PAXIL Film‑coated tablet / Oral suspension Ref.[10593] Active ingredients: Paroxetine

Source: FDA, National Drug Code (US)  Revision Year: 2020 

Product description

PAXIL (paroxetine hydrochloride) is an orally administered psychotropic drug. It is the hydrochloride salt of a phenylpiperidine compound identified chemically as ()trans4R(4'-fluorophenyl)3S[(3',4'-methylenedioxyphenoxy) methyl] piperidine hydrochloride hemihydrate and has the empirical formula of C19H20FNO3•HCl•1/2H2O. 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.

Tablets

Each film‑coated tablet contains paroxetine hydrochloride equivalent to paroxetine as follows: 10 mg–yellow (scored); 20 mg–pink (scored); 30 mg–blue, 40 mg–green. Inactive ingredients consist of dibasic calcium phosphate dihydrate, hypromellose, magnesium stearate, polyethylene glycols, polysorbate 80, sodium starch glycolate, titanium dioxide, and 1 or more of the following: D&C Red No. 30 aluminum lake, D&C Yellow No. 10 aluminum lake, FD&C Blue No. 2 aluminum lake, FD&C Yellow No. 6 aluminum lake.

Suspension for Oral Administration

Each 5 mL of orange‑colored, orange‑flavored liquid contains paroxetine hydrochloride equivalent to paroxetine, 10 mg. Inactive ingredients consist of polacrilin potassium, microcrystalline cellulose, propylene glycol, glycerin, sorbitol, methylparaben, propylparaben, sodium citrate dihydrate, citric acid anhydrous, sodium saccharin, flavorings, FD&C Yellow No. 6 aluminum lake, and simethicone emulsion, USP.

How Supplied

Tablets

Film‑coated, modified‑oval as follows:

10-mg yellow, scored tablets engraved on the front with PAXIL and on the back with 10.
NDC 60505-3663-3 Bottles of 30

20-mg pink, scored tablets engraved on the front with PAXIL and on the back with 20.
NDC 60505-3664-3 Bottles of 30

30-mg blue tablets engraved on the front with PAXIL and on the back with 30.
NDC 60505-3665-3 Bottles of 30

40-mg green tablets engraved on the front with PAXIL and on the back with 40.
NDC 60505-3666-3 Bottles of 30

Oral Suspension

Orange‑colored, orange‑flavored, 10 mg/5 mL, in white bottles containing 250 mL.
NDC 60505-0402-5

PAXIL is a registered trademark of GlaxoSmithKline.

Manufactured by: GlaxoSmithKline, Research Triangle Park, NC 27709

Distributed by: Apotex Corp., Weston, FL 33326

Drugs

Drug Countries
PAXIL Brazil, Canada, Ecuador, Japan, Mexico, Turkey, United States, South Africa

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