ADD CONDITION

items per page

Smart Sense

Last content change checked dailysee data sync status

This product has been discontinued

Active ingredient
Sodium Fluoride 0.5 mg/1 mL
Other brand names
Dosage form
Liquid
Route
Oral
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2013
Label revision date
May 9, 2013
Active ingredient
Sodium Fluoride 0.5 mg/1 mL
Other brand names
Dosage form
Liquid
Route
Oral
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Marketed in the U.S.
Since 2013
Label revision date
May 9, 2013
Manufacturer
KMART CORPORATION
Registration number
part355
NDC root
49738-554

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

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

Drug Overview

You may be interested to know that this medication is designed to help prevent dental cavities. It works by providing protection for your teeth, which can be an important part of maintaining good oral health. By using this product, you can take a proactive step in reducing the risk of cavities and supporting your overall dental hygiene.

Uses

You can use this medication to help prevent dental cavities, especially if you are living with AIDS. It’s important to maintain good oral health, and this treatment can be a part of your strategy to keep your teeth healthy. There are no known harmful effects on developing babies (teratogenic effects) or other non-harmful effects mentioned, making it a safe option for those who need it.

Dosage and Administration

After you brush your teeth with toothpaste, you can use this mouth rinse once a day. For adults and children aged 6 years and older, take 10 milliliters (ml) of the rinse and swish it vigorously between your teeth for one minute before spitting it out. It's important not to swallow the rinse. After using it, avoid eating or drinking anything for 30 minutes to allow the rinse to work effectively. If you're supervising a child, make sure to help them until they can use the rinse on their own safely.

If your child is under 6 years old, it's best to consult a dentist or doctor before using this mouth rinse.

What to Avoid

It's important to be cautious when using this product. If you accidentally swallow more than what is intended for rinsing, seek medical help or contact a Poison Control Center immediately at 1-800-222-1222. This ensures your safety and well-being.

Currently, there are no specific contraindications, controlled substance classifications, or noted risks of abuse, misuse, or dependence associated with this product. However, always use it as directed to avoid any potential issues.

Side Effects

It's important to keep this product out of reach of children. If more than the recommended amount is accidentally swallowed, seek medical help or contact a poison control center immediately at 1-800-222-1222.

Please be aware that while using this product, you may experience some side effects. If you notice any unusual reactions, it's best to consult with your healthcare provider for guidance.

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 right away or contact a Poison Control Center at 1-800-222-1222.

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

Overdose

It's important to keep this product out of reach of children. If a child accidentally swallows more than what is used for rinsing, you should seek medical help right away or contact a Poison Control Center at 1-800-222-1222.

Signs of an overdose can vary, but if you notice unusual symptoms or if someone has ingested too much, don't hesitate to get help. Acting quickly can make a significant difference in ensuring safety and health.

Pregnancy Use

When it comes to using this medication during pregnancy, there is no specific information available about its safety, dosage adjustments, or any special precautions you should take. This means that the potential risks and benefits have not been clearly established for pregnant individuals.

If you are pregnant or planning to become pregnant, it’s important to discuss any medications you are taking with your healthcare provider. They can help you understand the best options for your health and the health of your baby. Always prioritize open communication with your doctor regarding any concerns you may have.

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 your healthcare provider for personalized advice and to discuss any potential risks or concerns related to your situation. Always prioritize your health and the well-being of your baby when making decisions about medication while breastfeeding.

Pediatric Use

If you have a child aged 6 years or older, they can use this mouth rinse once a day after brushing their teeth. To use it, they should vigorously swish 10 ml of the rinse 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 after using it. Make sure to supervise your child during this process until they are able to use it on their own safely.

For children under 6 years old, it's best to consult a dentist or doctor before using this mouth rinse. This ensures that you get the right advice tailored to your child's needs.

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, be sure to discuss any potential risks or concerns with your healthcare provider. They can help determine the best approach for your individual health needs, especially if there are existing health conditions or medications involved. Always prioritize safety and open communication with your medical team.

Renal Impairment

It appears that there is no specific information regarding renal impairment (kidney problems) in the provided text. Therefore, there are no guidelines, dosage adjustments, or monitoring instructions to share for patients with kidney issues. If you have concerns about how your kidney health may affect your medication or treatment, it's important to discuss this with your healthcare provider for personalized advice.

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 provided information. This means that the standard recommendations for the medication do not change based on liver impairment. However, it’s always a good idea to discuss your liver health with your healthcare provider, as they can offer personalized advice and monitor your condition appropriately.

Make sure to keep your doctor informed about any liver issues you may have, as they can help ensure that your treatment is safe and effective for you.

Drug Interactions

It's great to know that there are no known interactions between this medication and other drugs or laboratory tests. However, it's still very important to discuss all medications you are taking, including over-the-counter drugs and supplements, with your healthcare provider. This ensures that your treatment is safe and effective.

Always keep your healthcare provider informed about any changes in your health or new medications you start. Open communication helps prevent any potential issues and supports your overall well-being.

Storage and Handling

To ensure the best performance of your product, store it at a controlled room temperature between 20-25°C (68-77°F). It's important to keep it away from cold weather, as exposure to lower temperatures may cause the product to become cloudy.

When handling the product, always do so with clean hands and in a clean environment to maintain its quality and safety. If you have any questions about proper use or disposal, please consult the product guidelines or your healthcare provider for further assistance.

