Oravig® Buccal Tablets
Read the Patient Information that comes with Oravig® before you start taking it and each time you get a refill. There may be new information. The information on this website does not take the place of talking with your doctor or about your medical condition or your treatment.
Oravig® is a prescription antifungal medicine used in adults to treat fungal (yeast) infections of the mouth and the throat.
It is not known if Oravig® is safe and effective in children under the age of 16 years. It is not known if children can follow the instructions on what to do with the buccal tablet. In younger children, there is a possible risk of choking.
Do not use Oravig® if you:
Before taking Oravig®, tell your doctor if you:
Tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements.
Oravig® may affect the way other medicines work, and other medicines may affect how Oravig® works.
Especially tell your doctor if you take:
Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine.
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You should avoid activities that may prevent Oravig® from sticking to your gum, including:
Oravig® may cause serious side effects, including:
Allergic reactions. Tell your doctor or get emergency medical help right away if you have any of the symptoms below:
The most common side effects of Oravig® include:
Tell your doctor if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of Oravig®. For more information, ask your doctor or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information page. Do not use Oravig® for a condition for which it was not prescribed. Do not give Oravig® to other people, even if they have the same symptoms that you have. It may harm them. This Patient Information page summarizes the most important information about Oravig®. If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about Oravig® that is written for health professionals. You can also visit www.Oravig.com for more information.
Active ingredient: miconazole
Inactive ingredients: hypromellose, milk protein concentrate, corn starch, lactose monohydrate, sodium lauryl sulfate, magnesium stearate, and talc.
Manufactured By:
Catalent Germany Schorndorf GmbH
Steinbeisstraße 1-2
73614 Schorndorf
Germany
Distributed by:
Galt Pharmaceuticals
3350 Riverwood Parkway
Suite 1900
Atlanta, GA 30339
Phone:678-821-2428
Address medical inquiries to::
Galt Pharmaceuticals
3350 Riverwood Parkway
Suite 1900
Atlanta, GA 30339
Phone:678-821-2428
US patent numbers: 6,916,485; 7,651,698; 8,518,442.
©2022 Galt Pharmaceuticals
Indication
Important Safety Information
Read the Patient Information that comes with Oravig® before you start taking it and each time you get a refill. There may be new information. This brochure does not take the place of talking with your doctor or about your medical condition or your treatment.
Do not use Oravig® if you:
Before taking Oravig®, tell your doctor if you:
Tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements.
Oravig® may affect the way other medicines work, and other medicines may affect how Oravig® works.
Especially tell your doctor if you take:
Allergic reactions. Tell your doctor or get emergency medical help right away if you have any of the symptoms below:
The most common side effects of Oravig® include diarrhea, change in taste, headache, upper stomach (abdominal) pain, nausea and vomiting. Tell your doctor if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of Oravig®. For more information, ask your doctor or pharmacist.
Healthcare professionals and patients should report any adverse events associated with Tolectin to the FDA's MedWatch program at 1-800-FDA-1088 or www.fda.gov/medwatch.
For additional information about Oravig®, please refer to the Full Prescribing Info.