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Paxil CR: Uses, Side Effects and Dosage

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Facts
Status:
Prescription (Rx) Boxed warning
Strength:
12.5 mg
Other brand names:
Drug class:
Active ingredient:
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Source: FDA drug labeling via NLM DailyMed · About this document

Patient information: uses, side effects, how to take - Paxil CR

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.

  1. 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?

  • Pay close attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings. This is very important when an antidepressant medicine is started or when the dose is changed.
  • Call the healthcare provider right away to report new or sudden changes in mood, behavior, thoughts, or feelings.
  • Keep all follow-up visits with the healthcare provider as scheduled. Call the healthcare provider between visits as needed, especially if you have concerns about symptoms.

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:

  • Thoughts about suicide or dying
  • Attempts to commit suicide
  • New or worse depression
  • New or worse anxiety
  • Feeling very agitated or restless
  • Panic attacks
  • Trouble sleeping (insomnia)
  • New or worse irritability
  • Acting aggressive, being angry, or violent
  • Acting on dangerous impulses
  • An extreme increase in activity and talking (mania)
  • Other unusual changes in behavior or mood

What else do I need to know about antidepressant medicines?

  • Never stop an antidepressant medicine without first talking to a healthcare provider. Stopping an antidepressant medicine suddenly can cause other symptoms.
  • Antidepressants are medicines used to treat depression and other illnesses. It is important to discuss all the risks of treating depression and also the risks of not treating it. Patients and their families or other caregivers should discuss all treatment choices with the healthcare provider, not just the use of antidepressants.
  • Antidepressant medicines have other side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1–800–FDA-1088.
  • Antidepressant medicines can interact with other medicines. Know all of the medicines that you or your family member takes. Keep a list of all medicines to show the healthcare provider. Do not start new medicines without first checking with your healthcare provider.
  • Not all antidepressant medicines prescribed for children are FDA approved for use in children. Talk to your child’s healthcare provider for more information.

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 panel

NDC 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

About this document

Source: FDA drug labeling via NLM DailyMed · Application number: NDA 020936 · View the label on DailyMed

Revision date stated in the text: April 2008

Found a mistake? Write to us via the contact page.

The information on this site does not replace the advice of a doctor or pharmacist.

Drug information for Paxil CR

Rx or OTC
Prescription (Rx)?
  • This drug is available only with a prescription from a licensed healthcare provider.
  • Rx
Boxed warning Yes – this drug has a boxed warning (also called a black box warning), the strongest warning of the FDA.
Drug class Serotonin Reuptake Inhibitor
Active ingredient Paroxetine hydrochloride 12.5 mg
Dosage form Tablet, film coated, extended release
Route Oral
Marketing status not in the current FDA NDC Directory
Company (applicant) APOTEX
FDA approval NDA 020936New Drug Application (NDA) Approved February 16, 1999
Reference listed drug This is the reference listed drug (RLD) that generics are compared with.
Therapeutic equivalence (TE) code ABCodes starting with A mean the FDA rates the drug therapeutically equivalent to its reference drug (Orange Book).
Generics Paroxetine Extended-Release with the same TE code
Manufacturers 1 labelers list this drug on DailyMed
Recalls
  • August 13, 2026: Class II recall: Failed Dissolution Specifications; product failed to meet 24-month stability testing acceptance criteria
Packages (NDC)
Package
12.5 mg – 30 in 1 bottle, plastic NDC 16590-514-30
12.5 mg – 60 in 1 bottle, plastic NDC 16590-514-60
12.5 mg – 90 in 1 bottle, plastic NDC 16590-514-90

Source: FDA drug labeling via NLM DailyMed, data as of October 31, 2026. FDA data (DailyMed, Orange Book, Drug Shortages, enforcement reports). Not a substitute for the advice of a doctor or pharmacist.