Your browser does not support JavaScript! 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 [VIRTUS PHARMACEUTICALS]
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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
[Virtus Pharmaceuticals]


Category DEA Schedule Marketing Status
HUMAN PRESCRIPTION DRUG LABEL unapproved drug other
NOTE: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.
Drug Label Sections

Rx

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*
Niacin20 mg*
Vitamin B6 (Pyridoxine HCl)16 mg*
Cyanocobalamin (B12)12 mcg*
Folic Acid1 mg*
Ascorbic Acid80 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 Sulfate1 mg*
Zinc Oxide20 mg*
Ferrous Fumarate28 mg*
Magnesium Oxide30 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.

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.

This product contains fish oil.

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).

DRUG INTERACTIONS

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

ADVERSE REACTIONS

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

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.

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.

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.

CONTRAINDICATIONS

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

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.

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.

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

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
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 TypeHUMAN PRESCRIPTION DRUG LABELItem Code (Source)NDC:76439-223
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Folic Acid (Folic Acid) Folic Acid1 mg
Pyridoxine (Pyridoxine) Pyridoxine16 mg
Calcium Carbonate (Calcium Cation) Calcium Carbonate50 mg
Thiamine Mononitrate (Thiamine Ion) Thiamine Mononitrate6 mg
Cholecalciferol (Cholecalciferol) Cholecalciferol400 [iU]
.Alpha.-Tocopherol, D- (.Alpha.-Tocopherol, D-) .Alpha.-Tocopherol, D-30 [iU]
Cyanocobalamin (Cyanocobalamin) Cyanocobalamin12 ug
Ferrous Fumarate (Ferrous Cation) Ferrous Fumarate28 mg
Magnesium Oxide (Magnesium Cation) Magnesium Oxide30 mg
Riboflavin (Riboflavin) Riboflavin2.2 mg
Niacin (Niacin) Niacin20 mg
Ascorbic Acid (Ascorbic Acid) Ascorbic Acid80 mg
Cupric Sulfate (Cupric Cation) Cupric Sulfate1 mg
Vitamin A Palmitate (Vitamin A) Vitamin A Palmitate2500 [iU]
Zinc Oxide (Zinc Oxide) Zinc Oxide20 mg
Doconexent (Doconexent) Doconexent200 mg
Ethyl Icosapentate (Icosapent) Ethyl Icosapentate15.8 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorBLUEScoreno score
ShapeOVALSize23mm
FlavorImprint Code V223
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76439-223-3030 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
UNAPPROVED DRUG OTHER04/01/2012
Labeler - Virtus Pharmaceuticals (969483143)

Revised: 8/2012
 
Virtus Pharmaceuticals

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