VP-CH-PNV Softgels

Generic Name: prenatal multi-vitamin, multi-mineral, and omega-3 fatty acid supplement
Dosage Form: capsule, gelatin coated

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.

VP-PNV-DHA
Prenatal Vitamins and Minerals

Rx

VP-CH-PNV Softgels 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.

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.

VP-CH-PNV Softgels 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 is VP-CH-PNV Softgels 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

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
1 NDC:76439-223-30 30 CAPSULE, GELATIN COATED 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)
Revised: 08/2012
 
Virtus Pharmaceuticals
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