Listerine Total Care Extra Mild Alcohol Free Anticavity Fluoride Mouthwash

Description

Sodium fluoride and acidulated phosphate topical solution is a combination product used for dental applications. The solution contains sodium fluoride, which is known for its ability to strengthen tooth enamel and prevent dental caries. The formulation is designed to be applied topically to the teeth. The specific composition and concentration of the active ingredients are tailored to enhance the efficacy of fluoride in promoting oral health.

Uses and Indications

This drug is indicated for the prevention of dental cavities. It is intended for use in individuals at risk of developing dental caries.

Dosage and Administration

Adults and children aged 6 years and older are instructed to use the rinse twice daily, following brushing with a toothpaste. The recommended method involves vigorously swishing 10 mL (2 teaspoonfuls) of the rinse between the teeth for a duration of 1 minute, after which the solution should be expectorated. It is imperative that the rinse is not swallowed. Additionally, patients should refrain from eating or drinking for 30 minutes following the rinsing procedure to ensure optimal efficacy.

For children under 12 years of age, it is essential to instruct them in proper rinsing techniques to minimize the risk of swallowing the rinse. Supervision may be required until the child demonstrates the ability to use the rinse independently.

For children under 6 years of age, consultation with a dentist or physician is recommended prior to use.

Contraindications

There are no specific contraindications listed for this product. However, it is advised that if more than the recommended amount used for rinsing is accidentally swallowed, medical assistance should be sought immediately or contact a Poison Control Center.

Warnings and Precautions

It is imperative to keep this product out of reach of children to prevent accidental ingestion. In the event that more than the recommended amount used for rinsing is accidentally swallowed, immediate medical assistance should be sought. Healthcare professionals are advised to instruct patients to contact a Poison Control Center or seek emergency medical help without delay.

No specific general precautions or laboratory tests have been identified for this product. However, the emphasis on the importance of adhering to the recommended usage guidelines cannot be overstated, as improper use may lead to serious health consequences.

Side Effects

Patients should be advised to keep the product out of reach of children. In the event that more than the recommended amount used for rinsing is accidentally swallowed, it is imperative to seek medical assistance or contact a Poison Control Center immediately. This warning underscores the importance of proper usage and the potential risks associated with accidental ingestion.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there is no information available regarding interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Listerine Total Care Extra Mild Alcohol Free Anticavity Fluoride Mouthwash (sodium fluoride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients should be closely monitored when using this product. It is essential to keep the product out of reach of children. In the event that more than the recommended amount for rinsing is accidentally swallowed, immediate medical assistance or contact with a Poison Control Center is advised.

For pediatric patients aged 6 years and older, the recommended usage is twice daily following tooth brushing. They should vigorously swish 10 mL (2 teaspoonfuls) of the rinse between their teeth for 1 minute and then spit it out. It is crucial that the rinse is not swallowed, and patients should refrain from eating or drinking for 30 minutes after rinsing. Children under 12 years of age should be instructed in proper rinsing techniques to minimize the risk of swallowing, and supervision is recommended until they are capable of using the product without assistance.

For children under 6 years of age, consultation with a dentist or doctor is recommended prior to use.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any adverse effects or changes in therapeutic response, given the lack of targeted data for this population.

Pregnancy

The safety of Listerine Total Care Extra Mild Alcohol Free Anticavity Fluoride Mouthwash during pregnancy has not been established. There are no specific contraindications regarding its use in pregnant patients. Additionally, there is no information available concerning potential risks to the fetus associated with the use of this product during pregnancy. No dosage modifications are specified for pregnant individuals, and no special precautions are mentioned regarding the use of this mouthwash in this population. Healthcare professionals should consider these factors when advising women of childbearing potential.

Lactation

There are no specific warnings or recommendations regarding the use of this product by lactating mothers. Additionally, there is no information available about the potential for excretion in breast milk or any associated risks to breastfed infants.

Renal Impairment

There is no information available regarding renal impairment, including dosage adjustments, special monitoring, or safety considerations for patients with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of specific guidance when treating patients with renal impairment.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there are no established dosage adjustments, special monitoring requirements, or precautions for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population. Regular monitoring of liver function may be prudent in these cases, although specific parameters are not defined in the available information.

Overdosage

In the event of an overdosage, immediate medical assistance is crucial. If an individual accidentally swallows more than the amount intended for rinsing, it is imperative to seek medical help or contact a Poison Control Center without delay.

Healthcare professionals should be aware that prompt intervention can significantly mitigate potential adverse effects associated with overdosage. Monitoring for symptoms and providing appropriate management based on clinical presentation is essential.

Nonclinical Toxicology

No teratogenic or non-teratogenic effects have been reported in the available nonclinical studies. Additionally, there is no information regarding animal pharmacology and toxicology. The absence of data limits the assessment of potential risks associated with the compound in these areas.

Postmarketing Experience

No postmarketing experience details are available in the insert.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental ingestion. It is important to inform patients that if more than the recommended amount used for rinsing is accidentally swallowed, they should seek medical help or contact a Poison Control Center immediately. This guidance is crucial for ensuring patient safety and minimizing potential risks associated with accidental ingestion.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at room temperature to maintain its integrity and efficacy. No special handling requirements are noted, ensuring straightforward management within standard storage conditions.

Additional Clinical Information

Patients should administer the rinse orally, using 10 mL (2 teaspoonfuls) twice daily after brushing their teeth. The rinse should be vigorously swished between the teeth for 1 minute before spitting it out, and it is important not to swallow the rinse. Patients are advised to refrain from eating or drinking for 30 minutes following the rinse.

Clinicians should instruct parents to teach children under 12 years of age proper rinsing techniques to minimize the risk of swallowing. Supervision may be necessary until children are capable of using the rinse independently.

Drug Information (PDF)

This file contains official product information for Listerine Total Care Extra Mild Alcohol Free Anticavity Fluoride Mouthwash, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

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