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O Bits Xylitol Toothpaste Yuja Mint Flavor

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This product has been discontinued

Active ingredient
Sodium Fluoride 0.22 g/100 1
Other brand names
Dosage form
Paste, Dentifrice
Route
Oral
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2022
Label revision date
September 23, 2022
Active ingredient
Sodium Fluoride 0.22 g/100 1
Other brand names
Dosage form
Paste, Dentifrice
Route
Oral
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Marketed in the U.S.
Since 2022
Label revision date
September 23, 2022
Manufacturer
Project Noah Inc.
Registration number
part355
NDC root
82989-020

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

If you are a consumer or patient please visit this version.

Drug Overview

O-Bits Xylitol Toothpaste Yuja Mint Flavor is a dental product designed to help protect your teeth. It works by combating cavities, plaque, and gingivitis (a type of gum disease). This toothpaste contains xylitol, a natural sweetener that can also contribute to oral health by reducing harmful bacteria in the mouth.

With its refreshing yuja mint flavor, using O-Bits can make your dental care routine more enjoyable while supporting your overall oral hygiene.

Uses

You can use this product to help protect your teeth from cavities, plaque, and gingivitis (a type of gum disease). It’s designed to support your oral health by reducing the buildup of harmful bacteria and promoting a cleaner mouth.

Rest assured, there are no known teratogenic effects (which means it doesn’t cause birth defects) associated with this product, making it a safe choice for most users.

Dosage and Administration

To use this medication effectively, you should chew the tablet briefly before brushing your teeth thoroughly at least twice a day, ideally after each meal. If you’re a parent or guardian, it’s important to guide children under 12 years old in proper brushing and rinsing techniques to help prevent swallowing the tablet.

For children under 6 years of age, you should only use this medication if directed by a dentist or doctor. Always follow the advice of your healthcare provider to ensure safe and effective use.

What to Avoid

It's important to ensure that any medication you use is kept safe and out of reach of children, especially those under 6 years of age. This precaution helps prevent accidental ingestion, which can be harmful.

Currently, there are no specific contraindications, controlled substance classifications, or concerns regarding abuse, misuse, or dependence associated with this medication. Always follow the guidance provided by your healthcare professional and use medications responsibly.

Side Effects

It's important to keep this product out of reach of children under 6 years old. If a child accidentally swallows more than what is used for brushing, seek medical help or contact a Poison Control Center immediately. This precaution helps ensure their safety and well-being.

Warnings and Precautions

It's important to keep this product out of reach of children under 6 years old. If a child accidentally swallows more than what is typically used for brushing, you should seek medical help or contact a Poison Control Center immediately.

Always use this product as directed and be aware of any unusual reactions. If you experience any concerning symptoms or side effects, stop using the product and call your doctor for guidance. Your safety is a priority, so don’t hesitate to reach out for help if needed.

Overdose

It's important to keep this product out of reach of children under 6 years old. If a child accidentally swallows more than what is typically used for brushing their teeth, you should seek medical help or contact a Poison Control Center immediately.

Signs of an overdose can vary, but if you notice unusual symptoms or if someone has ingested too much, don't hesitate to get help right away. Always prioritize safety and act quickly in these situations.

Pregnancy Use

When it comes to using this medication during pregnancy, there is no specific information available about its safety, recommended dosage adjustments, or any special precautions you should take. This means that if you are pregnant or planning to become pregnant, it’s important to discuss your options with your healthcare provider. They can help you weigh the potential risks and benefits based on your individual situation. Always prioritize open communication with your doctor to ensure the best care for you and your baby.

Lactation Use

If you are breastfeeding or planning to breastfeed, it's important to be aware that there is no specific information available regarding the effects of this medication on nursing mothers or lactation (the process of producing breast milk). Since there are no guidelines or data provided, it’s advisable to consult with your healthcare provider to discuss any potential risks or concerns related to your situation. They can help you make informed decisions about your health and your baby's well-being.

Pediatric Use

It's important to keep this product out of reach of children under 6 years old. If a child accidentally swallows more than the amount used for brushing, seek medical help or contact a Poison Control Center immediately. For children aged 6 and older, you should have them chew the tablet briefly before brushing their teeth thoroughly at least twice a day, ideally after each meal or as directed by a dentist or doctor.

