Denta 5000 Plus (Oral, Dental, Oromucosal)

Fluoride helps reduce cavities in teeth and is usually found naturally in drinking water. However, some areas do not have enough fluoride in the water to prevent cavities. To address this, additional fluoride may be included in the diet. Some children may need both dietary fluoride and fluoride treatments from the dentist. Using fluoride toothpaste or rinse can also be beneficial.

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

Fluoride may also be used for other conditions as determined by your doctor.

This medicine is available only with a prescription.

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

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

The daily amount of fluoride needed is defined in 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 may 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 percent of the recommended daily amount of each nutrient that a serving provides. DV replaces the previous designation of 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 reduce 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 receive each day includes what you get from foods and beverages and any supplements you may take.
• This total should not exceed the recommendations above unless advised by your health care professional. Taking too much fluoride can lead to serious problems with teeth and bones.

The amount of fluoride in the water varies in different areas of the U.S. If you move to a new area, check with a health care professional there as soon as possible to find out if you still need this medicine or if your dose should be adjusted. Also, consult your health care professional if you change how you feed your infant (for example, from breast-feeding to infant formula), your drinking water (for example, from city water to nonfluoridated bottled water), or your filtration method (for example, from tap water to filtered tap water).

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

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

In deciding to use a medicine, you and your doctor need to think about the risks of taking it compared to the benefits it may provide. Here are some important points to consider:

Allergies

Let your doctor know if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also inform your healthcare professional about any other allergies you may have, such as allergies 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 they take normal daily recommended amounts. However, taking too much sodium fluoride or taking it for a long time might cause bone problems and teeth discoloration in children.

Geriatric

There have been no reported problems in older adults when they take normal daily recommended amounts. However, older adults are more likely to experience joint pain, kidney problems, or stomach ulcers, which may worsen with large doses of sodium fluoride. You should consult your healthcare professional.

Breast Feeding

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

Interactions with Medicines

Some medicines should not be used together at all, while others might be used together even if there is a chance of interaction. In these cases, your doctor might 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 possible interactions. Using alcohol or tobacco with certain medicines may also cause interactions. The following interactions are notable and might not cover everything.

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

• Dairy Food

Other Medical Problems

Having other medical issues may affect how you can use this medicine. Be sure to tell your doctor if you have any other medical problems, 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 intended effects, a medicine may cause some unwanted effects. Not all of these side effects may happen, but if they do, you may need medical attention.

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

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

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

Stop taking this medicine and get emergency help immediately 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 occur:

• 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 happen 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.