Acetaminophen, codeine, guaifenesin, and pseudoephedrine

Generic Name: acetaminophen, codeine, guaifenesin, and pseudoephedrine (a SEET oh MIN oh fen, KOE deen, gwye FEN e sin, SOO doe ee FED rin)Brand Names: Maxiflu CD, Maxiflu CDX

What is acetaminophen, codeine, guaifenesin, and pseudoephedrine?

Acetaminophen is a pain reliever and fever reducer.

Codeine is a narcotic cough suppressant.

Guaifenesin is an expectorant. It helps loosen mucus congestion in your chest and throat, making it easier to cough out through your mouth.

Pseudoephedrine is a decongestant that shrinks blood vessels in the nasal passages. Dilated blood vessels can cause nasal congestion (stuffy nose).

The combination of acetaminophen, codeine, guaifenesin, and pseudoephedrine is used to treat stuffy nose, cough, pain and fever, and to reduce chest congestion caused by upper respiratory infections or the common cold.

Acetaminophen, codeine, guaifenesin, and pseudoephedrine may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about acetaminophen, codeine, guaifenesin, and pseudoephedrine?

Do not take 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. Serious, life-threatening side effects can occur if you take a cough and cold medicine before the MAO inhibitor has cleared from your body.

Do not take more of this medication than is recommended. An overdose of acetaminophen can cause damage to your liver. The maximum amount of acetaminophen for adults is 1 gram (1000 mg) per dose and 4 grams (4000 mg) per day. If you drink more than three alcoholic beverages per day, do not take this medication without your doctor's advice, and never take more than 2 grams (2000 mg) of acetaminophen per day.

Do not use any other cough, cold, or allergy 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 are using to see if it contains acetaminophen (sometimes abbreviated as "APAP"), guaifenesin, or pseudoephedrine.

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.

What should I discuss with my health care provider before taking acetaminophen, codeine, guaifenesin, and pseudoephedrine?

Do not use a cough or 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 cough or cold medicine before the MAO inhibitor has cleared from your body. You should not use acetaminophen, codeine, guaifenesin, and pseudoephedrine if you have ever had an allergic reaction to it, or if you have:
  • severe or uncontrolled high blood pressure;

  • severe coronary artery disease;

  • enlarged prostate; or

  • if you are breast-feeding a baby.

If you have any of these other conditions, you may need a dose adjustment or special tests to safely take acetaminophen, codeine, guaifenesin, and pseudoephedrine:

  • heart disease or high blood pressure;

  • ischemic heart disease (reduced circulation of blood to the heart);

  • asthma, COPD, or other breathing disorder;

  • diabetes;

  • glaucoma;

  • a history of head injury or brain tumor;

  • epilepsy or other seizure disorder;

  • a thyroid disorder;

  • kidney or liver disease;
  • urination problems;

  • a stomach or intestinal disorder;

  • Addison's disease or other adrenal gland disorders; or

  • if you have recently had surgery on your stomach, intestines, kidney, or bladder.

FDA pregnancy category C. It is not known whether this medication is harmful to an unborn baby. Codeine can cause breathing problems or addiction/withdrawal symptoms in a newborn. Before taking this medication, tell your doctor if you are pregnant or plan to become pregnant during treatment. This medication can pass into breast milk and may harm a nursing baby. The use of codeine by some nursing mothers may lead to life-threatening side effects in the baby. Do not use this medication if you are breast-feeding a baby. Codeine may be habit-forming and should be used only by the person it was prescribed for. This medication should never be shared with another person, especially someone who has a history of drug abuse or addiction. Keep the medication in a secure place where others cannot get to it. Older adults may be more likely to have side effects from this medication.

How should I take acetaminophen, codeine, guaifenesin, and pseudoephedrine?

Take this medication exactly as it was prescribed for you. Do not take it in larger amounts, or use it for longer than recommended by your doctor. Follow the directions on your prescription label. Cough and cold medicine is usually taken for only a short time until your symptoms clear up.

Take guaifenesin with food if it upsets your stomach. 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. 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. Call your doctor if your cough does not improve after 5 days of treatment, or if you also have a fever.

This medication can cause you to have unusual results with certain medical tests. Tell any doctor who treats you that you are using acetaminophen, codeine, guaifenesin, and pseudoephedrine.

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

Keep track of how many pills have been used from each bottle of this medication. Codeine is a drug of abuse and you should be aware if any person in the household is using this medicine improperly or without a prescription.

