Analgesic/antitussive/decongestant (By mouth)

Treats the symptoms of cold and flu, such as cough, sore throat, fever, runny or stuffy nose, and body aches.

Brand Name(s):

Children's Tylenol Plus Cold & Cough, Comtrex Cold & Cough, Contac Severe Cold & Flu/Non-Drowsy, Day Time, Good Neighbor Pharmacy Day Time Cold & Flu, Good Neighbor Pharmacy Flu Relief Therapy, Good Sense Daytime Flu & Severe Cold & Cough, Good Sense Flu Relief Therapy, Leader Cold Multi-Symptom, Leader Pain Relief Cold PE, Rite Aid DayTime Cold/Flu Formula, Theraflu Day & Night Relief Value Pack, Theraflu Daytime Severe Cold & Cough, Theraflu ExpressMax Severe Cold & Cough Daytime, Theraflu ExpressMax Severe Cold & Cough Value Pack

There may be other brand names for this medicine.

When This Medicine Should Not Be Used:

You should not use this medicine if you have had an allergic reaction to any type of cold medicine, or if you have severe high blood pressure or coronary artery disease. Do not use this medicine if you have taken an MAO inhibitor such as Eldepryl®, Marplan®, Nardil®, or Parnate® within the past 14 days. Do not give any over-the-counter (OTC) cough and cold medicine to a baby or child under 4 years old. Using these medicines in very young children might cause serious or possibly life-threatening side effects.

How to Use This Medicine:

Liquid, Packet, Tablet, Capsule

Your doctor will tell you how much medicine to use. Do not use more than directed. It is not safe to take more than 4 grams (4,000 milligrams) of acetaminophen in one day (24 hours).
Follow the instructions on the medicine label if you are using this medicine without a prescription.
Do not take more than 4 doses of this medicine (8 tablespoons) in one day.
Measure this medicine with the medicine cup provided in the package, or with a marked measuring spoon or oral syringe.

If a dose is missed:

Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose.

How to Store and Dispose of This Medicine:

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.
Ask your pharmacist, doctor, or health caregiver about the best way to dispose of any outdated medicine or medicine no longer needed.
Keep all medicine out of the reach of children. Never share your medicine with anyone.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

Do not drink alcohol while you are using this medicine. Acetaminophen can damage your liver and drinking alcohol can increase this risk. If you regularly drink 3 or more alcoholic drinks every day, do not take acetaminophen without asking your doctor.
Do not also use other medicines that contain acetaminophen, or you may be getting more than a safe amount of this medicine. Many combination medicines contain acetaminophen, including products with brand names such as Alka-Seltzer Plus®, Comtrex®, Drixoral®, Excedrin Migraine®, Midol®, Sinutab®, Sudafed®, Theraflu®, and Vanquish®. Carefully check the labels of all other medicines you are using to be sure they do not also contain acetaminophen.
Tell your doctor if you use anything else that makes you sleepy. Some examples are allergy medicine, narcotic pain medicine, and alcohol.

Warnings While Using This Medicine:

Make sure your doctor knows if you are pregnant or breast feeding. Tell your doctor if you have heart disease, liver disease, diabetes, thyroid problems, glaucoma, high blood pressure, or an enlarged prostate. Your doctor should know if you smoke or have asthma, emphysema, bronchitis, or a chronic cough.
Do not give this medicine to a child under 12 years old unless your doctor tells you to.
Call your doctor if your symptoms do not improve or if they get worse.
This medicine may make you dizzy or drowsy. Avoid driving, using machines, or doing anything else that could be dangerous if you are not alert.
Tell any doctor or dentist who treats you that you are using this medicine. This medicine may affect certain medical test results.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
Dark-colored urine or pale stools.
Fever that lasts longer than 3 days.
Lightheadedness, fainting, weakness, sweating.
Nausea, vomiting, loss of appetite, pain in your upper stomach.
Ongoing cough with headache and skin rash.
Redness, swelling, or any new symptoms.
Unusual bleeding or bruising.
Vomiting blood or material that looks like coffee grounds.
Yellowing of your skin or the whites of your eyes.

If you notice these less serious side effects, talk with your doctor:

Nervousness, dizziness, or drowsiness.
Trouble sleeping.

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088

Last Updated: 1/27/2017