ADD CONDITION

items per page

Therabreath Fresh Breath Anticavity Mild Mint

Last content change checked dailysee data sync status

Active ingredient
Sodium Fluoride 0.24 g/100 g
Other brand names
Dosage form
Paste, Dentifrice
Route
Oral
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2024
Label revision date
February 6, 2024
Active ingredient
Sodium Fluoride 0.24 g/100 g
Other brand names
Dosage form
Paste, Dentifrice
Route
Oral
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Marketed in the U.S.
Since 2024
Label revision date
February 6, 2024
Manufacturer
Church & Dwight Co. , Inc.
Registration number
M021
NDC root
10237-263

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 is a dentist-formulated anti-cavity fluoride toothpaste designed to help you maintain fresh breath and prevent dental decay. It contains Aloe Vera and is available in a Mild Mint flavor, making it a pleasant addition to your oral care routine.

This toothpaste not only fights cavities but also combats bad breath for up to 12 hours, providing you with long-lasting freshness and protection for your teeth.

Uses

You can use this product to help prevent dental decay, which is the process that leads to cavities in your teeth. By incorporating it into your oral care routine, you can support your dental health and reduce the risk of developing issues related to tooth decay. Regular use can be an effective way to maintain a healthy smile.

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. If you're an adult or a child aged 6 years and older, you should follow this routine or any specific instructions given by your dentist or doctor.

For children under 12, it's essential to teach them proper brushing and rinsing techniques to help prevent swallowing toothpaste. You should supervise younger children while they brush their teeth until they are able to do it on their own safely. If your child is under 6 years old, do not use this product unless a dentist or doctor has specifically advised you to do so.

What to Avoid

It's important to ensure that you use this product safely. Keep it out of reach of children under 6 years old to prevent any accidental ingestion. If a child accidentally swallows more than what is typically used for brushing, seek medical help or contact a Poison Control Center immediately.

By following these guidelines, you can help ensure the safe use of this product.

Side Effects

It's important to keep this product out of reach of children under 6 years old. If a child accidentally swallows more than what is typically used for brushing, seek medical help or contact a Poison Control Center immediately.

Always use this product as directed to minimize any risks associated with accidental ingestion. Your safety is a priority, so please take these precautions seriously.

Warnings and Precautions

It's important to keep this product out of the reach of children under 6 years old to prevent accidental ingestion. If a child accidentally swallows more than what is typically used for brushing, seek medical help or contact a Poison Control Center immediately.

Always use this product as directed. If you experience any unusual symptoms or reactions, stop using it and call your doctor for further advice. Your safety is a priority, so don’t hesitate to reach out for help if needed.

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 can vary, 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

There is currently no specific information available regarding the use of TheraBreath Fresh Breath Anticavity Mild Mint toothpaste during pregnancy. This means that the drug insert does not provide details on safety concerns, dosage adjustments, or any special precautions you should take if you are pregnant or planning to become pregnant.

If you have any concerns about using this toothpaste while pregnant, it’s a good idea to consult with your healthcare provider for personalized advice. They can help you make informed decisions about your dental care during this important time.

Lactation Use

Currently, there is no specific information available about the use of TheraBreath Fresh Breath Anticavity Mild Mint toothpaste for nursing mothers or during lactation (the period of breastfeeding). This means that if you are breastfeeding, you may want to consult with your healthcare provider for personalized advice regarding the use of this toothpaste. It's always best to ensure that any products you use are safe for both you and your nursing infant.

Pediatric Use

It's important to keep this product out of reach of children under 6 years old. If a child accidentally swallows more than what is typically used for brushing, seek medical help or contact a Poison Control Center immediately. For children aged 6 and older, 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 you have children under 12, make sure to teach them proper brushing and rinsing techniques to help prevent swallowing. Always supervise younger children until they are able to brush their teeth independently and safely. For children under 6, only use this product if directed by a dentist or doctor.

Geriatric Use

When it comes to using this medication in older adults, there is no specific information available about dosage adjustments, safety concerns, or special precautions. This means that if you or a loved one is an older adult considering this medication, it’s important to consult with a healthcare provider. They can help determine the best approach based on individual health needs and any other medications being taken. Always prioritize open communication with your healthcare team to ensure safe and effective treatment.

Renal Impairment

If you have kidney problems, it's important to know that the information provided does not include specific guidelines for dosage adjustments, special monitoring, or safety considerations related to renal impairment (kidney issues). This means that there are no tailored recommendations for how your treatment may need to change based on your kidney function.

Always consult your healthcare provider for personalized advice and to ensure that your treatment plan is safe and effective for your specific situation. They can help monitor your kidney health and make any necessary adjustments to your medications.

