varenicline tartrate 0.5 mg

1 INDICATIONS AND USAGE Varenicline tablets are indicated for use as an aid to smoking cessation treatment. Varenicline is a nicotinic receptor partial agonist indicated for use as an aid to smoking cessation treatment. ( 1 and 2.1 )

par pharmaceutical, inc.

FDA Reported Adverse Reactions
`[1] drug ineffective` `[2] nausea` `[3] diarrhoea` `[4] fatigue` `[5] dyspnoea` `[6] off label use` `[7] acute kidney injury` `[8] pyrexia` `[9] death` `[10] renal failure`

2 years ago

ROUND WHITE P 155

16 HOW SUPPLIED/STORAGE AND HANDLING Varenicline tablets are supplied for oral administration in two strengths: a 0.5 mg circular, biconvex, white to off-white film-coated tablets, debossed with “P” on one side and “155” on other side and a 1 mg circular, biconvex, light blue film-coated tablets, debossed with “P” on one side and “156” on other side. Varenicline tablets are supplied in the following package configurations: Description NDC Packs Starting 4-week card: 0.5 mg x 11 tablets and 1 mg x 42 tablets NDC 49884-944-99 Starting Month Box: 0.5 mg x 11 tablets and 1 mg x 42 tablets NDC 49884-944-99 Continuing 4-week card: 1 mg x 56 tablets NDC 49884-156-52 Continuing Month Box: 1 mg x 56 tablets NDC 49884-156-52 Bottles 0.5 mg - bottle of 56 NDC 49884-155-76 1 mg - bottle of 56 NDC 49884-156-76 Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

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