Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Each tablet contains 0.25 mg Fluoride from 0.55 mg Sodium Fluoride. White to off-white, orange flavor, round-shaped chewable tablet. Debossed with "M160" on one side. NDC 58657-160-12 (120 count). Each tablet contains 0.5 mg Fluoride from 1.1 mg Sodium Fluoride. White to off-white, orange flavor, round-shaped chewable tablet. Debossed with "M161" on one side. NDC 58657-161-12 (120 count). NDC 58657-161-10 (1,000 count). Each tablet contains 1.0 mg Fluoride from 2.2 mg Sodium Fluoride. White to off-white, orange flavor, round-shaped chewable tablet. Debossed with "M162" on one side. NDC 58657-162-12 (120 count).; PRINCIPAL DISPLAY PANEL NDC 58657-160-12 Sodium Fluoride Chewable Tablets 0.25 mg 120 Tablets Rx Only 0.25-120; PRINCIPAL DISPLAY PANEL NDC 58657-161-12 Sodium Fluoride Chewable Tablets 0.5 mg 120 Tablets Rx Only 0.5mg-120; PRINCIPAL DISPLAY PANEL NDC 58657-161-10 Sodium Fluoride Chewable Tablets 0.5 mg 1000 Tablets Rx Only 0.5mg-1000; PRINCIPAL DISPLAY PANEL NDC 58657-162-12 Sodium Fluoride Chewable Tablets 1.0 mg (From 2.2 mg Sodium Fluoride) 120 Tablets Rx Only 1mg-120
- HOW SUPPLIED Each tablet contains 0.25 mg Fluoride from 0.55 mg Sodium Fluoride. White to off-white, orange flavor, round-shaped chewable tablet. Debossed with "M160" on one side. NDC 58657-160-12 (120 count). Each tablet contains 0.5 mg Fluoride from 1.1 mg Sodium Fluoride. White to off-white, orange flavor, round-shaped chewable tablet. Debossed with "M161" on one side. NDC 58657-161-12 (120 count). NDC 58657-161-10 (1,000 count). Each tablet contains 1.0 mg Fluoride from 2.2 mg Sodium Fluoride. White to off-white, orange flavor, round-shaped chewable tablet. Debossed with "M162" on one side. NDC 58657-162-12 (120 count).
- PRINCIPAL DISPLAY PANEL NDC 58657-160-12 Sodium Fluoride Chewable Tablets 0.25 mg 120 Tablets Rx Only 0.25-120
- PRINCIPAL DISPLAY PANEL NDC 58657-161-12 Sodium Fluoride Chewable Tablets 0.5 mg 120 Tablets Rx Only 0.5mg-120
- PRINCIPAL DISPLAY PANEL NDC 58657-161-10 Sodium Fluoride Chewable Tablets 0.5 mg 1000 Tablets Rx Only 0.5mg-1000
- PRINCIPAL DISPLAY PANEL NDC 58657-162-12 Sodium Fluoride Chewable Tablets 1.0 mg (From 2.2 mg Sodium Fluoride) 120 Tablets Rx Only 1mg-120
Overview
INDICATIONS AND USAGE For once daily self-applied 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. Sodium Fluoride Chewable Tablets were developed to provide systemic fluoride for use as a supplement in pediatric patients from age 3 years to age 16 years and older living in areas where the drinking water fluoride contents does not exceed 0.6 ppm F¯.
Indications & Usage
For once daily self-applied 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. Sodium Fluoride Chewable Tablets were developed to provide systemic fluoride for use as a supplement in pediatric patients from age 3 years to age 16 years and older living in areas where the drinking water fluoride contents does not exceed 0.6 ppm F¯.
Dosage & Administration
(for dosage see table) Dissolve in the mouth or chew before swallowing, preferably at bedtime after brushing teeth. See schedule below to determine dosage.
Warnings & Precautions
WARNING 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. This product, as all chewable tablets, is not recommended for children under age 3 due to risk of choking. Keep out of the reach of infants and children.
Contraindications
Fluoride 1.0 mg Tablets are contraindicated when the fluoride content of drinking water is >0.3 ppm F¯ and should not be administered to pediatric patients under 6 years. Fluoride 0.5 mg Tablets are contraindicated when the fluoride content of drinking water is more than 0.6 ppm F¯ and should not be administered to pediatric patients under age 6 when the fluoride content of drinking water is 0.3 ppm F¯ or more or to pediatric patients under age 3 years. Fluoride 0.25 mg Tablets are contraindicated when the fluoride content of drinking water is more than 0.6 ppm F¯ and should not be administered to pediatric patients under age 3 years when the fluoride content of drinking water is 0.3 ppm F¯ or more. Do not administer Sodium Fluoride Chewable Tablets (any strength) to pediatric patients under age 3 years. Sodium Fluoride Chewable Tablets (any strength) are not indicated for use in adults.
Adverse Reactions
Allergic rash and other idiosyncrasies have been rarely reported.
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