paroxetine hydrochloride 40 MG Oral Tablet
1 INDICATIONS AND USAGE Paroxetine tablets are indicated in adults for the treatment of: • Major depressive disorder (MDD) • Obsessive compulsive disorder (OCD) • Panic disorder (PD) • Social anxiety disorder (SAD) • Generalized anxiety disorder (GAD) • Posttraumatic stress disorder (PTSD) Paroxetine tablets are a selective serotonin reuptake inhibitor (SSRI) indicated in adults for the treatment of ( 1 ): • Major Depressive Disorder (MDD) • Obsessive Compulsive Disorder (OCD) • Panic Disorder (PD) • Social Anxiety Disorder (SAD) • Generalized Anxiety Disorder (GAD) • Posttraumatic Stress Disorder (PTSD)
Mylan Pharmaceuticals Inc.
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16 HOW SUPPLIED/STORAGE AND HANDLING Paroxetine Tablets, USP are available containing paroxetine hydrochloride, USP (hemihydrate) equivalent to 10 mg, 20 mg, 30 mg or 40 mg of paroxetine. The 10 mg tablets are blue, film-coated, modified capsule-shaped, scored tablets debossed with M on one side of the tablet and N to the left of the score and 1 to the right of the score on the other side. They are available as follows: NDC 0378-7001-93 bottles of 30 tablets NDC 0378-7001-10 bottles of 1000 tablets The 20 mg tablets are blue, film-coated, modified capsule-shaped, scored tablets debossed with M on one side of the tablet and N to the left of the score and 2 to the right of the score on the other side. They are available as follows: NDC 0378-7002-93 bottles of 30 tablets NDC 0378-7002-10 bottles of 1000 tablets The 30 mg tablets are blue, film-coated, round, unscored tablets debossed with M over N3 on one side of the tablet and blank on the other side. They are available as follows: NDC 0378-7003-93 bottles of 30 tablets NDC 0378-7003-10 bottles of 1000 tablets The 40 mg tablets are blue, film-coated, round, unscored tablets debossed with M over N4 on one side of the tablet and blank on the other side. They are available as follows: NDC 0378-7004-93 bottles of 30 tablets NDC 0378-7004-10 bottles of 1000 tablets Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. PHARMACIST: Dispense a Medication Guide with each prescription.
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