Label: ARONAMIN GOLD- fursultiamine, riboflavin tetrabutyrate, pyridoxal phosphate, hydroxocobalamin acetate, ascorbic acid, tocopheryl acetate tablet, film coated

  • Category: HUMAN OTC DRUG LABEL

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.

Drug Label Information

Updated December 12, 2018

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  • ACTIVE INGREDIENT

    Fursultiamine(Active vitamin B1) 50.0mg
    Riboflavin tetrabutyrate(Active vitamin B2) 2.5mg
    Pyridoxal phosphate(Active vitamin B6) 2.5mg
    Hydroxocobalamin acetate(Active vitamin B12) 5.22μg
    Ascorbic acid(Vitamin C) 70mg
    Tocopheryl acetate(Vitamin E) 20.0mg

  • PURPOSE

    Vitamines, Mineral & nutrients

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

  • INDICATIONS & USAGE

    Adults: take 1 tablet twice a day.

  • WARNINGS

    1) Do not take this medicine.

    (1) Patients with hypersensitivity reactions to NSAIDs and the components contained in NSAIDs

    (2) Infants under three months of age

    (3) Because this drug contains lactose, patients with genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption Do not administer.

    2) Do not take the following medicine while taking this medicine.

    (1) levodopa

    3) Consult a doctor, dentist or pharmacist before taking this medicine.

    (1) Patients receiving medical treatment

    (2) patients with hyperoxaluria (excessive urinary excretion of urine)

    (3) Pregnant women and possibly pregnant women, lactating women, premature infants, infants

    (4) Patients with gout or kidney stones

    4) Stop taking this drug immediately and consult a doctor, dentist, or pharmacist if you: Whenever possible, bring this attached document with you.

    (1) If you have any of the following symptoms

    Stomach discomfort, diarrhea, constipation, rash, fever, nausea, vomiting, dilated stool, stomatitis (mouth salt), anorexia, abdominal bloating

    (2) Administration of this drug may result in faster or more frequent menstruation, and bleeding may last for a long time.

    (3) The risk of thrombosis may be increased if a woman taking an oral contraceptive containing estrogen or a patient with thrombotic placenta is taking vitamin E.

    (4) Long-term administration of high doses may result in resistance.

    (5) Prolonged use of pyridoxine at a dose of 500 mg to 2 g / day may result in neuropathy or neuropathy (functional disorder or pathologic changes) in the peripheral nervous system.

    (6) Hematologic adverse events may occur when vitamin B12 is administered at a dose of 10 μg or more per day in patients with insufficient folic acid.

    5) Other Precautions for Taking

    (1) Keep the prescribed dosage and dosage.

    (2) it may interfere with the detection of blood glucose during various urine tests

    (3) The urine may turn yellow, which may affect the clinical examination

    6) Storage Precautions

    (1) Keep out of the reach of children.

    (2) Avoid direct sunlight. Store in a cool, dry place.

    (3) To prevent misuse (misuse) and to preserve quality, please do not put in another container.

  • INACTIVE INGREDIENT

    Microcrystalline Cellulose, Magnesium Stearate, Crospovidone, Copovidone, Colloidal Silicon Dioxide, OY-25014, OY-S-29019

  • DOSAGE & ADMINISTRATION

    For oral use only

  • PRINCIPAL DISPLAY PANEL

    1

  • INGREDIENTS AND APPEARANCE
    ARONAMIN GOLD 
    fursultiamine, riboflavin tetrabutyrate, pyridoxal phosphate, hydroxocobalamin acetate, ascorbic acid, tocopheryl acetate tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72689-0024
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    RIBOFLAVIN TETRABUTYRATE (UNII: F211C9MSGY) (RIBOFLAVIN TETRABUTYRATE - UNII:F211C9MSGY) RIBOFLAVIN TETRABUTYRATE2.5 mg
    FURSULTIAMINE (UNII: 05J61265PX) (FURSULTIAMINE - UNII:05J61265PX) FURSULTIAMINE50 mg
    HYDROXOCOBALAMIN ACETATE (UNII: S535M27N3Q) (HYDROXOCOBALAMIN - UNII:Q40X8H422O) HYDROXOCOBALAMIN5.22 ug
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) (.ALPHA.-TOCOPHEROL - UNII:H4N855PNZ1) .ALPHA.-TOCOPHEROL ACETATE20 mg
    ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID70 mg
    Inactive Ingredients
    Ingredient NameStrength
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    COPOVIDONE K25-31 (UNII: D9C330MD8B)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSPOVIDONE (UNII: 2S7830E561)  
    Product Characteristics
    ColorredScoreno score
    ShapeOVALSize16mm
    FlavorImprint Code AroG
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72689-0024-1100 in 1 BLISTER PACK; Type 0: Not a Combination Product11/20/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other11/20/2018
    Labeler - OASIS TRADING (689991468)
    Registrant - OASIS TRADING (689991468)
    Establishment
    NameAddressID/FEIBusiness Operations
    OASIS TRADING689991468manufacture(72689-0024) , label(72689-0024)