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Anticavity

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Active ingredient
Sodium Fluoride 0.2 mg/1 mL
Other brand names
Dosage form
Mouthwash
Route
Oral
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2006
Label revision date
February 3, 2026
Active ingredient
Sodium Fluoride 0.2 mg/1 mL
Other brand names
Dosage form
Mouthwash
Route
Oral
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Marketed in the U.S.
Since 2006
Label revision date
February 3, 2026
Manufacturer
Demoulas Super Markets, Inc.
Registration number
M021
NDC root
53942-163

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Drug Overview

Sodium Fluoride and Acidulated Phosphate Topical Solution is an anticavity mouthwash that comes in a refreshing Eucalyptus Mint flavor. This mouthwash is designed to help prevent dental cavities, strengthen your teeth, and kill germs that can cause bad breath. Additionally, it freshens your breath and aids in restoring enamel, making it a beneficial addition to your oral hygiene routine.

Uses

You can use this product to help keep your teeth healthy and strong. It aids in the prevention of dental cavities, which means it helps stop those pesky holes from forming in your teeth. By strengthening your teeth, it also makes them more resistant to decay.

In addition to cavity prevention, this product helps kill the germs that cause bad breath, leaving your mouth feeling fresh. It also works to restore enamel, the protective outer layer of your teeth, which is essential for maintaining overall dental health. With regular use, you can enjoy a brighter smile and fresher breath.

Dosage and Administration

After brushing your teeth, you can use this mouth rinse twice a day. For adults and children aged 12 and older, take 10 mL (which is about 2 teaspoonfuls) of the rinse. Vigorously swish it between your teeth for one minute, then spit it out. It's important not to swallow the rinse.

After using the mouth rinse, avoid eating or drinking for 30 minutes to allow it to work effectively. If you're helping children under 12, make sure to teach them how to rinse properly to prevent swallowing the rinse. You should supervise younger children 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 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 help or contact a Poison Control Center immediately. Your safety is a priority, so please follow these guidelines closely.

Side Effects

You may not experience any specific adverse reactions from this medication. However, it's important to be cautious. If you accidentally swallow more than what is intended for rinsing, seek medical help or contact a Poison Control Center immediately.

Warnings and Precautions

It’s important to use this product safely. Keep it out of reach of children to prevent accidental ingestion. If you or someone else accidentally swallows more than what is needed for rinsing, seek emergency medical help or contact a Poison Control Center immediately.

Currently, there are no specific laboratory tests required for monitoring while using this product. Always prioritize safety and be aware of how to respond in case of an emergency.

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. 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

There is currently no specific information available regarding the use of Anticavity sodium 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 important to consult with your healthcare provider before using this mouthwash or any other medication. They can provide personalized advice based on your health needs and circumstances.

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 are no particular considerations or precautions related to lactation (the process of producing breast milk) or concerns about the product being present in breast milk. This means you can use the product without worrying about potential effects on your milk production or your nursing infant.

Pediatric Use

It's important to keep this product out of reach of children. If a child accidentally swallows more than what is used for rinsing, seek medical help or contact a Poison Control Center immediately. For adults and children aged 12 and older, the product can be used twice daily after brushing teeth with toothpaste.

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

Geriatric Use

When it comes to using this medication in older adults, there is no specific information available about dosage adjustments, safety concerns, or special precautions. This means that if you or a loved one is an older adult, it’s important to consult with a healthcare provider for personalized advice. They can help determine the best approach based on individual health needs and any other medications being taken. Always prioritize open communication with your healthcare team to ensure safe and effective treatment.

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 or how it should be managed in the context of liver impairment.

Always consult your healthcare provider for personalized advice and to ensure that any treatment plan is safe and effective for your specific health needs. 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 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 tests you are undergoing. This way, you can avoid any potential issues and receive the best care possible.

Storage and Handling

To ensure the best performance of your product, store it at a controlled room temperature between 20°C and 25°C (68°F and 77°F). This temperature range helps maintain its effectiveness. Be aware that if the product is exposed to cold weather, it may temporarily become cloudy, but this does not affect its safety or function.

Handle the product with care, and always ensure that it is stored properly to avoid any potential issues. If you have any questions about its use or storage, feel free to reach out for more information.

Additional Information

You should take this medication orally, twice a day, after brushing your teeth with toothpaste. It's important to keep this product out of reach of children. If a child accidentally swallows more than the amount used for rinsing, seek medical help or contact a Poison Control Center immediately.

For children under 12, make sure to teach them proper rinsing habits to reduce the chance of swallowing the product, and supervise them until they can rinse without help. If the user is under 6 years old, consult a dentist or doctor before use.

FAQ

What is Sodium Fluoride and Acidulated Phosphate Topical Solution?

It is an anticavity mouthwash with an Eucalyptus Mint flavor that helps prevent cavities and strengthen teeth.

How should I use this mouthwash?

Use twice daily after brushing your teeth. Vigorously swish 10 mL (2 teaspoonfuls) 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?

Get medical help or contact a Poison Control Center right away.

Can children use this mouthwash?

Yes, but children under 12 should be instructed in good rinsing habits, and those under 6 years of age should consult a dentist or doctor.

