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 purposes not listed in this medication guide.

Do not give pseudoephedrine 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.

Ask a doctor or pharmacist before using any other cough or cold medicine. Pseudoephedrine or other decongestants are contained in many combination medicines. Taking certain products together can cause you to get too much of a certain drug. Check the label to see if a medicine contains pseudoephedrine or a decongestant. Do not use pseudoephedrine if you have used a MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects.

Before taking this medicine

Do not use pseudoephedrine if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects. Do not use this medication if you are allergic to pseudoephedrine or to other decongestants, diet pills, stimulants, or ADHD medications.

Ask a doctor or pharmacist if it is safe for you to take pseudoephedrine if you have:

• heart disease or high blood pressure;

• diabetes; or

• a thyroid disorder.

FDA pregnancy category C. It is not known whether pseudoephedrine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. Pseudoephedrine can pass into breast milk and may harm a nursing baby. Do not use pseudoephedrine without telling your doctor if you are breast-feeding a baby.

Artificially sweetened liquid cold medicine may contain phenylalanine. If you have phenylketonuria (PKU), check the medication label to see if the product contains phenylalanine.

Use pseudoephedrine 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 pseudoephedrine 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. Do not crush, chew, or break an extended-release tablet. Swallow it whole. Breaking or opening the pill may cause too much of the drug to be released at one time. You may need to shake the oral suspension (liquid) well just before you measure a dose. Measure the liquid with a special dose measuring spoon or medicine cup, not with a regular table spoon. If you do not have a dose measuring device, ask your pharmacist for one.

Do not take pseudoephedrine for longer than 7 days in a row. 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 surgery, tell the surgeon ahead of time that you are using pseudoephedrine. You may need to stop using the medicine for a short time.

Store pseudoephedrine at room temperature away from moisture and heat.

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/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.
Alternative dosing: 1 mg/kg/dose every 6 hours; maximum dose: 15 mg.

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/day.

Do not use pseudoephedrine if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects. Do not use this medication if you are allergic to pseudoephedrine or to other decongestants, diet pills, stimulants, or ADHD medications.

Ask a doctor or pharmacist if it is safe for you to take pseudoephedrine if you have:

• heart disease or high blood pressure;

• diabetes; or

• a thyroid disorder.

FDA pregnancy category C. It is not known whether pseudoephedrine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. Pseudoephedrine can pass into breast milk and may harm a nursing baby. Do not use pseudoephedrine without telling your doctor if you are breast-feeding a baby.

Artificially sweetened liquid cold medicine may contain phenylalanine. If you have phenylketonuria (PKU), check the medication label to see if the product contains phenylalanine.

Since pseudoephedrine is taken 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. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

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

Overdose symptoms may include feeling restless or nervous.

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Foods and drinks that contain large amounts of caffeine can make the side effects of pseudoephedrine worse.

Avoid taking pseudoephedrine if you also take diet pills, caffeine pills, or other stimulants (such as ADHD medications). Taking a stimulant together with a decongestant can increase your risk of unpleasant side effects.

Ask a doctor or pharmacist before using any other cough or cold medicine. Pseudoephedrine or other decongestants are contained in many combination medicines. Taking certain products together can cause you to get too much of a certain drug. Check the label to see if a medicine contains pseudoephedrine or a decongestant.

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 pseudoephedrine and call your doctor at once if you have a serious side effect such as:

• fast, pounding, or uneven heartbeat;

• severe dizziness or anxiety;

• easy bruising or bleeding, unusual weakness, fever, chills, body aches, flu symptoms; or

• dangerously high blood pressure (severe headache, blurred vision, ringing in your ears, anxiety, confusion, chest pain, trouble breathing, uneven heart rate, seizure).

Less serious pseudoephedrine side effects may include:

• loss of appetite;

• warmth, tingling, or redness under your skin;

• feeling restless or excited (especially in children);

• 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.

Tell your doctor about all other medicines you use, especially:

• blood pressure medications;

• a beta blocker such as atenolol (Tenormin, Tenoretic), carvedilol (Coreg), labetalol (Normodyne, Trandate), metoprolol (Dutoprol, Lopressor, Toprol), nadolol (Corgard), propranolol (Inderal, InnoPran), sotalol (Betapace), and others; or

• an antidepressant such as amitriptyline (Elavil, Vanatrip, Limbitrol), doxepin (Sinequan), nortriptyline (Pamelor), and others.

This list is not complete and other drugs may interact with pseudoephedrine. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

If you are taking the 24-hour extended-release tablets, you may notice something that looks like a tablet in your stool. This is just the empty tablet shell, and this does not mean that you did not get your complete dose of medication.

