Sudafed PE (Generic)

Phenylephrine is used for the temporary relief of stuffy nose, sinus, and ear symptoms caused by the common cold, flu, allergies, or other breathing illnesses (e.g., sinusitis, bronchitis). This medication works by decreasing swelling in the nose and ears, thereby lessening discomfort and making it easier to breathe.

Cough-and-cold products have not been shown to be safe or effective in children younger than 6 years. Therefore, do not use this product to treat cold symptoms in children younger than 6 years unless specifically directed by the doctor. Some products (such as long-acting tablets/capsules) are not recommended for use in children younger than 12 years. Ask your doctor or pharmacist for more details about using your product safely.

These products do not cure or shorten the length of the common cold and may cause serious side effects. To decrease the risk for serious side effects, carefully follow all dosage directions. Do not use this product to make a child sleepy. Do not give other cough-and-cold medication that might contain the same or similar ingredients (see also Drug Interactions section). Ask the doctor or pharmacist about other ways to relieve cough and cold symptoms (such as drinking enough fluids, using a humidifier or saline nose drops/spray).

If you are using the over-the-counter product, read and follow all directions on the product package before taking this medication.

Take this medication by mouth with or without food or as directed by your doctor. Taking it with food may decrease stomach upset.

If you are using the liquid, carefully measure your prescribed dose using a medication-measuring device or spoon. Do not use a household spoon because you may not get the correct dose.

If you are using chewable tablets, chew each tablet thoroughly before swallowing.

If you are using a product made to dissolve in the mouth (tablets or strips), dry your hands before handling the medication. Place each dose on the tongue and allow to dissolve completely, then swallow it with saliva or with water.

The dosage is based on your age. Do not increase your dose or take this medication more often than directed without your doctor's approval. Improper use (abuse) of this medication may result in serious harm (e.g., hallucinations, seizure, death).

If your symptoms worsen or do not improve after 7 days, if you develop fever/chills, or if you think you may have a serious medical problem, seek immediate medical attention.

Mild upset stomach, trouble sleeping, dizziness, lightheadedness, headache, nervousness, shaking, or fast heartbeat may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

This product may reduce blood flow to your hands or feet, causing them to feel cold. Smoking may worsen this effect. Dress warmly and avoid tobacco use.

If your doctor has directed you to take this medication, remember that he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if any of these unlikely but serious side effects occur: fast/irregular heartbeat, severe/uncontrolled shaking, difficulty urinating.

Tell your doctor right away if any of these rare but very serious side effects occur: seizures, mental/mood changes (e.g., anxiety, panic, confusion, unusual thoughts/behavior).

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any of the following symptoms of a serious allergic reaction: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before taking phenylephrine, tell your doctor or pharmacist if you are allergic to it; or to pseudoephedrine/ephedrine; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: blood vessel problems (e.g., Raynaud's disease, low blood flow to the brain/legs/hands), high blood pressure, diabetes, glaucoma, heart disease (e.g., angina, fast/irregular heartbeat, heart failure), mental/mood disorders (e.g., anxiety, bipolar disorder, mania), difficulty sleeping, seizure disorder, overactive thyroid (hyperthyroidism), trouble urinating (e.g., due to enlarged prostate).

This drug may make you dizzy or lightheaded. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

Liquid products, chewable tablets, or dissolving tablets/strips may contain sugar or aspartame. Liquid products may also contain alcohol. Caution is advised if you have diabetes, alcohol dependence, liver disease, phenylketonuria (PKU), or any other condition that requires you to limit/avoid these substances in your diet. Ask your doctor or pharmacist about using this product safely.

Before having surgery, tell your doctor or dentist that you are taking this medication.

Older adults may be more sensitive to the side effects of this drug, especially fast/irregular heartbeat, dizziness, problems urinating, trouble sleeping, or confusion.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

This medication may pass into breast milk. Though there have been no reports of harm to nursing infants, consult your doctor before breast-feeding.

Store at room temperature at 59-86 degrees F (15-30 degrees C) or as directed on the package label, away from light and moisture. Do not store in the bathroom. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

If this product has been prescribed, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor or pharmacist first.

Taking MAO inhibitors with this medication may cause a serious (possibly fatal) drug interaction. Avoid taking MAO inhibitors (isocarboxazid, linezolid, methylene blue, moclobemide, phenelzine, procarbazine, rasagiline, safinamide, selegiline, tranylcypromine) during treatment with this medication. Most MAO inhibitors should also not be taken for two weeks before treatment with this medication. Ask your doctor when to start or stop taking this medication.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: blood pressure medications (especially guanethidine, methyldopa, beta blockers such as atenolol, or calcium channel blockers such as nifedipine), other decongestants (taken by mouth or applied in the nose), digoxin, tricyclic antidepressants (e.g., amitriptyline, imipramine).

This medication may worsen the serious side effects of some medications used for migraine headaches (e.g., sumatriptan, naratriptan, zolmitriptan, ergotamine). Consult your pharmacist or doctor for more details.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: severe dizziness/fainting, hallucinations, fast/irregular heartbeat, slow/shallow breathing, vomiting, seizures.

If you are taking this medication on a prescribed schedule and miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

If this product has been prescribed, do not share this medication with others.

This medication is for temporary use only. Do not use for more than 7 days in a row without first consulting your doctor.