Fluoride Chewable Tablets (Sodium Fluoride) 0.25 mg

配合成分

出典: DSLD（米国 NIH）ラベル ID 12949配合量は製品ラベルの表示値です。購入前に最新の製品表示をご確認ください。

購入リンク

対象

• 成人（18〜50 歳）
• 砂糖不使用
• 4 歳以上の子ども
• 1 歳超 4 歳未満の子ども

ラベルの注意・使い方

ラベルの英語の原文のままです。メーカーの宣伝文（効き目の説明など）は載せていません。

使い方

INDICATIONS AND USAGE: For once daily self-applied systemic use as a dental caries preventative. 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

DOSAGE2 AND ADMINISTRATION: Dissolve in the mouth or chew before swallowing, preferably at bedtime after brushing teeth. See schedule below to determine dosage.

注意

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.

OVERDOSAGE: Accidental ingestion of large amounts of fluoride may result in acute burning in the mouth and sore tongue. Nausea, vomiting, and diarrhea may occur soon after ingestion (within 30 minutes) and are accompanied by salivation, hematemesis, and epigastric cramping abdominal pain. These symptoms may persist for 24 hours. If less than 5 mg fluoride/kg body weight (i.e., less than 2.3 mg fluoride/lb body weight) have been ingested, give calcium (e.g., milk) orally to relieve gastrointestinal symptoms and observe for a few hours. If more than 5 mg fluoride/kg body weight (i.e., more than 2.3 mg fluoride/lb body weight) have been ingested, induce vomiting, give orally soluble calcium (e.g., milk, 5% calcium gluconate or calcium lactate solution) and immediately seek medical assistance. For accidental ingestion of more than 15 mg fluoride/kg of body weight (i.e., more than 6.9 mg fluoride/ lb body weight), induce vomiting and admit immediately to a hospital facility.

Geriatric Use: Fluoride Chewable Tablets (any strength) are not indicated for use in geriatric patients.

注意（子ども）

CONTRAINDICATIONS: Fluoride 1 mg F- Tablets are contraindicated when the fluoride content of drinking water is 0.3 ppm F- or more and should not be administered to pediatric patients under age 6 years. Fluoride 0.5 mg F- 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 For more or to pediatric patients under age 3 years. Fluoride 0.25 mg F- 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 Fluoride Chewable Tablets (any strength) to pediatric patients under age 3 years due to choking hazard.

WARNINGS: 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. PRECAUTIONS: General: Please refer to the CONTRAINDICATIONS, WARNINGS and OVERDOSAGE sections for overdosage concerns. Use in pediatric patients below the age of 3 years not recommended by current American Dental Association and American Academy of Pediatrics guidelines.

注意（妊娠・授乳中、服薬中）

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 Fluoride Chewable Tablets 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 Fluoride Chewable Tablets.

注意（アレルギー）

ADVERSE REACTIONS: Allergic rash and other idiosyncrasies have been rarely reported.

含むもの

Each Fluoride 1 mg F- tablet (full-strength) contains 1 mg fluoride ion (F-) from 2.2 mg sodium fluoride (NaF). Each Fluoride 0.5 mg F- tablet (halfstrength) contains 0.5 mg F- from 1.1 mg NaF. Each Fluoride 0.25 mg F- tablet (quarter-strength) contains 0.25 mg F- from 0.55 mg NaF.

A treatment dose of Fluoride Chewable Tablets contains 0.25, 0.5 or 1 mg fluoride. The treatment of choice depends upon the age of the child and the water fluoride content. A bottle of 120 0.25 mg tablets contains 30 mg fluoride. A bottle of 120 0.5 mg tablets contains 60 mg fluoride. A bottle of 120 1 mg tablets contains 120 mg fluoride. [The total amount of sodium fluoride in a bottle of 120 Fluoride Chewable Tablets (all strengths) conforms with the recommendations of the American Dental Association for the maximum to be dispensed at one time for safety purposes.]

含まないもの

DESCRIPTION: Each Fluoride Chewable Tablet is sugar free, saccharin free and erythrosine (FD&C Red Dye #3) free.

保管

STORAGE: Store in a cool, dry place at a controlled room temperature 20(0) - 25(0)C (68(0) - 77(0)F); excursions permitted to 15(0) - 30(0)C (59(0) - 86(0)F) and away from heat and sunlight. Store in original container. Dispense in a tight, light-resistant container with a child-resistant closure as defined in the USP/NF.