ramelteon
1 INDICATIONS AND USAGE Ramelteon tablets are indicated for the treatment of insomnia characterized by difficulty with sleep onset. The clinical trials performed in support of efficacy were up to six months in duration. The final formal assessments of sleep latency were performed after two days of treatment during the crossover study (elderly only), at five weeks in the six month studies (adults and elderly), and at the end of the six month study (adults and elderly) [see Clinical Studies (14) ] . Ramelteon tablets are indicated for the treatment of insomnia characterized by difficulty with sleep onset. ( 1 )
Upsher-Smith Laboratories, LLC
ROUND YELLOW AC 414
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16 HOW SUPPLIED/STORAGE AND HANDLING
RAMELTEON tablets are available as yellow, round shaped film coated tablets, debossed with "AC 414" on one side and plain on other side, in the following quantities: NDC 0832-1250-30 Bottles of 30 NDC 0832-1250-11 Bottles of 100 Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Keep container tightly closed and protected from moisture and humidity.
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