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Therabreath Overnight Chamomile Mint

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Active ingredient
Sodium Fluoride 5 mg/10 mL
Other brand names
Dosage form
Rinse
Route
Oral
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2024
Label revision date
December 11, 2025
Active ingredient
Sodium Fluoride 5 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 2024
Label revision date
December 11, 2025
Manufacturer
Church & Dwight Co. , Inc.
Registration number
M021
NDC root
10237-262

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Drug Overview

TheraBreath ANTICAVITY FLUORIDE RINSE is a specially formulated mouthwash designed to strengthen your teeth and help prevent cavities. This dentist-created rinse not only fights bad breath for up to 12 hours but also works to rebuild enamel, making it a great addition to your oral care routine.

With a gentle formula that contains no alcohol or dyes, TheraBreath ANTICAVITY FLUORIDE RINSE provides a non-burning experience, allowing you to maintain fresh breath and healthy teeth comfortably. The refreshing Chamomile Mint flavor adds a pleasant touch to your daily oral hygiene.

Uses

You can use this product to help prevent dental cavities, which is essential for maintaining good oral health. It not only aids in cavity prevention but also helps to rebuild enamel, the protective outer layer of your teeth. This means that it can contribute to stronger teeth and a healthier smile.

Additionally, there are no teratogenic effects (harmful effects on fetal development) or nonteratogenic effects (harmful effects that do not affect fetal development) associated with this product, making it a safe option for most users.

Dosage and Administration

To use this mouth rinse effectively, make sure you are an adult aged 18 or older. After brushing your teeth, take 10 milliliters of the rinse and swish it vigorously between your teeth for one minute. It’s important to spit the rinse out afterward and not to swallow it.

After using the rinse, avoid eating or drinking for at least 30 minutes. This will help ensure that the rinse has enough time to work effectively in your mouth. Remember, using the rinse once a day is all you need for optimal results.

What to Avoid

It's important to follow specific guidelines when using this product to ensure your safety and effectiveness. You should not use this fluoride rinse on the same day as another fluoride rinse, as this could lead to unwanted effects.

Currently, there are no listed contraindications, controlled substance classifications, or concerns regarding abuse, misuse, or dependence associated with this product. Always consult with your healthcare provider if you have any questions or concerns about your treatment.

Side Effects

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 a serious situation that requires prompt attention. 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 a child accidentally swallows more than what is used for rinsing, seek medical help or contact a Poison Control Center immediately.

You should also avoid using this fluoride rinse on the same day as another fluoride rinse. This helps prevent any potential issues that could arise from using multiple fluoride products at once. Always follow the instructions carefully to ensure your safety and the effectiveness of the product.

Overdose

If you accidentally swallow more of the 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

There is currently no specific information available about the use of Therabreath Overnight Chamomile Mint 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 drug insert.

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 oral 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 consult with your healthcare professional before using this product. There is a possibility that the ingredients may be passed into your breast milk, so exercising caution is advised. Your healthcare provider can help you weigh the benefits and risks to ensure the safety 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 intended for rinsing, you should seek medical help or contact a Poison Control Center immediately.

This product is specifically directed for use by adults aged 18 years and older, so it should not be used by younger individuals. Always follow the instructions carefully to ensure safety.

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, it’s important to consult with a healthcare provider for personalized advice. 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 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 share your complete list of medications and any health conditions you have to 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.

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

Additional Information

You should use this rinse 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 using it.

Keep this product out of the reach of children. If you accidentally swallow more than the recommended amount, seek medical help or contact a Poison Control Center immediately. Do not use this rinse on the same day as another fluoride rinse, and ensure the safety seal is intact before use.

FAQ

What is TheraBreath ANTICAVITY FLUORIDE RINSE used for?

TheraBreath ANTICAVITY FLUORIDE RINSE is used to strengthen teeth, fight bad breath for 12 hours, prevent cavities, and rebuild enamel.

How should I use TheraBreath ANTICAVITY FLUORIDE RINSE?

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

Are there any contraindications for using this rinse?

There are no contraindications listed for TheraBreath ANTICAVITY FLUORIDE RINSE.

Can I use TheraBreath ANTICAVITY FLUORIDE RINSE if I am pregnant?

There is no specific information regarding the use of this rinse during pregnancy, so consult your healthcare provider for advice.

