TRAZODONE HYDROCHLORIDE- trazodone hydrochloride tablet 
RPK Pharmaceuticals, Inc.

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MEDICATION GUIDE

Trazodone hydrochloride tablets, USP, for oral use

(traz' oh done hye" droe klor' ide)

What is the most important information I should know about trazodone hydrochloride tablets?

Antidepressant medicines, depression or other serious mental illnesses, and suicidal thoughts or actions: Talk to your healthcare provider about:

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 higher 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?

Call a healthcare provider right away if you have any of the following symptoms, especially if they are new, worse, or worry you:

Only some people are at risk for these problems. You may want to undergo an eye examination to see if you are at risk and receive preventative treatment if you are.

What else do I need to know about antidepressant medicines?

It is not known if trazodone is safe and effective in children.

What are trazodone hydrochloride tablets?

Trazodone hydrochloride tablets are a prescription medicine used in adults to treat major depressive disorder (MDD). Trazodone belongs to a class of medicines known as SSRIs (or selective serotonin reuptake inhibitors).

Do not take trazodone hydrochloride tablets:

Before you take trazodone hydrochloride tablets tell your healthcare provider about all of your medical conditions, including if you:

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Using trazodone hydrochloride tablets with certain other medicines can affect each other causing serious side effects.

Especially tell your healthcare provider if you take:

Know the medicines you take. Keep a list of them and show it to your healthcare provider and pharmacist when you get a new medicine.

How should I take trazodone hydrochloride tablets?

What should I avoid while taking trazodone hydrochloride tablets?

What are the possible side effects of trazodone hydrochloride tablets?

Trazodone hydrochloride tablets can cause serious side effects or death, including:

Only some people are at risk for these problems. You may want to undergo an eye examination to see if you are at risk and receive preventative treatment if you are.

Get medical help right away, if you have any of the symptoms listed above.

The most common side effects of trazodone hydrochloride tablets include:

These are not all the possible side effects of trazodone hydrochloride tablets. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800- FDA-1088.

How should I store trazodone hydrochloride tablets?

Keep trazodone hydrochloride tablets and all medicines out of the reach of children.

General information about the safe and effective use of trazodone hydrochloride tablets.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use trazodone hydrochloride tablets for a condition for which it was not prescribed. Do not give trazodone hydrochloride tablets to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about trazodone hydrochloride tablets that is written for health professionals .

What are the ingredients in trazodone hydrochloride tablets?

Active ingredient: trazodone hydrochloride, USP

Inactive ingredients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, pregelatinized maize starch, sodium lauryl sulfate, and sodium starch glycolate.

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Manufactured by:

TORRENT PHARMACEUTICALS LTD., INDIA.

For:

TORRENT PHARMA INC., Levittown, PA 19057

For more information, go to www.torrentpharma.com or call 1-800-FDA-1088

This Medication Guide has been approved by the U.S. Food and Drug Administration.    

8082845                                                                                                                      Revised: July 2021

Revised: 3/2022
RPK Pharmaceuticals, Inc.