Just Right 5000

Description

The drug is identified by SPL code 34089-3 and is presented as a white to off-white, round, biconvex tablet, which is debossed with "34089" on one side and "3" on the opposite side. Each tablet contains 3 mg of the active ingredient. The formulation includes several inactive ingredients: lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, magnesium stearate, and a film coating composed of hypromellose, titanium dioxide, polyethylene glycol, and iron oxide.

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 should wet a toothbrush and pump the toothpaste dispenser once to apply a pea-sized amount, approximately 0.25 grams, onto the toothbrush. It is recommended to brush thoroughly after meals or at least twice a day, or as directed by a dentist or physician.

For children under 6 years, to minimize the risk of swallowing, it is advised to pump the dispenser only once to dispense a pea-sized amount. Caregivers should supervise children's brushing until proper 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. This precaution is necessary to prevent potential harm due to the product's formulation or effects in this age group.

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 used for brushing is accidentally swallowed, immediate medical assistance should be sought, or contact with a poison control center is advised without delay.

Healthcare professionals should ensure that caregivers are aware of this critical safety information to prevent accidental ingestion and potential harm to young children.

Side Effects

Patients should be advised to keep this 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, it is imperative to seek medical help or contact a poison control center immediately. This warning highlights the potential seriousness of accidental ingestion in young children and underscores the importance of proper usage and supervision.

Drug Interactions

There are no documented drug interactions associated with this medication. Additionally, there is no information available regarding interactions with laboratory tests. Therefore, no specific recommendations for dosage adjustments or monitoring are necessary based on drug interactions.

Packaging & NDC

Below are the non-prescription pack sizes of Just Right 5000 (1.1% sodium fluoride toothpaste). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients should be supervised during brushing to establish good oral hygiene habits. For children aged 2 years and older, a pea-sized amount (approximately 0.25 grams) of toothpaste should be applied to a wet toothbrush, and they should brush thoroughly after meals or at least twice daily, or as directed by a dentist or physician. To minimize the risk of swallowing, it is recommended that only one pump be used to dispense the toothpaste for children under 6 years of age.

For children under 2 years, consultation with a dentist or physician is advised before use. It is important to keep this product out of reach of children under 6 years. In the event that more than the recommended amount is accidentally swallowed, medical assistance or contact with a poison control center should be sought immediately.

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 Just Right 5000 - 1.1% sodium fluoride toothpaste gel, dentifrice, in pregnant patients. The prescribing information does not provide safety concerns, dosage modifications, or special precautions for use during pregnancy. Healthcare professionals should consider the absence of data when advising women of childbearing potential and weigh the benefits against any potential risks when recommending this product.

Lactation

There are no specific warnings or recommendations regarding the use of this medication in nursing mothers. Additionally, there are no specific warnings or recommendations related to lactation. Healthcare professionals should consider the absence of data when advising lactating mothers about the use of this medication.

Renal Impairment

Patients with renal impairment may not have specific information regarding 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 optimal therapeutic outcomes.

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, it is crucial to ensure that the product is kept out of reach of children under 6 years of age. Accidental ingestion of amounts exceeding the recommended usage for brushing may lead to adverse effects.

Should an overdose occur, immediate medical assistance should be sought. Healthcare professionals are advised to contact a poison control center without delay to obtain guidance on the appropriate management of the situation. Prompt action is essential to mitigate potential risks associated with overdosage.

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 this product out of reach of children under 6 years of age to prevent accidental ingestion.

Patients should be instructed on the proper usage of the product. For adults and children aged 2 years and older, they should wet a toothbrush and pump the dispenser once to apply a pea-sized amount of toothpaste (approximately 0.25 grams) onto the toothbrush. It is recommended that they brush thoroughly after meals or at least twice a day, or as directed by a dentist or physician. To minimize the risk of swallowing, patients should be advised to pump only once to dispense a pea-sized amount for children under 6 years. Additionally, it is important for caregivers to supervise children's brushing until good oral hygiene habits are established. For children under 2 years of age, patients should be encouraged to consult with a dentist or physician before use.

For any questions or further information, patients can be directed to contact customer service at 1-877-866-9113 or visit the website at www.elevateoralcare.com.

Storage and Handling

The product is supplied in configurations that include 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. Once opened, the product must be discarded to ensure safety and efficacy.

Additional Clinical Information

The route of administration for the product is topical. There are no additional details available regarding laboratory tests, abuse information, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Just Right 5000, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)