Acetaminophen; Dextromethorphan; Guaifenesin; Pseudoephedrine Tablets

What is this medication?

ACETAMINOPHEN; DEXTROMETHORPHAN; GUAIFENESIN; PSEUDOEPHEDRINE (a set a MEE noe fen; dex troe meth OR fan; gwye FEN e sin; soo doe e FED rin) is a combination of an analgesic, cough suppressant, expectorant, and decongestant. It is used to treat fever and the symptoms of colds. This medicine will not treat an infection.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): Duraflu, Flutabs, Maxiflu DM, Maxiflu-G, Tylenol Severe Congestion Daytime

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Diabetes (high blood sugar)
• Heart disease
• High blood pressure
• If you often drink alcohol
• Kidney disease
• Liver disease
• Lung or breathing disease (asthma, COPD)
• Prostate disease
• Taken a MAOI like Marplan, Nardil, or Parnate in last 14 days
• Thyroid disease
• An unusual or allergic reaction to acetaminophen, dextromethorphan, guaifenesin, pseudoephedrine, other medicines, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breastfeeding

How should I use this medication?

Take this medicine by mouth with water. Take it as directed on the label. Do not use it more often than directed.

Talk to your health care provider about the use of this medicine in children. While it may be given to children for selected conditions, precautions do apply.

Patients over 65 years of age may have a stronger reaction and need a smaller dose.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

This does not apply. This medicine is not for regular use. It should only be used as needed.

What may interact with this medication?

Do not take this medicine with any of the following medications:

• Ergot alkaloids like dihydroergotamine, ergonovine, ergotamine, methylergonovine
• MAOIs like Marplan, Nardil, and Parnate
• Ozanimod

This medicine may also interact with the following medications:

• Certain medicines that treat or prevent blood clots like warfarin

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your health care provider for regular checks on your progress. Tell your health care provider if your symptoms do not start to get better or if they get worse. If you need to use this medicine for more than 7 days, talk to your health care provider.

Do not take other medicines that contain acetaminophen with this medicine. Many non-prescription medicines contain acetaminophen. Always read labels carefully. If you have questions, ask your health care provider.

If you take too much acetaminophen, get medical help right away. Too much acetaminophen can be very dangerous and cause liver damage. Even if you do not have symptoms, it is important to get help right away.

This medicine may cause serious skin reactions. They can happen weeks to months after starting the medicine. Contact your health care provider right away if you notice fevers or flu-like symptoms with a rash. The rash may be red or purple and then turn into blisters or peeling of the skin. Or, you might notice a red rash with swelling of the face, lips or lymph nodes in your neck or under your arms.

What side effects may I notice from receiving this medication?

Side effects that you should report to your doctor or health care professional as soon as possible:

• Allergic reactions (skin rash, itching or hives, swelling of the face, lips, or tongue)
• Increase in blood pressure
• Liver injury (dark yellow or brown urine; general ill feeling or flu-like symptoms; loss of appetite, right upper belly pain; unusually weak or tired, yellowing of the eyes or skin).
• Light-colored stool
• Redness, blistering, peeling, or loosening of the skin, including inside the mouth
• Seizures
• Serotonin syndrome (irritable; confusion; diarrhea; fast or irregular heartbeat; muscle twitching; stiff muscles; trouble walking; sweating; high fever; seizures; chills; vomiting)

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• Anxious
• Dizziness
• Headache
• Trouble sleeping

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children and pets.

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Get rid of any unused medicine after the expiration date.

To get rid of medicines that are no longer needed or have expired:

• Take the medicine to a medicine take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medicine, check the label or package insert to see if the medicine should be thrown out in the garbage or flushed down the toilet. If you are not sure, ask your health care provider. If it is safe to put it in the trash, take the medicine out of the container. Mix the medicine with cat litter, dirt, coffee grounds, or other unwanted substance. Seal the mixture in a bag or container. Put it in the trash.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

What’s in Duraflu?

Duraflu™ is a brand name of medication that contains four active ingredients:

• Acetaminophen, a pain reliever and fever reducer
• Dextromethorphan, a cough suppressant that helps calm your cough reflex
• Guaifenesin, an expectorant that thins mucus in your airways so it can come up more easily
• Pseudoephedrine, a nasal decongestant that reduces swelling in your nasal cavities so you can breathe more easily through your nose

Duraflu is a combination medicine. This means it contains multiple active ingredients to temporarily ease your symptoms. As with any medication, talk to a healthcare provider to make sure all of the ingredients are safe for you. Your provider will also advise you on which medicines are OK to take along with Duraflu.

What is Duraflu prescribed for?

Your healthcare provider may recommend Duraflu or a similar medication to treat cold or flu symptoms like:

• Fever
• Headache
• Mild body aches
• Cough
• Stuffy nose

Is Duraflu available over the counter?

Sort of. You don’t need a prescription to get Duraflu, but it’s available behind the pharmacy counter. This means you need to ask a pharmacist for it and show your ID to purchase it. This is because Duraflu contains pseudoephedrine — an ingredient people have used to make methamphetamine (a type of amphetamine). Methamphetamine can be highly addictive, and misuse is dangerous.

As required by law, stores in the U.S. must keep all medications containing pseudoephedrine behind the counter. There’s also a limit on how much pseudoephedrine you can purchase within a month. The goal of these policies is to prevent pseudoephedrine misuse.

Talk to your provider if you have questions or concerns about getting Duraflu or other medications.

Is Duraflu the same as Tamiflu?

No, Duraflu and Tamiflu® are two very different medications. Duraflu treats cold or flu symptoms. It doesn’t treat the underlying cause (viral infection), and it doesn’t make your infection go away any sooner.

Tamiflu is a brand name of oseltamivir, which is a prescription antiviral medication. Tamiflu treats an influenza (flu) infection. It slows the spread of the virus in your body and shortens the amount of time you have symptoms. Providers also prescribe Tamiflu as a preventive (prophylactic) medication. This means you take it after exposure to the flu to reduce your chances of getting sick.

Is Duraflu an antibiotic?

No, Duraflu isn’t an antibiotic. It’s a nonprescription medication that temporarily relieves cold and flu symptoms. It doesn’t kill the germs that are causing your infection or prevent you from spreading the infection to others.

An antibiotic is a prescription medication that treats bacterial infections by killing bacteria or preventing the bacteria from multiplying. Antibiotics target the underlying cause of your infection to help you feel better. They also shorten the amount of time that you’re contagious.