24 HR Paroxetine Hydrochloride 25 MG Extended Release Oral Tablet
1 INDICATIONS AND USAGE Paroxetine extended-release tablets are indicated in adults for the treatment of: • Major depressive disorder (MDD) • Panic disorder (PD) • Social anxiety disorder (SAD) • Premenstrual dysphoric disorder (PMDD) Paroxetine extended-release tablets are a selective serotonin reuptake inhibitor (SSRI) indicated in adults for the treatment of ( 1 ): • Major Depressive Disorder (MDD) • Panic Disorder (PD) • Social Anxiety Disorder (SAD) • Premenstrual Dysphoric Disorder (PMDD)
Mylan Pharmaceuticals Inc.
ROUND PURPLE M P4
M P4 ROUND PURPLE
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16 HOW SUPPLIED/STORAGE AND HANDLING Paroxetine Extended-Release Tablets, USP are available containing paroxetine hydrochloride (hemihydrate) USP, equivalent to 12.5 mg, 25 mg or 37.5 mg paroxetine. The 12.5 mg tablets are white, enteric film-coated, round, unscored tablets with M over P3 imprinted in black ink on one side of the tablet and blank on the other side. They are available as follows: NDC 0378-2003-93 bottles of 30 tablets The 25 mg tablets are Lavender, enteric film-coated, round, unscored tablets with M over P4 imprinted in black ink on one side of the tablet and blank on the other side. They are available as follows: NDC 0378-2004-93 bottles of 30 tablets The 37.5 mg tablets are orange, enteric film-coated, round, unscored tablets with M over P5 imprinted in black ink on one side of the tablet and blank on the other side. They are available as follows: NDC 0378-2005-93 bottles of 30 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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