Therabreath for Kids Anti Cavity Oral Rinse

Description

TheraBreath Kids Anti Cavity Oral Rinse is formulated specifically for pediatric use. The product is designed to help prevent cavities in children. It is presented in a liquid dosage form, with a net volume of 16 fluid ounces. The effective date of this formulation is October 3, 2018. For reference, the product label is documented under the media reference Kids Anti Cavity Oral Rinse Label, identified by the image file THB-LB-00340R1_Label Rinse Kids 16oz.2019.03.01.jpg.

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 6 years of age and older should use the rinse once daily, following brushing with a toothpaste. The recommended method of administration involves vigorously swishing 10 milliliters of the rinse between the teeth for 1 minute before spitting it out. It is imperative that the rinse is not swallowed.

After rinsing, patients should refrain from eating or drinking for a period of 30 minutes to ensure optimal effectiveness of the product.

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 product without assistance.

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

Contraindications

Use is contraindicated in individuals who are unable to keep the product out of reach of children. This precaution is essential to prevent accidental ingestion or misuse by minors. No other contraindications have been identified.

Warnings and Precautions

In the event that more than the recommended amount used for rinsing is accidentally ingested, immediate medical assistance should be sought, or the individual should contact a Poison Control Center without delay.

It is imperative to keep this product out of the reach of children to prevent accidental ingestion and potential harm.

Side Effects

Patients should be aware 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. This warning highlights the potential seriousness of accidental ingestion and underscores the importance of adhering to the recommended usage guidelines.

Drug Interactions

No drug interactions have been identified in the available data. Additionally, there are no reported interactions between drugs 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 Therabreath for Kids Anti Cavity Oral Rinse (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, immediate assistance should be sought by contacting a Poison Control Center.

For children aged 6 years and older, the recommended usage is once daily after brushing teeth with toothpaste. Patients should vigorously swish 10 milliliters of the rinse between their teeth for 1 minute and then spit it out, ensuring that the rinse is not swallowed.

It is important to instruct children under 12 years of age in proper rinsing techniques to minimize the risk of swallowing the rinse. Supervision may be necessary until the child is capable of using the product without assistance.

For children under 6 years of age, consultation with a dentist or doctor is advised 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.

Pregnancy

There is no specific information available regarding the use of this medication during pregnancy, including safety concerns, dosage modifications, or special precautions. Healthcare professionals should consider the lack of data when prescribing this medication to pregnant patients. It is advisable to weigh the potential benefits against any unknown risks to fetal outcomes. Women of childbearing potential should be counseled on the importance of effective contraception during treatment.

Lactation

There is no specific information available regarding the use of this medication in nursing mothers or 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 the safety profile in this population.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available data regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the lack of information necessitates careful clinical judgment and monitoring.

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 action is crucial. If an individual accidentally swallows more than the amount intended for rinsing, it is imperative to seek assistance promptly. Healthcare professionals should advise contacting a Poison Control Center without delay to ensure appropriate management and intervention.

Potential symptoms of overdosage may vary, and vigilance is necessary to monitor the patient for any adverse effects. The management of overdosage should be guided by the severity of symptoms and the specific circumstances surrounding the incident. Prompt evaluation and treatment by healthcare professionals are essential to mitigate any potential risks associated with the overdosage.

Nonclinical Toxicology

No information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided 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 or misuse. It is important to emphasize the potential risks associated with improper access to the medication, ensuring that patients understand the necessity of safeguarding it in a secure location.

Storage and Handling

The product is supplied in configurations that include specific NDC numbers. It is essential to inspect the safety seal prior to use; the product should not be utilized if the safety seal is broken or missing.

For optimal storage, the product must be kept in a controlled environment, adhering to the recommended temperature ranges. Special handling precautions should be observed to maintain the integrity of the product throughout its shelf life.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Therabreath for Kids Anti Cavity Oral Rinse, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)