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Act Total Care Dry Mouth Anticavity Mouth

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Active ingredient
Sodium Fluoride 0.09 mg/1 mL
Other brand names
Dosage form
Rinse
Route
Topical
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2011
Label revision date
December 13, 2024
Active ingredient
Sodium Fluoride 0.09 mg/1 mL
Other brand names
Dosage form
Rinse
Route
Topical
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Marketed in the U.S.
Since 2011
Label revision date
December 13, 2024
Manufacturer
Chattem, Inc.
Registration number
M021
NDC root
41167-0968

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Drug Overview

ACT® Total Care Anticavity Fluoride Rinse is a mouthwash designed to help prevent dental cavities and is recommended by dentists. It contains sodium fluoride (a mineral that helps strengthen teeth) at a concentration of 0.02%. This rinse not only aids in cavity prevention but also soothes dry mouth, moisturizes mouth tissue, and freshens breath, making it a comprehensive option for maintaining oral health.

This product is particularly beneficial for individuals experiencing dry mouth, as it provides relief while also contributing to overall dental care. With an 18 fl oz (532 mL) bottle, it offers a convenient way to incorporate fluoride into your daily oral hygiene routine.

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

If you are an adult or a child aged 6 years and older, you should use this mouth rinse twice a day after brushing your teeth with toothpaste. 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. It’s important not to swallow the rinse.

After using the mouth rinse, avoid eating or drinking for 30 minutes to allow the product to work effectively. If you are supervising a child under 12, make sure to guide them in good rinsing habits to help prevent swallowing the rinse. For children under 6 years of age, it’s best to consult a dentist or doctor before use.

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

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. Always use the product as directed to avoid any potential risks.

Warnings and Precautions

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 immediately or contact a Poison Control Center.

There are no specific general precautions or laboratory tests mentioned, but always use the product as directed to ensure safety. 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 the 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 about the use of ACT Total Care Dry Mouth Anticavity Mouth Rinse during pregnancy. This means that the drug insert does not provide details on safety concerns, dosage adjustments, or any special precautions you should take if you are pregnant or planning to become pregnant.

If you have any questions or concerns about using this mouth rinse while pregnant, it’s best to consult with your healthcare provider for personalized advice. They can help you make informed decisions based on your individual health needs.

Lactation Use

If you are breastfeeding or planning to breastfeed, it's important to be aware that there is no specific information available regarding the effects of this medication on nursing mothers or lactation (the process of producing breast milk). Since there are no guidelines or data provided, it’s advisable to consult with your healthcare provider to discuss any potential risks or concerns related to your situation. They can help you make informed decisions that prioritize both your health and your baby's well-being.

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 twice a day after brushing their teeth with toothpaste.

For younger children, especially those 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

When it comes to using this medication in older adults, there is no specific information available about how it may affect you or if any dosage adjustments are necessary. This means that the drug insert does not highlight any unique safety concerns or special precautions for elderly patients.

As always, it’s important to discuss your individual health needs with your healthcare provider, especially if you are an older adult or caring for one. They can help determine the best approach for using this medication safely and effectively.

Renal Impairment

If you have kidney problems, it's important to know that the information provided does not include specific guidelines for dosage adjustments or monitoring related to renal impairment (kidney issues). This means that there are no detailed recommendations available for how your treatment may need to be altered 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 condition. They can help determine the best approach for managing your health, especially if you have concerns about your kidneys.

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 differently due to your liver health.

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your liver condition. They can help monitor your liver function and make any necessary adjustments to your treatment plan.

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 recent lab tests to avoid any potential issues. Your health and safety should always come first.

Storage and Handling

To ensure the best use of your product, store it at room temperature. This helps maintain its effectiveness and safety. Before using, always check that the safety seal is intact; do not use the product if the seal is broken or missing, as this could indicate that it is no longer safe to use. Following these simple guidelines will help you handle the product safely and effectively.

Additional Information

You will use this medication topically, which means it is applied directly to the skin. If you are using this product for children under 12 years old, it's important to teach them good rinsing habits to help prevent swallowing the medication. Additionally, supervise younger children while they are using it until they can do so safely on their own.

