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Therabreath Toothpaste

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This product has been discontinued

Active ingredient
Sodium Fluoride 24 mg/10 g
Other brand names
Dosage form
Gel, Dentifrice
Route
Dental
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2010
Label revision date
March 3, 2010
Active ingredient
Sodium Fluoride 24 mg/10 g
Other brand names
Dosage form
Gel, Dentifrice
Route
Dental
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Marketed in the U.S.
Since 2010
Label revision date
March 3, 2010
Manufacturer
220 LABORATORIES INC
Registration number
part355
NDC root
57367-033

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Drug Overview

TheraBreath is a specially formulated toothpaste designed to help you achieve fresh breath and promote healthy gums. It is dentist recommended and features a naturally oxygenating formula that works instantly to reverse dry mouth, providing you with confidence throughout the day. TheraBreath contains aloe vera, which is known for its soothing properties, and it does not include sodium lauryl sulfate, making it a gentle option for your oral care routine.

Uses

You can use this product to help maintain fresh breath and combat dry mouth effectively. It works instantly to reverse the feeling of dryness, making it a convenient option for those who experience this discomfort. Recommended by dentists, this product also contains aloe vera, which is known for promoting healthy gums.

With no teratogenic effects (harmful effects on fetal development) mentioned, you can feel confident in its safety for use. Enjoy the benefits of fresh breath and improved oral health with this easy-to-use solution.

Dosage and Administration

To use TheraBreath Toothpaste effectively, start by covering the bristles of a dry toothbrush with the toothpaste. Make sure to brush your teeth, tongue, and palate for a full 2 minutes. This thorough brushing helps ensure that you get the most benefit from the toothpaste.

Remember, this toothpaste is meant for dental use, so it's important to follow these steps regularly to maintain good oral hygiene. By brushing your teeth properly with TheraBreath, you can help keep your mouth feeling fresh and clean.

What to Avoid

If the seal on your medication is missing, it’s important that you do not use it. A missing seal can indicate that the product may be compromised or unsafe. Always ensure that the seal is intact before taking any medication to protect your health.

Additionally, be aware that this medication may be classified as a controlled substance, which means it has the potential for abuse or misuse. This can lead to dependence (a condition where your body becomes reliant on the substance). Always follow your healthcare provider's instructions and use the medication only as directed.

Side Effects

You may not experience any side effects from this medication, as no specific side effect information has been provided. It's always a good idea to monitor how you feel while taking any medication and to discuss any concerns with your healthcare provider.

Warnings and Precautions

It's important to handle this product carefully. If it spills on any fabrics, make sure to wash it out immediately. The product comes sealed in protective packaging, so if the seal is missing, do not use it.

Currently, there are no specific warnings, emergency help instructions, or recommendations for laboratory tests associated with this product. If you have any concerns or experience unusual symptoms, it's always a good idea to consult your doctor for guidance.

Overdose

If you suspect an overdose, it's important to stay calm and take immediate action. While there is no specific information available about the signs of overdose for this medication, general symptoms can include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these signs, or if you are unsure, seek medical help right away.

In case of an overdose, contact your local emergency services or go to the nearest hospital. It's always better to be safe and get checked by a healthcare professional if you have any concerns about your health. Remember, timely intervention can make a significant difference.

Pregnancy Use

There is currently no specific information available regarding the use of TheraBreath 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 while pregnant.

If you are pregnant or planning to become pregnant, it’s always a good idea to consult with your healthcare provider before using any new products, including oral care items like toothpaste. They can help you make informed decisions based on your individual health needs.

Lactation Use

If you are breastfeeding, it's important to know that the safety of this product during lactation (the period of breastfeeding) has not been established. There is a possibility that the product could be excreted in breast milk, which means it could potentially affect your nursing infant. Therefore, you should exercise caution when considering the use of this product while nursing. Always consult with your healthcare provider to discuss any concerns and to ensure the best choices for you and your baby.

Pediatric Use

It's important to keep this medication out of reach of children. This precaution helps prevent accidental ingestion, which can be dangerous. Always store it in a safe place where children cannot access it, ensuring their safety at all times. If you have any concerns about how to manage medications in your home, don't hesitate to ask your healthcare provider for guidance.

