Doctrust Doublex Tooth

Description

No description information is available for the drug.

Uses and Indications

This drug is indicated for the protection against cavities.

There are no teratogenic effects associated with this drug. Additionally, no nonteratogenic effects have been reported.

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 recommended to use a pea-sized amount of toothpaste to minimize the risk of swallowing. Caregivers should supervise the brushing process until proper oral hygiene habits are established.

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

Contraindications

Use is contraindicated in children under 6 years of age due to safety concerns. Ensure that the product is kept out of reach of this age group to prevent accidental ingestion or misuse. No other contraindications have been identified.

Warnings and Precautions

The product should not be swallowed; users are advised to rinse the mouth thoroughly after use to minimize any potential adverse effects. For children under the age of 6, it is imperative to use only a pea-sized amount of toothpaste and to do so under the supervision of a guardian. This precaution is essential to prevent the child from sucking or swallowing the toothpaste.

In the event that a child under 6 years of age ingests a large quantity of toothpaste, it is crucial to seek immediate consultation with a physician or dentist. Additionally, the product must be stored out of reach of children under 6 years of age to ensure their safety.

General precautions emphasize the importance of keeping the product away from children under 6 years of age, reinforcing the need for vigilant supervision and proper storage to prevent accidental ingestion.

Side Effects

Patients may experience various adverse reactions associated with the use of this product. It is important to note that the product should not be swallowed; users are advised to rinse their mouths thoroughly after use to minimize any potential side effects.

For children under 6 years of age, it is recommended to use only a pea-sized amount of toothpaste under the supervision of a guardian to prevent the risk of sucking or swallowing. In the event that a child under 6 years of age swallows a large amount of toothpaste, it is crucial to consult a physician or dentist immediately.

Additionally, the product should be kept out of reach of children under 6 years of age to ensure their safety. These precautions are essential to mitigate the risk of adverse reactions in this vulnerable population.

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 warranted at this time.

Packaging & NDC

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

Pediatric Use

Pediatric patients under 6 years of age should use only a pea-sized amount of toothpaste, applied under the supervision of a guardian, to minimize the risk of sucking or swallowing. It is essential to supervise brushing until good oral hygiene habits are established. In the event that a child under 6 years swallows a large amount of toothpaste, immediate consultation with a physician or dentist is advised. Additionally, toothpaste should be kept out of reach of children in this age group. For children under 2 years, it is recommended to consult a dentist or doctor 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. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population.

Pregnancy

There is no specific information available regarding the use of this medication during pregnancy, including safety concerns, dosage modifications, or special precautions that should be taken. Healthcare professionals are advised to consider the lack of data when prescribing this medication to pregnant patients and 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 and should be informed of the need to discuss any plans for pregnancy with their healthcare provider.

Lactation

There are no specific warnings or recommendations regarding the use of this product in nursing mothers. Additionally, there is no information available about the potential for excretion in breast milk or any associated risks to 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 relation to the use of 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 overdosage, particularly in pediatric patients, immediate medical consultation is advised. Specifically, if a child under 6 years of age ingests a significant quantity of toothpaste, it is imperative to seek guidance from a physician or dentist without delay.

Healthcare professionals should be aware that symptoms of overdosage may vary based on the specific formulation of the toothpaste ingested. Prompt assessment and management are crucial to mitigate any potential adverse effects. It is recommended that caregivers provide as much information as possible regarding the amount and type of toothpaste consumed when seeking medical assistance.

In summary, the immediate action for any suspected overdosage in young children involves contacting a healthcare provider to ensure appropriate evaluation and intervention.

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 in these areas limits the understanding of the compound's safety profile in nonclinical settings.

Postmarketing Experience

No postmarketing experience details are available in the insert.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of the reach of children under 6 years of age. It is important to emphasize the potential risks associated with accidental ingestion by young children and to encourage patients to store the medication in a secure location.

Storage and Handling

This product is supplied in various package configurations, with specific NDC numbers available upon request. It is essential to store the product within the recommended temperature range to maintain its efficacy. The product should not be exposed to extreme temperatures or direct sunlight, as improper storage conditions may compromise its integrity. Care should be taken to ensure that the product is kept in a suitable environment to prevent degradation.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Doctrust Doublex Tooth, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)