PAROXETINE TABLETS USP

DESCRIPTION

id: 025a248d-5e15-4e9c-bd7d-b13b569cde24
displayName: DESCRIPTION SECTION
FDA Article Code: 34089-3

Paroxetine hydrochloride is an orally administered psychotropic drug. It is the hydrochloride salt of a phenylpiperidine compound identified chemically as (-)-trans-4R-(4’-fluorophenyl)-3S-[(3’,4’-methylenedioxyphenoxy)methyl]piperidine hydrochloride and has the molecular formula of C₁₉H₂₀FNO_3˙HCl. The molecular weight is 365.8 (329.4 as free base). The structural formula is:

Paroxetine hydrochloride is an odorless, white to off-white powder, slightly soluble in water and soluble in methanol and in alcohol. Each film-coated tablet contains paroxetine hydrochloride equivalent to paroxetine as follows: 10 mg-white; 20 mg-white; 30 mg-white; 40 mg-white. Inactive ingredients consist of anhydrous dibasic calcium phosphate, hypromellose 6 cP, lactose anhydrous, magnesium stearate, polyethylene glycol 6000, povidone, sodium starch glycolate, talc, and titanium dioxide.

CONTRAINDICATIONS

id: 67537fb7-230f-40ed-8616-0b7db875ae83
displayName: CONTRAINDICATIONS SECTION
FDA Article Code: 34070-3

Concomitant use in patients taking either monoamine oxidase inhibitors (MAOIs) or thioridazine is contraindicated (see WARNINGS and PRECAUTIONS). Concomitant use in patients taking pimozide is contraindicated (see PRECAUTIONS). Paroxetine is contraindicated in patients with a hypersensitivity to paroxetine or any of the inactive ingredients in Paroxetine Tablets USP.

HOW SUPPLIED

id: 8cfea09b-d9ce-4352-9574-6e560759e27c
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5

Paroxetine Tablets USP, 10 mg are white to off-white, round-shaped, biconvex, film-coated tablets debossed with the logo of “ZC”, 15 and bisect on one side and plain on other side. Paroxetine Tablets USP, 20 mg are white to off-white, round-shaped, biconvex, film-coated tablets debossed with the logo of “ZC”, 16 and bisect on one side and plain on other side. Paroxetine Tablets USP, 30 mg are white to off-white, round-shapped, biconvex, film-coated tablets debossed with the logo of “ZC17” on one side and plain on other side. Paroxetine Tablets USP, 40 mg are white to off-white, round-shapped, biconvex, film-coated tablets debossed with the logo of “ZC18” on one side and plain on other sid. Store at 20° to 25°C (68° to 77°F) (See USP Controlled Room Temperature). MANUFACTURED BY: Cadila Healthcare Ltd. Ahmedabad, India Repackaged by:

Contract Pharmacy Services-PA
125 Titus Ave Suite 200
Warrington, PA 18976 USA Original–08/2010–NJW Rev: 02/09

PRINCIPAL DISPLAY PANEL

id: 8942b390-d671-4f3b-8c28-dc15d9ef2bc1
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4

PRINCIPAL DISPLAY PANEL

id: 777b0d15-8d07-443c-ad1b-fa423a35932d
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4

PRINCIPAL DISPLAY PANEL

id: 469d0966-c477-4eab-b59f-05ca55208b43
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4

PRINCIPAL DISPLAY PANEL

id: d7392cae-842a-4b21-af5a-d03fb4b5291c
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4