pseudoephedrine-oral (cont.)
SIDE EFFECTS: Mild stomach upset, trouble sleeping, dizziness, lightheadedness, headache, nervousness, fast heartbeat, loss of appetite, shaking, or unusual sweating may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.
This product may reduce blood flow to your hands and feet, causing them to feel cold.
Smoking may worsen this effect. Dress warmly and avoid tobacco use.
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.
Notify your doctor immediately if any of these unlikely but serious side effects occur: fast irregular heartbeat, severe/uncontrolled shaking, difficulty urinating, decreased sexual ability.
Tell your doctor immediately if any of these rare but very serious side effects occur:
seizures, mental/mood changes (e.g., anxiety, panic, unusual thoughts/behavior).
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.
Contact your doctor for medical advice about side effects. The following numbers do not provide medical advice, but in the US you may report side effects to the Food and Drug Administration (FDA) at 1-800-FDA-1088. In Canada, you may call Health Canada at 1-866-234-2345.
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 (e.g., ephedrine, phenylephrine).
This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: severe high blood pressure, heart disease (e.g., severe coronary artery disease, angina, heart failure), certain types of fast heart rhythm problems (e.g.,
atrial fibrillation/flutter, paroxysmal supraventricular tachycardia-PSVT), a certain slow heart rhythm problem (sinus bradycardia), closed-angle glaucoma, difficulty urinating (e.g., due to enlarged prostate).
Before using this medication, tell your doctor or pharmacist your medical history, especially of: stroke, high blood pressure, chest pain (angina), heart attack, mental/mood disorders (e.g., anxiety, bipolar disorder, mania), epilepsy/seizure problems, certain blood vessel problems (e.g.,
Raynaud's disease, peripheral vascular disease), overactive thyroid (hyperthyroidism), low blood flow to the brain (cerebral insufficiency), diabetes, difficulty sleeping.
This drug may make you dizzy or lightheaded; use caution engaging in activities requiring alertness such as driving or using machinery. Limit alcoholic beverages.
Caution is advised when using this drug in the elderly because they may be more sensitive to its effects, especially dizziness and lightheadedness.
Caution is advised when using this product in children because they may be more sensitive to its side effects, especially excitation, agitation, or increased blood pressure.
Some liquid/chewable forms of pseudoephedrine may contain aspartame. If you have phenylketonuria (PKU) or any other condition that requires you to restrict your intake of aspartame (phenylalanine), consult your doctor or pharmacist regarding the safe use of this medicine.
This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor.
The medication in this product passes into breast milk. However, the amount in breast milk is small, and there are no reports of serious harm to infants. Consult your doctor before
breast-feeding.
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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