VP-PNV-DHA

Virtus Pharmaceuticals

VP-PNV-DHAPrenatal Vitamins and Minerals

FULL PRESCRIBING INFORMATION: CONTENTS*

• VP-PNV-DHA DESCRIPTION
  • OTHER INGREDIENTS
• PRECAUTIONS
• DRUG INTERACTIONS
• VP-PNV-DHA ADVERSE REACTIONS
• VP-PNV-DHA DOSAGE AND ADMINISTRATION
• HOW SUPPLIED
• INDICATIONS
• VP-PNV-DHA CONTRAINDICATIONS
• WARNINGS
• STORAGE
• PRINCIPAL DISPLAY PANEL - 30 Day Blister Pack Carton

FULL PRESCRIBING INFORMATION

Rx

VP-PNV-DHA 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:

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	Daily Value not established.
Vitamins:
Thiamine Mononitrate (Vit. B1)	6 mg	Daily Value not established.
Riboflavin (Vit. B2)	2.2 mg	Daily Value not established.
Niacin	20 mg	Daily Value not established.
Vitamin B6 (Pyridoxine HCl)	16 mg	Daily Value not established.
Cyanocobalamin (B12)	12 mcg	Daily Value not established.
Folic Acid	1 mg	Daily Value not established.
Ascorbic Acid	80 mg	Daily Value not established.
Vitamin D3 (Cholecalciferol)	400 IU	Daily Value not established.
Vitamin E Oil (d-alpha Tocopherol)	30 IU	Daily Value not established.
Vitamin A (Palmitate)	2,500 IU	Daily Value not established.
Minerals:
Calcium (Carbonate)	50 mg	Daily Value not established.
Cupric Sulfate	1 mg	Daily Value not established.
Zinc Oxide	20 mg	Daily Value not established.
Ferrous Fumarate	28 mg	Daily Value not established.
Magnesium Oxide	30 mg	Daily Value not established.

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.

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.

VP-PNV-DHA ADVERSE REACTIONS

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

VP-PNV-DHA 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.

VP-PNV-DHA 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