Sumatriptan 25 MG Oral Tablet
1 INDICATIONS AND USAGE Sumatriptan tablets are indicated for the acute treatment of migraine with or without aura in adults. 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, reconsider the diagnosis of migraine before sumatriptan tablets are administered to treat any subsequent attacks. • Sumatriptan tablets are not indicated for the prevention of migraine attacks. • Safety and effectiveness of sumatriptan tablets have not been established for cluster headache. Sumatriptan is a serotonin (5-HT 1B/1D ) receptor agonist (triptan) indicated for acute treatment of migraine with or without aura in adults. ( 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 )
Dr. Reddy's Laboratories Limited
ROUND WHITE RDY 291
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16 HOW SUPPLIED/STORAGE AND HANDLING Sumatriptan tablets USP, 25, 50, and 100 mg of sumatriptan (base) as the succinate. Sumatriptan tablets USP, 25 mg are white, round, biconvex film-coated tablets debossed with “RDY” on one side and “291” on the other side. The tablets are supplied in bottles of 30, 36, 90, 100, 500 and unit of use blister pack of 9’s and 27's. Bottles of 30 NDC 55111-291-30 Bottles of 36 NDC 55111-291-36 Bottles of 90 NDC 55111-291-90 Bottles of 100 NDC 55111-291-01 Bottles of 500 NDC 55111-291-05 Unit of use blister pack of 9 (1 x 9) NDC 55111-291-09 Unit of use blister pack of 27(3 x 9) NDC 55111-291-98 Sumatriptan tablets USP, 50 mg are white, round, biconvex film-coated tablets debossed with “RDY” on one side and “292” on the other side. The tablets are supplied in bottles of 30, 36, 90, 100, 500 and unit of use blister pack of 9’s and 27's. Bottles of 30 NDC 55111-292-30 Bottles of 36 NDC 55111-292-36 Bottles of 90 NDC 55111-292-90 Bottles of 100 NDC 55111-292-01 Bottles of 500 NDC 55111-292-05 Unit of use blister pack of 9 (1 x 9) NDC 55111-292-09 Unit of use blister pack of 27(3 x 9) NDC 55111-292-98 Sumatriptan tablets USP, 100 mg are white, capsule shaped, biconvex film-coated tablets debossed with “RDY” on one side and “293” on the other side. The tablets are supplied in bottles of 30, 36, 90, 100, 500 and unit of use blister pack of 9’s and 27's. Bottles of 30 NDC 55111-293-30 Bottles of 36 NDC 55111-293-36 Bottles of 90 NDC 55111-293-90 Bottles of 100 NDC 55111-293-01 Bottles of 500 NDC 55111-293-05 Unit of use blister pack of 9 (1 x 9) NDC 55111-293-09 Unit of use blister pack of 27(1 x 9) NDC 55111-293-98 Store at 20° to 25°C (68°to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).
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