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Therabreath Anticavity

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Active ingredient
Sodium Fluoride 0.005 mg/10 mL
Other brand names
Dosage form
Rinse
Route
Oral
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2023
Label revision date
May 28, 2025
Active ingredient
Sodium Fluoride 0.005 mg/10 mL
Other brand names
Dosage form
Rinse
Route
Oral
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Marketed in the U.S.
Since 2023
Label revision date
May 28, 2025
Manufacturer
Church & Dwight Co. , Inc.
Registration number
M021
NDC root
10237-260

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Drug Overview

TheraBreath™ Anticavity Oral Rinse is a specially formulated mouthwash designed to help prevent dental cavities and strengthen your teeth and enamel. It contains sodium fluoride (a mineral that helps protect against tooth decay) at a concentration of 0.05%, which works to rebuild weakened tooth enamel and fight cavities for up to 12 hours. Additionally, this alcohol-free rinse freshens your breath and is non-burning, making it a gentle option for daily oral care.

You can use TheraBreath™ Anticavity Oral Rinse once a day to maintain your dental health. With its refreshing Sparkle Mint flavor, it not only supports cavity prevention 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 effectively for up to 12 hours, fighting off cavity-causing bacteria.

Additionally, this product strengthens your teeth and enamel, which is the hard outer layer that protects your teeth. It also helps rebuild weakened enamel, making it more resilient against cavities in the future. By incorporating this into your dental care routine, you can support your overall oral health.

Dosage and Administration

After you brush your teeth with toothpaste, you can use this mouth rinse once a day. Measure out 10 milliliters (which is about two teaspoons) 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.

To get the best results, avoid eating or drinking anything for 30 minutes after you use the rinse. This will help ensure that the rinse has enough time to work effectively in your mouth.

What to Avoid

It's important to be aware of specific instructions regarding the use of this product. While there are no listed contraindications or concerns about abuse, misuse, or dependence, you should take care when using it. If you accidentally swallow more than what is intended for rinsing, seek medical help or contact a Poison Control Center immediately. Your safety is a priority, so please follow these guidelines closely.

Side Effects

If you accidentally swallow more of this product than intended for rinsing, it's important to seek medical help or contact a Poison Control Center immediately. This is a serious situation that requires prompt attention to ensure your safety. Always use the product as directed to avoid any potential risks.

Warnings and Precautions

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

While there are no specific general precautions or laboratory tests mentioned, always use the product as directed to ensure safety. If you have any concerns or experience unusual symptoms, don't hesitate to reach out to your healthcare provider for guidance.

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

Currently, there is no information available about the use of Therabreath Anticavity Sodium Fluoride Rinse 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 is always best to consult with your healthcare provider before using any new products, including mouth rinses, to ensure they are safe for you and your baby.

Lactation Use

If you are breastfeeding or planning to breastfeed, it's important to be aware that there is no specific information available regarding the use of this medication during nursing. This means that the effects on breast milk production and the nursing infant are not clearly defined.

As always, it's best to consult with your healthcare provider about any medications you are considering while breastfeeding to ensure the safety and well-being of both you and your baby.

Pediatric Use

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

For adults and children aged 18 and older, the recommended use is once a day after brushing your teeth. You should swish 10 milliliters of the rinse vigorously between your teeth for one minute and then spit it out. Remember, do not swallow the rinse, and avoid eating or drinking for 30 minutes after using it.

Geriatric Use

While there is no specific information about the use of Therabreath Anticavity Oral Rinse in older adults, it’s always important to approach any new product with caution. Since the drug insert does not mention dosage adjustments or safety concerns for elderly patients, you should consider consulting with a healthcare professional before starting this rinse, especially if you have any underlying health conditions or are taking other medications.

As you or your loved ones age, changes in health and medication interactions can occur, so it’s wise to ensure that any new oral care product is safe and appropriate for your needs.

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 information provided does not include specific guidelines for dosage adjustments, special monitoring, or precautions related to your condition. This means that there are no tailored recommendations for how the 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 about taking this medication with your liver condition. They can help ensure that your treatment 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 receive the best possible care tailored to your needs.

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.

For optimal storage, keep the product in a cool, dry place away from direct sunlight. Following these guidelines will help maintain the quality and safety of the product for your use.

Additional Information

You should use this product once a day after brushing your teeth. To use it, vigorously swish 10 milliliters of the rinse between your teeth for 1 minute, then spit it out. Remember not to swallow the rinse, and avoid eating or drinking for 30 minutes after rinsing to ensure the best results.

