What is the most important information I should know about this medicine?
Do not use this medicine if you have used an MAO inhibitor in the past 14 days, such as isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, or tranylcypromine.
Do not take more of this medication than is recommended. An overdose of acetaminophen can damage your liver or cause death. Call your doctor at once if you have nausea, pain in your upper stomach, itching, loss of appetite, dark urine, clay-colored stools, or jaundice (yellowing of your skin or eyes).
In rare cases, acetaminophen may cause a severe skin reaction. Stop taking this medicine and call your doctor right away if you have skin redness or a rash that spreads and causes blistering and peeling.
What is acetaminophen, dextromethorphan, doxylamine, and pseudoephedrine?
Acetaminophen is a pain reliever and fever reducer.
Dextromethorphan is a cough suppressant. It affects the cough reflex in the brain that triggers coughing.
Doxylamine is an antihistamine that reduces the effects of natural chemical histamine in the body. Histamine can produce symptoms of sneezing, itching, watery eyes, and runny nose.
Pseudoephedrine is a decongestant that shrinks blood vessels in the nasal passages. Dilated blood vessels can cause nasal congestion (stuffy nose).
Acetaminophen, dextromethorphan, doxylamine, and pseudoephedrine is a combination medicine used to treat headache, fever, body aches, cough, runny nose, sneezing, and sinus congestion caused by the common cold, or the flu.
This medicine will not treat a cough that is caused by smoking, asthma, or emphysema.
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 this medicine?
You should not use this medicine if you are allergic to acetaminophen, dextromethorphan, doxylamine, or pseudoephedrine.
Do not use this medicine if you have taken an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, and tranylcypromine.
Ask a doctor or pharmacist if it is safe for you to take this medicine if you have other medical conditions, especially:
- a cough with mucus;
- liver disease, cirrhosis, a history of alcoholism, or if you drink more than 3 alcoholic beverages per day;
- heart disease, high blood pressure;
- a thyroid disorder;
- enlarged prostate with urination problems; or
- if you take a blood thinner such as warfarin (Coumadin, Jantoven).
It is not known whether this medication will harm an unborn baby. Do not use this medicine without a doctor's advice if you are pregnant.
Acetaminophen, dextromethorphan, doxylamine, and pseudoephedrine may pass into breast milk and may harm a nursing baby. Antihistamines and decongestants may also slow breast milk production. Do not use this medicine without a doctor's advice if you are breast-feeding a baby.
How should I take this medicine?
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. This medicine is usually taken only for a short time until your symptoms clear up.
Do not take more of this medication than is recommended. An overdose of acetaminophen can damage your liver or cause death.
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.
Measure liquid medicine with the dosing syringe provided, or with a special dose-measuring spoon or medicine cup. If you do not have a dose-measuring device, ask your pharmacist for one.
Do not take for longer than 7 days in a row. Stop taking the medicine and call your doctor if:
- your symptoms get worse, or you have new symptoms;
- you still have a fever after 3 days of use;
- you still have a sore throat after 2 days of use;
- you have any redness or swelling; or
- you have a sore throat with fever, skin rash, ongoing headache, nausea, or vomiting.
If you need surgery or medical tests, tell the surgeon or doctor ahead of time if you have taken this medicine within the past few days.
Store at room temperature away from moisture and heat. Do not allow liquid medicine to freeze.
What happens if I miss a dose?
Since this 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?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of acetaminophen can be fatal.
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.
What should I avoid while taking this medicine?
Ask a doctor or pharmacist before using any other cold, allergy, pain, or sleep medication. Acetaminophen (sometimes abbreviated as APAP) is contained in many combination medicines. Taking certain products together can cause you to get too much acetaminophen which can lead to a fatal overdose. Check the label to see if a medicine contains acetaminophen or APAP.
Avoid drinking alcohol. It may increase your risk of liver damage while you are taking acetaminophen, and can increase certain side effects of doxylamine.
This medicine may cause blurred vision or impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert and able to see clearly.
What are the possible side effects of this medicine?
Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
In rare cases, acetaminophen may cause a severe skin reaction that can be fatal. This could occur even if you have taken acetaminophen in the past and had no reaction. Stop taking this medicine and call your doctor right away if you have skin redness or a rash that spreads and causes blistering and peeling. If you have this type of reaction, you should never again take any medicine that contains acetaminophen.
Stop using this medicine and call your doctor at once if you have:
- pounding heartbeats or fluttering in your chest;
- a light-headed feeling, like you might pass out;
- anxiety, feeling nervous, trouble sleeping;
- little or no urination; or
- liver problems --nausea, upper stomach pain, itching, tiredness, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).
Side effects such as dry mouth, constipation, and confusion may be more likely in older adults.
Common side effects may include:
- constipation, diarrhea, upset stomach, vomiting; or
- feeling restless or excited (especially in children).
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 this medicine?
Ask a doctor or pharmacist before using this medicine if you are also using any other drugs, including prescription and over-the-counter medicines, vitamins, and herbal products. Some medicines can cause unwanted or dangerous effects when used together. Not all possible interactions are listed in this medication guide.
Taking this medicine with other drugs that make you sleepy or slow your breathing can worsen these effects. Ask your doctor before taking acetaminophen, dextromethorphan, doxylamine, and pseudoephedrine with a sleeping pill, narcotic pain medicine, muscle relaxer, or medicine for anxiety, depression, or seizures.
Where can I get more information?
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.
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