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Act Restoring Anticavity Fluoride Cool Mint

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Active ingredient
Sodium Fluoride 0.2 mg/1 mL
Other brand names
Dosage form
Mouthwash
Route
Topical
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2006
Label revision date
January 12, 2026
Active ingredient
Sodium Fluoride 0.2 mg/1 mL
Other brand names
Dosage form
Mouthwash
Route
Topical
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Marketed in the U.S.
Since 2006
Label revision date
January 12, 2026
Manufacturer
Chattem, Inc.
Registration number
M021
NDC root
41167-0957

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If you are a consumer or patient please visit this version.

Drug Overview

ACT Restoring Anticavity Fluoride Mouthwash is a dentist-recommended mouthwash designed to help strengthen your tooth enamel and prevent dental cavities. With a refreshing cool mint flavor, this mouthwash comes in an 18 fl oz (532 mL) bottle, making it easy to incorporate into your daily oral hygiene routine.

By using this mouthwash, you can support your dental health and maintain a brighter smile, as it works to protect your teeth from decay.

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. Regular use can be an effective way to maintain a healthy smile.

Dosage and Administration

After you brush your teeth with toothpaste, you can use this mouth rinse once a day. Start by removing the cap and pouring 10 milliliters (mL) of the rinse, making sure not to fill above the 10 mL mark on the inside of the cap. Vigorously swish the rinse between your teeth for one minute, then spit it out. Remember, do not swallow the rinse, and avoid eating or drinking anything for 30 minutes after using it.

If you are supervising children under 12, make sure to teach them how to rinse properly to prevent swallowing the rinse. For children under 6 years old, it’s important to consult a dentist or doctor before use.

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 assistance 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 to ensure your safety. Always use the product as directed to avoid any potential risks.

Warnings and Precautions

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. This is crucial to ensure your safety and address any potential risks.

There are no specific general precautions or laboratory tests mentioned for this product, but always stay informed about how to use it safely. 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 intended for rinsing, it’s important to seek medical help immediately or contact a Poison Control Center. Overdosing can lead to serious health issues, so don’t hesitate to get assistance.

Signs of an overdose may include unusual symptoms, but specific details on these symptoms are not provided. If you notice anything concerning after swallowing too much, it’s best to err on the side of caution and reach out for help right away. Your health and safety are the top priority.

Pregnancy Use

There is currently no specific information available about the use of ACT Restoring Anticavity Fluoride Mouthwash during pregnancy. This means that safety concerns, dosage adjustments, or any special precautions for pregnant individuals have not been addressed in the drug insert.

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 mouthwash, 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 any potential risks to your infant. Always consult with your healthcare provider if you have any concerns or questions about medications while breastfeeding.

Pediatric Use

It's important to keep this product out of reach of children. If your child accidentally swallows more than what is needed for rinsing, seek medical help or contact a Poison Control Center immediately. For children aged 6 years and older, the recommended use is once a day after brushing their teeth with toothpaste.

For children under 12, it's essential to teach them proper rinsing habits to reduce the chance of swallowing the product. Always supervise younger children until they can use it safely on their own. If your child is under 6 years old, please consult a dentist or doctor before use.

Geriatric Use

While there is no specific information about how this medication should be used by 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 in the available information. This means that the standard recommendations for the medication do not include 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 medication you take is safe and appropriate for your health situation. They can provide guidance based on your individual needs and kidney function.

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 regarding your liver health and how it may relate to your treatment. They can help ensure that you receive the safest and most effective care.

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 receive the best possible care tailored to your needs.

Storage and Handling

To ensure the best performance and safety of your product, store it at room temperature. It's important to check the safety seal before use; do not use the product if the seal is broken or missing, as this could indicate that the product is compromised. Following these guidelines will help you use the product safely and effectively.

Additional Information

You should apply this medication topically once a day, ideally after brushing your teeth. If you are supervising children under 12, make sure to teach them good rinsing habits to help prevent swallowing the product. It's important to supervise them until they are able to use it safely on their own.

FAQ

What is ACT Restoring Anticavity Fluoride Mouthwash?

