benzocaine/antipyrine/phenylephrine - otic, Otogesic, Tympagesic (cont.)
SIDE EFFECTS: Temporary stinging/burning in the ear canal may occur. If this effect persists or worsens, tell 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: redness on the outside of the ear, fluid leaking out of the ear.Tell your doctor immediately if any of these rare but very serious side effects occur: bluish skin, severe tiredness/weakness.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 benzocaine/antipyrine/phenylephrine, tell your doctor or pharmacist if you are allergic to any of these medications; or to other anesthetics (e.g., procaine, tetracaine) or to decongestants (e.g., pseudoephedrine); or if you have any other allergies.This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: a hole in the eardrum (perforated tympanic membrane), ear discharge.Before using this medication, tell your doctor or pharmacist your medical history, especially of: ear injuries/surgery, ear tubes.During pregnancy, this medication should be used only when clearly needed. Though the risks are probably small, discuss the use of this medication with your doctor.It is not known whether this drug 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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