SPL Set ID: d315e0da-f829-408b-be5d-2bca2e06913c

Paroxetine extended-release tablets USP contains paroxetine hydrochloride, an SSRI. It is the hydrochloride salt of a phenylpiperidine compound identified chemically as (-)-(3 S , 4 R )-4-(p-Fluorophenyl)-3-([(3,4 methylenedioxy) phenoxy]methyl)piperidine hydrochloride hemihydrate and has the empirical formula of C 19 H 21 ClFNO 3 •1/2H 2 O. The molecular weight is 374.83. The structural formula of paroxetine hydrochloride USP is: Paroxetine hydrochloride USP is a white or almost white, crystalline powder. Paroxetine extended-release tablets USP are intended for oral administration. Each film-coated, extended-release tablet contains paroxetine hydrochloride hemihydrate USP equivalent to paroxetine 12.5 mg, 25 mg and 37.5 mg. Inactive ingredients consist of aluminum oxide, colloidal silicon dioxide, hydrogenated vegetable oil, hypromelloses, iron oxide black, lactose monohydrate, magnesium stearate, methacrylic acid co-polymer dispersion, microcrystalline cellulose, polyethylene glycols, povidone, propylene glycol, shellac glaze, talc, titanium dioxide, triacetin and triethyl citrate. The 12.5 mg tablets also contain D&C Yellow No. 10 Aluminum Lake, FD&C Yellow No. 5 Aluminum Lake (tartrazine) and FD&C Yellow No. 6 Aluminum Lake. The 25 mg tablets also contain D&C Red No. 30 Aluminum Lake and FD&C Blue No. 2 Aluminum Lake. The 37.5 mg tablets also contain FD&C Blue No. 1 Aluminum Lake. USP Dissolution Test is Pending. Image