Percara Kids Bubble Gum

Description

PERCARA™ is an alcohol-free fluoride rinse formulated for cavity protection. This product is specifically designed for children and features a bubble gum flavor to enhance palatability. The rinse is available in a dosage form of 18 fluid ounces (532 mL).

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 aged 6 years and older should use the product once daily, following brushing with toothpaste. To administer, the user should remove the cap and pour approximately one tablespoon of the rinse into a cup. The rinse should be used to vigorously swish between the teeth for a duration of 1 minute, after which it must be spat out. It is imperative that the rinse is not swallowed.

Following the rinsing procedure, patients should refrain from eating or drinking for at least 30 minutes to ensure optimal effectiveness. For children under 12 years of age, it is essential to instruct them in proper rinsing techniques and to supervise their use of the product until they are capable of using it independently. For children under 6 years of age, consultation with a dentist or doctor is recommended prior to use.

Contraindications

Use of this product is contraindicated in the event of accidental ingestion beyond the recommended rinsing amount. In such cases, immediate medical assistance or contact with a Poison Control Center is advised. No other contraindications have been identified.

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 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, vigilance is essential in monitoring for any adverse effects or complications that may arise from improper use.

Side Effects

Patients should be aware that if 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 highlights the potential seriousness of ingesting excessive amounts of the product, underscoring the importance of adhering to the usage guidelines to prevent adverse outcomes.

Drug Interactions

There are no specific drug interactions or laboratory test interactions identified in the available data. Therefore, no recommendations for dosage adjustments or monitoring are necessary at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Percara Kids Bubble Gum (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 once daily after brushing teeth with toothpaste. It is important to instruct children under 12 years of age in proper rinsing techniques and to supervise them as necessary until they are capable of using the product without supervision.

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 PerCara Kids Bubble Gum Sodium Fluoride Rinse in geriatric patients. The prescribing information does not indicate any dosage adjustments, safety concerns, or special precautions that are applicable to elderly patients. Therefore, healthcare providers should exercise clinical judgment when considering the use of this product in the geriatric population, as individual patient factors may necessitate careful monitoring and assessment.

Pregnancy

There is no specific information regarding the use of PerCara Kids Bubble Gum Sodium Fluoride Rinse in pregnant patients. The prescribing information 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

Nursing mothers should consult a healthcare professional before using this product. There is a potential for excretion in breast milk; therefore, caution is advised when administering to nursing mothers. The effects on a nursing infant are not well studied; thus, the risks versus benefits should be considered.

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 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, it is critical to seek immediate medical assistance or contact a Poison Control Center if an amount exceeding that intended for rinsing is accidentally ingested.

Healthcare professionals should be aware that prompt intervention is essential in managing potential complications associated with overdosage. Symptoms may vary depending on the specific substance involved, and monitoring for adverse effects is recommended.

Management procedures should include supportive care and symptomatic treatment as necessary. Continuous assessment of the patient's condition is advised to ensure appropriate interventions are implemented based on the severity of symptoms presented.

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 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 information is crucial for ensuring patient safety and preventing potential adverse effects associated with misuse.

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 necessary beyond standard storage practices.

Additional Clinical Information

The medication is administered orally. 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. It is important to instruct children under 12 years of age on proper rinsing habits and to supervise them as needed until they can use the product independently. For children under 6 years of age, consultation with a dentist or doctor is advised.

Drug Information (PDF)

This file contains official product information for Percara Kids Bubble Gum, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)