VIRT-GARD (PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, AND CYANOCOBALAMIN) TABLET [VIRTUS PHARMACEUTICALS OPCO II]

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VIRT-GARD (PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, AND CYANOCOBALAMIN) TABLET [VIRTUS PHARMACEUTICALS OPCO II]
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NDC 76439-353-10
Set ID 3f014670-1d2f-4ee5-8cce-298275dcf664
Category DIETARY SUPPLEMENT
Packager Virtus Pharmaceuticals
Generic Name
Product Class
Product Number
Application Number
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  • HEALTH CLAIM

    76439-353-10

    Rx

    Prescription Folic Acid-Containing
    Dietary Supplement

  • DESCRIPTION

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

    Supplement Facts
    Serving Size: 1 Tablet
    Amount Per Serving% Daily Value*

    Vitamin B6

    (Pyridoxine HCl)

    25 mg

      1471%

    Folate

    (2200 mcg Folic Acid)

    3667 mcg DFE

        917%

    Vitamin B12

    (Cyanocobalamin)

    1 mg

    41667%

    *Percent Daily Values are based on a 2,000 calorie diet.

    Other Ingredients: Dicalcium Phosphate, Microcrystalline Cellulose, Pregelatinized Starch, Pink Coating (Hypromellose, Polydextrose, Titanium Dioxide, Talc, Maltodextrin, Medium Chain Triglycerides, FD&C Red #40, FD&C Yellow #6, FD&C Blue #1), Stearic Acid, Silicon Dioxide, Magnesium Stearate.

  • INDICATIONS AND USAGE

    Virt-Gard tablets are indicated for nutritional support and folic acid supplementation. This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.

  • CONTRAINDICATIONS

    This product is contraindicated in people with known history of hypersensitivity to any of the ingredients.

  • CAUTIONS

    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).

  • Pediatric Use

    Safety and effectiveness in pediatric patients have not been established.

  • SIDE EFFECTS

    Allergic sensitization has been reported following oral administration of folic acid. Paresthesia, somnolence, nausea and headaches have been reported with pyridoxine hydrochloride.

    Mild transient diarrhea, polycythemia vera, itching, transitory exanthema and the feeling of swelling of the entire body have been associated with cyanocobalamin.

  • DIRECTIONS FOR USE (Adults)

    1 tablet daily or as directed by a licensed medical practitioner.

  • HOW SUPPLIED

    Supplied as round, pink tablets imprinted with "V353," dispensed in bottles of 100 tablets.

    76439-353-10

  • STORAGE

    Store at controlled room temperature 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.

    Call your licensed medical practitioner about side effects. You may report side effects by calling Virtus at 1-855-255-6076.

    KEEP OUT OF REACH OF CHILDREN.

    Rx

    Manufactured for:
    Virtus Pharmaceuticals OPCO II, LLC
    Nashville, TN 37217
    1-855-255-6076

    Made in USA

    Rev. 06/2018

  • PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Label

    100 Tablet Bottle Label

    VIRTUS®
    PHARMACEUTICALS OPCO II

    76439-353-10

    Virt-Gard

    Prescription Folic Acid-Containing
    Dietary Supplement

    Rx
    100 Tablets
    Made in USA

  • INGREDIENTS AND APPEARANCE
    VIRT-GARD 
    pyridoxine hydrochloride, folic acid, and cyanocobalamin tablet
    Product Information
    Product TypeDIETARY SUPPLEMENTItem Code (Source)NHRIC:76439-353
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE25 mg
    FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID2.2 mg
    CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN1 mg
    Inactive Ingredients
    Ingredient NameStrength
    DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    POLYDEXTROSE (UNII: VH2XOU12IE)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TALC (UNII: 7SEV7J4R1U)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NHRIC:76439-353-10100 in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Dietary Supplement09/30/2015
    Supplement Facts
    Serving Size : Serving per Container :
    Amount Per Serving% Daily Value
    color
    size (solid drugs)10 mm
    shape
    scoring1
    imprint
    Labeler - Virtus Pharmaceuticals (079659493)
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