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Therabreath Healthy Smile Oral Rinse

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This product has been discontinued

Active ingredient
Sodium Fluoride 0.0005 g/1 g
Other brand names
Dosage form
Rinse
Route
Oral
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2018
Label revision date
February 4, 2022
Active ingredient
Sodium Fluoride 0.0005 g/1 g
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 2018
Label revision date
February 4, 2022
Manufacturer
Dr. Harold Katz, LLC
Registration number
part355
NDC root
72551-246

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Drug Overview

TheraBreath Healthy Smile Oral Rinse is a mouthwash designed to help prevent dental cavities. It works by promoting oral health and maintaining a clean mouth, making it a useful addition to your daily dental care routine. By using this rinse, you can support your efforts to keep your teeth healthy and reduce the risk of cavities.

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

After you brush your teeth with toothpaste, you can use this mouth rinse once a day. Take 10 milliliters (which is about two teaspoons) of the rinse and swish it vigorously between your teeth for one 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 on their own safely. 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 certain precautions when considering medication. While specific contraindications (conditions that make a treatment inadvisable) and details about controlled substances (drugs regulated by law due to potential for abuse) are not provided here, you should always consult with your healthcare provider about your medical history and any other medications you are taking.

Additionally, be cautious about the potential for abuse or misuse, which refers to using a medication in a way not intended by your doctor, and the risk of dependence (a condition where your body becomes reliant on a substance). Always follow your healthcare provider's instructions and never take or use medication without their guidance. If you have any concerns or questions, don't hesitate to reach out to your healthcare professional for clarification.

Side Effects

If you accidentally swallow more than the amount recommended for brushing, 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 minimize any risks.

Warnings and Precautions

If you accidentally swallow more of this product than intended for brushing, it’s important to seek medical help immediately or contact a Poison Control Center. This is crucial to ensure your safety and address any potential health risks.

Always use this product as directed and avoid swallowing it. If you experience any unusual symptoms or reactions, stop using the product and call your doctor for further advice. Your health and safety are the top priority, so don’t hesitate to reach out for help if needed.

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

Currently, there is no specific information available about the use of TheraBreath Healthy Smile Oral 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 information.

If you are pregnant or planning to become pregnant, it’s 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, you can feel reassured that there are no specific warnings or recommendations regarding the use of this product while nursing. Additionally, there is no information available about whether this product is excreted in breast milk or if it poses any risk to your infant. Always consult with your healthcare provider if you have any concerns or questions about medications while breastfeeding.

Pediatric Use

When using this product for children, it's important to follow specific guidelines to ensure their safety and effectiveness. For children aged 6 years and older, you can use it once a day after brushing their teeth. If your child is under 12, make sure to teach them proper rinsing habits to help prevent swallowing the product. It's also a good idea to supervise younger children until they can use it independently.

For children under 6 years old, it's best to consult with a dentist or doctor before use. This ensures that you are making the right choice for their dental care.

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, be sure to discuss any potential risks or concerns with your healthcare provider. They can help determine the best approach, considering factors like overall health and any other medications being taken.

Always keep in mind that older adults may have different needs when it comes to medication, 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 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 if you have hepatic impairment (liver issues).

Always consult your healthcare provider for personalized advice and to discuss any concerns you may have regarding your liver health and medication use. They can help ensure that you receive the safest and most effective treatment based on your individual needs.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications or tests you may be taking. In this case, there are no known drug interactions or laboratory test interactions associated with the medication. However, always ensure that your healthcare provider is aware of all the medications you are using, as this helps them provide the best care tailored to your needs. Your safety and well-being are the top priority, so don't hesitate to ask questions or express any concerns you may have.

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. This will help maintain its quality and ensure it works as intended when you need it. Always handle the product with care to avoid any damage.

Additional Information

No further information is available.

FAQ

What is TheraBreath Healthy Smile Oral Rinse used for?

TheraBreath Healthy Smile Oral Rinse aids in the prevention of dental cavities.

How should I use TheraBreath Healthy Smile 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.

Can children use TheraBreath Healthy Smile Oral Rinse?

