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

ARONAMIN GOLD by

Drug Labeling and Warnings

ARONAMIN GOLD by is a Otc medication manufactured, distributed, or labeled by OASIS TRADING. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

ARONAMIN GOLD 
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)