{"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: Extra-Virt Plus DHA Softgels are contraindicated in patients with a known hypersensitivity to any of the ingredients. Do not take this product if you are presently taking mineral oil, unless directed by a healthcare practitioner."],"description":["DESCRIPTION: Extra-Virt Plus DHA is an orally administered prescription prenatal/postnatal multivitamin/ mineral softgel with fish-based DHA. Extra-Virt Plus DHA is available as opaque brown, oblong softgels imprinted \"V251\" and are available in 30-count bottles (NDC 76439-251-30). Each softgel contains: Vitamin C (ascorbic acid) 28 mg Vitamin D 3 (cholecalciferol) 800 IU Vitamin E (d-alpha tocopherol) 30 IU (Vitamin B 6 ) (pyridoxine hydrochloride) 25 mg Folic Acid 1.25 mg Biotin 250 mcg Calcium 160 mg 158 mg calcium from calcium carbonate and 2 mg calcium from docusate calcium. Iron (ferrous fumarate) 29 mg Omega oil blend 660 mg Providing 350 mg DHA (docosahexaenoic acid) Docusate Calcium 55 mg"],"description_table":["<table width=\"50%\"> <col width=\"36%\"/> <col width=\"15%\"/> <tbody> <tr> <td styleCode=\"Toprule \" valign=\"top\"> <paragraph> <content styleCode=\"bold\">Each softgel contains:</content> </paragraph> </td> <td styleCode=\"Toprule \" valign=\"top\"/> </tr> <tr> <td valign=\"top\"> <paragraph>Vitamin C (ascorbic acid)</paragraph> </td> <td valign=\"top\"> <paragraph>28 mg</paragraph> </td> </tr> <tr> <td valign=\"top\"> <paragraph>Vitamin D<sub>3</sub> (cholecalciferol)</paragraph> </td> <td valign=\"top\"> <paragraph>800 IU</paragraph> </td> </tr> <tr> <td valign=\"top\"> <paragraph>Vitamin E (d-alpha tocopherol)</paragraph> </td> <td valign=\"top\"> <paragraph>30 IU</paragraph> </td> </tr> <tr> <td valign=\"top\"> <paragraph>(Vitamin B<sub>6</sub>) (pyridoxine hydrochloride)</paragraph> </td> <td valign=\"top\"> <paragraph>25 mg</paragraph> </td> </tr> <tr> <td valign=\"top\"> <paragraph> Folic Acid</paragraph> </td> <td valign=\"top\"> <paragraph>1.25 mg</paragraph> </td> </tr> <tr> <td valign=\"top\"> <paragraph> Biotin</paragraph> </td> <td valign=\"top\"> <paragraph>250 mcg</paragraph> </td> </tr> <tr> <td valign=\"top\"> <paragraph>Calcium</paragraph> </td> <td valign=\"top\"> <paragraph>160 mg<footnote ID=\"_RefFN1\">158 mg calcium from calcium carbonate and 2 mg calcium from docusate calcium.</footnote> </paragraph> </td> </tr> <tr> <td valign=\"top\"> <paragraph>Iron (ferrous fumarate)</paragraph> </td> <td valign=\"top\"> <paragraph>29 mg</paragraph> </td> </tr> <tr> <td valign=\"top\"> <paragraph>Omega oil blend</paragraph> </td> <td valign=\"top\"> <paragraph>660 mg<footnote ID=\"_RefFN2\">Providing 350 mg DHA (docosahexaenoic acid)</footnote> </paragraph> </td> </tr> <tr> <td styleCode=\"Botrule \" valign=\"top\"> <paragraph>Docusate Calcium</paragraph> </td> <td styleCode=\"Botrule \" valign=\"top\"> <paragraph>55 mg</paragraph> </td> </tr> </tbody> </table>"],"dosage_and_administration":["DOSAGE AND ADMINISTRATION: Before, during and/or after pregnancy, one softgel daily or as directed by a licensed healthcare practitioner."],"drug_interactions":["CAUTION: Exercise caution to ensure that the prescribed dosage of DHA does not exceed 1 gram (1000 mg) per day."],"effective_time":"20190329","how_supplied":["HOW SUPPLIED: Extra-Virt Plus DHA is available as opaque brown, oblong softgels imprinted \"V251\" and are available in 30-count bottles (NDC 76439-251-30). KEEP OUT OF REACH OF CHILDREN. All prescriptions using this product shall be pursuant to state statutes as applicable. This is not an Orange Book product. Call your medical practitioner about side effects. You may also report side effects to Virtus Pharmaceuticals, LLC at 813-283-1344."],"id":"02a6f971-bc2b-46cf-bea6-3b2615d925c1","indications_and_usage":["INDICATIONS: Extra-Virt Plus DHA Softgels are indicated to provide vitamin/mineral and fish-based DHA supplementation throughout pregnancy, during the postnatal period for both lactating and non-lactating mothers, and throughout the childbearing years. Extra-Virt Plus DHA Softgels may be useful in improving the nutritional status of women prior to conception."],"openfda":{},"package_label_principal_display_panel":["PACKAGE LABEL.PRINCIPAL DISPLAY PANEL VIRTUS PHARMACEUTICALS NDC 76439 -251- 30 Extra-Virt Plus DHA Softgels R x 30 Softgels PRINCIPAL DISPLAY PANEL - 100 tablets"],"precautions":["PRECAUTION: 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 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress."],"set_id":"d426fcad-0b68-4412-b5bb-0187892f07eb","spl_product_data_elements":["Extra-Virt Plus DHA ascorbic acid, cholecalciferol, .alpha.-tocopherol, d-, pyridoxine hydrochloride, folic acid, biotin, calcium carbonate, docusate calcium, ferrous fumarate and doconexent ASCORBIC ACID ASCORBIC ACID CHOLECALCIFEROL CHOLECALCIFEROL .ALPHA.-TOCOPHEROL, D- .ALPHA.-TOCOPHEROL, D- PYRIDOXINE HYDROCHLORIDE PYRIDOXINE FOLIC ACID FOLIC ACID BIOTIN BIOTIN CALCIUM CARBONATE CALCIUM CATION DOCUSATE CALCIUM DOCUSATE FERROUS FUMARATE FERROUS CATION DOCONEXENT DOCONEXENT ANNATTO YELLOW WAX CITRIC ACID MONOHYDRATE ETHYL VANILLIN GELATIN, UNSPECIFIED GLYCERIN WATER LECITHIN, SOYBEAN TITANIUM DIOXIDE opaque brown V251 natural creamy orange"],"spl_unclassified_section":["Rx","Other Ingredients: Annatto, Beeswax, Citric Acid, Ethyl Vanillin, Gelatin, Glycerin, Natural Creamy Orange Flavor, Purified Water, Soy Lecithin, Titanium Dioxide. This product contains soy and fish oil, derived from Scombridae fish, from purified fish oil containing less than one percent EPA.","Manufactured for: Virtus Pharmaceuticals, LLC Tampa, FL 33619 Made in Canada Rev. 03/13"],"storage_and_handling":["Store at 20 – 25°C (68 – 77°F). [See USP Controlled Room Temperature.] Dispense in a tight, light resistant container. Protect from light and moisture."],"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."]}