Ask your pharmacist any questions you have about pseudoephedrine.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

• AccuHist DM® (containing Brompheniramine, Dextromethorphan, Guaifenesin, Pseudoephedrine)
• Advil Allergy Sinus® (containing Chlorpheniramine, Ibuprofen, Pseudoephedrine)
• Advil Cold and Sinus® (containing Ibuprofen, Pseudoephedrine)
• Alavert Allergy and Sinus D-12® (containing Loratadine, Pseudoephedrine)
• Aldex GS® (containing Guaifenesin, Pseudoephedrine)
• Aldex GS DM® (containing Dextromethorphan, Guaifenesin, Pseudoephedrine)
• Aleve-D Sinus and Cold® (containing Naproxen, Pseudoephedrine)
• Allergy Relief D® (containing Cetirizine, Pseudoephedrine)
• Ambifed® (containing Guaifenesin, Pseudoephedrine)
• Ambifed DM® (containing Dextromethorphan, Guaifenesin, Pseudoephedrine)
• Biodec DM® (containing Dextromethorphan, Pseudoephedrine)
• BP 8® (containing Dextromethorphan, Guaifenesin, Pseudoephedrine)
• Brofed® (containing Brompheniramine, Pseudoephedrine)
• Bromdex® (containing Brompheniramine, Dextromethorphan, Pseudoephedrine)
• Bromfed® (containing Brompheniramine, Pseudoephedrine)
• Bromfed DM® (containing Brompheniramine, Dextromethorphan, Pseudoephedrine)
• Bromhist DM® (containing Brompheniramine, Dextromethorphan, Guaifenesin, Pseudoephedrine)
• Bromphenex DM® (containing Brompheniramine, Dextromethorphan, Pseudoephedrine)
• Bromuphed® (containing Brompheniramine, Pseudoephedrine)
• Bromuphed PD® (containing Brompheniramine, Pseudoephedrine)
• Brotapp® (containing Brompheniramine, Pseudoephedrine)
• Brotapp-DM Cold and Cough® (containing Brompheniramine, Dextromethorphan, Pseudoephedrine)
• Brovex PSB® (containing Brompheniramine, Pseudoephedrine)
• Brovex PSB DM® (containing Brompheniramine, Dextromethorphan, Pseudoephedrine)
• Brovex SR® (containing Brompheniramine, Pseudoephedrine)
• Carbofed DM® (containing Brompheniramine, Dextromethorphan, Pseudoephedrine)
• Certuss-D® (containing Chlophedianol, Guaifenesin, Pseudoephedrine)
• Cetiri-D® (containing Cetirizine, Pseudoephedrine)
• Children's Advil Cold® (containing Ibuprofen, Pseudoephedrine)
• Children's Motrin Cold® (containing Ibuprofen, Pseudoephedrine)
• Chlorfed A SR® (containing Chlorpheniramine, Pseudoephedrine)
• Clarinex-D® (containing Desloratadine, Pseudoephedrine)
• Claritin-D® (containing Loratadine, Pseudoephedrine)
• Coldamine® (containing Chlorpheniramine, Methscopolamine, Pseudoephedrine)
• Coldmist DM® (containing Dextromethorphan, Guaifenesin, Pseudoephedrine)
• Coldmist LA® (containing Guaifenesin, Pseudoephedrine)
• Colfed A® (containing Chlorpheniramine, Pseudoephedrine)
• Corzall® (containing Carbetapentane, Pseudoephedrine)
• Dallergy PSE® (containing Chlorpheniramine, Methscopolamine, Pseudoephedrine)
• Deconamine® (containing Chlorpheniramine, Pseudoephedrine)
• Deconomed SR® (containing Chlorpheniramine, Pseudoephedrine)
• Defen LA® (containing Guaifenesin, Pseudoephedrine)
• Dimetane DX® (containing Brompheniramine, Dextromethorphan, Pseudoephedrine)
• Drixoral® (containing Dexbrompheniramine, Pseudoephedrine)
• Drymax® (containing Chlorpheniramine, Methscopolamine, Pseudoephedrine)
• Dynahist ER® (containing Chlorpheniramine, Pseudoephedrine)
• EndaCof-DC® (containing Codeine, Pseudoephedrine)
• EndaCof-PD® (containing Brompheniramine, Dextromethorphan, Pseudoephedrine)
• Entex PSE® (containing Guaifenesin, Pseudoephedrine)
• Exall D® (containing Carbetapentane, Guaifenesin, Pseudoephedrine)
• ExeFen DMX® (containing Dextromethorphan, Guaifenesin, Pseudoephedrine)
• ExeFen IR® (containing Guaifenesin, Pseudoephedrine)
• Guaidex TR® (containing Chlorpheniramine, Dextromethorphan, Guaifenesin, Methscopolamine, Pseudoephedrine)
• Hexafed® (containing Dexchlorpheniramine, Pseudoephedrine)
