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Tablet
Files
Ramelteon
Strength: 8mg
Count: 50
NDC
50268-708-15
Class
Rx
Brand Name
Rozerem
Imprint Code
R;8
Color(s)
ORANGE (Pale Orange-Yellow)
Shape
ROUND
Score
no score
Case Count
NA
Inactive Ingredients
hydroxypropyl cellulose, hypromellose, iron oxide red, iron oxide yellow, lactose monohydrate, magnesium stearate, pregelatinized corn starch, titanium dioxide, and triacetin.
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 week studies (adults and elderly), and at the end of the six month study (adults and elderly)
