Sudafed PE

Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Cold medicine is usually taken only for a short time until your symptoms clear up.

Do not give this medication to a child younger than 4 years old. Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children.

Take this medicine with a full glass of water.

The chewable tablet must be chewed before you swallow it.

You may need to shake the oral suspension (liquid) well just before you measure a dose. Measure liquid medicine with the dosing syringe provided, or with a special dose-measuring spoon or medicine cup. If you do not have a dose-measuring device, ask your pharmacist for one.

If you need surgery, tell the surgeon ahead of time that you are using phenylephrine. You may need to stop using the medicine for a short time.

Call your doctor if your symptoms do not improve after 7 days of treatment, or if you have a fever with a headache, cough, or skin rash.

Store at room temperature away from moisture and heat.

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.
• Headache.
• Feeling nervous and excitable.
• Not able to sleep.
• Restlessness.
• Upset stomach or throwing up.

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.

• Store at room temperature.
• Store in a dry place. Do not store in a bathroom.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.

Use Sudafed PE exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Cold medicine is usually taken only for a short time until your symptoms clear up.

Do not give this medication to a child younger than 4 years old. Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children.

Take this medicine with a full glass of water.

The chewable tablet must be chewed before you swallow it.

You may need to shake the oral suspension (liquid) well just before you measure a dose. Measure liquid medicine with the dosing syringe provided, or with a special dose-measuring spoon or medicine cup. If you do not have a dose-measuring device, ask your pharmacist for one.

If you need surgery, tell the surgeon ahead of time that you are using Sudafed PE. You may need to stop using the medicine for a short time.

Call your doctor if your symptoms do not improve after 7 days of treatment, or if you have a fever with a headache, cough, or skin rash.

Store at room temperature away from moisture and heat.

Since Sudafed PE 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.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Applies to phenylephrine: intravenous solution

Along with its needed effects, phenylephrine (the active ingredient contained in Sudafed PE Congestion) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur while taking phenylephrine:

• Blurred vision
• chest pain or discomfort
• difficult or labored breathing
• dizziness
• fainting
• fast, slow, or irregular heartbeat
• headache
• nausea or vomiting
• nervousness
• pain in the shoulders, arms, jaw, or neck
• pounding in the ears
• sweating
• tightness in the chest
• unusual tiredness

Get emergency help immediately if any of the following symptoms of overdose occur while taking phenylephrine:

• Feeling of fullness in the head
• pounding or rapid pulse
• tingling in the arms or legs
• vomiting

Some side effects of phenylephrine may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Heartburn
• itching skin
• nausea
• pain in the neck
• pain or discomfort in chest, upper stomach, or throat