Ibuprofen and pseudoephedrine

Ibuprofen is a type of medicine called a nonsteroidal anti-inflammatory drug (NSAID). Pseudoephedrine is a medicine that helps relieve nasal congestion.

Ibuprofen and pseudoephedrine is a combination medicine that treats a stuffy nose, sinus congestion, cough, and pain or fever caused by the common cold or flu.

Ibuprofen and pseudoephedrine may also be used for other reasons that are not listed in this medication guide.

Use exactly as directed on the label, or as your doctor prescribed. Taking too much ibuprofen can harm your stomach or intestines.

Take this medicine with food or milk to reduce stomach upset.

Call your doctor if your fever lasts more than 3 days, if you develop new symptoms, or if your condition does not get better after taking this medication for 7 days.

If you are having surgery, inform the surgeon in advance if you have taken this medicine in the last few days.

Store at room temperature, away from moisture and heat.

Ibuprofen can raise your chances of a serious heart attack or stroke. Do not use this medicine right before or after heart bypass surgery (coronary artery bypass graft, or CABG). Ibuprofen can also lead to bleeding in the stomach or intestines, which may be life-threatening.

Ibuprofen can increase your risk of a fatal heart attack or stroke, even if you do not have any risk factors. Do not use ibuprofen and pseudoephedrine 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 issues can occur without warning while you are using ibuprofen and pseudoephedrine, especially in older adults.

You should not use this medicine if you are allergic to 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 ibuprofen and pseudoephedrine if you have used an MAO inhibitor in the past 14 days. A dangerous drug interaction could happen. MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, tranylcypromine, and others.

Do not give ibuprofen to a child younger than 12 years old.

Ask a doctor or pharmacist if this medicine is safe to use if you have ever had:

• heart disease, high blood pressure, high cholesterol, diabetes, or if you smoke;
• a heart attack, stroke, or blood clot;
• stomach ulcers or bleeding;
• asthma;
• liver or kidney disease;
• a thyroid disorder;
• diabetes; or
• enlarged prostate, urination problems.

If you are pregnant, you should not take ibuprofen and pseudoephedrine unless your doctor tells you to. Taking an NSAID during the last 20 weeks of pregnancy can cause serious heart or kidney problems in the unborn baby and possible complications with your pregnancy.

Ask a doctor before using this medicine if you are breastfeeding.

Get emergency medical help if you notice signs of an allergic reaction (sneezing, runny or stuffy nose, hives, wheezing or trouble breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Get emergency medical help if you experience 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.

ibuprofen and pseudoephedrine may cause serious side effects. Stop using ibuprofen and pseudoephedrine and call your doctor immediately if you have:

• confusion, severe drowsiness, ringing in your ears, severe dizziness, feeling faint;
• fast, pounding, or uneven heartbeat;
• easy bruising or bleeding (nosebleeds, bleeding gums);
• a skin rash, regardless of how mild;
• signs of stomach bleeding--bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;
• liver problems--loss of appetite, stomach pain (upper right side), tiredness, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
• kidney problems--little or no urination, swelling in your feet or ankles, feeling tired or short of breath; or
• nerve problems--fever, headache, neck stiffness, chills, increased sensitivity to light, seizure (convulsions).

Common side effects of ibuprofen and pseudoephedrine may include:

• diarrhea, constipation;
• headache, dizziness, drowsiness, weakness;
• upset stomach, nausea, vomiting, loss of appetite;
• feeling anxious or excited;
• sleep problems (insomnia); or
• flushing (warmth, redness, or tingly feeling).

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.

Usual Adult Dose for Sinus Symptoms:

200 mg ibuprofen / 30 mg pseudoephedrine caplets or liquid filled capsules: 1 cap orally every 4 to 6 hours while symptoms persist-May use 2 caps if symptoms do not respond to 1 cap.Maximum dose: 6 caps per 24-hour periodComments:-Do not take more than directed.-Use the smallest effective dose.

Usual Pediatric Dose for Sinus Symptoms:

200 mg ibuprofen / 30 mg pseudoephedrine caplets or liquid filled capsules:12 years and older: 1 cap orally every 4 to 6 hours while symptoms persist-May use 2 caps if symptoms do not respond to 1 cap.Maximum dose: 6 caps per 24-hour periodComments:-Do not take more than directed.-Use the smallest effective dose.

Since ibuprofen and pseudoephedrine is taken as needed, you might not be following a dosing schedule. If you miss a dose and it's almost time for your next dose, just skip the missed dose. Do not take two doses at the same time.

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

Signs of an overdose may include vomiting, stomach pain, diarrhea, ringing in your ears, severe drowsiness, agitation, sweating, coughing up blood, weak or shallow breathing, fainting, or seizure (convulsions).

Do not drink alcohol. It may raise your risk of stomach bleeding.

Ask a doctor or pharmacist before using other cough or cold medicines that may have similar ingredients.

Ask your doctor before using ibuprofen and pseudoephedrine if you take an antidepressant. Taking certain antidepressants with an NSAID may cause you to bruise or bleed easily.

Ask a doctor or pharmacist before using ibuprofen and pseudoephedrine with any other medications, especially:

• lithium;
• methotrexate;
• 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 affect ibuprofen and pseudoephedrine, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.