MONTELUKAST SODIUM - montelukast sodium tablet, chewable
RPK Pharmaceuticals, Inc.
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MEDICATION GUIDE
Montelukast Sodium Tablets USP and Montelukast Sodium Chewable Tablets USP (mon te loo' kast soe' dee um) |
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:
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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 have 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 tablets and montelukast sodium chewable tablets. 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 over the counter 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 anyone 2 years of age and older with seasonal allergic rhinitis, or for anyone 2 years of age and older with perennial allergic rhinitis:
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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:
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How should I store montelukast sodium?
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General information about the safe and effective use of montelukast sodium
Medicines are sometimes prescribed for purposes other than those listed 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 tablets and montelukast sodium chewable tablets?
Active ingredient: montelukast sodium Inactive ingredients: 4 mg and 5 mg chewable tablet: artificial cherry flavor, aspartame, croscarmellose sodium, ferric oxide, hydroxypropyl cellulose, magnesium stearate, mannitol, and microcrystalline cellulose. People with Phenylketonuria: Montelukast sodium chewable tablets 4 mg contain 0.674 mg of phenylalanine, and montelukast sodium chewable tablets 5 mg contain 0.842 mg of phenylalanine. 10 mg tablet: carnauba wax, croscarmellose sodium, hydroxypropyl cellulose, hypromellose, iron oxide red, iron oxide yellow, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and titanium dioxide. Dispense with medication guide available at: http://www.risingpharma.com/med-guides.html Distributed by: Rising Health, LLC Saddle Brook, NJ 07663 Made in India Code: TS/DRUGS/22/2009 |
This Medication Guide has been approved by the U.S. Food and Drug Administration
Revised: 04/2021