Listerine Total Care Intense Anticavity Fluoride Mouthwash

Description

Sodium Fluoride & Acidulated Phosphate Topical Solution is presented in a volume of 1.0 L (1 Qt 1.8 FL Oz).

Uses and Indications

This drug is indicated for the prevention of dental cavities.

There are no teratogenic effects associated with this drug. Additionally, no nonteratogenic effects have been reported.

Dosage and Administration

Adults and children 12 years of age and older should 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 1 minute, after which the solution should be spat out. 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 advised to consult a dentist or doctor prior to use. Caregivers should supervise children as necessary until they are capable of using the rinse without supervision.

Contraindications

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

Warnings and Precautions

It is imperative to keep this product out of reach of children. In the event that more than the recommended amount for rinsing is accidentally ingested, immediate medical assistance should be sought, or contact a Poison Control Center without delay.

Healthcare professionals should be aware that if an overdose occurs, emergency medical help is necessary. Prompt action is crucial in such situations to ensure patient safety and appropriate management.

While no specific instructions for discontinuation or general precautions are provided, it is advisable for healthcare providers to remain vigilant and monitor patients for any adverse reactions or unusual symptoms.

Currently, there are no specified laboratory tests recommended for monitoring the safe use of this product. However, healthcare professionals should exercise clinical judgment and consider appropriate assessments based on individual patient circumstances.

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.

Drug Interactions

There are currently no documented drug interactions associated with the use of 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 Intense 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 adults and children aged 12 years and older, the recommended usage is twice daily following tooth brushing. Patients should vigorously swish 10 mL (2 teaspoonfuls) of the rinse between their teeth for 1 minute and then spit it out. It is important not to swallow the rinse and to refrain from eating or drinking for 30 minutes after use. Caregivers should supervise younger children until they are capable of using the product without assistance.

For children under 12 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

There is no specific information regarding the use of Listerine Total Care Intense Anticavity Fluoride Mouthwash during pregnancy. The drug insert does not provide safety concerns, dosage modifications, or special precautions for pregnant patients. Therefore, healthcare professionals should exercise caution and consider the lack of data when advising women of childbearing potential regarding the use of this product during pregnancy. It is recommended that pregnant patients consult their healthcare provider for personalized guidance.

Lactation

There are no specific warnings or recommendations regarding the use of Listerine Total Care Intense Anticavity Fluoride Mouthwash in lactating mothers. Additionally, there is no information available about the potential for excretion of the product in breast milk or any associated risks to breastfed infants.

Renal Impairment

There is no specific information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients to ensure safety and efficacy.

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 significantly mitigate potential adverse effects associated with overdosage. Monitoring for symptoms related to the specific substance involved is essential, although specific symptoms were not detailed in the provided information.

Management procedures should include supportive care and symptomatic treatment as necessary, guided by the clinical presentation of the patient. It is advisable to have the product label or information readily available when contacting medical professionals or poison control for tailored guidance.

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 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 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. Exposure to cold weather may cause the product to cloud, which could affect its appearance but not its efficacy. Care should be taken to avoid temperature fluctuations during storage to ensure optimal quality.

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 rinsing procedure.

Clinicians should counsel patients to keep the product out of reach of children. In the event that more than the recommended amount is accidentally swallowed, patients should seek medical assistance or contact a Poison Control Center immediately. Additionally, supervision of children is recommended until they are capable of using the product without assistance.

Drug Information (PDF)

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

View product document (PDF)