Maxalt 5 MG Oral Tablet
1 INDICATIONS AND USAGE MAXALT ® and MAXALT-MLT ® are indicated for the acute treatment of migraine with or without aura in adults and in pediatric patients 6 to 17 years old. Limitations of Use MAXALT should only be used where a clear diagnosis of migraine has been established. If a patient has no response for the first migraine attack treated with MAXALT, the diagnosis of migraine should be reconsidered before MAXALT is administered to treat any subsequent attacks. MAXALT is not indicated for use in the management of hemiplegic or basilar migraine [see Contraindications (4) ] . MAXALT is not indicated for the prevention of migraine attacks. Safety and effectiveness of MAXALT have not been established for cluster headache. MAXALT is a serotonin (5-HT) 1B/1D receptor agonist (triptan) indicated for the acute treatment of migraine with or without aura in adults and in pediatric patients 6 to 17 years of age ( 1 ) Limitations of Use : Use only after 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 )
Merck Sharp & Dohme Corp.
OVAL PINK MRK 266
MRK 266 OVAL PINK
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16 HOW SUPPLIED/STORAGE AND HANDLING No. 3733 — MAXALT Tablets, 10 mg, are pale pink, capsule-shaped, compressed tablets coded MAXALT on one side and MRK 267 on the other: NDC 0006-0267-18, carton of 18 tablets. No. 3801 — MAXALT-MLT Orally Disintegrating Tablets, 10 mg, are white to off-white, round lyophilized orally disintegrating tablets debossed with a modified square on one side, and measuring 12.0-13.8 mm (side-to-side) with a peppermint flavor. Each orally disintegrating tablet is individually packaged in a blister inside an aluminum pouch (sachet). They are supplied as follows: NDC 0006-3801-18, 6 × unit of use carrying case of 3 orally disintegrating tablets (18 tablets total). Storage Store MAXALT Tablets at room temperature, 15°C-30°C (59°F-86°F). Store MAXALT-MLT Orally Disintegrating Tablets at room temperature, 15°C-30°C (59°F-86°F).
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