Panel OTHER INGREDIENTS Beeswax, soy lecithin and vegetable shortening. Gelatin capsule (bovine gelatin, FD&C Blue #1, FD&C Yellow #5, FD&C Yellow #6, glycerin, purified water and titanium dioxide). Contains soy. Contains FD&C Yellow No. 5 (tartrazine) and FD&C Yellow No. 6. INDICATIONS PNV - Omega is a multivitamin/ multimineral dietary supplement indicated for use in the dietary management of patients with nutritional deficiencies or are in need of nutritional supplementation. CONTRAINDICATIONS This product is contraindicated in patients with a known hypersensitivity to any of the ingredients."],"dosage_and_administration":["DOSAGE AND ADMINISTRATION Before, during and/or after pregnancy, one softgel daily or as directed by a physician."],"effective_time":"20260722","how_supplied":["HOW SUPPLIED PNV - Omega is supplied in child-resistant bottles of 30 softgels (42192-332-30). The listed product is not a National Drug Code, but has merely been formatted to comply with standard industry practice for pharmacy and insurance computer systems. 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."],"id":"5737b004-3ab9-2d28-e063-6294a90a4ba0","inactive_ingredient":["OTHER INGREDIENTS Beeswax, soy lecithin and vegetable shortening. Gelatin capsule (bovine gelatin, FD&C Blue #1, FD&C Yellow #5, FD&C Yellow #6, glycerin, purified water and titanium dioxide). Contains soy. Contains FD&C Yellow No. 5 (tartrazine) and FD&C Yellow No. 6."],"indications_and_usage":["INDICATIONS PNV - Omega is a multivitamin/ multimineral dietary supplement indicated for use in the dietary management of patients with nutritional deficiencies or are in need of nutritional supplementation."],"openfda":{"brand_name":["PNV-Omega"],"generic_name":["ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, CYANOCOBALAMIN, CALCIUM CORBONATE, FERROUS FUMARATE, POTASSIUM IODIDE, MAGNESIUM, DOCONEXENT, ICOSAPENT"],"is_original_packager":[true],"manufacturer_name":["Acella Pharmaceuticals, LLC"],"nui":["N0000193618","M0001797","M0022797","N0000175952","M0022794","N0000175951"],"package_ndc":["42192-332-30"],"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":["42192-332"],"product_type":["HUMAN PRESCRIPTION DRUG"],"route":["ORAL"],"spl_id":["5737b004-3ab9-2d28-e063-6294a90a4ba0"],"spl_set_id":["735c5531-137f-4cee-8c68-ae121045a8ff"],"substance_name":["ASCORBIC ACID","CHOLECALCIFEROL",".ALPHA.-TOCOPHEROL","PYRIDOXINE HYDROCHLORIDE","FOLIC ACID","CYANOCOBALAMIN","BIOTIN","CALCIUM CARBONATE","FERROUS FUMARATE","POTASSIUM IODIDE","MAGNESIUM OXIDE","DOCONEXENT","ICOSAPENT"],"unii":["PQ6CK8PD0R","1C6V77QF41","H4N855PNZ1","68Y4CF58BV","935E97BOY8","P6YC3EG204","6SO6U10H04","H0G9379FGK","R5L488RY0Q","1C4QK22F9J","3A3U0GI71G","ZAD9OKH9JC","AAN7QOV9EA"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 30 Softgel Tablets NDC 42192-332-30 PNV - Omega Rx Prenatal Vitamin and DHA Rx Only 30 Softgels Acella PHARMACEUTICALS, LLC PNV-Omega BL L-0151 Rev. 0325-03"],"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 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":"735c5531-137f-4cee-8c68-ae121045a8ff","spl_product_data_elements":["PNV-Omega ascorbic acid, cholecalciferol, .alpha.-tocopherol, pyridoxine hydrochloride, folic acid, cyanocobalamin, calcium corbonate, ferrous fumarate, potassium iodide, magnesium, doconexent, icosapent ASCORBIC ACID ASCORBIC ACID CHOLECALCIFEROL CHOLECALCIFEROL .ALPHA.-TOCOPHEROL .ALPHA.-TOCOPHEROL PYRIDOXINE HYDROCHLORIDE PYRIDOXINE FOLIC ACID FOLIC ACID CYANOCOBALAMIN CYANOCOBALAMIN BIOTIN BIOTIN CALCIUM CARBONATE CALCIUM CATION FERROUS FUMARATE FERROUS CATION POTASSIUM IODIDE IODIDE ION MAGNESIUM OXIDE MAGNESIUM CATION DOCONEXENT DOCONEXENT ICOSAPENT ICOSAPENT BEESWAX PALM OIL LECITHIN, SOYBEAN GELATIN TYPE B BOVINE (150 BLOOM) GLYCERIN WATER TITANIUM DIOXIDE FD&C BLUE NO. 1 FD&C YELLOW NO. 5 FD&C YELLOW NO. 6 332"],"spl_unclassified_section":["PNV - Omega Rx Only","KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. All prescription substitutions and/or recommendations using this product shall be made subject to state and federal statutes as applicable. Please note: this is not an Orange Book product and has not been subjected to FDA therapeutic equivalency or other equivalency testing. No representation is made as to generic status or bioequivalency. Each person recommending a prescription substitution using this product shall make such recommendations based on each such person’s professional opinion and knowledge, upon evaluating the dietary ingredients, other ingredients and information provided herein. 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.","MANUFACTURED FOR: Acella Pharmaceuticals, LLC Alpharetta, GA 30005 1-800-541-4802 L-0151 Rev. 0325-03"],"version":"6","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."]}