chlorpheniramine, ibuprofen, and pseudoephedrine

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Pronunciation: KLOR fen EER a meen, EYE bue pro fen, SOO doe ee FED rin

Brand: Advil Allergy Sinus, Advil Childrens Allergy Sinus, Advil Multi-Symptom Cold

What is the most important information I should know about chlorpheniramine, ibuprofen, and pseudoephedrine?

Do not give this medicine to anyone younger than 6 years old.

Do not use this medicine if you have used an MAO inhibitor in the past 14 days, such as isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, or tranylcypromine.

Ibuprofen can increase your risk of fatal heart attack or stroke, especially if you use it long term or take high doses, or if you have heart disease. Do not use this medicine just before or after heart bypass surgery (coronary artery bypass graft, or CABG).

Ibuprofen may also cause stomach or intestinal bleeding, which can be fatal. These conditions can occur without warning while you are using this medicine, especially in older adults.

What is chlorpheniramine, ibuprofen, and pseudoephedrine?

Chlorpheniramine is an antihistamine that reduces the effects of natural chemical histamine in the body. Histamine can produce symptoms of sneezing, itching, watery eyes, and runny nose.

Ibuprofen is a nonsteroidal anti-inflammatory drug (NSAID). Ibuprofen works by reducing hormones that cause inflammation and pain in the body.

Pseudoephedrine is a decongestant that shrinks blood vessels in the nasal passages. Dilated blood vessels can cause nasal congestion (stuffy nose).

Chlorpheniramine, ibuprofen, and pseudoephedrine is a combination medicine used to treat sneezing, itching, watery eyes, runny nose, stuffy nose, sinus congestion, headache, and pain or fever caused by allergies or the common cold.

Chlorpheniramine, ibuprofen, and pseudoephedrine may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before taking chlorpheniramine, ibuprofen, and pseudoephedrine?

Ibuprofen can increase your risk of fatal heart attack or stroke, especially if you use it long term or take high doses, or if you have heart disease. Even people without heart disease or risk factors could have a stroke or heart attack while taking this medicine.

Do not use this medicine just before or after heart bypass surgery (coronary artery bypass graft, or CABG).

Ibuprofen may also cause stomach or intestinal bleeding, which can be fatal. These conditions can occur without warning while you are using this medicine, especially in older adults.

You should not use this medicine if you are allergic to chlorpheniramine, ibuprofen, or pseudoephedrine, or if you have ever had an asthma attack or severe allergic reaction after taking aspirin or an NSAID.

Do not use this medicine if you have used an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, tranylcypromine, and others.

Ask a doctor or pharmacist if it is safe for you to take this medicine if you have:

  • heart disease, high blood pressure, high cholesterol, diabetes, or if you smoke;
  • a history of heart attack, stroke, or blood clot;
  • a history of stomach ulcers or bleeding;
  • a breathing problem, such as asthma, emphysema, or bronchitis;
  • liver or kidney disease;
  • a thyroid disorder;
  • glaucoma;
  • diabetes;
  • enlarged prostate or problems with urination; or
  • fluid retention.

This medicine is not approved for use by anyone younger than 6 years old. Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children.

You should not use antihistamine medication to make a child sleepy.

This medicine may be harmful to an unborn baby. Taking ibuprofen during the last 3 months of pregnancy may result in birth defects and prolonged labor and delivery. Ask a doctor before using this medicine if you are pregnant.

Chlorpheniramine, ibuprofen, and pseudoephedrine can pass into breast milk and may harm a nursing baby. Ask a doctor before using this medicine if you are breast-feeding.

How should I take chlorpheniramine, ibuprofen, and pseudoephedrine?

Use exactly as directed on the label, or as prescribed by your doctor. Do not take this medicine in larger amounts or for longer than recommended. Use the lowest dose that is effective in treating your condition. Cold or allergy medicine is usually taken only for a short time until your symptoms clear up.

A child's dose is based on the age and weight of the child. Carefully follow the dosing instructions for the age and weight of your child. Ask a doctor or pharmacist if you have questions.

