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Bio Spectra

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Active ingredient
Sodium Fluoride 0.243 g/100 g
Other brand names
Dosage form
Gel, Dentifrice
Route
Dental
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2021
Label revision date
October 20, 2025
Active ingredient
Sodium Fluoride 0.243 g/100 g
Other brand names
Dosage form
Gel, Dentifrice
Route
Dental
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Marketed in the U.S.
Since 2021
Label revision date
October 20, 2025
Manufacturer
9055-7588 Québec Inc. DBA Attitude
Registration number
M021
NDC root
61649-724

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

ATTITUDE™ is a natural, vegan toothpaste that comes in a refreshing watermelon flavor. It is designed to help prevent, fight, and protect against cavities and tooth decay, making it an effective choice for maintaining oral health. This toothpaste contains fluoride, which provides additional protection by penetrating tooth enamel to help rebuild weak spots and protect teeth from acid erosion.

With its gentle formulation and commitment to natural care, ATTITUDE™ is a great option for those looking to support their dental hygiene in a safe and effective way.

Uses

You can use this product to help keep your teeth healthy and strong. It prevents, fights, and protects against cavities and tooth decay, ensuring your smile stays bright. With effective fluoride protection, it works to shield your teeth from harmful acids that can cause erosion.

Additionally, this product penetrates tooth enamel, which is the hard outer layer of your teeth, to help rebuild weak spots. By incorporating it into your dental care routine, you can maintain better oral health and reduce the risk of dental issues.

Dosage and Administration

To use this medication effectively, make sure you do not swallow it. It’s important to incorporate it into a complete oral health routine that includes regular flossing and dental check-ups. You should brush your teeth thoroughly for at least one minute, twice a day—ideally after each meal or as your dentist recommends.

If you have children under 6 years old, use only a pea-sized amount for them and supervise their brushing to ensure they do it correctly and do not swallow any. For children under 2 years of age, consult with a dentist or healthcare professional before use. Lastly, store the medication at room temperature, between 15 to 30 degrees Celsius (59 to 86 degrees Fahrenheit), to keep it effective.

What to Avoid

You can feel reassured that there are no specific contraindications, controlled substance classifications, or risks of abuse or misuse associated with this medication. Additionally, there are no concerns regarding dependence (a condition where the body becomes reliant on a substance).

Since there are no "do not take" or "do not use" instructions provided, it suggests that this medication is generally safe for use as directed. However, always consult with your healthcare provider for personalized advice and to ensure it’s appropriate for your situation.

Side Effects

It's important to keep this medication out of reach of children. If a child accidentally swallows it, you should contact a poison control center or seek medical help immediately.

Please be aware that there are potential side effects associated with this medication. While specific adverse reactions were not detailed, it's always a good idea to monitor for any unusual symptoms and consult your healthcare provider if you have concerns.

Warnings and Precautions

It's important to keep this medication out of reach of children to prevent accidental ingestion. If a child swallows it, you should call a poison control center or seek medical help immediately.

Always be cautious when using this medication. If you have any concerns or experience unusual symptoms, stop using it and contact your doctor for guidance. Your health and safety are the top priority.

Overdose

If you or someone else has swallowed too much of a medication, it’s important to act quickly. Call a poison control center or seek medical help immediately. This is crucial to ensure safety and receive the appropriate care.

While there are no specific signs of overdose mentioned, being aware of any unusual symptoms or changes in behavior is important. If you notice anything concerning, don’t hesitate to reach out for help. Remember, acting quickly can make a significant difference in managing the situation effectively.

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 the potential risks and benefits of using this medication while pregnant are not clearly defined.

If you are pregnant or planning to become pregnant, it’s important to discuss any medications you are considering with your healthcare provider. They can help you understand the best options for 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 are no statements indicating that this product is excreted in breast milk or that it poses any risk to your infant during lactation. Always consult with your healthcare provider if you have any concerns or questions about medications while breastfeeding.

Pediatric Use

When it comes to using this product for children, it's important to take some precautions. For kids under 6 years old, you should only use a pea-sized amount and supervise them while brushing to ensure they do it correctly and don’t swallow any.

If your child is under 2 years of age, it's best to consult with a dentist or healthcare professional before using the product. This way, you can ensure that it’s safe and appropriate for their specific needs.

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 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 condition. They can help determine the best approach for managing your health, especially if you have concerns about your kidneys.

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).

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 important to have open conversations with your healthcare provider about any medications or tests you may be taking. While there are no specific drug interactions or laboratory test interactions noted for this medication, your healthcare provider can help ensure that everything you are taking works well together and is safe for you. Always share your complete list of medications and any recent lab tests to avoid any potential issues. Your health and safety should always come first.

Storage and Handling

To ensure the best performance of your product, store it at room temperature, which is between 15 and 30 degrees Celsius (59 to 86 degrees Fahrenheit). This temperature range helps maintain the integrity and effectiveness of the device.

When handling the product, be sure to do so with clean hands and in a clean environment to avoid contamination. Always follow any specific disposal instructions provided to ensure safe and responsible disposal of any components.

Additional Information

This product is intended for dental use only. It’s important that you do not swallow it. To maintain good oral health, use this product as part of a routine that includes regular flossing and dental check-ups. Brush your teeth thoroughly for at least one minute, twice a day, ideally after each meal, or as your dentist advises.