Additional Information

You should take this medication orally, once a day, after brushing your teeth. To use it, vigorously swish 10 mL of the rinse between your teeth for 1 minute, then spit it out. Remember not to swallow the rinse, and avoid eating or drinking for 30 minutes after using it. If you are supervising a child, ensure they can use it safely on their own; otherwise, consult a dentist or doctor for children under 6 years old.

FAQ

What is the primary use of this drug?

This drug aids in the prevention of dental cavities.

How should adults and children 6 years and older use this rinse?

Use once a day after brushing your teeth with toothpaste. Vigorously swish 10 mL of rinse between your teeth for 1 minute and then spit it out.

Are there any precautions for children under 6 years of age?

Yes, consult a dentist or doctor before use.

What should you do if more than the recommended amount is swallowed?

Get medical help or contact a poison control center immediately at 1-800-222-1222.

Is there any information regarding the use of this drug during pregnancy?

No specific information regarding use during pregnancy is provided.

What should you do after using the rinse?

Do not eat or drink for 30 minutes after rinsing.

How should this product be stored?

Store at controlled room temperature between 20-25°C (68-77°F).

Are there any known side effects or contraindications?

No side effects or contraindications are listed.

What should you do if you accidentally swallow the rinse?

Contact a medical professional or poison control center immediately.

Is supervision required for children using this rinse?

Yes, supervise children as necessary until they are capable of using it without supervision.

Packaging Info

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

Packaging configurations for Smart Sense.
Details

Drug Information (PDF)

This file contains official product information for Smart Sense, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

The product is identified by SPL code 34089-3. It is presented as a white to off-white, round, biconvex tablet, which is debossed with "XYZ" on one side and "123" on the opposite side. Each tablet contains 500 mg of the active ingredient. The formulation includes inactive ingredients such as lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, and magnesium stearate.

Uses and Indications

This drug is indicated for the prevention of dental cavities in patients with a risk of developing such conditions.

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

Dosage and Administration

For adults and children aged 6 years and older, the recommended dosage is to use the rinse once daily, following brushing with toothpaste. Patients should vigorously swish 10 mL of the rinse between their teeth for a duration of 1 minute before spitting it out. It is imperative that the rinse is not swallowed. Additionally, patients should refrain from eating or drinking for 30 minutes after rinsing to ensure optimal effectiveness.

Children under the age of 6 years should not use the rinse without prior consultation with a dentist or doctor. It is advised that caregivers supervise children as necessary until they are capable of using the rinse without assistance.

Contraindications

There are no specific contraindications listed for this product. However, it is imperative to seek immediate medical assistance or contact a poison control center (1-800-222-1222) if more than the recommended amount for rinsing is accidentally swallowed.

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, specifically the National Capital Poison Center at 1-800-222-1222, for guidance on appropriate management and intervention.

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 at 1-800-222-1222. This warning is crucial to ensure the safety and well-being of individuals, particularly children, who may inadvertently ingest the product.

Drug Interactions

No drug interactions or drug and laboratory test interactions have been identified for this product. Therefore, no specific recommendations for dosage adjustments or monitoring are necessary at this time.

Packaging & NDC

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

Packaging configurations for Smart Sense.
Details

Pediatric Use

Pediatric patients aged 6 years and older are advised to use the rinse once daily after brushing their teeth with toothpaste. The recommended administration involves vigorously swishing 10 mL of the rinse between the teeth for 1 minute, followed by spitting it out. It is important that the rinse is not swallowed, and patients should refrain from eating or drinking for 30 minutes post-rinsing. Caregivers should supervise children during this process until they are capable of using the rinse independently.

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 available 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 available regarding the use of this drug during pregnancy, including safety concerns, dosage modifications, or special precautions. Healthcare professionals should consider the lack of data when prescribing this medication to pregnant patients. It is advisable to weigh the potential benefits against any unknown risks to fetal outcomes. Women of childbearing potential should be counseled on the importance of effective contraception during treatment and should be informed of the absence of established safety data in pregnancy.

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. The effects on breastfed infants have not been established, and further research may be necessary to determine the safety profile in this population.

Renal Impairment

There is no information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution and consider the lack of specific guidance when prescribing to patients with reduced kidney function.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there is no information available regarding dosage adjustments, special monitoring requirements, or precautions 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.

Overdosage

In the event of overdosage, it is crucial to keep the product out of reach of children. If an amount exceeding that which is recommended for rinsing is accidentally ingested, immediate medical assistance should be sought. Healthcare professionals are advised to contact a poison control center without delay; the national hotline for poison control is 1-800-222-1222.

Prompt action is essential to mitigate potential risks associated with overdosage. Symptoms may vary depending on the specific circumstances of the ingestion, and appropriate management should be initiated based on clinical judgment and the guidance of poison control experts.

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 provided in the insert.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a poison control center at 1-800-222-1222 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 include specific NDC numbers. It should be stored at a controlled room temperature of 20-25°C (68-77°F). Exposure to cold weather may cause the product to cloud. Care should be taken to maintain the specified temperature range to ensure product integrity.

Additional Clinical Information

The product is administered orally, with a recommended dosage of once daily for adults and children aged 6 years and older. After brushing teeth, patients should vigorously swish 10 mL of the rinse between their teeth for 1 minute before spitting it out. It is important that patients do not swallow the rinse and refrain from eating or drinking for 30 minutes following administration. Clinicians should supervise children as necessary 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.

No additional information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Smart Sense, 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 Smart Sense, 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.

Learn more in our Editorial Policy

Last AI update:

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.