bupropion 75 mg

1 INDICATIONS AND USAGE Bupropion hydrochloride tablets are indicated for the treatment of major depressive disorder (MDD), as defined by the Diagnostic and Statistical Manual (DSM). The efficacy of bupropion hydrochloride tablets in the treatment of a major depressive episode was established in two 4-week controlled inpatient trials and one 6-week controlled outpatient trial of adult subjects with MDD [see Clinical Studies (14) ] . Bupropion hydrochloride tablets are an aminoketone antidepressant, indicated for the treatment of major depressive disorder (MDD). ( 1 )

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

6 months ago

ROUND ORANGE B 75

16 HOW SUPPLIED/STORAGE AND HANDLING

BUPROPION HYDROCHLORIDE Tablets, USP are available containing 75 mg or 100 mg of

BUPROPION HYDROCHLORIDE, USP. The 75 mg tablets are a peach, film-coated, round, biconvex, beveled edge tablet debossed with 75 on one side of the tablet and B on the other side. They are available as follows: Bottles of 100 NDC 59651-874-01 The 100 mg tablets are a light blue, film-coated, round, biconvex, beveled edge tablet debossed with 100 on one side of the tablet and B on the other side. They are available as follows: Bottles of 100 NDC 59651-875-01 Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light and moisture. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.

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