rufinamide 400 mg tablet film coated
1 INDICATIONS AND USAGE Rufinamide tablets are indicated for adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome in pediatric patients 1 year of age and older and in adults. Rufinamide tablets are indicated for adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome (LGS) in pediatric patients 1 year of age and older, and in adults ( 1 )
mylan pharmaceuticals inc.
OVAL PINK RU 400
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rufinamide 200 mg tablet film coated
mylan pharmaceuticals inc.
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16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied
RUFINAMIDE Tablets, USP are available containing 200 mg or 400 mg of
RUFINAMIDE, USP. The 200 mg tablets are pink, film-coated, oval, functionally scored tablets debossed with RU to the left of the score and 200 to the right of the score on one side of the tablet and a score on the other side. They are available as follows: NDC 0378-2330-91 bottles of 60 tablets NDC 0378-2330-78 bottles of 120 tablets NDC 0378-2330-05 bottles of 500 tablets The 400 mg tablets are pink, film-coated, oval, functionally scored tablets debossed with RU to the left of the score and 400 to the right of the score on one side of the tablet and a score on the other side. They are available as follows: NDC 0378-2331-91 bottles of 60 tablets NDC 0378-2331-78 bottles of 120 tablets NDC 0378-2331-05 bottles of 500 tablets 16.2 Storage and Handling Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from moisture. Replace cap securely after opening. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. PHARMACIST: Dispense a Medication Guide with each prescription.
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