Sodium fluoride chewable tablets is used for:

Preventing cavities in children over 6 months old when the amount of fluoride in the water supply is too low.

Sodium fluoride chewable tablets is a mineral and a non-cavity-promoting sweetener combination. The mineral works by strengthening the teeth and decreasing the effects of acid and bacteria on the teeth. The sweetener works by decreasing the risk of cavities.

Do NOT use sodium fluoride chewable tablets if:

• you are allergic to any ingredient in sodium fluoride chewable tablets
• your drinking water has a fluoride content greater than 0.6 parts per million (ppm)
• you have severe kidney problems, joint pain, stomach or bowel ulcers, or softening of your bones (osteomalacia, rickets)

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

Before using sodium fluoride chewable tablets:

Some medical conditions may interact with sodium fluoride chewable tablets. 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
• if you have kidney problems

Some MEDICINES MAY INTERACT with sodium fluoride chewable tablets. However, no specific interactions with sodium fluoride chewable tablets are known at this time.

Ask your health care provider if sodium fluoride chewable tablets 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 sodium fluoride chewable tablets:

Use sodium fluoride chewable tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take sodium fluoride chewable tablets by mouth with or without food. Do not eat or drink dairy products within 1 hour before or after you take sodium fluoride chewable tablets.
• Do not take an antacid that has aluminum, calcium, or magnesium in it for several hours after you take sodium fluoride chewable tablets.
• Dissolve sodium fluoride chewable tablets in your mouth or chew it well before you swallow it.
• Take sodium fluoride chewable tablets at bedtime after you brush your teeth unless your doctor tells you otherwise.
• If you miss a dose of sodium fluoride chewable tablets, take 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 take 2 doses at once.

Ask your health care provider any questions you may have about how to use sodium fluoride chewable tablets.

Important safety information:

• Do not exceed the dose recommended by your doctor or dentist.
• Notify your dentist if your teeth become spotted or stained.
• Sodium fluoride chewable tablets is not recommended for use in CHILDREN younger than 6 months old; safety and effectiveness in these children have not been confirmed.
• Caution is advised when using sodium fluoride chewable tablets in CHILDREN younger than 6 years old. The appropriate dose of sodium fluoride chewable tablets depends on the child’s age and the amount of fluoride in the drinking water. Talk with your doctor if you have questions about the appropriate dose for your child or the amount of fluoride in your drinking water.
• PREGNANCY and BREAST-FEEDING: If you become pregnant while taking sodium fluoride chewable tablets, contact your doctor. You will need to discuss the benefits and risks of using sodium fluoride chewable tablets while pregnant. It is not known if sodium fluoride chewable tablets is found in breast milk. If you are or will be breast-feeding while you are using sodium fluoride chewable tablets, check with your doctor. Discuss the risks to your baby.

Possible side effects of sodium fluoride chewable tablets:

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 sodium fluoride chewable tablets. Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; 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 about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include bloody vomit or vomit that looks like coffee grounds; burning in the mouth; diarrhea; increased drooling; nausea; sore tongue; stomach pain or cramping; vomiting.

Proper storage of sodium fluoride chewable tablets:

Store sodium fluoride chewable tablets at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep sodium fluoride chewable tablets out of the reach of children and away from pets.

General information:

• If you have any questions about sodium fluoride chewable tablets, please talk with your doctor, pharmacist, or other health care provider.
• Sodium fluoride chewable tablets 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.
• Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take sodium fluoride chewable tablets or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about sodium fluoride chewable tablets. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to sodium fluoride chewable tablets. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using sodium fluoride chewable tablets.

Fluoride Side Effects

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Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.