febuxostat 80 MG Oral Tablet
1 INDICATIONS AND USAGE Febuxostat tablets are a xanthine oxidase (XO) inhibitor indicated for the chronic management of hyperuricemia in adult patients with gout who have an inadequate response to a maximally titrated dose of allopurinol, who are intolerant to allopurinol, or for whom treatment with allopurinol is not advisable. For the safe and effective use of allopurinol, see allopurinol prescribing information. Limitations of Use: Febuxostat tablets are not recommended for the treatment of asymptomatic hyperuricemia. Febuxostat tablets are a xanthine oxidase (XO) inhibitor indicated for the chronic management of hyperuricemia in adult patients with gout who have an inadequate response to a maximally titrated dose of allopurinol, who are intolerant to allopurinol, or for whom treatment with allopurinol is not advisable. ( 1 ) For the safe and effective use of allopurinol, see allopurinol prescribing information. Limitations of Use: Febuxostat tablets are not recommended for the treatment of asymptomatic hyperuricemia. ( 1 )
Mylan Pharmaceuticals Inc.
OVAL WHITE M FX2
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febuxostat 40 MG Oral Tablet
Mylan Pharmaceuticals Inc.
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16 HOW SUPPLIED/STORAGE AND HANDLING Febuxostat Tablets are available containing 40 mg or 80 mg of febuxostat. The 40 mg tablets are white to off-white, film-coated, round, unscored tablets debossed with M on one side of the tablet and FX1 on the other side. They are available as follows: NDC 0378-3925-93 bottles of 30 tablets NDC 0378-3925-77 bottles of 90 tablets NDC 0378-3925-05 bottles of 500 tablets The 80 mg tablets are white to off-white, film-coated, oval, unscored tablets debossed with M on one side of the tablet and FX2 on the other side. They are available as follows: NDC 0378-3926-93 bottles of 30 tablets NDC 0378-3926-77 bottles of 90 tablets NDC 0378-3926-05 bottles of 500 tablets Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. PHARMACIST: Dispense a Medication Guide with each prescription.
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