Is it safe to use TheraBreath ANTICAVITY FLUORIDE RINSE while breastfeeding?

Nursing mothers should consult a healthcare professional before using this product, as there is a potential for excretion in breast milk.

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

If more than the recommended amount is swallowed, seek medical help or contact a Poison Control Center immediately.

Can I use TheraBreath ANTICAVITY FLUORIDE RINSE with another fluoride rinse?

Do not use TheraBreath ANTICAVITY FLUORIDE RINSE with another fluoride rinse on the same day.

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

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

What flavor does TheraBreath ANTICAVITY FLUORIDE RINSE come in?

TheraBreath ANTICAVITY FLUORIDE RINSE is available in Chamomile Mint flavor.

What is the volume of TheraBreath ANTICAVITY FLUORIDE RINSE?

The rinse comes in a 16 fl. oz. (473 mL) bottle.

Packaging Info

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

Packaging configurations for Therabreath Overnight Chamomile Mint.
Details

Drug Information (PDF)

This file contains official product information for Therabreath Overnight Chamomile Mint, 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 drug.

Uses and Indications

This drug is indicated for the prevention of dental cavities. It aids in the prevention of cavities and assists in the rebuilding of enamel. There are no teratogenic or nonteratogenic effects associated with its use.

Dosage and Administration

Adults 18 years of age or older are instructed to use the rinse once daily, following the brushing of their teeth with toothpaste. The recommended method of 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. Additionally, patients should refrain from eating or drinking for 30 minutes following the rinsing procedure to ensure optimal efficacy.

Contraindications

Use of this product is contraindicated in patients who are concurrently using another fluoride rinse on the same day. This is to prevent potential overexposure to fluoride, which may lead to adverse effects. No other contraindications have been identified.

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, or the Poison Control Center should be contacted without delay.

Healthcare professionals are advised to instruct patients not to use this product concurrently with another fluoride rinse on the same day. This precaution is essential to prevent potential adverse effects associated with excessive fluoride exposure.

Side Effects

In clinical use, it is important to note that if more than the recommended amount for rinsing is accidentally swallowed, patients should seek medical help or contact a Poison Control Center immediately. This warning underscores the potential seriousness of ingesting excessive amounts of the product, highlighting the need for caution during use.

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 Overnight Chamomile Mint (sodium fluoride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Therabreath Overnight Chamomile Mint.
Details

Pediatric Use

Pediatric patients should not use this product, as it is specifically directed for adults aged 18 years and older. Caregivers are advised to keep the product out of the reach of children to prevent accidental ingestion. In the event that more than the recommended amount for rinsing is swallowed, immediate medical assistance should be sought, or contact with a Poison Control Center is recommended.

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 they may have altered pharmacokinetics and pharmacodynamics. Close monitoring is recommended to ensure safety and efficacy in this population.

Pregnancy

There is no specific information regarding the use of Therabreath Overnight Chamomile Mint sodium fluoride rinse in pregnant patients. The prescribing information does not provide safety concerns, dosage modifications, or special precautions for use during pregnancy. 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

Lactating mothers should consult a healthcare professional before using this product. There is a potential for excretion in breast milk; therefore, caution is advised when administering to nursing mothers.

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, it is critical to seek immediate medical assistance. If an individual accidentally ingests more than the amount intended for rinsing, it is imperative to contact a healthcare professional or reach out to a Poison Control Center without delay.

Prompt intervention is essential to manage potential complications associated with overdosage. Healthcare providers should be prepared to assess the situation and provide appropriate care based on the specific circumstances of the ingestion.

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 these contexts.

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 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 preventing potential adverse effects associated with misuse.

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 cool, dry place, away from direct sunlight and moisture. Specific temperature ranges for storage are not provided; however, it is advisable to maintain a stable environment to ensure product efficacy.

Care should be taken to handle the product gently to avoid damage to the packaging and the contents within.

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 important not to swallow the rinse and to refrain from eating or drinking for 30 minutes following the rinsing.

Clinicians should advise patients to keep the product out of the reach of children. In the event that more than the recommended amount is accidentally swallowed, patients should seek medical assistance or contact a Poison Control Center immediately. Patients should also be counseled not to use this rinse in conjunction with another fluoride rinse on the same day and to avoid use if the safety seal is broken or missing.

Drug Information (PDF)

This file contains official product information for Therabreath Overnight Chamomile 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 Overnight Chamomile 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.