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Linhart

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This product has been discontinued

Active ingredient
Sodium Fluoride 2.5 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
January 16, 2020
Active ingredient
Sodium Fluoride 2.5 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
January 16, 2020
Manufacturer
Nutrix International, LLC
Registration number
part355
NDC root
73333-096

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 decay. It works by providing support to your dental health, making it easier for you to maintain a healthy smile. While specific details about its mechanism of action are not provided, its primary purpose is to aid in the prevention of cavities and other dental issues.

Uses

You can use this product to help prevent dental decay, which is the process that leads to cavities in your teeth. By incorporating it into your oral care routine, you can support your dental health and reduce the risk of developing issues related to tooth decay. Regular use can be an important step in maintaining 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 who is 6 years old or younger, make sure to teach them proper brushing and rinsing techniques to avoid swallowing toothpaste. Use only a pea-sized amount of toothpaste for them, and supervise their brushing until they can do it on their own.

If your child is under 2 years old, it's best to consult with a dentist or doctor for guidance on how to care for their teeth. Following these steps will help ensure good dental hygiene for you and your family.

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 your healthcare provider for personalized advice.

Side Effects

If you accidentally swallow more of this product than intended for brushing, it’s important to seek medical help or contact a Poison Control Center immediately. This is a serious situation, and prompt action is necessary to ensure your safety. Always use the product as directed to avoid any potential risks.

Warnings and Precautions

If you accidentally swallow more of this product than intended for brushing, it’s important to seek medical help immediately or contact a Poison Control Center. This ensures you receive the appropriate care and guidance.

Always use this product as directed to avoid any potential risks. If you have any concerns or experience unusual symptoms, stop using the product and call your doctor for advice. Your health and safety are the top 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 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 professional assistance. Your well-being is the top priority.

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 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 if you have any concerns or questions about your specific situation.

Pediatric Use

It's important to keep this product out of reach of children under 6 years old. For children aged 2 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.

For children who are 6 years old, teach them proper brushing and rinsing techniques to help prevent swallowing the product, and make sure they only use a pea-sized amount. Always supervise younger children while they brush until they can do it on their own. If your child is under 2 years old, please consult 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. 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 condition. They can help you understand any necessary precautions or adjustments based on your kidney health.

Hepatic Impairment

If you have liver problems, it's important to know that the information provided does not include specific guidelines for dosage adjustments, special monitoring, or precautions related to your condition. This means that there are no tailored recommendations for how the medication may affect you differently due to your liver health.

It's always best to discuss your liver condition with your healthcare provider before starting any new medication. They can provide personalized advice and ensure that your treatment is safe and effective for you.

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 known drug interactions or laboratory test interactions associated with the medication. However, always ensure that your healthcare provider is aware of all the medications you are using, as this helps them provide the best care tailored to your needs.

Remember, even if no interactions are listed, your health is unique, and discussing your full medical history is essential for safe and effective treatment.

Storage and Handling

To ensure the best performance of your product, store it at room temperature and keep the tube tightly closed when not in use. It's important to protect the product from excessive heat, as this can affect its quality. If you open the tube and do not use the product within a specified time frame, please discard it to maintain safety and effectiveness. Following these guidelines will help you handle the product safely and effectively.

Additional Information

You should take this medication orally. If you are giving it to a child, make sure to instruct them on proper brushing and rinsing habits to minimize swallowing, and only use a pea-sized amount. It's important to supervise children until they can use it without help. If your child is under 2 years old, consult a dentist or doctor before use.

FAQ

What is the purpose of this drug?

This drug aids in the prevention of dental decay.

Who can use this drug?

Adults and children 2 years of age and older can use this drug. Children under 2 years of age should consult a dentist or doctor.

How should I use this drug?

Brush your teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor.

What should I instruct children about using this drug?

Instruct children 6 years of age in good brushing and rinsing habits to minimize swallowing, and use only a pea-sized amount.

What precautions should I take for children under 6 years of age?

Keep this drug out of reach of children under 6 years of age and supervise children as necessary until they can use it without supervision.

What should I do if more than the recommended amount 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 this drug?

No contraindications are listed for this drug.

How should I store this drug?

Store at room temperature, keep the tube tightly closed when not in use, and protect from excessive heat.

Packaging Info

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

Packaging configurations for Linhart.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

The product is identified by the SPL code 34089-3. No specific description details are provided in the text.

Uses and Indications

This drug is indicated for the prevention of dental decay. 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.

For children aged 6 years and younger, it is important to instruct them in proper brushing and rinsing techniques to minimize the risk of swallowing. A pea-sized amount of toothpaste should be used for this age group. Caregivers should supervise children as necessary until they are capable of brushing without assistance.

For children under 2 years of age, consultation with a dentist or physician is recommended prior to use.

Contraindications

Use is contraindicated in children under 6 years of age. This precaution is necessary to prevent potential harm, as the safety and efficacy of the product have not been established in this age group. Additionally, it is advised to keep the product out of reach of children to avoid accidental ingestion or misuse.

Warnings and Precautions

In the event of accidental ingestion of an amount exceeding that typically used for brushing, immediate medical assistance should be sought. Healthcare professionals are advised to contact a Poison Control Center without delay to ensure appropriate management and intervention.

Side Effects

Patients should be aware that if 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 warning highlights the potential seriousness of accidental ingestion and underscores the importance of adhering to the recommended usage guidelines to prevent adverse outcomes.

Drug Interactions

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

Packaging & NDC

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

Packaging configurations for Linhart.
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 doctor. Children aged 6 years and older should be instructed in proper brushing and rinsing techniques to minimize swallowing, using only a pea-sized amount of the product. Supervision is advised for children until they are capable of using the product without assistance. For children under 2 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 potential 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 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 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 assessing the patient's condition and providing supportive care as necessary. It is advisable to follow established protocols for the treatment of overdosage, which may involve symptomatic treatment and monitoring of vital signs.

In all cases of suspected overdosage, the involvement of a medical professional is crucial to ensure appropriate care and intervention.

Nonclinical Toxicology

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

Postmarketing Experience

No postmarketing experience details are provided in the insert.

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 encourage patients to store the medication in a secure location.

Storage and Handling

The product is supplied in a tube that must be kept tightly closed when not in use to maintain its integrity. It should be stored at room temperature, away from excessive heat to ensure optimal quality. It is important to discard the product after opening if it is not used within the specified time frame, which is not detailed in the provided information.

Additional Clinical Information

The medication is administered orally. Clinicians should instruct parents to teach children aged 6 years and older proper brushing and rinsing techniques to minimize swallowing, recommending the use of only a pea-sized amount. Supervision is advised for children until they are capable of using the product independently. For children under 2 years of age, consultation with a dentist or doctor is recommended. No additional information is available regarding laboratory tests, abuse potential, or postmarketing experience.

Drug Information (PDF)

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