It's important to read the directions carefully for proper use. If you have any questions or concerns, consult your healthcare provider for guidance.

FAQ

What is TheraBreath™ Anticavity Oral Rinse used for?

TheraBreath™ Anticavity Oral Rinse aids in the prevention of dental cavities and helps fight cavities for 12 hours.

How should I use TheraBreath™ Anticavity Oral Rinse?

Use once a day after brushing your teeth. Vigorously swish 10 milliliters of 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.

Is TheraBreath™ Anticavity Oral Rinse safe for children?

TheraBreath™ Anticavity Oral Rinse is intended for adults and children 18 years of age or older.

What are the key ingredients in TheraBreath™ Anticavity Oral Rinse?

The rinse contains Sodium Fluoride 0.05%, which helps strengthen teeth and enamel.

Are there any warnings associated with TheraBreath™ Anticavity Oral Rinse?

Keep out of the reach of children. If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

What flavor does TheraBreath™ Anticavity Oral Rinse come in?

It comes in a Sparkle Mint flavor.

What should I do if the safety seal on the bottle is broken or missing?

Do not use the product if the safety seal is broken or missing.

Is there any specific information regarding use during pregnancy or nursing?

No specific information is provided regarding use during pregnancy or nursing mothers.

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 12 hours and is designed to strengthen teeth and enamel. Additionally, it helps to rebuild weakened tooth enamel, thereby contributing to the prevention of cavities.

Dosage and Administration

For adults and children 18 years of age or older, the recommended dosage is to use the rinse once daily following the brushing of teeth with toothpaste.

The administration 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.

To maximize the effectiveness of the treatment, patients should refrain from eating or drinking for 30 minutes following the rinsing procedure.

Contraindications

There are no specific contraindications listed for this product. However, it is advised that if more than the recommended amount used for rinsing is accidentally swallowed, immediate medical assistance should be sought or contact with a Poison Control Center is recommended.

Warnings and Precautions

It is imperative to keep this product out of the reach of children to prevent accidental ingestion. In the event that more than the recommended amount for rinsing is accidentally swallowed, 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 adhering to the recommended usage guidelines cannot be overstated, as improper use may lead to serious health consequences.

Side Effects

Patients should be aware that if 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 highlights the potential seriousness of ingesting excessive amounts of the product, underscoring the importance of adhering to the usage guidelines to prevent adverse outcomes.

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 the 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.

For adults and children aged 18 years and older, the recommended usage is once daily after brushing teeth with toothpaste. Patients should vigorously swish 10 milliliters of the rinse between their teeth for 1 minute and then spit it out. It is important to avoid swallowing the rinse and to refrain from eating or drinking for 30 minutes following the rinse.

Geriatric Use

Elderly patients may not have specific dosage adjustments, safety concerns, or special precautions outlined in the drug insert for Therabreath Anticavity Oral Rinse. As such, healthcare providers should exercise clinical judgment when prescribing this product to geriatric patients, considering the individual health status and potential comorbidities that may influence treatment outcomes. Monitoring for any adverse effects or changes in efficacy is advisable, given the lack of targeted data for this population.

Pregnancy

There is no information available regarding the use of Therabreath Anticavity Sodium Fluoride Rinse during pregnancy. Consequently, there are no safety concerns, dosage modifications, or special precautions outlined for pregnant patients. Healthcare professionals should consider this lack of data when advising women of childbearing potential and weigh the potential benefits against any unknown risks associated with the use of this product during pregnancy.

Lactation

There is no specific information available regarding the use of this medication in nursing mothers or any considerations related to lactation. 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

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 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 limits the assessment of potential risks associated with the compound in these areas.

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 the reach of children to prevent accidental ingestion. It is important to emphasize that if a patient accidentally swallows more than the recommended amount used for rinsing, they should seek medical assistance immediately or contact a Poison Control Center for guidance. This precaution is crucial to ensure patient safety and to address any 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 extreme temperatures and humidity. Specific temperature ranges and container requirements are not provided; however, general best practices for storage should be followed to ensure product stability and efficacy. Special handling needs are not specified, but care should be taken to maintain the product's condition during transport and storage.

Additional Clinical Information

Patients should use the rinse once a day after brushing their teeth with toothpaste. The recommended method involves vigorously swishing 10 milliliters of the rinse between the teeth for 1 minute before spitting it out. It is crucial that patients do not swallow the rinse and refrain from eating or drinking for 30 minutes following the rinsing procedure.

Clinicians should emphasize the importance of reading the directions for proper use to ensure effective administration. There is no additional information available regarding laboratory tests, abuse potential, 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.