Sudafed PE Cold & Cough

Since this medicine is used when needed, you may not be on a dosing schedule. If you are on a schedule, use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

Avoid drinking alcohol. It may increase your risk of liver damage while you are taking acetaminophen.

Ask a doctor or pharmacist before using any other cold, allergy, pain, or sleep medication. Acetaminophen (sometimes abbreviated as APAP) is contained in many combination medicines. Taking certain products together can cause you to get too much acetaminophen which can lead to a fatal overdose. Check the label to see if a medicine contains acetaminophen or APAP.

This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

In rare cases, acetaminophen may cause a severe skin reaction that can be fatal. This could occur even if you have taken acetaminophen in the past and had no reaction. Stop taking this medicine and call your doctor right away if you have skin redness or a rash that spreads and causes blistering and peeling. If you have this type of reaction, you should never again take any medicine that contains acetaminophen.

Stop using this medicine and call your doctor at once if you have:

• chest pain, fast, slow, or uneven heart rate;

• severe dizziness, feeling like you might pass out;

• mood changes, confusion, hallucinations;

• tremor, seizure (convulsions);

• fever;

• urinating less than usual or not at all;

• nausea, pain in your upper stomach, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of your skin or eyes); or

• dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, chest pain, uneven heartbeats, seizure).

Common side effects may include:

• dizziness, weakness;

• mild headache;

• mild nausea, diarrhea, upset stomach;

• dry mouth, nose, or throat;

• feeling nervous, restless, irritable, or anxious; or

• sleep problems (insomnia).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Use this medicine as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Take with or without food. Take with food if it causes an upset stomach.
• Drink lots of noncaffeine liquids unless told to drink less liquid by your doctor.

What do I do if I miss a dose?

• If you take Sudafed PE Cold/Cough on a regular basis, take a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.
• Many times this medicine is used on an as needed basis. Do not use more often than told by the doctor.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Dizziness.
• Feeling nervous and excitable.
• Not able to sleep.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about Sudafed PE Cold/Cough, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Sudafed PE Cold/Cough (acetaminophen, dextromethorphan, guaifenesin, phenylephrine caps & tabs). It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using Sudafed PE Cold/Cough.

Review Date: October 4, 2017

Applies to acetaminophen / dextromethorphan / guaifenesin / phenylephrine: oral capsule, oral liquid, oral tablet

Applies to acetaminophen / dextromethorphan / guaifenesin / phenylephrine: oral capsule, oral liquid, oral powder for reconstitution, oral tablet

Cardiovascular

Cardiovascular side effects of phenylephrine have included palpitations, arrhythmias, and cardiovascular collapse with hypotension.[Ref]

Gastrointestinal

Gastrointestinal side effects of dextromethorphan have included upset stomach.

Gastrointestinal side effects of guaifenesin have included stomach upset and vomiting with higher than recommended doses. Doses recommended for expectoration have rarely been associated with gastrointestinal upset.

Gastrointestinal side effects of phenylephrine have included nausea.[Ref]

General

General side effects of phenylephrine have included pallor and weakness.[Ref]

Genitourinary

Genitourinary side effects of phenylephrine have included dysuria.[Ref]

Hepatic

Hepatic side effects of acetaminophen have included severe and sometimes fatal dose dependent hepatitis in alcoholic patients. Hepatotoxicity has been increased during fasting.[Ref]

Hypersensitivity

Hypersensitivity side effects of dextromethorphan have included rare reports of fixed-drug eruptions.[Ref]

Nervous system

Nervous system side effects of dextromethorphan have included drowsiness and dizziness. Other side effects such as excitation, mental confusion, and opioid like respiratory depression have been rare and occurred at higher dosages. In some cases of abuse, patients experienced euphoria, hyperactivity, mania, and auditory and visual hallucinations.

Nervous system side effects of guaifenesin have occasionally included dizziness and headache.

Nervous system side effects of phenylephrine have included headache, dizziness, nervousness, restlessness, tremor, insomnia, convulsions, and central nervous system depression.[Ref]

Psychiatric

Psychiatric side effects of phenylephrine have included hallucinations, fear, and anxiety.[Ref]

Respiratory

Respiratory side effects of phenylephrine have included respiratory difficulty.[Ref]

Dermatologic

Dermatologic side effects associated with acetaminophen includes the risk of rare but potentially fatal serious skin reactions known as Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and acute generalized exanthematous pustulosis (AGEP).

Dermatologic side effects of guaifenesin have included rare reports of rash.[Ref]

Some side effects of Sudafed PE Cold & Cough may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.