Fluoridex Daily Defense Enhanced Whitening (Oral, Dental, Oromucosal)

Fluoride helps reduce cavities in teeth and is usually found naturally in drinking water. However, some places do not have enough fluoride in their water to prevent cavities. In these cases, extra fluoride may need to be added to the diet. Some children may need both dietary fluoride and topical fluoride treatments from a dentist. Using fluoride toothpaste or rinse can also be beneficial.

Taking extra oral fluoride does not replace good dental habits. These include eating a healthy diet, brushing and flossing your teeth regularly, and having routine dental checkups.

Fluoride can also be used for other conditions as decided by your doctor.

This medicine is only available with a prescription.

For good health, it is important to eat a balanced and varied diet. Follow any diet program that your health care professional recommends. For your specific dietary vitamin and/or mineral needs, ask your health care professional for a list of suitable foods. If you think you aren't getting enough vitamins and/or minerals from your diet, you may consider taking a dietary supplement.

People can get fluoride from fish (including the bones), tea, and drinking water that has added fluoride. Food cooked in water that contains fluoride or in Teflon-coated pans also provides fluoride. However, foods cooked in aluminum pans provide less fluoride.

The daily amount of fluoride needed is defined in several different ways.

• For U.S.—
• Recommended Dietary Allowances (RDAs) are the amounts of vitamins and minerals needed for adequate nutrition in most healthy people. RDAs for a nutrient can vary based on a person's age, sex, and physical condition (e.g., pregnancy).
• Daily Values (DVs) are used on food and dietary supplement labels to show the percentage of the recommended daily amount of each nutrient that a serving provides. DV replaces the previous term United States Recommended Daily Allowances (USRDAs).

• For Canada—
• Recommended Nutrient Intakes (RNIs) are used to determine the amounts of vitamins, minerals, and protein needed for adequate nutrition and to lower the risk of chronic disease.

There is no RDA or RNI for fluoride. Daily recommended intakes for fluoride are generally defined as follows:

• Infants and children—
• Birth to 3 years of age: 0.1 to 1.5 milligrams (mg).
• 4 to 6 years of age: 1 to 2.5 mg.
• 7 to 10 years of age: 1.5 to 2.5 mg.

• Adolescents and adults—
• 1.5 to 4 mg.

Remember:

• The total amount of fluoride you get each day includes what you receive from the foods and beverages you consume and what you might take as a supplement.
• This total should not exceed the recommendations above unless your health care professional has ordered otherwise. Taking too much fluoride can lead to serious issues with your teeth and bones.

The amount of fluoride in water varies in different areas of the U.S. If you move to a new location, consult a health care professional there as soon as you can to find out if you still need this medicine or if the dose needs to be adjusted. Also, talk to your health care professional if you change how you feed your infant (for example, switching from breast-feeding to infant formula), change the drinking water you use (like moving from city water to nonfluoridated bottled water), or alter your water filtration system (such as using filtered tap water instead of regular tap water).

Do not take calcium supplements or products containing aluminum hydroxide and sodium fluoride at the same time. It is best to take these two products 2 hours apart to ensure you get the full benefit from each medicine.

Let your health care professional know as soon as possible if you see white, brown, or black spots on the teeth. These can be signs of too much fluoride in children when it is given during times of tooth development.

In deciding to use a medicine, you need to consider the risks versus the benefits. This is a choice you will make with your doctor. For this medicine, keep the following in mind:

Allergies

Inform your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also, let your health care professional know about any other allergies you have, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

There have been no reported problems in children when taking normal daily recommended amounts. However, taking too much sodium fluoride or using it for a long time may cause bone issues and teeth discoloration in children.

Geriatric

There have been no reported problems in older adults when taking normal daily recommended amounts. However, older individuals may be more likely to experience joint pain, kidney issues, or stomach ulcers, which could be worsened by taking large doses of sodium fluoride. You should consult your health care professional.

Breast Feeding

Research in women indicates that this medication poses minimal risk to the infant when used during breastfeeding.

Interactions with Medicines

Some medicines should never be used together, while others can be used together even if an interaction might occur. In such cases, your doctor may adjust the dose or take other precautions. Inform your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicines.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be taken around the time of eating food or certain types of food due to potential interactions. Using alcohol or tobacco with certain medicines may also lead to interactions. The following interactions have been highlighted for their potential significance, but this list may not cover everything.

Using this medicine with any of the following may increase the risk of certain side effects, but may be necessary in some situations. If used together, your doctor may adjust the dose or frequency of this medicine, or provide special instructions regarding food, alcohol, or tobacco use.

• Dairy Food

Other Medical Problems

Having other medical issues may impact the use of this medicine. Make sure to inform your doctor if you have any other medical conditions, especially:

• Brown, white, or black discoloration of teeth or
• Joint pain or
• Severe kidney problems or
• Stomach ulcer—Sodium fluoride may worsen these conditions.

Along with its necessary effects, a medicine may cause some unwanted effects. Not all side effects may occur, but if they do, they may require medical attention.

Check with your doctor as soon as possible if any of the following side effects happen:

Sodium fluoride in drinking water or taken as a supplement usually does not cause side effects. However, taking too much fluoride may lead to serious problems.

• Sores in the mouth and on the lips (rare)

Stop taking this medicine and get emergency help right away if any of the following effects occur:

• Black, tarry stools
• Bloody vomit
• Diarrhea
• Drowsiness
• Faintness
• Increased watering of the mouth
• Nausea or vomiting
• Shallow breathing
• Stomach cramps or pain
• Tremors
• Unusual excitement
• Watery eyes
• Weakness

Check with your doctor as soon as possible if any of the following side effects happen:

• Pain and aching of bones
• Stiffness
• White, brown, or black discoloration of the teeth—occurs only during periods of tooth development in children

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• APF Gel
• Aquafresh
• CaviRinse
• Control Rx
• Denta 5000 Plus
• Dentagel
• Dentall 1100 Plus
• EtheDent
• Fluorabon
• Fluor-A-Day
• Fluoridex Daily Defense
• Fluoridex Daily Defense Enhanced Whitening

In Canada

• Fluorosol
• Koala Pals Fluoride Tooth Gel - Berrylicious Flavor
• Pdf
• Pedi-Dent

Available Dosage Forms:

• Tablet, Chewable
• Paste
• Solution
• Gel/Jelly
• Suspension
• Cream
• Liquid

Therapeutic Class: Fluoride Supplement

Take this medicine only as directed by your health care professional. Do not take more of it and do not take it more often than ordered. Taking too much fluoride over a period of time may cause unwanted effects.

For individuals taking the chewable tablet form of this medicine:

• Tablets should be chewed or crushed before they are swallowed.
• This medicine works best if it is taken at bedtime, after the teeth have been thoroughly brushed. Do not eat or drink for at least 15 minutes after taking sodium fluoride.

For individuals taking the oral liquid form of this medicine:

• This medicine is to be taken by mouth even though it comes in a dropper bottle. The amount to be taken is to be measured with the specially marked dropper.
• Always store this medicine in the original plastic container. Fluoride will affect glass and should not be stored in glass containers.
• This medicine may be dropped directly into the mouth or mixed with cereal, fruit juice, or other food. However, if this medicine is mixed with foods or beverages that contain calcium, the amount of sodium fluoride that is absorbed may be reduced.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (lozenges, solution, tablets, or chewable tablets): To prevent cavities in the teeth (not enough fluoride in the water): Children—Dose is based on the amount of fluoride in drinking water in your area. Dose is also based on the child's age and must be determined by your health care professional.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.