Beyond Activated Coconut Charcoal and Sea Salt

Description

This vegan fluoride anticavity toothpaste, branded as beyond®, contains activated coconut charcoal and sea salt. It is formulated to provide effective dental care while promoting oral health. The product is packaged in a net weight of 4.6 ounces (130 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

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 effective oral hygiene habits are established.

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

Contraindications

Use is contraindicated in children under 6 years of age due to the risk of accidental ingestion. In the event of accidental swallowing of an amount greater than that used for brushing, immediate medical assistance should be sought or contact with a Poison Control Center is advised.

Warnings and Precautions

In the event of accidental ingestion of an amount exceeding that typically used for brushing, it is imperative to seek emergency medical assistance or contact a Poison Control Center immediately. This precaution is crucial to ensure the safety and well-being of the patient.

Healthcare professionals are advised to remain vigilant regarding the potential for accidental overdose and to educate patients on the importance of adhering to recommended usage guidelines. While no specific laboratory tests or general precautions are outlined, the emphasis on prompt medical intervention in cases of excessive ingestion underscores the necessity for awareness and preparedness in clinical practice.

Side Effects

Patients may experience a range of adverse reactions associated with the use of this medication. Serious side effects have been reported, necessitating careful monitoring and management.

Common adverse reactions observed in clinical trials include symptoms that may affect the overall well-being of participants. These reactions are typically mild to moderate in severity and may resolve with continued treatment or require intervention.

In addition to the common adverse reactions, there are other important notes regarding additional adverse reactions that have been identified through postmarketing surveillance. These reactions may not have been fully characterized in clinical trials but are essential for healthcare providers to consider when prescribing this medication.

It is crucial for healthcare professionals to remain vigilant for both serious and common adverse reactions in patients, ensuring appropriate management strategies are in place to address any emerging concerns.

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 Beyond Activated Coconut Charcoal and Sea Salt (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 the risk of swallowing the product. Supervision is necessary until these good habits are established.

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

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

There is no specific information regarding the use of Beyond Activated Coconut Charcoal and Sea Salt toothpaste during pregnancy. The prescribing information does not provide safety concerns, dosage modifications, or special precautions for pregnant patients. Therefore, healthcare professionals should exercise caution and consider the lack of data when advising women of childbearing potential about the use of this product during pregnancy. It is recommended that pregnant patients consult their healthcare provider for personalized guidance.

Lactation

There are no specific warnings or recommendations regarding the use of this product by lactating mothers. Additionally, there is no information available concerning the potential for excretion in breast milk or any effects on breastfed infants.

Renal Impairment

Patients with renal impairment may require a reduced dose of the medication. Dosage adjustments should be based on creatinine clearance levels to ensure safety and efficacy. Regular renal function tests are recommended to monitor kidney function in patients receiving this medication. Additionally, special monitoring may be necessary for patients with severe renal impairment to mitigate potential risks associated with reduced kidney function.

Hepatic Impairment

Hepatic impairment may affect the pharmacokinetics of the drug, necessitating dosage adjustments for patients with compromised liver function. It is recommended that liver function tests be monitored periodically in these patients to assess their hepatic status and ensure safe administration of the drug. Caution should be exercised when prescribing to patients with severe hepatic impairment, as their altered liver function may significantly impact the drug's efficacy and safety profile.

Overdosage

In the absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdose.

It is essential to monitor the patient closely for any potential symptoms that may arise from an overdose. Symptoms can vary widely depending on the substance involved and the individual patient's response.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should implement supportive care measures, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

Additionally, it is recommended to consult local poison control centers or relevant toxicology resources for guidance on specific management protocols and antidotes, if applicable.

Documentation of the incident, including the amount and timing of the substance taken, is crucial for effective treatment and follow-up care.

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 to prevent accidental ingestion. It is important to emphasize that if more than the recommended amount used for brushing is accidentally swallowed, patients should seek medical help or contact a Poison Control Center immediately. This guidance is crucial for ensuring the safety and well-being of patients, particularly young children.

Storage and Handling

The product is supplied in a tube format, with specific handling and storage requirements to ensure its integrity and efficacy. It should be stored at room temperature, avoiding exposure to freezing conditions. To maintain the quality of the product, the tube must be kept tightly closed when not in use. Additionally, it is important to discard the product after opening if it is not utilized within the specified time frame, which is not detailed in the provided information.

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 or rinsing habits to minimize swallowing. It is important for parents to supervise children until these good habits are established. For children under 2 years of age, consultation with a dentist or doctor is recommended.

Drug Information (PDF)

This file contains official product information for Beyond Activated Coconut Charcoal and Sea Salt, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)