Listerine Smart Rinse Anticavity Fluoride Rinse - Bubble Blast

Description

LISTERINE® SMART RiNSE® is a sodium fluoride and acidulated phosphate topical solution formulated for oral care. This product is presented in a bubble blast flavor and is alcohol-free, making it suitable for a wide range of users. The solution is packaged in a 500 mL (16.9 Fl Oz) bottle, ensuring ample volume for regular use.

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 dosage is to vigorously swish 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.

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 is recommended until the child is capable of using the rinse independently.

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

Contraindications

Use is contraindicated if more than the recommended amount for rinsing is accidentally swallowed. In such cases, seek medical assistance or contact a Poison Control Center immediately.

Warnings and Precautions

It is imperative to keep this product out of the reach of children. In the event that more than the recommended amount for rinsing is accidentally ingested, 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 additional general precautions or laboratory tests are specified in the available information. Therefore, healthcare providers should remain vigilant and ensure that patients are aware of the potential risks associated with improper use of the product.

Side Effects

Patients should be advised to keep the product out of reach of children. In the event that more than the recommended amount 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

No specific drug interactions have been identified in the available data. Additionally, there are no reported interactions between the drug and laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on the current information.

Packaging & NDC

Below are the non-prescription pack sizes of Listerine Smart Rinse Anticavity Fluoride Rinse - Bubble Blast (sodium fluoride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients should be instructed to keep the product out of reach of children. In the event that more than the recommended amount for rinsing is accidentally swallowed, medical assistance or contact with a Poison Control Center is advised immediately.

For children aged 6 years and older, the recommended usage is twice daily after brushing teeth with toothpaste. The proper technique involves vigorously swishing 10 mL (2 teaspoonfuls) of the rinse between the teeth for 1 minute before spitting it out. It is crucial that the rinse is not swallowed, and children should refrain from eating or drinking for 30 minutes following the rinse.

Children under 12 years of age should be instructed in proper rinsing habits to minimize the risk of swallowing the rinse. Supervision is recommended until children are capable of using the product without assistance. For children under 6 years of age, consultation with a dentist or doctor is necessary prior to use.

Geriatric Use

There is no specific information available regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy, given the lack of targeted data for this population.

Pregnancy

There is no specific information regarding the use of LISTERINE SMART RINSE ANTICAVITY FLUORIDE RINSE in pregnant patients. The drug insert does not provide safety concerns, dosage modifications, or special precautions for use during pregnancy. Healthcare professionals should consider the absence of data when advising women of childbearing potential and weigh the potential benefits against any unknown risks to fetal outcomes.

Lactation

There are no specific warnings or recommendations regarding nursing mothers or lactation in the provided text. Therefore, healthcare professionals should consider the absence of data when advising lactating mothers about the use of this medication. It is advisable to monitor breastfed infants for any potential effects, although no specific concerns have been identified in the available information.

Renal Impairment

Patients with renal impairment may not have specific information regarding dosage adjustments, special monitoring, or safety considerations outlined in the prescribing information. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment and monitoring of these patients.

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 outlined 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 relevant information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no pertinent data concerning nonclinical toxicology, animal pharmacology, or toxicology.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental ingestion. It is important to emphasize that if more than the recommended amount used for rinsing is accidentally swallowed, patients 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 effectiveness. In colder weather conditions, the product may temporarily cloud; however, this does not affect its quality. Care should be taken to avoid exposure to extreme temperatures to ensure optimal performance.

Additional Clinical Information

The product is administered orally, with a recommended frequency of twice daily following tooth brushing. Patients should vigorously swish 10 mL (2 teaspoonfuls) of the rinse between their teeth for one minute before spitting it out. It is important that patients do not swallow the rinse and refrain from eating or drinking for 30 minutes after use.

Clinicians should counsel patients, particularly parents of children under 12 years of age, on the importance of good rinsing habits to minimize swallowing. Supervision is advised for children until they are capable of using the rinse independently. For children under 6 years of age, consultation with a dentist or doctor is recommended.

Drug Information (PDF)

This file contains official product information for Listerine Smart Rinse Anticavity Fluoride Rinse - Bubble Blast, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

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