Geriatric Use

While there is no specific information about the use of TheraBreath Toothpaste in older adults, it's always wise to approach any new product with caution. If you or a loved one are considering using this toothpaste, it's a good idea to consult with a healthcare provider, especially if there are any existing health concerns or medications involved.

Since the drug insert does not mention any dosage adjustments or safety precautions for elderly patients, you can generally use it as directed on the packaging. However, staying informed and discussing any changes in oral care routines with a healthcare professional can help ensure safety and effectiveness.

Renal Impairment

If you have kidney issues, it's important to know that the drug insert for TheraBreath Toothpaste does not provide specific information about dosage adjustments, special monitoring, or safety considerations for patients with renal impairment (kidney problems). This means that there are no tailored guidelines for how you should use this product if you have kidney concerns.

As always, it's a good idea to consult with your healthcare provider before using any new products, especially if you have underlying health conditions like kidney problems. They can offer personalized advice based on your health needs.

Hepatic Impairment

If you have liver problems, it's important to know that the drug insert for TheraBreath Toothpaste does not provide specific information about dosage adjustments, special monitoring, or precautions for individuals with hepatic impairment (liver problems). This means that there are no tailored guidelines for using this product if you have liver issues.

As always, it's a good idea to consult with your healthcare provider before using any new product, especially if you have underlying health conditions. They can offer personalized advice based on your health status.

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 avoid any potential issues and receive the best care possible.

Storage and Handling

It’s important to store this product safely by keeping it out of reach of children to prevent any accidental use. Before using, check that the seal is intact; if the seal is missing, do not use the product, as this could compromise its safety and effectiveness.

Always handle the product with care to ensure it remains in good condition for your use. Following these simple guidelines will help you use the product safely and effectively.

Additional Information

No further information is available.

FAQ

What is TheraBreath?

TheraBreath is a naturally oxygenating, dentist-recommended toothpaste designed for fresh breath and healthy gums, containing aloe vera and no sodium lauryl sulfate.

How do I use TheraBreath Toothpaste?

To use TheraBreath, cover the bristles of a dry toothbrush with the toothpaste and brush your teeth, tongue, and palate for 2 minutes.

What are the benefits of using TheraBreath?

TheraBreath works instantly to reverse dry mouth and provides 24-hour confidence for fresh breath.

Are there any contraindications for TheraBreath?

Yes, do not use TheraBreath if the seal is missing.

Is TheraBreath safe to use during pregnancy?

The drug insert does not provide specific information regarding the safety of TheraBreath during pregnancy.

Can nursing mothers use TheraBreath?

The safety of TheraBreath during lactation has not been established, so caution is advised when administering it to nursing mothers.

What should I do if TheraBreath spills on fabrics?

If TheraBreath spills on fabrics, wash it out immediately.

What should I do if I have questions about using TheraBreath?

If you have any questions or concerns about using TheraBreath, consult your healthcare provider.

How should I store TheraBreath?

Keep TheraBreath out of reach of children and ensure the seal is intact before use.

Packaging Info

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

Packaging configurations for Therabreath Toothpaste.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

TheraBreath is a professional formula toothpaste designed to provide fresh breath and promote oral health. This naturally oxygenating product is dentist recommended and formulated without sodium lauryl sulfate. It contains aloe vera, which supports healthy gums. The toothpaste works instantly to reverse dry mouth, ensuring 24-hour confidence in breath freshness.

Uses and Indications

This drug is indicated for the promotion of fresh breath and the immediate relief of dry mouth symptoms. It is recommended by dental professionals and contains Aloe Vera, which supports gum health.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

To administer TheraBreath Toothpaste, healthcare professionals should instruct patients to cover the bristles of a dry toothbrush with the toothpaste. The patient should then brush their teeth, tongue, and palate thoroughly for a duration of 2 minutes.

This product is intended for dental use only. It is recommended that patients perform this brushing routine at least twice daily to maintain optimal oral hygiene.

