Comtrex Cold and Flu Maximum Strength Tablet

Acetaminophen helps reduce pain and fever. Chlorpheniramine is used to relieve allergy symptoms. Dextromethorphan helps control coughing. Pseudoephedrine works to relieve nasal congestion.

Comtrex Cold and Flu Maximum Strength Tablet is a combination medicine that treats headache, fever, body aches, cough, sore throat, runny or stuffy nose, sneezing, or sinus pressure caused by the flu or common cold.

Comtrex Cold and Flu Maximum Strength Tablet may also be used for other reasons not mentioned in this medication guide.

Use exactly as directed on the label, or as prescribed by your doctor. An acetaminophen overdose can harm your liver or cause death. Cold or cough medicine is only for short-term use until your symptoms go away.

Always follow the instructions on the medicine label about giving cough or cold medicine to a child. Do not use the medicine just to make a child sleepy. Death can happen from the misuse of cough or cold medicines in very young children.

You must chew the chewable tablet before swallowing it.

Measure liquid medicine carefully. Use the dosing syringe provided, or a medicine dose-measuring device (not a kitchen spoon).

Dissolve one packet of the powder in at least 4 ounces of water. Stir this mixture and drink all of it right away.

Call your doctor if you have a sore throat for more than 2 days, especially if you also have a fever, headache, rash, nausea, or vomiting.

If you need surgery or medical tests, tell the surgeon or doctor if you have taken this medicine in the past few days.

Store at room temperature away from moisture and heat. Do not let liquid medicine freeze.

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.

Do not use this medicine if you have taken an MAO inhibitor in the last 14 days. A dangerous interaction with the drug could happen. 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 for you to use if you have:

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

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

Get emergency medical help if you notice signs of an allergic reaction: hives; trouble breathing; swelling of your face, lips, tongue, or throat.

In rare cases, acetaminophen may cause a severe skin reaction that can be life-threatening. This can happen even if you have taken acetaminophen before and had no issues. Stop taking this medicine and call your doctor immediately if you notice skin redness or a rash that spreads and leads to blistering and peeling. If you have this kind of reaction, you should never take any medicine that contains acetaminophen again.

This medicine may cause serious side effects. Stop using this medicine and call your doctor right away if you experience:

• any new or worsening symptoms;
• severe drowsiness;
• fever lasting more than 3 days;
• redness, swelling, or rash;
• a headache that does not go away; or
• pain, cough, or sinus congestion that lasts more than 7 days;

Some side effects may be more likely in older adults.

Common side effects of Comtrex Cold and Flu Maximum Strength Tablet 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.

Since Comtrex Cold and Flu Maximum Strength Tablet is used as needed, you might not have a set dosing schedule. If you miss a dose and it's almost time for your next dose, just skip the missed dose. Do not take two doses at the same time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of acetaminophen can damage your liver or cause death.

Early signs of acetaminophen overdose include loss of appetite, nausea, vomiting, sweating, or weakness. Later symptoms may include upper stomach pain, dark urine, and yellowing of your skin or eyes.

Avoid drinking alcohol. It may increase your risk of liver damage.

Avoid driving or hazardous activity until you know how this medicine will affect you. Your reactions could be impaired.

Ask a doctor or pharmacist before using any other medicine that may contain acetaminophen (sometimes abbreviated as APAP). Taking too much acetaminophen can lead to a fatal overdose.

Avoid using this medicine with other drugs that can make you sleepy 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.