If your child is under 12, make sure to teach them proper brushing and rinsing habits to help prevent swallowing. For children under 6, do not use this product unless specifically directed by a dentist or doctor.

Geriatric Use

When it comes to using this medication in older adults, there is no specific information available about dosage adjustments, safety concerns, or special precautions. This means that if you or a loved one is an older adult considering this medication, it’s important to consult with a healthcare provider. They can help determine the best approach based on individual health needs and any other medications being taken. Always prioritize open communication with your healthcare team to ensure safe and effective treatment.

Renal Impairment

If you have kidney problems, it's important to know that there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the standard recommendations for the medication do not include special monitoring or safety considerations tailored for patients with renal impairment (kidney issues).

Always consult your healthcare provider for personalized advice and to ensure that your treatment plan is safe and effective for your specific health needs. They can provide guidance based on your kidney function and overall health.

Hepatic Impairment

If you have liver problems, it's important to know that the drug insert does not provide specific information about dosage adjustments, special monitoring, or precautions for your condition. This means that there are no tailored guidelines for how this medication may affect you if you have hepatic impairment (liver issues).

Before starting any new medication, including this one, you should discuss your liver health with your healthcare provider. They can help determine the best approach for your treatment and ensure your safety.

Drug Interactions

It's great to know that there are no known interactions between this medication and other drugs or laboratory tests. However, it's still very important to discuss all medications you are taking, including over-the-counter drugs and supplements, with your healthcare provider. This ensures that your treatment is safe and effective.

Always keep your healthcare provider informed about any changes in your health or new medications you start. Open communication helps prevent any potential issues and supports your overall well-being.

Storage and Handling

To ensure the best performance of your product, store it in a cool, dry place at a temperature between 33.8°F and 86°F (1°C to 30°C). This temperature range helps maintain the product's effectiveness and safety.

When handling the product, be sure to do so with clean hands and in a sterile field (a clean area free from germs) to prevent contamination. Always follow any specific disposal instructions provided to ensure safe and responsible disposal of any components.

Additional Information

No further information is available.

FAQ

What is O-Bits Xylitol Toothpaste Yuja Mint Flavor used for?

O-Bits Xylitol Toothpaste helps protect against cavities, plaque, and gingivitis.

Who can use O-Bits Xylitol Toothpaste?

Adults and children 6 years of age and older can use it. Children under 6 years should not use it unless directed by a dentist or doctor.

How should I use O-Bits Xylitol Toothpaste?

Chew the tablet briefly before brushing your teeth thoroughly at least twice a day, after each meal, or as directed by a dentist or doctor.

Are there any warnings for using O-Bits Xylitol Toothpaste?

Keep out of reach of children under 6 years of age. If more than used for brushing is accidentally swallowed, seek medical help or contact a Poison Control Center immediately.

Are there any contraindications for O-Bits Xylitol Toothpaste?

No contraindications are listed for O-Bits Xylitol Toothpaste.

Is O-Bits Xylitol Toothpaste safe to use during pregnancy or while nursing?

No specific information is provided regarding the use of O-Bits Xylitol Toothpaste during pregnancy or nursing.

What should I do if I accidentally swallow O-Bits Xylitol Toothpaste?

If more than used for brushing is swallowed, get medical help or contact a Poison Control Center right away.

What is the storage temperature for O-Bits Xylitol Toothpaste?

Store O-Bits Xylitol Toothpaste at a temperature between 33.8-86℉ (1-30°C).

Packaging Info

Below are the non-prescription pack sizes of O Bits Xylitol Toothpaste Yuja Mint Flavor (sodium fluoride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for O Bits Xylitol Toothpaste Yuja Mint Flavor.
Details

Drug Information (PDF)

This file contains official product information for O Bits Xylitol Toothpaste Yuja Mint Flavor, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

O-Bits Xylitol Toothpaste Yuja Mint Flavor is presented in a dosage form of 30 tablets. The product is identified by the National Drug Code (NDC) 82989-020-01. The packaging is designed as a cello pack, which provides a convenient and hygienic method of storage and dispensing.

Uses and Indications

This drug is indicated for the protection against cavities, plaque, and gingivitis.

