Consumer Information

Sudafed PE

Generic Name: acetaminophen, diphenhydramine, and phenylephrine (a see tah MIH no fen, dye fen HYE dra meen, and fen L ef fren)
Brand Names: Sudafed PE Severe Cold, Theraflu Warming Severe Cold Nighttime

What is Sudafed PE?

Acetaminophen is a pain reliever and a fever reducer. It is used to treat many conditions, including headache, muscle aches, arthritis, backache, toothaches, colds, and fevers.

Diphenhydramine is an antihistamine. It blocks the effects of the naturally occurring chemical histamine in the body. Diphenhydramine prevents sneezing; itchy, watery eyes and nose; and other symptoms of allergies and hay fever.

Phenylephrine is a decongestant. It constricts (shrinks) blood vessels (veins and arteries). This reduces the blood flow to certain areas, which decreases swelling and allows nasal and respiratory (breathing) passages to open up.

Sudafed PE is used to treat nasal congestion; itchy, watery eyes; itchy throat; sneezing; headache; fever; and other symptoms associated with allergies, hay fever, and the common cold.

Sudafed PE may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about Sudafed PE?

Use caution when driving, operating machinery, or performing other hazardous activities. Sudafed PE may cause dizziness or drowsiness. If you experience dizziness or drowsiness, avoid these activities. Use alcohol cautiously. Alcohol may increase drowsiness and dizziness while taking Sudafed PE. Alcohol and acetaminophen can also be damaging to the liver when used together.

Do not take Sudafed PE for longer than 7 days in a row. If your symptoms do not improve, if they get worse, or if you have a fever, talk to your doctor.

Do not take more Sudafed PE than is recommended. An overdose of Sudafed PE can cause serious harm.

Who should not take Sudafed PE?

Do not take Sudafed PE without first talking to your doctor if you drink more than three alcoholic beverages per day or if you have had alcoholic liver disease. You may not be able to take acetaminophen. Do not take Sudafed PE if you have taken a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), phenelzine (Nardil), or tranylcypromine (Parnate) in the last 14 days. A drug interaction could occur, leading to serious side effects.

Before taking Sudafed PE, tell your doctor if you have

kidney disease,
liver disease,
diabetes,
glaucoma,
heart disease or high blood pressure,
thyroid disease,
emphysema or chronic bronchitis, or
difficulty urinating or an enlarged prostate.

You may not be able to take Sudafed PE, or you may require a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above.

It is not known whether Sudafed PE will be harmful to an unborn baby. Do not take Sudafed PE without first talking to your doctor if you are pregnant or could become pregnant during treatment. Sudafed PE can pass into breast milk and may affect a nursing infant. Do not take this medication without first talking to your doctor if you are breast-feeding a baby. Read the package label for directions or consult your doctor or pharmacist before treating a child with this medication. Children are more susceptible than adults to the effects of medicines and may have unusual reactions. If you are over 60 years of age, you may be more likely to experience side effects from Sudafed PE. You may need a lower dose of the medication.

How should I take Sudafed PE?

Take Sudafed PE exactly as directed. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.

Take each dose with a full glass of water. Do not crush, chew, or break the long-acting or sustained-release forms of this medication that are intended to release slowly. Swallow them whole. If you are unsure about the formulation of your medicine, ask your pharmacist for help. If you cannot swallow the tablets or capsules, look for a liquid form of the medication.

Do not take Sudafed PE for longer than 7 to 10 days in a row. If your symptoms do not improve, if they get worse, or if you have a fever, see your doctor.

Do not take more of this medication than is recommended. An overdose of this medication can cause serious harm. Store Sudafed PE at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. However, if it is almost time for the next dose, skip the missed dose and take only the next regularly scheduled dose. Do not take a double dose of this medication.

What happens if I overdose?

Seek emergency medical attention if an overdose is suspected.

Symptoms of an Sudafed PE overdose include dry mouth, large pupils, flushing, nausea, vomiting, abdominal pain, diarrhea, seizures, confusion, sweating, and an irregular heartbeat.

What should I avoid while taking Sudafed PE?

Do not take other over-the-counter cough, cold, allergy, diet, pain, or sleep medications while taking acetaminophen, diphenhydramine, and pseudoephrine without first talking to your pharmacist or doctor. Other medications may also contain acetaminophen, diphenhydramine, phenylephrine or other similar drugs, and you may accidentally take too much of these medicines.

Sudafed PE may increase the effects of other drugs that cause drowsiness, including antidepressants, alcohol, other antihistamines, pain relievers, anxiety medicines, seizure medicines, and muscle relaxants. Dangerous sedation, dizziness, or drowsiness may occur if Sudafed PE is taken with any of these medications.

What are the possible side effects of Sudafed PE?

If you experience any of the following uncommon but serious side effects, stop taking Sudafed PE and seek emergency medical attention or contact your doctor immediately:

an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives);
liver problems (yellowing of the skin or eyes, abdominal pain);
blood problems (easy or unusual bleeding or bruising); or
low blood sugar (fatigue, increased hunger or thirst, dizziness or fainting).

Other, less serious side effects are more likely to occur including:

dryness of the eyes, nose, or mouth;
drowsiness or dizziness;
blurred vision;
difficulty urinating; or
excitation in children.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

What other drugs will affect Sudafed PE?

Do not take Sudafed PE if you have taken a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), phenelzine (Nardil), or tranylcypromine (Parnate) in the last 14 days. A drug interaction could occur, leading to serious side effects.

Urine glucose tests for diabetics may produce false results while taking acetaminophen. Talk to your doctor if you are diabetic and you notice changes in your glucose levels while taking Sudafed PE.

Do not take other over-the-counter cough, cold, allergy, diet, pain, or sleep medicines while taking Sudafed PE without first talking to your doctor or pharmacist. Other medications may also contain diphenhydramine, phenylephrine, acetaminophen, or other similar drugs, and you may accidentally take too much of these medicines.

Drugs other than those listed here may also interact with Sudafed PE. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines, including vitamins, minerals, and herbal products.

Where can I get more information?

Your pharmacist has additional information about Sudafed PE written for health professionals that you may read.

What does my medication look like?

Acetaminophen, diphenhydramine, and phenylephrine is available over-the-counter under several brand and generic names. Ask your pharmacist any questions you have about this medication, especially if it is new to you.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.