FLUOXETINE- fluoxetine hydrochloride capsule 
Barr Laboratories Inc.




Read the Medication Guide that comes with fluoxetine capsules USP before you start taking them and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your doctor about your medical condition or treatment. Talk with your doctor or pharmacist if there is something you do not understand or you want to learn more about fluoxetine capsules USP.

What is the most important information I should know about fluoxetinecapsules USP?

Antidepressant medicines, depression and other serious mental illnesses, and suicidal thoughts or actions:

Talk to your, or your family member’s, 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 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.

3How can I watch for and try to prevent suicidal thoughts and actions in

myself or a family member?

behaviors, thoughts, or feelings. This is very important when an antidepressant medicine is started or when the dose is changed

mood, behavior, thoughts, or feelings.

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:

What else do I need to know about antidepressant medicines?


What are fluoxetine capsules USP?

Fluoxetine capsules USP are a prescription medicine used:

It is not known if fluoxetine and olanzapine (Zyprexa®) taken together is safe and works in children under 18 years of age.

The symptoms of depression (Major Depressive Disorder and Bipolar I Disorder) include decreased mood, decreased interest, increased guilty feelings, decreased energy, decreased concentration, changes in appetite, and suicidal thoughts or behavior. With treatment, some of your symptoms of depression may improve.

OCD is an anxiety disorder and is characterized by recurrent, unwanted thoughts (obsessions) and/or repetitive behaviors (compulsions). With treatment, some of your symptoms of OCD may improve.

Panic Disorder is an anxiety disorder that includes panic attacks, which are sudden feelings of terror for no reason. You may also have physical symptoms, such as; fast heartbeat, chest pain, breathing difficulty, dizziness. With treatment, some of your symptoms of Panic Disorder may improve.

Bulimia Nervosa, involves periods of overeating followed by purging (e.g., vomiting, excessive laxative use). With treatment, some of your symptoms of Bulimia Nervosa may improve.

If you do not think you are getting better, call your doctor.

Who should not take fluoxetine capsules USP?


What should I tell my doctor before taking fluoxetinecapsules USP?

Fluoxetine capsules USP may not be right for you. Before starting fluoxetine capsules USP, tell your doctor about all your medical conditions, including if you have or had any of the following:

capsules USP will harm your unborn baby.

breast milk and may harm your baby. You should not breast-feed while taking fluoxetine capsules USP. Talk to your doctor about the best way to feed your baby if you take fluoxetine capsules USP.


Tell your doctor about all the medicines that you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Fluoxetine capsules USP and some medicines may interact with each other and may not work as well, or cause possible serious side effects. Your doctor can tell you if it is safe to take fluoxetine capsules USP with your other medicines. Do not start or stop any medicine while taking fluoxetine capsules USP without talking to your doctor first.

If you take fluoxetinecapsules USP, you should not take any other medicines that contain fluoxetine hydrochloride:

You could take too much medicine (overdose).

How should I take fluoxetinecapsules USP?


What should I avoid while taking fluoxetinecapsules USP?

What are the possible side effects of fluoxetine capsules USP?

Fluoxetine capsules USP may be associated with the following serious risks:

Common possible side effects of fluoxetine capsules USP include: abnormal dreams, orgasm problems, decreased appetite, anxiety, weakness, diarrhea, dry mouth, indigestion, flu, difficulty maintaining an erection for sexual activity, trouble sleeping, decreased sex drive, feeling sick to your stomach, nervousness, sore throat, rash, watery nasal discharge, sleepiness, sweating, tremor (shakes), hot flashes, and yawn.

Tell your doctor about any side effect that bothers you or that does not go away.

These are not all the possible side effects with fluoxetine capsules USP. For more information, ask your doctor or pharmacist.

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 fluoxetinecapsules USP?

Keep fluoxetinecapsules USP and all medicines out of the reach of children.

General information about fluoxetinecapsules USP

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use fluoxetine capsules USP for a condition for which they were not prescribed. Do not give fluoxetine capsules USP to other people, even if they have the same condition. They may harm them.

This Medication Guide summarizes the most important information about fluoxetine capsules USP. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about fluoxetine capsules USP that was written for healthcare professionals. For more information about fluoxetine capsules USP call 1-888-838-2872, MEDICAL AFFAIRS.

What are the ingredients in fluoxetine capsules USP?

Active ingredient: fluoxetine hydrochloride.

Inactive ingredients: butylparaben, corn starch, D&C yellow no. 10 aluminum lake, D&C red no. 28, edetate calcium disodium, FD&C blue no. 1, FD&C blue no. 1 aluminum lake, FD&C blue no. 2 aluminum lake, FD&C red no. 40 aluminum lake, gelatin, lactose monohydrate, methylparaben, microcrystalline cellulose, pharmaceutical glaze, propylene glycol, propylparaben, sodium lauryl sulfate, sodium propionate, stearic acid, synthetic black iron oxide, and titanium dioxide. In addition, the 10 mg contains D&C yellow no. 10 and the 20 mg contains carboxymethyl cellulose sodium.

Symbyax® and Sarafem® are registered trademarks of Eli Lilly and Company.

Prozac® Weekly is a trademark of Eli Lilly and Company.

Mellaril® is a registered trademark of Novartis AG Corporation.

Orap® is a registered trademark of Teva Pharmaceuticals USA.

Coumadin® is a registered trademark of Bristol Myers Squibb.

Jantoven® is a registered trademark of Upsher-Smith Laboratories Inc.

Zyprexa® is a registered trademark of Eli Lilly and Company


POMONA, NY 10970

Rev. A 3/2010

Revised: 9/2013
Barr Laboratories Inc.