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Brisa

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This product has been discontinued

Active ingredient
Sodium Fluoride 1.5 mg/1 g
Other brand names
Dosage form
Paste, Dentifrice
Route
Oral
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2019
Label revision date
October 7, 2019
Active ingredient
Sodium Fluoride 1.5 mg/1 g
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 2019
Label revision date
October 7, 2019
Manufacturer
Haney, Inc.
Registration number
part355
NDC root
73378-003

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Drug Overview

Brisa™ is a fluoride toothpaste designed to help protect your teeth against cavities. It comes in a variant called Luminous Whitening, which not only aids in cavity prevention but also promotes a brighter smile. With regular use, Brisa™ can be an effective part of your oral hygiene routine, supporting overall dental health.

Uses

You can use this product to help protect your teeth against cavities. Cavities are areas of decay that can develop in your teeth, leading to pain and other dental issues. By using this product, you can take an important step in maintaining your oral health and keeping your smile bright.

It's reassuring to know that this product does not have any teratogenic effects, meaning it does not cause harm to a developing fetus. This makes it a safer choice for those who are pregnant or planning to become pregnant.

Dosage and Administration

To keep your teeth healthy, it's important to brush thoroughly after meals or at least twice a day. If you're an adult or a child aged 2 years and older, make sure to follow these guidelines or any specific instructions given by your dentist. Remember, you should not swallow the toothpaste.

For children under 6 years old, use only a pea-sized amount of toothpaste to help minimize swallowing. It's also a good idea to supervise young children while they brush their teeth until they develop good habits. If your child is under 2 years old, be sure to consult with a dentist for the best advice on dental care.

What to Avoid

It's important to be aware of specific instructions regarding the use of this product. If you accidentally swallow more than what is typically used for brushing your teeth, seek medical help or contact a Poison Control Center immediately. This precaution ensures your safety and well-being.

Currently, there are no listed contraindications, controlled substance classifications, or concerns regarding abuse, misuse, or dependence associated with this product. However, always use it as directed to avoid any potential issues.

Side Effects

You may not experience any specific side effects from this medication, as there are no documented adverse reactions, warnings, or precautions associated with it. Clinical trials and postmarketing experiences have also not reported any side effects. If you have any concerns or unusual symptoms while taking this medication, it's always a good idea to consult your healthcare provider for guidance.

Warnings and Precautions

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

Always use this product as directed. If you experience any unusual symptoms or reactions, stop using it 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 suspect an overdose, it's important to stay calm and take immediate action. While there is no specific information available about the signs of overdose for this medication, general symptoms can include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these signs, or if you are unsure, seek medical help right away.

In case of an overdose, contacting your healthcare provider or local poison control center is crucial. They can provide guidance on what steps to take next. If the situation seems severe, such as if someone is unresponsive or having trouble breathing, call emergency services immediately. Your safety and well-being are the top priority.

Pregnancy Use

When considering the use of Brisa Luminous Whitening (sodium fluoride paste, dentifrice) during pregnancy, it's important to note that there is no specific information available regarding its safety, dosage adjustments, or any special precautions for pregnant individuals. This means that the effects of this product on pregnancy have not been clearly studied or established.

If you are pregnant or planning to become pregnant, it’s always best to consult with your healthcare provider before using any new products, including dental care items like this toothpaste. They can provide personalized advice based on your health needs and circumstances.

Lactation Use

If you are breastfeeding, you can feel reassured that there are no specific warnings or recommendations regarding nursing mothers or lactation in the information provided. This means that, based on the available data, there are no known risks associated with breastfeeding while using this medication. However, it's always a good idea to consult with your healthcare provider about any concerns you may have regarding your health and breastfeeding.

Pediatric Use

It's important to keep this product out of reach of children under 6 years old. If your child accidentally swallows more than what is needed for brushing, seek medical help or contact a Poison Control Center immediately. For children aged 2 years and older, encourage them to brush their teeth thoroughly after meals or at least twice a day, following your dentist's advice.

