relpax eletriptan hydrobromide 40 mg
1 INDICATIONS AND USAGE RELPAX is 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 RELPAX, reconsider the diagnosis of migraine before RELPAX is administered to treat any subsequent attacks. • RELPAX is not intended for the prevention of migraine attacks. • Safety and effectiveness of RELPAX have not been established for cluster headache. RELPAX is 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 )
viatris specialty llc
ROUND ORANGE REP 40 VLE
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relpax eletriptan hydrobromide 20 mg
viatris specialty llc
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16 HOW SUPPLIED/STORAGE AND HANDLING RELPAX Tablets containing 20 mg or 40 mg eletriptan (base) as the hydrobromide salt. RELPAX Tablets are orange, round, convex shaped, film-coated tablets with appropriate debossing. They are supplied in the following strengths and package configurations: RELPAX Tablets Package Configuration Tablet Strength (mg) NDC Code Debossing Carton of 6 tablets One blister of 6 tablets in a carton. 20 mg 58151-367-56 REP 20 on one side and VLE on the other side Carton of 6 tablets One blister of 6 tablets in a carton. 40 mg 58151-368-56 REP 40 on one side and VLE on the other side Carton of 12 tablets. Two blisters of 6 tablets in each carton. 40 mg 58151-368-96 REP 40 on one side and VLE on the other side Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].
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