Label: ARONAMIN GOLD- fursultiamine, riboflavin tetrabutyrate, pyridoxal phosphate, hydroxocobalamin acetate, ascorbic acid, tocopheryl acetate tablet, film coated
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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.
Updated December 12, 2018
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- ACTIVE INGREDIENT
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
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.
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
- DOSAGE & ADMINISTRATION
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
fursultiamine, riboflavin tetrabutyrate, pyridoxal phosphate, hydroxocobalamin acetate, ascorbic acid, tocopheryl acetate tablet, film coated
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72689-0024 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength RIBOFLAVIN TETRABUTYRATE (UNII: F211C9MSGY) (RIBOFLAVIN TETRABUTYRATE - UNII:F211C9MSGY) RIBOFLAVIN TETRABUTYRATE 2.5 mg FURSULTIAMINE (UNII: 05J61265PX) (FURSULTIAMINE - UNII:05J61265PX) FURSULTIAMINE 50 mg HYDROXOCOBALAMIN ACETATE (UNII: S535M27N3Q) (HYDROXOCOBALAMIN - UNII:Q40X8H422O) HYDROXOCOBALAMIN 5.22 ug .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) (.ALPHA.-TOCOPHEROL - UNII:H4N855PNZ1) .ALPHA.-TOCOPHEROL ACETATE 20 mg ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID 70 mg Inactive Ingredients Ingredient Name Strength 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 Color red Score no score Shape OVAL Size 16mm Flavor Imprint Code AroG Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72689-0024-1 100 in 1 BLISTER PACK; Type 0: Not a Combination Product 11/20/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 11/20/2018 Labeler - OASIS TRADING (689991468) Registrant - OASIS TRADING (689991468) Establishment Name Address ID/FEI Business Operations OASIS TRADING 689991468 manufacture(72689-0024) , label(72689-0024)