"Jan. 18, 2011 -- McNeil Consumer Healthcare, which makes Tylenol pain relief drugs, says it is recalling a number of lots of its Tylenol products as well as some lots of Sinutab, Benadryl, and Sudafed PE because the medications were made at a pla"...
IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.
PSEUDOEPHEDRINE - ORAL
COMMON BRAND NAME(S): Afrinol, Sudafed
USES: 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: 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. Some tablets should be swallowed with plenty of water. Check your product package for specific directions. 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.
Additional Sudafed Information
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