Uses of Ibuprofen, Pseudoephedrine, and Chlorpheniramine:

• It is used to treat nose stuffiness.
• It is used to ease pain and fever.
• It is used to ease allergy signs.

What do I need to tell my doctor BEFORE I take Ibuprofen, Pseudoephedrine, and Chlorpheniramine?

For all patients taking ibuprofen, pseudoephedrine, and chlorpheniramine:

• If you have an allergy to ibuprofen, pseudoephedrine, chlorpheniramine, or any other part of ibuprofen, pseudoephedrine, and chlorpheniramine.
• If you are allergic to ibuprofen, pseudoephedrine, and chlorpheniramine; any part of ibuprofen, pseudoephedrine, and chlorpheniramine; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you have any of these health problems: GI (gastrointestinal) bleeding or kidney problems.
• If you are having trouble getting pregnant or you are having your fertility checked.
• If you have taken certain drugs for depression or Parkinson's disease in the last 14 days. This includes isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline. Very high blood pressure may happen.
• If you are taking any other NSAID.
• If you are taking a salicylate drug like aspirin.
• If you are taking pemetrexed.
• If you are pregnant or may be pregnant. Do not take ibuprofen, pseudoephedrine, and chlorpheniramine if you are in the third trimester of pregnancy. You may also need to avoid ibuprofen, pseudoephedrine, and chlorpheniramine at other times during pregnancy. Talk with your doctor to see when you need to avoid taking ibuprofen, pseudoephedrine, and chlorpheniramine during pregnancy.

Children:

• If your child is younger than 12 years of age. Do not give ibuprofen, pseudoephedrine, and chlorpheniramine to a child younger than 12 years of age.

This is not a list of all drugs or health problems that interact with ibuprofen, pseudoephedrine, and chlorpheniramine.

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 ibuprofen, pseudoephedrine, and chlorpheniramine 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 Ibuprofen, Pseudoephedrine, and Chlorpheniramine?

• Tell all of your health care providers that you take ibuprofen, pseudoephedrine, and chlorpheniramine. This includes your doctors, nurses, pharmacists, and dentists.
• Do not take more than what your doctor told you to take. Taking more than you are told may raise your chance of very bad side effects.
• Do not take ibuprofen, pseudoephedrine, and chlorpheniramine for longer than you were told by your doctor.
• Avoid driving and doing other tasks or actions that call for you to be alert until you see how ibuprofen, pseudoephedrine, and chlorpheniramine affects you.
• Avoid drinking alcohol while taking ibuprofen, pseudoephedrine, and chlorpheniramine.
• Talk with your doctor before you use other drugs and natural products that slow your actions.
• This medicine may raise the risk of heart and blood vessel problems like heart attack and stroke. These effects can be deadly. The risk may be greater if you have heart disease or risks for heart disease. However, it can also be raised even if you do not have heart disease or risks for heart disease. The risk can happen within the first weeks of using ibuprofen, pseudoephedrine, and chlorpheniramine and may be greater with higher doses or long-term use. Do not use ibuprofen, pseudoephedrine, and chlorpheniramine right before or after bypass heart surgery.
• This medicine may raise the chance of severe and sometimes deadly stomach or bowel problems like ulcers or bleeding. The risk is greater in older people, and in people who have had stomach or bowel ulcers or bleeding before. These problems may occur without warning signs.
• You may bleed more easily. Be careful and avoid injury. Use a soft toothbrush and an electric razor.
• The chance of heart failure is raised with the use of drugs like this one. In people who already have heart failure, the chance of heart attack, having to go to the hospital for heart failure, and death is raised. Talk with the doctor.
• The chance of heart attack and heart-related death is raised in people taking drugs like this one after a recent heart attack. People taking drugs like this one after a first heart attack were also more likely to die in the year after the heart attack compared with people not taking drugs like this one. Talk with the doctor.
• If you are taking aspirin to help prevent a heart attack, talk with your doctor.
• If you are 60 or older, use ibuprofen, pseudoephedrine, and chlorpheniramine with care. You could have more side effects.
• Use with care in children. Talk with the doctor.
• This medicine may cause harm to the unborn baby if you take it while you are pregnant. If you are pregnant or you get pregnant while taking ibuprofen, pseudoephedrine, and chlorpheniramine, call your doctor right away.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

How is this medicine (Ibuprofen, Pseudoephedrine, and Chlorpheniramine) best taken?

Use ibuprofen, pseudoephedrine, and chlorpheniramine as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Take with or without food. Take with food if it causes an upset stomach.

What do I do if I miss a dose?

• If you take ibuprofen, pseudoephedrine, and chlorpheniramine on a regular basis, take a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.
• Many times ibuprofen, pseudoephedrine, and chlorpheniramine is taken on an as needed basis. Do not take more often than told by the doctor.

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:

• 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.
• Weakness on 1 side of the body, trouble speaking or thinking, change in balance, drooping on one side of the face, or blurred eyesight.
• Chest pain or pressure.
• Shortness of breath, a big weight gain, or swelling in the arms or legs.
• Very bad dizziness or passing out.
• Any unexplained bruising or bleeding.
• Very bad belly pain.
• Black, tarry, or bloody stools.
• Throwing up blood or throw up that looks like coffee grounds.

What are some other side effects of Ibuprofen, Pseudoephedrine, and Chlorpheniramine?

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:

• Dizziness.
• Feeling nervous and excitable.
• Not able to sleep.
• Feeling sleepy.
• Stomach pain or heartburn.
• Upset stomach or throwing up.

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 Ibuprofen, Pseudoephedrine, and Chlorpheniramine?

• Store at room temperature.
• Protect from heat.
• Store in a dry place. Do not store in a bathroom.
• 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 ibuprofen, pseudoephedrine, and chlorpheniramine, 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.