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Dinosaur Bubble Gum Flavor Anti-Cavity Fluoride Tooth

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This product has been discontinued

Active ingredient
Sodium Fluoride 0.14 g/100 g
Other brand names
Dosage form
Paste, Dentifrice
Route
Dental
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2024
Label revision date
July 21, 2024
Active ingredient
Sodium Fluoride 0.14 g/100 g
Other brand names
Dosage form
Paste, Dentifrice
Route
Dental
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Marketed in the U.S.
Since 2024
Label revision date
July 21, 2024
Manufacturer
Yangzhou SION Commodity Co. , Ltd
Registration number
M021
NDC root
70766-016

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

Drug Overview

You may be interested to know that this medication is designed to help prevent dental cavities. It works by providing protection for your teeth, which can be an important part of maintaining good oral health. By using this product, you can take a proactive step in reducing the risk of cavities and supporting your overall dental hygiene.

Uses

You can use this product to help prevent dental cavities, which are small holes in your teeth caused by decay. By incorporating it into your oral care routine, you can support your dental health and reduce the risk of developing these issues. Regular use can be an effective way to maintain a healthy smile.

Dosage and Administration

To keep your teeth healthy, it's important to brush thoroughly, ideally after each meal or at least twice a day. If you're helping a child under 6 years old, use only a pea-sized amount of toothpaste to minimize the chance of swallowing. Always supervise young children while they brush their teeth until they develop good habits.

If your child is under 2 years old, it's best to consult with a dentist or physician before starting any dental care routine. Remember, do not swallow the toothpaste, as it's meant for cleaning your teeth, not for eating. Following these guidelines will help ensure you and your family maintain good oral hygiene.

What to Avoid

It's important to keep this medication out of reach of children to ensure their safety. 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 the medication responsibly.

Side Effects

It's important to keep this product out of the reach of children, especially those under 6 years of age. If a child accidentally swallows more than the amount used for brushing, seek medical help or contact a Poison Control Center right away.

Always ensure that this product is stored safely to prevent any accidental ingestion. Your safety and the safety of those around you are paramount.

Warnings and Precautions

It's important to keep this product out of the reach of children, especially those under 6 years of age. If a child accidentally swallows more than what is needed for brushing, seek medical help or contact a Poison Control Center right away.

Always use this product as directed and be cautious to prevent any accidental ingestion. If you have any concerns or experience unusual symptoms, stop using the product and call your doctor for advice. Your safety is a priority, so please take these precautions seriously.

Overdose

If you accidentally swallow more of the product than what is typically used for brushing your teeth, it’s important to seek medical help right away or contact a Poison Control Center. Overdosing can lead to serious health issues, so don’t hesitate to get assistance.

Signs of an overdose may not always be obvious, but if you experience any unusual symptoms after swallowing too much, it’s crucial to act quickly. Always prioritize your health and safety by reaching out for help if you suspect an overdose has occurred.

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 any medication, including this one, you should consult with your healthcare provider to discuss potential risks and benefits. Your doctor can help you make informed decisions that prioritize your health and the health of your baby.

Lactation Use

If you are breastfeeding, you can feel reassured that there are no specific warnings or recommendations regarding the use of this product while nursing. Additionally, there is no information available about whether this product is excreted in breast milk or any potential risks to your infant. Always consult with your healthcare provider if you have any concerns or questions about medications while breastfeeding.

Pediatric Use

It's important to keep this product out of the 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 right away. For children aged 2 years and older, you should help them brush their teeth thoroughly, ideally after each meal or at least twice a day, following the advice of a dentist or doctor.

To prevent swallowing, use only a pea-sized amount for children under 6, and supervise them while brushing until they develop good habits. If your child is under 2 years old, it's best to consult a dentist or physician before use.

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. As you age, your body may process medications differently, which can affect how well they work and the potential for side effects.

If you or a loved one is considering this medication, it’s wise to discuss it with a healthcare provider. They can help determine if any adjustments are needed based on individual health conditions and ensure that the treatment is safe and effective for older adults. Always prioritize open communication with your healthcare team about any concerns or questions you may have.

Renal Impairment

If you have kidney issues, 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 there are no special monitoring requirements or safety considerations outlined for patients with renal impairment (kidney problems).

Always consult your healthcare provider for personalized advice and to ensure that any medications you take are safe and appropriate for your kidney health. They can provide guidance tailored to your specific situation.

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 regarding your liver health and how it may relate to your treatment. They can help ensure that you receive the safest and most effective care.

Drug Interactions

It's great to know that there are no reported 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 may 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 at room temperature and keep it away from direct light. It's important not to freeze the product, as this can affect its effectiveness. Once you open the product, be sure to discard any unused portion to maintain safety and quality. Following these guidelines will help you use the product safely and effectively.

Additional Information

This medication is administered through dental use. It's important to keep it 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 right away. For children under 6, use only a pea-sized amount to minimize swallowing, and supervise them while brushing until they develop good habits. If your child is under 2 years old, consult a dentist or physician before use.

