Smart Sense

Description

The product is identified by SPL code 34089-3 and 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 the following inactive ingredients: microcrystalline cellulose, croscarmellose sodium, magnesium stearate, talc, hydroxypropyl methylcellulose, titanium dioxide, iron oxide (red), and iron oxide (yellow).

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 12 years of age and older should use the rinse once daily, following brushing with a toothpaste. The recommended method of administration 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 following the rinsing procedure to ensure optimal efficacy.

For children under 12 years of age, it is advised to consult a dentist or physician prior to use. Caregivers should supervise the administration of the rinse to ensure safety and proper technique until the child is capable of using the product independently.

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 the 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; the national hotline is available at 1-800-222-1222 for guidance and support in such situations.

Side Effects

Patients should be advised to keep the product out of reach of children. In the event that 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 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

There are no documented drug interactions associated with the use of this medication. Additionally, there are no reported interactions between this drug and laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug interactions.

Packaging & NDC

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

Pediatric Use

Pediatric patients under 12 years of age should consult a dentist or doctor prior to use. It is important for caregivers to supervise children as necessary until they are capable of using the product without supervision.

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 regarding the use of this product in pregnant patients. The prescribing information does not indicate whether the product is contraindicated during pregnancy or outline any associated risks to the fetus. Additionally, there are no dosage modifications or special precautions recommended for use in this population. Healthcare professionals should consider the lack of data when prescribing this product to women of childbearing potential and weigh the potential benefits against any unknown risks.

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

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

There is no available information regarding the use of this medication in patients with hepatic impairment. Consequently, there are no dosage adjustments, special monitoring requirements, or precautions specified for individuals with compromised liver function. Healthcare professionals should exercise caution and consider the overall clinical context when prescribing this medication to patients with liver problems, as the absence of specific guidance necessitates careful evaluation of potential risks and benefits.

Overdosage

In the event of overdosage, it is crucial to keep the product out of reach of children. Accidental ingestion of amounts exceeding those recommended for rinsing may lead to serious health concerns.

Should an overdose occur, immediate medical assistance is necessary. Healthcare professionals are advised to contact a poison control center without delay. The national poison control hotline can be reached at 1-800-222-1222 for guidance on appropriate management and treatment protocols.

Prompt action is essential to mitigate potential adverse effects associated with overdosage.

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. Further studies may be necessary to elucidate these aspects of nonclinical toxicology.

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 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 for adults and children aged 12 years and older being once daily after brushing teeth. Patients should vigorously swish 10 mL of the rinse between their teeth for 1 minute before spitting it out, ensuring not to swallow the rinse. It is advised that patients refrain from eating or drinking for 30 minutes following the rinse. Clinicians should supervise children as necessary until they are capable of using the product without assistance, and for children under 12 years of age, consultation with a dentist or doctor is recommended.

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)