allopurinol 300 MG Oral Tablet
1 INDICATIONS AND USAGE Allopurinol Tablets are indicated for: The management of adults with signs and symptoms of primary or secondary gout (acute attacks, tophi, joint destruction, uric acid lithiasis, and/or nephropathy) The management of adult and pediatric patients with leukemia, lymphoma and solid tumor malignancies who are receiving cancer therapy which causes elevations of serum and urinary uric acid levels The management of adult patients with recurrent calcium oxalate calculi whose daily uric acid excretion exceeds 800 mg/day in male patients and 750 mg/day in female patients, despite lifestyle changes (such as reduction of dietary sodium, non-dairy animal protein, oxylate rich foods, refined sugars and increases in oral fluids and fruits and vegetables) Limitations of Use Allopurinol Tablets are not recommended for the treatment of asymptomatic hyperuricemia. Allopurinol Tablets is a xanthine oxidase inhibitor indicated for the management of: Adult patients with signs and symptoms of primary or secondary gout (acute attacks, tophi, joint destruction, uric acid lithiasis, and/or nephropathy) ( 1 ) Adult and pediatric patients with leukemia, lymphoma and solid tumor malignancies who are receiving cancer therapy which causes elevations of serum and urinary uric acid levels ( 1 ) Adult patients with recurrent calcium oxalate calculi whose daily uric acid excretion exceeds 800 mg/day in male patients and 750 mg/day in female patients, despite lifestyle changes ( 1 ) Limitations of Use Allopurinol Tablets is not recommended for the treatment of asymptomatic hyperuricemia. ( 1 )
Actavis Pharma, Inc.
ROUND ORANGE DAN DAN 5544
DAN DAN 5544 ROUND ORANGE
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16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied
ALLOPURINOL Tablets is available in multiple tablet strengths and package sizes (bottles with child-resistant caps) as listed in Table 4. TABLE 4:
ALLOPURINOL Tablet Presentations Tablet Strength Tablet Description Package Sizes (NDC) 100 mg round, flat-faced, beveled, scored, white tablets imprinted with “ DAN DAN ” on one side and “ 5543 ” on the other side Bottles of: 100 tablets (NDC 0591-5543-01) 1,000 tablets (NDC 0591-5543-10) 300 mg round, standard convex, scored, orange tablets imprinted with “ DAN DAN ” on one side and “ 5544 ” on the other side Bottles of: 100 tablets (NDC 0591-5544-01) 500 tablets (NDC 0591-5544-05) Storage and Handling Store at 20°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature]. Protect from light. Dispense in a tight, light-resistant container with child-resistant closure.
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