PAXIL CR- paroxetine hydrochloride tablet, film coated, extended release
STAT RX USA LLC
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Antidepressant Medicines, Depression and Other Serious Mental Illnesses, and Suicidal Thoughts or Actions
PAXIL CR® (PAX-il) (paroxetine
hydrochloride) Controlled-Release Tablets
Read the Medication Guide that comes with your or your family member’s antidepressant medicine. This Medication Guide is only about the risk of suicidal thoughts and actions with antidepressant medicines. Talk to your, or your family member’s, healthcare provider about:
What is the most important information I should know about
antidepressant medicines, depression and other serious mental illnesses, and
suicidal thoughts or action?
1. Antidepressant medicines may increase suicidal thoughts or actions in some children, teenagers, and young adults within the first few months of treatment.
2. Depression and other serious mental illnesses are the most important causes of suicidal thoughts and actions. Some people may have a particularly high risk of having suicidal thoughts or actions. These include people who have (or have a family history of) bipolar illness (also called manic-depressive illness) or suicidal thoughts or actions.
3. How can I watch for and try to prevent suicidal thoughts and actions in myself or a family member?
Call a healthcare provider right away if you or your
family member has any of the following symptoms, especially if they are new,
worse, or worry you:
What else do I need to know about antidepressant
medicines?
This Medication Guide has been approved by the U.S. Food and Drug
Administration for all antidepressants.
January 2008 PCR:3MG
GlaxoSmithKline
Research Triangle Park, NC 27709
©2009, GlaxoSmithKline. All rights reserved.
August 2009 PCR:32PI
principal display panelNDC 0029-3206-13
PAXIL CR®
PAROXETINE HCl
CONTROLLED-RELEASE TABLETS
30 Tablets
Rx only
Federal Law requires dispensing of Paxil CR® with the Medication Guide under this label. Store at or below 25oC (77oF) [see USP].
Each controlled-release tablet contains paroxetine hydrochloride equivalent to 12.5 mg paroxetine.
Dosage: See accompanying prescribing information.
Important: Use safety closures when dispensing this product unless otherwise directed by physician or requested by purchaser.
GlaxoSmithKline
RTP, NC 27709
Made in Ireland
A053835 Rev. 4/08