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 

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  • NDC Code(s): 76439-223-30
  • Packager: Virtus Pharmaceuticals
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

Drug Label Information

Updated 08/12

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  • SPL UNCLASSIFIED SECTION

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  • DESCRIPTION

    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 *

    OTHER INGREDIENTS

    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.

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  • WARNINGS

    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.
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  • SPL UNCLASSIFIED SECTION

    This product contains fish oil.

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  • PRECAUTIONS

    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).

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  • DRUG INTERACTIONS

    Pyridoxine supplements should be avoided in patients receiving levodopa alone, as the actions of levodopa may be antagonized.

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  • ADVERSE REACTIONS

    Allergic sensitization has been reported following both oral and parenteral administration of folic acid.

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  • 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.

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  • HOW SUPPLIED

    VP-PNV-DHA is supplied as child-resistant blister cards containing 30 softgel capsules in a light-resistant container.
    NDC 76439-223-30.

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  • INDICATIONS

    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.

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  • CONTRAINDICATIONS

    This product is contraindicated in patients with known hypersensitivity to any of the ingredients including fish or fish oil.

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  • WARNINGS

    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.

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  • STORAGE

    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.

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  • SPL UNCLASSIFIED SECTION

    RX

    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.

    Manufactured for:
    Virtus Pharmaceuticals
    Tampa, FL 33619
    WWW.VirtusRX.com
    MADE IN CANADA

    Rev. 07/12

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  • PRINCIPAL DISPLAY PANEL - 30 Day Blister Pack Carton

    VIRTUS
    PHARMACEUTICALS

    76439-223-30
    VP-PNV-DHA
    Prenatal Vitamins and Minerals

    Gluten Free

    30 Day Supply
    30 Day Softgel Capsules

    Rx

    PRINCIPAL DISPLAY PANEL - 30 Day Blister Pack Carton
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  • INGREDIENTS AND APPEARANCE
    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
    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)
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