Naproxen sodium 500 MG Sumatriptan 85 MG Oral Tablet
1 INDICATIONS AND USAGE Sumatriptan and naproxen sodium tablets are indicated for the acute treatment of migraine with or without aura in adults and pediatric patients 12 years of age and older. Limitations of Use • Use only if a clear diagnosis of migraine headache has been established. If a patient has no response to the first migraine attack treated with sumatriptan and naproxen sodium tablets, reconsider the diagnosis of migraine before sumatriptan and naproxen sodium tablets are administered to treat any subsequent attacks. • Sumatriptan and naproxen sodium tablets are not indicated for the prevention of migraine attacks. • Safety and effectiveness of sumatriptan and naproxen sodium tablets have not been established for cluster headache. Sumatriptan and naproxen sodium tablets are a combination of sumatriptan, a serotonin (5-HT) 1b/1d receptor agonist (triptan), and naproxen sodium, a nonsteroidal anti-inflammatory drug, indicated for the acute treatment of migraine with or without aura in adults and pediatric patients 12 years of age and older. ( 1 ) Limitations of Use : • Use only if a clear diagnosis of migraine headache has been established. ( 1 ) • Not indicated for the prophylactic therapy of migraine attacks. ( 1 ) • Not indicated for the treatment of cluster headache. ( 1 )
Mylan Pharmaceuticals Inc.
OVAL WHITE M N S
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16 HOW SUPPLIED/STORAGE AND HANDLING Sumatriptan and Naproxen Sodium Tablets are available containing 119 mg of sumatriptan succinate, USP equivalent to 85 mg of sumatriptan and 500 mg of naproxen sodium, USP. The 85 mg/500 mg tablets are white, film-coated, oblong, unscored tablets debossed with M on one side of the tablet and N-S on the other side. They are available as follows: NDC 0378-8755-59 bottles of 9 tablets Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Do not repackage; dispense and store in original container with desiccant. PHARMACIST: Dispense a Medication Guide with each prescription.
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