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Therabreath Fresh Breath

Last content change checked dailysee data sync status

This product has been discontinued

Active ingredient
Sodium Fluoride 0.0024 g/1 g
Other brand names
Dosage form
Paste, Dentifrice
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2018
Label revision date
February 4, 2022
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Sodium Fluoride 0.0024 g/1 g
Other brand names
Dosage form
Paste, Dentifrice
Route
Oral
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2018
Label revision date
February 4, 2022
Manufacturer
Dr. Harold Katz, LLC
Registration number
part355
NDC root
72551-250
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (2 NDCs)
Packaging & NDC Codes (2)

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

If you are a consumer or patient please visit this version.

Drug Overview

TheraBreath Fresh Breath is a product designed to help prevent dental cavities. It works by promoting oral health, ensuring that your mouth stays fresh and clean. This can be particularly beneficial for maintaining good dental hygiene and preventing issues related to cavities.

Uses

You can use this product to help prevent dental cavities, which are small holes in your teeth caused by decay. By incorporating it into your oral care routine, you can support your dental health and reduce the risk of developing these issues. Keeping your teeth healthy is essential for maintaining a bright smile and overall well-being.

Dosage and Administration

To keep your teeth healthy, it's important to brush them thoroughly, ideally after each meal or at least twice a day. This applies to both adults and children aged 2 years and older. If you have any specific questions about your brushing routine, don’t hesitate to ask your dentist or doctor for guidance.

For children under 6 years old, it's essential to teach them proper brushing and rinsing techniques to help prevent swallowing toothpaste. Make sure to supervise them while they brush until they are capable of doing it on their own. If your child is under 2 years old, it's best to consult with a dentist or doctor before starting any dental care routine.

What to Avoid

It's important to ensure that any medication you use is kept safe and out of reach of children, especially those under 6 years of age. This precaution helps prevent accidental ingestion, which can be dangerous for young children.

Currently, there are no specific contraindications, controlled substance classifications, or concerns regarding abuse, misuse, or dependence associated with this medication. However, always follow the guidance of your healthcare provider and use medications responsibly.

Side Effects

If you accidentally swallow more than the amount used for brushing, it's important to seek medical help or contact a Poison Control Center immediately. Additionally, please ensure that this product is kept out of reach of children under 6 years old to prevent any potential harm.

Warnings and Precautions

If you accidentally swallow more of this product than intended for brushing, it’s important to seek medical help immediately or contact a Poison Control Center. This is crucial to ensure your safety and well-being.

To keep children safe, always store this product out of their reach, especially for those under 6 years of age. Taking these precautions can help prevent any accidental ingestion and potential harm.

Overdose

If you accidentally swallow more of this product than what is typically used for brushing your teeth, it’s important to seek medical help immediately or contact a Poison Control Center. This is crucial to ensure your safety and receive the appropriate care.

Signs of an overdose may not be obvious, but if you experience any unusual symptoms after swallowing too much, don’t hesitate to reach out for assistance. Remember, it’s always better to be cautious when it comes to your health.

Pregnancy Use

Currently, there is no information available about the use of TheraBreath Fresh Breath (sodium fluoride paste, dentifrice) during pregnancy. This means that safety concerns, dosage adjustments, or any special precautions for pregnant individuals have not been addressed in the product's guidelines.

If you are pregnant or planning to become pregnant, it's important to consult with your healthcare provider before using this product to ensure it is safe for you and your baby.

Lactation Use

If you are breastfeeding, you can feel reassured that there are no specific warnings or recommendations regarding the use of this product while nursing. Additionally, there is no information available about whether this product is excreted in breast milk or any potential risks to your infant. Always consult with your healthcare provider if you have any concerns or questions about medications while breastfeeding.

Pediatric Use

It's important to establish good dental hygiene habits for your child. For children aged 2 years and older, you should encourage them to brush their teeth thoroughly, ideally after each meal or at least twice a day, following the guidance of a dentist or doctor. If your child is under 6 years old, make sure to teach them proper brushing and rinsing techniques to help prevent swallowing toothpaste. Always supervise younger children while they brush until they can do it safely on their own.

For children under 2 years of age, it's best to consult with a dentist or doctor before introducing any dental products. Additionally, keep all dental care items out of reach of children under 6 to ensure their safety.

