Acetaminophen; Dextromethorphan; Phenylephrine Capsule or Tablet

What is this medication?

ACETAMINOPHEN; DEXTROMETHORPHAN; PHENYLEPHRINE (a set a MEE noe fen; dex troe meth OR fan; fen il EF rin) is a combination of pain reliever, a cough suppressant, and a decongestant. It is used to treat the aches and pains, cough, and congestion of a cold. 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): Comtrex Cold and Cough, Mapap Multi-Symptom Cold, Sudafed PE Pressure + Pain + Cough, Theraflu ExpressMax Severe Cold & Cough, Theraflu Multi-Symptom Cold Daytime Warming, Theraflu Severe Cold Daytime, Tylenol Cold, Tylenol Cold Head Congestion Daytime, Tylenol Cold Multi-Symptom Daytime, Tylenol Cold Multi-Symptom Daytime Rapid Release, Vicks DayQuil Nature Fusion, Vicks Nature Fusion Cold & Flu

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

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

• asthma
• diabetes
• heart disease
• high blood pressure
• if you often drink alcohol
• liver disease
• taken a MAOI like Carbex, Eldepryl, Marplan, Nardil, or Parnate in last 14 days
• thyroid disease
• trouble passing urine
• an unusual or allergic reaction to acetaminophen, dextromethorphan, phenylephrine, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medication?

Take this medicine by mouth with a glass of water. Follow the directions on the package label. Do not cut, crush or chew this medicine. Take your medicine at regular intervals. Do not take it more often than directed.

Talk to your pediatrician regarding the use of this medicine in children. While this drug may be prescribed for children as young as 12 years of age for selected conditions, precautions do apply.

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?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medication?

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

•cocaine

•ergot alkaloids like dihydroergotamine, ergonovine, ergotamine, methylergonovine

•MAOIs like Carbex, Eldepryl, Marplan, Nardil, and Parnate

•stimulant medicines like dextroamphetamine and others

This medicine may also interact with the following medications:

•alcohol

•atomoxetine

•atropine

•bretylium

•digoxin

•furazolidone

•imatinib

•isoniazid

•linezolid

•maprotiline

•mecamylamine

•midodrine

•medicines for chest pain like isosorbide dinitrate, nitroglycerin

•medicines for depression, anxiety, or psychotic disturbances

•medicines for sleep during surgery

•other medicines for cold, cough or allergy

•other medicines with acetaminophen

•procarbazine

•St. John's Wort

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?

Tell your doctor or healthcare professional if your symptoms do not start to get better or if they get worse. Let your doctor know if you have pain, nasal congestion or cough that gets worse or lasts for more than 7 days. Call your doctor if you have a sore throat that gets worse or lasts for more than 2 days. Or, if you have a sore throat with a fever, rash, headache, nausea, or vomiting, see your doctor.

Do not take other medicines that contain acetaminophen with this medicine. Always read labels carefully. If you have questions, ask your doctor or pharmacist.

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.

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 like skin rash, itching or hives, swelling of the face, lips, or tongue

•chest pain, tightness

•dizziness, nervousness, or sleeplessness

•fast, irregular heartbeat

•trouble passing urine or change in the amount of urine

•unusual bleeding or bruising

•unusually weak or tired

•yellowing of skin or eyes

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

•drowsiness

•dry eyes, mouth

•loss of appetite

•stomach upset

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.

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Protect from moisture. Throw away any unused medicine after the expiration date.

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.