antipyrine/benzocaine/phenylephrine

Antipyrine/benzocaine/phenylephrine is a pain-relieving medication used to treat ear pain and ear congestion caused by a middle ear infection (otitis media) and to remove earwax. The three drugs in the formulation combine together and work in different ways to reduce inflammation and pain in the ear.

Antipyrine/benzocaine/phenylephrine is available over the counter (OTC) as an ear solution that can be instilled into the ear canal with a dropper.

Antipyrine, benzocaine, and phenylephrine work in the following ways:

• Antipyrine: An analgesic that reduces inflammation and pain
• Benzocaine: A local anesthetic that numbs and blocks the initiation and conduction of pain signals from the ear canal to the brain
• Phenylephrine: A decongestant that constricts swollen blood vessels and reduces swelling in the ear

• Do not use antipyrine/benzocaine/phenylephrine ear drops if you are hypersensitive to any of the components of the formulation.
• Do not use if you have a perforated eardrum or discharge from the ear.
• Consult with your physician if you develop severe pain or burning after instilling antipyrine/benzocaine/phenylephrine ear drops.
• Discontinue use if you develop a rash, dry skin, or redness of skin.

Common side effects of antipyrine/benzocaine/phenylephrine include:

• Temporary stinging or burning in the ear canal
• Local hypersensitivity reaction

Call your doctor immediately if you experience any of the following symptoms or serious side effects while using this drug:

• Serious heart symptoms include fast or pounding heartbeats, fluttering in your chest, shortness of breath, and sudden dizziness;
• Severe headache, confusion, slurred speech, severe weakness, vomiting, loss of coordination, feeling unsteady;
• Severe nervous system reaction with very stiff muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, and feeling like you might pass out; or
• Serious eye symptoms include blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights.

This is not a complete list of all side effects or adverse reactions that may occur from the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may also report side effects or health problems to the FDA at 1-800-FDA-1088.

Otic solution

• 5%/5%/0.25%

Adult and Pediatric:

Ear Pain/Congestion

• Apply to the ear canal (drop by drop) until the ear canal is filled, insert gauze into the ear opening; may apply three times daily for two to three days.

Overdose

• Appropriate use of antipyrine/benzocaine/phenylephrine is unlikely to result in overdose, however, oral ingestion may be harmful.
• There is no information on an oral overdose of the ear drops, report your symptoms to Poison Control.

Inform your doctor of all medications you are currently taking, who can advise you on any possible drug interactions. Never begin taking, suddenly discontinue, or change the dosage of any medication without your doctor’s recommendation.

• Antipyrine/benzocaine/phenylephrine has no listed severe, serious, moderate, or mild interactions with other drugs.

The drug interactions listed above are not all of the possible interactions or adverse effects. For more information on drug interactions, visit the RxList Drug Interaction Checker.

It is important to always tell your doctor, pharmacist, or health care provider about all prescription and over-the-counter medications you use, as well as the dosage for each, and keep a list of the information. Check with your doctor or healthcare provider if you have any questions about the medication.

• Use antipyrine/benzocaine/phenylephrine with caution during pregnancy, only if it is clearly needed.
• It is not known if use of antipyrine/benzocaine/phenylephrine ear drops can result in sufficient systemic absorption to pass into breastmilk. Check with your physician before using.
• Check with your physician before using any OTC product, including antipyrine/benzocaine/phenylephrine ear drops, if you are pregnant or breastfeeding.

• Use antipyrine/benzocaine/phenylephrine ear drops exactly as prescribed or as per label instructions. Do not use a higher dosage or more frequently than recommended.
• Store safely out of reach of children.
• In case of oral ingestion and overdose, seek medical help or contact Poison Control.