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What is the most important information I should know about APAP/dextromethorphan/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 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.

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 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 (sometimes abbreviated as "APAP”), dextromethorphan, or pseudoephedrine.

Avoid drinking alcohol. It can increase the risk of liver damage while you are taking acetaminophen. 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) per day.

Dextromethorphan will not treat a cough that is caused by smoking.

Warning

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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What is APAP/dextromethorphan/pseudoephedrine?

Acetaminophen is a pain reliever and fever reducer.

Dextromethorphan is a cough suppressant. It affects the signals in the brain that trigger cough reflex.

Pseudoephedrine is a decongestant. It constricts (shrinks) blood vessels (veins and arteries). This reduces the blood flow to certain areas, which decreases swelling and allows nasal and respiratory (breathing) passages to open up.

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

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

Precautions

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

Do not use a cough and cold medicine 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 cough and cold medicine before the MAO inhibitor has cleared from your body.

Dextromethorphan will not treat a cough that is caused by smoking.

Before using acetaminophen, dextromethorphan, 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;
  • diabetes;
  • emphysema or chronic bronchitis;
  • glaucoma;
  • an enlarged prostate; or
  • a thyroid disorder.

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

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

This medication 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 cold medicine 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.

This medication can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

Do not use any other cough, cold, allergy, or pain medication without first asking your doctor or pharmacist. Acetaminophen (sometimes abbreviated as "APAP”), dextromethorphan, 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, dextromethorphan, or pseudoephedrine.

Avoid drinking alcohol. It can increase the risk of liver damage while you are taking acetaminophen. 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 cough or cold medicine 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.

Symptoms of an overdose may include dizziness, drowsiness, feeling restless or nervous, 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;
  • confusion, hallucinations;
  • slow, shallow breathing;
  • 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).

Keep taking the medication and talk to your doctor if you have any of these less serious side effects:

  • mild loss of appetite, upset stomach;
  • 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:

  • celecoxib (Celebrex);
  • cinacalcet (Sensipar);
  • darifenacin (Enablex);
  • imatinib (Gleevec);
  • isoniazid;
  • quinidine (Quinaglute, Quinidex);
  • ranolazine (Ranexa)
  • ritonavir (Norvir);
  • sibutramine (Meridia);
  • terbinafine (Lamisil);
  • zidovudine (Retrovir, AZT);
  • medicines to treat high blood pressure;
  • an antidepressant such as amitriptyline (Elavil, Etrafon), bupropion (Wellbutrin, Zyban), fluoxetine (Prozac, Sarafem), fluvoxamine (Luvox), imipramine (Janimine, Tofranil), paroxetine (Paxil), sertraline (Zoloft), and others;
  • a beta-blocker such as atenolol (Tenormin), carteolol (Cartrol), metoprolol (Lopressor, Toprol), nadolol (Corgard), propranolol (Inderal), sotalol (Betapace), timolol (Blocadren), and others;
  • gout medications such as probenecid (Benbemid) or sulfinpyrazone; or
  • seizure medication such as phenytoin (Dilantin) or phenobarbital (Luminal, Solfoton).

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

There may be other drugs not listed that can affect acetaminophen, dextromethorphan, 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