Medications and Drugs

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Brand Names: Cold & Cough PE, Non-Pseudo Cold Relief, Phenflu DM, Sudafed PE Cold & Cough, Tylenol Cold Head Congestion Severe, Tylenol Cold Multi-Symptom Severe, Tylenol Cold Multi-Symptom Severe Daytime

Generic Name: acetaminophen, dextromethorphan, guaifenesin, phenylephrine (Pronunciation: a SEET oh MIN oh fen, DEX troe me THOR fan, gwye FEN e sin, FEN il EFF rin)

• What is acetaminophen, dextromethorphan, guaifenesin, and phenylephrine (Cold & Cough PE, Non-Pseudo Cold Relief, Phenflu DM, Sudafed PE Cold & Cough, Tylenol Cold Head Congestion Severe, Tylenol Cold Multi-Symptom Severe, Tylenol Cold Multi-Symptom Severe Daytime)?
• What are the possible side effects of acetaminophen, dextromethorphan, guaifenesin, and phenylephrine?
• What is the most important information I should know about acetaminophen, dextromethorphan, guaifenesin, and phenylephrine?
• What should I discuss with my healthcare provider before taking acetaminophen, dextromethorphan, guaifenesin, and phenylephrine?
• How should I take acetaminophen, dextromethorphan, guaifenesin, and phenylephrine?
• What happens if I miss a dose?
• What happens if I overdose?
• What should I avoid while taking acetaminophen, dextromethorphan, guaifenesin, and phenylephrine?
• What other drugs will affect acetaminophen, dextromethorphan, guaifenesin, and phenylephrine?
• Where can I get more information?

What is acetaminophen, dextromethorphan, guaifenesin, and phenylephrine (Cold & Cough PE, Non-Pseudo Cold Relief, Phenflu DM, Sudafed PE Cold & Cough, Tylenol Cold Head Congestion Severe, Tylenol Cold Multi-Symptom Severe, Tylenol Cold Multi-Symptom Severe Daytime)?

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 up.

Phenylephrine is a decongestant. It constricts (shrinks) blood vessels (veins and arteries). This reduces the blood flow to certain areas, which decreases swelling and allows nasal and respiratory (breathing) passages to open up.

The combination of acetaminophen, dextromethorphan, guaifenesin, and phenylephrine is used to treat stuffy nose, sinus congestion, cough, chest congestion, and pain or fever caused by the common cold or flu, or conditions such as bronchitis or sinusitis.

Dextromethorphan and guaifenesin will not treat a cough that is caused by smoking or emphysema.

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

What are the possible side effects of acetaminophen, dextromethorphan, guaifenesin, and phenylephrine?

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 any of these serious side effects:

• fast, slow, or uneven heartbeat;
• nervousness, tremors, mood changes, or confusion;
• unusual weakness; 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;
• feeling restless or nervous;
• sleep problems (insomnia); or
• nausea.

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.

What is the most important information I should know about acetaminophen, dextromethorphan, guaifenesin, and phenylephrine?

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.

Do not use 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.

Do not take more of this medication than is recommended. An overdose of acetaminophen can cause damage to your liver.

Do not use any other cough, cold, allergy, or pain 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 take to see if it contains acetaminophen (sometimes abbreviated as "APAP"), dextromethorphan, guaifenesin, or phenylephrine.

Avoid drinking alcohol. It can increase the risk of liver damage while you are 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) per day.

Dextromethorphan and guaifenesin will not treat a cough that is caused by smoking or emphysema.