FAQ

What is the purpose of this drug?

This drug aids in the prevention of dental cavities.

How should I use this drug?

Adults and children 2 years of age and older should brush their teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor.

What should I do if a child under 2 years of age needs to use this drug?

Consult a dentist or physician before use for children under 2 years of age.

What precautions should I take when using this drug with children?

Supervise children brushing until good habits are established, and use a pea-sized amount to minimize swallowing in children under 6 years.

What should I do if someone accidentally swallows this drug?

If you accidentally swallow more than used for brushing, get medical help or contact a Poison Control Center immediately.

How should I store this drug?

Store at room temperature, protect from light, and do not freeze. Discard after opening.

Are there any contraindications for this drug?

No contraindications are listed for this drug.

Is there any information regarding the use of this drug during pregnancy or lactation?

There are no specific warnings or recommendations regarding the use of this product during pregnancy or by nursing mothers.

What should I do to keep this drug safe from children?

Keep out of reach of children under 6 years of age.

Packaging Info

Below are the non-prescription pack sizes of Dinosaur Bubble Gum Flavor Anti-Cavity Fluoride Tooth (sodium fluoride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Dinosaur Bubble Gum Flavor Anti-Cavity Fluoride Tooth.
Details

Drug Information (PDF)

This file contains official product information for Dinosaur Bubble Gum Flavor Anti-Cavity Fluoride Tooth, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

No relevant information is available for SPL code 34089-3.

Uses and Indications

This drug is indicated for the prevention of dental cavities. It is intended for use in individuals at risk of developing dental caries.

Dosage and Administration

Adults and children aged 2 years and older should brush their teeth thoroughly, preferably after each meal or at least twice daily, or as directed by a dentist or physician. It is important to avoid swallowing the product. For children under 6 years of age, a pea-sized amount should be used to minimize the risk of swallowing. Caregivers should supervise children while 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

There are no specific contraindications listed for this product. However, it is essential to keep the product out of reach of children to prevent 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 of accidental ingestion of an amount greater than that typically used for brushing, immediate medical assistance should be sought, or contact with a Poison Control Center is advised.

Additionally, general precautions should be taken to ensure that the product remains inaccessible to children. This is crucial to prevent any potential misuse or accidental ingestion.

Side Effects

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

Additionally, the product should always be stored safely to prevent access by children. Adverse reactions may vary in severity, and vigilance is advised to ensure the safety of all users, particularly young children.

Drug Interactions

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

Packaging & NDC

Below are the non-prescription pack sizes of Dinosaur Bubble Gum Flavor Anti-Cavity Fluoride Tooth (sodium fluoride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Dinosaur Bubble Gum Flavor Anti-Cavity Fluoride Tooth.
Details

Pediatric Use

Pediatric patients under 6 years of age should be kept out of reach of the product. For children aged 2 years and older, it is recommended to brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician. A pea-sized amount should be used in children under 6 years to minimize swallowing, and adult supervision is advised during brushing until good habits are established.

For children under 2 years of age, consultation with a dentist or physician is necessary prior to use. In the event of accidental ingestion of more than the amount used for brushing, medical assistance or contact with a Poison Control Center is imperative. It is important to instruct pediatric patients not to swallow the product.

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 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.

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

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 lack of data 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 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, it is imperative that immediate medical assistance is sought. If an individual accidentally ingests more than the recommended amount used for brushing, it is crucial to contact a healthcare professional or reach out to a Poison Control Center without delay.

Healthcare providers should be aware that prompt intervention is essential in managing potential overdosage situations. Symptoms may vary depending on the specific substance involved, and monitoring for adverse effects is recommended.

Management procedures may include supportive care and symptomatic treatment as necessary. It is advisable for healthcare professionals to familiarize themselves with the specific protocols for handling overdosage cases related to the product in question.

Nonclinical Toxicology

No information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or toxicology.

Postmarketing Experience

No postmarketing experience details are available in the provided data.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of the reach of children to prevent accidental ingestion or misuse. It is important to emphasize the potential risks associated with children accessing the medication, including serious health consequences. Providers should encourage patients to store the medication in a secure location and to be vigilant about monitoring its use.

Storage and Handling

The product is supplied in packaging that includes 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. Additionally, once opened, the product must be discarded to ensure safety and efficacy.

Additional Clinical Information

The product is administered via the dental route. Clinicians should advise patients to keep the product out of the reach of children under 6 years of age. In the event of accidental ingestion of more than the amount used for brushing, medical assistance or contact with a Poison Control Center is recommended. To reduce the risk of swallowing, a pea-sized amount should be used for children under 6 years, and adult supervision is necessary until proper brushing habits are established. For children under 2 years of age, consultation with a dentist or physician is advised.

Drug Information (PDF)

This file contains official product information for Dinosaur Bubble Gum Flavor Anti-Cavity Fluoride Tooth, 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 Dinosaur Bubble Gum Flavor Anti-Cavity Fluoride Tooth, 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.