Fluor-A-Day

There may be other drugs that can interact with fluoride. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

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.

Each Fluor-a-Day® chewable tablet is sugar free, saccharin free and erythrosine (FD&C Red Dye #3) free. Fluor-a-Day® sodium fluoride and xylitol supplement is for use as a dental caries preventative in children. Each Fluor-a-Day® 1.0 mg F (full strength) chewable tablet contains 2.2 mg sodium fluoride USP (equivalent to 1.0 mg Fluoride ion) and 236.79 mg xylitol; Each Fluor-a-Day® 0.5 mg F (half-strength) chewable tablet contains 1.1 mg sodium fluoride USP (equivalent to 0.5 mg Fluoride ion) and 236.79 mg xylitol; Each Fluor-a-Day® 0.25 mg F (quarter strength) chewable tablet contains 0.55 mg sodium fluoride (equivalent to 0.25 mg Fluoride ion) and 236.79 mg xylitol. Fluor-a-Day® Drops are flavorless, colorless, and odorless. Each ml (20 drops) contains 2.50 mg fluoride ion (F) from 5.56 mg sodium fluoride (NaF), approximately 0.125 mg F per drop.

Prolonged daily ingestion of quantities greater than the recommended amount may result in various degrees of dental fluorosis in pediatric patients under age 6 years, especially if the water fluoridation exceeds 0.6 ppm. Read directions carefully before using. Keep out of reach of infants and children.

General

Please refer to the CONTRAINDICATIONS, WARNINGS and OVERDOSAGE sections for overdosage concerns. Use in pediatric patients below the age of 6 months is not recommended by current American Dental Association and American Academy of Pediatrics guidelines.

Drug Interactions

Do not eat or drink dairy products within one hour of fluoride administration. Incompatibility of fluoride with dairy foods has been reported due to formation of calcium fluoride which is poorly absorbed.

Carcinogenesis, Mutagenesis, Impairment of Fertility

In a study conducted in rodents, no carcinogenesis was found in male and female mice and female rats treated with fluoride at dose levels ranging from 4.1 to 9.1 mg/kg of body weight. Equivocal evidence of carcinogenesis was reported for male rats treated with 2.5 and 4.1 mg/kg of body weight. In a second study, no carcinogenesis was observed in rats, males or females, treated with fluoride up to 11.3 mg/kg of body weight. This dose is at least 400 times greater than the recommended daily dose of Fluor-a-Day® Chewable Tablets or Drops. Fluoride ion is not mutagenic in standard bacterial systems. It has been shown that fluoride ion has potential to induce chromosome aberrations in cultured human and rodent cells at doses much higher than those to which humans are exposed. In vivo data are conflicting. Some studies report chromosome damage in rodents while other studies using similar protocols report negative results. Potential adverse reproductive effects of fluoride exposure in humans have not been adequately evaluated. Adverse effects on reproduction were reported for rats, mice, fox, and cattle exposed to 100 ppm or greater concentrations of fluoride in their diet or drinking water. Other studies conducted in rats demonstrated that lower doses of fluoride (5 mg/kg of body weight) did not result in impaired fertility and reproductive capabilities. This dose is approximately 200 times greater than the recommended daily dose of Fluor-a-Day® Chewable Tablets or Drops.

Pregnancy

Pregnancy Category B

It has been shown that fluoride crosses the placenta of rats, but only 0.01% of the amount administered is incorporated in fetal tissue. Animal studies (rats, mice, rabbits) have shown that fluoride is not a teratogen. Maternal exposure to 12.2 mg fluoride/kg of body weight (rats) or 13.1 mg/kg of body weight (rabbits) did not affect the litter size or fetal weight and did not increase the frequency of skeletal or visceral malformations. Epidemiological studies conducted in areas with high levels of naturally fluoridated water showed no increase in birth defects. Heavy exposure to fluoride during in utero development may result in skeletal fluorosis which becomes evident in childhood.

Nursing Mothers

It is not known if fluoride is excreted in human milk. However, many drugs are excreted in human milk and caution should be exercised when Fluor-a-Day® Chewable Tablets or Drops are administered to a nursing woman. Reduced milk production was reported in farm-raised fox when the animals were fed a diet containing a high concentration of fluoride (98-137 mg/kg of body weight). No adverse effects on parturition, lactation, or offspring were seen in rats administered fluoride up to 5 mg/kg of body weight. This dose is at least 200 times greater than the recommended daily dose of Fluor-a-Day® Chewable Tablets or Drops. Fluor-a-Day® Chewable Tablets and Drops (any strength) are not indicated for use in adults.

Pediatric Use

The use of Fluor-a-Day® Chewable Tablets and Drops as a caries preventive in pediatric age groups 6 months to 16 years is supported by evidence from adequate and well controlled studies on fluoride supplementation from birth through adolescence.1-5

Geriatric Use

Fluor-a-Day® Chewable Tablets (any strength) or Drops are not indicated for use in geriatric patients.

Allergic rash and other idiosyncrasies have been rarely reported.

NDC 24438-622-16

FLUOR•A•DAY®
CHEWABLE

Sodium Fluoride
USP and Xylitol
Chewable Tablets

1.0 mg F-

Rx only

120 Tablets

arbor™
PHARMACEUTICALS, INC.

www.arborpharma.com

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Very upset stomach or throwing up.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if you have any side effects that bother you or do not go away.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Some side effects of Fluor-A-Day may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.