• Histacol DM® (containing Brompheniramine, Guaifenesin, Dexchlorpheniramine, Pseudoephedrine)
• Histex® (containing Chlorpheniramine, Pseudoephedrine)
• Lodrane® (containing Brompheniramine, Pseudoephedrine)
• LoHist-D® (containing Chlorpheniramine, Pseudoephedrine)
• LoHist-PD® (containing Brompheniramine, Pseudoephedrine)
• LoHist-PSB® (containing Brompheniramine, Pseudoephedrine)
• LoHist-PSB-DM® (containing Brompheniramine, Dextromethorphan, Pseudoephedrine)
• Lortuss DM® (containing Dextromethorphan, Doxylamine, Pseudoephedrine)
• Lortuss EX® (containing Codeine, Guaifenesin, Pseudoephedrine)
• Lortuss LQ® (containing Doxylamine, Pseudoephedrine)
• Medent DM® (containing Dextromethorphan, Guaifenesin, Pseudoephedrine)
• Medent LD® (containing Guaifenesin, Pseudoephedrine)
• Mintex® (containing Chlorpheniramine, Pseudoephedrine)
• Mucinex D® (containing Guaifenesin, Pseudoephedrine)
• Myphetane Dx® (containing Brompheniramine, Dextromethorphan, Pseudoephedrine)
• Nalex® (containing Guaifenesin, Pseudoephedrine)
• Nasatab LA® (containing Guaifenesin, Pseudoephedrine)
• Neutrahist® (containing Chlorpheniramine, Pseudoephedrine)
• Notuss-NXD® (containing Chlorcyclizine, Codeine, Pseudoephedrine)
• Pediahist DM® (containing Brompheniramine, Dextromethorphan, Guaifenesin, Pseudoephedrine)
• Polyvent® (containing Guaifenesin, Pseudoephedrine)
• Pseudodine® (containing Pseudoephedrine, Triprolidine)
• Relcof PSE® (containing Chlorpheniramine, Methscopolamine, Pseudoephedrine)
• Respa 1st® (containing Guaifenesin, Pseudoephedrine)
• Respaire® (containing Guaifenesin, Pseudoephedrine)
• Respivent D® (containing Chlorpheniramine, Methscopolamine, Pseudoephedrine)
• Rezira® (containing Hydrocodone, Pseudoephedrine)
• Rondamine DM® (containing Dextromethorphan, Pseudoephedrine)
• Rondec® (containing Brompheniramine, Pseudoephedrine)
• Rondec DM® (containing Dextromethorphan, Pseudoephedrine)
• Ru-Tuss DM® (containing Dextromethorphan, Guaifenesin, Pseudoephedrine)
• Semprex-D® (containing Acrivastine, Pseudoephedrine)
• Suclor® (containing Chlorpheniramine, Pseudoephedrine)
• Sudafed 12 Hour Pressure/Pain® (containing Naproxen, Pseudoephedrine)
• Sudafed Triple Action® (containing Acetaminophen, Guaifenesin, Pseudoephedrine)
• Sudahist® (containing Chlorpheniramine, Pseudoephedrine)
• Sudatex DM® (containing Dextromethorphan, Guaifenesin, Pseudoephedrine)
• Sudatrate® (containing Methscopolamine, Pseudoephedrine)
• Tekral® (containing Diphenhydramine, Pseudoephedrine)
• Tenar DM® (containing Dextromethorphan, Guaifenesin, Pseudoephedrine)
• Tenar PSE® (containing Guaifenesin, Pseudoephedrine)
• Theraflu Max-D Severe Cold and Flu® (containing Acetaminophen, Dextromethorphan, Guaifenesin, Pseudoephedrine)
• Touro CC® (containing Dextromethorphan, Guaifenesin, Pseudoephedrine)
• Touro LA® (containing Guaifenesin, Pseudoephedrine)
• Triacin® (containing Pseudoephedrine, Triprolidine)
• Trikof D® (containing Dextromethorphan, Guaifenesin, Pseudoephedrine)
• Trispec PSE® (containing Dextromethorphan, Guaifenesin, Pseudoephedrine)
• Tussafed LA® (containing Dextromethorphan, Guaifenesin, Pseudoephedrine)
• Tylenol Sinus Severe Congestion Daytime® (containing Acetaminophen, Guaifenesin, Pseudoephedrine)
• Vanacof® (containing Chlophedianol, Dexchlorpheniramine, Pseudoephedrine)
• Vanacof DX® (containing Chlophedianol, Guaifenesin, Pseudoephedrine)
• Viravan P® (containing Pseudoephedrine, Pyrilamine)
• Viravan PDM® (containing Dextromethorphan, Pseudoephedrine, Pyrilamine)
• Z-Cof DM® (containing Dextromethorphan, Guaifenesin, Pseudoephedrine)
• Zodryl DEC® (containing Codeine, Guaifenesin, Pseudoephedrine)
• Zutripro® (containing Chlorpheniramine, Hydrocodone, Pseudoephedrine)
• Zymine DRX® (containing Pseudoephedrine, Triprolidine)
• Zyrtec-D® (containing Cetirizine, Pseudoephedrine)