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Pseudoephedrine is used for the temporary relief of stuffy nose and sinus pain/pressure caused by infection (such as the common cold, flu) or other breathing illnesses (such as hay fever, allergies, bronchitis). Pseudoephedrine is a decongestant (sympathomimetic). It works by narrowing the blood vessels to decrease swelling and congestion.
If you are self-treating with this medication, it is important to read the manufacturer\'s package instructions carefully so you know when to consult your doctor or pharmacist. (See also Precautions section.)
Cough-and-cold products have not been shown to be safe or effective in children younger than 6 years. Do not use this product in children younger than 6 years unless specifically directed by the doctor. Long-acting tablets/capsules are not recommended for use in children younger than 12 years. Ask your doctor or pharmacist for more details about using your product safely.
These products do not cure or shorten the length of the common cold and may cause serious side effects. To decrease the risk for serious side effects, carefully follow all dosage directions. Do not use this product to make a child sleepy. Do not give other cough-and-cold medication that might contain the same or similar decongestants (see also Drug Interactions section). Ask the doctor or pharmacist about other ways to relieve cough and cold symptoms (such as drinking enough fluids, using a humidifier or saline nose drops/spray).
OTHER USES: This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.
Your doctor may direct you to use pseudoephedrine to decrease pain and swelling in the ear or to help \"open up\" the ear canal when there is a change in air pressure (such as during air travel, underwater diving). Follow your doctor\'s directions carefully.
How to use Fedrin Oral
If you are taking the over-the-counter product to self-treat, read all directions on the product package before taking this medication. If you have any questions, ask your doctor or pharmacist. If your doctor has prescribed this medication, take it as directed.
Take this medication by mouth with or without food, usually every 4-6 hours, as directed by the product package or by your doctor. Do not take more than 4 doses in a day. Dosage is based on your age, medical condition, and response to treatment. Do not increase your dose or take this drug more often than directed. Do not take more of this medication than recommended for your age.
If you are using the chewable tablets, chew each tablet well and swallow. If you are using the liquid form of this medication, measure the dose carefully using a special measuring device/cup. Do not use a household spoon because you may not get the correct dose.
There are many brands and forms of pseudoephedrine available. Read the dosing instructions carefully for each product because the amount of pseudoephedrine may be different between products. Do not take more pseudoephedrine than recommended.
Caffeine can increase the side effects of this medication. Avoid drinking large amounts of beverages containing caffeine (coffee, tea, colas), eating large amounts of chocolate, or taking nonprescription products that contain caffeine.
If your symptoms do not improve after 7 days, if they worsen or return, if you develop fever, rash, or a persistent headache, or if you think you may have a serious medical problem, seek immediate medical attention.
Nausea, vomiting, trouble sleeping, dizziness, headache, or nervousness may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly. Stop taking this medication and tell your doctor promptly if you have dizziness, nervousness, or trouble sleeping.
If your doctor has directed you to use this medication, remember that he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Stop taking this medication and tell your doctor immediately if any of these rare but very serious side effects occur: fast/irregular/pounding heartbeat, mental/mood changes (such as anxiety, confusion, restlessness), shaking (tremor), difficulty urinating.
A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Before taking pseudoephedrine, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. Also tell your doctor if you have had negative reactions to other sympathomimetics (such as ephedrine, phenylephrine). This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
If you have any of the following health problems, consult your doctor or pharmacist before using this product: diabetes, a certain eye condition (glaucoma), heart problems (such as heart attack, chest pain, heart failure), fast/irregular heart beat, high blood pressure, kidney disease, overactive thyroid (hyperthyroidism), difficulty urinating (such as due to enlarged prostate).
This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.
Liquid products, chewable tablets, or dissolving tablets/strips may contain sugar and/or aspartame. Liquid products may also contain alcohol. Caution is advised if you have diabetes, alcohol dependence, liver disease, phenylketonuria (PKU), or any other condition that requires you to limit/avoid these substances in your diet. Ask your doctor or pharmacist about using this product safely.
Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).
Older adults may be more sensitive to the effects of this medication, especially dizziness and problems urinating.
Children may be more sensitive to the effects of this medication, especially restlessness.
During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.
Pseudoephedrine passes into breast milk. Discuss the risks and benefits with your doctor before breast-feeding.
The effects of some drugs can change if you take other drugs or herbal products at the same time. This can increase your risk for serious side effects or may cause your medications not to work correctly. These drug interactions are possible, but do not always occur. Your doctor or pharmacist can often prevent or manage interactions by changing how you use your medications or by close monitoring.
To help your doctor and pharmacist give you the best care, be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products) before starting treatment with this product. While using this product, do not start, stop, or change the dosage of any other medicines you are using without your doctor\'s approval.
Some products that may interact with this drug include: stimulants (such as caffeine, dextroamphetamine, methamphetamine, herbal products like ephedra/ma huang), bronchodilators (such as albuterol, terbutaline).
Do not take this medication if you are taking MAO inhibitors (isocarboxazid, linezolid, methylene blue, moclobemide, phenelzine, procarbazine, rasagiline, selegiline, tranylcypromine) or have used MAO inhibitors in the past 2 weeks. In some cases a serious, possibly fatal, drug interaction may occur.
Pseudoephedrine may decrease the effectiveness of blood pressure medications (such as beta blockers, calcium channel blockers, reserpine, guanethidine, methyldopa).
Check the labels on all your medicines (such as allergy or cough-and-cold products) because they may contain similar ingredients (decongestants such as phenylephrine). Ask your pharmacist about using those products safely.
This document does not contain all possible drug interactions. Keep a list of all the products you use. Share this list with your doctor and pharmacist to lessen your risk for serious medication problems.
If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call the US National Poison Hotline at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: slow/shallow breathing, hallucinations, seizures.
NOTES:
This medication is for temporary use only. Do not use for more than 7 days without first consulting your doctor.
MISSED DOSE:
If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.
STORAGE:
Different brands of this medication have different storage needs. Check the product package for instructions on how to store your brand, or ask your pharmacist. Keep all medications away from children and pets.
Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.
Information last revised September 2011. Copyright(c) 2011 First Databank, Inc.
