asenapine asenapine maleate tablet

1 INDICATIONS AND USAGE Asenapine sublingual tablets are indicated for: Schizophrenia in adults [see Clinical Studies (14.1) ] Bipolar I disorder [see Clinical Studies (14.2) ] Acute monotherapy of manic or mixed episodes, in adults and pediatric patients 10 to 17 years of age Adjunctive treatment to lithium or valproate in adults Maintenance monotherapy treatment in adults Asenapine sublingual tablets are an atypical antipsychotic indicated for ( 1 ): Schizophrenia in adults Bipolar I disorder Acute monotherapy treatment of manic or mixed episodes, in adults and pediatric patients 10 to 17 years of age Adjunctive treatment to lithium or valproate in adults Maintenance monotherapy treatment in adults

breckenridge pharmaceutical, inc.

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

4 years ago

ROUND WHITE B 5

16 HOW SUPPLIED/STORAGE AND HANDLING Asenapine sublingual tablets are supplied as: 5 mg Tablets round, white, uncoated tablets debossed "B" on one side and "1" on the other side. Child-resistant packaging Box of 60 - 6 blisters with 10 tablets NDC 51991-359-60 Hospital Unit Dose Box of 100 - 10 blisters with 10 tablets NDC 51991-359-11 10 mg Tablets round, white, uncoated tablets debossed "B" on one side and "2" on the other side. Child-resistant packaging Box of 60 - 6 blisters with 10 tablets NDC 51991-361-60 Hospital Unit Dose Box of 100 - 10 blisters with 10 tablets NDC 51991-361-11 2.5 mg Tablets, black cherry flavor white colored, round shaped, uncoated tablets debossed with "B" on one side and "5" on the other side. Child-resistant packaging Box of 60 - 6 blisters with 10 tablets NDC 51991-928-60 Hospital Unit Dose Box of 100 - 10 blisters with 10 tablets NDC 51991-928-11 5 mg Tablets, black cherry flavor round, white, uncoated tablets debossed "B" on one side and "3" on the other side. Child-resistant packaging Box of 60 - 6 blisters with 10 tablets NDC 51991-358-60 Hospital Unit Dose Box of 100 - 10 blisters with 10 tablets NDC 51991-358-11 10 mg Tablets, black cherry flavor round, white, uncoated tablets debossed "B" on one side and "4" on the other side. Child-resistant packaging Box of 60 - 6 blisters with 10 tablets NDC 51991-360-60 Hospital Unit Dose Box of 100 - 10 blisters with 10 tablets NDC 51991-360-11 Storage Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature].

More pills like ROUND B 5

Related Pills

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