eszopiclone tablet

1 INDICATIONS AND USAGE Eszopiclone Tablets are indicated for the treatment of insomnia. In controlled outpatient and sleep laboratory studies, Eszopiclone Tablets administered at bedtime decreased sleep latency and improved sleep maintenance. The clinical trials performed in support of efficacy were up to 6 months in duration. The final formal assessments of sleep latency and maintenance were performed at 4 weeks in the 6-week study (adults only), at the end of both 2-week studies (elderly only) and at the end of the 6-month study (adults only). Eszopiclone Tablets are indicated for the treatment of insomnia. Eszopiclone Tablets have been shown to decrease sleep latency and improve sleep maintenance ( 1 )

roxane laboratories, inc.

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

9 years ago

ROUND WHITE 54 396

9 years ago

54 396 ROUND WHITE

16 HOW SUPPLIED/STORAGE AND HANDLING Eszopiclone Tablets, USP are round, white, biconvex, film-coated tablets and are supplied as follows: The 1 mg tablets are debossed with product identification “54” over “746” on one side and plain on the other side. NDC 0054-0290-13 1 mg, bottle of 30 NDC 0054-0290-25 1 mg, bottle of 100 The 2 mg tablets are debossed with product identification “54” over “029” on one side and plain on the other side. NDC 0054-0291-25 2 mg, bottle of 100 The 3 mg tablets are debossed with product identification “54” over “396” on one side and plain on the other side. NDC 0054-0292-25 3 mg, bottle of 100 Storage Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]

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eszopiclone tablet

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

ROUND WHITE 54 396

54 396 ROUND WHITE

More pills like ROUND 54 396

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