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. 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 without assistance.

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

Contraindications

Use of this product is contraindicated in the following situations:

• Swallowing the product is prohibited due to potential adverse effects associated with ingestion.

• Application in the eye area is contraindicated to prevent irritation or injury to the ocular tissues.

Warnings and Precautions

The product is contraindicated for ingestion and should not be swallowed. It is also essential 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. This precaution is critical to prevent accidental ingestion or misuse.

In the event of accidental ingestion, particularly if more than the recommended amount for brushing is swallowed, immediate medical assistance should be sought. Healthcare professionals are advised to contact a Poison Control Center without delay to ensure appropriate management of the situation.

No specific instructions for discontinuation of use and consultation with a healthcare provider are provided in the insert. However, practitioners should remain vigilant and assess the need for further evaluation based on individual patient circumstances.

Side Effects

Patients should be aware of the following warnings associated with the use of this product. It is imperative that the product is not swallowed and is not used in the eye area. Additionally, the product should 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 swallowed, it is crucial to seek medical assistance or contact a Poison Control Center immediately.

These precautions are essential to ensure the safe use of the product and to mitigate any potential adverse reactions.

Drug Interactions

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

Packaging & NDC

Below are the non-prescription pack sizes of Hismile (grape bubblegum 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. It is important to instruct these children in proper brushing and rinsing habits to minimize the risk of swallowing. Supervision is recommended for children until they 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.

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. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy.

Pregnancy

The safety of this product during pregnancy has not been established. Caution is advised as the effects on fetal development are not well studied, and no specific information regarding risks to the fetus is provided. Healthcare providers should be consulted before use in pregnant patients or those planning to become pregnant. There are no specific dosage modifications for pregnant individuals mentioned in the available data.

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 information available 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 clinical judgment when considering the use of this medication in patients with liver problems, as the absence of specific guidance necessitates careful evaluation of the patient's overall health status and liver function.

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 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 text.

Patient Counseling

Healthcare providers should advise patients to avoid swallowing the product, as it is intended solely for brushing purposes. Instruct patients to seek immediate medical assistance or contact a Poison Control Center if they accidentally swallow more than the amount used for brushing. Additionally, it is important to inform patients that the product should not be used in the eye area to prevent potential 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. The container must be protected from light to prevent degradation of the product. Additionally, it is important to keep the container tightly closed when not in use to ensure stability. Any unused product should be discarded after opening if it is not utilized within the specified time frame, which is not detailed in the provided information.

Additional Clinical Information

The product is administered via the dental route. Clinicians should counsel patients on important safety measures: the product should not be swallowed or used in the eye area, and it 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, patients should seek medical assistance or contact a Poison Control Center immediately.

For children under 6, it is essential to instruct them in proper brushing and rinsing techniques to minimize swallowing, and supervision is recommended until they can use the product independently. Additionally, for children under 2 years of age, consultation with a dentist or doctor is advised.

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)