Take this medicine with food or milk if it upsets your stomach.

Shake the oral suspension (liquid) well just before you measure a dose. Measure liquid medicine with the dosing syringe provided, or with a special dose-measuring spoon or medicine cup. If you do not have a dose-measuring device, ask your pharmacist for one.

Do not take this medicine for longer than 10 days without your doctor's advice.

If you need to have any type of surgery, tell the surgeon ahead of time if you have taken a cold medicine within the past few days.

Call your doctor if you have any new symptoms, or if you have a fever lasting longer than 3 days, stuffy nose lasting longer than 7 days, or any redness or swelling.

Chlorpheniramine can cause you to have unusual results with allergy skin tests. Tell any doctor who treats you that you are taking this medicine.

Store this medicine at room temperature away from moisture and heat.

What happens if I miss a dose?

Since cold medicine is usually taken only as needed, you may not be on a dosing schedule. If you are on a schedule, use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking chlorpheniramine, ibuprofen, and pseudoephedrine?

This medicine can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

Avoid drinking alcohol. It may increase your risk of stomach bleeding.

Avoid taking aspirin or other NSAIDs while you are taking chlorpheniramine, ibuprofen, and pseudoephedrine.

Ask a doctor or pharmacist before using any cold, allergy, or pain medicine. Many medicines available over the counter contain chlorpheniramine, ibuprofen, or pseudoephedrine. Taking certain products together can cause you to get too much of these types of medication. Check the label to see if a medicine contains an antihistamine, decongestant, or pain reliever.

Avoid becoming overheated or dehydrated during exercise and in hot weather.

What are the possible side effects of chlorpheniramine, ibuprofen, and pseudoephedrine?

Get emergency medical help if you have signs of an allergic reaction: sneezing, runny or stuffy nose; wheezing or trouble breathing; hives; swelling of your face, lips, tongue, or throat.

Get emergency medical help if you have signs of a heart attack or stroke: chest pain spreading to your jaw or shoulder, sudden numbness or weakness on one side of the body, slurred speech, leg swelling, feeling short of breath.

Stop using this medicine and call your doctor at once if you have:

  • severe dizziness, trouble sleeping, or nervousness;
  • shortness of breath (even with mild exertion);
  • swelling or rapid weight gain;
  • the first sign of any skin rash, no matter how mild;
  • signs of stomach bleeding --bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;
  • liver problems --nausea, upper stomach pain, itching, tired feeling, flu-like symptoms, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
  • kidney problems --little or no urinating, painful or difficult urination, swelling in your feet or ankles, feeling tired or short of breath;
  • dangerously high blood pressure --severe headache, blurred vision, pounding in your neck or ears, nosebleed, anxiety, confusion, severe chest pain, shortness of breath, irregular heartbeats; or
  • severe skin reaction --fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Common side effects may include:

  • upset stomach, mild heartburn, nausea, vomiting;
  • bloating, gas, diarrhea, constipation;
  • dizziness, headache, nervousness;
  • flushing (warmth, redness, or tingly feeling);
  • mild itching or rash; or
  • ringing in your ears.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect chlorpheniramine, ibuprofen, and pseudoephedrine?

Ask your doctor before using ibuprofen if you take an antidepressant such as citalopram, escitalopram, fluoxetine (Prozac), fluvoxamine, paroxetine, sertraline (Zoloft), trazodone, or vilazodone. Taking any of these medicines with an NSAID may cause you to bruise or bleed easily.

Ask a doctor or pharmacist if it is safe for you to use chlorpheniramine, ibuprofen, and pseudoephedrine if you are also using any of the following drugs:

  • a blood thinner (warfarin, Coumadin, Jantoven);
  • heart or blood pressure medication, including a diuretic or "water pill"; or
  • steroid medicine (such as prednisone).

This list is not complete. Other drugs may interact with chlorpheniramine, ibuprofen, and pseudoephedrine, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Where can I get more information?

Your pharmacist can provide more information about chlorpheniramine, ibuprofen, and pseudoephedrine.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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