Label: VP-PNV-DHA- folic acid, pyridoxine, calcium carbonate, thiamine mononitrate, cholecalciferol, .alpha.-tocopherol, d-, cyanocobalamin, ferrous fumarate, magnesium oxide, riboflavin, niacin, ascorbic acid, cupric sulfate, vitamin a palmitate, zinc oxide, doconexent and ethyl icosapentate capsule, gelatin coated
- NDC Code(s): 76439-223-30
- Packager: Virtus Pharmaceuticals
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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- SPL UNCLASSIFIED SECTION
VP-PNV-DHA is a regimen of prenatal multi-vitamin, multi-mineral, and omega-3 fatty acid supplements, supplied as softgel capsules. The VP-PNV-DHA softgel capsules are dark blue, oval shaped debossed with "V223" on one side.
Each Dark Blue, oval VP- PNV-DHA softgel capsule contains:
- Daily Value not established.
Supplement Facts Serving Size: 1 softgel capsule
Servings per Container: 30
Amount Per Serving % Daily Value DHA and EPA (EPA 15.8 mg and DHA 200 mg) 215.8 mg * Vitamins: Thiamine Mononitrate (Vit. B1) 6 mg * Riboflavin (Vit. B2) 2.2 mg * Niacin 20 mg * Vitamin B6 (Pyridoxine HCl) 16 mg * Cyanocobalamin (B12) 12 mcg * Folic Acid 1 mg * Ascorbic Acid 80 mg * Vitamin D3 (Cholecalciferol) 400 IU * Vitamin E Oil (d-alpha Tocopherol) 30 IU * Vitamin A (Palmitate) 2,500 IU * Minerals: Calcium (Carbonate) 50 mg * Cupric Sulfate 1 mg * Zinc Oxide 20 mg * Ferrous Fumarate 28 mg * Magnesium Oxide 30 mg *
Gelatin, Glycerin, Purified Water, Yellow Beeswax, Soybean Oil, Soy Lecithin, Natural Creamy Orange Flavor, FD&C Blue #1 Lake, Sodium Citrate, Titanium Dioxide, Ethyl Vanillin, and FD&C Yellow #6.
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.
- SPL UNCLASSIFIED SECTION
This product contains fish oil.Close
Folic acid in dose above 0.1 mg daily may obscure the diagnosis of pernicious anemia (hematologic remission may occur while neurological manifestations remain progressive).Close
- DRUG INTERACTIONS
Pyridoxine supplements should be avoided in patients receiving levodopa alone, as the actions of levodopa may be antagonized.Close
- ADVERSE REACTIONS
Allergic sensitization has been reported following both oral and parenteral administration of folic acid.Close
- DOSAGE AND ADMINISTRATION
Before, during and after pregnancy, one softgel capsule taken by mouth daily, or as directed by a physician. Caution should be exercised to ensure that the prescribed dose of DHA does not exceed 1 gram (1,000 mg) per day.Close
- HOW SUPPLIED
VP-PNV-DHA is supplied as child-resistant blister cards containing 30 softgel capsules in a light-resistant container.Close
VP-PNV-DHA is a regimen of prenatal multi-vitamin, multi-mineral, and omega-3 fatty acid supplements indicated for use in improving the nutritional status of women throughout pregnancy and in the post-natal period for both lactating and non-lactating mothers. VP-PNV-DHA is also useful in improving nutritional status prior to conception.Close
This product is contraindicated in patients with known hypersensitivity to any of the ingredients including fish or fish oil.Close
Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where Vitamin B12 is deficient. Since daily ingestion of more than 3 grams per day of omega-3 fatty acids (including alpha linolenic acid (ALA), eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA)) from fish oils may have potential antithrombotic activities and may increase bleeding times, administration of DHA should be avoided in patients with inherited or acquired bleeding diatheses, including those taking anticoagulants.Close
Store at controlled room temperature 20°-25°C (68°-77°F). [See USP.] Protect from moisture and excessive heat. Note that contact with moisture may produce surface discolorations of the tablet.
KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.Close
- SPL UNCLASSIFIED SECTION
Call your doctor about side effects. You may report side effects by calling (813) 283-1344.
All prescriptions using this product shall be pursuant to state statutes as applicable. This is not an Orange Book product. There are no implied or explicit claims on therapeutic equivalence.
Tampa, FL 33619
MADE IN CANADA
- PRINCIPAL DISPLAY PANEL - 30 Day Blister Pack Carton
Prenatal Vitamins and Minerals
30 Day Supply
30 Day Softgel Capsules
- INGREDIENTS AND APPEARANCE
folic acid, pyridoxine, calcium carbonate, thiamine mononitrate, cholecalciferol, .alpha.-tocopherol, d-, cyanocobalamin, ferrous fumarate, magnesium oxide, riboflavin, niacin, ascorbic acid, cupric sulfate, vitamin a palmitate, zinc oxide, doconexent, and ethyl icosapentate capsule, gelatin coated
Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:76439-223 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Folic Acid (Folic Acid) Folic Acid 1 mg Pyridoxine (Pyridoxine) Pyridoxine 16 mg Calcium Carbonate (Calcium Cation) Calcium Carbonate 50 mg Thiamine Mononitrate (Thiamine Ion) Thiamine Mononitrate 6 mg Cholecalciferol (Cholecalciferol) Cholecalciferol 400 [iU] .Alpha.-Tocopherol, D- (.Alpha.-Tocopherol, D-) .Alpha.-Tocopherol, D- 30 [iU] Cyanocobalamin (Cyanocobalamin) Cyanocobalamin 12 ug Ferrous Fumarate (Ferrous Cation) Ferrous Fumarate 28 mg Magnesium Oxide (Magnesium Cation) Magnesium Oxide 30 mg Riboflavin (Riboflavin) Riboflavin 2.2 mg Niacin (Niacin) Niacin 20 mg Ascorbic Acid (Ascorbic Acid) Ascorbic Acid 80 mg Cupric Sulfate (Cupric Cation) Cupric Sulfate 1 mg Vitamin A Palmitate (Vitamin A) Vitamin A Palmitate 2500 [iU] Zinc Oxide (Zinc Oxide) Zinc Oxide 20 mg Doconexent (Doconexent) Doconexent 200 mg Ethyl Icosapentate (Icosapent) Ethyl Icosapentate 15.8 mg Inactive Ingredients Ingredient Name Strength Titanium Dioxide Ethyl Vanillin Gelatin Glycerin FD&C Blue No. 1 Aluminum Oxide Lecithin, Soybean Citrus Sinensis Fruit Oil Water Soybean Oil Yellow Wax Sodium Citrate FD&C Yellow No. 6 Product Characteristics Color BLUE Score no score Shape OVAL Size 23mm Flavor Imprint Code V223 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:76439-223-30 30 in 1 BLISTER PACK Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date UNAPPROVED DRUG OTHER 04/01/2012 Labeler - Virtus Pharmaceuticals (969483143)