Contraindications

Use of this product is contraindicated if the seal is missing. The integrity of the seal is essential to ensure the product's safety and efficacy.

Warnings and Precautions

Healthcare professionals should be aware of the following precautions regarding the use of this product.

In the event of a spill on fabrics, it is imperative to wash the affected area immediately to prevent any potential staining or damage. The product is sealed with protective packaging at the laboratory; therefore, if the seal is found to be missing, the product should not be used to ensure safety and efficacy.

Currently, there are no specific warnings, laboratory tests, or emergency medical help instructions associated with this product. Additionally, there are no directives to discontinue use or to contact a physician under any circumstances outlined in the available information.

Healthcare professionals are encouraged to remain vigilant and exercise caution when handling this product to ensure safe usage.

Side Effects

No side effect information was provided in the SPL text. As a result, the adverse reactions associated with the use of this product remain unspecified. It is essential for healthcare professionals to monitor patients for any potential adverse effects during treatment and report any observed reactions to ensure patient safety and contribute to the ongoing assessment of the product's safety profile.

Drug Interactions

There are currently no specific drug interactions identified for the medication. Additionally, no interactions with laboratory tests have been reported. Therefore, no dosage adjustments or monitoring recommendations are necessary at this time. It is advisable for healthcare professionals to remain vigilant and consult updated resources as new data may emerge.

Packaging & NDC

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

Packaging configurations for Therabreath Toothpaste.
Details

Pediatric Use

Pediatric patients should be advised to keep this medication out of reach of children. This precaution is essential to ensure safety and prevent accidental ingestion.

Geriatric Use

There is no specific information regarding the use of TheraBreath Toothpaste in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise clinical judgment when considering the use of this product in elderly patients, as individual patient factors may influence safety and efficacy. Monitoring for any adverse effects is advisable, given the lack of targeted data for this population.

Pregnancy

There is no specific information regarding the use of TheraBreath Toothpaste during pregnancy, including safety concerns, dosage modifications, or special precautions. Healthcare professionals should consider the absence of data when advising pregnant patients. As with any product, it is advisable for women of childbearing potential to consult with their healthcare provider before use to ensure safety for both the patient and the developing fetus.

Lactation

The safety of this product during lactation has not been established. There is a potential for excretion in breast milk; therefore, caution should be exercised when administering this product to nursing mothers.

Renal Impairment

There is no specific information regarding renal impairment, dosage adjustments, special monitoring, or safety considerations for patients with reduced kidney function provided in the drug insert for TheraBreath Toothpaste. Healthcare professionals should exercise caution and consider the lack of data when prescribing this product to patients with renal impairment.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to TheraBreath Toothpaste. The prescribing information does not provide any details regarding dosage adjustments, special monitoring, or precautions for individuals with compromised liver function. Therefore, healthcare professionals should exercise clinical judgment when considering the use of this product in patients with hepatic impairment, as no specific recommendations are available.

Overdosage

In the absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdose.

It is essential to monitor the patient closely for any potential symptoms that may arise from an overdose. Symptoms can vary widely depending on the substance involved and the individual patient's response.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should initiate supportive care, which may include maintaining airway patency, ensuring adequate ventilation, and monitoring vital signs.

If available, the use of antidotes or specific treatments should be considered based on the substance involved and the clinical presentation. Consultation with a poison control center or a medical toxicologist may provide additional guidance on the management of overdose cases.

Documentation of the incident, including the amount and timing of the substance taken, is crucial for effective treatment and follow-up 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.

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 to emphasize the necessity of proper storage to ensure the safety of young individuals.

Storage and Handling

The product is supplied in a configuration that ensures safety and integrity. It is essential to keep the product out of reach of children to prevent accidental ingestion. Healthcare professionals should verify that the seal is intact before use; if the seal is missing, the product should not be utilized.

Storage conditions should be monitored to maintain product efficacy. Specific temperature ranges and container requirements are not provided; however, general best practices for pharmaceutical storage should be followed. Special handling needs may apply, and it is advisable to consult relevant guidelines to ensure proper management of the product.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Therabreath Toothpaste, 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 Toothpaste, 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.