Bupropion Hydrochloride 75 mg

1 INDICATIONS AND USAGE Bupropion hydrochloride tablets are an aminoketone antidepressant, indicated for the treatment of major depressive disorder (MDD). ( 1 ) 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) ].

Heritage Pharmaceuticals Inc.

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

3 years ago

ROUND YELLOW 191

3 years ago

191 ROUND YELLOW

16 HOW SUPPLIED/STORAGE AND HANDLING

BUPROPION HYDROCHLORIDE Tablets USP, 75 mg are available as round, yellow colored tablets, debossed " 191 " on one side and plain on other side. They are supplied as follows: Bottles of 100: NDC 23155-191-01 Bottles of 1000: NDC 23155-191-10

BUPROPION HYDROCHLORIDE Tablets USP, 100 mg are available as round, red colored tablets, debossed " 192 " on one side and plain on other side. They are supplied as follows: Bottles of 100: NDC 23155-192-01 Bottles of 1000: NDC 23155-192-10 The tablets should be protected from light and moisture and stored at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature.] Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Keep container tightly closed. Protect from light and moisture.

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