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O Bits Xylitol Toothpaste Fresh Mint Flavor

Last content change checked dailysee data sync status

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
82989-010

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 Fresh Mint Flavor is a toothpaste designed to help protect your teeth from cavities, plaque, and gingivitis (a type of gum disease). It contains xylitol, a natural sweetener that can also contribute to oral health by reducing harmful bacteria in the mouth.

Using this toothpaste can be a beneficial part of your daily dental care routine, helping to keep your smile healthy and fresh.

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 healthier gums.

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

When using this medication, you should chew the tablet briefly before brushing your teeth thoroughly at least twice a day, ideally after each meal. If you have any specific instructions from your dentist or doctor, be sure to follow those as well.

If you are helping a child under 12 years old, it's important to teach them good brushing and rinsing habits to reduce the chance of swallowing the tablet. For children under 6 years old, do not use this medication unless a dentist or doctor has specifically directed you to do so.

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. While there are no specific contraindications or concerns about abuse, misuse, or dependence associated with this medication, always prioritize safety by following this guideline. If you have any questions or concerns about using this medication, consult with your healthcare provider for personalized advice.

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 the amount 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 their teeth, 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 further advice. Your safety is a priority, so don’t hesitate to reach out for help if needed.

Overdose

If you accidentally swallow more of this product than what is typically used for brushing your teeth, it’s important to seek medical help immediately or contact a Poison Control Center. This is crucial to ensure your safety and receive the appropriate care.

Signs of an overdose may not be obvious, but if you experience any unusual symptoms after swallowing too much, don’t hesitate to reach out for assistance. Remember, it’s always better to be cautious when it comes to your health.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to be aware that there is no specific information available regarding the use of this medication during pregnancy. This means that safety concerns, dosage adjustments, or any special precautions have not been established.

Before taking this medication, you should consult with your healthcare provider to discuss any potential risks and to ensure that you are making informed decisions for your health and the health of your baby. Always prioritize open communication with your doctor about any medications you are considering during pregnancy.

Lactation Use

If you are breastfeeding, you can feel reassured that there are no specific warnings or recommendations regarding nursing mothers in the information provided. Additionally, there are no particular considerations or precautions related to lactation mentioned. This suggests that the use of the medication may not pose significant risks to you or your nursing infant. However, it's always a good idea to consult with your healthcare provider about any medications you are taking while breastfeeding to ensure the best care for you and your baby.

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 good 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

While there is no specific information available about the use of this medication in older adults, it’s important to approach any new treatment with caution. Since older adults may have different health needs and responses to medications, you should always consult with a healthcare provider before starting any new medication. They can help determine the right dosage and monitor for any potential side effects, ensuring that the treatment is safe and effective for you or your loved one.

Renal Impairment

If you have kidney problems, it's important to know that the information provided does not include specific guidelines for dosage adjustments, special monitoring, or safety considerations related to renal impairment (kidney issues). This means that there are no tailored recommendations for how your treatment may need to change based on your kidney function.

Always consult your healthcare provider for personalized advice and to ensure that your treatment is safe and effective for your specific health needs. They can help determine the best approach for managing your condition while considering your kidney 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 (issues with liver function).

Always consult your healthcare provider for personalized advice and to discuss any concerns you may have regarding your liver health and medication use. They can help ensure that your treatment is safe and effective based on your individual health needs.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications you are taking. In this case, there are no specific drug interactions or laboratory test interactions noted, which means that this medication is generally considered safe to use alongside other treatments and tests. However, every individual is different, and your healthcare provider can help ensure that your overall treatment plan is safe and effective for you.

Always remember that discussing your full list of medications and any lab tests with your healthcare provider is crucial. This way, you can avoid any potential issues and receive the best care tailored to your needs.

Storage and Handling

To ensure the best performance and safety of your product, store it at a temperature between 33.8°F and 86°F (1°C to 30°C). Keeping it within this range helps maintain its effectiveness.

When handling the product, always do so with clean hands or gloves to prevent contamination. If there are any specific components included with the product, make sure to follow any additional instructions provided for their use or safety. Proper storage and careful handling are key to ensuring the product works as intended.

Additional Information

No further information is available.

FAQ

What is O-Bits Xylitol Toothpaste used for?

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

What age group 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?

Yes, keep it 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.

Can I use O-Bits Xylitol Toothpaste during pregnancy or while nursing?

The insert does not provide specific information regarding use during pregnancy or lactation.

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 temperatures between 33.8-86℉ (1-30°C).

Packaging Info

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

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

Drug Information (PDF)

This file contains official product information for O Bits Xylitol Toothpaste Fresh 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 is presented in a tablet form, specifically designed for oral hygiene. Each pack contains 30 tablets, formulated with a fresh mint flavor to enhance the user experience. The product is identified by the National Drug Code (NDC) 82989-010-01. The packaging is a cello pack, ensuring the integrity and freshness of the tablets.

Uses and Indications

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

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

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 physician.

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 physician.

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 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 this product out of reach of children under 6 years of age. In the event that more than the recommended amount 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 specific drug interactions have been identified for this medication. Additionally, there are no reported interactions with laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug or laboratory test interactions.

Packaging & NDC

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

Packaging configurations for O Bits Xylitol Toothpaste Fresh 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. For children 6 years of age and older, the recommended usage 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.

Healthcare professionals should instruct children under 12 years of age in proper brushing and rinsing techniques to minimize the risk of swallowing 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.

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

There is no specific information regarding the use of this medication during pregnancy, including safety concerns, dosage modifications, or special precautions. Healthcare professionals should consider the lack of data when prescribing this medication to pregnant patients. It is advisable 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 the need to inform their healthcare provider if they become pregnant or plan to become pregnant while on this medication.

Lactation

There are no specific warnings or recommendations regarding nursing mothers. Additionally, there are no specific considerations or precautions related to lactation mentioned. Therefore, healthcare professionals may consider the use of this medication in lactating mothers without specific concerns based on the available data.

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 an overdosage, immediate medical assistance is crucial. If an individual accidentally swallows more than the amount typically used for brushing, it is imperative to seek medical help or contact a Poison Control Center without delay.

Healthcare professionals should be aware that prompt intervention can mitigate potential adverse effects associated with overdosage. Monitoring for symptoms and providing appropriate management based on clinical presentation is essential.

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 understanding of the potential toxicological profile in nonclinical settings.

Postmarketing Experience

No postmarketing experience details are available for SPL code 90375-7.

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 at a temperature range of 33.8 to 86°F (1 to 30°C) to ensure its stability and efficacy. Proper storage conditions must be maintained, and the product should be kept in its original container to protect it from environmental factors. Special handling requirements should be observed to prevent any compromise to the product's integrity.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for O Bits Xylitol Toothpaste Fresh 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 Fresh 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

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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.