ibuprofen and pseudoephedrine

Brand name(s):

ibuprofen-pseudoephedrine, Advil Cold and Sinus, Advil Cold and Sinus Liqui-Gel, Dayquil Pressure and Pain Caplet, Dristan Sinus, Motrin Childrens Cold, Motrin Cold and Flu, Motrin IB Sinus, Motrin Sinus Headache

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

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.

What is ibuprofen and pseudoephedrine?

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 other purposes not listed in this medication guide.

What should I discuss with my doctor before taking ibuprofen and pseudoephedrine?

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.

You should 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 need a dose adjustment or special tests to safely take ibuprofen and pseudoephedrine.

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.

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