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Megafresh

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This product has been discontinued

Active ingredient
Sodium Fluoride 0.10 g/100 g
Other brand names
Dosage form
Gel, Dentifrice
Route
Dental
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2013
Label revision date
January 16, 2015
Active ingredient
Sodium Fluoride 0.10 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 2013
Label revision date
January 16, 2015
Manufacturer
American Amenities, Inc.
Registration number
part355
NDC root
54157-102

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

You may be interested to know that this medication is designed to help prevent dental cavities. It works by providing protection for your teeth, making it an important part of maintaining good oral health. While specific details about how it functions are not provided, its primary purpose is to support your dental hygiene efforts and reduce the risk of cavities.

Uses

You can use this product to help prevent dental cavities, which are holes in your teeth caused by decay. It's an effective way to support your oral health and keep your smile bright.

Rest assured, there are no concerns regarding teratogenic effects (which means it doesn't cause birth defects) or nonteratogenic effects (which refers to other potential harmful effects that don't involve birth defects) associated with this product. This makes it a safe choice for maintaining your dental hygiene.

Dosage and Administration

To keep your teeth healthy, it's important to brush them thoroughly, ideally after each meal or at least twice a day. This applies to both adults and children who are two years old and older. If you're helping a child under six, make sure to teach them how to brush and rinse properly to reduce the chance of swallowing toothpaste. You should supervise them until they can brush their teeth on their own safely.

If your child is under two years old, it's best to consult with a dentist or doctor before starting any dental care routine. They can provide guidance tailored to your child's needs.

What to Avoid

It's important to be aware of specific instructions regarding the use of this product. While there are no listed contraindications or concerns about abuse, misuse, or dependence, you should take care when using it. If you accidentally swallow more than what is typically used for brushing, seek medical help or contact a poison control center right away. Your safety is a priority, so please follow these guidelines closely.

Side Effects

It's important to use this product only as directed and keep it out of reach of children. If you accidentally swallow more than what is recommended for brushing, seek medical help or contact a poison control center right away.

Please remember that this product is intended for external use only. Always follow the instructions carefully to ensure your safety.

Warnings and Precautions

This product is intended for external use only, so it's important to keep it out of reach of children, especially those under six 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 right away.

Always use this product as directed to ensure safety. If you have any concerns or experience unusual reactions, don’t hesitate to stop using it and consult your doctor for further advice.

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 right away or contact a poison control center. This is crucial to ensure your safety and receive the appropriate care.

Signs of an overdose may not always be obvious, so it's best to err on the side of caution. If you have any concerns about your health after swallowing too much, don’t hesitate to reach out for assistance. Remember, your well-being is the top priority.

Pregnancy Use

When considering the use of MEGAFRESH, a sodium fluoride gel, during pregnancy, it's important to note that there is no specific information available about its safety or any necessary dosage adjustments for pregnant individuals. This means that the drug insert does not provide guidance on whether it is safe to use during pregnancy or if any special precautions should be taken.

If you are pregnant or planning to become pregnant, it is always best to consult with your healthcare provider before using any new products, including dental care items like MEGAFRESH. They can help you weigh the potential benefits and risks based on your individual health needs.

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 six years old. For children aged two years and older, you should encourage them to brush their teeth thoroughly, ideally after each meal or at least twice a day, following the guidance of a dentist or doctor.

If your child is under six, make sure to teach them proper brushing and rinsing techniques to help prevent swallowing the product. Always supervise younger children while they brush their teeth until they can do it safely on their own. For children under two years old, it's best to consult with a dentist or doctor 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. If you or a loved one is an older adult, it’s always a good idea to discuss any medications with a healthcare provider. They can help ensure that the treatment is safe and appropriate, considering any unique health needs or conditions that may be present.

Remember, even in the absence of specific guidelines, your healthcare team can provide valuable insights and monitor for any potential side effects or interactions with other medications you may be taking. Always prioritize open communication with your doctor about your health and any concerns you may have.

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 plan is safe and effective for your specific situation. They can help monitor your kidney health and make any necessary adjustments to your medications.

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. 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 or 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 feel free to ask questions and share your complete list of medications and tests with them.

