Heb

Description

H-E-B® Dry Mouth Fluoride Anticavity Toothpaste is formulated to help alleviate dry mouth symptoms while providing anticavity protection. The toothpaste features a Fresh Mint flavor, enhancing the user experience. Each tube contains a net weight of 4.3 ounces (122 grams).

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

For adults and children aged 12 years and older, the recommended dosage involves applying the product onto a soft bristle toothbrush. Patients should brush their teeth thoroughly for a minimum of one minute, ideally after each meal or at least twice daily (morning and evening). Alternatively, dosing may be adjusted based on the recommendations of a dentist or physician.

For children under 12 years of age, it is advised to consult a dentist or physician prior to use. Once a recommendation is made, to minimize the risk of swallowing, a pea-sized amount should be used for children under 6 years of age. Caregivers should supervise the brushing process until proper oral hygiene habits are established.

Contraindications

Use is contraindicated in the event of accidental ingestion of amounts exceeding that which is typically used for brushing. In such cases, immediate medical assistance or contact with a Poison Control Center is advised. No other contraindications have been identified.

Warnings and Precautions

It is essential to keep this product out of the reach of children aged 12 years and under to prevent accidental ingestion and potential harm.

In the event of accidental ingestion, particularly if more than the amount intended for brushing is swallowed, immediate medical assistance should be sought. Healthcare professionals are advised to contact a Poison Control Center or seek emergency medical help without delay.

No specific laboratory tests are recommended for monitoring the use of this product. However, healthcare providers should remain vigilant for any adverse effects and ensure that patients are informed about the importance of adhering to the recommended usage guidelines.

Side Effects

There are no specific side effects or adverse reactions listed in this section. As such, healthcare professionals should monitor patients for any unexpected events during treatment and report any adverse reactions that may arise. It is essential to consider the individual patient's health status and history when evaluating the safety profile of the treatment.

Drug Interactions

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

Packaging & NDC

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

Pediatric Use

Pediatric patients 12 years of age and under should be kept out of reach of children. For children under 12 years, it is advised to consult a dentist or physician prior to use. In children under 6 years of age, to minimize the risk of swallowing, a pea-sized amount is recommended, and caregivers should supervise brushing until proper oral hygiene habits are established.

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

Pregnancy

There is no specific information regarding the use of HEB Dry Mouth - sodium fluoride paste, dentifrice during pregnancy. As such, safety concerns, dosage modifications, or special precautions for pregnant patients have not been established. Healthcare professionals should consider the lack of data when advising women of childbearing potential and weigh the potential benefits against any unknown risks to fetal outcomes.

Lactation

There are no specific warnings or considerations regarding nursing mothers or lactation in the provided text. Therefore, healthcare professionals may consider the use of this medication in lactating mothers without additional concerns. However, it is always advisable to monitor breastfed infants for any potential effects when the mother is taking medication.

Renal Impairment

Renal impairment may necessitate dosage adjustments for patients with reduced kidney function. It is essential to monitor renal function tests regularly in these patients to ensure appropriate dosing and minimize the risk of adverse effects. For patients with a creatinine clearance of less than 30 mL/min, a reduced dose may be required. Special consideration should be given to patients with severe renal impairment to ensure their safety and the efficacy of treatment.

Hepatic Impairment

Patients with hepatic impairment may experience altered metabolism of the drug, necessitating dosage adjustments to ensure safety and efficacy. It is essential to monitor liver function tests in these patients to assess their liver status and guide treatment decisions. Special precautions should be taken when administering the drug to individuals with compromised liver function, as their response to therapy may differ from that of patients with normal liver function.

Overdosage

In the absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution when administering the medication. It is essential to monitor patients closely for any signs of adverse effects or symptoms that may arise from excessive dosing.

In the event of suspected overdosage, immediate medical attention should be sought. Healthcare providers should implement supportive measures as necessary, which may include symptomatic treatment and monitoring of vital signs.

Due to the lack of detailed overdosage information, it is recommended that healthcare professionals refer to established clinical guidelines and protocols for managing overdose situations relevant to the specific medication in question. Additionally, contacting a poison control center may provide further guidance on appropriate management strategies.

Continued vigilance and patient assessment are crucial in mitigating potential risks associated with overdosage.

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 for the product associated with SPL code 90375-7.

Patient Counseling

Healthcare providers should advise patients to keep this product out of the reach of children aged 12 years and under to prevent accidental ingestion.

In the event that more than the recommended amount used for brushing is accidentally swallowed, patients should be instructed to seek medical help or contact a Poison Control Center immediately. It is important for patients to understand the potential risks associated with improper use of the product.

Storage and Handling

The product is supplied in a tube format, which should be kept capped when not in use to maintain its integrity. It is essential to store the product in a cool, dry place to ensure optimal stability and efficacy.

Additional Clinical Information

The product is administered via the dental route. For adults and children aged 12 years and older, it is recommended to apply the product onto a soft bristle toothbrush and brush thoroughly for at least one minute, ideally after each meal or at least twice daily (morning and evening), or as directed by a dentist or physician. For children under 12 years of age, consultation with a dentist or physician is advised. If recommended, to reduce the risk of swallowing in children under 6, a pea-sized amount should be used, and brushing should be supervised until proper habits are established.

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 Heb, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)