rizatriptan 5 MG Oral Tablet
1 INDICATIONS AND USAGE Rizatriptan benzoate tablets are indicated for the acute treatment of migraine with or without aura in adults and in pediatric patients 6 to 17 years old. Rizatriptan benzoate tablets are 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 ) Limitations of Use Rizatriptan benzoate tablets 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 rizatriptan benzoate tablets, the diagnosis of migraine should be reconsidered before rizatriptan benzoate tablets is administered to treat any subsequent attacks. Rizatriptan benzoate tablets are not indicated for use in the management of hemiplegic or basilar migraine [see Contraindications (4) ] . Rizatriptan benzoate tablets are not indicated for the prevention of migraine attacks. Safety and effectiveness of rizatriptan benzoate tablets have not been established for cluster headache.
breckenridge pharmaceutical, inc.
OVAL PINK NAT 123
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rizatriptan benzoate 10 mg
Breckenridge Pharmaceutical, Inc.
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16 HOW SUPPLIED/STORAGE AND HANDLING Rizatriptan Benzoate Tablets, USP 5 mg, are light pink to pink-colored, capsule-shaped, biconvex, uncoated tablets with "NAT" on one side and "123" on the other side. They are supplied as follows: NDC 51991-354-99, Blister of 6 tablets NDC 51991-354-78, Carton of 18 tablets (3 × 6 blisters) unit dose tablets. Rizatriptan Benzoate Tablets, USP 10 mg, are light pink to pink-colored, capsule-shaped, biconvex, uncoated tablets with "NAT" on one side and "121" on the other side. They are supplied as follows: NDC 51991-355-99, Blister of 6 tablets NDC 51991-355-78, Carton of 18 tablets (3 × 6 blisters) unit dose tablets. Storage Store at 20° – 25°C (68° – 77°F) [See USP Controlled Room Temperature]. Dispense in a tight container, if product is subdivided.
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