Geriatric Use

While there is no specific information about the use of TheraBreath Fresh Breath (sodium fluoride paste, dentifrice) in older adults, it’s always important to approach any new product with caution. If you or a loved one are considering using this toothpaste, it’s a good idea to consult with a healthcare provider, especially if there are any existing health concerns or medications involved.

Since the drug insert does not mention dosage adjustments or safety precautions for elderly patients, you should monitor for any unusual reactions or changes in oral health after starting the product. Always prioritize open communication with your healthcare team to ensure the best care.

Renal Impairment

If you have kidney issues, it's important to know that there are no specific guidelines, dosage adjustments, or monitoring requirements mentioned for your condition in the provided information. This means that the standard recommendations for medication use may apply to you without any special considerations. However, always consult your healthcare provider for personalized advice and to ensure your treatment is safe and effective based on your kidney health.

Hepatic Impairment

If you have liver problems, it's important to know that there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the standard recommendations apply, and there are no special monitoring or precautions outlined for patients with liver impairment.

Always consult your healthcare provider for personalized advice and to ensure that any medications you take are safe for your liver health. They can provide guidance based on your individual situation and any other health considerations you may have.

Drug Interactions

It's great to know that there are no reported interactions between this medication and other drugs or laboratory tests. However, it's still very important to discuss all medications you are taking, including over-the-counter drugs and supplements, with your healthcare provider. This ensures that your treatment is safe and effective, tailored specifically to your health needs.

Always keep your healthcare provider informed about any changes in your medication or health status. Open communication helps prevent any potential issues and supports your overall well-being.

Storage and Handling

To ensure the safe use of this product, it's important to handle it with care. The product comes sealed in protective packaging from the laboratory, so if you notice that the seal is missing, do not use it. In case of any spills on fabrics, make sure to wash the affected area immediately to prevent any potential damage.

Always store the product in a safe place where it won't be exposed to extreme temperatures or conditions. Following these guidelines will help maintain the product's integrity and ensure your safety during use.

Additional Information

No further information is available.

FAQ

What is TheraBreath Fresh Breath used for?

TheraBreath Fresh Breath aids in the prevention of dental cavities.

Who can use TheraBreath Fresh Breath?

It is suitable for adults and children 2 years of age and older. Children under 2 years should consult a dentist or doctor.

How should I use TheraBreath Fresh Breath?

Brush your teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor.

What precautions should I take for children using this product?

Instruct children under 6 years in good brushing and rinsing habits and supervise them until they can use it without assistance.

Are there any contraindications for TheraBreath Fresh Breath?

No contraindications are listed for this product.

What should I do if TheraBreath Fresh Breath is accidentally swallowed?

If more than used for brushing is swallowed, get medical help or contact a Poison Control Center immediately.

Is there any information about using TheraBreath Fresh Breath during pregnancy?

There is no information regarding the use of this product during pregnancy.

Can nursing mothers use TheraBreath Fresh Breath?

There are no specific warnings or recommendations for nursing mothers regarding this product.

What should I do if the seal on TheraBreath Fresh Breath is missing?

If the seal is missing, do not use the product.

What should I do if TheraBreath Fresh Breath spills on fabrics?

Wash out the spill immediately.

Packaging Info

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

Packaging configurations for Therabreath Fresh Breath.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

TheraBreath Fresh Breath is a dental care product designed to promote oral freshness. The product is packaged in a 4 oz tube and features a mild mint flavor. The effective date for the formulation is October 4, 2018, while the outer packaging box has an effective date of February 6, 2019. The reference value for the outer box is denoted as "THB-PK-00272R2_Box Toothpaste Mild Mint 4oz.2019.02.01.jpg."

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 daily, or as directed by a dentist or doctor.

For children under 6 years of age, it is essential to 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, consultation with a dentist or doctor is advised prior to use.

Contraindications

Use is contraindicated in children under 6 years of age. This precaution is necessary to prevent potential harm, as the safety and efficacy of the product have not been established in this age group. Additionally, it is advised to keep the product out of reach of children to avoid accidental ingestion or misuse.

Warnings and Precautions

In the event that more than the recommended amount used for brushing is accidentally ingested, it is imperative to seek medical assistance or contact a Poison Control Center immediately. This precaution is critical to ensure the safety and well-being of the patient.

