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February 10, 2012
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carbetapentane/decongestant/antihistamine - oral (cont.)

SIDE EFFECTS: Drowsiness, dizziness, flushing, headache, nausea, nervousness, blurred vision, or dry mouth/nose/throat may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.To relieve dry mouth, suck on (sugarless) hard candy or ice chips, chew (sugarless) gum, drink water, or use a saliva substitute.Remember that your doctor has prescribed this medication because 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.Tell your doctor immediately if any of these unlikely but serious side effects occur: mental/mood changes (e.g., hallucinations, confusion), shaking (tremors), trouble urinating, weakness.Tell your doctor immediately if any of these rare but very serious side effects occur: fast/slow/irregular heartbeat, seizure.A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: 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.

PRECAUTIONS: Before taking this medication, tell your doctor if you are allergic to any of its ingredients; or if you have any other allergies.Before taking this medication, tell your doctor or pharmacist your medical history, especially of: breathing problems (e.g., asthma, emphysema), diabetes, glaucoma, heart problems, high blood pressure, kidney problems, liver disease, seizures, stomach/intestinal problems (e.g., ulcers, blockage), overactive thyroid (hyperthyroidism), urination problems (e.g., trouble urinating due to enlarged prostate, urinary retention).This drug may make you dizzy or drowsy or cause blurred vision. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are sure you can perform such activities safely. Limit alcoholic beverages.Some brands may contain sugar, alcohol, or aspartame. 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 that you are taking this medication.Children may be more sensitive to the effects of antihistamines. In young children, this medication may cause agitation/excitement instead of drowsiness.Older adults may be more sensitive to the effects of this drug, especially dizziness, drowsiness, mental/mood changes, and blood pressure changes.During the first 6 months of pregnancy, this medication should be used only if clearly needed. It should not be used during the last 3 months of pregnancy because it may increase the risk of serious side effects in a newborn baby (e.g., seizures). Discuss the risks and benefits with your doctor.This drug may pass into breast milk and could have undesirable effects on a nursing infant. Therefore, breast-feeding is not recommended while using this drug. Consult your doctor before breast-feeding.



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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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