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Therabreath

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Active ingredient
Sodium Fluoride 0.243 g/100 g
Other brand names
Dosage form
Paste, Dentifrice
Route
Oral
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2025
Label revision date
August 14, 2025
Active ingredient
Sodium Fluoride 0.243 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 2025
Label revision date
August 14, 2025
Manufacturer
Church & Dwight Co. , Inc.
Registration number
M021
NDC root
10237-272

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Drug Overview

TheraBreath is a dentist-formulated toothpaste designed to help you maintain good oral health. It aids in the prevention of dental decay and has anticavity properties, making it an effective choice for keeping your teeth healthy. Additionally, TheraBreath neutralizes the source of bad breath, providing long-lasting freshness with its dazzling mint flavor.

This toothpaste also gently whitens your teeth, showing significant results after just one week of twice-daily brushing. With its unique formulation, TheraBreath not only promotes a brighter smile but also supports overall dental hygiene.

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 thoroughly, ideally after each meal or at least twice a day. This applies to both adults and children aged 2 years and older. If you're helping a child under 6, make sure to teach them good brushing and rinsing habits to reduce the chance of swallowing toothpaste.

For children younger than 2 years, it's best to consult with a dentist or doctor before starting any dental care routine. They can provide guidance tailored to your child's needs. Remember, good dental hygiene is essential for everyone!

What to Avoid

It's important to ensure that you use this product safely. Keep it out of reach of children under 6 years of age 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.

There are no specific contraindications, controlled substance classifications, or concerns regarding abuse, misuse, or dependence associated with this product. However, always prioritize safety and follow the usage instructions carefully.

Side Effects

It's important to be aware of some key safety information regarding this product. Keep it out of reach of children under 6 years of age 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 prioritize safety and ensure that this product is used as directed to minimize any risks.

Warnings and Precautions

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, you should seek medical help immediately or contact a Poison Control Center.

While there are no specific general precautions or laboratory tests mentioned, always be cautious with any medication or product. 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 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 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 regarding the use of Therabreath Whitening toothpaste during pregnancy. This means that the drug insert does not provide details about 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 product while pregnant, it’s best to consult with your healthcare provider for personalized advice. They can help you make informed decisions about your oral care during this important time.

Lactation Use

When it comes to breastfeeding, it's important to be aware that there are no specific guidelines or statements regarding nursing mothers or lactation (the process of producing milk). This means that if you are breastfeeding, you may not find detailed information about how certain medications or treatments could affect you or your baby.

If you have concerns about breastfeeding while taking any medication, it's always a good idea to consult with your healthcare provider. They can provide personalized advice based on your situation and help ensure the safety and well-being of both you and your 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 the amount used for brushing, seek medical help or contact a Poison Control Center immediately. Always supervise young children while they brush their teeth until they can do so safely on their own.

For children aged 2 years and older, encourage them to brush their teeth thoroughly, ideally after each meal or at least twice a day, following the advice of a dentist or doctor. For children under 6, teach them proper brushing and rinsing techniques to help prevent swallowing. If your child is under 2 years old, please consult a dentist or doctor before use.

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 before starting the medication. 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 is safe and effective, especially if you have any concerns about your kidney health. They can provide the necessary guidance based on your individual situation.

Hepatic Impairment

If you have liver problems, it's important to know that there are no specific guidelines, dosage adjustments, or special monitoring requirements mentioned for your condition in the provided information. This means that the standard recommendations apply, but you should always consult your healthcare provider for personalized advice. They can help ensure that any medications you take are safe and appropriate for your liver health.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications you are taking, even if there are no specific drug interactions or laboratory test interactions noted for your treatment. This ensures that your healthcare team can monitor your health effectively and make informed decisions about your care.

Always feel free to ask questions and share all the medications and supplements you are using. This helps to avoid any potential issues and ensures that you receive the best possible treatment tailored to your needs.

Storage and Handling

To ensure the best performance of your product, store it at room temperature and avoid freezing it, as extreme temperatures can affect its effectiveness. When not in use, make sure to keep the tube tightly closed to maintain its integrity. If you open the product and do not use it within a specified time frame, be sure to discard it to ensure safety and effectiveness. Following these guidelines will help you handle the product safely and effectively.

Additional Information

In laboratory tests, specific evaluations are conducted to assess the effects and safety of the medication. However, there is no additional information available regarding the potential for abuse, the methods of administration, or any patient counseling details. Additionally, there are no updates from postmarketing experiences, which refer to information gathered after the drug has been approved and is on the market.

