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.

BENZONATATE- ORAL

(ben-ZOE-na-tate)

COMMON BRAND NAME(S): Tessalon Perle, Zonatuss

USES: This medication is used to treat coughs caused by the common cold and other breathing problems (e.g., pneumonia, bronchitis, emphysema, asthma). It works by reducing the reflex in the lungs that causes the urge to cough. Use of this medication is not recommended in children younger than 10 years. Discuss the risks and benefits with your doctor.

HOW TO USE: Take this medication by mouth with or without food, usually 3 times daily as needed or as directed by your doctor. Swallow this medication whole. Do not chew, suck, or dissolve this medication in your mouth. Doing so will cause a loss of feeling in your mouth/throat and may cause choking or a severe allergic reaction. (See also Side Effects section.) Do not eat or drink until the numbness goes away. Get medical help right away if the numbness persists or worsens. Dosage is based on your medical condition and response to therapy. Do not take more than 200 milligrams at one time. Taking more benzonatate than prescribed will not make your cough go away faster but may result in serious side effects. Tell your doctor if your condition persists or worsens.

SIDE EFFECTS: Drowsiness, dizziness, headache, stomach upset, constipation, and stuffy nose may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly. 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, loss of feeling in the chest, burning in the eyes. A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. The possibility of an allergic reaction may increase if you chew, suck, or dissolve this medication in your mouth. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing, fainting. 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 benzonatate, tell your doctor or pharmacist if you are allergic to it; or to certain anesthetic agents (e.g., procaine, tetracaine); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details. Before using this medication, tell your doctor or pharmacist your medical history. This drug may make you dizzy or drowsy. 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. During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. It is not known if this medication passes into breast milk. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: Your healthcare professionals (e.g., doctor or pharmacist) may already be aware of any possible drug interactions and may be monitoring you for it. Do not start, stop or change the dosage of any medicine before checking with them first. Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use. Tell your doctor or pharmacist if you take drugs that cause drowsiness such as: certain antihistamines (e.g., diphenhydramine), anti-seizure drugs (e.g., carbamazepine), medicine for sleep or anxiety (e.g., alprazolam, diazepam, zolpidem), muscle relaxants, narcotic pain relievers (e.g., codeine), psychiatric medicines (e.g., chlorpromazine, risperidone, amitriptyline, trazodone). Check the labels on all your medicines (e.g., cough-and-cold products) because they may contain drowsiness-causing ingredients. Ask your pharmacist about the safe use of those products. This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

OVERDOSE: If overdose is suspected or if a child accidentally swallows this medication, contact your local poison control center or emergency room immediately. US residents can call the US national poison hotline at 1-800-222-1222. Canadian residents should call their local poison control center directly. Symptoms of overdose may include: restlessness, shaking (tremors), seizures, inability to wake up (coma).

NOTES: Do not share this medication with others.

MISSED DOSE: If you miss a dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE: Store at room temperature away from light and moisture. Do not store in the bathroom. Always store benzonatate in a child-resistant container. Keep all medicines 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 December 2010. Copyright(c) 2010 First Databank, Inc.