ACETAMINOPHEN; PSEUDOEPHEDRINE (a set a MEE noe fen; soo doe e FED rin) treats the symptoms of the common cold, allergies, or flu. It works by reducing pain and fever. It also decreases a runny or stuffy nose. It is a combination of acetaminophen and a decongestant.

How should I use this medication?

Take this medication by mouth with water. Take it as directed on the label. You can take it with or without food. If it upsets your stomach, take it with food. Do not take it more often than directed. Talk to your care team about the use of this medication in children. While it may be given to children as young as 12 years of age for selected conditions, precautions do apply. People 65 years and older 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 medication is not for regular use. It should only be used as needed.

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 medication after the expiration date. To get rid of medications that are no longer needed or have expired: -Take the medication to a medication take-back program. Check with your pharmacy or law enforcement to find a location. -If you cannot return the medication, check the label or package insert to see if the medication should be thrown out in the garbage or flushed down the toilet. If you are not sure, ask your care team. If it is safe to put it in the trash, take the medication out of the container. Mix the medication 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 side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible: -Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat -Heart palpitations—rapid, pounding, or irregular heartbeat -Increase in blood pressure -Liver injury—right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, unusual weakness or fatigue -Redness, blistering, peeling, or loosening of the skin, including inside the mouth Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome): -Anxiety, nervousness -Headache -Nausea -Trouble sleeping -Upset stomach

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.

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

They need to know if you have any of these conditions: -Diabetes -Frequently drink alcohol -Glaucoma -Heart disease -High blood pressure -Liver disease -Lung or breathing disease, such as COPD or asthma -Taken a MAOI, such as Marplan, Nardil, or Parnate in last 14 days -Thyroid disease -Trouble passing urine -An unusual or allergic reaction to acetaminophen, pseudoephedrine, other medications, foods, dyes, or preservatives -Pregnant or trying to get pregnant -Breastfeeding

What may interact with this medication?

Do not take this medication with any of the followings: -Ergot alkaloids, such as dihydroergotamine, ergotamine, methylergonovine -MAOIs, such as Marplan, Nardil, and Parnate This medication may also interact with the following: -Alcohol -Certain medications for depression, such as amitriptyline or nortriptyline -Imatinib -Isoniazid -Medications that cause drowsiness before a procedure -St. John's wort -Stimulant medications for ADHD, weight loss, or staying awake -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 care team for regular checks on your progress. Tell your care team if your symptoms do not start to get better or if they get worse. If you need to use this medication for more than 7 days, talk to your care team. Tell your care team if your fever lasts more than 3 days. Do not take other medications that contain acetaminophen with this medication. Many non-prescription medications contain acetaminophen. Always read labels carefully. If you have questions, ask your care team. 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 medication may affect your coordination, reaction time, or judgment. Do not drive or operate machinery until you know how this medication affects you. Sit up or stand slowly to reduce the risk of dizzy or fainting spells. Drinking alcohol with this medication can increase the risk of these side effects. This medication may cause serious skin reactions. They can happen weeks to months after starting the medication. Contact your care team 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. You may also notice a red rash with swelling of the face, lips, or lymph nodes in your neck or under your arms.