Acetaminophen, dextromethorphan, guaifenesin, and phenylephrine

Name: Acetaminophen, dextromethorphan, guaifenesin, and phenylephrine

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 out through your mouth.

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

Acetaminophen, dextromethorphan, guaifenesin, and phenylephrine is a combination medicine used to treat headache, fever, body aches, cough, chest congestion, stuffy nose, and sinus congestion caused by allergies, the common cold, or the flu.

This medicine will not treat a cough that is caused by smoking, asthma, or emphysema.

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

What is the most important information I should know about this medicine?

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.

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 happens if I miss a dose?

Since this medicine is used when needed, you may not be on a dosing schedule. If you are on a schedule, use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

What are some other side effects of this drug?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

  • Dizziness.
  • Feeling nervous and excitable.
  • Not able to sleep.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Usual Adult Dose for Cold Symptoms

Acetaminophen/dextromethorphan/guaifenesin/PE 325 mg-10 mg-200 mg-5 mg oral tablet, or
Acetaminophen/dextromethorphan/guaifenesin/PE 325 mg-10 mg-100 mg-5 mg oral tablet:
2 tablets orally every 4 hours not to exceed 12 tablets daily.

Acetaminophen/dextromethorphan/guaifenesin/PE 500 mg-20 mg-400 mg-10 mg oral tablet:
1 tablet orally every 4 to 6 hours not to exceed 6 tablets daily.

Acetaminophen/dextromethorphan/guaifenesin/PE 325 mg-10 mg-200 mg-5 mg/15 mL oral liquid:
30 mL orally every 4 hours not to exceed 180 mL daily.

Acetaminophen/dextromethorphan/guaifenesin/PE 650 mg-20 mg-400 mg-10 mg/20 mL oral liquid:
20 mL orally every 4 hours not to exceed 6 doses (120 mL) daily

Usual Pediatric Dose for Cold Symptoms

Acetaminophen/dextromethorphan/guaifenesin/PE 325 mg-10 mg-200 mg-5 mg oral tablet, or
Acetaminophen/dextromethorphan/guaifenesin/PE 325 mg-10 mg-100 mg-5 mg oral tablet:
12 years or older: 2 tablets orally every 4 hours not to exceed 12 tablets daily.

Acetaminophen/dextromethorphan/guaifenesin/PE 500 mg-20 mg-400 mg-10 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.

Acetaminophen/dextromethorphan/guaifenesin/PE 325 mg-10 mg-200 mg-5 mg/10 mL oral liquid:
6 to 11 years: 10 mL orally every 4 hours not to exceed 50 mL daily.
Acetaminophen/dextromethorphan/guaifenesin/PE 325 mg-10 mg-200 mg-5 mg/15 mL oral liquid:
12 years or older: 30 mL orally every 4 hours not to exceed 180 mL daily.

Acetaminophen/dextromethorphan/guaifenesin/PE 650 mg-20 mg-400 mg-10 mg/20 mL oral liquid:
12 years or older: 20 mL orally every 4 hours not to exceed 6 doses (120 mL) daily

Usual Pediatric Dose for Influenza

Acetaminophen/dextromethorphan/guaifenesin/PE 325 mg-10 mg-200 mg-5 mg oral tablet, or
Acetaminophen/dextromethorphan/guaifenesin/PE 325 mg-10 mg-100 mg-5 mg oral tablet:
12 years or older: 2 tablets orally every 4 hours not to exceed 12 tablets daily.

Acetaminophen/dextromethorphan/guaifenesin/PE 500 mg-20 mg-400 mg-10 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.

Acetaminophen/dextromethorphan/guaifenesin/PE 325 mg-10 mg-200 mg-5 mg/10 mL oral liquid:
6 to 11 years: 10 mL orally every 4 hours not to exceed 50 mL daily.
Acetaminophen/dextromethorphan/guaifenesin/PE 325 mg-10 mg-200 mg-5 mg/15 mL oral liquid:
12 years or older: 30 mL orally every 4 hours not to exceed 180 mL daily.

Acetaminophen/dextromethorphan/guaifenesin/PE 650 mg-20 mg-400 mg-10 mg/20 mL oral liquid:
12 years or older: 20 mL orally every 4 hours not to exceed 6 doses (120 mL) daily

Liver Dose Adjustments

Data not available

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