Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED 120 count Chewable tablets Each tablet contains 0.25 mg Fluoride from 0.55 mg Sodium Fluoride. Pink-colored, grape flavor, un-scored, round chewable tablet, debossed with "WL" "163" on one side and plain on other side of tablet. NDC 75826-163-20 (120 count). Each tablet contains 0.5 mg Fluoride from 1.1 mg Sodium Fluoride. Peach-colored, grape flavor, un-scored, round chewable tablet, debossed with “WL" "164” on one side and plain on other side of tablet. NDC 75826-164-20 (120 count). Each tablet contains 1.0 mg Fluoride from 2.2 mg Sodium Fluoride. Purple-colored, grape flavor, un-scored, round chewable tablet, debossed with “WL” “165” on one side and plain on other side of tablet. NDC 75826-165-20 (120 count).; FLUORIDE CHEWABLE TABLETS 0.25mg 120 count pack size; FLUORIDE CHEWABLE TABLETS 0.5mg 120 count pack size; FLUORIDE CHEWABLE TABLETS 1.0mg 120 count pack size
- HOW SUPPLIED 120 count Chewable tablets Each tablet contains 0.25 mg Fluoride from 0.55 mg Sodium Fluoride. Pink-colored, grape flavor, un-scored, round chewable tablet, debossed with "WL" "163" on one side and plain on other side of tablet. NDC 75826-163-20 (120 count). Each tablet contains 0.5 mg Fluoride from 1.1 mg Sodium Fluoride. Peach-colored, grape flavor, un-scored, round chewable tablet, debossed with “WL" "164” on one side and plain on other side of tablet. NDC 75826-164-20 (120 count). Each tablet contains 1.0 mg Fluoride from 2.2 mg Sodium Fluoride. Purple-colored, grape flavor, un-scored, round chewable tablet, debossed with “WL” “165” on one side and plain on other side of tablet. NDC 75826-165-20 (120 count).
- FLUORIDE CHEWABLE TABLETS 0.25mg 120 count pack size
- FLUORIDE CHEWABLE TABLETS 0.5mg 120 count pack size
- FLUORIDE CHEWABLE TABLETS 1.0mg 120 count pack size
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. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1(800) FDA-1088.
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.
Storage & Handling
STORAGE Store at 25° C (77° F); excursions permitted to 15° - 30° C (59° - 86° F). See USP Controlled Room Temperature. Protect from light and moisture. Dispense in a tight, light-resistant container with a child-resistant closure as defined in the USP/NF. Warning: Keep this and all medications out of the reach of children. In case of accidental overdose, seek professional assistance or contact a poison control center immediately.
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