eletriptan 20 MG Oral Tablet
1 INDICATIONS AND USAGE Eletriptan hydrobromide tablets are indicated for the acute treatment of migraine with or without aura in adults. L i m itati o n s 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 eletriptan hydrobromide tablets, reconsider the diagnosis of migraine before eletriptan hydrobromide tablets are administered to treat any subsequent attacks. Eletriptan hydrobromide tablets are not intended for the prevention of migraine attacks. Safety and effectiveness of eletriptan hydrobromide tablets have not been established for cluster headache. Eletriptan hydrobromide tablets 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 after a clear diagnosis of migraine has been established (1) Not indicated for the prophylactic therapy of migraine (1) Not indicated for the treatment of cluster headache (1)
Amneal Pharmaceuticals LLC
ROUND YELLOW AN 42
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16 HOW SUPPLIED/STORAGE AND HANDLING
ELETRIPtan HYDROBROMIDE tablets, 20 mg are light yellow to yellow colored, round shaped, biconvex, film-coated tablets, debossed with “AN” on one side and “42” on other side. Each tablet contains 20 mg of eletriptan (base) as the hydrobromide salt. They are available as follows: Bottles of 30: NDC 65162-042-03 Carton of 6 tablets: NDC 65162-042-80 (Packages of 6 unit doses, 1 card of 6 tablets each)
ELETRIPtan HYDROBROMIDE tablets, 40 mg are light orange to dark yellow colored, round shaped, biconvex, film coated tablets, debossed with “AN” on one side and “43” on other side. Each tablet contains 40 mg of eletriptan (base) as the hydrobromide salt. They are available as follows: Bottles of 30: NDC 65162-043-03 Carton of 6 tablets: NDC 65162-043-80 (Packages of 6 unit doses, 1 card of 6 tablets each) Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].
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