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Virt-Select

Generic Name: prenatal/postnatal multivitamin/mineral
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.

Virt-Select
Softgel Capsules

Rx

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:

*
Derived from at least 338.1 mg omega-3s from at least 476.1 mg purified fish oil.
Vitamin C (ascorbic acid) 28 mg
Vitamin E (d-alpha tocopherol) 30 IU
Vitamin B6 (pyridoxine hydrochloride) 25 mg
Folic Acid, USP 1.25 mg
Calcium (tribasic calcium phosphate) 160 mg
Iron (ferrous fumarate) 29 mg
Vitamin D3 (cholecalciferol) 800 IU
DHA (docosahexaenoic acid, contained in the oil derived from fish) 325 mg*
Docusate Sodium, USP 55 mg

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.

Indications and Usage for Virt-Select

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.

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.

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.

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 is Virt-Select 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.

Rx

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

Rx

30 Capsules

Virt-Select 
folic acid, pyridoxine, calcium phosphate, ascorbic acid, cholecalciferol, .alpha.-tocopherol, d-, ferrous fumarate, docusate sodium, and doconexent capsule, gelatin coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:76439-249
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Folic Acid (Folic Acid) Folic Acid 1.25 mg
Pyridoxine (Pyridoxine) Pyridoxine 25 mg
Calcium Phosphate (Calcium Cation) Calcium Phosphate 160 mg
Ascorbic Acid (Ascorbic Acid) Ascorbic Acid 28 mg
Cholecalciferol (Cholecalciferol) Cholecalciferol 800 [iU]
.Alpha.-Tocopherol, D- (.Alpha.-Tocopherol, D-) .Alpha.-Tocopherol, D- 30 [iU]
Ferrous Fumarate (Ferrous Cation) Ferrous Fumarate 29 mg
Docusate Sodium (Docusate) Docusate Sodium 55 mg
Doconexent (Doconexent) Doconexent 325 mg
Inactive Ingredients
Ingredient Name Strength
Annatto  
Ethyl Vanillin  
Gelatin  
Glycerin  
Citric Acid Monohydrate  
Egg Phospholipids  
Citrus Sinensis Fruit Oil  
Water  
Soybean Oil  
Yellow Wax  
Titanium Dioxide  
Product Characteristics
Color BROWN Score no score
Shape OVAL Size 25mm
Flavor Imprint Code 249
Contains         
Packaging
# Item Code Package Description
1 NDC:76439-249-30 30 CAPSULE, GELATIN COATED in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
UNAPPROVED DRUG OTHER 10/18/2012
Labeler - Virtus Pharmaceuticals (969483143)
Revised: 10/2012
 
Virtus Pharmaceuticals
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