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Therabreath Anticavity

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Active ingredient
Sodium Fluoride 0.002 mg/10 mL
Other brand names
Dosage form
Rinse
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2024
Label revision date
September 19, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Sodium Fluoride 0.002 mg/10 mL
Other brand names
Dosage form
Rinse
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 2024
Label revision date
September 19, 2025
Manufacturer
Church & Dwight Co. , Inc.
Registration number
M021
NDC root
10237-265
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 Anticavity Oral Rinse is a specially formulated mouthwash designed to help prevent dental cavities and strengthen your teeth. It contains sodium fluoride (a mineral that helps protect against tooth decay) at a concentration of 0.02%, which works to rebuild weakened tooth enamel and fight cavities for up to 24 hours. This non-burning rinse is alcohol-free and also freshens your breath, making it a gentle yet effective addition to your oral care routine.

Using TheraBreath Anticavity Oral Rinse twice daily can significantly contribute to maintaining your dental health by providing essential fluoride protection. With its refreshing Sparkle Mint flavor, it not only helps keep your teeth strong but also leaves your mouth feeling clean and fresh.

Uses

You can use this product to help prevent dental cavities and keep your teeth healthy. It works around the clock, fighting cavities for up to 24 hours.

Additionally, this product strengthens your teeth and enamel, which is the hard outer layer that protects your teeth. It also helps rebuild weakened tooth enamel, making it an effective choice for preventing tooth decay. By incorporating this into your dental care routine, you can support your overall oral health.

Dosage and Administration

To use this mouth rinse effectively, you should start by brushing your teeth with toothpaste. After brushing, take 10 milliliters of the rinse and swish it vigorously between your teeth for one minute. Make sure to spit it out afterward, as you should not swallow the rinse.

For the best results, use the mouth rinse twice a day. After rinsing, it's important to avoid eating or drinking anything for 30 minutes to allow the rinse to work effectively. Following these steps will help you maintain good oral health.

What to Avoid

It's important to be cautious when using this product. If you accidentally swallow more than what is intended for rinsing, you should seek medical help immediately or contact a Poison Control Center. This is a critical step to ensure your safety.

Currently, there are no specific contraindications, risks of abuse or misuse, or concerns about dependence associated with this product. However, always follow the usage instructions carefully to avoid any potential issues.

Side Effects

It's important to keep this product out of reach of children. If a child accidentally swallows more than what is used for rinsing, seek medical help or contact a Poison Control Center immediately. This precaution helps ensure safety and prevent any potential harm.

Warnings and Precautions

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

In case of any accidental ingestion beyond the recommended use, getting emergency medical assistance is crucial. Always prioritize safety and act quickly if such an incident occurs.

Overdose

If you accidentally swallow more of this product than intended for rinsing, 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

If you are pregnant or planning to become pregnant, it's important to be cautious about the products you use. Currently, there is no specific information available regarding the safety, dosage adjustments, or any special precautions for using TheraBreath Anticavity sodium fluoride rinse during pregnancy.

Given this lack of information, it’s advisable to consult with your healthcare provider before using this product. They can help you make informed decisions that prioritize your health and the health of 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 are no particular considerations or precautions mentioned for lactation. This means that, based on the available information, you can use the product without concern for its effects on your milk production or your nursing infant. Always consult with your healthcare provider if you have any questions or concerns about your specific situation.

Pediatric Use

It's important to keep this product out of reach of children. If your child accidentally swallows more than what is intended for rinsing, seek medical help or contact a Poison Control Center immediately.

The instructions for using this product are specifically designed for adults aged 18 and older, and there is no dosing information available for children. Always prioritize safety and consult a healthcare professional if you have any concerns regarding its use in younger individuals.

Geriatric Use

While there is no specific information about the use of TheraBreath Anticavity sodium fluoride rinse in older adults, it's important to approach any new treatment with caution. Since the drug insert does not mention dosage adjustments or safety concerns for elderly patients, you should consult with a healthcare professional before starting this rinse. They can provide personalized advice based on your health needs and any other medications you may be taking. Always prioritize your safety and well-being when considering new products.

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 is safe and effective for your specific condition. They can help determine the best approach for managing your health, especially if you have concerns about your kidneys.

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 differently due to your liver health.

Always consult your healthcare provider for personalized advice and to discuss any concerns you may have regarding your liver function and how it relates to your treatment. They can help ensure that your medication is safe and effective for you.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications or tests you may be taking. While there are no specific drug interactions or laboratory test interactions noted for this medication, your healthcare provider can help ensure that everything you are taking works well together and is safe for you.

Always feel free to ask questions and share your complete list of medications and any lab tests you may be undergoing. This way, you can avoid any potential issues and receive the best care possible.

Storage and Handling

To ensure your product remains safe and effective, always check that the safety seal is intact before use. If the seal is broken or missing, do not use the product, as this could compromise its safety and effectiveness.

When handling the product, make sure to follow any additional instructions provided to maintain its integrity. Proper storage and careful handling are key to ensuring your safety and the product's performance.

Additional Information

You should take this medication orally, using it twice a day after brushing your teeth. To use the rinse, vigorously swish 10 milliliters (about 2 teaspoons) between your teeth for 1 minute, then spit it out. It's important not to swallow the rinse. After using it, avoid eating or drinking for 30 minutes to allow the medication to work effectively.

