Brush Buddies Squishmallows Anticavity Fluoride Mint Flavor

Description

SPL code 34089-3 corresponds to the product Squishmallows-102. This item is identified within the relevant regulatory frameworks and is categorized accordingly. Further details regarding its formulation, usage, and specifications may be available in the comprehensive product documentation.

Uses and Indications

This drug is indicated for the protection against cavities.

There are no teratogenic effects associated with this drug, nor are there any nonteratogenic effects mentioned.

Dosage and Administration

Adults and children aged 2 years and older are advised to brush their teeth thoroughly after meals or at least twice daily, or as directed by a dentist. It is important to ensure that the product is not swallowed during use.

For children aged 2 to 6 years, a pea-sized amount of the product should be used to minimize the risk of swallowing. Caregivers should supervise the brushing and rinsing process until proper oral hygiene habits are established.

For children under 2 years of age, it is recommended to consult a dentist or doctor prior to use.

Contraindications

Use is contraindicated in children under 6 years of age; the product should be kept out of their reach. In the event of accidental ingestion beyond the recommended amount for brushing, it is imperative to seek professional assistance or contact a Poison Control Center immediately.

Warnings and Precautions

It is imperative to keep this product out of the reach of children under 6 years of age to prevent accidental ingestion. In the event of accidental swallowing of an amount greater than that used for brushing, it is crucial to seek professional medical assistance or contact a Poison Control Center immediately.

No specific general precautions or laboratory tests have been identified for this product. Additionally, there are no outlined instructions for stopping the use of the product or contacting a healthcare provider. Healthcare professionals should remain vigilant and ensure that patients are aware of these critical safety measures.

Side Effects

Patients should be aware of the potential risks associated with the use of this product. It is crucial to keep the product out of reach of children under 6 years of age. In the event of accidental ingestion of an amount greater than that used for brushing, it is imperative to seek professional help or contact a Poison Control Center immediately.

This warning highlights the importance of proper usage and supervision to prevent serious adverse reactions in young children.

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 Brush Buddies Squishmallows Anticavity Fluoride Mint Flavor (sodium fluoride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 6 years of age should be kept out of reach of the product. For children aged 2 to 6 years, it is recommended to use a pea-sized amount to minimize the risk of swallowing, and caregivers should supervise the child's brushing and rinsing until proper oral hygiene habits are established. For children under 2 years of age, consultation with a dentist or doctor is advised prior to use.

Geriatric Use

There is no specific information 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 regarding the use of this drug 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 and the need to inform their healthcare provider if they become pregnant or plan to become pregnant while using this medication.

Lactation

There are no specific warnings or recommendations regarding the use of this medication in nursing mothers. Additionally, there are no specific warnings or recommendations related to lactation. Healthcare professionals should consider the absence of data when advising lactating mothers about the use of this medication.

Renal Impairment

There is no information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution and consider the lack of specific guidance when prescribing to patients with reduced kidney function.

Hepatic Impairment

There is no information available regarding the use of this medication in patients with hepatic impairment. Consequently, there are no dosage adjustments, special monitoring requirements, or precautions specified for individuals with compromised liver function. Healthcare professionals should exercise caution and consider the overall clinical context when prescribing this medication to patients with liver problems, as the absence of specific guidance necessitates careful evaluation of potential risks and benefits.

Overdosage

In the event of an overdosage, it is imperative that healthcare professionals take immediate action. If a patient accidentally ingests more than the recommended amount used for brushing, it is crucial to seek professional assistance without delay.

Healthcare providers should advise the patient or caregiver to contact a Poison Control Center immediately for guidance on the appropriate steps to take. Prompt intervention is essential to mitigate potential adverse effects associated with overdosage.

Monitoring for symptoms related to overdosage is also important, although specific symptoms were not detailed in the provided information. Therefore, healthcare professionals should remain vigilant and assess the patient for any unusual signs or reactions following an overdosage incident.

In summary, immediate professional help and contact with a Poison Control Center are the recommended actions in the case of overdosage.

Nonclinical Toxicology

The available nonclinical data does not provide information regarding teratogenic or non-teratogenic effects. Additionally, there are no details concerning animal pharmacology and toxicology. No findings related to carcinogenesis or mutagenesis have been reported. Consequently, the nonclinical toxicology profile remains undefined based on the current data.

Postmarketing Experience

No postmarketing experience details are provided in the insert.

Patient Counseling

Healthcare providers should advise patients to keep this product out of the reach of children under 6 years of age to prevent accidental ingestion. It is important to emphasize the potential risks associated with misuse.

In the event that a patient accidentally swallows more than the amount recommended for brushing, healthcare providers should instruct them to seek professional help or contact a Poison Control Center immediately. This guidance is crucial for ensuring patient safety and addressing any potential health concerns promptly.

Storage and Handling

The product is supplied in configurations that include specific NDC numbers. It should be stored at room temperature, ensuring that it is protected from excessive heat. Freezing is not permitted, as it may compromise the integrity of the product. Once opened, the product must be discarded to ensure safety and efficacy.

Additional Clinical Information

The product is administered via the dental route. Clinicians should advise patients to keep the product out of reach of children under 6 years of age. In the event of accidental ingestion of more than the amount used for brushing, patients should seek professional help or contact a Poison Control Center immediately. It is important to instruct patients not to swallow the product.

For children aged 2 to 6 years, a pea-sized amount should be used to minimize swallowing, and caregivers should supervise brushing and rinsing until proper habits are established. For children under 2 years of age, consultation with a dentist or doctor is recommended.

Drug Information (PDF)

This file contains official product information for Brush Buddies Squishmallows Anticavity Fluoride Mint Flavor, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)