Tidalove Smile More Oral Care

Description

The product is identified by the SPL code 34089-3. No specific description details are provided in the text.

Uses and Indications

This drug is indicated for the oral hygiene of adults and children aged 6 years and older. Patients are advised to chew 1 tablet until it is thoroughly crushed, followed by brushing their teeth thoroughly at least twice a day, or as directed by a dentist or physician. It is important to note that the tablet should be spat out and not swallowed.

Children under the age of 6 years should be supervised while using this product to ensure safe and appropriate use.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

Healthcare professionals should instruct patients to gently chew 1 tablet until it is fully crushed. Following the administration of the tablet, it is essential for patients to brush their teeth thoroughly to maintain oral hygiene and prevent any potential adverse effects associated with the medication.

Contraindications

Use of this product is contraindicated in patients who experience irritation or sensitivity during use; in such cases, discontinuation is required. Additionally, the tablet must not be swallowed; it should be spat out after use. No other contraindications have been specified.

Warnings and Precautions

The product is intended solely for the purpose of brushing teeth. It is imperative that users exercise caution to avoid swallowing the product. In the event that an amount exceeding the recommended usage for brushing is accidentally ingested, immediate medical assistance should be sought, or contact with a Poison Control Center is advised.

To ensure safety, the product must be kept out of the reach of children. Special attention should be given to the risk of choking, as small tablets may pose a hazard for children under the age of three.

Users should be vigilant for any signs of irritation or sensitivity while using the product. Should such reactions occur, it is essential to discontinue use immediately to prevent further complications.

Side Effects

Patients may experience irritation or sensitivity while using the product. In such cases, it is advised to discontinue use immediately. Monitoring for these reactions is essential to ensure patient safety and comfort.

Drug Interactions

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

Packaging & NDC

Below are the non-prescription pack sizes of Tidalove Smile More Oral Care (sodium fluoride tablet). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients aged 6 years and older are instructed to chew 1 tablet until it is fully crushed. For children under 6 years of age, supervision is recommended during use to ensure safety. It is important to note that small tablets may pose a choking hazard for children under 3 years old. In the event that more than the recommended amount for brushing is accidentally swallowed, immediate medical assistance should be sought or contact with a Poison Control Center is advised.

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. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy, given the lack of targeted data for this population.

Pregnancy

The safety of this product during pregnancy has not been established. Caution is advised as the effects on fetal development are not well studied, and no specific data regarding risks to the fetus are provided. Healthcare providers should be consulted before use in pregnant patients or those planning to become pregnant. There are no specific dosage modifications for pregnant individuals mentioned in the available data.

Lactation

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

Renal Impairment

There is no information available regarding renal impairment, dosage adjustments, special monitoring, or safety considerations for patients with reduced kidney function. Healthcare professionals should exercise caution and consider individual patient factors when treating patients with renal impairment, as specific guidelines or recommendations are not provided in the current data.

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 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 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 readily 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

Postmarketing experience has indicated that in cases where irritation or sensitivity occurs during the use of this product, discontinuation of use is recommended. This information has been reported voluntarily and through surveillance programs.

Patient Counseling

Healthcare providers should advise patients to keep this product out of the reach of children to prevent accidental ingestion. It is important to inform patients that if irritation or sensitivity occurs while using the product, they should discontinue use immediately.

For adults and children aged 6 years and older, patients should be instructed to chew 1 tablet until it is crushed. They should also be reminded to brush their teeth thoroughly at least twice a day or use the product as directed by a dentist or physician. Patients must be cautioned to spit out the tablet and not to swallow it.

Additionally, healthcare providers should emphasize that children under 6 years of age should be supervised when using this product to ensure safety. In the event that more than the recommended amount is accidentally swallowed, patients should seek medical help or contact a Poison Control Center without delay.

Storage and Handling

The product is supplied in configurations that include specific NDC numbers. It should be stored at a temperature range of 25-30 °C (68-77 °F). Care must be taken to protect the product from excessive moisture to ensure its integrity and efficacy.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Tidalove Smile More Oral Care, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)