Brand Names: Chlor Trimeton Nasal Decongestant, Contac Cold, Drixoral Decongestant Non-Drowsy, Elixsure Decongestant, Entex, Genaphed, Kid Kare Drops, nasofed, Seudotabs, Silfedrine, Sudafed, Sudafed 12-Hour, Sudafed 24-Hour, Sudafed Children's Nasal Decongestant, Sudodrin, SudoGest, SudoGest 12 Hour, Suphedrin, Triaminic Softchews Allergy Congestion, Unifed

Generic Name: pseudoephedrine (Pronunciation: SOO doe ee FED rin)

• What is pseudoephedrine (Sudafed)?
• What are the possible side effects of pseudoephedrine?
• What is the most important information I should know about pseudoephedrine?
• What should I discuss with my healthcare provider before taking pseudoephedrine?
• How should I take pseudoephedrine?
• What happens if I miss a dose?
• What happens if I overdose?
• What should I avoid while taking pseudoephedrine?
• What other drugs will affect pseudoephedrine?
• Where can I get more information?

What is pseudoephedrine (Sudafed)?

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.

Pseudoephedrine 30 mg-ROX

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Pseudoephedrine 60 mg-ROX

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What are the possible side effects of pseudoephedrine?

Get emergency medical help if you have any of these signs of an allergic reaction: 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 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.

What is the most important information I should know about pseudoephedrine?

Do not give this medication to a child younger than 2 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.

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.