{"adverse_reactions":["ADVERSE REACTIONS Allergic sensitization has been reported following both oral and parenteral administration of folic acid, as well as possibly the use of other forms of folates – including reduced folates. Paresthesia, somnolence, nausea and headaches have been reported with pyridoxine hydrochloride. Mild transient diarrhea, polycythemia vera, itching, transitory exanthema and the feeling of swelling of the entire body have been associated with cyanocobalamin."],"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, including fish or fish oil."],"description":["DESCRIPTION Virt-PN Plus is a prescription prenatal/postnatal multivitamin/mineral softgel with an essential fatty acid. Each softgel has the following active ingredient: Folate (L-methylfolate, or 6(S)-5-MTHF 600 mcg) (folic acid, USP 400 mcg) 1 mg Each softgel also contains the following ingredients for nutritional supplementation: Vitamin C 85 mg Vitamin D 3 200 IU Vitamin E 10 IU Vitamin B 6 25 mg Vitamin B 12 12 mcg Biotin 250 mcg Calcium (calcium carbonate) 140 mg Iron (ferrous fumarate) 28 mcg Iodine (potassium iodide) 150 mcg Magnesium (magnesium oxide) 45 mg Docosahexaenoic Acid (DHA) 300 mg from at least 340 mg omega-3s from at least 390 mg purified fish oils. Eicosapentaenoic Acid (EPA) 40 mg"],"description_table":["
Each softgel has the following active ingredient:
Folate (L-methylfolate, or 6(S)-5-MTHF 600 mcg) (folic acid, USP 400 mcg) 1 mg
","
Each softgel also contains the following ingredients for nutritional supplementation:
Vitamin C 85 mg
Vitamin D3 200 IU
Vitamin E 10 IU
Vitamin B6 25 mg
Vitamin B12 12 mcg
Biotin 250 mcg
Calcium (calcium carbonate) 140 mg
Iron (ferrous fumarate) 28 mcg
Iodine (potassium iodide) 150 mcg
Magnesium (magnesium oxide) 45 mg
Docosahexaenoic Acid (DHA) 300 mgfrom at least 340 mg omega-3s from at least 390 mg purified fish oils.
Eicosapentaenoic Acid (EPA) 40 mg
"],"dosage_and_administration":["DOSAGE AND ADMINISTRATION Before, during, and/or after pregnancy, one softgel daily or as directed by a physician."],"effective_time":"20170804","how_supplied":["HOW SUPPLIED Virt-PN Plus is supplied as oblong, green soft gelatin capsules imprinted with '243', dispensed in bottles of 30 softgels. NDC 76439-243-30"],"id":"326fde63-5721-49d8-9b85-12223e32a535","inactive_ingredient":["Inactive Ingredients: Yellow Beeswax, Lecithin, Soybean Oil, Gelatin (Bovine), Glycerin, DI Water, Titanium Dioxide, FD&C Yellow #5, FD&C Blue #1 and Ethyl Vanillin."],"indications_and_usage":["INDICATIONS AND USAGE Virt-PN Plus is indicated for the supplemental requirements of patients with nutritional deficiencies or are in need of nutritional supplementation."],"openfda":{},"package_label_principal_display_panel":["PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 76439-243-30 Rx Only Virt-PN Plus Softgels Virtus PHARMACEUTICALS R x 30 Softgels PRINCIPAL DISPLAY PANEL - 30 tablets"],"patient_medication_information":["PATIENT INFORMATION Virt-PN Plus is a prescription vitamin for use only under the direction and supervision of a licensed physician."],"precautions":["CAUTION Exercise caution to ensure that the prescribed dosage of DHA does not exceed 1 gram (1000 mg) per day.","PRECAUTIONS General: Folates (including folic acid and reduced folates), when administered as a single agent in doses above 0.1 mg daily, may obscure the detection of B 12 deficiency (specifically, the administration of folic acid may reverse the hematological manifestations of B 12 deficiency, including pernicious anemia, while not addressing the neurological manifestations). Reduced folates may be less likely than folic acid to mask vitamin B 12 deficiency. Folate therapy alone is inadequate for the treatment of B 12 deficiency."],"set_id":"1189d7d6-d0ee-4576-a531-effb52ba7d8b","spl_product_data_elements":["Virt-PN Plus folic acid, ascorbic acid, cholecalciferol, .alpha.-tocopherol, pyridoxine, cyanocobalamin, biotin, calcium carbonate, ferrous fumarate, potassium iodide, magnesium oxide, doconexent and icosapent FOLIC ACID FOLIC ACID ASCORBIC ACID ASCORBIC ACID CHOLECALCIFEROL CHOLECALCIFEROL .ALPHA.