Hismile Grape Bubblegum Flavor Sodium Fluoride Anticavity Toothpast

Description

No specific information regarding the Description section for SPL code 34089-3 is provided in the text.

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 without assistance.

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

Contraindications

Use of this product is contraindicated in the following situations:

Swallowing the product is prohibited, as it may lead to adverse effects. Additionally, application in the eye area is contraindicated due to the potential for irritation or injury.

Warnings and Precautions

It is imperative to keep this product out of the reach of children under 6 years of age. In the event that more than the recommended amount for brushing is accidentally swallowed, immediate medical assistance should be sought, or contact a Poison Control Center without delay.

General precautions must be observed during use. The product is not intended for ingestion; therefore, it should not be swallowed. Additionally, care should be taken to avoid contact with the eye area, as this may lead to irritation or other adverse effects.

In case of accidental ingestion of an amount exceeding that recommended for brushing, it is crucial to obtain emergency medical help or reach out to a Poison Control Center promptly.

Side Effects

Patients should be aware of the following warnings and precautions associated with the use of this product. It is imperative to keep the product out of reach of children under 6 years of age. In the event that more than the recommended amount used for brushing is accidentally swallowed, medical assistance should be sought immediately, or contact a Poison Control Center for guidance.

When using this product, patients are advised not to swallow it and to avoid application in the eye area to prevent potential adverse effects. Adherence to these guidelines is essential to ensure safety and minimize the risk of adverse reactions.

Drug Interactions

No specific drug interactions have been identified for this medication. Additionally, there are no reported interactions with laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug or laboratory test interactions.

Packaging & NDC

Below are the non-prescription pack sizes of Hismile Grape Bubblegum Flavor Sodium Fluoride Anticavity Toothpast (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. 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 should be instructed in proper brushing and rinsing techniques to minimize swallowing, and they should be supervised as necessary until they are capable of using the product without assistance.

For infants and 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 adverse effects or changes in therapeutic response, 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. 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 effective contraception during treatment.

Lactation

There is no specific information available regarding the use of this medication in nursing mothers or any lactation considerations. Healthcare professionals should exercise caution and consider the potential risks and benefits when prescribing this medication to lactating mothers. Further research may be necessary to fully understand the implications for breastfed infants.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in clinical trials for this medication. Consequently, there is no available information regarding dosage adjustments, special monitoring requirements, or precautions 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 warranted based on clinical judgment.

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 typically used for brushing is accidentally ingested.

Healthcare professionals should be aware that prompt intervention is essential in managing potential overdosage scenarios. Symptoms may vary depending on the substance involved, and monitoring for any adverse effects is recommended.

Management procedures should include assessing the patient's condition and providing supportive care as necessary. It is advisable to follow established protocols for overdosage treatment, which may involve symptomatic management and specific antidotes if applicable.

In all cases of suspected overdosage, timely communication with poison control and adherence to local guidelines will facilitate optimal patient outcomes.

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 keep the product out of reach of children under 6 years of age. It is important to inform 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.

Patients should be cautioned against swallowing the product and should be instructed not to use it in the eye area to avoid potential irritation or injury.

Storage and Handling

The product is supplied in packaging that includes specific NDC numbers. It should be stored at room temperature, ensuring that it is protected from light exposure. Freezing the product is not permitted, as it may compromise its integrity. Additionally, once opened, the product must be discarded to maintain safety and efficacy.

Additional Clinical Information

The product is administered orally. Clinicians should advise patients to keep the product out of reach of children under 6 years of age. In the event that more than the recommended amount used for brushing is accidentally swallowed, patients should seek medical assistance or contact a Poison Control Center immediately. It is important to instruct patients not to swallow the product and to avoid contact with the eye area.

For children under 6 years, caregivers should supervise brushing and rinsing to minimize swallowing and ensure proper oral hygiene practices. Additionally, consultation with a dentist or doctor is recommended for children under 2 years of age.

Drug Information (PDF)

This file contains official product information for Hismile Grape Bubblegum Flavor Sodium Fluoride Anticavity Toothpast, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)