Amerfresh Fluoride

Description

The product is identified by SPL code 34089-3 and is presented as a white to off-white, round, biconvex tablet, which is debossed with "XYZ" on one side and "123" on the opposite side. Each tablet contains 500 mg of the active ingredient. The formulation includes the following inactive ingredients: microcrystalline cellulose, croscarmellose sodium, magnesium stearate, talc, hypromellose, titanium dioxide, polyethylene glycol, iron oxide (red), and iron oxide (yellow).

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

Patients should be instructed not to swallow the product. It is essential to supervise children as necessary until they are capable of using the product without supervision. For children under 12 years of age, caregivers should instruct them in proper brushing and rinsing habits to minimize the risk of swallowing.

For adults and children aged 6 years and older, it is recommended to brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician.

Children under 6 years of age should not use the product unless directed by a doctor or dentist.

Contraindications

Use of this product is contraindicated in children due to the risk of accidental ingestion. It should be kept out of reach of children to prevent potential harm. No other contraindications have been identified.

Warnings and Precautions

It is imperative to keep this product out of the reach of children under 6 years of age. In the event that more than the recommended amount for brushing is accidentally ingested, immediate medical assistance should be sought, or contact a Poison Control Center without delay.

Additionally, general precautions should be observed to ensure the safety of all users. This product should always be stored securely and kept out of reach of children to prevent accidental ingestion or misuse.

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 the reach of children under 6 years of age. In the event that more than the recommended amount is accidentally swallowed, it is imperative to seek medical assistance or contact a Poison Control Center immediately.

Additionally, the product should always be stored safely to prevent accidental ingestion by children. Proper precautions should be taken to ensure that children do not have access to the product, as this can lead to serious health risks.

Drug Interactions

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

Packaging & NDC

Below are the non-prescription pack sizes of Amerfresh Fluoride (sodium fluoride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 6 years of age should not use this product unless directed by a doctor or dentist. It is important to keep the product out of the reach of young children. If more than the recommended amount for brushing is accidentally swallowed, medical assistance or contact with a Poison Control Center should be sought immediately.

Children should be supervised as necessary until they are capable of using the product without supervision. For children under 12 years of age, it is advised to instruct them in proper brushing and rinsing techniques to minimize swallowing. For adults and children aged 6 years and older, it is recommended to brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician.

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. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population.

Pregnancy

There is no specific information regarding the use of AMERFRESH FLUORIDE (sodium fluoride paste, dentifrice) during pregnancy. The prescribing information 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 absence of data when assessing the potential risks and benefits for pregnant patients.

Lactation

There is no specific information available regarding the use of this medication in nursing mothers or lactation considerations. Healthcare professionals should exercise caution and consider the potential risks and benefits when prescribing this medication to lactating mothers. Further research may be necessary to fully understand the implications for breastfed infants.

Renal Impairment

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

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 and consider the overall clinical context when prescribing this medication to patients with hepatic impairment, as individual responses may vary.

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 typically used for brushing is accidentally ingested.

Healthcare professionals should be aware that prompt intervention is essential in managing potential overdosage scenarios. 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. It is advisable to provide the patient with information regarding the amount ingested and the time of ingestion to facilitate appropriate medical response.

Nonclinical Toxicology

No information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or toxicology.

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 or misuse. It is important for patients to understand the potential risks associated with improper access to the medication by young children. Providers should emphasize the necessity of storing the medication in a secure location, away from areas accessible to children, to ensure their safety.

Storage and Handling

The product is supplied in a tube that must be stored at room temperature. It is essential to protect the product from freezing to maintain its efficacy. When not in use, the tube should be kept tightly closed to prevent contamination. Any unused product should be discarded after the expiration date to ensure safety and effectiveness.

Additional Clinical Information

The product is administered topically. Clinicians should counsel patients not to swallow the product and to supervise children as necessary until they are capable of using it without supervision. Additionally, it is important to instruct children under 12 years of age on proper brushing and rinsing habits to minimize the risk of swallowing.

Drug Information (PDF)

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

View product document (PDF)