Ibuprofen is in a group of drugs called nonsteroidal anti-inflammatory drugs (NSAIDs). 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).

The combination of ibuprofen and pseudoephedrine is used to treat stuffy nose, sinus congestion, cough, and pain or fever caused by the common cold or flu.

Ibuprofen and pseudoephedrine may also be used for purposes other than those listed in this medication guide.

Use this medication exactly as directed on the label, or as it has been prescribed by your doctor. Do not use the medication in larger amounts, or use it for longer than recommended. Cold medicine is usually taken only for a short time until your symptoms clear up.

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.

Do not take more of this medication than is recommended. An overdose of ibuprofen can cause damage to your stomach or intestines. The maximum amount of ibuprofen for adults is 800 milligrams per dose or 3200 mg per day (4 maximum doses). Use only the smallest amount of ibuprofen and pseudoephedrine needed to get relief from your pain, fever, or cold symptoms.

Shake the oral suspension (liquid) well just before you measure a dose. To be sure you get the correct dose, measure the liquid with a marked measuring spoon or medicine cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

Call your doctor if you have a fever lasting longer than 3 days, if you have new symptoms, or if your condition does not improve after taking this medication for 7 days.

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.

Store ibuprofen and pseudoephedrine at room temperature away from moisture and heat.

Before taking ibuprofen and pseudoephedrine, tell your doctor if you are taking any of the following drugs:

• a blood thinner such as warfarin (Coumadin);

• steroids (prednisone and others);

• diuretics (water pills), or medicines to treat high blood pressure;

• a beta-blocker such as atenolol (Tenormin), carteolol (Cartrol), metoprolol (Lopressor, Toprol), propranolol (Inderal), sotalol (Betapace), timolol (Blocadren), and others;

• antidepressants such as amitriptyline (Elavil), clomipramine (Anafranil), imipramine (Janimine, Tofranil), and others; or

• aspirin or other NSAIDs (non-steroidal anti-inflammatory drugs) such as diclofenac (Voltaren), etodolac (Lodine), flurbiprofen (Ansaid), indomethacin, ketoprofen (Orudis), ketorolac (Toradol), mefenamic acid (Ponstel), meloxicam (Mobic), nabumetone (Relafen), naproxen (Aleve, Naprosyn), piroxicam (Feldene), and others.

If you are using any of these drugs, you may not be able to use ibuprofen and pseudoephedrine, or you may need dosage adjustments or special tests during treatment.

There may be other drugs not listed that can affect ibuprofen and pseudoephedrine. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Do not use any other over-the-counter cough, cold, or pain medication without first asking your doctor or pharmacist. Ibuprofen and pseudoephedrine are contained in many medicines available over the counter. If you take certain products together you may accidentally take too much of either medication. Read the label of any other medicine you are using to see if it contains ibuprofen or pseudoephedrine.

Avoid drinking alcohol while taking ibuprofen and pseudoephedrine. If you drink more than 3 alcoholic beverages a day, ibuprofen may increase your risk of stomach bleeding.

Seek emergency medical attention if you think you have used too much of this medicine.

Symptoms of an ibuprofen and pseudoephedrine overdose may include nausea, vomiting, stomach pain, dizziness, feeling restless or nervous, blurred vision, sweating, breathing problems, or seizure (convulsions).

Since cold medicine is usually taken only as needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at your next regularly scheduled time. Do not take extra medicine to make up the missed dose.

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.

Do not use ibuprofen and pseudoephedrine if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days.

Ibuprofen can increase your risk of life-threatening heart or circulation problems, including heart attack or stroke. Do not use this medicine just before or after having heart bypass surgery (also called coronary artery bypass graft, or CABG).

Seek emergency medical help if you have symptoms of heart or circulation problems, such as chest pain, weakness, shortness of breath, slurred speech, or problems with vision or balance.

Ibuprofen can also increase your risk of serious effects on the stomach or intestines, including bleeding or perforation (forming of a hole). These conditions can be fatal and can occur without warning at any time while you are taking ibuprofen.

Call your doctor at once if you have symptoms of bleeding in your stomach or intestines. This includes black, bloody, or tarry stools, or coughing up blood or vomit that looks like coffee grounds.

Do not take more of this medication than is recommended. An overdose of ibuprofen can cause damage to your stomach or intestines.

Do not use ibuprofen and pseudoephedrine if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Serious, life-threatening side effects can occur if you take ibuprofen and pseudoephedrine before the MAO inhibitor has cleared from your body.

Taking an NSAID can increase your risk of life-threatening heart or circulation problems, including heart attack or stroke. This risk will increase the longer you use an NSAID. Do not use this medicine just before or after having heart bypass surgery (also called coronary artery bypass graft, or CABG).

NSAIDs can also increase your risk of serious effects on the stomach or intestines, including bleeding or perforation (forming of a hole). These conditions can be fatal and gastrointestinal effects can occur without warning at any time while you are taking an NSAID. Older adults may have an even greater risk of these serious gastrointestinal side effects.

Do not use this medication if you are allergic to ibuprofen or pseudoephedrine, or if you have:

• a stomach ulcer or active bleeding in your stomach or intestines;

• polyps in your nose; or

• a history of allergic reaction to aspirin or other NSAIDs.

Before taking ibuprofen and pseudoephedrine, tell your doctor if you are allergic to any drugs, or if you have:

• a history of stomach ulcers or bleeding;

• heart disease, congestive heart failure, high blood pressure;

• systemic lupus erythematosus (SLE);

• liver or kidney disease;

• a thyroid disorder;

• diabetes;

• enlarged prostate or problems with urination;

• a bleeding or blood clotting disorder; or

• if you smoke.

If you have any of these conditions, you may not be able to use ibuprofen and pseudoephedrine, or you may need a dosage adjustment or special tests during treatment.

FDA pregnancy category B. This medication is not expected to be harmful to an unborn baby during early pregnancy. However, taking ibuprofen and pseudoephedrine during the last 3 months of pregnancy may result in birth defects and prolonged labor and delivery. Do not take ibuprofen and pseudoephedrine during the last 3 months of pregnancy unless your doctor has told you to.

It is not known whether ibuprofen and pseudoephedrine passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Your pharmacist has information about ibuprofen and pseudoephedrine written for health professionals that you may read.

Ibuprofen and pseudoephedrine is available over-the-counter (without a prescription) under many different brand and generic names and formulations.