VIRT-PN PLUS- folic acid, ascorbic acid, cholecalciferol, .alpha.-tocopherol, pyridoxine, cyanocobalamin, biotin, calcium carbonate, ferrous fumarate, potassium iodide, magnesium oxide, doconexent and icosapent capsule, gelatin coated
Virtus Pharmaceuticals LLC
Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.
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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 |
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Each softgel also contains the following ingredients for nutritional supplementation: |
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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 mg* |
Eicosapentaenoic Acid (EPA) | 40 mg* |
Yellow Beeswax, Lecithin, Soybean Oil, Gelatin (Bovine), Glycerin, DI Water, Titanium Dioxide, FD&C Yellow #5, FD&C Blue #1 and Ethyl Vanillin.
Virt-PN Plus is indicated for the supplemental requirements of patients with nutritional deficiencies or are in need of nutritional supplementation.
This product is contraindicated in patients with a known hypersensitivity to any of the ingredients, including fish or fish oil.
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.
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.
Exercise caution to ensure that the prescribed dosage of DHA does not exceed 1 gram (1000 mg) per day.
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 B12 deficiency (specifically, the administration of folic acid may reverse the hematological manifestations of B12 deficiency, including pernicious anemia, while not addressing the neurological manifestations). Reduced folates may be less likely than folic acid to mask vitamin B12 deficiency. Folate therapy alone is inadequate for the treatment of B12 deficiency.
Virt-PN Plus is a prescription vitamin for use only under the direction and supervision of a licensed physician.
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:
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.
Before, during, and/or after pregnancy, one softgel daily or as directed by a physician.
Virt-PN Plus is supplied as oblong, green soft gelatin capsules imprinted with '243', dispensed in bottles of 30 softgels.
NDC 76439-243-30
Store at 20°-25°C (68°-77°F). Excursions permitted to 15°-30°C (59°-86°F). [See USP Controlled Room Temperature].
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.
VIRT-PN PLUS
folic acid, ascorbic acid, cholecalciferol, .alpha.-tocopherol, pyridoxine, cyanocobalamin, biotin, calcium carbonate, ferrous fumarate, potassium iodide, magnesium oxide, doconexent and icosapent capsule, gelatin coated |
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Labeler - Virtus Pharmaceuticals LLC (969483143) |