Discount Drug Mart

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. There are no teratogenic or nonteratogenic effects associated with its use.

Dosage and Administration

For adults and children aged 6 years and older, the recommended dosage is 10 mL of rinse, to be used once daily following the brushing of teeth with toothpaste. The patient should vigorously swish the rinse between the 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 the rinsing procedure to ensure optimal efficacy.

For children under 6 years of age, it is advised to consult a dentist or doctor 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 without assistance.

Contraindications

There are no specific contraindications listed for this product. However, it is advised that if more than the recommended amount for rinsing is accidentally swallowed, medical assistance should be sought immediately or contact a poison control center.

Warnings and Precautions

In the event that more than the recommended amount used for rinsing is accidentally ingested, it is imperative to seek medical assistance or contact a poison control center without delay. This precaution is critical to ensure the safety and well-being of the patient. Healthcare professionals should be vigilant in educating patients about the proper use of the product to minimize the risk of accidental ingestion.

Side Effects

Patients should be aware that if more than the recommended amount for rinsing is accidentally swallowed, it is imperative to seek medical help or contact a poison control center immediately. This warning highlights the potential seriousness of accidental ingestion and underscores the importance of adhering to the prescribed usage guidelines.

In clinical practice, it is essential for healthcare providers to educate patients on the proper use of the product to minimize the risk of adverse reactions associated with misuse.

Drug Interactions

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

Packaging & NDC

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

Pediatric Use

Pediatric patients should be closely monitored when using this product. It is essential 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 adults and children aged 6 years and older, the recommended usage is once daily after brushing teeth with toothpaste. Patients should vigorously swish 10 mL of the rinse between their teeth for 1 minute and then spit it out. It is crucial that the rinse is not swallowed, and patients should refrain from eating or drinking for 30 minutes following rinsing. Caregivers should supervise children as necessary until they are capable of using the product without supervision.

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 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 informing their healthcare provider if they become pregnant or plan to become pregnant while using this medication.

Lactation

There are no specific warnings or recommendations regarding the use of this medication in lactating mothers. Additionally, no information is available concerning the excretion of the drug in breast milk or its effects on breastfed infants. Healthcare professionals should consider the absence of data when advising lactating mothers on the use of this medication.

Renal Impairment

Patients with renal impairment may not have specific dosage adjustments, special monitoring, or safety considerations outlined in the prescribing information. Therefore, healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment and individualized patient assessment. Regular monitoring of renal function is 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, it is critical to seek immediate medical assistance or contact a poison control center if an amount exceeding that intended for rinsing is accidentally ingested.

Healthcare professionals should be aware that prompt intervention is essential in managing potential complications associated with overdosage. Symptoms may vary depending on the specific substance involved, and therefore, a thorough assessment of the patient's condition is necessary.

Management procedures should include monitoring the patient for any adverse effects and providing supportive care as needed. It is advisable to have the product's labeling and any relevant medical history available to assist healthcare providers in determining the appropriate course of action.

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.

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 swiftly in such situations to ensure their safety.

Storage and Handling

This product is supplied in various package configurations, with specific NDC numbers available upon request. It should be stored at room temperature to maintain its integrity. Exposure to cold weather may cause cloudiness in the product; however, this does not affect its antiseptic properties. Care should be taken to avoid extreme temperature fluctuations during storage.

Additional Clinical Information

The product is administered orally, with specific instructions for both adults and children aged 6 years and older. Patients should use the rinse once daily after brushing their teeth with toothpaste. The recommended method involves vigorously swishing 10 mL of the rinse between the 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 the rinse. 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 Discount Drug Mart, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)