Theraflu Nighttime Maximum Strength

Acetaminophen is a pain reliever and fever reducer. Chlorpheniramine is an antihistamine. Dextromethorphan is a cough suppressant. Pseudoephedrine is a decongestant.

Theraflu Nighttime Maximum Strength is a combination medicine used to treat headache, fever, body aches, cough, sore throat, runny or stuffy nose, sneezing, or sinus pressure caused by the flu or common cold.

Theraflu Nighttime Maximum Strength may also be used for purposes not listed 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 lead to death. Cold or cough medicine is only for short-term use until your symptoms improve.

Always follow the instructions on the medicine label when giving cough or cold medicine to a child. Do not use the medicine just to make a child sleepy. Misusing cough or cold medicines in very young children can lead to death.

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 the 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, inform 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 past 14 days. A dangerous drug interaction could occur. 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 to use if you have:

• liver disease, cirrhosis, alcoholism, or more than 3 alcoholic beverages per day;
• heart problems, high blood pressure;
• diabetes;
• glaucoma;
• an enlarged prostate or urination problems;
• a thyroid disorder; or
• cough with mucus, or 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 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 can happen even if you have taken acetaminophen before without any 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.

This medicine may cause serious side effects. Stop using this medicine and call your doctor immediately if you have:

• any new or worsening symptoms;
• severe drowsiness;
• fever for longer than 3 days;
• redness, swelling, or rash;
• ongoing headache; or
• pain, cough, or sinus congestion lasting more than 7 days;

Some side effects may be more likely in older adults.

Common side effects of Theraflu Nighttime Maximum Strength 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 Theraflu Nighttime Maximum Strength is taken as needed, you might not have a regular 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 once.

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 doing dangerous activities 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.

Do not use this medicine with other drugs that can make you drowsy or slow your breathing (like 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.