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Toms Childrens Anticavity Mouthwash Silly Strawberry

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Active ingredient
Sodium Fluoride 2 mg/10 mL
Other brand names
Dosage form
Rinse
Route
Dental
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2018
Label revision date
January 18, 2024
Active ingredient
Sodium Fluoride 2 mg/10 mL
Other brand names
Dosage form
Rinse
Route
Dental
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Marketed in the U.S.
Since 2018
Label revision date
January 18, 2024
Manufacturer
Tom's of Maine, Inc.
Registration number
M021
NDC root
51009-840

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Drug Overview

Tom's of Maine children's anticavity fluoride rinse is a natural, alcohol-free mouthwash designed to help protect against dental cavities, promoting a healthy smile for your child. It features a great taste and is free from dyes, making it a pleasant option for kids. This rinse contains real fruit juice and has been accepted by the American Dental Association (ADA), ensuring its effectiveness in cavity prevention.

Since its introduction in 1970, this fluoride rinse has been a trusted choice for parents looking to support their children's oral health. With a package size of 16 fluid ounces (473 mL), it provides a convenient way to incorporate cavity protection into your child's daily routine.

Uses

If you're looking to keep your teeth healthy, this product can help you prevent dental cavities. It's specifically designed for children and acts as an anticavity fluoride rinse, making it a fun and effective way to protect their smiles. By using this rinse regularly, you can support cavity protection and promote a healthy smile for your little ones.

Dosage and Administration

To use this mouth rinse effectively, you should follow a simple routine. For adults and children aged 6 years and older, rinse your mouth twice a day after brushing your teeth with toothpaste. Take 10 milliliters of the rinse and swish it vigorously between your teeth for one minute before spitting it out. Remember, do not swallow the rinse.

After using the mouth rinse, it's important to 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, and supervise them until they can do it 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 certain precautions when using this product. While there are no specific contraindications or concerns about abuse, misuse, or dependence, you should take care not to swallow more than what is intended for rinsing. If you accidentally swallow a larger amount, seek medical help or contact a Poison Control Center immediately. Your safety is a priority, so please use this product as directed.

Side Effects

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 or contact a Poison Control Center immediately. This ensures your safety and addresses any potential risks associated with misuse.

Warnings and Precautions

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

Always use this product as directed, and if you experience any unusual symptoms or reactions, stop using it and call your doctor for further advice. Your safety is a priority, so please take these precautions seriously.

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

When considering the use of Tom's Children's Anticavity Mouthwash Silly Strawberry during pregnancy, it's important to note that there is no specific information available regarding its safety, dosage adjustments, or any special precautions for pregnant individuals. This means that the effects of this mouthwash on pregnancy have not been studied or documented.

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 mouthwash, to ensure the safety of both you and your baby.

Lactation Use

If you are breastfeeding or planning to breastfeed, you can feel reassured that there are no specific warnings or recommendations regarding nursing mothers or lactation in the information provided. This means that, based on the available data, there are no known risks associated with breastfeeding while using this medication. However, it's always a good idea to consult with your healthcare provider about any concerns you may have regarding your health and 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 twice a day after brushing their teeth with toothpaste. If your child is under 12, make sure to teach them good rinsing habits to help prevent swallowing the product. It's also essential to supervise younger children until they can use it safely on their own.

For children under 6 years of age, it's best to consult with a dentist or doctor before use. This will help you determine the most appropriate care for your little one.

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. Since older adults may have different health needs and may be taking multiple medications, it’s always a good idea to consult with a healthcare provider before starting any new medication. They can help ensure that the treatment is safe and appropriate for your individual health situation.

If you or a loved one is an older adult, be sure to discuss any concerns about potential side effects or interactions with other medications you may be taking. Your healthcare provider can provide guidance tailored to your specific needs.

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 information provided does not include specific guidelines for dosage adjustments, special monitoring, or precautions related to your condition. This means that there are no tailored recommendations for how the medication may affect you differently due to your liver health.

Always consult your healthcare provider for personalized advice and to ensure that any treatment plan is safe and effective for your specific situation. They can help determine the best approach based on your liver function and overall health.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications you are taking. In this case, there are no specific drug interactions or laboratory test interactions noted, which means that this medication is generally considered safe to use alongside other treatments and tests. However, every individual is different, and your healthcare provider can help ensure that your overall treatment plan is safe and effective for you. Always feel free to ask questions and share any concerns you may have regarding your medications or tests.

Storage and Handling

To ensure the best quality and safety of your product, store it at room temperature. It's important to keep the bottle tightly closed when not in use to prevent contamination and maintain its effectiveness. Additionally, protect the product from light, as exposure can affect its quality. Once opened, please remember to discard the product to ensure your safety and the safety of others. Following these guidelines will help you use the product effectively and safely.

Additional Information

You should use this dental rinse twice a day after brushing your teeth. It's important to instruct children under 12 on proper rinsing habits to help them avoid swallowing the rinse. Make sure to supervise them until they can use it safely on their own. Remember, do not swallow the rinse, and avoid eating or drinking for 30 minutes after using it to ensure the best results.

