Ludent

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Ludent Recall

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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. 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.

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Legal Issues

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FDA Safety Alerts

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Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

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FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

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Uses

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¯.

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History

There is currently no drug history available for this drug.

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Other Information

This product is a prescription product for the clinical dietary management of the metabolic processes of caries prophylaxis.

7, 60 and120 Tablets per bottle and 30 count blister

	Water F¯ Content
Ages	0 ppm F¯ to <0.3 ppm F¯	0.3 ppm F¯ to 0.6ppm F¯	>0.6ppm F¯
* Per day
3 yrs. to 6 yrs.	0.5mg*	0.25mg*	0
>6yrs. to 16 yrs.	1.0mg*	0.5mg*	0

Active Ingredient: Fluoride (as Sodium Fluoride) 0.25 mg / 0.5 mg / 1.0 mg

Inactive Ingredients: Xylitol, microcrystalline cellulose, malic acid, magnesium stearate, talc, citric acid, orange flavor, sucralose.

Caution: 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.

Sources

Ludent Manufacturers

Sancilio & Company Inc

Ludent | Sancilio & Company Inc

(for dosage see table)

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

No Recall
Sancilio & Company Inc.

Ludent | Sancilio & Company Inc.

USE AS DIRECTED BY YOUR PHYSICIAN.

No Recall
Sancilio & Company Inc

Ludent | Sancilio & Company Inc

USE AS DIRECTED BY YOUR PHYSICIAN.

No Recall
Sancilio & Company Inc

Ludent | Sancilio & Company Inc

USE AS DIRECTED BY YOUR PHYSICIAN.

No Recall
Bryant Ranch Prepack

Ludent | Bryant Ranch Prepack

USE AS DIRECTED BY YOUR PHYSICIAN.

No Recall