If you have children under 6 years old, make sure they use only a pea-sized amount and are supervised while brushing to prevent swallowing. For children under 2 years of age, consult a dentist or healthcare professional before use. Store the product at room temperature, between 15-30 °C.

FAQ

What is ATTITUDE™?

ATTITUDE™ is a natural, vegan toothpaste with fluoride, available in a watermelon flavor, designed to prevent cavities and tooth decay.

How does ATTITUDE™ work?

It prevents, fights, and protects against cavities and tooth decay, provides effective fluoride protection, and helps rebuild weak spots in tooth enamel.

What are the instructions for using ATTITUDE™?

Brush your teeth thoroughly for at least 1 minute twice a day, preferably after each meal. Children under 6 should use a pea-sized amount and be supervised.

Are there any warnings for using ATTITUDE™?

Keep ATTITUDE™ out of reach of children. If swallowed, call a poison control center or seek medical help immediately.

Can children use ATTITUDE™?

Yes, but children under 6 years should use only a pea-sized amount and should be supervised to avoid swallowing.

Is ATTITUDE™ safe for pregnant or nursing mothers?

There are no specific warnings or recommendations regarding the use of ATTITUDE™ during pregnancy or lactation.

How should ATTITUDE™ be stored?

Store ATTITUDE™ at room temperature, between 15-30 °C.

Are there any contraindications for ATTITUDE™?

No contraindications are listed for ATTITUDE™.

Packaging Info

Below are the non-prescription pack sizes of Bio Spectra (sodium fluoride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Bio Spectra.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

No description information is available for the drug.

Uses and Indications

This drug is indicated for the prevention and treatment of dental caries, commonly known as cavities, and for the protection against tooth decay. It provides effective fluoride protection, which is essential in maintaining oral health. Additionally, this drug protects teeth from acid erosion, a significant factor in dental deterioration. It is designed to penetrate tooth enamel, aiding in the remineralization of weak spots, thereby enhancing the overall strength and integrity of the teeth.

Dosage and Administration

The product is intended for use as part of a comprehensive oral health program, which includes regular flossing and dental check-ups. It is recommended that healthcare professionals instruct patients to brush their teeth thoroughly for a minimum of 1 minute, twice daily, preferably after each meal, or as directed by a dentist.

For children under 6 years of age, a pea-sized amount of the product should be used, and they must be supervised to ensure proper brushing technique and to prevent swallowing. Prior to use in children under 2 years of age, consultation with a dentist or healthcare professional is advised.

The product should be stored at room temperature, within the range of 15-30 °C. It is important to note that the product should not be swallowed.

Contraindications

There are no contraindications associated with the use of this product. It is deemed safe for use in the absence of specific conditions or situations that would warrant avoidance.

Warnings and Precautions

It is imperative to keep this medication out of reach of children to prevent accidental ingestion. In the event of swallowing the medication, immediate action is required. Healthcare professionals should advise patients or caregivers to contact a poison control center or seek medical assistance without delay.

Monitoring for potential adverse effects is essential to ensure patient safety. Regular assessments and appropriate interventions should be implemented as necessary.

Side Effects

Patients should be advised to keep the product out of reach of children. In the event of accidental ingestion, it is crucial to contact a poison control center or seek medical assistance immediately.

No additional adverse reactions have been reported in clinical trials or postmarketing experiences.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there is no information available regarding interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Bio Spectra (sodium fluoride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Bio Spectra.
Details

Pediatric Use

Pediatric patients under 6 years of age should use only a pea-sized amount of the product, and they must be supervised to ensure proper brushing techniques and to prevent swallowing. For children under 2 years of age, it is recommended to consult a dentist or healthcare professional prior to use.

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 available regarding the use of this drug 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 are no statements concerning the potential for excretion in breast milk or any associated risks to breastfed infants during the use of this product.

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 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 overdose, immediate action is crucial. If the substance is swallowed, it is imperative to contact a poison control center or seek medical assistance without delay.

Due to the absence of specific overdosage information, healthcare professionals are advised to rely on standard protocols for managing overdose situations. This includes monitoring the patient for any potential symptoms that may arise and providing supportive care as necessary.

Prompt intervention and adherence to established medical guidelines are essential in mitigating the risks associated with overdose.

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 in these areas limits the understanding of the compound's potential effects in nonclinical settings.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental ingestion. It is crucial to emphasize the importance of immediate action in the event of swallowing the medication; patients should be instructed to call a poison control center or seek medical assistance without delay. This information is vital for ensuring patient safety and minimizing potential risks associated with accidental exposure.

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 room temperature, maintaining a temperature range of 15 to 30 °C. Proper storage conditions are crucial to ensure the integrity and efficacy of the product.

Additional Clinical Information

The product is administered via the dental route. It is essential for patients to incorporate this product into a comprehensive oral health program that includes regular flossing and dental check-ups. Patients should brush their teeth thoroughly for at least one minute, twice daily, preferably after each meal, or as directed by a dentist. For children under 6 years of age, only a pea-sized amount should be used, and they should be supervised to ensure proper brushing and to prevent swallowing. Clinicians are advised to consult a dentist or healthcare professional before using this product in children under 2 years of age. The product should be stored at room temperature, between 15-30 °C.

No additional information is available regarding laboratory tests, abuse potential, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Bio Spectra, 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 Bio Spectra, 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.