"The U.S. Food and Drug Administration today announced its intention to take enforcement action against companies that manufacture and/or distribute certain unapproved prescription ear drop products (known as otic products) labeled to relieve ear "...
Auralgan Consumer (continued)
Tell your doctor immediately if any of these unlikely but serious side effects occur: burning/stinging/redness/new pain in or around the ears.
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 of the following symptoms of a serious allergic reaction: 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.
Read the Auralgan (antipyrine, benzocaine and glycerin dehydrated) Side Effects Center for a complete guide to possible side effects
PRECAUTIONS: Before using this medication, tell your doctor or pharmacist if you are allergic to antipyrine, benzocaine, or other ingredients in this product (e.g., glycerin, zinc acetate); or to other ester-type anesthetics (e.g., procaine, tetracaine); 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 medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: hole in the eardrum (perforated tympanic membrane).
Before using this medication, tell your doctor or pharmacist your medical history, especially of: ear injuries/surgery.
During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.
It is not known if this medication passes into breast milk. Consult your doctor before breast-feeding.
Additional Auralgan Information
Auralgan - User Reviews
Auralgan User Reviews
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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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