SPL Set ID: 134e76f0-45cf-47eb-b6e1-cdb3bb522a0a

1 drug(s) with this SPL Set ID

Open DailyMed details

Paroxetine PAROXETINE
#42 10 mg/5 ml Suspension
ANI PHARMACEUTICALS, INC. FDA Rx Only

Paroxetine Oral Suspension contains paroxetine hydrochloride, an SSRI. It is the hydrochloride salt of a phenylpiperidine compound identified chemically as (-)- trans -4 R -(4'-fluorophenyl)-3 S -[(3',4'­methylenedioxyphenoxy) methyl] piperidine hydrochloride hemihydrate and has the empirical formula of C 19 H 20 FNO 3 •HCl•1/2H 2 O. The molecular weight is 374.8 (329.4 as free base). The structural formula of paroxetine hydrochloride is: Paroxetine hydrochloride is an odorless, off-white powder, having a melting point range of 120° to 138°C and a solubility of 5.4 mg/mL in water. Paroxetine Oral Suspension Paroxetine Oral Suspension is for oral administration. Each 5 mL contains 10 mg of paroxetine equivalent to 11.1 mg of paroxetine hydrochloride. Inactive ingredients consist of polacrilin potassium, microcrystalline cellulose, carboxymethyl cellulose sodium, propylene glycol, glycerin, sorbitol, methylparaben, propylparaben, sodium citrate dihydrate, citric acid anhydrous, sodium saccharin, orange flavor (triacetin, propylene glycol, natural and artificial flavor), FD&C Yellow No. 6, simethicone emulsion and purified water. structure

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