Hismile

Description

No description information is available for the drug.

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 are advised to brush their teeth thoroughly, preferably after each meal or at least twice daily, or as directed by a dentist or physician.

For children under 6 years of age, it is important to instruct them in proper brushing and rinsing techniques to minimize the risk of swallowing. Caregivers should supervise children as necessary until they are capable of brushing without assistance.

For children under 2 years of age, consultation with a dentist or physician is recommended prior to use.

Contraindications

Use of this product is contraindicated in the following situations:

Swallowing the product is prohibited, as ingestion may lead to adverse effects. Application in the eye area is also contraindicated due to the potential for irritation or injury. Additionally, the product should be kept out of reach of children under 6 years of age. In the event of accidental ingestion exceeding the amount used for brushing, immediate medical assistance or contact with a Poison Control Center is advised.

Warnings and Precautions

The product is intended for external use only and should not be swallowed. It is imperative to avoid application in the eye area to prevent potential irritation or injury.

To ensure safety, the product must be kept out of reach of children under 6 years of age. In the event that more than the recommended amount for brushing is accidentally ingested, immediate medical assistance should be sought, or contact with a Poison Control Center is advised.

Healthcare professionals should be aware that if an overdose occurs, characterized by the accidental swallowing of more than the prescribed amount, prompt medical help is essential. Monitoring for any adverse effects following such an incident is recommended.

Patients are advised to discontinue use and consult their healthcare provider if they experience any concerning symptoms, although specific instructions for cessation were not provided in the available information.

Side Effects

Patients should be advised of specific warnings associated with the use of this product. It is crucial that the product is not swallowed and is not used in the eye area.

Additionally, the product must be kept out of reach of children under 6 years of age. In the event that more than the recommended amount is accidentally swallowed, it is imperative to seek medical assistance or contact a Poison Control Center immediately.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there is no information available regarding interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Hismile (strawberry flavor sodium fluoride anticavity toothpaste). 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. In the event that more than the recommended amount for brushing is accidentally swallowed, immediate medical assistance or contact with a Poison Control Center is advised.

For children aged 2 years and older, it is recommended to brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor. Children under 6 years of age should be instructed in proper brushing and rinsing techniques to minimize the risk of swallowing the product. Supervision is necessary until children are capable of using the product without assistance.

For children under 2 years of age, consultation with a dentist or doctor is recommended prior to use.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any potential adverse effects or changes in efficacy, given the lack of targeted data for this population.

Pregnancy

There is no specific information regarding the use of this medication 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. The potential risks and benefits should be carefully evaluated, and alternative treatments may be considered in the absence of established safety profiles. Women of childbearing potential should be counseled on the importance of effective contraception while using this medication.

Lactation

There are no specific warnings or recommendations regarding the use of this product by lactating mothers. Additionally, there are no statements concerning the potential for excretion in breast milk or any associated risks to breastfed infants.

Renal Impairment

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

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to 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. Monitoring for symptoms and providing appropriate management based on clinical presentation is essential. It is recommended that healthcare providers familiarize themselves with local Poison Control resources to ensure rapid access to expert guidance in such situations.

Nonclinical Toxicology

No information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or toxicology.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep the product out of reach of children under 6 years of age to prevent accidental ingestion. Instruct patients that if more than the recommended amount used for brushing is accidentally swallowed, they should seek medical help or contact a Poison Control Center immediately.

It is important to emphasize that the product is not intended for swallowing. Patients should be informed to avoid using the product in the eye area to prevent irritation or injury.

Storage and Handling

The product is supplied in a configuration that includes 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 effectiveness.

To ensure optimal preservation, the product must be protected from light exposure. Additionally, it is crucial to keep the container tightly closed when not in use to prevent contamination and degradation. If applicable, any remaining product should be discarded after opening if not used within the specified time frame.

Additional Clinical Information

The route of administration for the product is dental. Clinicians should instruct parents to teach children under 6 years of age proper brushing and rinsing habits to minimize swallowing. Additionally, supervision is recommended for children until they are capable of using the product without assistance. For children under 2 years of age, it is advised to consult a dentist or doctor prior to use.

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)