See also: Acetaminophen, codeine, guaifenesin, and pseudoephedrine dosage in more detail

What happens if I miss a dose?

Since cough or cold medicine is usually taken only as 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. 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 extreme dizziness or drowsiness, feeling restless or excited, hallucinations, nausea, vomiting, stomach pain, loss of appetite, increased sweating, blue-colored lips or fingernails, pinpoint pupils, seizure (convulsions), fainting, or fast or slow breathing (breathing may stop).

What should I avoid while taking acetaminophen, codeine, guaifenesin, and pseudoephedrine?

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, pain, or allergy medication without first asking your doctor or pharmacist. Acetaminophen (sometimes abbreviated as "APAP"), guaifenesin, and pseudoephedrine 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, guaifenesin, or pseudoephedrine.

Avoid drinking alcohol. It can increase some side effects of codeine, and increases 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) of acetaminophen per day. Avoid exposure to sunlight or artificial UV rays (sunlamps or tanning beds). This medication can make your skin more sensitive to sunlight and sunburn may result. Use a sunscreen (minimum SPF 15) and wear protective clothing if you must be out in the sun.

Acetaminophen, codeine, guaifenesin, and pseudoephedrine 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 a serious side effect such as:
  • fast, pounding, or uneven heartbeat;

  • slow heart rate, weak pulse, fainting, weak or shallow breathing;

  • confusion, hallucinations, unusual thoughts or behavior;

  • severe dizziness, anxiety, restless feeling, or nervousness;

  • urinating less than usual or not at all;

  • increased blood pressure (severe headache, blurred vision, trouble concentrating, chest pain, numbness, seizure); 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;

  • constipation;

  • mild nausea, vomiting, or stomach upset;

  • mild loss of appetite;

  • mild itching or skin rash;

  • warmth, tingling, or redness under your skin;

  • increased sweating;

  • feeling excited or restless; or

  • sleep problems (insomnia).

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.

Acetaminophen, codeine, guaifenesin, and pseudoephedrine Dosing Information

Usual Adult Dose for Cough and Nasal Congestion:

APAP/codeine/guaifenesin/pseudoephedrine 500 mg-10 mg-400 mg-40 mg oral tablet:1 tablet orally every 4 to 6 hours not to exceed 6 tablets daily.APAP/codeine/guaifenesin/pseudoephedrine 500 mg-20 mg-400 mg-60 mg oral tablet:1 tablet orally every 4 to 6 hours not to exceed 4 tablets daily.

Usual Pediatric Dose for Cough and Nasal Congestion:

APAP/codeine/guaifenesin/pseudoephedrine 500 mg-10 mg-400 mg-40 mg oral tablet:6 to 11 years: 1/2 tablet orally every 4 to 6 hours not to exceed 3 tablets daily.12 years or older: 1 tablet orally every 4 to 6 hours not to exceed 6 tablets daily.APAP/codeine/guaifenesin/pseudoephedrine 500 mg-20 mg-400 mg-60 mg oral tablet:6 to 11 years: 1/2 tablet orally every 4 to 6 hours not to exceed 2 tablets daily.12 years or older: 1 tablet orally every 4 to 6 hours not to exceed 4 tablets daily.

What other drugs will affect acetaminophen, codeine, guaifenesin, and pseudoephedrine?

Before taking this medication, tell your doctor if you regularly use other medicines that make you sleepy (such as narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression, or anxiety). They can add to sleepiness caused by codeine or guaifenesin.

Also tell your doctor about all other medicines you use, especially:

  • indomethacin (Indocin);

  • methyldopa (Aldomet);

  • medicines to treat high blood pressure;

  • a beta-blocker such as atenolol (Tenormin), carteolol (Cartrol), metoprolol (Lopressor, Toprol), nadolol (Corgard), propranolol (Inderal), sotalol (Betapace), timolol (Blocadren), and others; or

  • an antidepressant such as amitriptyline (Elavil), clomipramine (Anafranil), imipramine (Janimine, Tofranil), and others.

This list is not complete and there may be other drugs that can interact with codeine and pseudoephedrine. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

Where can I get more information?

  • Your pharmacist can provide more information about acetaminophen, codeine, guaifenesin, 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 1996-2006 Cerner Multum, Inc. Version: 1.04. Revision Date: 11/17/2009 11:06:56 AM.