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Therabreath Complete Oral Rinse

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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)
Marketed in the U.S.
Since 2024
Label revision date
February 23, 2026
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
Marketed in the U.S.
Since 2024
Label revision date
February 23, 2026
Manufacturer
Church & Dwight Co. , Inc.
Registration number
M021
NDC root
10237-267

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Drug Overview

THERABREATH is an anticavity fluoride rinse designed to help you maintain good oral health. Formulated by dentists, it aids in the prevention of dental cavities while also freshening your breath. This rinse works by fighting cavities, killing bad breath bacteria, and cleaning your whole mouth. Additionally, it strengthens your teeth and helps rebuild enamel, providing multiple benefits in one product.

With a revitalizing mint flavor and a non-burning, alcohol-free formula, THERABREATH offers a gentle yet effective way to care for your teeth and gums. It's an easy addition to your daily oral hygiene routine, helping you achieve a healthier smile.

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 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 aware of specific instructions regarding the use of this product. While there are no listed contraindications, controlled substance classifications, or concerns about abuse 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. Always use the product as directed to avoid any potential risks.

Warnings and Precautions

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

Always be cautious and follow the instructions carefully to ensure your safety while using this product. If you have any concerns or experience unusual symptoms, don't hesitate to reach out to your healthcare provider.

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. Acting quickly can help ensure your safety.

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

There is currently no specific information available about the use of TheraBreath Complete Oral 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 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 and your baby are not clearly defined.

As a precaution, you may want to discuss any medications you are considering with your healthcare provider to ensure they are safe for you and your nursing infant. Always prioritize open communication with your doctor about your breastfeeding status when discussing treatment options.

Pediatric Use

It's important to keep this medication out of reach of children to prevent accidental ingestion. If your child accidentally swallows more than what is typically used for rinsing, seek medical help immediately or contact a Poison Control Center. Taking these precautions can help ensure your child's safety while using this product.

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 there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the standard recommendations apply, but you should always consult your healthcare provider for personalized advice. They can help monitor your liver function and determine the best course of action for your treatment.

Make sure to keep your doctor informed about your liver health, as they may need to conduct regular tests to ensure your safety while using any medication. Your well-being is a priority, so don't hesitate to ask questions or express any concerns you may have.

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.

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

Additional Information

No further information is available.

FAQ

What is THERABREATH?

THERABREATH is an anticavity fluoride rinse formulated to aid in the prevention of dental cavities and freshen breath.

How does THERABREATH work?

It fights cavities, kills bad breath bacteria, cleans the whole mouth, strengthens teeth, and helps rebuild enamel.

What are the instructions for using THERABREATH?

Use twice 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 or eat or drink for 30 minutes after rinsing.

Are there any contraindications for THERABREATH?

No contraindications are listed for THERABREATH.

What should I do if I accidentally swallow THERABREATH?

If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Is THERABREATH safe for children?

Keep THERABREATH out of reach of children, and do not use it if the safety seal is broken or missing.

Is there any information regarding the use of THERABREATH during pregnancy or nursing?

No specific information is provided regarding the use of THERABREATH during pregnancy or for nursing mothers.

What is the volume of THERABREATH?

THERABREATH comes in a volume of 16 fl. oz. (473 mL).

Who formulated THERABREATH?

THERABREATH was formulated by Dr. Harold Katz.

Packaging Info

Below are the non-prescription pack sizes of Therabreath Complete Oral Rinse (anticavity oral rinse). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Therabreath Complete Oral Rinse.
Details

Drug Information (PDF)

This file contains official product information for Therabreath Complete Oral Rinse, 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 is intended for use in individuals at risk of developing dental caries.

Dosage and Administration

Adults 18 years of age and older are instructed to use the rinse twice daily, following the brushing of their 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 of this product is contraindicated in the event of accidental ingestion beyond the recommended rinsing amount. In such cases, immediate medical assistance or contact with a Poison Control Center is advised. No other contraindications have been identified.

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 used for rinsing is accidentally swallowed, immediate medical assistance should be sought, or the individual should contact a Poison Control Center without delay.

Side Effects

In clinical use, patients should be aware of the potential for serious adverse reactions associated with the accidental ingestion of the product. If more than the recommended amount for rinsing is swallowed, it is imperative to seek medical assistance or contact a Poison Control Center immediately. This warning underscores the importance of adhering to the prescribed usage guidelines to prevent serious health consequences.

Healthcare professionals should educate patients on the proper use of the product and the actions to take in the event of accidental ingestion to ensure safety and minimize risks.

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 Complete Oral Rinse (anticavity oral rinse). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Therabreath Complete Oral Rinse.
Details

Pediatric Use

Pediatric patients should be advised to keep this product out of reach of children. In the event that more than the recommended amount for rinsing is accidentally swallowed, it is crucial to seek medical assistance or contact a Poison Control Center immediately.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any potential adverse effects or changes in efficacy, given the lack of targeted data for this population.

Pregnancy

There is no specific information regarding the use of TheraBreath Complete Oral Rinse during pregnancy, including safety concerns, dosage modifications, or special precautions. Healthcare professionals should consider the lack of data when advising pregnant patients or women of childbearing potential. It is recommended that the potential benefits and risks be carefully weighed before use in this population.

Lactation

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

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 potential risks and benefits.

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 related to the specific substance involved is essential, as these may vary based on the active ingredients and the amount ingested.

Management procedures should include a thorough assessment of the patient's condition, including vital signs and any presenting symptoms. Supportive care may be necessary, and specific treatment protocols should be followed as per established guidelines for the substance in question.

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 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 extreme temperatures and humidity. Specific temperature ranges and container requirements are not provided; however, general best practices for pharmaceutical 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 integrity throughout its storage and handling processes.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Therabreath Complete Oral Rinse, 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 Complete Oral Rinse, 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.