Listerine Smart Rinse Berry Splash

Description

LISTERINE® SMART RiNSE® is an anticavity fluoride rinse formulated as a sodium fluoride and acidulated phosphate topical solution. This alcohol-free rinse is presented in a berry flavor and is packaged in a 500 mL (16.9 fl oz) container.

Uses and Indications

This drug is indicated for the prevention of dental cavities. It has been evaluated and found to have no teratogenic effects. Additionally, there are no nonteratogenic effects associated with its use.

Dosage and Administration

Adults and children 6 years of age and older are instructed to use the rinse twice daily, following brushing with toothpaste. To prepare the rinse, the cap should be removed, and the bottle held upright. The user should fill the bottle to the 10 mL line by squeezing the front and back of the bottle (not the sides), then stop squeezing to allow excess liquid to drain back into the bottle. The filled liquid should then be poured into a cup.

For administration, the user should vigorously swish 10 mL (equivalent to 2 teaspoonfuls) of the rinse between the teeth for 1 minute before spitting it out. It is crucial that the rinse is not swallowed. After use, the cap should be replaced promptly, and users should refrain from eating or drinking for 30 minutes post-rinsing.

For children under 12 years of age, it is recommended to instruct them in proper rinsing techniques to minimize the risk of swallowing the rinse. Supervision may be necessary until the child is capable of using the rinse without assistance. For children under 6 years of age, consultation with a dentist or doctor 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 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 contact a Poison Control Center without delay to ensure appropriate management of the situation.

Side Effects

In clinical use, there are important safety considerations regarding the accidental ingestion of the product. If more than the recommended amount for rinsing is swallowed, patients should seek medical assistance or contact a Poison Control Center immediately. This warning underscores the necessity for careful handling and adherence to the recommended usage guidelines to prevent potential adverse effects associated with overdose.

Drug Interactions

There are no documented drug interactions associated with this medication. Additionally, there is no information regarding interactions between this drug and laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug interactions.

Packaging & NDC

Below are the non-prescription pack sizes of Listerine Smart Rinse Berry Splash (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 product is to be used twice daily following tooth brushing with toothpaste. It is important to instruct children under 12 years of age in proper rinsing techniques to minimize the risk of swallowing. Supervision is recommended for children 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

There is no specific information regarding the use of LISTERINE SMART RINSE BERRY SPLASH in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when recommending this product to elderly patients, as individual responses may vary. Monitoring for any adverse effects or changes in efficacy is advisable when this product is used in the geriatric population.

Pregnancy

There is no specific information regarding the use of LISTERINE SMART RINSE BERRY SPLASH during pregnancy. The prescribing information does not provide safety concerns, dosage modifications, or special precautions for pregnant patients. Therefore, healthcare professionals should exercise caution when recommending this product to women of childbearing potential and consider the absence of data when assessing the potential risks and benefits for pregnant patients.

Lactation

There is no specific information available regarding the use of this medication in nursing mothers or any lactation considerations. Healthcare professionals should exercise caution and consider the potential risks and benefits when prescribing this medication to lactating mothers. The effects on breastfed infants have not been established, and further research may be necessary to determine safety and efficacy in this population.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

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 amount exceeding that which is typically used for rinsing is accidentally ingested, it is imperative to seek medical help or contact a Poison Control Center without delay.

Healthcare professionals should be aware that prompt intervention can mitigate potential adverse effects associated with overdosage. Monitoring the patient for any symptoms that may arise is essential, although specific symptoms related to overdosage are not detailed in the available data.

Management of overdosage should focus on supportive care and symptomatic treatment as necessary. It is recommended that healthcare providers follow established protocols for the management of poisoning and overdosage cases, ensuring that the patient receives appropriate evaluation and treatment based on their clinical presentation.

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 use of the compound in these contexts.

Postmarketing Experience

No postmarketing experience details are available in the provided data.

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 a patient accidentally swallows more than the recommended amount used for rinsing, they should seek medical assistance immediately or contact a Poison Control Center for guidance. This precaution is crucial to ensure the safety and well-being of patients, particularly in households with children.

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. Proper handling should be observed to ensure optimal conditions are met throughout the storage period.

Additional Clinical Information

The product is administered orally. Clinicians should counsel patients to keep the product out of reach of children and to seek medical assistance or contact a Poison Control Center immediately if more than the recommended amount is swallowed. It is important to instruct children under 12 years in proper rinsing techniques to minimize swallowing and to supervise them until they can use the product independently. For children under 6 years of age, consultation with a dentist or doctor is advised. Additionally, patients should refrain from eating or drinking for 30 minutes after rinsing to ensure optimal effectiveness.

Drug Information (PDF)

This file contains official product information for Listerine Smart Rinse Berry Splash, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

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