| acetaminophen, dextromethorphan, doxylamine, and pseudoephedrine |
| Pronunciation: a SEET a MIN o fen, DEX troe meth OR fan, dox IL a meen, SOO doe e FED rin |
| Brand: Alka-Seltzer Plus Night Time Cold Liquigel, All-Nite Multi-Symptom Cold/Flu Relief, Nyquil Cold Medicine, NyQuil D, Nyquil Liquicap, Robitussin Night Cold |
| What is the most important information I should know about acetaminophen, dextromethorphan, doxylamine, and pseudoephedrine? |
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Always ask your doctor before giving a 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 a cough or cold medicine 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. |
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Tell your doctor if you have ever had alcoholic liver disease (cirrhosis). You may not be able to take medication that contains acetaminophen. |
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Do not take more of this medication than is recommended. An overdose of acetaminophen can cause damage to your liver. |
| What is acetaminophen, dextromethorphan, doxylamine, and pseudoephedrine? |
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Acetaminophen is a pain reliever and fever reducer. |
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Doxylamine 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, doxylamine, and pseudoephedrine is used to treat runny or stuffy nose, sinus congestion, cough, and pain or fever caused by the common cold, allergies, or the flu. |
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Dextromethorphan will not treat a cough that is caused by smoking. |
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Acetaminophen, dextromethorphan, doxylamine, and pseudoephedrine may also be used for purposes not listed in this medication guide. |
| What should I discuss with my healthcare provider before taking acetaminophen, dextromethorphan, doxylamine, and pseudoephedrine? |
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Do not use this medication if you are allergic to acetaminophen, dextromethorphan, doxylamine, or pseudoephedrine, or to similar medications such as other decongestants, diet pills, stimulants, or ADHD medications. |
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Tell your doctor if you have ever had alcoholic liver disease (cirrhosis). You may not be able to take medication that contains acetaminophen. |
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Do not use 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 about using acetaminophen, dextromethorphan, doxylamine, and pseudoephedrine if you have: |
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liver or kidney disease; |
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heart disease or high blood pressure; |
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problems with urination. |
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FDA pregnancy category C. It is not known whether this medication will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. |
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The liquid form may contain phenylalanine. Talk to your doctor before using this form of acetaminophen, dextromethorphan, doxylamine, and pseudoephedrine if you have phenylketonuria (PKU). |
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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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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, doxylamine, and pseudoephedrine? |
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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 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. 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 the liquid form of this medicine 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. |
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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 to have any type of surgery, tell the surgeon ahead of time if you have used this medication within the past few days. |
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Store at room temperature away from moisture, heat, and light. |
| 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. |
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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, doxylamine, and pseudoephedrine? |
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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, doxylamine, and pseudoephedrine 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 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. |
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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. |
| What are the possible side effects of acetaminophen, dextromethorphan, doxylamine, and pseudoephedrine? |
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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, stomach pain, low fever, 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 nausea, upset stomach, constipation; |
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warmth, tingling, or redness under your skin; |
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problems with memory or concentration, sleep problems (insomnia); |
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blurred vision, dry mouth, ringing in your ears; or |
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mild skin rash or itching. |
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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, doxylamine, and pseudoephedrine? |
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Before using this medicine, tell your doctor if you regularly use other medicines that make you sleepy (such as cold or allergy medicine, sedatives, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression, or anxiety). They can add to sleepiness caused by doxylamine or dextromethorphan. |
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Also your doctor if you are using any of the following drugs: |
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gout medication such as probenecid (Benemid); |
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HIV or AIDS medication; |
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heart or blood pressure medication; or |
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This list is not complete and there are many other drugs that can interact with acetaminophen, dextromethorphan, doxylamine, and pseudoephedrine. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor. Keep a list of all your medicines and show it to any healthcare provider who treats you. |
| Where can I get more information? |
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Your pharmacist can provide more information about acetaminophen, dextromethorphan, doxylamine, and pseudoephedrine. |
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: 9.01. Revision Date: 5/19/2011.