Label: VIRT-PN DHA- ascorbic acid, cholecalciferol, .alpha.-tocopherol, d-, pyridoxine hydrochloride, levomefolate calcium, folic acid, cyanocobalamin, calcium carbonate, ferrous fumarate, magnesium oxide, and doconexent capsule

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

Drug Label Information

Updated March 8, 2016

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  • HEALTH CLAIM

    Supplement Facts
    Serving Size: 1 Softgel
    Amount Per Serving% Daily Value for Pregnant and Lactating Women
    *
    From at least 330 mg purified fish oil.
    †
    Daily Value not established
    Vitamin C (ascorbic acid)85 mg142%
    Vitamin D (Vitamin D3 as cholecalciferol)200 IU50%
    Vitamin E (d-alpha tocopherol)10 IU33%
    Vitamin B6 (pyridoxine HCl)25 mg1000%
    Folate (L-Methylfolate calcium, or 6(S)-5-MTHF-Ca 600 mcg) (folic acid, USP 400 mcg)1 mg125%
    Vitamin B12 (cyanocobalamin)12 mcg150%
    Calcium (calcium carbonate) 140 mg11%
    Iron (ferrous fumarate)27 mg150%
    Magnesium (magnesium oxide)45 mg10%
    Docosahexaenoic Acid (DHA)300 mg*†

    Other Ingredients: Soybean Oil, Gelatin, Glycerin, DI Water, Yellow Beeswax, Lecithin, Annatto Extract, Titanium Dioxide, FD&C Red #40, and FD&C Blue #1.

    CAUTION: Contains Soy, Fish Oil, FD&C Red #40, and FD&C Blue #1.

  • DESCRIPTION

    Virt-PN DHA is a prescription prenatal/postnatal multivitamin/mineral dietary supplement with fish-based DHA and should be administered under the supervision of a licensed medical practitioner.

  • DOSAGE AND ADMINISTRATION

    Before, during and/or after pregnancy, one softgel daily or as directed by a licensed healthcare 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 can cause nerve damage.

  • SAFE HANDLING WARNING

    Store at 20° to 25°C (68° to 77°F). Excursions permitted to 15° to 30°C (59° to 86°F. Protect from light and moisture. Dispense in a tight, light-resistant container. Notice: Contact with moisture may produce surface discoloration or erosion.

  • 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, annatto-colored softgel, imprinted "340" and dispensed in 30 count bottles.

  • HEALTH CLAIM

    Manufactured for:
    Virtus Pharmaceuticals, LLC
    Tampa, Florida 33619 1-888-848-3593

    Rev. 12/2015

  • PRINCIPAL DISPLAY PANEL - 30 Softgel Bottle Label

    VIRTUS
    PHARMACEUTICALS

    69543-340-30

    Virt-PN DHA

    PRENATAL/POSTNATAL

    Prescription Multivitamin/Mineral
    Dietary Supplement with Fish-Based DHA

    Rx

    30 Softgels
    Made in USA

    PRINCIPAL DISPLAY PANEL - 30 Softgel Bottle Label
  • INGREDIENTS AND APPEARANCE
    VIRT-PN DHA 
    ascorbic acid, cholecalciferol, .alpha.-tocopherol, d-, pyridoxine hydrochloride, levomefolate calcium, folic acid, cyanocobalamin, calcium carbonate, ferrous fumarate, magnesium oxide, and doconexent capsule
    Product Information
    Product TypeDIETARY SUPPLEMENTItem Code (Source)NHRIC:69543-340
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID85 mg
    CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL200 [iU]
    .ALPHA.-TOCOPHEROL, D- (UNII: N9PR3490H9) (.ALPHA.-TOCOPHEROL, D- - UNII:N9PR3490H9) .ALPHA.-TOCOPHEROL, D-10 [iU]
    PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE25 mg
    LEVOMEFOLATE CALCIUM (UNII: A9R10K3F2F) (LEVOMEFOLIC ACID - UNII:8S95DH25XC) LEVOMEFOLIC ACID600 ug
    FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID400 ug
    CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN12 ug
    CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CATION140 mg
    FERROUS FUMARATE (UNII: R5L488RY0Q) (FERROUS CATION - UNII:GW89581OWR) FERROUS CATION27 mg
    MAGNESIUM OXIDE (UNII: 3A3U0GI71G) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM CATION45 mg
    DOCONEXENT (UNII: ZAD9OKH9JC) (DOCONEXENT - UNII:ZAD9OKH9JC) DOCONEXENT300 mg
    Inactive Ingredients
    Ingredient NameStrength
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    ANNATTO (UNII: 6PQP1V1B6O)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NHRIC:69543-340-3030 in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    DIETARY SUPPLEMENT09/08/2015
    Supplement Facts
    Serving Size : Serving per Container :
    Amount Per Serving% Daily Value
    color
    scoring1
    shape
    size (solid drugs)25 mm
    imprint
    Labeler - Virtus Pharmaceuticals (079659493)
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