ACT Restoring Anticavity Fluoride Mouthwash is a dentist-recommended brand for strengthening enamel and preventing dental cavities, available in a cool mint flavor.

How should I use ACT Restoring Anticavity Fluoride Mouthwash?

Use it once a day after brushing your teeth. Pour 10 milliliters into the cap, swish it between your teeth for 1 minute, and then spit it out. Do not swallow the rinse.

What should I do if I accidentally swallow more than the recommended amount?

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

Can children use ACT Restoring Anticavity Fluoride Mouthwash?

Yes, children 6 years of age and older can use it, but they should be instructed in good rinsing habits and supervised until capable of using it without help. For children under 6, consult a dentist or doctor.

Are there any specific precautions for nursing mothers?

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

How should I store ACT Restoring Anticavity Fluoride Mouthwash?

Store it at room temperature and do not use it if the safety seal is broken or missing.

Packaging Info

Below are the non-prescription pack sizes of Act Restoring Anticavity Fluoride Cool Mint (sodium fluoride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Act Restoring Anticavity Fluoride Cool Mint.
Details

Drug Information (PDF)

This file contains official product information for Act Restoring Anticavity Fluoride Cool Mint, 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 aged 6 years and older should use the rinse once daily, following brushing with toothpaste. To administer, the cap should be removed, and 10 milliliters (mL) should be poured, ensuring not to exceed the 10 mL mark indicated on the inside of the cap. The user should vigorously swish the 10 mL of rinse between the teeth for a duration of 1 minute before spitting it out. It is imperative that the rinse is not swallowed. After rinsing, individuals should refrain from eating or drinking for 30 minutes to maximize effectiveness.

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 is capable of using the product without assistance.

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

Contraindications

Use is contraindicated if more than the recommended amount for rinsing is accidentally swallowed. In such cases, seek medical assistance or contact a Poison Control Center immediately.

Warnings and Precautions

In the event that more than the recommended amount for rinsing is accidentally ingested, immediate medical assistance should be sought. It is imperative 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. Healthcare professionals are advised to remain vigilant and ensure that patients are informed about the potential risks associated with accidental ingestion.

Side Effects

Patients should be aware that if more than the recommended amount used 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 such an event and underscores the importance of adhering to the prescribed usage guidelines.

Drug Interactions

There are currently no documented drug interactions associated with the use of 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 Act Restoring Anticavity Fluoride Cool Mint (sodium fluoride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Act Restoring Anticavity Fluoride Cool Mint.
Details

Pediatric Use

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

For children aged 6 years and older, the product is to be used once daily after brushing 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 necessary 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. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population, given the lack of targeted data.

Pregnancy

There is no specific information regarding the use of ACT Restoring Anticavity Fluoride Mouthwash during pregnancy. The drug insert 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 warnings or recommendations regarding the use of this product by lactating mothers. Additionally, there is no information available about the potential for excretion in breast milk or any associated risks to breastfed infants.

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 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 question.

Postmarketing Experience

No postmarketing experience details are available in the insert.

Patient Counseling

Healthcare providers should advise patients that if more than the recommended amount used for rinsing is accidentally swallowed, they should seek medical help or contact a Poison Control Center immediately. It is important for patients to understand the potential risks associated with accidental ingestion and to act promptly in such situations.

Storage and Handling

The product is supplied in configurations that include specific NDC numbers, which should be referenced for accurate identification. It is essential to store the product at room temperature to maintain its integrity and effectiveness. Additionally, the product should not be used if the safety seal is broken or missing, as this may compromise safety and efficacy. Proper handling and storage conditions are crucial to ensure the product remains safe for use.

Additional Clinical Information

The product is administered topically, with a recommended frequency of once daily following tooth brushing. Clinicians should instruct patients, particularly children under 12 years of age, on proper rinsing techniques to minimize swallowing, and supervision is advised until the child is capable of using the product independently.

Drug Information (PDF)

This file contains official product information for Act Restoring Anticavity Fluoride Cool Mint, 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 Act Restoring Anticavity Fluoride Cool Mint, 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.