Mirtazapine OD Tabs / 15 mg / 5 √ó 6 unit dosage forms

Mirtazapine OD Tabs

15 mg / 5 √ó 6 unit dosage forms
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Brand name: Remeron SolTab®

Mirtazapine Orally Disintegrating Tablets, USP are indicated for the treatment of major depressive disorder.

For more information please see the prescribing information.

Suicidality and Antidepressant Drugs: Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of mirtazapine orally disintegrating tablets or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Mirtazapine orally disintegrating tablets are not approved for use in pediatric patients. (See WARNINGS: Clinical Worsening and Suicide Risk, PRECAUTIONS: Information for Patients, and PRECAUTIONS: Pediatric Use)

For more information please see the prescribing information on DailyMed.

Product Information
Product Name Mirtazapine OD Tabs
Strength 15 mg
Strength 15 mg
Dosage Form Orally Disintegrating Tablets
Pack Size 5 √ó 6 unit dosage forms
NDC 57237-011-06
OTC/Rx Rx
TE Code AB
Product Characteristics
Color White
Shape Round (Embossed Circular Edge)
Gluten Free from Gluten
Lactose This product contains Lactose as an inactive ingredient in the formulation and is derived from animal milk
Sweeteners Free from Sweeteners
Soy Free from Soy
Gelatin Free from Gelatin
Allergen Info Free from Allergen
Other Product Info Contains Lactose as an inactive ingredient in the formulation and is derived from animal milk
Other Information
Inactive Ingredients

mannitol, aspartame, natural and artificial peppermint flavor, strawberry guarana flavor, crospovidone, magnesium stearate, colloidal silicon dioxide, and microcrystalline cellulose

Imprint/Markings 36;A
Special Instructions

Store at 20°C – 25°C (68°F – 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Product Shelf Life 36 months

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