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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 2017
Label revision date
March 22, 2021
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 2017
Label revision date
March 22, 2021
Manufacturer
Linhart Inc
Registration number
part355
NDC root
70926-100

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

LINHART with Linamel is a fluoride toothpaste designed to help you maintain good oral health. Its primary purpose is to aid in the prevention of tooth decay, making it an important part of your daily dental care routine. With regular use, this toothpaste can help protect your teeth and keep your smile bright.

Uses

You can use this product to help prevent tooth decay, which is the damage that occurs to your teeth when bacteria in your mouth produce acids that eat away at the tooth structure. By incorporating this into your dental care routine, you can support your oral health and keep your smile bright.

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. 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 children, and supervise them while brushing until they can do it on their own.

For children under 2 years old, it's best to consult with a dentist or doctor before starting any dental care routine. This way, you can ensure that you're taking the right steps for their dental health.

What to Avoid

It's important to keep this medication out of the reach of children under 6 years of age 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 these guidelines to use the medication safely and effectively.

Side Effects

If you accidentally swallow more than the amount used for brushing, it's important to seek medical help or contact a Poison Control Center immediately. This is a serious situation that requires prompt attention to ensure your safety. Always use the product as directed to minimize any 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. Taking quick action can help ensure your safety.

Always use this product as directed and keep it out of reach of children to prevent accidental ingestion. If you experience any unusual symptoms or reactions, stop using the product and call your doctor for further 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 assistance. Remember, your well-being is the top priority.

Pregnancy Use

There is currently no specific information available regarding the use of Linhart sodium fluoride toothpaste during pregnancy. This means that safety concerns, dosage adjustments, or any special precautions for pregnant individuals have not been addressed in the drug insert.

If you are pregnant or planning to become pregnant, it’s always a good idea to consult with your healthcare provider about any products you plan to use, including toothpaste, to ensure they are safe for you and 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. 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 brushing 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

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 healthcare providers may not have tailored guidelines for elderly patients.

If you or a loved one is an older adult considering this medication, it’s important to discuss any potential risks or concerns with your healthcare provider. They can help determine the best approach based on individual health needs and circumstances. Always prioritize open communication about any changes in health or medication effects.

Renal Impairment

If you have kidney problems, 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 the usual recommendations for monitoring or safety considerations related to renal impairment (kidney issues) are not provided.

It's always best to discuss your individual situation with your healthcare provider, who can offer personalized advice and ensure that any medications you take are safe and appropriate for 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 interactions with other drugs or laboratory tests. However, always ensure that your healthcare team is aware of all the medications you are using, as this helps them provide the safest and most effective care tailored to your needs.

By discussing your full medical history and any current treatments, you can help prevent potential issues and ensure that your healthcare provider can make the best decisions for your health.

Storage and Handling

To ensure the best performance of your product, store it at room temperature and protect it from freezing. It's important to keep the tube tightly closed when not in use to maintain its integrity and safety. Following these simple guidelines will help you use the product effectively and safely.

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 use only 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 LINHART?

LINHART is a fluoride toothpaste that aids in the prevention of tooth decay.

Who can use LINHART?

LINHART is suitable for adults and children 2 years of age and older. Children under 2 years should consult a dentist or doctor.

How should I use LINHART?

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

What precautions should I take when using LINHART with children?

Instruct children 6 years of age in good brushing and rinsing habits, using only a pea-sized amount, and supervise them until they can use it without help.

What should I do if more than the recommended amount of LINHART 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 LINHART?

No contraindications are listed for LINHART in the provided information.

Is LINHART safe for nursing mothers?

There are no specific warnings or recommendations regarding the use of LINHART by nursing mothers.

How should I store LINHART?

Store LINHART at room temperature, protect it from freezing, and keep the tube tightly closed when not in use.

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

LINHART is a fluoride toothpaste formulated with Linamel. It is presented in a net weight of 3.5 ounces (99 grams).

Uses and Indications

This drug is indicated for the prevention of tooth 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 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 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 due to the product's formulation or effects 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 ingesting excessive amounts of the product, underscoring the importance of adhering to the recommended usage guidelines to prevent adverse outcomes.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there is no information available regarding interactions between this drug 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 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 adults and 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

There is no specific information regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population.

Pregnancy

There is no specific information regarding the use of Linhart sodium fluoride toothpaste during pregnancy, including safety concerns, dosage modifications, or special precautions. Healthcare professionals should consider the absence of data when advising pregnant patients. As with any medication or dental product, it is advisable for women of childbearing potential to consult with their healthcare provider to weigh the potential benefits against any unknown risks during pregnancy.

Lactation

There are no specific warnings or recommendations regarding the use of this product by lactating mothers. Additionally, there is no information available concerning the potential for excretion of the product in breast milk or any associated risks to breastfed infants.

Renal Impairment

There is no specific information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in 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 use of the compound in these contexts.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

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 format, with specific handling and storage requirements to ensure its integrity and efficacy. It should be stored at room temperature, away from extreme temperatures, and must be protected from freezing. To maintain the quality of the product, it is essential to keep the tube tightly closed when not in use.

Additional Clinical Information

The route of administration for the medication is oral. 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. It is important for parents to supervise younger 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 advised.

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.

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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.