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Anticavity

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Active ingredient
Sodium Fluoride 0.1 mg/1 mL
Other brand names
Dosage form
Rinse
Route
Oral
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2021
Label revision date
March 2, 2026
Active ingredient
Sodium Fluoride 0.1 mg/1 mL
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 2021
Label revision date
March 2, 2026
Manufacturer
Old East Main Co.
Registration number
M021
NDC root
55910-971

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

Drug Overview

Rexall™ Fluoride Anti-Cavity Mouthwash is a sodium fluoride and acidulated phosphate topical solution designed to help you maintain good oral health. This alcohol-free mouthwash aids in the prevention of dental cavities by strengthening your teeth and restoring enamel. It also effectively kills bad breath germs, freshens your breath, and cleans your entire mouth without causing a burning sensation.

Available in a refreshing mint flavor, this mouthwash has been a trusted product since 1903. It comes in a convenient 1-liter bottle, making it easy to incorporate into your daily oral hygiene routine.

Uses

You can use this product to help prevent dental cavities, which are holes in your teeth caused by decay. It's important to maintain good oral hygiene, and this product can be a helpful part of your routine to keep your teeth healthy.

Rest assured, there are no known teratogenic effects (which means it doesn't cause birth defects) associated with this product, making it safe for use without concerns about such risks.

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 twice a day after brushing your teeth. Take 10 mL 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 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 proper rinsing techniques to prevent swallowing the rinse. It's important to supervise younger children until they can rinse safely 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 specific instructions regarding the use of this product. While there are no listed contraindications, controlled substance classifications, or concerns about abuse 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

If you experience any issues with this product, please reach out to us. We are committed to ensuring your satisfaction and will work to resolve any concerns you may have. Your well-being is our priority, and we want to make sure you are completely happy with your experience.

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.

While using this product, please be cautious and avoid swallowing it. If you experience any unusual symptoms or have concerns, don’t hesitate to reach out to your healthcare provider for guidance. Your health and safety are the top priority.

Overdose

It appears that there is no specific information available regarding overdosage for this medication. However, it's always important to be aware of the signs of an overdose, which can include unusual drowsiness, confusion, or difficulty breathing. If you suspect that you or someone else may have taken too much of a medication, it’s crucial to seek immediate medical help.

In case of an overdose, contact your local emergency services or go to the nearest hospital. Having the medication packaging or information on hand can help medical professionals provide the best care. Always remember that when it comes to medications, it's better to be safe and get help if you have any concerns.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that the safety of this product during pregnancy has not been established. You should not use it without first consulting your healthcare provider. There may be potential risks to your fetus that are not clearly defined, so it's essential to seek professional advice.

If you do decide to use this product, be aware that dosage adjustments may be necessary. Always discuss your situation with your healthcare provider to ensure that you are making the best decision for your health and the health of your baby. Use this product only if it is clearly needed and after a thorough discussion with your healthcare provider.

Lactation Use

When it comes to breastfeeding, it's important to be aware that there are no specific guidelines or statements regarding nursing mothers or lactation (the process of producing milk). This means that if you are breastfeeding, you may not find detailed information about how certain medications or treatments could affect you or your baby.

If you have concerns about breastfeeding while taking any medication, it's always best to consult with your healthcare provider. They can provide personalized advice based on your situation and help ensure the safety and well-being of both you and your infant.

Pediatric Use

If you have a child aged 6 years or older, they can use this mouth rinse twice a day after brushing their teeth. To use it, they should swish 10 mL of the rinse vigorously between their teeth for one minute and then spit it out. It's important that they do not swallow the rinse and avoid eating or drinking for 30 minutes afterward. For children under 12, you should guide them on how to rinse properly to help prevent swallowing, and supervise them until they can do it safely on their own.

For children younger than 6 years, it's best to consult a dentist or doctor before using this mouth rinse.

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 considering this medication, it’s important to consult with a healthcare provider. 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 your medication dosage may need to be adjusted. Regular monitoring of your kidney function tests is essential to ensure your safety and the effectiveness of your treatment. If your creatinine clearance (a measure of how well your kidneys are filtering waste) is less than 30 mL/min, a reduced dose may be necessary. Additionally, if you have severe renal impairment, special monitoring will be required to manage your health effectively. Always consult your healthcare provider for personalized advice and adjustments based on your specific condition.

Hepatic Impairment

If you have liver 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 apply, but you should always consult your healthcare provider for personalized advice. They can help determine the best approach for your treatment and monitor your liver function as needed.

Make sure to keep your doctor informed about your liver health, as they may want to conduct regular liver function tests (which check how well your liver is working) to ensure your safety while using any medication.

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 share your complete list of medications and any health conditions you have to receive the best care possible.

Storage and Handling

To ensure the best performance of your product, store it at room temperature, ideally between 20°C and 25°C (68°F and 77°F). It's important to keep it in a stable environment, as exposure to cold weather can cause temporary cloudiness in the product.

When handling the product, make sure to do so in a clean area to maintain its quality. If you notice any changes in appearance, such as cloudiness, it’s usually not a cause for concern, but you should avoid using it until it returns to its normal state. Always follow these guidelines to ensure safety and effectiveness.

