Fraiche 5000

Store at room temperature away from heat. Keep all medications 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.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669. Symptoms of overdose may include: burning in the mouth, sore tongue, nausea, vomiting, diarrhea, increased saliva, stomach pain/cramping, muscle weakness, shaking, seizures.

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

Use this medication as directed by your doctor/dentist, usually once daily just before bedtime.

First brush your teeth thoroughly with toothpaste, and rinse as usual. Then apply a thin ribbon of this medication to your teeth with a toothbrush or mouth tray. Leave the medication on for at least 1 minute.

Spit out the medication after use. Do not swallow. Children should rinse their mouth thoroughly right away. For adults, do not rinse your mouth, eat, or drink for at least 30 minutes after use to get the best results.

Use this medication regularly in order to get the most benefit from it. To help you remember, use it at the same time each day.

Mouth/gum irritation may rarely occur. If this effect lasts or gets worse, tell your doctor/dentist or pharmacist promptly.

Tell your doctor/dentist right away if your teeth become stained or pitted. This is often a result of too much fluoride.

Remember that this medication has been prescribed because your doctor or dentist 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.

A very serious allergic reaction to this drug is rare. However, get medical help right away 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/dentist 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 or at MedWatch: The FDA Safety Information and Adverse Event Reporting Program.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before using this medication, tell your doctor/dentist or pharmacist if you are allergic to it; 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.

Before using this medication, tell your doctor/dentist or pharmacist your medical history, especially of: mouth problems (such as sores, mucositis).

Children may be more sensitive to the side effects of this drug, especially if this medication is swallowed. Watch children closely when they are using this medication to make sure that they do not swallow this medication.

Tell your doctor if you are pregnant before using this medication.

It is unknown if this drug passes into breast milk. Consult your healthcare professional before breastfeeding.

Do not share this medication with others.

Using this medication does not replace good dental habits. Continue to brush and floss your teeth regularly as directed by your dentist, and have regular dental checkups.