Acetaminophen is a pain reliever and fever reducer.

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

The combination of acetaminophen and pseudoephedrine is used to treat stuffy nose, sinus congestion, and pain or fever casued by the common cold. Pseudoephedrine also treats congestion of the tubes that drain fluid from your inner ears, called the eustachian (yoo-STAY-shun) tubes.

Acetaminophen 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 should be taken only for a short time until your symptoms clear up.

Drink extra fluids while you are taking acetaminophen and pseudoephedrine.

An overdose of acetaminophen can cause serious harm. The maximum amount of acetaminophen for adults is 1 gram (1000 mg) per dose and 4 grams (4000 mg) per day. Taking more acetaminophen could cause damage to your liver. One acetaminophen and pseudoephedrine tablet may contain up to 500 mg of acetaminophen. Know the amount of acetaminophen in the specific product you are taking.

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.

Measure the liquid form of acetaminophen and pseudoephedrine with a special dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

Talk with your doctor if your symptoms do not improve after 7 days of treatment, or if you have a fever with a headache, cough, or skin rash.

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 this medication at room temperature, away from heat, light, and moisture.

Before taking this medication, tell your doctor if you are using any of the following drugs:

• isoniazid;

• zidovudine (Retrovir, AZT);

• medicines to treat high blood pressure;

• gout medications such as probenecid (Benbemid) or sulfinpyrazone;

• seizure medication such as phenytoin (Dilantin) or phenobarbital (Luminal, Solfoton);

• stimulants (caffeine, diet pills, ADHD medications such as Ritalin or Adderall);

• antidepressants such as amitriptyline (Elavil, Etrafon), amoxapine (Ascendin), clomipramine (Anafranil), desipramine (Norpramin), doxepin (Sinequan), imipramine (Janimine, Tofranil), nortriptyline (Pamelor), protriptyline (Vivactil), or trimipramine (Surmontil); or

• a beta-blocker such as atenolol (Tenormin), bisoprolol (Zebeta), carvedilol (Coreg), esmolol (Brevibloc), labetalol (Normodyne, Trandate), metoprolol (Lopressor, Toprol), nadolol (Corgard), propranolol (Inderal, InnoPran), sotalol (Betapace), or timolol (Blocadren).

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

There may be other drugs not listed that can affect acetaminophen 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, allergy, or pain medication without first asking your doctor or pharmacist. Acetaminophen and pseudoephedrine are contained in many cold and pain medicines available over the counter. If you take certain products together you may accidentally take too much of a certain drug. Read the label of any other medicine you are using to see if it contains acetaminophen or pseudoephedrine.

If you drink more than three alcoholic beverages per day, do not take acetaminophen without your doctor’s advice, and never take more than 2 grams (2000 mg) of acetaminophen per day.

Avoid taking diet pills, caffeine pills, or other stimulants (such as ADHD medications) without your doctor’s advice. Taking a stimulant together with a decongestant can increase your risk of unpleasant side effects.

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

Symptoms of an overdose may include feeling restless or nervous, dizziness, drowsiness, nausea, vomiting, diarrhea, stomach pain, loss of appetite, increased sweating, seizure (convulsions), or coma.

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 cough or cold medicine to a child. Death can occur from the misuse of cough or cold medicine in very young children.

Do not take more of this medication than is recommended. An overdose of acetaminophen can cause damage to your liver.

Do not use any other over-the-counter cough, cold, allergy, or pain medication without first asking your doctor or pharmacist. If you take certain products together you may accidentally take too much of a certain drug. Read the label of any other medicine you take to see if it contains acetaminophen or pseudoephedrine.

If you drink more than three alcoholic beverages per day, do not take this medication without your doctor’s advice.

Do not use this medication if you are allergic to acetaminophen or pseudoephedrine, or to other decongestants, diet pills, stimulants, or ADHD medications.

Do not use this medication 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 a decongestant before the MAO inhibitor has cleared from your body.

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

• liver disease;

• alcoholism or cirrhosis of the liver;

• heart disease or high blood pressure;

• glaucoma;

• an enlarged prostate;

• diabetes; or

• a thyroid disorder.

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

FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

Acetaminophen and pseudoephedrine may pass into breast milk and could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Artifically-sweetened liquid forms of cough-and-cold medications may contain phenylalanine. This would be important to know if you have phenylketonuria (PKU). Check the ingredients and warnings on the medication label if you are concerned about phenylalanine.

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

Acetaminophen and pseudoephedrine is available over the counter under many brand and generic names. Ask your pharmacist any questions you have about this medication, especially if it is new to you.