Additionally, it is essential to keep this product out of the reach of children under 6 years of age. Proper storage and handling are necessary to prevent accidental ingestion and potential harm. Healthcare professionals should advise caregivers on the importance of safeguarding this product to minimize risks associated with its use.

Side Effects

Patients should be aware of the potential risks associated with the use of this product. In the event that more than the recommended amount intended for brushing is accidentally swallowed, it is imperative to seek medical assistance or contact a Poison Control Center immediately.

Additionally, it is crucial to keep this product out of the reach of children under 6 years of age to prevent accidental ingestion and potential harm.

Drug Interactions

There are no reported drug interactions associated with the use of this medication. Additionally, no interactions with laboratory tests have been identified. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug interactions.

Packaging & NDC

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

Packaging configurations for Therabreath Fresh Breath.
Details

Pediatric Use

Pediatric patients aged 2 years and older are advised to brush their teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor. For children under 6 years of age, it is important to instruct them in proper brushing and rinsing techniques to minimize the risk of swallowing. Supervision is recommended for these children until they are capable of brushing without assistance. For infants and children under 2 years of age, consultation with a dentist or doctor is necessary prior to use. Additionally, products should be kept out of reach of children under 6 years of age to ensure safety.

Geriatric Use

There is no specific information regarding the use of TheraBreath Fresh Breath (sodium fluoride paste, dentifrice) in geriatric patients. The prescribing information does not provide guidance on dosage adjustments, safety concerns, or special precautions that may be necessary 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 and assessment may be warranted to ensure safety and efficacy in this demographic.

Pregnancy

There is currently no information available regarding the use of TheraBreath Fresh Breath (sodium fluoride paste, dentifrice) during pregnancy. This includes any safety concerns, dosage modifications, or special precautions that may be necessary for pregnant patients. Healthcare professionals should consider the absence of data when advising women of childbearing potential and weigh the potential risks and benefits of using this product during pregnancy.

Lactation

There are no specific warnings or recommendations regarding the use of this product by lactating mothers. Additionally, there is no information available about the potential for excretion in breast milk or any associated risks to 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 treating patients with renal impairment.

Hepatic Impairment

There is no information available regarding the use of this medication in patients with hepatic impairment. Consequently, there are no dosage adjustments, special monitoring requirements, or precautions specified for individuals with compromised liver function. Healthcare professionals should exercise clinical judgment when considering the use of this medication in patients with liver problems, as the absence of specific guidance necessitates careful evaluation of the patient's overall health status and liver function.

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 prompt intervention can mitigate potential adverse effects associated with overdosage. Monitoring for symptoms may be necessary, although specific symptoms related to overdosage are not detailed in the provided information.

Management procedures should include supportive care and symptomatic treatment as required. It is essential to follow established protocols for handling cases of overdosage to ensure patient safety and effective care.

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 question. Further studies may be necessary to fully evaluate the nonclinical toxicology profile.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of the reach of children under 6 years of age. It is important to emphasize the potential risks associated with accidental ingestion by young children and to encourage patients to store the medication in a secure location.

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

No further data are available.

Drug Information (PDF)

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

View product document (PDF)

Data Generation & Sources

This page was automatically generated and is maintained by the AllDrugs AI Data-Science Team. It was built from the FDA Structured Product Label (DailyMed) for Therabreath Fresh Breath, retrieved by a validated AI data-extraction workflow.

All FDA-listed dosage forms and strengths are shown in the Packaging & NDC Codes section above. Regulatory status appears in the Summary Information panel above and was verified in the FDA National Drug Code directory and the NSDE NDC Directory daily file.

Note: an automated daemon monitors NSDE checksums; when the record for this NDC changes, the new file is pulled instantly and this page is refreshed.

No human clinician has reviewed this version.

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Primary FDA sources:

Orange Book data shown on this page are limited to Regulatory Status (Rx), Established Pharmacologic Class (EPC), and Mechanism of Action (MoA).

Regulatory data notice: Information on this page is reproduced verbatim from FDA public databases (NSDE, Orange Book, Purple Book, DailyMed SPL). NDA/ANDA drugs are FDA-approved, BLA biologics are FDA-licensed. Inclusion alone does not guarantee current market availability or imply FDA endorsement.

Medical disclaimer: This AI-generated content is provided for educational purposes only and does not constitute medical advice. Always consult a licensed healthcare professional for diagnosis or treatment decisions.