Hepatic Impairment

If you have liver problems, it's important to know that the drug insert does not provide specific information about dosage adjustments, special monitoring, or precautions for your condition. This means that there are no tailored guidelines for how this medication may affect you if you have hepatic impairment (liver issues).

Always consult your healthcare provider for personalized advice and to discuss any concerns regarding your liver health and medication use. They can help ensure that your treatment is safe and effective based on your individual health needs.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications you are taking. In this case, there are no specific drug interactions or laboratory test interactions noted, which means that this medication is generally considered safe to use alongside other treatments and tests. However, every individual is different, and your healthcare provider can help ensure that your overall treatment plan is safe and effective for you. Always feel free to ask questions or express any concerns you may have regarding your medications or tests.

Storage and Handling

To ensure the safe use of this product, it's important to store it properly and 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 keep the product in its original packaging until you're ready to use it, and handle it gently to maintain its integrity. Following these guidelines will help ensure your safety and the effectiveness of the product.

Additional Information

You should take this medication orally, but be careful not to swallow it. If you have children, supervise them while they use it until they can do so safely on their own. For children under 12, make sure to teach them proper brushing and rinsing techniques to help prevent swallowing.

FAQ

What is TheraBreath?

TheraBreath is a dentist-formulated anti-cavity fluoride toothpaste designed to fight cavities and bad breath while providing fresh breath for up to 12 hours.

What age group can use TheraBreath?

TheraBreath is indicated for adults and children 6 years of age and older. Children under 6 should not use it unless directed by a dentist or doctor.

How should I use TheraBreath?

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

Are there any warnings for TheraBreath?

Yes, keep TheraBreath out of reach of children under 6 years of age. If more than the recommended amount is swallowed, seek medical help or contact a Poison Control Center immediately.

Does TheraBreath have any contraindications?

No specific contraindications are listed for TheraBreath.

Can I use TheraBreath during pregnancy or while nursing?

The product insert does not provide specific information regarding the use of TheraBreath during pregnancy or lactation.

What should I do if TheraBreath spills on fabrics?

If TheraBreath spills on fabrics, wash it out immediately.

What flavor does TheraBreath come in?

TheraBreath is available in a Mild Mint flavor.

Packaging Info

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

Packaging configurations for Therabreath Fresh Breath Anticavity Mild Mint.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

TheraBreath™ Fresh Breath AntiCavity Fluoride Toothpaste is a dentist-formulated oral care product designed to combat cavities and bad breath for up to 12 hours. This toothpaste contains anticavity fluoride and is enhanced with aloe vera. It is presented in a mild mint flavor, providing a refreshing taste. The product is packaged in a net weight of 4 oz (113.5 g).

Uses and Indications

This drug is indicated for the prevention of dental decay. 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 brush their teeth thoroughly, preferably after each meal or at least twice daily, or as directed by a dentist or physician. It is essential to instruct children under 12 years of age in proper brushing and rinsing techniques to minimize the risk of swallowing. Caregivers should supervise children as necessary until they are capable of brushing without assistance.

For children under 6 years of age, the product should not be used unless directed by a dentist or physician.

Contraindications

Use is contraindicated in children under 6 years of age due to the risk of accidental ingestion. In the event of accidental swallowing of an amount greater than that used for brushing, immediate medical assistance 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 care.

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 used 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

No specific drug interactions have been identified for this medication. Additionally, there are no reported interactions with laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug or laboratory test interactions.

Packaging & NDC

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

Packaging configurations for Therabreath Fresh Breath Anticavity Mild Mint.
Details

Pediatric Use

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

For 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 doctor. Parents and caregivers should instruct children under 12 years of age in proper brushing and rinsing techniques to minimize the risk of swallowing the product. Supervision is advised for younger children until they are capable of using the product without assistance.

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 TheraBreath Fresh Breath Anticavity Mild Mint toothpaste 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.

Lactation

There is no specific information regarding the use of TheraBreath Fresh Breath Anticavity Mild Mint toothpaste in nursing mothers or its effects on lactation. Consequently, the safety and efficacy of this product in lactating mothers and its potential excretion in breast milk remain undetermined. Healthcare professionals should consider this lack of data when advising lactating mothers on the use of this product.

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

Healthcare professionals should be aware that timely intervention can 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 in these areas limits the understanding of the compound's potential effects in nonclinical settings.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

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 patient safety and preventing adverse effects related to accidental ingestion.

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, immediate washing is recommended to prevent staining or damage. Proper handling and adherence to these guidelines are crucial for maintaining the product's quality and effectiveness.

Additional Clinical Information

The medication is administered orally. Clinicians should advise patients not to swallow the medication whole 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. No further information is available regarding laboratory tests, abuse potential, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Therabreath Fresh Breath Anticavity Mild Mint, 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 Anticavity Mild Mint, 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.

Learn more in our Editorial Policy

Last AI update:

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.