"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"...
Sudafed Consumer (continued)
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.
Read the Sudafed (pseudoephedrine) Side Effects Center for a complete guide to possible side effects
PRECAUTIONS: 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 side effects of this drug, especially fast/irregular heartbeat, dizziness, problems urinating, trouble sleeping, or confusion.
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.
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