MONTELUKAST SODIUM- montelukast sodium tablet, coated 
American Health Packaging


Medication Guide


Montelukast Sodium (mon te loo' kast soe' dee um) TabletsUSP, and Chewable Tablets

What is the most important information I should know about montelukast sodium?

Serious mental health problems have happened in people taking montelukast sodium or even after treatment has stopped. This can happen in people with or without a history of mental health problems. Stop taking montelukast sodium and tell your healthcare provider right away if you or your child have any unusual changes in behavior or thinking, including any of these symptoms:

What is Montelukast sodium?
Montelukast sodium is a prescription medicine that blocks substances in the body called leukotrienes. This may help to improve symptoms of asthma and inflammation of the lining of the nose (allergic rhinitis). Montelukast sodium does not contain a steroid.

Montelukast sodium is used to:

1. Prevent asthma attacks and for the long-term treatment of asthma in adults and children ages 2 years and older.

Do not take montelukast sodium if you need relief right away for a sudden asthma attack. If you get an asthma attack, you should follow the instructions your healthcare provider gave you for treating asthma attacks.

2. Prevent exercise-induced asthma in people 6 years of age and older.

3. Help control the symptoms of allergic rhinitis such as sneezing, stuffy nose, runny nose, and itching of the nose. Montelukast sodium is used to treat the following in people who have already taken other medicines that did not work well enough or in people who could not tolerate other medicines:

Do not take Montelukast sodium if you are allergic to any of its ingredients.
See the end of this Medication Guide for a complete list of the ingredients in montelukast sodium.

Before taking montelukast sodium, tell your healthcare provider about all your medical conditions, including if you:

Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Some medicines may affect how montelukast sodium works, or montelukast sodium may affect how your other medicines work.

How should I take montelukast sodium?
For anyone who takes montelukast sodium:

For adults and children 2 years of age and older with asthma:

For people 6 years of age and older for the prevention of exercise-induced asthma:

For anyone 2 years of age and older with seasonal allergic rhinitis, or for anyone 2 years of age and older with perennial allergic rhinitis:

What should I avoid while taking montelukast sodium?
If you have asthma and aspirin makes your asthma symptoms worse, continue to avoid taking aspirin or other medicines called non-steroidal anti-inflammatory drugs (NSAIDs) while taking montelukast sodium.

What are the possible side effects of montelukast sodium?
Montelukast sodium may cause serious side effects, including:

Tell your healthcare provider right away if you get one or more of these symptoms:

The most common side effects of montelukast sodium include:

These are not all the possible side effects of montelukast sodium. Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store montelukast sodium?

General Information about the safe and effective use of montelukast sodium
Medicines are sometimes prescribed for purposes other than those mentioned in a Medication Guide. Do not use montelukast sodium for a condition for which it was not prescribed. Do not give montelukast sodium to other people even if they have the same symptoms you have. It may harm them.

You can ask your pharmacist or healthcare provider for information about montelukast sodium that is written for health professionals.

What are the ingredients in montelukast sodium?
Active ingredient: montelukast sodium
Inactive ingredients:

People with Phenylketonuria: Montelukast sodium 4 mg (montelukast) chewable tablets contain 0.6 mg of phenylalanine, and montelukast sodium 5 mg (montelukast) chewable tablets contain 0.75 mg of phenylalanine.

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

Rx only

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Distributed by:
American Health Packaging
Columbus, OH 43217


Revised: 10/2022
American Health Packaging