GENERIC NAME: BENZOCAINE/ANTIPYRINE/PHENYLEPHRINE - OTIC (BEN-zoe-kane/an-tee-PYE-reen/FEN-il-EF-rin)
BRAND NAME(S): Otogesic, Tympagesic
USES: This medication is used to help relieve pain and feeling of stuffy ears due to infections of the tube (canal) of the outer ear (external otitis) and middle ear (otitis media). This product contains 3 ingredients. Benzocaine belongs to a class of drugs known as local anesthetics, and it helps to numb ear pain. Antipyrine is a pain reliever. Phenylephrine is a decongestant, and it helps relieve the feeling of stuffy ears.This medication does not treat infections. The proper ear drops (e.g., acetic acid, antibiotics) should be used to treat the infection.
HOW TO USE: To apply ear drops to the affected ear(s), wash your hands first. To avoid contamination, be careful not to touch the dropper or let it touch your ear or any other surface. It may be easier to have another person give the drops if possible.Lie on your side or tilt the affected ear upward. Place the dropper directly over the ear and give the prescribed number of drops. To help the drops roll into the ear, gently pull the earlobe up and back in adults. In children, gently pull the earlobe down and back. Keep your head tilted for about 5 minutes, or insert a piece of cotton if your doctor directs you to do so to keep the medication in contact with your ear canal. Do not rinse the dropper.This medication may be used as needed, but regular use will control ear pain more effectively. To help you remember, use it at the same times each day. Continue to use this medication only as long as you need to for ear pain. Do not use this medication longer or more often than prescribed.Dosage is based on your medical condition and response to treatment.Tell your doctor if your ear symptoms worsen or if they persist for more than 7 days.Avoid contact with the eyes. If you get some of the medication in the eye, rinse the eye with a steady, gentle stream of tap water for at least 15 minutes. Contact your doctor if irritation continues.
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.
DRUG INTERACTIONS: Your doctor or pharmacist may already be aware of any 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 product may be harmful if swallowed. If overdose or swallowing 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.
NOTES: Do not share this medication with others.This medication has been prescribed for your current condition only. Do not use it later for another ear problem unless told to do so by your doctor. A different medication may be necessary in that case.For certain ear problems, it is important to keep the affected ear(s) clean and dry. Try not to get the affected ear(s) wet when bathing. Avoid swimming unless your doctor tells you otherwise. Consult your doctor for more details.
MISSED DOSE: If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.
STORAGE: Store at room temperature between 59-86 degrees F (15-30 degrees C) away from light and moisture. Protect from freezing. Discard the solution if it turns brown or cloudy or contains particles. 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.
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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.