Label: VIRT-C DHA- ascorbic acid, thiamine mononitrate, riboflavin, niacin, pyridoxine hydrochloride, folic acid, cyanocobalamin, biotin, calcium pantothenate, ferrous fumarate, iron, magnesium sulfate, zinc sulfate, cupric sulfate, doconexent, and icosapent capsule, gelatin coated

  • Category: DIETARY SUPPLEMENT
  • DEA Schedule: None
  • Marketing Status: Dietary Supplement

Drug Label Information

Updated November 8, 2019

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  • DESCRIPTION

    Virt-C DHA is an orally administered prescription dietary supplement and should be administered under the supervision of a licensed medical practitioner.

    Supplement Facts
    Serving Size: 1 Softgel
    Amount Per Serving% Daily Value for Pregnant & Lactating Women
    *
    Also containing Ascorbic Acid Precursors as (1) Acid Metabolites including niacinamide ascorbate, calcium ascorbate, magnesium ascorbate, potassium ascorbate and sodium ascorbate; (2) Basic Amino Acids including lysine acetate; (3) Flavonoids including hesperidin; and (4) Glutathione.
    †
    Minimum Iron Salt content.
    ‡
    Total Iron: Ferrous Fumarate + Polysaccharide Iron Complex.
    §
    At least 200 mg Omega-3 Fatty Acids derived from 310 mg fish oil.
    Daily Value not established.

    Vitamin C*

    25 mg

    42%

    Thiamine Mononitrate (B1)

    2 mg

    118%

    Riboflavin (B2)

    3 mg

    150%

    Niacin (B3)*

    1.8 mg

    9%

    Pyridoxine HCl (B6)

    25 mg

    1000%

    Folic Acid

    1 mg

    125%

    Cyanocobalamin (B12)

    12.5 mcg

    156%

    Biotin (B7)

    300 mcg

    100%

    d-Calcium Pantothenate (B5)

    5 mg

    50%

    Ferrous Fumarate (anhydrous)
    (Equivalent to about 17.5 mg of Elemental iron)

    53.5 mg†

    Polysaccharide Iron Complex
    (Equivalent to about 17.5 mg of Elemental iron)

    38 mg†

    ‡194%

    Magnesium (as magnesium sulfate)

    5 mg

    1%

    Zinc (as zinc sulfate)

    10 mg

    67%

    Copper (as copper sulfate)

    2 mg

    100%

    Omega-3 Fatty Acids§

    200 mg

      Docosahexaenoic Acid (DHA)

    156 mg

      Eicosapentaenoic Acid (EPA)

    39 mg

    Other Ingredients: Lecithin, Beeswax, Soybean Oil, Caramel, Capsule (Gelatin, Glycerin, Water, and Caramel). Contains Soy and Fish Oil.

  • DOSAGE AND ADMINISTRATION

    1 softgel daily, in between meals, or as prescribed by a licensed medical practitioner regardless of lactation status.

  • CAUTION

    Ingestion of more than 3 grams per day of omega-3 fatty acids (ALA, EPA, and DHA) may have potential antithrombotic activities, or effects, and may increase bleeding times. Administration of omega-3 fatty acids, including DHA, should be avoided in patients with inherited or acquired bleeding diathesis, including those taking anticoagulants. Exercise caution to ensure that the prescribed dosage of DHA does not exceed 1 gram (1000 mg) per day.

  • WARNINGS

    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.

  • CAUTION

    High levels of folic acid may, especially in older adults, hide signs of Vitamin B-12 deficiency (such as pernicious anemia), a condition that that can cause nerve damage.

  • HEALTH CLAIM

    Store at controlled room temperature 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F). Protect from light and moisture. Dispense in a tight, light-resistant container.

  • HEALTH CLAIM

    Call your licensed medical practitioner about side effects. You may report side effects by calling Virtus at 1-888-848-3593 or FDA at 1-800-FDA-1088.

  • HOW SUPPLIED

    Supplied as oblong, dark black color softgel imprinted with "V355" dispensed in 30 count bottles.

  • HEALTH CLAIM

    Manufactured for:
    Virtus Pharmaceuticals, LLC
    Langhorne, PA 19047
    1-888-848-3593

    Rev. 07/2019

  • PRINCIPAL DISPLAY PANEL - 30 Softgel Bottle Label

    VIRTUS®
    PHARMACEUTICALS

    76439-331-30

    Virt-C DHA

    PRENATAL/POSTNATAL

    Prescription Folic Acid-Containing
    Dietary Supplement
    with Omega-3 Fatty Acids

    RX

    30 Softgels
    Made in the USA

    Principal Display Panel - 30 Softgel Bottle Label
  • INGREDIENTS AND APPEARANCE
    VIRT-C DHA 
    ascorbic acid, thiamine mononitrate, riboflavin, niacin, pyridoxine hydrochloride, folic acid, cyanocobalamin, biotin, calcium pantothenate, ferrous fumarate, iron, magnesium sulfate, zinc sulfate, cupric sulfate, doconexent, and icosapent capsule, gelatin coated
    Product Information
    Product TypeDIETARY SUPPLEMENTItem Code (Source)NHRIC:76439-331
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID25 mg
    THIAMINE MONONITRATE (UNII: 8K0I04919X) (THIAMINE ION - UNII:4ABT0J945J) THIAMINE2 mg
    RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR) RIBOFLAVIN3 mg
    NIACIN (UNII: 2679MF687A) (NIACIN - UNII:2679MF687A) NIACIN1.8 mg
    PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE HYDROCHLORIDE25 mg
    FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID1 mg
    CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN12.5 ug
    BIOTIN (UNII: 6SO6U10H04) (BIOTIN - UNII:6SO6U10H04) BIOTIN300 ug
    CALCIUM PANTOTHENATE (UNII: 568ET80C3D) (PANTOTHENIC ACID - UNII:19F5HK2737) PANTOTHENIC ACID5 mg
    FERROUS FUMARATE (UNII: R5L488RY0Q) (FERROUS CATION - UNII:GW89581OWR) FERROUS CATION53.5 mg
    IRON (UNII: E1UOL152H7) (IRON - UNII:E1UOL152H7) IRON38 mg
    MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM SULFATE, UNSPECIFIED FORM5 mg
    ZINC SULFATE, UNSPECIFIED FORM (UNII: 89DS0H96TB) (ZINC CATION - UNII:13S1S8SF37) ZINC SULFATE, UNSPECIFIED FORM10 mg
    CUPRIC SULFATE (UNII: LRX7AJ16DT) (CUPRIC CATION - UNII:8CBV67279L) CUPRIC CATION2 mg
    DOCONEXENT (UNII: ZAD9OKH9JC) (DOCONEXENT - UNII:ZAD9OKH9JC) DOCONEXENT156 mg
    ICOSAPENT (UNII: AAN7QOV9EA) (ICOSAPENT - UNII:AAN7QOV9EA) ICOSAPENT39 mg
    Inactive Ingredients
    Ingredient NameStrength
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    CARAMEL (UNII: T9D99G2B1R)  
    GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NHRIC:76439-331-3030 in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Dietary Supplement03/31/2015
    Supplement Facts
    Serving Size : Serving per Container :
    Amount Per Serving% Daily Value
    color
    size (solid drugs)15 mm
    shape
    scoring1
    imprint
    Labeler - Virtus Pharmaceuticals (079659493)
    Establishment
    NameAddressID/FEIBusiness Operations
    Captek Pharma015869178MANUFACTURE
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