This medication is applied to teeth to prevent cavities. Fluoride is a mineral that works by making the teeth stronger and more resistant to decay caused by acid and bacteria.

Do not use this medication in children younger than 6 years unless directed to do so by your doctor/dentist.

Use this rinse as directed by your dentist/doctor, usually once weekly (at bedtime). After brushing your teeth, place 2 teaspoonfuls (10 milliliters) of the solution into your mouth, swish vigorously for 1 minute, and spit it out. Do not swallow the medication.

Carefully watch children during use and teach proper rinsing habits to avoid swallowing.

To get the most benefit, you should not eat, drink, or rinse your mouth for at least 30 minutes after using the solution.

Dosage is based on age and the amount of fluoride in your drinking water. Do not exceed the recommended dose without checking with your dentist/doctor. Doing so will not do more to prevent cavities but may lead to side effects instead.

Use this medication regularly to get the most benefit from it. To help you remember, use it on the same day each week. Mark your calendar with a reminder.

Do not treat this medication like a normal mouthwash: do not use it more often than prescribed, or just to freshen your breath.

Tell your dentist/doctor right away if you notice any changes in the color or appearance of your teeth. These effects may be 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 dentist/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 or at www.fda.gov/medwatch.

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 sodium fluoride, tell your doctor 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 or pharmacist your medical history, especially of:

• mouth problems (such as sores, mucositis)
• swallowing problems (dysphagia)

Children may be more sensitive to the side effects of this drug, especially if they swallow this medication.

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

This medication passes into breast milk. Consult your doctor before breastfeeding.

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.

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.

If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Use your next dose at the regular time. Do not double the dose to catch up.

Store at room temperature. 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.