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

This medication is intended for dental use only and should be kept out of reach of children, especially those under six 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. It's important to teach children under six good brushing and rinsing habits to minimize swallowing, and you should supervise them until they can brush independently. For children under two years of age, consult a dentist or doctor before use.

FAQ

What is the primary use of this drug?

This drug aids in the prevention of dental cavities.

What should adults and children over two years do with this drug?

Adults and children of two years 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 precautions should be taken for children under six years of age?

Instruct children under six in good brushing and rinsing habits to minimize swallowing, and supervise them until they can use it without assistance.

What should you do if more than the recommended amount is swallowed?

If more than used for brushing is accidentally swallowed, seek medical help or contact a poison control center immediately.

Are there any contraindications for this drug?

No contraindications are listed for this drug.

Is this drug safe for use during pregnancy or lactation?

There are no specific warnings or recommendations regarding use during pregnancy or lactation provided in the text.

How should this drug be stored?

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

What should you do if you have children under two years?

Consult a dentist or doctor before using this drug for children under two years of age.

Is this drug for external use only?

Yes, this drug is for external use only and should be kept out of reach of children.

Packaging Info

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

Packaging configurations for Megafresh.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

The drug is identified by SPL code 34089-3. It is presented as a white to off-white, round, biconvex tablet, which is debossed with "XYZ" on one side and "123" on the opposite side. Each tablet contains 500 mg of the active ingredient. The formulation includes inactive ingredients such as lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, and magnesium stearate.

Uses and Indications

This drug is indicated for the prevention of dental cavities.

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

Dosage and Administration

Adults and children aged two years and older are advised to brush their teeth thoroughly, preferably after each meal or at least twice daily, or as directed by a dentist or physician.

For children under six years of age, it is essential to instruct them in proper brushing and rinsing techniques to minimize the risk of swallowing. Caregivers should supervise children as necessary until they are capable of brushing without assistance.

For children under two years of age, consultation with a dentist or physician is recommended prior to use.

Contraindications

There are no contraindications listed for this product. However, it is important to note that if more than the recommended amount for brushing is accidentally swallowed, medical assistance should be sought or a poison control center contacted immediately.

Warnings and Precautions

For external use only. It is imperative to keep this product out of reach of children, particularly those under six years of age, to prevent accidental ingestion or misuse.

In the event that more than the recommended amount for brushing is accidentally swallowed, immediate medical assistance should be sought. Healthcare professionals are advised to contact a poison control center for further guidance in such situations.

Side Effects

Patients should be aware that the product is for external use only and must be kept out of reach of children to prevent accidental ingestion.

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 precaution is crucial to ensure the safety and well-being of individuals who may inadvertently ingest the product.

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 Megafresh (sodium fluoride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Megafresh.
Details

Pediatric Use

Pediatric patients under six years of age should be kept out of reach of the product. For children aged two 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 doctor. It is important to instruct children under six in proper brushing and rinsing techniques to minimize swallowing. Supervision is advised for these children until they are capable of using the product without assistance. For children under two years of age, consultation with a dentist or doctor is necessary 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 regarding the use of MEGAFRESH - sodium fluoride gel, dentifrice during pregnancy. The prescribing information 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 concerning 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 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, it is critical to seek immediate medical assistance or contact a poison control center if an amount exceeding that typically used for brushing is accidentally ingested.

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

Management procedures should include supportive care and symptomatic treatment as necessary. It is advisable to have the product's labeling and any relevant patient information available when contacting medical professionals or poison control for guidance.

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 compound in these areas.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep the product out of reach of children under six years of age to prevent accidental ingestion. It is important to emphasize the potential risks associated with misuse. Instruct patients that if more than the recommended amount used for brushing is accidentally swallowed, they should seek medical help or contact a poison control center immediately. This guidance is crucial for ensuring patient safety and minimizing the risk of adverse effects.

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. It is intended for external use only and should be kept out of reach of children, particularly those under six years of age. In the event that more than the recommended amount for brushing is accidentally swallowed, patients should seek medical assistance or contact a poison control center immediately. Clinicians are advised to instruct children under six in proper brushing and rinsing techniques to minimize swallowing, and to supervise their use until they are capable of doing so independently. For children under two years of age, consultation with a dentist or doctor is recommended.

Drug Information (PDF)

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