| acetaminophen, dextromethorphan, guaifenesin, and phenylephrine |
| Pronunciation: a SEET oh MIN oh fen, DEX troe me THOR fan, gwye FEN e sin, FEN il EFF rin |
| Brand: Cold & Cough PE, Non-Pseudo Cold Relief, Phenflu DM, Sudafed PE Cold & Cough, Tylenol Cold Head Congestion Severe, Tylenol Cold Multi-Symptom Severe, Tylenol Cold Multi-Symptom Severe Daytime |
| What is the most important information I should know about acetaminophen, dextromethorphan, guaifenesin, and phenylephrine? |
 | • |
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. |
 | • |
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, guaifenesin, or phenylephrine. |
 | • |
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 and guaifenesin will not treat a cough that is caused by smoking or emphysema. |
| What is acetaminophen, dextromethorphan, guaifenesin, and phenylephrine? |
| • |
Acetaminophen is a pain reliever and fever reducer. |
| • |
Dextromethorphan is a cough suppressant. It affects the signals in the brain that trigger cough reflex. |
| • |
Guaifenesin is an expectorant. It helps loosen congestion in your chest and throat, making it easier to cough up. |
| • |
Phenylephrine 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, guaifenesin, and phenylephrine is used to treat stuffy nose, sinus congestion, cough, chest congestion, and pain or fever caused by the common cold or flu, or conditions such as bronchitis or sinusitis. |
| • |
Dextromethorphan and guaifenesin will not treat a cough that is caused by smoking or emphysema. |
| • |
Acetaminophen, dextromethorphan, guaifenesin, and phenylephrine may also be used for purposes not listed in this medication guide. |
| What should I discuss with my healthcare provider before taking acetaminophen, dextromethorphan, guaifenesin, and phenylephrine? |
| • |
Do not take this medication if you are allergic to acetaminophen, dextromethorphan, guaifenesin, or phenylephrine. |
| • |
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. |
| • |
Ask a doctor or pharmacist if it is safe for you to take this medicine if you have: |
|
· |
alcoholism or cirrhosis of the liver; |
|
· |
heart disease or high blood pressure; |
|
· |
an enlarged prostate or urination problems; |
 | • |
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. |
| • |
Older adults may be more sensitive to the effects of this medication. |
| • |
The liquid form of this medicine may contain sugar or phenylalanine. Talk to your doctor before using this form if you have diabetes or phenylketonuria (PKU). |
| How should I take acetaminophen, dextromethorphan, guaifenesin, and phenylephrine? |
| • |
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. Cold medicine is usually taken only for a short time until your symptoms clear up. |
| • |
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. Ask a doctor before taking acetaminophen if you drink more than 3 alcoholic beverages per day, and never take more than 2 grams (2000 mg) of acetaminophen per day. |
| • |
One packet of the oral powder may contain up to 1000 mg of acetaminophen. Know the amount of acetaminophen in the specific product you are taking. |
| • |
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. |
| • |
You may take this medicine with or without food. |
| • |
Measure liquid 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. |
 | • |
Drink extra fluids to help loosen the congestion and lubricate your throat while you are taking this medication. |
| • |
Talk with your doctor if your symptoms do not improve after a few days of using this medication, or if you have: |
|
· |
nervous feeling, dizziness, or trouble sleeping; |
|
· |
a severe sore throat lasting longer than 2 days; |
|
· |
pain, stuffy nose, or cough lasting longer than 7 days; |
|
· |
a fever with headache, nausea, vomiting, or skin rash; |
|
· |
redness or swelling; or |
|
· |
any other new or worsening symptoms. |
| • |
This medication can cause unusual results with certain medical tests. Tell any doctor who treats you that you are taking this medicine. |
| • |
If you need surgery, tell the surgeon ahead of time if you have taken a cold medicine within the past few days. |
 | • |
Store at room temperature, away from moisture, heat, and light. |
| What happens if I miss a dose? |
| • |
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 damage your liver. |
| • |
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. |
| • |
Overdose symptoms may also include agitation, confusion, hallucinations, or seizure (convulsions). |
| What should I avoid while taking acetaminophen, dextromethorphan, guaifenesin, and phenylephrine? |
 | • |
This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. |
| • |
Ask a doctor or pharmacist before using any other cough, cold, allergy, or pain medication. Acetaminophen (sometimes abbreviated as "APAP"), dextromethorphan, guaifenesin, and phenylephrine 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, dextromethorphan, guaifenesin, or phenylephrine. |
| • |
Avoid drinking alcohol. It may increase your risk of liver damage. |
| What are the possible side effects of acetaminophen, dextromethorphan, guaifenesin, and phenylephrine? |
| • |
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 a serious side effect such as: |
|
· |
fast, slow, or uneven heartbeat; |
|
· |
nervousness, tremors, mood changes, or confusion; |
|
· |
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: |
|
· |
feeling restless or nervous; |
|
· |
sleep problems (insomnia); or |
| • |
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, guaifenesin, and phenylephrine? |
| • |
Before using this medicine, tell your doctor if you regularly use other medicines that make you sleepy (such as other 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 acetaminophen, dextromethorphan, guaifenesin, and phenylephrine. |
| • |
Tell your doctor about all other medicines you use, especially: |
|
· |
a blood thinner such as warfarin (Coumadin); |
|
· |
isoniazid (for treating tuberculosis); |
|
· |
an antidepressant such as amitriptyline (Elavil, Vanatrip), doxepin (Sinequan), nortriptyline (Pamelor), and others; or |
|
· |
a beta-blocker such as atenolol (Tenormin, Tenoretic), carvedilol (Coreg), labetalol (Normodyne, Trandate), metoprolol (Lopressor, Toprol), nadolol (Corgard), propranolol (Inderal, InnoPran), sotalol (Betapace), and others. |
| • |
This list is not complete and other drugs may interact with acetaminophen, dextromethorphan, guaifenesin, and phenylephrine. 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. |
| Where can I get more information? |
| • |
Your pharmacist can provide more information about acetaminophen, dextromethorphan, guaifenesin, and phenylephrine. |
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: 2.03. Revision Date: 12/15/2010.
