Mirtazapine 30 MG Oral Tablet
INDICATIONS AND USAGE Mirtazapine tablets, USP are indicated for the treatment of major depressive disorder. The efficacy of mirtazapine tablets, USP in the treatment of major depressive disorder was established in 6-week controlled trials of outpatients whose diagnoses corresponded most closely to the Diagnostic and Statistical Manual of Mental Disorders - 3 rd edition (DSM-III) category of major depressive disorder (see CLINICAL PHARMACOLOGY ). A major depressive episode (DSM-IV) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed or dysphoric mood that usually interferes with daily functioning, and includes at least 5 of the following 9 symptoms: depressed mood, loss of interest in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attempt, or suicidal ideation. The effectiveness of mirtazapine tablets, USP in hospitalized depressed patients has not been adequately studied. The efficacy of mirtazapine tablets, USP in maintaining a response in patients with major depressive disorder for up to 40 weeks following 8 to 12 weeks of initial open-label treatment was demonstrated in a placebo-controlled trial. Nevertheless, the physician who elects to use mirtazapine tablets, USP for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see CLINICAL PHARMACOLOGY ).
Eon Labs, Inc.
ROUND BROWN E 212
E 212 ROUND BROWN
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
HOW SUPPLIED Mirtazapine Tablets, USP, for oral administration, are available as 15 mg round, biconvex, yellow, film coated tablets, debossed " E " over "20" on one side and bisected on the other side and supplied as: NDC 0185-0020-30 bottles of 30 NDC 0185-0020-01 bottles of 100 NDC 0185-0020-05 bottles of 500 NDC 0185-0020-10 bottles of 1000 30 mg round, biconvex, red-brown, film coated tablets, debossed " E " over "212" on one side and bisected on the other side and supplied as: NDC 0185-0212-30 bottles of 30 NDC 0185-0212-01 bottles of 100 NDC 0185-0212-05 bottles of 500 NDC 0185-0212-10 bottles of 1000 45 mg round, biconvex, white, film coated tablets, debossed " E " over "222" on one side and plain on the other side and supplied as: NDC 0185-0222-30 bottles of 30 NDC 0185-0222-01 bottles of 100 NDC 0185-0222-05 bottles of 500 NDC 0185-0222-10 bottles of 1000 Storage Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light and moisture. Dispense contents in a tight, light-resistant container as defined in the USP with a child-resistant closure, as required. Protect from light and moisture. KEEP TIGHTLY CLOSED. KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
More pills like ROUND E 212