FAQ

What is ACT Total Care Anticavity Fluoride Rinse used for?

ACT Total Care Anticavity Fluoride Rinse aids in the prevention of dental cavities and is recommended by dentists.

What is the active ingredient in this mouth rinse?

The rinse contains Sodium Fluoride 0.02%, which helps strengthen teeth.

How should I use ACT Total Care Anticavity Fluoride Rinse?

Use twice 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.

Is this product safe for children?

Children under 6 years of age should consult a dentist or doctor. For children under 12, supervise them to ensure they use it properly and minimize swallowing.

Are there any contraindications for using this mouth rinse?

No specific contraindications are listed for ACT Total Care Anticavity Fluoride Rinse.

How should I store this mouth rinse?

Store ACT Total Care Anticavity Fluoride Rinse at room temperature and do not use it if the safety seal is broken or missing.

Can I use this rinse if I am pregnant or nursing?

No specific information is provided regarding the use of this rinse during pregnancy or nursing.

What are the warnings associated with this product?

Keep out of reach of children, and if more than used for rinsing is accidentally swallowed, seek medical help immediately.

Packaging Info

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

Packaging configurations for Act Total Care Dry Mouth Anticavity Mouth.
Details

Drug Information (PDF)

This file contains official product information for Act Total Care Dry Mouth Anticavity Mouth, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

Sodium Fluoride is presented in a concentration of 0.02%. The product is contained in a volume of 18 fluid ounces (532 mL).

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 are instructed to use the rinse twice daily, following brushing with toothpaste. The cap should be removed, and 10 milliliters (mL) of the rinse 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 the effectiveness of the treatment.

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 rinse without assistance.

For children under 6 years of age, consultation with a dentist or doctor 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

It is imperative to keep this product out of the reach of children to prevent accidental ingestion. In the event that more than the recommended amount for rinsing is accidentally swallowed, 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.

No specific general precautions or laboratory tests have been identified for this product. However, vigilance is essential in monitoring for any adverse effects or complications that may arise from improper use.

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 ingesting excessive amounts of the product, underscoring the importance of adhering to the usage guidelines to prevent adverse outcomes.

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 necessary at this time.

Packaging & NDC

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

Packaging configurations for Act Total Care Dry Mouth Anticavity Mouth.
Details

Pediatric Use

Pediatric patients should be kept 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 recommended usage is twice 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 the product. Supervision is necessary 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 recommended 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.

Pregnancy

There is no specific information regarding the use of ACT Total Care Dry Mouth Anticavity Mouth Rinse in pregnant patients. The prescribing information does not provide safety concerns, dosage modifications, or special precautions related to its use during pregnancy. 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 is no specific information available regarding the use of this medication in nursing mothers or lactation considerations. Healthcare professionals should exercise caution and consider the potential risks and benefits when prescribing this medication to lactating mothers. Further research may be necessary to fully understand the implications for breastfed infants.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available prescribing information regarding dosage adjustments, monitoring, or precautions. As such, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, given the absence of detailed guidance on its use in this population. Regular monitoring of renal function may be advisable to ensure patient safety and therapeutic efficacy.

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 understanding of potential risks associated with the compound in nonclinical settings.

Postmarketing Experience

No postmarketing experience details are provided in the insert.

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 assistance immediately or contact a Poison Control Center for guidance. This precaution is crucial to ensure patient safety and to address any potential risks associated with accidental overdose.

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 efficacy. Additionally, the product should not be used if the safety seal is broken or missing, as this may compromise its safety and effectiveness. Proper handling and storage conditions are crucial to ensure the product remains safe for use.

Additional Clinical Information

The product is administered topically. Clinicians should instruct patients, particularly parents of children under 12 years of age, to ensure good rinsing habits to minimize swallowing. Additionally, supervision of children is recommended until they are capable of using the product without assistance. No further information is available regarding laboratory tests, abuse potential, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Act Total Care Dry Mouth Anticavity Mouth, 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 Total Care Dry Mouth Anticavity Mouth, 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.