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What is acetaminophen-pseudoephedrine?

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 caused by the common cold.

Acetaminophen and pseudoephedrine may also be used for other purposes not listed in this medication guide.

Precautions

Do not use this medication if you are allergic to acetaminophen or pseudoephedrine.

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:

  • cirrhosis or other liver disease;
  • a history of alcoholism;
  • heart disease or high blood pressure;
  • glaucoma;
  • an enlarged prostate;
  • diabetes; or
  • a thyroid disorder.

If you have any of these conditions, you may need a dose adjustment or special tests to safely take this medication.

FDA pregnancy category C. It is not known whether this medication is harmful to an unborn baby. Before taking acetaminophen and pseudoephedrine, 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.

Artificially-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.

Do not use any other cough, cold, allergy, or pain medication without first asking your doctor or pharmacist. Acetaminophen (sometimes abbreviated as "APAP”) and pseudoephedrine are contained in many combination medicines. 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, APAP, 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.

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Instructions

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

Overdose symptoms 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.

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Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using this medication and call your doctor at once if you have any of these serious side effects:

  • fast, pounding, or uneven heartbeat;
  • severe dizziness, anxiety, restless feeling, or nervousness;
  • easy bruising or bleeding, unusual weakness, fever, chills, body aches, flu symptoms;
  • increased blood pressure (severe headache, blurred vision, trouble concentrating, chest pain, numbness, seizure); or
  • nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious side effects may include:

  • mild loss of appetite;
  • warmth, tingling, or redness under your skin;
  • feeling excited or restless;
  • sleep problems (insomnia); or
  • skin rash or itching;

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. You may report side effects to FDA at 1-800-FDA-1088.

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Interactions

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 (Benemid) or sulfinpyrazone;
  • seizure medication such as phenytoin (Dilantin) or phenobarbital (Luminal, Solfoton);
  • stimulants (caffeine, diet pills, ADHD medications such as Ritalin or Adderall);
  • an antidepressant such as amitriptyline (Elavil, Etrafon), clomipramine (Anafranil), desipramine (Norpramin), imipramine (Janimine, Tofranil), and others; or
  • a beta-blocker such as atenolol (Tenormin), bisoprolol (Zebeta), metoprolol (Lopressor, Toprol), propranolol (Inderal, InnoPran), sotalol (Betapace), and others.

This list is not complete and there may be other drugs that can interact with 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.

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Disclaimer

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2004 Cerner Multum, Inc. Version 2.05. Revision date 8/23/04