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|Glycyrrhetinic Acid/Povidone/Sodium Hyaluronate Gel

Glycyrrhetinic Acid/Povidone/Sodium Hyaluronate Gel

Glycyrrhetinic Acid/Povidone/Sodium Hyaluronate Gel is used for:

Managing and relieving mouth pain and irritation that may occur as a result of oral surgery, braces, dentures, disease, or following cancer chemotherapy or radiation therapy. It may also be used to treat mouth ulcers or for other conditions as determined by your doctor.

Glycyrrhetinic Acid/Povidone/Sodium Hyaluronate Gel is a bioadherent oral gel. It works by coating the mouth to help relieve mouth pain and irritation.

Do NOT use Glycyrrhetinic Acid/Povidone/Sodium Hyaluronate Gel if:

• you are allergic to any ingredient in Glycyrrhetinic Acid/Povidone/Sodium Hyaluronate Gel

Contact your doctor or health care provider right away if any of these apply to you.

Before using Glycyrrhetinic Acid/Povidone/Sodium Hyaluronate Gel:

Some medical conditions may interact with Glycyrrhetinic Acid/Povidone/Sodium Hyaluronate Gel. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances

Some MEDICINES MAY INTERACT with Glycyrrhetinic Acid/Povidone/Sodium Hyaluronate Gel. However, no specific interactions with Glycyrrhetinic Acid/Povidone/Sodium Hyaluronate Gel are known at this time.

This may not be a complete list of all interactions that may occur. Ask your health care provider if Glycyrrhetinic Acid/Povidone/Sodium Hyaluronate Gel may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Glycyrrhetinic Acid/Povidone/Sodium Hyaluronate Gel:

Use Glycyrrhetinic Acid/Povidone/Sodium Hyaluronate Gel as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Pour the entire contents of 1 packet into a glass and mix with 1 tablespoon (15 mL) of water. Stir the mixture well. If the mixture is too thick, you may add 1 to 2 additional tablespoons (15 to 30 mL) of water until the mixture is the right thickness.
• If no water is available, you may use Glycyrrhetinic Acid/Povidone/Sodium Hyaluronate Gel undiluted. Contact your doctor or pharmacist for instructions if you are unsure how to use Glycyrrhetinic Acid/Povidone/Sodium Hyaluronate Gel without water.
• Rinse or swish the medicine around the mouth for at least 1 minute or as long as possible. Coat the entire area, including the tongue, top of the mouth, throat, and inside of the cheeks.
• Gargle and spit the medicine out. Try not to swallow.
• Avoid eating or drinking for at least 1 hour after using Glycyrrhetinic Acid/Povidone/Sodium Hyaluronate Gel.
• If you miss a dose of Glycyrrhetinic Acid/Povidone/Sodium Hyaluronate Gel, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Glycyrrhetinic Acid/Povidone/Sodium Hyaluronate Gel.

Important safety information:

• If your symptoms do not improve within 7 days or if they become worse, check with your doctor.
• The gel may become darker or thicker over time. This will not affect its safety or effectiveness. Do not use Glycyrrhetinic Acid/Povidone/Sodium Hyaluronate Gel after the expiration date listed on the packaging.
• PREGNANCY and BREAST-FEEDING: If you become pregnant while taking Glycyrrhetinic Acid/Povidone/Sodium Hyaluronate Gel, discuss with your doctor the benefits and risks of using Glycyrrhetinic Acid/Povidone/Sodium Hyaluronate Gel during pregnancy. If you are or will be breast-feeding while you are using Glycyrrhetinic Acid/Povidone/Sodium Hyaluronate Gel, check with your doctor or pharmacist to discuss the risks to your baby.

Possible side effects of Glycyrrhetinic Acid/Povidone/Sodium Hyaluronate Gel:

All medicines may cause side effects, but many people have no, or minor, side effects. When used in small doses, no COMMON side effects have been reported with this product. Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue).

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately.

Store Glycyrrhetinic Acid/Povidone/Sodium Hyaluronate Gel at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not refrigerate. Do not store in the bathroom. Keep Glycyrrhetinic Acid/Povidone/Sodium Hyaluronate Gel out of the reach of children and away from pets.

General information:

• If you have any questions about Glycyrrhetinic Acid/Povidone/Sodium Hyaluronate Gel, please talk with your doctor, pharmacist, or other health care provider.
• Glycyrrhetinic Acid/Povidone/Sodium Hyaluronate Gel is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Glycyrrhetinic Acid/Povidone/Sodium Hyaluronate Gel. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.