-TOCOPHEROL .ALPHA.-TOCOPHEROL PYRIDOXINE PYRIDOXINE CYANOCOBALAMIN CYANOCOBALAMIN BIOTIN BIOTIN CALCIUM CARBONATE CALCIUM CATION FERROUS FUMARATE FERROUS CATION POTASSIUM IODIDE IODIDE ION MAGNESIUM OXIDE MAGNESIUM CATION DOCONEXENT DOCONEXENT ICOSAPENT ICOSAPENT YELLOW WAX LECITHIN, SOYBEAN SOYBEAN OIL GELATIN, UNSPECIFIED GLYCERIN WATER TITANIUM DIOXIDE FD&C BLUE NO. 1 FD&C YELLOW NO. 5 ETHYL VANILLIN 243"],"spl_unclassified_section":["Rx Only","This product contains soybean oil and fish oil.","INTERACTIONS Pyridoxine hydrochloride should not be given to patients receiving the drug levodopa, because the action of levodopa is antagonized by pyridoxine hydrochloride. However, pyridoxine hydrochloride may be used concurrently in patients receiving a preparation containing both carbidopa and levodopa. Drugs which may interact with folate include: Antiepileptic drugs (AED): The AED class including, but not limited to, phenytoin, carbamazepine, primidone, valproic acid, phenobarbital and lamotrigine have been shown to impair folate absorption and increase the metabolism of circulating folate. Additionally, concurrent use of folic acid has been associated with enhanced phenytoin metabolism, lowering the level of this AED in the blood and allowing breakthrough seizures to occur. Capecitabine: Folinic acid (5-formyltetrahydrofolate) may increase the toxicity of Capecitabine. Cholestyramine: Reduces folic acid absorption and reduces serum folate levels. Colestipol: Reduces folic acid absorption and reduces serum folate levels. Cycloserine: Reduces folic acid absorption and reduces serum folate levels. Dihydrofolate Reductase Inhibitors (DHFRI): DHFRIs block the conversion of folic acid to its active forms, and lower plasma and red blood cell folate levels. DHFRIs include aminopterin, methotrexate, pyrimethamine, triamterene, and trimethoprim. Fluoxetine: Fluoxetine exerts a noncompetitive inhibition of the 5-methyltetrahydrofolate active transport in the intestine. Isotretinoin: Reduced folate levels have occurred in some patients taking isotretinoin. Nonsteroidal Anti-inflammatory Drugs (NSAIDs): NSAIDs have been shown to inhibit some folate dependent enzymes in laboratory experiments. NSAIDs include ibuprofen, naproxen, indomethacin and sulindac. Oral Contraceptives: Serum folate levels may be depressed by oral contraceptive therapy. Methylprednisolone: Reduced serum folate levels have been noted after treatment with methylprednisolone. Pancreatic Enzymes: Reduced folate levels have occurred in some patients taking pancreatic extracts. Pentamidine: Reduced folate levels have been seen with prolonged intravenous pentamidine. Smoking and Alcohol: Reduced serum folate levels have been noted. Sulfasalazine: Inhibits the absorption and metabolism of folic acid. Metformin treatment in patients with type 2 diabetes decreases serum folate. Warfarin can produce significant impairment in folate status after a 6-month therapy.","Call your doctor about side effects. You may report side effects to FDA at 1-800-FDA-1088. KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN. Rx Only Reserved for Professional Recommendation All prescriptions using this product shall be pursuant to state statutes as applicable. This is not an Orange Book product. This product may be administered only under a physician's supervision. There are no implied or explicit claims on therapeutic equivalence.","Manufactured For: Virtus Pharmaceuticals, LLC. Tampa, FL 33619 www.virtusrx.com Virtus PHARMACEUTICALS Rev. 04/13"],"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":"2","warnings":["Warning: This product contains FD&C Yellow #5 and FD&C Blue #1.","WARNING Daily ingestion of more than 3 g per day of omega-3 fatty acids (ALA, EPA, and DHA) from fish oils may have potential antithrombotic activities, or effects, and may increase bleeding times. Administration of omega-3 fatty acids − including DHA, should be avoided in patients with inherited or acquired bleeding diatheses, including those taking anticoagulants."]}