Rozerem 8 MG Oral Tablet

1 INDICATIONS AND USAGE ROZEREM is 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) ] . ROZEREM is indicated for the treatment of insomnia characterized by difficulty with sleep onset. ( 1 )

Takeda Pharmaceuticals America, Inc.

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

10 years ago

ROUND ORANGE TAK RAM 8

10 years ago

TAK RAM 8 ROUND ORANGE

16 HOW SUPPLIED/STORAGE AND HANDLING ROZEREM is available as round, pale orange-yellow, film-coated, 8 mg tablets, with "TAK" and "RAM-8" printed on one side, in the following quantities: NDC 64764-805-30 Bottles of 30 NDC 64764-805-10 Bottles of 100 NDC 64764-805-50 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.

More pills like ROUND TAK RAM 8

DISCLAIMER:

"This tool does not provide medical advice, and is for informational and educational purposes only, and is not a substitute for professional medical advice, treatment or diagnosis. Call your doctor to receive medical advice. If you think you may have a medical emergency, please dial 911."

"Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service."

"This product uses publicly available data from the U.S. National Library of Medicine (NLM), National Institutes of Health, Department of Health and Human Services; NLM is not responsible for the product and does not endorse or recommend this or any other product."

PillSync may earn a commission via links on our site

Rozerem 8 MG Oral Tablet

FDA Reported Adverse Reactions [1] drug ineffective [2] toxicity to various agents [3] nausea [4] fatigue [5] pain [6] drug abuse [7] diarrhoea [8] headache [9] off label use [10] vomiting

ROUND ORANGE TAK RAM 8

TAK RAM 8 ROUND ORANGE

More pills like ROUND TAK RAM 8

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