Virt-Select

Virtus Pharmaceuticals

Virt-Select Softgel Capsules

FULL PRESCRIBING INFORMATION: CONTENTS*

• VIRT-SELECT DESCRIPTION
• VIRT-SELECT INDICATIONS AND USAGE
• VIRT-SELECT CONTRAINDICATIONS
• WARNINGS
• PRECAUTION
• VIRT-SELECT ADVERSE REACTIONS
• CAUTION
• VIRT-SELECT DOSAGE AND ADMINISTRATION
• HOW SUPPLIED
  • STORAGE
• PRINCIPAL DISPLAY PANEL - 30 Capsule Bottle Label

FULL PRESCRIBING INFORMATION

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VIRT-SELECT DESCRIPTION

Virt-Select is a prescription prenatal/postnatal multivitamin/mineral softgel capsule with fish-based DHA. Each softgel capsule is an oblong, annatto and imprinted with "V249" in white ink.

• 1.25 mg Folic Acid and 325 mg DHA (key omega-3 fatty acid from purified fish oil)
• Essential vitamins and minerals
• Gentle stool softener

Each softgel capsule contains:

Inactive Ingredients: Annatto, Citric Acid, Ethyl Vanillin, Gelatin, Glycerin, Natural Creamy Orange Flavor, Purified Water, Soy Lecithin, Soybean Oil, Titanium Dioxide, Yellow Beeswax.

THIS PRODUCT CONTAINS FISH OIL AND SOY.

VIRT-SELECT INDICATIONS AND USAGE

Virt-Select is indicated to provide vitamin/mineral and fish-based DHA supplementation throughout pregnancy, during the postnatal period for both lactating and non-lactating mothers, and throughout the childbearing years. Virt-Select may be useful in improving the nutritional status of women prior to conception.

VIRT-SELECT CONTRAINDICATIONS

This product is contraindicated in patients with a known hypersensitivity to any of the ingredients. Do not take this product if you are presently taking mineral oil, unless directed by a doctor.

WARNINGS

Ingestion of more than 3 grams of omega-3 fatty acids (such as DHA) per day has been shown to have potential antithrombotic effects, including an increased bleeding time and International Normalized Ratio (INR). Administration of omega-3 fatty acids should be avoided in patients taking anticoagulants and in those known to have an inherited or acquired predisposition to bleeding.

PRECAUTION

Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B₁₂ is deficient. Folic acid in doses above 1.0 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations remain progressive.

VIRT-SELECT ADVERSE REACTIONS

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

CAUTION

Exercise caution to ensure that the prescribed dosage of DHA does not exceed 1 gram (1000 mg) per day.

VIRT-SELECT DOSAGE AND ADMINISTRATION

Before, during and/or after pregnancy, one softgel capsule daily or as prescribed by a physician.

HOW SUPPLIED

Virt-Select is supplied in bottles of 30 softgel capsules.

Product Code: 76439-249-30

STORAGE

Store at Controlled Room Temperature 20° -25°C (68° - 77°F). [See USP].

Call your medical practitioner about side effects.
You may report side effects by calling 813-283-1344.

KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN.

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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, LLC
Tampa, Florida 33619

Rev. 07/12

PRINCIPAL DISPLAY PANEL - 30 Capsule Bottle Label

VIRTUS
PHARMACEUTICALS

Product Code: 76439-249-30

Virt-Select

Softgel Capsule

1.25 mg Folic Acid and 325 mg DHA
(key omega-3 fatty acid)

Essential Vitamins and Minerals

Gentle Stool Softener

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30 Capsules