Flura-Tab is a substance that strengthens tooth enamel, which helps prevent dental cavities.

Flura-Tab is used to prevent tooth decay in people whose drinking water contains low levels of fluoride (less than 0.6 parts per million).

Flura-Tab may also be used for other purposes not listed in this medication guide.

You should not use Flura-Tab if the level of fluoride in your drinking water is greater than 0.6 parts per million (ppm).

Carefully follow all dosing instructions when giving Flura-Tab to a child.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Flura-Tab doses are based on your age and on the this medicine content in your water supply. In general, you do not need to take Flura-Tab if the amount of fluoride in your water is greater than 0.6 ppm.

Carefully follow all dosing instructions when giving this medicine to a child.

Measure liquid medicine carefully. Use the dosing syringe provided, or use a medicine dose-measuring device (not a kitchen spoon).

Flura-Tab liquid (drops) can be taken undiluted, or mixed with liquid or food. Drink or eat this mixture right away. Do not save it for later use.

The chewable tablet may be chewed or dissolved in your mouth before you swallow it. It is best to take this medicine at bedtime after brushing your teeth.

Do not rinse your mouth, and do not eat or drink anything for 30 minutes after taking Flura-Tab.

Take Flura-Tab regularly to get the most benefit.

Store at room temperature away from moisture and heat.

You should not use Flura-Tab if the level of fluoride in your drinking water is greater than 0.6 parts per million (ppm).

To determine the amount of fluoride in your water supply, you may contact your local water company. You may also get information about water Flura-Tab content throughout the United States from the Centers for Disease Control and Prevention (CDC).

Tell your dentist or doctor if:

• you have ever had sores or ulcers in your mouth; or

• you are pregnant or breastfeeding.

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include sudden burning in your mouth, tongue pain, nausea, vomiting, stomach cramps, diarrhea, drooling, or vomiting blood.

Avoid eating or drinking dairy products such as milk or yogurt within 1 hour after you take Flura-Tab. Also avoid calcium-fortified juice for 1 hour after taking this medicine.

Ask your doctor before using an antacid or laxative, and use only the type your doctor recommends. The ingredient in some antacids or laxatives can make it harder for your body to absorb Flura-Tab.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Flura-Tab may cause serious side effects. Call your doctor at once if you have:

• very upset stomach;

• nausea and vomiting; or

• staining, pitting, or any other changes in the appearance of your teeth.

Less serious side effects may be more likely, and you may have none at all.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.