ramelteon 8 mg

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 week 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.

i3 pharmaceuticals, llc

FDA Reported Adverse Reactions
`[1] drug ineffective` `[2] fatigue` `[3] nausea` `[4] off label use` `[5] pain` `[6] headache` `[7] dyspnoea` `[8] diarrhoea` `[9] vomiting` `[10] arthralgia`

2 years ago

ROUND YELLOW 5 I3

2 years ago

5 I3 ROUND YELLOW

16 HOW SUPPLIED/STORAGE AND HANDLING

RAMELTEON Tablets are available as round, yellow, film coated tablets debossed with "I3" on one side and "5" on the other side in the following quantities: NDC 72319-005-01 Bottles of 30 NDC 72319-005-04 Bottles of 100 NDC 72319-005-05 Bottles of 500 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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ramelteon 8 mg

i3 pharmaceuticals, llc

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ramelteon 8 mg

FDA Reported Adverse Reactions [1] drug ineffective [2] fatigue [3] nausea [4] off label use [5] pain [6] headache [7] dyspnoea [8] diarrhoea [9] vomiting [10] arthralgia

ROUND YELLOW 5 I3

5 I3 ROUND YELLOW

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ramelteon 8 mg

FDA Reported Adverse Reactions
`[1] drug ineffective` `[2] fatigue` `[3] nausea` `[4] off label use` `[5] pain` `[6] headache` `[7] dyspnoea` `[8] diarrhoea` `[9] vomiting` `[10] arthralgia`