What are the benefits of using this mouthwash?

It helps prevent cavities, strengthens teeth, kills germs that cause bad breath, freshens breath, and restores enamel.

Are there any contraindications for this mouthwash?

No specific contraindications are listed for this product.

What precautions should I take when using this mouthwash?

Keep it out of reach of children and do not eat or drink for 30 minutes after rinsing.

What is the storage condition for this mouthwash?

Store at controlled room temperature between 20⁰ - 25⁰C (68⁰ - 77⁰F).

Is there any information regarding the use of this mouthwash during pregnancy or lactation?

No specific information or precautions are provided regarding its use during pregnancy or lactation.

Packaging Info

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

Packaging configurations for Anticavity.
Details

Drug Information (PDF)

This file contains official product information for Anticavity, 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 and the strengthening of teeth. It aids in the prevention of cavities by helping to restore enamel and kill germs that cause bad breath, thereby also contributing to breath freshness.

Limitations of Use: This drug is intended for use as part of a comprehensive oral hygiene regimen and should not be considered a substitute for regular dental care.

Dosage and Administration

Adults and children 12 years of age and older are instructed to use the rinse twice daily, following brushing with a toothpaste. The recommended method involves vigorously swishing 10 mL (2 teaspoonfuls) of the rinse between the teeth for a duration of 1 minute, after which the rinse should be expectorated. It is imperative that the rinse is not swallowed.

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 advised until the child is capable of performing the rinsing without assistance. For children under 6 years of age, consultation with a dentist or physician is recommended prior to use.

Contraindications

Use of this product is contraindicated in the event of accidental ingestion beyond the recommended rinsing amount. In such cases, immediate medical assistance or contact with a Poison Control Center is advised. No other contraindications have been identified.

Warnings and Precautions

For this product, it is imperative to adhere to the following warnings and precautions to ensure safe usage.

General precautions should be observed, particularly the necessity to keep the product out of reach of children to prevent accidental ingestion or misuse.

In the event of accidental ingestion, specifically if more than the recommended amount for rinsing is swallowed, it is crucial to seek emergency medical assistance immediately or contact a Poison Control Center. Prompt action is essential to mitigate potential risks associated with overdose.

Currently, there are no specified laboratory tests recommended for monitoring the use of this product. However, healthcare professionals should remain vigilant and provide guidance on safe usage practices to patients.

Side Effects

Patients should be aware that there are no specific adverse reactions listed for this product. However, it is important to note that if more than the recommended amount used for rinsing is accidentally swallowed, immediate medical assistance should be sought, or a Poison Control Center should be contacted without delay. This precaution is critical to ensure the safety and well-being of individuals using the product.

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 Anticavity (sodium fluoride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Anticavity.
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, immediate medical assistance or contact with a Poison Control Center is advised.

For children aged 12 years and older, the product is to be used twice daily following tooth brushing with toothpaste. It is important to instruct children under 12 years in proper rinsing techniques to minimize the risk of swallowing. Supervision is recommended for younger 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 recommended 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 efficacy, given the lack of targeted data for this population.

Pregnancy

There is no specific information regarding the use of Anticavity sodium 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 when recommending this product to women of childbearing potential and consider the lack of data on potential fetal impacts. It is advisable to weigh the benefits against any unknown risks when prescribing this mouthwash to pregnant patients.

Lactation

There are no specific warnings or recommendations regarding the use of this product by lactating mothers. Additionally, there are no specific considerations or precautions mentioned concerning lactation or the potential for excretion in breast milk.

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 prompt intervention can significantly mitigate potential adverse effects associated with overdosage. Monitoring the patient for any symptoms that may arise is essential, although specific symptoms related to overdosage are not detailed in the available data.

Management of overdosage should focus on supportive care and symptomatic treatment as necessary. It is advisable to follow established protocols for managing cases of overdosage, which may include gastric decontamination and monitoring of vital signs.

In summary, the key action in the case of overdosage is to obtain immediate medical assistance and to provide supportive care as needed.

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 seek immediate medical assistance or contact a Poison Control Center if more than the recommended amount for rinsing is accidentally swallowed. It is important for patients to understand the potential risks associated with improper use and to act promptly in such situations to ensure their safety.

Storage and Handling

The product is supplied in configurations that are compliant with the National Drug Code (NDC) standards. It should be stored at a controlled room temperature of 20°C to 25°C (68°F to 77°F).

It is important to note that exposure to cold weather may cause temporary cloudiness in the product. Therefore, care should be taken to avoid storage conditions that may lead to such exposure.

Additional Clinical Information

The product is administered orally, with a recommended frequency of twice daily following tooth brushing. Clinicians should advise patients to keep the product out of reach of children and to seek medical assistance or contact a Poison Control Center immediately if more than the recommended amount is accidentally swallowed. It is important to instruct children under 12 years in proper rinsing techniques to minimize swallowing and to supervise them until they can use the product independently. For children under 6 years of age, consultation with a dentist or doctor is advised.

Drug Information (PDF)

This file contains official product information for Anticavity, 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 Anticavity, 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.