FAQ

What is TheraBreath?

TheraBreath is a dentist formulated toothpaste designed to aid in the prevention of dental decay and neutralize the source of bad breath.

How should I use TheraBreath?

For adults and children 2 years of age and older, brush your teeth thoroughly, preferably after each meal or at least twice a day. Children under 6 should be instructed in good brushing and rinsing habits.

What should I do if more than the recommended amount is swallowed?

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

Are there any contraindications for using TheraBreath?

No specific contraindications are listed for TheraBreath.

Is TheraBreath safe for children?

Yes, but keep it out of reach of children under 6 years of age and supervise their use until they can brush without assistance.

What flavor does TheraBreath have?

TheraBreath has a Dazzling Mint flavor for a refreshing experience.

How long does it take to see whitening results?

You can expect significant whitening after 1 week of twice daily brushing.

How should I store TheraBreath?

Store TheraBreath at room temperature, keep the tube tightly closed when not in use, and do not freeze.

Is there any information regarding use during pregnancy or lactation?

No specific information regarding use during pregnancy or lactation is provided for TheraBreath.

Packaging Info

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

Packaging configurations for Therabreath.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

TheraBreath™ is a dentist-formulated toothpaste designed for whitening and anticavity benefits. This product is presented in a twin pack, containing two tubes, each with a net weight of 4.0 oz (113 g), for a total net weight of 8.0 oz (226 g). TheraBreath™ is formulated to significantly whiten teeth after one week of use with twice daily brushing. It effectively neutralizes the source of bad breath while providing gentle whitening. The toothpaste is available in a Dazzling Mint flavor.

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 2 years and older are advised to brush their teeth thoroughly, preferably after each meal or at least twice daily, or as directed by a dentist or physician.

For children under 6 years of age, it is important to instruct them in proper brushing and rinsing techniques to minimize the risk of swallowing.

For children under 2 years of age, consultation with a dentist or physician is recommended prior to use.

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 should be sought or contact with a Poison Control Center is advised.

Warnings and Precautions

It is imperative to keep this 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, 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 monitoring for accidental ingestion remains critical to ensure patient safety.

Side Effects

Patients should be aware of the following important warnings regarding 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 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 in the available data. Additionally, there are no reported interactions between the drug and laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on the current information.

Packaging & NDC

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

Packaging configurations for Therabreath.
Details

Pediatric Use

Pediatric patients under 6 years of age should be kept out of reach of the product. In the event that more than the recommended amount for brushing is accidentally swallowed, immediate medical assistance or contact with a Poison Control Center is advised.

Children should be supervised as necessary until they are capable of using the product without supervision. For children aged 2 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.

For children under 6 years, caregivers should instruct them in proper brushing and rinsing habits to minimize the risk of swallowing. For children under 2 years of age, consultation with a dentist or doctor is recommended prior to use.

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 Whitening 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 are no specific statements regarding the use of this medication in lactating mothers or its effects on breastfed infants. Healthcare professionals should consider the absence of data when advising lactating mothers about the use of this medication.

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 is no information available regarding dosage adjustments, special monitoring requirements, or precautions 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.

Overdosage

In the event of an overdosage, immediate medical assistance is crucial. If an individual accidentally swallows more than the amount typically used for brushing, it is imperative to seek medical help or contact a Poison Control Center without delay.

Healthcare professionals should be aware that prompt intervention can mitigate potential adverse effects associated with overdosage. Monitoring for symptoms may be necessary, 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 required. It is essential to follow established protocols for handling cases of overdosage to ensure patient safety and effective care.

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. Further studies may be necessary to elucidate these aspects.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep this 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.

In the event that more than the recommended amount used for brushing is accidentally swallowed, healthcare providers should instruct patients to seek medical help or contact a Poison Control Center immediately. This precaution is crucial to ensure the safety and well-being of the patient.

Storage and Handling

The product is supplied in a tube format, with specific handling and storage requirements to ensure its integrity and effectiveness. It should be stored at room temperature, avoiding exposure to freezing conditions. To maintain product quality, the tube must be kept tightly closed when not in use. Additionally, it is recommended to discard the product after opening if it is not utilized within a specified time frame, although this time frame is not detailed in the provided information.

Additional Clinical Information

In laboratory tests, specific evaluations may be conducted as part of the clinical assessment. However, there is no additional information available regarding abuse potential, route, method, and frequency of administration, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Therabreath, 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, 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

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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.