Uses of Montelukast Oral Granules:

• It is used to ease allergy signs.
• It is used to prevent breathing problems that happen with exercise.
• It is used to treat or prevent asthma.
• It may be given to you for other reasons. Talk with the doctor.

For breathing problems:

• This medicine is not to be used to treat intense flare-ups of shortness of breath. Use a rescue inhaler. Talk with the doctor.

What do I need to tell my doctor BEFORE I take Montelukast Oral Granules?

• If you are allergic to this medicine (montelukast oral granules); any part of this medicine (montelukast oral granules); or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.

This medicine may interact with other drugs or health problems.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine (montelukast oral granules) with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Montelukast Oral Granules?

For all uses of this medicine (montelukast oral granules):

• Tell all of your health care providers that you take this medicine (montelukast oral granules). This includes your doctors, nurses, pharmacists, and dentists.
• Tell your doctor if you are pregnant, plan on getting pregnant, or are breast-feeding. You will need to talk about the benefits and risks to you and the baby.

For breathing problems:

• Call your doctor right away if your breathing problems get worse, if your rescue inhaler does not work as well, or if you need to use your rescue inhaler more often.
• If you take this medicine (montelukast oral granules) for asthma or allergy, do not take another dose to prevent breathing problems that happen with exercise.
• If you have asthma and taking aspirin makes it worse, keep avoiding aspirin and NSAIDs while you take this medicine (montelukast oral granules).
• If you are switching to this medicine (montelukast oral granules) from a steroid, do not stop taking the steroid all of a sudden. The dose of the steroid may need to be slowly lowered to avoid side effects. Talk with the doctor.

How is this medicine (Montelukast Oral Granules) best taken?

Use this medicine (montelukast oral granules) as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Take with or without food.
• Granules may be placed right in the mouth or mixed with cold or room temperature applesauce, baby formula, breast milk, mashed carrots, rice, or ice cream. Do not mix granules in other liquids.
• Do not open the packet until you are ready to take a dose. If mixing, take your dose within 15 minutes. Do not store for future use.
• Keep taking this medicine (montelukast oral granules) even when you are not having symptoms.
• If working out or playing sports causes signs, use at least 2 hours before doing it.
• If this medicine (montelukast oral granules) is for asthma, take in the evening.

What do I do if I miss a dose?

• Skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

For all patients taking this medicine (montelukast oral granules):

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
• Signs of a pancreas problem (pancreatitis) like very bad stomach pain, very bad back pain, or very bad upset stomach or throwing up.
• Signs or symptoms of depression, suicidal thoughts, emotional ups and downs, abnormal thinking, anxiety, or lack of interest in life.
• Signs of a very bad skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in the mouth, throat, nose, or eyes.
• Hallucinations (seeing or hearing things that are not there).
• Memory problems or loss.
• Feeling confused, not able to focus, or change in behavior.
• Strange or odd dreams.
• Trouble sleeping.
• Trouble speaking.
• Restlessness.
• Sleepwalking.
• Shakiness.
• Trouble controlling body movements.
• Seizures.
• Trouble breathing that is new or worse.
• Fever.
• Flu-like signs.
• Sinus pain.
• Chest pain.
• A heartbeat that does not feel normal.
• Any unexplained bruising or bleeding.
• A burning, numbness, or tingling feeling that is not normal.
• Ear pain.
• Muscle or joint pain.
• Swelling.

Children:

• Bedwetting.

What are some other side effects of Montelukast Oral Granules?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Headache.
• Stomach pain or diarrhea.
• Signs of a common cold.
• Cough.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If OVERDOSE is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Montelukast Oral Granules?

• Store at room temperature protected from light. Store in a dry place. Do not store in a bathroom.
• Store in original container.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

Consumer Information Use and Disclaimer

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about this medicine (montelukast oral granules), please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.