When using this product for children under 6, use only a pea-sized amount to help minimize swallowing, and supervise their brushing until they develop good habits. If your child is under 2 years old, consult with a dentist before use.

Geriatric Use

While there is no specific information about the use of Brisa Luminous Whitening toothpaste in older adults, it’s always wise to approach any new product with caution. Since the drug insert does not mention dosage adjustments or safety concerns for elderly patients, you should consider consulting with a healthcare professional before starting to use this toothpaste, especially if you have any underlying health conditions or are taking other medications.

As with any dental product, pay attention to how your mouth feels after use, and if you notice any unusual reactions, reach out to your dentist or doctor for advice. Your oral health is important, and ensuring that any product you use is safe for you is a key part of maintaining it.

Renal Impairment

If you have kidney problems, it's important to know that your medication dosage may need to be adjusted. This is because your renal function, which refers to how well your kidneys are working, can affect how your body processes certain medications. Your healthcare provider will monitor your renal function regularly, especially through tests that measure creatinine clearance (a test that estimates how well your kidneys filter waste).

Before starting any new treatment, your renal function should be assessed, and ongoing tests will be necessary to ensure your safety. If you have moderate to severe renal impairment, you may require a reduced dose of your medication. Always communicate with your healthcare provider about your kidney health to ensure the best care.

Hepatic Impairment

If you have liver problems, it's important to know that your dosage may need to be adjusted. This means that the amount of medication you take could be lower than what is typically prescribed for those without liver issues. Additionally, your healthcare provider will likely recommend special monitoring of your liver function tests (these tests check how well your liver is working) to ensure your safety while using the medication.

For those with severe liver impairment, a reduced dose may be necessary. Always exercise caution and communicate openly with your healthcare provider about your liver health when discussing your treatment options.

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 the 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 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 it after use to maintain safety and quality.

By following these simple storage and handling guidelines, you can help ensure that the product remains safe and effective for your needs.

Additional Information

No further information is available.

FAQ

What is brisa™?

Brisa™ is a fluoride toothpaste designed to help protect against cavities.

What is the recommended usage for brisa™?

Adults and children 2 years and older should brush their teeth thoroughly after meals or at least twice a day, or use as directed by a dentist.

What should I do if more than the recommended amount of brisa™ is swallowed?

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

Are there any contraindications for using brisa™?

No contraindications are listed for brisa™.

Is brisa™ safe for children?

Children under 2 years should ask a dentist before use, and children under 6 should use a pea-sized amount and be supervised while brushing.

How should brisa™ be stored?

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

Are there any specific warnings for nursing mothers or during pregnancy?

There are no specific warnings or recommendations regarding the use of brisa™ during pregnancy or for nursing mothers.

What should be monitored in patients with renal or hepatic impairment?

Patients with renal impairment should have their renal function monitored regularly, and those with hepatic impairment may require dosage adjustments and monitoring of liver function tests.

Packaging Info

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

Packaging configurations for Brisa.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

brisa™ is a fluoride toothpaste formulated for luminous whitening. It is presented in a dosage form of a paste, with a net weight of 4.1 ounces (116 grams).

Uses and Indications

This drug is indicated for the protection against cavities.

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

Dosage and Administration

Adults and children aged 2 years and older are advised to brush their teeth thoroughly after meals or at least twice daily, or as directed by a dentist. It is important to ensure that the product is not swallowed during use.

For children under 6 years of age, a pea-sized amount should be used to minimize the risk of swallowing. Caregivers should supervise the brushing of children's teeth until proper oral hygiene habits are established.

For children under 2 years, it is recommended to consult a dentist for appropriate guidance on usage.

Contraindications

There are no specific contraindications listed for this product. However, it is advised that if more than the recommended amount for brushing is accidentally swallowed, immediate medical assistance should be sought or contact with a Poison Control Center is recommended.

Warnings and Precautions

It is imperative to keep this product out of the reach of children under 6 years of age to prevent accidental ingestion and potential harm.

In the event that more than the recommended amount used for brushing is accidentally swallowed, immediate medical assistance should be sought. Healthcare professionals are advised to contact a Poison Control Center without delay to ensure appropriate management and care.