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

Dosage and Administration

Adults and children aged 6 years and older are advised to chew the tablet briefly before brushing their teeth thoroughly at least twice a day, ideally after each meal or as directed by a dentist or doctor.

For children under 12 years of age, it is essential to instruct them in proper brushing and rinsing techniques to minimize the risk of swallowing the tablet.

The use of this product is not recommended for children under 6 years of age unless specifically directed by a dentist or doctor.

Contraindications

Use is contraindicated in children under 6 years of age. This precaution is necessary to prevent potential harm, as the safety and efficacy of the product have not been established in this age group. Additionally, it is advised to keep the product out of reach of children to avoid accidental ingestion or misuse.

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 for brushing is accidentally ingested, immediate medical assistance should be sought, or contact with a Poison Control Center is advised without delay. This precaution is essential to ensure the safety and well-being of young children who may be at risk of adverse effects from improper use.

Side Effects

Patients should be advised to keep the 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 assistance or contact a Poison Control Center immediately. This warning highlights the potential risks associated with accidental ingestion, underscoring the importance of proper usage and supervision.

Drug Interactions

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

Packaging & NDC

Below are the non-prescription pack sizes of O Bits Xylitol Toothpaste Yuja Mint Flavor (sodium fluoride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for O Bits Xylitol Toothpaste Yuja Mint Flavor.
Details

Pediatric Use

Pediatric patients under 6 years of age should not use this product unless directed by a dentist or doctor. It is important to keep the product out of reach of children in this age group. If more than the recommended amount for brushing is accidentally swallowed, medical assistance or contact with a Poison Control Center should be sought immediately.

For children aged 6 years and older, the recommended use is to chew the tablet briefly before brushing teeth thoroughly at least twice a day, after each meal, or as directed by a dentist or doctor. Additionally, caregivers should instruct children under 12 years of age in proper brushing and rinsing techniques to minimize the risk of swallowing the product.

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. 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

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. The potential risks and benefits should be carefully evaluated, and alternative treatments may be considered in consultation with the patient. Women of childbearing potential should be informed of the absence of established safety data during pregnancy.

Lactation

There is no specific information available regarding the use of this medication in nursing mothers or lactation considerations. Healthcare professionals should exercise caution when prescribing this medication to lactating mothers, as the effects on breastfed infants are not well characterized. It is advisable to weigh the potential benefits against any unknown risks when considering treatment options for lactating patients.

Renal Impairment

There is no specific information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in 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, 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 those recommended for brushing may lead to adverse effects.

If an overdose occurs, 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 question.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

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 ensure that patients understand the necessity of proper storage to prevent such incidents.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product within the temperature range of 33.8 to 86°F (1 to 30°C) to maintain its integrity and efficacy. Proper container requirements must be adhered to, ensuring that the product is kept in a suitable environment. Special handling needs should be observed to prevent any compromise to the product's quality during storage and transportation.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for O Bits Xylitol Toothpaste Yuja Mint Flavor, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Data Generation & Sources

This page was automatically generated and is maintained by the AllDrugs AI Data-Science Team. It was built from the FDA Structured Product Label (DailyMed) for O Bits Xylitol Toothpaste Yuja Mint Flavor, retrieved by a validated AI data-extraction workflow.

All FDA-listed dosage forms and strengths are shown in the Packaging & NDC Codes section above. Regulatory status appears in the Summary Information panel above and was verified in the FDA National Drug Code directory and the NSDE NDC Directory daily file.

Note: an automated daemon monitors NSDE checksums; when the record for this NDC changes, the new file is pulled instantly and this page is refreshed.

No human clinician has reviewed this version.

Learn more in our Editorial Policy

Last AI update:

Primary FDA sources:

Orange Book data shown on this page are limited to Regulatory Status (Rx), Established Pharmacologic Class (EPC), and Mechanism of Action (MoA).

Regulatory data notice: Information on this page is reproduced verbatim from FDA public databases (NSDE, Orange Book, Purple Book, DailyMed SPL). NDA/ANDA drugs are FDA-approved, BLA biologics are FDA-licensed. Inclusion alone does not guarantee current market availability or imply FDA endorsement.

Medical disclaimer: This AI-generated content is provided for educational purposes only and does not constitute medical advice. Always consult a licensed healthcare professional for diagnosis or treatment decisions.