Cold & Cough PE

Generic Name: acetaminophen, dextromethorphan, guaifenesin, phenylephrine (a SEET oh MIN oh fen, DEX troe me THOR fan, gwye FEN e sin, FEN il EFF rin)Brand Names: 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 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 other purposes not listed in this medication guide.

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 2 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 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.

Before using acetaminophen, dextromethorphan, guaifenesin, and phenylephrine, 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;
kidney disease;
asthma or emphysema;
glaucoma;
an enlarged prostate or urination problems;
diabetes; or
a thyroid disorder.

If you have any of these conditions, you may need a dose adjustment or special tests to safely take this medication.

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 this medication exactly as directed on the label, or as it has been prescribed by your doctor. Do not use the medication in larger amounts, or use it for longer than recommended. Cold medicine is usually taken only for a short time until your symptoms clear up.

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. 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 2 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 you to have unusual results with certain medical tests. Tell any doctor who treats you that you are taking this medicine..

If you need to have any type of surgery, tell the surgeon ahead of time if you have taken a cold medicine within the past few days.

Store the medicine at room temperature, away from heat, light, and moisture.

What happens if I miss a dose?

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.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine.

Overdose symptoms may include agitation, confusion, hallucinations, or seizure (convulsions).

What should I avoid while taking acetaminophen, dextromethorphan, guaifenesin, and phenylephrine?

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, guaifenesin, and phenylephrine 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, 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) of acetaminophen per day.

Acetaminophen, dextromethorphan, guaifenesin, and phenylephrine 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, slow, or uneven heartbeat;
nervousness, tremors, mood changes, or confusion;
unusual weakness; or
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:

dizziness, drowsiness;
headache;
feeling restless or nervous;
sleep problems (insomnia); or
nausea.

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?

Narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression or anxiety can add to sleepiness caused by acetaminophen, dextromethorphan, guaifenesin, and phenylephrine. Tell your doctor if you regularly use any of these medicines, or any other cold or allergy medication.

Before taking this medication, tell your doctor if you are using any of the following drugs:

a blood thinner such as warfarin (Coumadin);
isoniazid;
memantine;
methyldopa;
reserpine;
an antidepressant such as amitriptyline (Elavil, Etrafon), amoxapine (Asendin), clomipramine (Anafranil), desipramine (Norpramin), doxepin (Sinequan), imipramine (Janimine, Tofranil), nortriptyline (Pamelor), protriptyline (Vivactil), or trimipramine (Surmontil); or
a beta-blocker such as atenolol (Tenormin), carteolol (Cartrol), metoprolol (Lopressor, Toprol), nadolol (Corgard), propranolol (Inderal), sotalol (Betapace), timolol (Blocadren), and others.

This list is not complete and there may be other drugs that can interact with acetaminophen, dextromethorphan, guaifenesin, and phenylephrine. 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?

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.
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