Orajel Gabbys Dollhouse

Description

DREAMWORKS GABBY'S DOLLHOUSE Stage 2 is a fluoride-containing anti-cavity toothpaste specifically formulated for children aged 0-3 years. This product features a naturally sourced formulation with a natural fruity bubble flavor. It is packaged in a plastic tube with a net weight of 4.2 ounces (119 grams). The product is certified by Green-e® for renewable energy and is a proud supporter of the Arbor Day Foundation®.

Uses and Indications

This drug is indicated for the prevention of dental decay. 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 after meals or at least twice a day, 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 the product.

For children under 2 years, 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 or contact with a Poison Control Center is advised.

Warnings and Precautions

It is imperative to keep this product out of the reach of children under 6 years of age to prevent accidental ingestion. In the event that more than the recommended amount used for brushing is accidentally swallowed, immediate medical assistance should be sought. Healthcare professionals are advised to instruct patients to contact a Poison Control Center or seek emergency medical help without delay.

Patients should be informed of the importance of stopping the use of the product and consulting their healthcare provider if they experience any adverse effects, although specific instructions for discontinuation were not provided in the available information.

No specific general precautions or laboratory tests have been outlined; however, healthcare professionals should remain vigilant and monitor for any potential side effects or complications associated with the use of this product.

Side Effects

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

These precautions are essential to ensure the safety and well-being of patients, particularly young children who may be more susceptible to adverse effects from improper use.

Drug Interactions

No specific drug interactions have been identified in the available data. Additionally, there are no reported interactions between the drug and laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on the current information.

Packaging & NDC

Below are the non-prescription pack sizes of Orajel Gabbys Dollhouse (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.

Supervision is necessary for children until they are capable of using the product without assistance. For children aged 2 years and older, it is recommended to brush teeth thoroughly after meals or at least twice a day, or to use the product as directed by a dentist or physician.

For children under 6 years, caregivers should instruct them in proper brushing and rinsing techniques to minimize the risk of swallowing. For children under 2 years, consultation with a dentist or physician is recommended prior to use.

Geriatric Use

There is no specific information regarding the use of Orajel Gabby's Dollhouse toothpaste in geriatric patients. The prescribing information does not provide details on dosage adjustments, safety concerns, or special precautions that may be applicable to elderly patients. Therefore, healthcare providers should exercise clinical judgment when considering the use of this product in the geriatric population, as individual patient factors may influence safety and efficacy. Monitoring for any adverse effects is advisable when administering this product to elderly patients.

Pregnancy

There is no specific information regarding the use of Orajel Gabby's Dollhouse toothpaste during pregnancy. As such, safety concerns, dosage modifications, or special precautions for pregnant patients have not been established. Healthcare professionals should consider the absence of data when advising women of childbearing potential and weigh the potential risks and benefits of using this product during pregnancy.

Lactation

There is no specific information available regarding the use of Orajel Gabby's Dollhouse toothpaste in lactating mothers or its effects on breastfed infants. Healthcare professionals should consider this lack of data when advising lactating mothers on the use of this product.

Renal Impairment

Patients with renal impairment may not have specific dosage adjustments, special monitoring, or safety considerations outlined in the prescribing information. Therefore, healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment and individualized patient assessment. Regular monitoring of renal function is advisable to ensure patient safety and therapeutic efficacy.

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 specific substance involved, and monitoring for adverse effects is recommended.

Management procedures should include supportive care and symptomatic treatment as necessary. It is advisable to have the product's labeling and any relevant patient information available when contacting medical professionals or poison control for guidance.

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 configuration that ensures optimal usability. It should be stored at room temperature, away from extreme temperatures. It is essential to protect the product from freezing to maintain its integrity. Additionally, the cap must be kept tightly closed when not in use to prevent contamination and ensure the product remains effective.

Additional Clinical Information

The medication is administered orally. For adults and children aged 2 years and older, it is recommended to brush teeth thoroughly after meals or at least twice a day, or to use as directed by a dentist or physician. For children under 6 years, caregivers should instruct them in proper brushing and rinsing habits to minimize swallowing. For children under 2 years, consultation with a dentist or physician is advised.

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

View product document (PDF)