varenicline 0.5 mg

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

mylan pharmaceuticals inc.

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

7 months ago

OVAL WHITE M VT 0 5

16 HOW SUPPLIED/STORAGE AND HANDLING

VARENICLINE Tablets are available containing 0.855 mg or 1.710 mg

VARENICLINE tartrate equivalent to 0.5 mg or 1 mg

VARENICLINE free base, respectively. The 0.5 mg tablets are white, film-coated, capsule shaped, unscored tablets debossed with M on one side of the tablet and VT 0.5 on the other side. The 1 mg tablets are white, film-coated, capsule shaped, unscored tablets debossed with M on one side of the tablet and VT 1.0 on the other side. They are available as follows: Description NDC Packs Starting 4-week card: 0.5 mg x 11 tablets and 1 mg x 42 tablets NDC 0378-5091-85 Continuing 4-week card: 1 mg x 56 tablets NDC 0378-5090-85 Starting Month Box: 0.5 mg x 11 tablets and 1 mg x 42 tablets NDC 0378-5091-85 Continuing Month Box: 1 mg x 56 tablets NDC 0378-5090-85 Bottles 0.5 mg bottles of 56 tablets NDC 0378-5089-73 bottles of 500 tablets NDC 0378-5089-05 1 mg bottles of 56 tablets NDC 0378-5090-73 bottles of 500 tablets NDC 0378-5090-05 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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mylan pharmaceuticals inc.

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