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triethanolamine polypeptide oleate - otic, Cerumenex (cont.)

SIDE EFFECTS: This medication may cause a temporary burning feeling in your ear for 1 to 2 minutes when it is first applied. If this effect persists or worsens, contact your doctor or pharmacist promptly.A very serious allergic reaction to this drug is rare. However, stop using this medication and seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), ear pain, 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 using this medication, tell your doctor or pharmacist if you are allergic to it; or to natural rubber/latex (found in the packaging of some brands); or if you have any other allergies.If you have any of the following health problems, consult your doctor or pharmacist before using this product: other ear problems (e.g., ear drainage, infection, pain, rash, swelling, injury, hole/perforation in the eardrum), dizziness, history of skin reactions or allergies.During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: If you are using this product under your doctor's direction, your doctor or pharmacist may already be aware of possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor or pharmacist first.Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

OVERDOSE: This medicine may be harmful if swallowed. If swallowing or overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US National Poison Hotline at 1-800-222-1222. Canada residents can call a provincial poison control center.



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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