naratriptan 1 MG Oral Tablet
1 INDICATIONS AND USAGE Naratriptan tablets USP are indicated for the acute treatment of migraine with or without aura in adults. Limitations of Use: • Use only if a clear diagnosis of migraine has been established. If a patient has no response to the first migraine attack treated with naratriptan tablets USP, reconsider the diagnosis of migraine before naratriptan tablets USP are administered to treat any subsequent attacks. • Naratriptan tablets USP are not indicated for the prevention of migraine attacks. • Safety and effectiveness of naratriptan tablets USP have not been established for cluster headache. Naratriptan Tablets USP are a serotonin (5-HT 1B/1D ) receptor agonist (triptan) indicated for the acute treatment of migraine with or without aura in adults. ( 1 ) Limitations of Use: • Use only if a clear diagnosis of migraine has been established. ( 1 ) • Not indicated for the prophylactic therapy of migraine attacks. ( 1 ) • Not indicated for the treatment of cluster headache. ( 1 )
Teva Pharmaceuticals USA Inc
SEMI-CIRCLE GREY 8522 93
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Teva Pharmaceuticals USA Inc
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16 HOW SUPPLIED/STORAGE AND HANDLING Naratriptan Tablets USP are available as: 1 mg – light gray, D-shaped, film-coated tablets, debossed with “93” on one side of the tablet, and “8522” on the other side of the tablet, in unit-of-use blisters of 9 (NDC 0093-8522-90). 2.5 mg – green, D-shaped, film-coated tablets, debossed with “93” on one side of the tablet, and “8523” on the other side of the tablet, in unit-of-use blisters of 9 (NDC 0093-8523-90). Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].
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