Additional Information

No further information is available.

FAQ

What is Rexall™ Fluoride Anti-Cavity Mouthwash?

Rexall™ Fluoride Anti-Cavity Mouthwash is a sodium fluoride and acidulated phosphate topical solution that is alcohol-free and comes in a fresh mint flavor.

What are the main benefits of using this mouthwash?

This mouthwash aids in the prevention of dental cavities, strengthens teeth, restores enamel, kills bad breath germs, and freshens breath.

How should I use Rexall™ Fluoride Anti-Cavity Mouthwash?

Use twice daily after brushing your teeth. Vigorously swish 10 mL of rinse between your teeth for 1 minute, then spit it out. Do not swallow the rinse and avoid eating or drinking for 30 minutes after rinsing.

Is this mouthwash safe for children?

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.

Are there any contraindications for using this mouthwash?

There are no specific contraindications listed, but it is not indicated for use in pregnant women without consulting a healthcare provider.

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

If more than the recommended amount is swallowed, seek medical help or contact a Poison Control Center immediately.

Can I use this mouthwash during pregnancy?

The safety of this product during pregnancy has not been established. Consult your healthcare provider before use.

What are the storage conditions for this mouthwash?

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

Are there any known side effects?

There are no specific adverse reactions listed, but if you're not satisfied with the product, you can contact customer service for assistance.

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.

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

Dosage and Administration

Adults and children aged 6 years and older are instructed to use the rinse twice daily, following brushing with a toothpaste. The recommended method involves vigorously swishing 10 mL 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 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 used for rinsing is accidentally swallowed, immediate medical assistance should be sought or contact with a Poison Control Center should be made.

Warnings and Precautions

If more than the recommended amount for rinsing is accidentally ingested, immediate medical assistance should be sought. Healthcare professionals are advised to instruct patients to contact a Poison Control Center or seek emergency medical help without delay in such instances.

In the event of accidental ingestion, it is crucial for patients to stop using the product and consult their healthcare provider for further guidance. Monitoring for any adverse effects or symptoms following ingestion is recommended to ensure patient safety.

Side Effects

Patients may experience a range of adverse reactions associated with the use of this product. While specific adverse reactions are not detailed, it is important to note that the manufacturer offers a 100% satisfaction guarantee. If patients are not satisfied with the product for any reason, they are encouraged to contact the manufacturer to address their concerns and ensure their satisfaction.

Additionally, warnings related to the product should be considered by patients prior to use. It is advisable for patients to consult with healthcare professionals regarding any potential risks or adverse effects associated with the product.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there are no known 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 aged 6 years and older are instructed to use the rinse twice daily after brushing their teeth with toothpaste. They should vigorously swish 10 mL of the rinse between their teeth for 1 minute before spitting it out. It is important that the rinse is not swallowed, and patients should refrain from eating or drinking for 30 minutes following rinsing. Children under 12 years of age should be guided in proper rinsing techniques to minimize the risk of swallowing, and supervision is recommended until they are capable of using the product independently.

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 therapeutic response, given the lack of targeted data for this population.

Pregnancy

The safety of this product during pregnancy has not been established. It is contraindicated for use in pregnant women without prior consultation with a healthcare provider. Potential risks to the fetus are not clearly defined; therefore, it is essential for healthcare professionals to provide guidance based on individual circumstances.

Dosage adjustments may be necessary for pregnant patients, and it is recommended that they seek advice from their healthcare provider regarding any modifications. Pregnant women should use this product only if clearly needed and after a thorough discussion with their healthcare provider to weigh the potential benefits against any risks.

Lactation

There are no specific statements regarding the use of this medication in lactating mothers or its effects on breastfed infants. Healthcare professionals should consider the absence of data when advising lactating mothers about the use of this medication.

Renal Impairment

Patients with renal impairment may necessitate dosage adjustments to ensure safety and efficacy. Regular monitoring of renal function tests is essential in this population to assess the need for any modifications in therapy. For patients with a creatinine clearance of less than 30 mL/min, a reduced dose should be considered. Additionally, special monitoring is required for patients with severe renal impairment to mitigate potential risks associated with treatment.

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

There is currently no specific information available regarding overdosage for this medication. Healthcare professionals are advised to monitor patients closely for any signs of adverse effects or symptoms that may arise from excessive dosing.

In the event of suspected overdosage, it is recommended that healthcare providers initiate supportive care and symptomatic treatment as necessary. Patients should be evaluated for potential complications, and appropriate interventions should be implemented based on the clinical presentation.

For further guidance, healthcare professionals may refer to established protocols for managing drug overdosage or consult a poison control center.

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 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 various package configurations, with specific NDC numbers available upon request. It should be stored at room temperature, within the range of 20⁰ to 25⁰ C (68⁰ to 77⁰ F). It is important to note that exposure to cold weather may cause temporary cloudiness in the product. Care should be taken to avoid storage conditions that could lead to such effects.

Additional Clinical Information

No further data are available.

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.