VP-VITE RX (ASCORBIC ACID, THIAMINE MONONITRATE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, CYANOCOBALAMIN, BIOTIN, AND CALCIUM PANTOTHENATE) TABLET [VIRTUS PHARMACEUTICAL

VP-VITE RX (ASCORBIC ACID, THIAMINE MONONITRATE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, CYANOCOBALAMIN, BIOTIN, AND CALCIUM PANTOTHENATE) TABLET [VIRTUS PHARMACEUTICAL
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NDC 69543-356-10
Set ID fb8eb411-0bf2-4ba8-ae9a-b08f113d54d7
Category DIETARY SUPPLEMENT
Packager Virtus Pharmaceuticals
Generic Name
Product Class
Product Number
Application Number
  • HEALTH CLAIM

    69543-356-10

    Rx

    Prescription Folic Acid-Containing Dietary Supplement

  • DESCRIPTION

    VP-Vite Rx 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 C
    (ascorbic acid)
    60 mg100%
    Vitamin B1
    (thiamine mononitrate)
    1.5 mg100%
    Vitamin B2
    (riboflavin)
    1.7 mg100%
    Niacinamide
    (vitamin B3)
    20 mg100%
    Vitamin B6
    (pyridoxine HCl)
    10 mg500%
    Folic Acid1 mg250%
    Vitamin B12
    (cyanocobalamin)
    6 mcg100%
    Biotin300 mcg100%
    Pantothenic Acid
    (calcium pantothenate)
    10 mg100%

    Other Ingredients: Dicalcium Phosphate, Microcrystalline Cellulose, Stearic Acid, Magnesium Stearate, Croscarmellose Sodium, Silica, Hypromellose, Titanium Dioxide, and FD&C Yellow #5.

    Contains FD&C Yellow #5

  • INDICATIONS AND USAGE

    VP-Vite Rx is indicated for the supplemental requirements of persons with nutritional deficiencies or those who are in need of nutritional supplementation.

  • CONTRAINDICATIONS

    This product is contraindicated in persons with a known hypersensitivity to any of the ingredients.

  • PRECAUTIONS

    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).

  • PATIENT INFORMATION

    VP-Vite Rx is a prescription vitamin for use only under the direction and supervision of a licensed physician.

  • DRUG INTERACTIONS

    Pyridoxine hydrochloride should not be given to patients receiving the drug levodopa, because the action of levodopa is antagonized by pyridoxine hydrochloride. However, pyridoxine hydrochloride may be used concurrently in patients receiving a preparation containing both carbidopa and levodopa.

    Drugs which may interact with folate include:

    • Antiepileptic drugs (AED): The AED class including, but not limited to, phenytoin, carbamazepine, primidone, valproic acid, phenobarbital and lamotrigine have been shown to impair folate absorption and increase the metabolism of circulating folate. Additionally, concurrent use of folic acid has been associated with enhanced phenytoin metabolism, lowering the levels of this AED in the blood and allowing breakthrough seizures to occur.
    • Capecitabine: Folinic acid (5-formyltetrahydrofolate) may increase the toxicity of Capecitabine.
    • Cholestyramine: Reduces folic acid absorption and reduces serum folate levels.
    • Colestipol: Reduces folic acid absorption and reduces serum folate levels.
    • Cycloserine: Reduces folic acid absorption and reduces serum folate levels.
    • Dihydrofolate Reductase Inhibitors (DHFRI): DHFRIs including aminopterin, methotrexate, pyrimethamine, triamterene, and trimethoprim, block the conversion of folic acid to its active forms, and lower plasma and red blood cell folate levels.
    • Fluoxetine: Fluoxetine exerts a noncompetitive inhibition of 5-methyltetrahydrofolate active transport in the intestine.
    • Isotretinoin: Reduced folate levels have occurred in some patients taking isotretinoin.
    • Nonsteroidal Anti-inflammatory Drugs (NSAIDs): NSAIDs, including ibuprofen, naproxen, indomethacin and sulindac, have been shown to inhibit some folate-dependent enzymes in laboratory experiments.
    • Oral Contraceptives: Serum folate levels may be depressed by oral contraceptive therapy.
    • Methylprednisolone: Reduced serum folate levels have been noted after treatment with methylprednisolone.
    • Pancreatic Enzymes: Reduced folate levels have occurred in some patients taking pancreatic extracts.
    • Pentamidine: Reduced folate levels have been seen with prolonged intravenous pentamidine treatment.
    • Smoking and alcohol: Reduced serum folate levels have been noted.
    • Sulfasalazine: Inhibits the absorption and metabolism of folic acid.
    • Metformin treatment in patients with type 2 diabetes decreases serum folate.
    • Warfarin can produce significant impairment in folate status after a 6-month therapy.
  • 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

    1 tablet daily with or without food or as prescribed by a licensed medical practitioner.

  • HOW SUPPLIED

    VP-Vite Rx Supplied as round, yellow tablet imprinted with "V356" dispensed in 100 count bottles.

    69543-356-10

  • 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.

  • 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.

    KEEP OUT OF REACH OF CHILDREN

    Rx

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

    Rev. 06/15

  • PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Label

    VIRTUS
    PHARMACEUTICALS

    69543-356-10

    VP-Vite Rx

    Prescription Folic Acid-Containing
    Dietary Supplement

    Rx
    100 Tablets

    Made in the USA

    PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Label
  • INGREDIENTS AND APPEARANCE
    VP-VITE RX 
    ascorbic acid, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, biotin, and calcium pantothenate tablet
    Product Information
    Product TypeDIETARY SUPPLEMENTItem Code (Source)NHRIC:69543-356
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Ascorbic Acid (UNII: PQ6CK8PD0R) (Ascorbic Acid - UNII:PQ6CK8PD0R) Ascorbic Acid60 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) Pyridoxine10 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) Biotin300 ug
    Calcium Pantothenate (UNII: 568ET80C3D) (Pantothenic Acid - UNII:19F5HK2737, Calcium Cation - UNII:2M83C4R6ZB) Pantothenic Acid10 mg
    Inactive Ingredients
    Ingredient NameStrength
    Calcium Phosphate, Dibasic, Anhydrous (UNII: L11K75P92J)  
    Cellulose, Microcrystalline (UNII: OP1R32D61U)  
    Stearic Acid (UNII: 4ELV7Z65AP)  
    Magnesium Stearate (UNII: 70097M6I30)  
    Croscarmellose Sodium (UNII: M28OL1HH48)  
    Silicon Dioxide (UNII: ETJ7Z6XBU4)  
    Hypromelloses (UNII: 3NXW29V3WO)  
    Titanium Dioxide (UNII: 15FIX9V2JP)  
    FD&C Yellow No. 5 (UNII: I753WB2F1M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NHRIC:69543-356-10100 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)10 mm
    imprint
    Labeler - Virtus Pharmaceuticals (079659493)