Label: ONEVITE tablet

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

Drug Label Information

Updated June 14, 2019

If you are a consumer or patient please visit this version.

  • STATEMENT OF IDENTITY

    Each Tablet Contains:

    tab1

    Other Ingredients: Di calcium phosphate, microcrystalline cellulose, croscarmellose sodium, stearic acid, silicon dioxide, titanium dioxide, PEG 8000, magnesium stearate, talc, HPMC E15 & HPMC E5/E6

  • WARNINGS

    INDICATIONS AND USAGE

    ONEvite Tablets is an orally administered prescription vitamin supplement specifically formulated for the clinical dietary management of patients with unique nutritional needs requiring, increased folate levels and nutritional supplementation in physiologically stressful conditions. As well as for maintenance of good health and beneficial in maintaining overall skin health, also help maintain healthy blood sugar levels and help promote nerve health and function including normal vision.

    CONTRAINDICATIONS

    ONEvite Tablets is contraindicated in patients with hypersensitivity to any of its components.    Folic Acid is contraindicated in patients with untreated and uncomplicated pernicious anemia, and in those with anaphylactic sensitivity to folic acid.

    Cyanocobalamin is contraindicated in patients with sensitivity to cobalt or to cyanocobalamin (Vitamin B12).

    WARNING/PRECAUTIONS

    Vitamin D supplementation should be used with caution in those with hypercalcemia or conditions that may lead to hypercalcemia such as hyperparathyroidism and those who form calcium-containing kidney stones. High doses of vitamin D can lead to elevated levels of calcium that reside in the blood and soft tissues. Bone pain, high blood pressure, formation of kidney stones, renal failure, and increased risk of heart disease can occur.

    Folic acid, especially in doses above 0.1 mg daily, may obscure pernicious anemia, in that hematologic remission may occur while neurological manifestations remain progressive.

    The use of folic acid doses above 1 mg daily may precipitate or exacerbate the neurological damage of vitamin B12 deficiency.

    Avoid Over dosage. Keep out of the reach of children.

    Drug Interactions

    High doses of folic acid may result in decreased serum levels of anticonvulsant drugs.

    Vitamin D supplementation should not be given with large amounts of calcium in those with hypercalcemia or conditions that may lead to hypercalcemia such as hyperparathyroidism and those who form calcium-containing kidney stones.

    Consult appropriate references for additional specific vitamin-drug interactions.

    Information for Patients

    Patients should be counseled to disclose all medical conditions, including use of all medications, vitamins and supplements, pregnancy, and breastfeeding.

    Pediatric Use

    Not recommended for pediatric use.

    ADVERSE REACTIONS

    Adverse reactions have been reported with specific vitamins and minerals, but generally at levels substantially higher than those in ONEvite Tablets

    DOSAGE AND ADMINISTRATION

    ONEvite Tablets is a white film coating with caplet shape.

    One tablet daily or as directed by a physician.

  • HEALTH CLAIM

    HOW SUPPLIED

    ONEvite Tablets available 90 tablets per bottle,

    70898-198-09

    Store at room temperature 15°-30°C (59°-86°F). Avoid excessive heat and moisture.

    To report a serious adverse event or obtain product information, call 631-524-5758

    Manufactured for:

    Neomed Pharmaceutical

    Brentwood, NY 11717

    www.neomedpharmaceutical.com

    MADE IN USA

    DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    ONEVITE 
    onevite tablet
    Product Information
    Product TypeDIETARY SUPPLEMENTItem Code (Source)NHRIC:70898-198
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID125 mg
    CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL10 ug
    THIAMINE HYDROCHLORIDE (UNII: M572600E5P) (THIAMINE ION - UNII:4ABT0J945J) THIAMINE HYDROCHLORIDE1.5 mg
    RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR) RIBOFLAVIN1.7 mg
    NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE20 mg
    PYRIDOXINE (UNII: KV2JZ1BI6Z) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE12.5 mg
    FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID1000 ug
    CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN1000 ug
    BIOTIN (UNII: 6SO6U10H04) (BIOTIN - UNII:6SO6U10H04) BIOTIN300 ug
    CALCIUM PANTOTHENATE (UNII: 568ET80C3D) (PANTOTHENIC ACID - UNII:19F5HK2737) PANTOTHENIC ACID10 mg
    VITAMIN A ACETATE (UNII: 3LE3D9D6OY) (VITAMIN A - UNII:81G40H8B0T) VITAMIN A1500 ug
    VANADYL SULFATE (UNII: 6DU9Y533FA) (VANADIUM - UNII:00J9J9XKDE) VANADYL SULFATE200 ug
    .ALPHA.-LIPOIC ACID (UNII: 73Y7P0K73Y) (.ALPHA.-LIPOIC ACID - UNII:73Y7P0K73Y) .ALPHA.-LIPOIC ACID100 mg
    LUTEIN (UNII: X72A60C9MT) (LUTEIN - UNII:X72A60C9MT) LUTEIN1 mg
    Inactive Ingredients
    Ingredient NameStrength
    CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    POLYETHYLENE GLYCOL 8000 (UNII: Q662QK8M3B)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    TALC (UNII: 7SEV7J4R1U)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NHRIC:70898-198-091 in 1 PACKAGE
    190 in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    DIETARY SUPPLEMENT12/01/2018
    Supplement Facts
    Serving Size : Serving per Container :
    Amount Per Serving% Daily Value
    color
    scoring1
    shape
    size (solid drugs)4 mm
    Labeler - NEOMED PHARMACEUTICAL (048388130)