Acetaminophen, dextromethorphan, doxylamine, and phenylephrine

Name: Acetaminophen, dextromethorphan, doxylamine, and phenylephrine

What is acetaminophen, dextromethorphan, doxylamine, and phenylephrine?

Acetaminophen is a pain reliever and fever reducer.

Dextromethorphan is a cough suppressant. It affects the cough reflex in the brain that triggers coughing.

Doxylamine is an antihistamine that reduces the effects of natural chemical histamine in the body. Histamine can produce symptoms of sneezing, itching, watery eyes, and runny nose.

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

Acetaminophen, dextromethorphan, doxylamine, and phenylephrine is a combination medicine used to treat headache, fever, body aches, cough, runny nose, sneezing, itching, and watery eyes 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, doxylamine, 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, methylene blue injection, 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 taken when 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. 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 be fatal.

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.

This medicine 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.

Stop using this medicine and call your doctor at once if you have:

  • pounding heartbeats or fluttering in your chest;

  • a light-headed feeling, like you might pass out;

  • anxiety, hallucinations, feeling of fear;

  • little or no urinating;

  • pale skin, unusual weakness;

  • nausea, pain in your upper stomach, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of your skin or eyes); or

  • dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, chest pain, shortness of breath, uneven heartbeats, seizure).

Common side effects may include:

  • drowsiness;

  • constipation, diarrhea, upset stomach, vomiting; or

  • feeling restless or excited.

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, dextromethorphan, doxylamine, and phenylephrine dosing information

Usual Adult Dose for Cold Symptoms:

Acetaminophen/dextromethorphan/doxylamine/PE 250 mg-10 mg-6.25 mg-5 mg oral tablet, effervescent:
2 tablets at bedtime (may be taken up to every 4 hours). Dissolve tablets in 4 ounces of water.
Maximum dose: 8 tablets in 24 hours.
Acetaminophen/dextromethorphan/doxylamine/PE 325 mg-10 mg-6.25 mg-5 mg/15 mL oral liquid:
30 mL orally every 4 hours
Maximum dose: 180 mL in 24 hours
Acetaminophen/dextromethorphan/doxylamine/PE 650 mg-20 mg-12.5 mg-10 mg/30 mL oral liquid:
30 mL orally every 4 hours
Maximum dose: 120 mL (4 doses) in 24 hours

Usual Pediatric Dose for Cold Symptoms:

12 years and older:
Acetaminophen/dextromethorphan/doxylamine/PE 250 mg-10 mg-6.25 mg-5 mg oral tablet, effervescent:
2 tablets at bedtime (may be taken up to every 4 hours). Dissolve tablets in 4 ounces of water.
Maximum dose: 8 tablets in 24 hours.
Acetaminophen/dextromethorphan/doxylamine/PE 325 mg-10 mg-6.25 mg-5 mg/15 mL oral liquid:
30 mL orally every 4 hours
Maximum dose: 180 mL in 24 hours
Acetaminophen/dextromethorphan/doxylamine/PE 650 mg-20 mg-12.5 mg-10 mg/30 mL oral liquid:
30 mL orally every 4 hours
Maximum dose: 120 mL (4 doses) in 24 hours

For Healthcare Professionals

Applies to acetaminophen / dextromethorphan / doxylamine / phenylephrine: oral capsule, oral liquid, oral tablet, oral tablet effervescent

Cardiovascular

Cardiovascular side effects have included palpitations, arrhythmias, and cardiovascular collapse with hypotension.[Ref]

Dermatologic

Dermatologic side effects associated with acetaminophen includes the risk of rare but potentially fatal serious skin reactions known as Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and acute generalized exanthematous pustulosis (AGEP).

Gastrointestinal

Gastrointestinal side effects have included nausea and vomiting.[Ref]

Genitourinary

Genitourinary side effects have included dysuria.[Ref]

General

General side effects have included pallor and weakness.[Ref]

Hypersensitivity

Hypersensitivity side effects have included rare reports of fixed-drug eruptions.[Ref]

Nervous system

Nervous system side effects have included marked drowsiness and excitability.[Ref]

Psychiatric

Psychiatric side effects have included hallucinations, fear, and anxiety.[Ref]

Some side effects of acetaminophen / dextromethorphan / doxylamine / phenylephrine may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Usual Pediatric Dose for Cold Symptoms

12 years and older:
Acetaminophen/dextromethorphan/doxylamine/PE 250 mg-10 mg-6.25 mg-5 mg oral tablet, effervescent:
2 tablets at bedtime (may be taken up to every 4 hours). Dissolve tablets in 4 ounces of water.
Maximum dose: 8 tablets in 24 hours.
Acetaminophen/dextromethorphan/doxylamine/PE 325 mg-10 mg-6.25 mg-5 mg/15 mL oral liquid:
30 mL orally every 4 hours
Maximum dose: 180 mL in 24 hours
Acetaminophen/dextromethorphan/doxylamine/PE 650 mg-20 mg-12.5 mg-10 mg/30 mL oral liquid:
30 mL orally every 4 hours
Maximum dose: 120 mL (4 doses) in 24 hours

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