Act Kids Pure Protect Anticavity- Simply Strawberry

Description

No description information is available for the specified drug.

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 cap must be removed, and the bottle held upright while squeezing to fill the reservoir to the FILL LINE (10 mL). The user should then vigorously swish the 10 mL of rinse between the teeth for 1 minute before spitting it out. It is imperative that the rinse is not swallowed. After rinsing, individuals should refrain from eating or drinking for 30 minutes 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 required 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

Use is contraindicated if the safety seal is broken or missing, as this may compromise the integrity and safety of the product.

Warnings and Precautions

It is imperative to keep this product out of the 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.

The product should not be utilized if the safety seal is broken or missing, as this may compromise its integrity and safety.

Healthcare professionals are advised to ensure that patients are aware of the potential risks associated with accidental ingestion and the importance of adhering to the recommended usage guidelines.

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 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 Act Kids Pure Protect Anticavity- Simply Strawberry (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 regarding the use of ACT Kids Pure Protect Anticavity 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 when recommending this product to women of childbearing potential and consider the lack of data when assessing the potential risks and benefits for pregnant patients.

Lactation

There are no specific warnings or recommendations regarding nursing mothers or lactation in the provided text. Therefore, healthcare professionals should consider the absence of data when advising lactating mothers about the use of this medication. It is advisable to monitor breastfed infants for any potential effects, although no specific information is available.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available prescribing information regarding dosage adjustments, monitoring, or precautions. As such, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, given the absence of detailed guidance on its use in this population. Regular monitoring of renal function may be warranted 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 individual accidentally swallows more than the amount intended for rinsing, 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 and providing appropriate management based on clinical presentation is essential.

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 seek immediate medical assistance or contact a Poison Control Center if more than the recommended amount for rinsing is accidentally swallowed. It is important for patients to understand the potential risks associated with improper use of the product and to act promptly in such situations to ensure their safety.

Storage and Handling

The product is supplied in packaging that includes a safety seal. It is essential to store the product at room temperature to maintain its integrity and effectiveness. Healthcare professionals should ensure that the product is not used if the safety seal is broken or missing, as this may compromise the product's safety. Additionally, it is crucial to keep the product out of reach of children to prevent accidental ingestion or misuse.

Additional Clinical Information

The medication is administered orally. Clinicians should instruct parents or guardians to teach children under 12 years of age proper rinsing habits to minimize swallowing. Additionally, supervision is recommended for children until they are capable of using the medication without assistance. No further information is available regarding laboratory tests, abuse potential, or postmarketing experience.

Drug Information (PDF)

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

View product document (PDF)