Product Description

Generic Name: pseudoephedrine (SOO doe ee FED rin)
Brand names: Chlor Trimeton Nasal Decongestant, Contac Cold, Drixoral Decongestant Non-Drowsy, Elixsure Decongestant, Entex, Genaphed, Kid Kare Drops, Nasofed, Seudotabs, Silfedrine, Sudafed, Sudodrin, SudoGest, Suphedrin, Triaminic Softchews Allergy Congestion, Unifed

What is pseudoephedrine?

Pseudoephedrine is a decongestant that shrinks blood vessels in the nasal passages. Dilated blood vessels can cause nasal congestion (stuffy nose).
Pseudoephedrine is used to treat nasal and sinus congestion, or congestion of the tubes that drain fluid from your inner ears, called the eustachian (yoo-STAY-shun) tubes.
Pseudoephedrine may also be used for other purposes not listed in this medication guide.

Important information about pseudoephedrine

Always ask a doctor before giving pseudoephedrine to a child. Death can occur from the misuse of cough and cold medicines in very young children. Do not use any other over-the-counter cough or cold medication without first asking your doctor or pharmacist. If you take certain products together you may accidentally take too much of a certain drug. Read the label of any other medicine you are using to see if it contains pseudoephedrine.

Do not use a cough or cold medicine if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Serious, life-threatening side effects can occur if you take cough or cold medicine before the MAO inhibitor has cleared from your body.

Before taking pseudoephedrine

Do not use pseudoephedrine if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Serious, life-threatening side effects can occur if you take pseudoephedrine before the MAO inhibitor has cleared from your body.
Do not use this medication if you are allergic to pseudoephedrine or to other decongestants, diet pills, stimulants, or ADHD medications.

Before taking pseudoephedrine, tell your doctor if you are allergic to any drugs, or if you have:
- heart disease or high blood pressure;
- diabetes; or
- a thyroid disorder.

If you have any of these conditions, you may need a dose adjustment or special tests to safely take pseudoephedrine.

FDA pregnancy category C. Pseudoephedrine may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Pseudoephedrine can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Artificially-sweetened liquid forms of cold medicine may contain phenylalanine. This would be important to know if you have phenylketonuria (PKU). Check the ingredients and warnings on the medication label if you are concerned about phenylalanine.

How should I take pseudoephedrine?

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

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 pseudoephedrine with a full glass of water. Do not crush, chew, or break an extended-release tablet. Swallow the pill whole. It is specially made to release medicine slowly in the body. Breaking or opening the pill would cause too much of the drug to be released at one time.

Measure the liquid form of this medicine with a special dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

Talk with 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.

If you need to have any type of surgery, tell the surgeon ahead of time if you have taken pseudoephedrine within the past few days.

Store the medication at room temperature away from moisture and heat.

What happens if I miss a dose?

Since pseudoephedrine is usually taken only as needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at your next regularly scheduled time. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine.
Symptoms of a pseudoephedrine overdose may include feeling restless or nervous.
What should I avoid while taking pseudoephedrine?
Avoid taking diet pills, caffeine pills, or other stimulants (such as ADHD medications) without your doctor's advice. Taking a stimulant together with a decongestant can increase your risk of unpleasant side effects.

Do not use any other over-the-counter cough or cold medication without first asking your doctor or pharmacist. Pseudoephedrine is contained in many over-the-counter medications. If you take certain products together you may accidentally take too much of a certain drug. Read the label of any other medicine you are using to see if it contains pseudoephedrine.

Pseudoephedrine side effects

Get emergency medical help if you have any of these signs of an allergic reaction to pseudoephedrine: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using this medication and call your doctor at once if you have any of these serious side effects:
- fast, pounding, or uneven heartbeat;
- severe dizziness, anxiety, restless feeling, or nervousness;
- easy bruising or bleeding, unusual weakness, fever, chills, body aches, flu symptoms; or
- increased blood pressure (severe headache, blurred vision, trouble concentrating, chest pain, numbness, seizure).

Less serious pseudoephedrine side effects may include:
- mild loss of appetite;
- warmth, tingling, or redness under your skin;
- feeling excited or restless;
- sleep problems (insomnia); or
- skin rash or itching.

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.

Pseudoephedrine Dosing Information

Usual Adult Dose of Pseudoephedrine for Nasal Congestion:

Immediate release: 30 to 60 mg orally every 4 to 6 hours as needed.
 Sustained release: 120 mg orally every 12 hours as needed.
 Sustained release suspension: 45 to 100 mg orally every 12 hours as needed.
 Maximum daily dose is 240 mg pseudoephedrine per day.

Usual Pediatric Dose of Pseudoephedrine for Nasal Congestion:

2 years to 5 years:
 Immediate release: 15 mg every 6 hours.
 Sustained release suspension: 12.5 to 25 mg orally every 12 hours as needed.
 Maximum daily dose is 60 mg/day.

 6 years to 12 years:
 Immediate release: 30 mg every 6 hours.
 Sustained release suspension: 25 to 50 mg orally every 12 hours as needed.
 Maximum daily dose is 120 mg/day.

 over 12 years:
 Immediate release: 30 to 60 mg orally every 4 to 6 hours as needed.
 Sustained release: 120 mg orally every 12 hours as needed.
 Sustained release suspension: 50 to 100 mg orally every 12 hours as needed.
 Maximum daily dose is 240 mg pseudoephedrine per day.

What other drugs will affect pseudoephedrine?

Before taking pseudoephedrine, tell your doctor if you are using any of the following drugs:
- medicines to treat high blood pressure;
- a beta-blocker such as atenolol (Tenormin), carteolol (Cartrol), metoprolol (Lopressor, Toprol), nadolol (Corgard), propranolol (Inderal), sotalol (Betapace), timolol (Blocadren), and others; or
- antidepressants such as amitriptyline (Elavil), clomipramine (Anafranil), imipramine (Janimine, Tofranil), and others.

This list is not complete and there may be other drugs that can interact with pseudoephedrine. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.