Therabreath Plus Fresh Breath

Description

No description information is available for the 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 2 years and older should brush their teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor. It is important to ensure that brushing is performed effectively to maintain oral hygiene.

For children under 6 years of age, caregivers should instruct them in proper brushing and rinsing techniques to minimize the risk of swallowing. Supervision is recommended until the child is capable of brushing without assistance.

For children under 2 years of age, it is advised to consult a dentist or doctor for appropriate guidance on dental care.

Contraindications

Use is contraindicated in children under 6 years of age due to the potential risk of accidental ingestion. In the event of accidental swallowing of an amount greater than that used for brushing, immediate medical assistance should be sought or contact with a Poison Control Center is advised.

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 and potential harm.

In the event that more than the recommended amount used for brushing is accidentally swallowed, immediate medical assistance should be sought. Healthcare professionals are advised to contact a Poison Control Center without delay to ensure appropriate management and intervention.

Side Effects

Patients should be aware of the following warnings associated with the use of this product. It is crucial to keep the product out of reach of children under 6 years of age to prevent accidental ingestion. In the event that more than the recommended amount for brushing is accidentally swallowed, it is imperative to seek medical assistance or contact a Poison Control Center immediately.

These precautions are essential to ensure the safety and well-being of patients, particularly young children who may be more susceptible to adverse effects from improper use.

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 Therabreath Plus Fresh Breath (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. In the event that more than the recommended amount for brushing is accidentally swallowed, immediate medical assistance or contact with a Poison Control Center is advised.

For children aged 2 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 doctor. Caregivers should instruct children under 6 years in proper brushing and rinsing techniques to minimize the risk of swallowing the product. Supervision is necessary until children are capable of brushing without assistance.

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

Geriatric Use

There is no specific information regarding the use of TheraBreath Plus Fresh Breath (sodium fluoride paste, dentifrice) in geriatric patients. The prescribing information does not provide guidance on dosage adjustments, safety concerns, or special precautions for elderly patients. Therefore, healthcare providers should exercise clinical judgment when considering the use of this product in the geriatric population, taking into account the individual patient's health status and any potential risks associated with its use. Regular monitoring may be advisable to ensure safety and efficacy in elderly patients.

Pregnancy

There is no specific information regarding the use of TheraBreath Plus Fresh Breath (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 and consider the lack of data when advising women of childbearing potential regarding the use of this product during pregnancy. It is recommended that pregnant patients consult their healthcare provider for personalized guidance.

Lactation

There are no specific warnings or recommendations regarding the use of this product by lactating mothers. Additionally, there are no statements concerning the potential for excretion in breast milk or any associated risks to breastfed infants.

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 typically used for brushing, it is imperative to seek medical help or contact a Poison Control Center without delay.

Healthcare professionals should be aware that symptoms of overdosage may vary, and prompt evaluation is necessary to determine the appropriate course of action. Management procedures will depend on the specific circumstances of the overdosage, including the amount ingested and the patient's clinical status.

It is essential to monitor the patient closely and provide supportive care as needed. In cases of significant exposure, further interventions may be required based on the clinical judgment of the healthcare provider.

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 compound in these areas.

Postmarketing Experience

No postmarketing experience details are available for TheraBreath Plus Fresh Breath (sodium fluoride paste, dentifrice).

Patient Counseling

Healthcare providers should advise patients to keep the product out of reach of children under 6 years of age to prevent accidental ingestion. It is important to emphasize the potential risks associated with misuse. Instruct patients that if more than the recommended amount used for brushing is accidentally swallowed, they should seek medical help or contact a Poison Control Center immediately. This guidance is crucial for ensuring the safety and well-being of patients and their families.

Storage and Handling

This product is supplied in protective packaging to ensure its integrity during storage and handling. It is essential to inspect the packaging before use; if the seal is missing, the product should not be utilized.

In the event of a spill on fabrics, it is recommended to wash the affected area immediately to prevent staining or damage. Proper handling and adherence to these guidelines are crucial for maintaining the product's quality and safety.

Additional Clinical Information

The route of administration for the product is dental. Clinicians should instruct parents to teach children under 6 years of age proper brushing and rinsing habits to minimize the risk of swallowing. Additionally, supervision is recommended for children until they are capable of using the product without assistance. For children under 2 years of age, it is advised to consult a dentist or doctor prior to use.

Drug Information (PDF)

This file contains official product information for Therabreath Plus Fresh Breath, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)