Children under 6 years of age should consult a dentist or doctor. For children 6 years and older, supervise their rinsing habits to minimize swallowing.

What should I do if I accidentally swallow TheraBreath Healthy Smile Oral Rinse?

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 Healthy Smile Oral Rinse?

No specific contraindications are mentioned in the provided text.

Is TheraBreath Healthy Smile Oral Rinse safe to use during pregnancy?

There is no specific information regarding the safety of this product during pregnancy.

Can nursing mothers use TheraBreath Healthy Smile Oral Rinse?

There are no specific warnings or recommendations regarding the use of this product by nursing mothers.

What should I do if the safety seal on TheraBreath Healthy Smile Oral Rinse is broken or missing?

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

Packaging Info

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

Packaging configurations for Therabreath Healthy Smile Oral Rinse.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

TheraBreath Healthy Smile Oral Rinse is an oral care product designed to promote dental health. The effective time for this formulation is noted as January 1, 2019. The product is presented in a 16-ounce container and is visually represented in the observation media, which is an image file in JPEG format. The reference value for this labeling is THB-LB-00555R1_Label Healthy smile 16oz.2019.01.01.jpg.

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 aged 6 years and older should use the rinse once daily, following brushing 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 post-rinsing 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 may be required until the child demonstrates the ability to use the rinse independently and safely.

For children under 6 years of age, consultation with a dentist or physician is advised prior to use.

Contraindications

There are no specified contraindications for the use of this product. Healthcare professionals should exercise clinical judgment when considering its use in patients with potential risk factors or underlying conditions.

Warnings and Precautions

In the event of accidental ingestion of an amount exceeding that typically used for brushing, immediate medical assistance should be sought. Healthcare professionals are advised to contact a Poison Control Center without delay to ensure appropriate management and intervention.

Side Effects

Patients should be aware that if more than the recommended amount used for brushing is accidentally swallowed, it is imperative to seek medical assistance or contact a Poison Control Center immediately. This warning highlights the potential seriousness of accidental ingestion and underscores the importance of adhering to the recommended usage guidelines to prevent adverse outcomes.

Drug Interactions

No drug interactions or drug and laboratory test interactions have been identified in the available data. Therefore, no specific recommendations for dosage adjustments or monitoring are necessary at this time.

Packaging & NDC

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

Packaging configurations for Therabreath Healthy Smile Oral Rinse.
Details

Pediatric Use

Pediatric patients aged 6 years and older may use the product once daily after brushing their teeth with toothpaste. It is important to instruct children under 12 years of age in proper rinsing techniques to minimize the risk of swallowing. Supervision is recommended for children until they are 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

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 individual responses may vary. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy.

Pregnancy

There is no specific information available regarding the use of TheraBreath Healthy Smile Oral Rinse during pregnancy. As such, the safety of this product in pregnant patients has not been established, and there are no known dosage modifications or special precautions recommended for use during pregnancy. Healthcare professionals should consider the lack of data when advising women of childbearing potential and weigh the potential benefits against any unknown risks to fetal outcomes.

Lactation

There are no specific warnings or recommendations regarding the use of this product by lactating mothers. Additionally, there is no information available concerning the potential for excretion in breast milk or any associated risks to breastfed infants from the use of this product during lactation.

Renal Impairment

Patients with renal impairment may not have specific dosage adjustments, special monitoring, or safety considerations outlined in the prescribing information. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment and monitoring of these patients.

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 essential. If an individual accidentally swallows more than the amount typically used for brushing, it is crucial 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 procedures should include supportive care and symptomatic treatment as required. It is advisable for healthcare providers to remain vigilant and prepared to address any complications that may arise from an overdosage incident.

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 this medication out of reach of children to prevent accidental ingestion or misuse. It is important for patients to understand the potential risks associated with improper access to the medication by young individuals.

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 direct sunlight and moisture. Specific temperature ranges for storage are not provided; however, it is advisable to maintain standard room temperature conditions.

Care should be taken to handle the product gently to avoid damage to the packaging and ensure the safety seal remains intact.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Therabreath Healthy Smile 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 Healthy Smile 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.