VIRT-CAPS (ASCORBIC ACID, THIAMINE MONONITRATE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, CYANOCOBALAMIN, BIOTIN, AND CALCIUM PANTOTHENATE) CAPSULE [VIRTUS PHARMACEUTICAL

VIRT-CAPS (ASCORBIC ACID, THIAMINE MONONITRATE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, CYANOCOBALAMIN, BIOTIN, AND CALCIUM PANTOTHENATE) CAPSULE [VIRTUS PHARMACEUTICAL
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NDC 69543-260-10
Set ID 93ecc6fb-bde7-44b0-be29-7df42b26d6a0
Category DIETARY SUPPLEMENT
Packager Virtus Pharmaceuticals
Generic Name
Product Class
Product Number
Application Number
  • HEALTH CLAIM

    69543-260-10

    Rx

    Prescription Dietary Supplement

  • DESCRIPTION

    Virt-Caps is an orally administered prescription vitamin B dietary supplement formulated for the dietary management of persons who require increased amounts of folic acid and pyridoxine; it also includes vitamin C. Virt-Caps should be administered under the supervision of a licensed medical practitioner.

    Supplement Facts
    Serving Size: 1 Softgel
    Amount Per Serving% Daily Value
    Vitamin C (as ascorbic acid)100 mg167%
    Thiamine (as thiamine mononitrate)1.5 mg100%
    Riboflavin1.7 mg100%
    Niacin (as niacinamide)20 mg100%
    Vitamin B6 (as pyridoxine HCl)10 mg500%
    Folic Acid1 mg250%
    Vitamin B12 (as cyanocobalamin)6 mcg100%
    Biotin150 mcg50%
    Pantothenic Acid (as calcium pantothenate)5 mg50%

    Other Ingredients: Soybean Oil, Gelatin, Glycerin, Water, Bees Wax, Lecithin, Titanium Dioxide, FD&C Yellow #6, FD&C Red #40, and FD&C Blue #1.

    Contains Soy, FD&C Yellow #6, FD&C Red #40 and FD&C Blue #1.

  • Side Effects

    Allergic reactions have been reported following the use of oral folate.

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

    Paresthesia, somnolence, nausea, and headaches have been reported with pyridoxine.

    KEEP THIS PRODUCT OUT OF THE REACH OF CHILDREN.

  • INTERACTIONS

    Drugs which may interact with folate include but are not limited to:

    • First generation anticonvulsants (folate may reduce their effectiveness)
    • Capecitabine (folate may enhance its toxicity)
    • Fluorouracil (folate may enhance its toxicity)

    Drugs that may interfere with folate metabolism include, but are not limited to:

    • Dihydrofolate Reductase Inhibitors
    • Fluoxetine
    • Nonsteroidal Anti-inflammatory Drugs
    • Sulfasalazine
    • Warfarin

    Drugs which may interfere with the absorption of folate from the gastrointestinal tract or decrease plasma levels include, but are not limited to:

    • Cholestyramine
    • Colestipol
    • Colchicine
    • Levodopa
    • Cycloserine
    • Isotretinoin
    • Oral Contraceptives
    • Methylprednisolone
    • Pancreatic Enzymes
    • Pentamidine
    • Smoking and Alcohol
    • Sulfasalazine
    • Metformin

    Drugs which may interact with vitamin B6 include, but are not limited to:

    • Levodopa (the action of levodopa may be antagonized by vitamin B6.)

    Drugs which may interact with vitamin B12 include, but are not limited to:

    • Antibiotics, cholestyramine, colchicine, colestipol, metformin, para-aminosalicylic acid, and potassium chloride (may decrease the absorption of vitamin B12)
    • Nitrous oxide (can produce a functional vitamin B12 deficiency)
  • CONTRAINDICATIONS

    This product is contraindicated in patients with a known hypersensitivity to any of its components.

  • CAUTION

    High levels of folic acid may, especially in older adults, hide signs of vitamin B12 deficiency (such as pernicious anemia), a condition that can cause nerve damage.

  • PREGNANCY and NURSING MOTHERS

    This product contains only B and C vitamins and is not intended for use as a prenatal/postnatal multivitamin.

  • DIRECTIONS FOR USE

    One softgel daily or as directed by a licensed medical practitioner.

  • STORAGE

    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.

  • HOW SUPPLIED

    Virt-Caps is supplied as black softgels imprinted on one side with "V260" dispensed in child-resistant bottles of 100 softgels

    69543-260-10

    KEEP THIS OUT OF REACH OF CHILDREN.

    All prescriptions using this product shall be pursuant to state statutes as applicable. This is not an Orange Book product.

    Call your 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.

    Rx

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

    MADE IN USA

    Rev. 06/2015

  • PRINCIPAL DISPLAY PANEL - 100 Capsule Bottle Label

    VIRTUS
    PHARMACEUTICALS

    69543-260-10

    Virt-Caps

    Prescription Dietary Supplement

    Rx
    100 Softgels
    Made in USA

    PRINCIPAL DISPLAY PANEL - 100 Capsule Bottle Label
  • INGREDIENTS AND APPEARANCE
    VIRT-CAPS 
    ascorbic acid, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, biotin, and calcium pantothenate capsule
    Product Information
    Product TypeDIETARY SUPPLEMENTItem Code (Source)NHRIC:69543-260
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID100 mg
    THIAMINE MONONITRATE (UNII: 8K0I04919X) (THIAMINE ION - UNII:4ABT0J945J) THIAMINE1.5 mg
    RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR) RIBOFLAVIN1.7 mg
    NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE20 mg
    PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE HYDROCHLORIDE10 mg
    FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID1 mg
    CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN6 ug
    BIOTIN (UNII: 6SO6U10H04) (BIOTIN - UNII:6SO6U10H04) BIOTIN150 ug
    CALCIUM PANTOTHENATE (UNII: 568ET80C3D) (PANTOTHENIC ACID - UNII:19F5HK2737, CALCIUM CATION - UNII:2M83C4R6ZB) PANTOTHENIC ACID5 mg
    Inactive Ingredients
    Ingredient NameStrength
    SOYBEAN OIL (UNII: 241ATL177A)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NHRIC:69543-260-10100 in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    DIETARY SUPPLEMENT08/14/2015
    Supplement Facts
    Serving Size : Serving per Container :
    Amount Per Serving% Daily Value
    color
    scoring1
    shape
    size (solid drugs)15 mm
    imprint
    Labeler - Virtus Pharmaceuticals (079659493)