FDA records indicate that there are no current recalls for this drug.
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Fluor-a-day Recall
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Questions & Answers
Side Effects & Adverse Reactions
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.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
For once daily systemic use as a dental caries preventive in pediatric patients. It has been established that ingestion of fluoridated drinking water (1 ppm F-) during the period of tooth development results in a significant decrease in the incidence of dental caries.1 Fluor-a-day® Chewable Tablets and Drops were developed to provide systemic fluoride and xylitol for use as a supplement in pediatric patients from 6 months to age 16 years living in areas where the drinking water fluoride content does not exceed 0.6 ppm F-.
History
There is currently no drug history available for this drug.
Other Information
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.
Sources
Fluor-a-day Manufacturers
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Arbor Pharmaceuticals, Inc.
Fluor-a-day | Arbor Pharmaceuticals, Inc.
Dissolve in the mouth or chew before swallowing, preferably at bedtime after brushing teeth. Drops should be administered in juice or water. See schedule below to determine dosage.
Fluoride Ion Level In Drinking Water (ppm)* Age Less than 0.3ppm 0.3-0.6 ppm Greater than 0.6 ppm * 0.1 part per million (ppm) = 1 milligram/liter (mg/L) † 2.2 mg sodium fluoride contains 1 mg fluoride ion Birth-6 months None None None 6 months-3 years 0.25 mg/day† None None 3-6 years 0.50 mg/day† 0.25 mg/day None 6-16 years 1.0 mg/day 0.50 mg/day NoneDosing schedule approved by the American Dental Association, American Academy of Pediatrics, American Academy of Pediatric Dentistry
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