Denta 5000 Plus

Do not swallow fluoride topical. Spit it out after use.

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

Call your doctor if you have any of the following side effects:

• discolored teeth;

• weakened tooth enamel; or

• any changes in the appearance of your teeth.

Common side effects may include:

• stomach upset;

• headache; or

• weakness.

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.

It is not likely that other drugs you take orally or inject will have an effect on topically applied fluoride. But many drugs can interact with each other. Tell each of your health care providers about all medicines you use, including prescription and over-the-counter medicines, vitamins, and herbal products.

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:

• Gel/Jelly
• Tablet, Chewable
• Paste
• Solution
• Tablet
• Liquid
• Cream
• Tablet, Enteric Coated
• Lozenge/Troche
• Suspension

Therapeutic Class: Cariostatic

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

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

Pediatric

Problems in children have not been reported with intake of normal daily recommended amounts. Doses of sodium fluoride that are too large or are taken for a long time may cause bone problems and teeth discoloration in children.

Geriatric

Problems in older adults have not been reported with intake of normal daily recommended amounts. Older people are more likely to have joint pain, kidney problems, or stomach ulcers which may be made worse by taking large doses of sodium fluoride. You should check with your health care professional.

Breast Feeding

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

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Dairy Food

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Brown, white, or black discoloration of teeth or
• Joint pain or
• Kidney problems (severe) or
• Stomach ulcer—Sodium fluoride may make these conditions worse.

This section provides information on the proper use of a number of products that contain sodium fluoride. It may not be specific to Denta 5000 Plus. Please read with care.

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.

Applies to fluoride topical: dental cream, dental gel, dental paste, mouth/throat concentrate, mouth/throat liquid, mouth/throat paste, mouth/throat solution

Applies to fluoride topical: mucous membrane powder for reconstitution, mucous membrane solution, topical cream, topical gel, topical kit, topical paste, topical solution, topical swab

Hypersensitivity

Hypersensitivity side effects including allergic reactions have been reported.[Ref]

Oncologic

It has been shown that fluoride ion has potential to induce chromosome aberrations in cultured human and animal cells at doses much higher than those to which humans are exposed. In vivo data are conflicting.[Ref]

Some side effects of Denta 5000 Plus may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.