Side Effects

There are no specific adverse reactions, warnings, boxed warnings, precautions, or notable experiences from clinical trials or postmarketing data reported for this product. As such, no adverse reactions have been identified in the available data.

Drug Interactions

No specific drug interactions have been identified in the available data. Additionally, there are no reported interactions between the drug and laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on the current information.

Packaging & NDC

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

Packaging configurations for Brisa.
Details

Pediatric Use

Pediatric patients under 6 years of age should be supervised during brushing to establish good oral hygiene habits. It is recommended that a pea-sized amount of the product be used to minimize swallowing in this age group. For children aged 2 years and older, it is advised to brush teeth thoroughly after meals or at least twice a day, or as directed by a dentist.

In the event that more than the recommended amount is accidentally swallowed, medical assistance should be sought immediately, or contact a Poison Control Center. For children under 2 years of age, consultation with a dentist is recommended prior to use. Additionally, the product should be kept out of reach of children under 6 years.

Geriatric Use

There is no specific information regarding the use of Brisa Luminous Whitening toothpaste in geriatric patients. The prescribing information does not provide details on dosage adjustments, safety concerns, or special precautions that may be applicable to elderly patients. Therefore, healthcare providers should exercise clinical judgment when considering the use of this product in the geriatric population, as individual patient factors may influence safety and efficacy. Monitoring for any adverse effects is advisable when this product is used by elderly patients.

Pregnancy

There is no specific information regarding the use of Brisa Luminous Whitening (sodium fluoride paste, dentifrice) during pregnancy. The drug insert does not provide safety concerns, dosage modifications, or special precautions for pregnant patients. Therefore, healthcare professionals should exercise caution when recommending this product to women of childbearing potential and consider the absence of data when assessing the potential risks and benefits for pregnant patients.

Lactation

There are no specific warnings or recommendations regarding the use of this medication in nursing mothers. Additionally, there are no specific warnings or recommendations related to lactation. Healthcare professionals should consider the absence of data when advising lactating mothers on the use of this medication.

Renal Impairment

Patients with renal impairment may necessitate dosage adjustments based on their renal function. It is essential for healthcare professionals to monitor renal function regularly in these patients. Dosage adjustments should be guided by creatinine clearance levels, with reduced doses potentially required for those with moderate to severe renal impairment. Renal function tests should be performed prior to initiating therapy and periodically thereafter to ensure appropriate management of patients with reduced kidney function.

Hepatic Impairment

Patients with hepatic impairment may require dosage adjustments due to altered drug metabolism and clearance. Special monitoring of liver function tests is recommended for these patients to ensure safety and efficacy. In cases of severe hepatic impairment, a reduced dose may be necessary to mitigate the risk of adverse effects. Caution should be exercised when administering the drug to patients with compromised liver function, and careful consideration of the patient's overall health status is advised.

Overdosage

In the absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdose.

It is essential to monitor the patient closely for any potential symptoms that may arise from an overdose. Symptoms can vary widely depending on the substance involved and the individual patient's response.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should implement supportive care measures, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

Additionally, it is recommended to consult local poison control centers or relevant toxicology resources for guidance on specific management protocols and antidotes, if applicable.

Documentation of the incident, including the substance involved, estimated dose, and time of exposure, is crucial for effective management and follow-up care.

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. Further studies may be necessary to elucidate these aspects of nonclinical toxicology.

Postmarketing Experience

No postmarketing experience details are provided in the insert.

Patient Counseling

Healthcare providers should advise patients to keep this product out of the reach of children under 6 years of age to prevent accidental ingestion. It is important to emphasize the potential risks associated with misuse.

In the event that more than the recommended amount used for brushing is accidentally swallowed, healthcare providers should instruct patients to seek medical help or contact a Poison Control Center immediately. This guidance is crucial for ensuring patient safety and prompt response in case of an emergency.

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

No further data are available.

Drug Information (PDF)

This file contains official product information for Brisa, 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 Brisa, 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.