Act Kids Anticavity Fluoride

Description

ACT Kids Anticavity Fluoride Rinse is formulated with an active ingredient of Sodium Fluoride at a concentration of 0.05%. This oral rinse is designed for pediatric use and is presented in a 16.9 fl oz (500 mL) volume. The product features a Wild Watermelon flavor and is free from both sugar and alcohol, making it suitable for children.

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 aged 6 years and older should use the product once daily, following brushing with toothpaste. To administer, the user should remove the cap, hold the bottle upright, and squeeze to fill the bottle to the FILL LINE (10 mL). The user must then vigorously swish 10 milliliters of the rinse between the teeth for 1 minute before spitting it out. It is important to avoid swallowing the rinse. Additionally, users should refrain from eating or drinking for 30 minutes after rinsing to ensure optimal effectiveness.

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 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 recommended prior to use.

Contraindications

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

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 the Poison Control Center or seek emergency medical help without delay.

No specific general precautions or laboratory tests have been identified for this product. However, the emphasis on the importance of monitoring for accidental ingestion remains critical to ensure patient safety.

Side Effects

In clinical use, patients should be aware of the potential for serious adverse reactions associated with the accidental ingestion of the product. If more than the recommended amount for rinsing is swallowed, it is imperative to seek medical assistance or contact the Poison Control Center immediately. This warning underscores the importance of adhering to the prescribed usage guidelines to mitigate risks associated with misuse.

No additional common adverse reactions have been reported in clinical trials or postmarketing experiences. However, healthcare providers should remain vigilant and monitor patients for any unexpected reactions following use.

Drug Interactions

There are no specific drug interactions identified for the product, nor are there any noted interactions with laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on the available data.

Packaging & NDC

Below are the non-prescription pack sizes of Act Kids Anticavity Fluoride (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 medical assistance or contact with a Poison Control Center is advised.

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 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 necessary 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 available regarding the use of this medication during pregnancy, including safety concerns, dosage modifications, or special precautions that should be taken. Healthcare professionals should consider the lack of data when prescribing this medication to pregnant patients and weigh the potential risks and benefits. Women of childbearing potential should be counseled on the absence of established safety data and the importance of discussing any potential pregnancy with their healthcare provider.

Lactation

Lactating mothers should consult a healthcare professional before using this product. There is a potential for excretion in breast milk, and the effects on nursing infants are not well studied; therefore, caution is advised.

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 individual accidentally swallows more than the amount intended for rinsing, it is imperative to seek medical help or contact the 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, as these may vary based on the nature of the overdosage.

Management procedures should include a thorough assessment of the patient's condition and the implementation of appropriate supportive care measures. It is advisable to follow established protocols for the management of overdoses, which may involve decontamination, symptomatic treatment, and monitoring of vital signs.

In summary, swift action and adherence to recommended guidelines are critical in managing cases of overdosage effectively.

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 insert text.

Patient Counseling

Healthcare providers should advise patients to keep this product 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 assistance or contact the 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 a container that must be stored at room temperature. It is essential to ensure that the safety seal is intact; do not use the product if the seal is broken or missing. During use, the bottle should be kept in an upright position to maintain its integrity and effectiveness.

Additional Clinical Information

The product is administered topically, with a recommended frequency of once daily following tooth brushing. Clinicians should instruct patients, particularly children under 12 years of age, on proper rinsing techniques to minimize swallowing, and supervision is advised until children are capable of using the product independently. For children under 6 years of age, consultation with a dentist or doctor is recommended.

Drug Information (PDF)

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

View product document (PDF)