FAQ

What is Tom's of Maine children's anticavity fluoride rinse?

It is an alcohol-free, natural rinse designed for cavity protection and promoting a healthy smile, suitable for children.

How does this rinse help with dental health?

It aids in the prevention of dental cavities.

What is the recommended usage for adults and children 6 years and older?

Use twice a day after brushing your teeth, swishing 10 milliliters for 1 minute before spitting it out.

What should I do if a child under 6 years wants to use the rinse?

Consult a dentist or doctor before use.

Are there any warnings associated with this rinse?

Keep it out of reach of children, and seek medical help if more than the recommended amount is swallowed.

How should I store Tom's of Maine children's anticavity fluoride rinse?

Store at room temperature, keep the bottle tightly closed when not in use, and protect it from light.

Is there any specific information regarding use during pregnancy or lactation?

The provided information does not include specific warnings or recommendations for use during pregnancy or lactation.

What should I do if I accidentally swallow the rinse?

Get medical help or contact a Poison Control Center immediately.

Packaging Info

Below are the non-prescription pack sizes of Toms Childrens Anticavity Mouthwash Silly Strawberry (sodium fluoride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Toms Childrens Anticavity Mouthwash Silly Strawberry.
Details

Drug Information (PDF)

This file contains official product information for Toms Childrens Anticavity Mouthwash Silly Strawberry, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

This alcohol-free, natural fluoride rinse is specifically formulated for children's anticavity needs. It provides effective cavity protection, promoting a healthy smile. The product is dye-free and features a pleasant silly strawberry flavor, enhanced with real fruit juice to ensure an enjoyable experience for children. The rinse is packaged in a 16 FL OZ (473 mL) bottle and is accepted by the American Dental Association® (ADA).

Uses and Indications

This drug is indicated for the prevention of dental cavities in children. It serves as an anticavity fluoride rinse designed to provide cavity protection, contributing to the maintenance of a healthy smile.

Dosage and Administration

Adults and children aged 6 years and older are instructed to use the rinse twice 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.

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

Contraindications

There are no specific contraindications listed for this product. However, it is advised that if more than the recommended amount for rinsing is accidentally swallowed, immediate medical assistance should be sought or contact with a Poison Control Center should be made.

Warnings and Precautions

It is imperative to keep this product out of 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. Healthcare professionals are advised to contact a Poison Control Center without delay to ensure appropriate management of the situation.

Side Effects

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

Drug Interactions

There are no specific drug interactions identified for this medication. Additionally, no laboratory test interactions have been reported. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug or laboratory test interactions.

Packaging & NDC

Below are the non-prescription pack sizes of Toms Childrens Anticavity Mouthwash Silly Strawberry (sodium fluoride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Toms Childrens Anticavity Mouthwash Silly Strawberry.
Details

Pediatric Use

Pediatric patients aged 6 years and older are instructed to use the product twice a day after brushing their teeth with toothpaste. For children under 12 years of age, it is important to instruct them in proper rinsing habits to minimize 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

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 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 Tom's Children's Anticavity Mouthwash Silly Strawberry during pregnancy. As such, safety concerns, dosage modifications, or special precautions for pregnant patients have not been established. 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 nursing mothers or lactation in the provided text. Therefore, healthcare professionals should consider the absence of data when advising lactating mothers about the use of this medication. It is advisable to monitor breastfed infants for any potential effects, although no specific information is available.

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 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 timely intervention can significantly impact the outcome of an overdosage situation. Monitoring for any potential symptoms associated with the overdosage is essential, although specific symptoms are not detailed in the provided information.

Management procedures should include a thorough assessment of the patient's condition and the implementation of appropriate supportive care as needed. It is advisable to follow established protocols for the management of overdosage cases, ensuring that all necessary precautions are taken to safeguard the patient's health.

Nonclinical Toxicology

No information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or toxicology.

Postmarketing Experience

No postmarketing experience details are available for TOMS CHILDRENS ANTICAVITY MOUTHWASH SILLY STRAWBERRY (SPL code 90375-7).

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 a patient accidentally swallows more than the recommended amount used for rinsing, they should seek medical help or contact a Poison Control Center immediately. This guidance is crucial for ensuring patient safety and preventing potential adverse effects associated with misuse.

Storage and Handling

The product is supplied in a bottle that must be stored at room temperature. It is essential to keep the bottle tightly closed when not in use to maintain product integrity. Additionally, the product should be protected from light exposure. Once opened, the product must be discarded to ensure safety and efficacy.

Additional Clinical Information

The product is administered via the dental route, with a recommended frequency of twice daily following tooth brushing. Clinicians should instruct patients, particularly children under 12 years of age, on proper rinsing techniques to minimize swallowing. It is essential to supervise children until they are capable of using the product without assistance. Patients should be advised not to swallow the rinse and to refrain from eating or drinking for 30 minutes after use.

Drug Information (PDF)

This file contains official product information for Toms Childrens Anticavity Mouthwash Silly Strawberry, 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 Toms Childrens Anticavity Mouthwash Silly Strawberry, 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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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.