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CHAMPIX (varenicline tartrate) Dosage Forms, Composition And Packaging

Dosage Forms, Composition And Packaging

CHAMPIX is supplied for oral administration in two strengths:

0.5 mg: capsular biconvex, white to off-white, film-coated tablet debossed with "Pfizer" on one side and "CHX 0.5" on the other side. Each tablet contains 0.5 mg of varenicline (as tartrate). Supplied in high-density polyethylene (HDPE) bottles of 56 tablets and in packs containing blister strips of 11 tablets.

1.0 mg: capsular biconvex, light blue film-coated tablet debossed with "Pfizer" on one side and "CHX 1.0" on the other side. Each tablet contains 1.0 mg of varenicline (as tartrate). Supplied in high-density polyethylene (HDPE) bottles of 56 tablets and in packs containing blister strips of 14 or 28 tablets.

Initial dosing pack: Includes one blister containing both 11 x 0.5 mg and 14 x 1.0 mg tablets and a second blister of 28 x 1.0 mg tablets.

Nonmedicinal ingredients are microcrystalline cellulose, anhydrous dibasic calcium phosphate, croscarmellose sodium, colloidal silicon dioxide and magnesium stearate. The film-coating contains hypromellose, titanium dioxide, polyethylene glycol and triacetin. The 1.0 mg tablet also contains FD&C Blue #2/Indigo Carmine Aluminum Lake as a colouring agent.

 

Control #: 221214
January 22, 2019

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