FAQ

What is TheraBreath Anticavity Oral Rinse?

TheraBreath Anticavity Oral Rinse is an anticavity fluoride rinse formulated by dentists to help fight cavities for 24 hours, strengthen teeth and enamel, and freshen breath.

How should I use TheraBreath Anticavity Oral Rinse?

You should use it twice a day after brushing your teeth. Vigorously swish 10 milliliters of the rinse between your teeth for 1 minute and then spit it out. Do not swallow the rinse and avoid eating or drinking for 30 minutes after rinsing.

What are the key ingredients in TheraBreath Anticavity Oral Rinse?

The key ingredient is Sodium Fluoride at a concentration of 0.02%, which aids in the prevention of dental cavities and helps rebuild weakened tooth enamel.

Are there any contraindications for using this rinse?

There are no specific contraindications listed for TheraBreath Anticavity Oral Rinse.

What should I do if I accidentally swallow more than the recommended amount?

If you accidentally swallow more than used for rinsing, get medical help or contact a Poison Control Center immediately.

Is TheraBreath Anticavity Oral Rinse safe for children?

You should keep TheraBreath Anticavity Oral Rinse out of reach of children, as it is not specifically indicated for pediatric use.

Can I use TheraBreath Anticavity Oral Rinse while pregnant or nursing?

The provided information does not specify any safety concerns or recommendations for use during pregnancy or lactation.

What flavor does TheraBreath Anticavity Oral Rinse come in?

It comes in a Sparkle Mint flavor.

What is the package size of TheraBreath Anticavity Oral Rinse?

The package size is 33.8 FL OZ (1.05 QT) or 1 liter.

Packaging Info

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

Packaging configurations for Therabreath Anticavity.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

No description information is available for the specified drug.

Uses and Indications

This drug is indicated for the prevention of dental cavities. It aids in fighting cavities for a duration of 24 hours and is designed to strengthen teeth and enamel. Additionally, it helps to rebuild weakened tooth enamel and prevent tooth decay.

Dosage and Administration

Adults 18 years of age and older are instructed to use the rinse twice daily, following the brushing of teeth with toothpaste. The recommended method involves vigorously swishing 10 milliliters of the rinse between the teeth for a duration of 1 minute, after which the solution should be expectorated. It is imperative that the rinse is not swallowed. Additionally, patients should refrain from eating or drinking for 30 minutes following the rinsing procedure to ensure optimal efficacy.

Contraindications

Use is contraindicated if more than the recommended amount for rinsing is accidentally swallowed. In such cases, seek medical assistance or contact a Poison Control Center immediately.

Warnings and Precautions

It is imperative to keep this product out of the reach of children. In the event that more than the recommended amount for rinsing is accidentally ingested, 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.

No specific general precautions or laboratory tests have been identified for this product. However, the emphasis on the importance of proper usage and the potential risks associated with accidental ingestion should be communicated clearly to patients.

Side Effects

Patients should be advised to keep the product out of reach of children. In the event that more than the recommended amount for rinsing is accidentally swallowed, it is imperative to seek medical assistance or contact a Poison Control Center immediately. This warning underscores the importance of proper usage and the potential risks associated with accidental ingestion.

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

Packaging configurations for Therabreath Anticavity.
Details

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, immediate medical assistance or contact with a Poison Control Center is advised.

The directions for use are specifically intended for adults aged 18 years and older, and no pediatric dosing information is available. Therefore, healthcare professionals should exercise caution when considering this product for use in pediatric populations.

Geriatric Use

There is no specific information regarding the use of TheraBreath Anticavity sodium fluoride rinse 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 the safety and efficacy of the treatment in elderly patients.

Pregnancy

There is no specific information available regarding the use of TheraBreath Anticavity sodium fluoride rinse during pregnancy. As such, the safety of this product in pregnant patients has not been established, and there are no known dosage modifications or special precautions recommended for this population. Healthcare professionals should consider the lack of data when advising women of childbearing potential and weigh the potential benefits against any unknown risks when recommending this product during pregnancy.

Lactation

There are no specific warnings or recommendations regarding the use of this product by lactating mothers. Additionally, there are no specific considerations or precautions mentioned concerning lactation. Therefore, healthcare professionals may consider the use of this product in nursing mothers without specific concerns related to breastfeeding.

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 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 the patient for any symptoms that may arise is essential, although specific symptoms related to overdosage are not detailed in the provided information.

Management of overdosage should focus on supportive care and symptomatic treatment as necessary. It is advisable for healthcare providers to follow established protocols for the management of poisoning and to utilize resources such as local Poison Control Centers for guidance on specific cases.

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. 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 packaging that includes a safety seal. It is imperative that the product not be used if the safety seal is broken or missing, as this may compromise the integrity and safety of the product.

For optimal storage, the product should be kept in a controlled environment, away from direct sunlight and moisture. Specific temperature ranges for storage have not been provided; therefore, it is advisable to maintain standard room temperature conditions. Proper handling is essential to ensure the product remains effective and safe for use.

Additional Clinical Information

The product is administered orally, with a recommended frequency of twice daily following tooth brushing. Patients should vigorously swish 10 milliliters of the rinse between their teeth for one minute before spitting it out. It is important for patients not to swallow the rinse and to refrain from eating or drinking for 30 minutes after use.

No additional information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Therabreath Anticavity, 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 Anticavity, 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.