Comtrex Cold & Cough Side Effects

Generic name: acetaminophen / dextromethorphan / phenylephrine

Note: This document contains side effect information about acetaminophen / dextromethorphan / phenylephrine. Some of the dosage forms listed on this page may not apply to the brand name Comtrex Cold & Cough.

Some side effects of Comtrex Cold & Cough may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to acetaminophen / dextromethorphan / phenylephrine: oral capsule, oral liquid, oral powder for reconstitution, oral suspension, oral syrup, oral tablet

Get emergency medical help if you have any of these signs of an allergic reaction while taking acetaminophen / dextromethorphan / phenylephrine: 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:

• chest pain, fast, slow, or uneven heart rate;

• severe dizziness, feeling like you might pass out;

• mood changes, confusion, hallucinations;

• tremor, seizure (convulsions);

• fever;

• urinating less than usual or not at all;

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

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

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

Less serious side effects of acetaminophen / dextromethorphan / phenylephrine may include:

• dizziness, weakness;

• mild headache;

• mild nausea, diarrhea, upset stomach;

• dry mouth, nose, or throat;

• feeling nervous, restless, irritable, or anxious; 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.

For Healthcare Professionals

Applies to acetaminophen / dextromethorphan / phenylephrine: oral capsule, oral liquid, oral powder for reconstitution, oral suspension, oral syrup, oral tablet

Hepatic

Hepatic side effects of acetaminophen have included severe and sometimes fatal dose dependent hepatitis in alcoholic patients. Hepatotoxicity has been increased during fasting.

Nervous system

Nervous system side effects of dextromethorphan have included drowsiness and dizziness. Other side effects such as excitation, mental confusion, and opioid like respiratory depression have been rare and occurred at higher dosages. In some cases of abuse, patients experienced euphoria, hyperactivity, mania, and auditory and visual hallucinations.

Nervous system side effects of phenylephrine have included headache, dizziness, nervousness, restlessness, tremor, insomnia, convulsions, and central nervous system depression.

Cardiovascular

Cardiovascular side effects of phenylephrine have included palpitations, arrhythmias, and cardiovascular collapse with hypotension.

Gastrointestinal

Gastrointestinal side effects of dextromethorphan have included upset stomach.

Gastrointestinal side effects of phenylephrine have included nausea.

Hypersensitivity

Hypersensitivity side effects of dextromethorphan have included rare reports of fixed-drug eruptions.

Respiratory

Respiratory side effects of phenylephrine have included respiratory difficulty.

Genitourinary

Genitourinary side effects of phenylephrine have included dysuria.

General

General side effects of phenylephrine have included pallor and weakness.

Psychiatric

Psychiatric side effects of phenylephrine have included hallucinations, fear, and anxiety.

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