MONTELUKAST SODIUM- montelukast sodium granule
Teva Pharmaceuticals USA, Inc.
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Montelukast (mon′′ te loo′ kast soe′ dee um) Sodium
Oral Granules |
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What is the most important information I should know about montelukast sodium oral granules? Serious mental health problems have happened in people taking montelukast sodium oral granules or even after treatment has stopped. This can happen in people with or without a history of mental health problems. Stop taking montelukast sodium oral granules 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 are montelukast sodium oral granules? Montelukast sodium oral granules are 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 oral granules do not contain a steroid. Montelukast sodium oral granules are used to: 1. Prevent asthma attacks and for the long-term treatment of asthma in adults and children ages 12 months and older. Do not take montelukast sodium oral granules 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. Help control the symptoms of allergic rhinitis such as sneezing, stuffy nose, runny nose, and itching of the nose. Montelukast sodium oral granules are 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:
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Do not take montelukast sodium oral granules if you are allergic to any of their ingredients. See the end of this Medication Guide for a complete list of the ingredients in montelukast sodium oral granules. |
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Before taking montelukast sodium oral granules, 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 oral granules work, or montelukast sodium oral granules may affect how your other medicines work. |
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How should I take montelukast sodium oral granules?
For anyone who takes montelukast sodium oral granules:
For anyone 2 years of age and older with seasonal allergic rhinitis, or for anyone 6 months of age and older with perennial allergic rhinitis:
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What should I avoid while taking montelukast sodium oral granules? 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 oral granules. |
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What are the possible side effects of montelukast sodium oral granules? Montelukast sodium oral granules may cause serious side effects, including:
Tell your healthcare provider right away if you get one or more of these symptoms: |
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The most common side effects of montelukast sodium oral granules include: |
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These are not all the possible side effects of montelukast sodium oral granules. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. |
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How should I store montelukast sodium oral granules?
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General information about the safe and effective use of montelukast sodium oral granules Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use montelukast sodium oral granules for a condition for which they were not prescribed. Do not give montelukast sodium oral granules to other people even if they have the same symptoms you have. They may harm them. You can ask your pharmacist or healthcare provider for information about montelukast sodium oral granules that is written for health professionals. For more information, call 1-888-838-2872. |
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What are the ingredients in montelukast sodium oral granules? Active ingredient: montelukast sodium Inactive ingredients: hydroxypropyl cellulose, magnesium stearate, mannitol, and sodium lauryl sulfate. Distributed By: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054 |
This Medication Guide has been approved by the U.S. Food and Drug Administration Rev. B 5/2021