This medication is used to prevent cavities. It makes teeth stronger and more resistant to decay caused by acid and bacteria. Talk to your dentist or doctor about the benefits and risks of this product.

This medication is not recommended for use in infants less than 6 months of age.

This medication is not recommended for use in areas where the fluoride content in the water supply is greater than 0.6 parts per million. See Notes section for more information.

Take this medication by mouth as directed by your doctor/dentist, usually once daily.

The dosage is based on your age and the fluoride content in your water supply.

If you are using the liquid form of this medication, measure the dose carefully using the specially marked medicine dropper that is provided. Drops may be swallowed directly, added to a small amount of juice, or mixed with a small amount of food such as applesauce. Do not mix with food containing milk or other dairy products.

If you are using the chewable form of this medication, chew or dissolve it in the mouth before swallowing so that the teeth will also absorb the fluoride. If you are using the lozenge, place the lozenge in your mouth and allow it to dissolve. Take the chewable medication or lozenge at bedtime after brushing your teeth or as directed by your doctor/dentist. For best results, do not rinse your mouth, eat, or drink for 30 minutes after taking these forms of the medication.

Take this medication 1 hour apart from products that contain calcium, aluminum, or magnesium. Some examples include dairy products (such as milk, yogurt), antacids, laxatives, and vitamins/minerals. These products can bind with fluoride, preventing its full absorption.

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

Stomach upset may 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 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 taking 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)

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

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

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

See also How to Use section.

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.

Taking 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.

Check the fluoride content of your water supply by asking local town or city officials. Fluoride supplements are not necessary if the fluoride content in the water supply is greater than 0.6 parts per million. If your water supply changes or if you move, check with your doctor or dentist to determine if extra fluoride is still necessary.

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

Store at room temperature away from heat and moisture. Store the liquid form in the original plastic container. Do not store in the bathroom. 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.