Hismile

Description

Blue Raspberry Sodium Fluoride Anticavity Toothpaste is formulated to provide effective cavity protection. The active ingredient, sodium fluoride, contributes to the prevention of dental caries. This toothpaste is presented in a paste dosage form, characterized by its blue raspberry flavor. The product is designed for daily oral hygiene use, ensuring optimal dental health. The effective date for this formulation is July 15, 2024.

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 2 years and older should brush their teeth thoroughly, preferably after each meal or at least twice daily, or as directed by a dentist or doctor. It is important to instruct children under 6 years of age in proper brushing and rinsing techniques to minimize the risk of swallowing the product. Caregivers should supervise children as necessary until they are capable of brushing their teeth without assistance.

For children under 2 years of age, it is recommended to consult a dentist or doctor 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 brushing is accidentally swallowed, medical assistance should be sought immediately or contact a Poison Control Center.

Warnings and Precautions

The product is contraindicated for ingestion and should not be applied in the eye area. Healthcare professionals must advise patients to avoid swallowing the product. In the event of accidental ingestion, particularly if more than the amount typically used for brushing is swallowed, immediate medical assistance should be sought. Patients should be instructed to contact a Poison Control Center or seek emergency medical help without delay.

No specific instructions for discontinuation of use or additional precautions have been provided. As such, healthcare professionals should remain vigilant and monitor for any adverse reactions or complications that may arise during the use of this product.

Side Effects

Patients should be aware of specific warnings associated with the use of this product. It is crucial not to swallow the product and to avoid using it in the eye area. Additionally, the product should be kept out of reach of children under 6 years of age to prevent accidental ingestion.

In the event that more than the recommended amount is accidentally swallowed, patients are advised to seek medical help or contact a Poison Control Center immediately. This precaution is essential to ensure safety and mitigate any potential adverse effects.

Drug Interactions

There are no reported drug interactions associated with the use of this medication. Additionally, no interactions with laboratory tests have been identified. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug interactions.

Packaging & NDC

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

Pediatric Use

Pediatric patients under 6 years of age should be kept out of reach of the product. It is important to instruct children in this age group on proper brushing and rinsing techniques to minimize the risk of swallowing. Supervision is recommended until children are capable of using the product without assistance.

For children under 2 years of age, consultation with a dentist or doctor is advised prior to use. For those aged 2 years and older, it is recommended that they brush their teeth thoroughly, preferably after each meal or at least twice daily, or as directed by a dentist or doctor.

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

The available data regarding the use of this medication during pregnancy is limited. There are no specific safety concerns outlined for pregnant patients, nor are there any dosage modifications recommended for this population. Additionally, no special precautions have been identified for the use of this medication in pregnant individuals. Healthcare professionals should consider the potential benefits and risks when prescribing this medication to women of childbearing potential. As always, it is advisable to monitor for any adverse effects and to counsel patients accordingly.

Lactation

There are no specific warnings or recommendations regarding the use of this product by lactating mothers. Additionally, there are no specific considerations or precautions mentioned regarding lactation or the potential for excretion in breast milk.

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 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 typically used for brushing, it is imperative to seek medical help or contact a Poison Control Center without delay.

Healthcare professionals should be aware that prompt intervention can mitigate potential adverse effects associated with overdosage. Symptoms may vary depending on the specific substance involved, and monitoring for any signs of toxicity is essential.

Management procedures should include a thorough assessment of the patient's condition and the implementation of appropriate treatment protocols as guided by clinical judgment and established guidelines.

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 in these areas limits the understanding of the compound's potential effects in nonclinical settings.

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 they accidentally swallow more than the amount intended for brushing. It is important for patients to understand the potential risks associated with excessive ingestion and to act promptly in such situations.

Storage and Handling

The product is supplied in a container that must be kept tightly closed to maintain its integrity. It should be stored at room temperature, away from direct light exposure to protect its quality. Once opened, the product should be discarded to ensure safety and efficacy.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)