SIDE EFFECTS: Tell your doctor immediately if any of these unlikely but serious side effects occur: new or increased redness/swelling/pain/irritation in or around the ears.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.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 using this medication, tell your doctor or pharmacist if you are allergic to hydrocortisone or yerba santa; or to other corticosteroids (e.g., betamethasone); 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.This product should not be used if you have certain medical conditions. Before using this product, consult your doctor or pharmacist if you have: a hole in the eardrum (ruptured tympanic membrane), certain virus infections (vaccinia, chickenpox).If you have any of the following health problems, consult your doctor or pharmacist before using this product: ear surgery/injury/infection/swelling.During pregnancy, this product should be used only when clearly needed. Discuss the risks and benefits with your doctor.It is not known whether this product passes into breast milk. 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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