Act Anticavity Fluoride Cinnamon

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 a 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 crucial 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 recommended 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 advised 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.

In cases of accidental ingestion exceeding the recommended dosage, it is crucial for patients to stop using the product and consult their healthcare provider for further guidance.

While no specific general precautions or laboratory tests are outlined, healthcare professionals should remain vigilant and ensure that patients are aware of the importance of adhering to the recommended usage guidelines to mitigate risks associated with misuse.

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 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 Anticavity Fluoride Cinnamon (sodium fluoride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients should be kept 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 recommended usage is 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 the product. Supervision is necessary 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 recommended 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, given the lack of targeted data for this population.

Pregnancy

The safety of sodium fluoride rinse during pregnancy has not been established. Pregnant patients or those planning to become pregnant should consult a healthcare provider before use. There are no adequate and well-controlled studies in pregnant women, and the potential risks to the fetus remain unknown. No specific dosage modifications for pregnant women are provided; therefore, it is essential for healthcare providers to offer guidance tailored to individual circumstances.

Lactation

There are no specific warnings or recommendations regarding the use of this medication in lactating mothers. Additionally, there are no known data on excretion in breast milk or effects on breastfed infants. Healthcare professionals should consider the absence of specific guidance when advising lactating mothers about the use of this medication.

Renal Impairment

Patients with renal impairment may not have specific dosage adjustments, special monitoring, or safety considerations outlined in the prescribing information. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the lack of data necessitates careful clinical judgment. Regular monitoring of renal function is advisable to ensure patient safety and therapeutic efficacy.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in clinical trials for this medication. Consequently, there is no available information regarding dosage adjustments, special monitoring requirements, or precautions 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 warranted based on clinical judgment.

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 related to the specific substance involved is essential, as these may vary based on the nature of the overdose.

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 treatment of overdoses, which may involve decontamination, symptomatic treatment, and monitoring of vital signs.

In summary, swift action and adherence to recommended guidelines are vital 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 provided in the insert.

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 guidance is crucial for ensuring patient safety and minimizing potential risks associated with accidental ingestion.

Storage and Handling

The product is supplied in configurations that include specific NDC numbers, which should be referenced for accurate identification. It is essential to store the product at room temperature to maintain its integrity and effectiveness. Additionally, healthcare professionals should ensure that the safety seal is intact before use; the product should not be utilized if the safety seal is broken or missing. Proper handling and storage conditions are crucial for ensuring the product's safety and efficacy.

Additional Clinical Information

The product is administered topically, with a recommended frequency of once daily following tooth brushing. Clinicians should advise patients to keep the product out of reach of children and to seek medical assistance or contact a Poison Control Center immediately if more than the recommended amount is accidentally swallowed. It is important to instruct children under 12 years of age on proper rinsing techniques to minimize swallowing, and to supervise their use of the product until they are capable of using it independently.

Drug Information (PDF)

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

View product document (PDF)