Acetaminophen, chlorpheniramine, dextromethorphan, and pseudoephedrine

Generic name: Acetaminophen, Chlorpheniramine, Dextromethorphan, And Pseudoephedrine
Drug class: Upper respiratory combinations

Usage of Acetaminophen, chlorpheniramine, dextromethorphan, and pseudoephedrine

Acetaminophen is a pain reliever and fever reducer. Chlorpheniramine is an antihistamine. Dextromethorphan is a cough suppressant. Pseudoephedrine is a decongestant.

Acetaminophen, chlorpheniramine, dextromethorphan, and pseudoephedrine is a combination medicine used to treat headache, fever, body aches, cough, sore throat, runny or stuffy nose, sneezing, or sinus pressure caused by the flu or common cold.

Acetaminophen, chlorpheniramine, dextromethorphan, and pseudoephedrine may also be used for purposes not listed in this medication guide.

Acetaminophen, chlorpheniramine, dextromethorphan, and pseudoephedrine side effects

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.

This medicine may cause serious side effects. Stop using this medicine and call your doctor at once if you have:

  • any new or worsening symptoms;
  • severe drowsiness;
  • fever for longer than 3 days;
  • redness, swelling, or rash;
  • ongoing headache; or
  • pain, cough, or sinus congestion lasting more than 7 days;

    • Some side effects may be more likely in older adults.

    Common side effects of acetaminophen, chlorpheniramine, dextromethorphan, and pseudoephedrine may include:

  • dizziness, drowsiness;
  • dry mouth, nose, or throat;
  • blurred vision;
  • constipation;
  • feeling restless or excited (especially in children); 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.

    Before taking Acetaminophen, chlorpheniramine, dextromethorphan, and 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, phenelzine, rasagiline, selegiline, and tranylcypromine.

    You should not use this medicine if you are allergic to acetaminophen, chlorpheniramine, dextromethorphan, or pseudoephedrine.

    Ask a doctor or pharmacist if this medicine is safe to use if you have:

  • liver disease, cirrhosis, alcoholism, or more than 3 alcoholic beverages per day;
  • heart problems, high blood pressure;
  • diabetes;
  • glaucoma;
  • an enlarged prostate or urination problems;
  • a thyroid disorder; or
  • cough with mucus, or cough caused by smoking, asthma, or emphysema.

    • Ask a doctor before using this medicine if you are pregnant or breastfeeding.

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    How to use Acetaminophen, chlorpheniramine, dextromethorphan, and pseudoephedrine

    Usual Adult Dose for Cold Symptoms:

    acetaminophen/chlorpheniramine/dextromethorphan/PSE varying strength oral kit:Day time tablets (without chlorpheniramine): 2 tablets every 6 hours during waking hours as needed.Night time tablets: 2 tablets every 6 hours during sleeping hours as needed. Not to exceed a total of 8 tablets/day of day and night tablets combined.

    Usual Adult Dose for Influenza:

    acetaminophen/chlorpheniramine/dextromethorphan/PSE varying strength oral kit:Day time tablets (without chlorpheniramine): 2 tablets every 6 hours during waking hours as needed.Night time tablets: 2 tablets every 6 hours during sleeping hours as needed. Not to exceed a total of 8 tablets/day of day and night tablets combined.

    Usual Pediatric Dose for Cold Symptoms:

    acetaminophen/chlorpheniramine/dextromethorphan/PSE varying strength oral kit:12 yrs and older: Day time tablets (without chlorpheniramine): 2 tablets every 6 hours during waking hours as needed.Night time tablets: 2 tablets every 6 hours during sleeping hours as needed. Not to exceed a total of 8 tablets/day of day and night tablets combined.

    Usual Pediatric Dose for Influenza:

    acetaminophen/chlorpheniramine/dextromethorphan/PSE varying strength oral kit:12 yrs and older: Day time tablets (without chlorpheniramine): 2 tablets every 6 hours during waking hours as needed.Night time tablets: 2 tablets every 6 hours during sleeping hours as needed. Not to exceed a total of 8 tablets/day of day and night tablets combined.

    Warnings

    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.

    An acetaminophen overdose can damage your liver or cause death. Call your doctor at once if you have stomach pain (upper right side), loss of appetite, tiredness, itching, dark urine, clay-colored stools, or yellowing of your skin or eyes.

    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.

    Do not use this medicine only to make a child sleepy.

    What other drugs will affect Acetaminophen, chlorpheniramine, dextromethorphan, and pseudoephedrine

    Avoid using this medicine with other drugs that cause drowsiness or slow your breathing (such as opioid medicine, a muscle relaxer, or medicine for anxiety or seizures). Ask a doctor or pharmacist before using any other medication, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed in this medication guide.

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