Pseudoephedrine, Oral

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KEY POINTS

• This medicine is taken by mouth to relieve nasal, sinus, and ear congestion due to infections, colds, sinusitis, or allergies such as hay fever. Take it exactly as directed. Do not give a child under age 4 any cough and cold medicines unless specifically instructed to do so by your healthcare provider.
• Keep all appointments for tests to see how this medicine affects you.
• This medicine may cause unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: decongestant

Generic and brand names: pseudoephedrine, oral; Children's Silfedrine; Children's Sudafed; Sudafed; Sudafed 12 Hour; Sudafed 24 Hour; SudoGest (There may be other brand names for this medicine.)

What is this medicine used for?

This medicine is taken by mouth to relieve nasal, sinus, and ear congestion due to infections, colds, sinusitis, or allergies such as hay fever.

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine
• Diabetes
• Glaucoma or other eye problems
• Heart disease
• High blood pressure
• Lung problems such as COPD
• Thyroid problems
• Trouble urinating or an enlarged prostate gland

Do not take this medicine if you have taken an MAO inhibitor within the last 14 days. Using these products together can cause very serious side effects. If you are not sure if you take an MAO inhibitor, ask your pharmacist or healthcare provider before you use this medicine.

Females of childbearing age: Tell your healthcare provider if you are pregnant or plan to become pregnant. It is not known whether this medicine will harm an unborn baby. Do not breast-feed while taking this medicine without your healthcare provider's approval.

How do I use it?

You can buy this medicine without a prescription, but it is usually kept behind the pharmacy counter. Ask the pharmacist about this.

Check the label on the medicine for directions about your specific dose. Take this medicine exactly as directed by your healthcare provider or according to the directions on the package. Do not take more of it or take it more often than directed. Do not take this medicine for more than 7 days without your healthcare provider's approval. Taking too much of this medicine can cause side effects.

Swallow the extended-release capsules and tablets whole. Do not crush or chew them. The contents of the capsules may be mixed with soft food you can swallow without chewing (such as applesauce).

If you are using the liquid form of this medicine, use the measuring spoon, cup, dropper, or oral syringe that comes with the medicine, or ask your pharmacist for one. Do not use a kitchen spoon because the dose may not be correct.

This medicine can cause restlessness or nervousness. Take the last dose of the day a few hours before bedtime to avoid interrupting your sleep at night. Take extended-release products early in the day.

What if I miss a dose?

If you miss a dose, take it as soon as you remember unless it is almost time for the next scheduled dose. In that case, skip the missed dose and take the next one as directed. Do not take double doses. If you are not sure of what to do if you miss a dose, or if you miss more than one dose, contact your healthcare provider.

What if I overdose?

If you or anyone else has intentionally taken too much of this medicine, call 911 or go to the emergency room right away. If you pass out, have seizures, weakness or confusion, or have trouble breathing, call 911. If you think that you or anyone else may have taken too much of this medicine, call the poison control center. Do this even if there are no signs of discomfort or poisoning. The poison control center number is 800-222-1222.

Symptoms of an acute overdose may include: restlessness, nervousness, seizures, nausea, vomiting, fast or irregular heartbeat.

What should I watch out for?

Do not give a child under age 4 any cough and cold medicines unless specifically instructed to do so by your healthcare provider. If your child is over the age of 4, ask your healthcare provider before giving cough and cold medicines.

Decongestants are contained in many allergy and cold medicines. If you take certain products together you may accidentally take too much decongestant. To prevent overdose while you are taking this medicine, ask your pharmacist or healthcare provider before you take any other nonprescription medicine.

Contact your healthcare provider if your symptoms do not improve in 7 days, if you develop a high fever, or if your symptoms get worse.

This medicine may make you dizzy. Do not drive or operate machinery unless you are fully alert.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are taking this medicine.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; rash; trouble breathing; tightness in your chest; swelling of your lips, tongue, and throat); seizures; sudden weakness, numbness, or tingling, especially on one side of your body; sudden or severe headache; sudden trouble with vision, speech, balance, or walking.

Serious (Report these to your healthcare provider right away.): Fast breathing, increased blood pressure, fast or irregular heartbeat, chest pain, severe nausea or vomiting, severe dizziness or nervousness, confusion, hallucinations.

Other: Nervousness, trouble sleeping, headache, dizziness, drowsiness, trembling.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• Beta blockers such as acebutolol (Sectral), atenolol (Tenormin), carvedilol (Coreg), labetalol (Trandate), metoprolol (Lopressor, Toprol), nadolol (Corgard), and pindolol
• Caffeine and stimulants such as diet pills, amphetamine/dextroamphetamine (Adderall), armodafinil (Nuvigil), atomoxetine (Strattera), benzphetamine (Regimex), dexmethylphenidate (Focalin), dextroamphetamine (Dexedrine), diethylpropion (Tenuate), methamphetamine (Desoxyn), methylphenidate (Concerta, Daytrana, Metadate, Ritalin), modafinil (Provigil), and phentermine (Adipex-P, Suprenza)
• Ergot medicines such as cabergoline, dihydroergotamine (D.H.E. 45, Migranal), ergotamine (Ergomar), and methylergonovine
• Linezolid (Zyvox)
• MAO inhibitors such as isocarboxazid (Marplan), phenelzine (Nardil), selegiline (Eldepryl, Emsam, Zelapar), and tranylcypromine (Parnate) (Do not take this medicine and an MAO inhibitor within 14 days of each other.)
• Methyldopa
• Midodrine
• Natural remedies such as ephedra, ephedrine, ginseng, green tea, or yohimbe
• Procarbazine (Matulane)
• Propranolol (Hemangeol, Inderal, InnoPran)
• Rasagiline (Azilect)
• Reserpine
• Sodium bicarbonate (Alka-Seltzer)
• Theophylline

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Store this medicine at room temperature. Keep the container tightly closed. Protect it from heat, high humidity, and bright light.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicine in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.