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Therabreath Kids Anticavity Oral Rinse Bubblegum

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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 2024
Label revision date
February 6, 2026
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 2024
Label revision date
February 6, 2026
Manufacturer
Church & Dwight Co. , Inc.
Registration number
M021
NDC root
10237-266

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Drug Overview

TheraBreath is an anticavity fluoride oral rinse specifically formulated for kids. It is designed to strengthen teeth and enamel, helping to prevent dental cavities. This dentist-formulated rinse comes in a fun Bubblegum Blast flavor, making it an enjoyable addition to your child's oral hygiene routine. Importantly, it contains no dyes and is alcohol-free, ensuring a safe option for young users.

Uses

You can use this product to help prevent dental cavities. By incorporating it into your oral care routine, you can support your dental health and reduce the risk of developing cavities, which are small holes in your teeth caused by decay. Regular use can be an effective way to maintain a healthy smile.

Dosage and Administration

After brushing your teeth with toothpaste, you can use this mouth rinse once a day. For adults and children aged 6 years and older, take 10 milliliters of the rinse and swish it vigorously between your teeth for 1 minute before spitting it out. It's important not to swallow the rinse. After using it, avoid eating or drinking for 30 minutes to allow the rinse to work effectively.

If you're helping a child under 12, make sure to teach them how to rinse properly to prevent swallowing the rinse. You should supervise them until they can use it safely on their own. For children under 6 years old, it's best to consult a dentist or doctor before using the rinse.

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.

Please be aware that while using this product, you should monitor for any unusual reactions and consult a healthcare professional if you have concerns. Your safety is a priority, so don’t hesitate to reach out for assistance if needed.

Warnings and Precautions

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

There are no specific general precautions or laboratory tests mentioned, but always be cautious with any medication or product you use. 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 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

Currently, there is no information available about the use of TheraBreath Kids Anticavity Oral Rinse Bubblegum 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’s important to consult with your healthcare provider before using this product to ensure it is safe for you and your baby.

Lactation Use

If you are breastfeeding or planning to breastfeed, it's important to know that there is no specific information available about the effects of this medication on nursing mothers or lactation (the process of producing breast milk). Since the insert does not provide guidance on these topics, it’s advisable to consult your healthcare provider for personalized advice and to discuss any potential risks or concerns related to your situation. Your healthcare provider can help ensure that both you and your baby remain healthy while breastfeeding.

Pediatric Use

If you have a child aged 6 years or older, you can help them use this mouth rinse safely. They should use it once a day after brushing their teeth with toothpaste. Instruct them to swish 10 milliliters of the rinse vigorously between their teeth for 1 minute before spitting it out. It's important that they do not swallow the rinse and avoid eating or drinking for 30 minutes after using it. For children under 12, make sure to teach them proper rinsing habits to reduce the risk of swallowing, and supervise them until they can rinse independently.

For children younger than 6 years, it's best to consult a dentist or doctor before using this mouth rinse.

Geriatric Use

While there is no specific information available about the use of this medication in older adults, it’s important to approach any new treatment with caution. If you or a loved one is an older adult, it’s wise to discuss any potential risks or concerns with your healthcare provider. They can help determine the best approach based on individual health needs and any other medications being taken.

Always keep in mind that older adults may have different responses to medications, so regular check-ins with your doctor can ensure safety and effectiveness.

Renal Impairment

If you have kidney problems, it's important to know that there are no specific guidelines or dosage adjustments mentioned for your condition. This means that the information available does not provide special monitoring or safety considerations tailored for patients with renal impairment (kidney issues).

Always consult your healthcare provider for personalized advice and to ensure that any medications you take are safe and appropriate for your kidney health. They can help you understand how your condition may affect your treatment.

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 should be used if you have hepatic impairment (liver issues).

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your liver health. They can help determine the best course of action based on your individual situation.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications or tests you may be taking. Currently, there are no specific drug interactions or laboratory test interactions noted for this medication. However, every individual’s health situation is unique, and your provider can help ensure that your treatment plan is safe and effective for you. Always feel free to ask questions and share all the medications and supplements you are using to avoid any potential issues.

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 a sterile environment (a clean area free from germs) and ensure proper usage. Always store the product in a cool, dry place to preserve its quality.

Additional Information

No further information is available.

FAQ

What is TheraBreath?

TheraBreath is an anticavity fluoride oral rinse formulated for kids, designed to strengthen teeth and enamel. It comes in a Bubblegum Blast flavor and is alcohol-free with no dyes.

How does TheraBreath work?

TheraBreath aids in the prevention of dental cavities by strengthening teeth and enamel.

What is the recommended usage for TheraBreath?

For adults and children 6 years and older, use once a day after brushing your teeth. Vigorously swish 10 milliliters of rinse for 1 minute and then spit it out, avoiding swallowing.

What should I do if I accidentally swallow TheraBreath?

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

Can children under 6 years use TheraBreath?

Children under 6 years of age should consult a dentist or doctor before using TheraBreath.

Are there any contraindications for TheraBreath?

No specific contraindications are listed for TheraBreath.

Is there any information about using TheraBreath during pregnancy or lactation?

The insert does not provide specific information regarding the use of TheraBreath during pregnancy or lactation.

What precautions should I take when using TheraBreath?

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

Packaging Info

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

Packaging configurations for Therabreath Kids Anticavity Oral Rinse Bubblegum.
Details

Drug Information (PDF)

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

Dosage and Administration

Adults and children 6 years of age and older are instructed to use the rinse once 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.

For children under 12 years of age, it is essential to instruct them in proper rinsing techniques to minimize the risk of swallowing the rinse. Supervision is recommended until the child is capable of using the product without assistance. For children under 6 years of age, consultation with a dentist or physician is advised prior to use.

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, medical assistance should be sought immediately or contact a Poison Control Center.

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 monitoring for accidental ingestion remains critical to ensure patient safety.

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

Packaging configurations for Therabreath Kids Anticavity Oral Rinse Bubblegum.
Details

Pediatric Use

Pediatric patients aged 6 years and older are instructed to use the rinse once daily after brushing their teeth with toothpaste. They should vigorously swish 10 milliliters of the rinse between their teeth for 1 minute before spitting it out. It is important that the rinse is not swallowed, and patients should refrain from eating or drinking for 30 minutes following the rinse.

For children under 12 years of age, caregivers should instruct them in proper rinsing techniques to minimize the risk of swallowing the rinse. Supervision is recommended until the child is capable of using the product without assistance.

For children under 6 years of age, consultation with a dentist or doctor is advised 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 therapeutic response, given the lack of targeted data for this population.

Pregnancy

There is currently no information available regarding the use of TheraBreath Kids Anticavity Oral Rinse Bubblegum during pregnancy. This includes any safety concerns, dosage modifications, or special precautions that may be necessary for pregnant patients. Healthcare professionals are advised to exercise caution and consider the lack of data when recommending this product to women of childbearing potential. Further studies may be needed to fully understand the implications of its use during pregnancy.

Lactation

There is no specific information available regarding the use of this medication in lactating mothers or its effects on breastfed infants. Healthcare professionals should consider the lack 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 data regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the lack of information necessitates careful clinical judgment and monitoring.

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 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 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 Kids Anticavity Oral Rinse Bubblegum, 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 Kids Anticavity Oral Rinse Bubblegum, 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.