| acetaminophen, dextromethorphan, pseudoephedrine, and pyrilamine |
| Pronunciation: a SEET a MIN oh fen, pir IL a meen, DEX troe meth OR fan, SOO doe e FED rin |
| Brand: Robitussin Night Relief |
| What is the most important information I should know about acetaminophen, dextromethorphan, pseudoephedrine, and pyrilamine? |
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Always ask your 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. |
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Do not take this medication if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects. |
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Do not take more of this medication than is recommended. An overdose of acetaminophen can damage your liver. Adults should not take more than 1 gram (1000 mg) of acetaminophen per dose or 4 grams (4000 mg) per day. |
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Ask a doctor or pharmacist before using any other cold, allergy, pain, or sleep medication. Acetaminophen (sometimes abbreviated as APAP), dextromethorphan, pseudoephedrine, and pyrilamine are contained in many combination medicines. Taking certain products together can cause you to get too much of a certain drug. Check the label to see if a medicine contains acetaminophen, APAP, or a decongestant, antihistamine, or cough suppressant. |
| What is acetaminophen, dextromethorphan, pseudoephedrine, and pyrilamine? |
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Acetaminophen is a pain reliever and fever reducer. |
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Pyrilamine is an antihistamine that reduces the effects of natural chemical histamine in the body. Histamine can produce symptoms such as sneezing, runny nose, and watery eyes. |
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Dextromethorphan is a cough suppressant. It affects the cough reflex in the brain that triggers coughing. |
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Pseudoephedrine is a decongestant that shrinks blood vessels in the nasal passages. Dilated blood vessels can cause nasal congestion (stuffy nose). |
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The combination of acetaminophen, dextromethorphan, pseudoephedrine, and pyrilamine is used to treat runny or stuffy nose, sinus congestion, cough, and pain or fever caused by the common cold or flu. |
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Dextromethorphan will not treat a cough that is caused by smoking. |
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Acetaminophen, dextromethorphan, pseudoephedrine, and pyrilamine may also be used for purposes not listed in this medication guide. |
| What should I discuss with my healthcare provider before taking acetaminophen, dextromethorphan, pseudoephedrine, and pyrilamine? |
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Do not use this medication if you are allergic to acetaminophen, dextromethorphan, pyrilamine, or pseudoephedrine, or to similar medications such as other decongestants, diet pills, stimulants, or ADHD medications. |
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Do not take this medication if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects. |
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Ask a doctor or pharmacist if it is safe for you to take this medicine if you have: |
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alcoholism or cirrhosis of the liver; |
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heart disease or high blood pressure; |
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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. |
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FDA pregnancy category C. It is not known whether this medication is harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. |
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Artificially sweetened liquid cough or cold medicine may contain phenylalanine. If you have phenylketonuria (PKU), check the medication label to see if the product contains phenylalanine. |
| How should I take acetaminophen, dextromethorphan, pseudoephedrine, and pyrilamine? |
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Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Cough or cold medicine is usually taken only for a short time until your symptoms clear up. |
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An overdose of acetaminophen can damage your liver. Adults should not take more than 1 gram (1000 mg) of acetaminophen per dose or 4 grams (4000 mg) per day. |
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One teaspoon of the acetaminophen, dextromethorphan, pseudoephedrine, and pyrilamine liquid contains 108 mg of acetaminophen. Know the amount of acetaminophen in the specific product you are taking. |
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Do not give this medication to a child younger than 4 years old. 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. |
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Measure liquid medicine with a special dose 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. |
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Drink extra fluids to help loosen the congestion and lubricate your throat while you are taking this medication. |
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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. |
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If you need surgery, tell the surgeon ahead of time if you have used a cold medicine within the past few days. |
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Store at room temperature away from moisture and heat. |
| What happens if I miss a dose? |
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Since cough or cold medicine is taken when 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. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose. |
| What happens if I overdose? |
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Seek emergency medical attention or call the Poison Help line at 1 800 222 1222. An overdose of acetaminophen can be fatal. |
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The first signs of an acetaminophen overdose include loss of appetite, nausea, vomiting, stomach pain, sweating, and confusion or weakness. Later symptoms may include pain in your upper stomach, dark urine, and yellowing of your skin or the whites of your eyes. |
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Overdose symptoms may also include dry mouth, feeling restless or nervous, dizziness, drowsiness, diarrhea, loss of appetite, warmth or tingly feeling, seizure (convulsions), or coma. |
| What should I avoid while taking acetaminophen, dextromethorphan, pseudoephedrine, and pyrilamine? |
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Ask a doctor or pharmacist before using any other cold, allergy, pain, or sleep medication. Acetaminophen (sometimes abbreviated as APAP), dextromethorphan, pseudoephedrine, and pyrilamine are contained in many combination medicines. Taking certain products together can cause you to get too much of a certain drug. Check the label to see if a medicine contains acetaminophen, APAP, or a decongestant, antihistamine, or cough suppressant. |
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Avoid drinking alcohol. It can increase your 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. |
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This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. |
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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. |
| What are the possible side effects of acetaminophen, dextromethorphan, pseudoephedrine, and pyrilamine? |
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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. |
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Stop using this medication and call your doctor at once if you have any of these serious side effects: |
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fast, pounding, or uneven heartbeat; |
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severe dizziness, anxiety, restless feeling, or nervousness; |
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confusion, hallucinations, unusual thoughts or behavior; |
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slow, shallow breathing; |
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easy bruising or bleeding, unusual weakness, fever, chills, body aches, flu symptoms; |
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increased blood pressure (severe headache, blurred vision, trouble concentrating, chest pain, numbness, seizure); or |
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nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes). |
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Less serious side effects may include: |
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mild loss of appetite, upset stomach; |
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warmth, tingling, or redness under your skin; |
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feeling excited or restless; |
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sleep problems (insomnia); or |
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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. |
| What other drugs will affect acetaminophen, dextromethorphan, pseudoephedrine, and pyrilamine? |
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Tell your doctor about all other medicines you use, especially: |
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HIV or AIDS medication such as ritonavir (Norvir, Kaletra) or zidovudine (Retrovir, AZT); |
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an antidepressant such as amitriptyline (Elavil, Vanatrip, Limbitrol), bupropion (Wellbutrin, Zyban), fluoxetine (Prozac, Sarafem), fluvoxamine (Luvox), imipramine (Janimine, Tofranil), paroxetine (Paxil), sertraline (Zoloft), and others; |
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heart or blood pressure medicine such as atenolol (Tenormin, Tenoretic), carvedilol (Coreg), labetalol (Normodyne, Trandate), metoprolol (Lopressor, Toprol), nadolol (Corgard), propranolol (Inderal, InnoPran), quinidine (Quin-G), sotalol (Betapace), and others; or |
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seizure medication such as phenytoin (Dilantin) or phenobarbital (Solfoton). |
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This list is not complete and there may be other drugs that can interact with acetaminophen, dextromethorphan, pseudoephedrine, and pyrilamine. 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. |
| Where can I get more information? |
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Your pharmacist can provide more information about acetaminophen, dextromethorphan, pseudoephedrine, and pyrilamine. |
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.
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 1996-2011 Cerner Multum, Inc. Version: 8.01. Revision Date: 5/19/2011.
