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Plak Smacker Anti Cavity Fluoride

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This product has been discontinued

Active ingredient
Sodium Fluoride 0.24 g/100 g
Other brand names
Dosage form
Paste
Route
Dental
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2016
Label revision date
January 6, 2018
Active ingredient
Sodium Fluoride 0.24 g/100 g
Other brand names
Dosage form
Paste
Route
Dental
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Marketed in the U.S.
Since 2016
Label revision date
January 6, 2018
Manufacturer
Yangzhou Hongshengding Chemical Co. , Ltd.
Registration number
part356
NDC root
71035-700

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If you are a consumer or patient please visit this version.

Drug Overview

This medication is designed to help prevent dental cavities, which are small holes in your teeth caused by decay. By using this drug, you can support your oral health and reduce the risk of developing cavities, contributing to a healthier smile.

Uses

You can use this product to help prevent dental cavities, which are holes in your teeth caused by decay. By incorporating it into your oral care routine, you can support your dental health and reduce the risk of developing these issues.

It's important to note that there are no reported teratogenic effects (harmful effects on the development of a fetus) or nonteratogenic effects (harmful effects that do not involve fetal development) associated with this product, making it a safe option for most users.

Dosage and Administration

To keep your teeth healthy, it's important to brush thoroughly, ideally after each meal or at least twice a day. This applies to both adults and children aged 2 years and older. When brushing, make sure not to swallow the toothpaste. For children under 6, use only a pea-sized amount to help minimize swallowing.

It's also essential to teach young children good brushing and rinsing habits. You should supervise them as needed until they are able to brush their teeth on their own effectively. Following these guidelines will help ensure proper dental care for you and your family.

What to Avoid

It's important to keep this medication out of reach of children 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 the guidance provided by your healthcare professional and use the medication responsibly.

Side Effects

It's important to keep this product out of the reach of children, especially those under 6 years of age. If a child accidentally swallows more than the amount used for brushing, seek medical help or contact a Poison Control Center immediately. Always ensure that this product is stored safely to prevent any accidental ingestion.

Warnings and Precautions

It's important to keep this product out of the reach of children, especially those under 6 years of age. If a child accidentally swallows more than what is typically used for brushing, you should seek medical help or contact a Poison Control Center immediately.

Always ensure that this product is stored safely to prevent accidental ingestion. Your safety and the safety of your loved ones is a priority, so please take these precautions seriously.

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 be obvious, but if you experience any unusual symptoms after swallowing too much, don’t hesitate to reach out for assistance. Remember, it’s always better to be cautious when it comes to your health.

Pregnancy Use

When it comes to using this medication during pregnancy, there is no specific information available about its safety, dosage adjustments, or any special precautions you should take. This means that the potential risks and benefits 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. Always prioritize open communication with your doctor regarding any concerns you may have.

Lactation Use

If you are breastfeeding, it's important to know that some substances can be passed into your breast milk. This means that anything you take, including certain medications, may affect your baby. There is a potential risk to your infant when using this product while nursing, so it's crucial to discuss any medications with your healthcare provider to ensure they are safe for you and your baby. Always prioritize your child's health and well-being when considering treatment options during lactation.

Pediatric Use

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

When helping younger children, use only a pea-sized amount to reduce the risk of swallowing. Make sure to teach them proper brushing and rinsing techniques, and supervise them until they can brush their teeth independently and safely.

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, it’s important to consult with a healthcare provider for personalized advice. 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

There are no specific guidelines, dosage adjustments, or monitoring requirements mentioned for patients with kidney problems in the provided information. If you have renal impairment (kidney issues), it's important to consult your healthcare provider for personalized advice regarding your medications and treatment plan. They can help ensure your safety and effectiveness of any treatments you may be receiving.

Hepatic Impairment

If you have liver 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 standard dosing and monitoring practices apply, but you should always consult your healthcare provider for personalized advice. They can help ensure that any medications you take are safe and effective for your liver health.

Make sure to keep your doctor informed about your liver condition, as they may need to monitor your liver function tests (which check how well your liver is working) more closely while you are on medication. Your health and safety are the top priority, so don’t hesitate to ask questions or express any concerns you may have.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications you are taking, even if there are no specific drug interactions or laboratory test interactions noted for your treatment. This ensures that your healthcare team can monitor your health effectively and make informed decisions about your care.

Always feel free to ask questions and share any other medications or supplements you might be using. This way, you can work together to ensure your treatment is safe and effective.

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. If you open the tube and do not use the contents within a specified time, be sure to discard it to ensure safety and effectiveness. Following these guidelines will help you handle the product safely and effectively.

Additional Information

This medication is administered through the dental route, meaning it is used in the mouth for oral care. It's important to keep this product out of the reach of children under 6 years old. If a child accidentally swallows more than the amount used for brushing, seek medical help or contact a Poison Control Center immediately.

To ensure safety, do not swallow the product. For children under 6, use only a pea-sized amount to minimize swallowing. Additionally, teach young children proper brushing and rinsing habits, and supervise them until they can brush their teeth independently.

FAQ

What is the primary use of this drug?

This drug aids in the prevention of dental cavities.

Are there any teratogenic effects associated with this drug?

No teratogenic effects are mentioned.

What should I do if a child under 6 accidentally swallows this drug?

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

How should adults and children 2 years and older use this drug?

Brush 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 this drug with children under 6?

Use a pea-sized amount to minimize swallowing, instruct them in good brushing and rinsing habits, and supervise them until they can use it without assistance.

Is there any information regarding the use of this drug during pregnancy?

No specific information regarding safety concerns or precautions during pregnancy is provided.

What should nursing mothers know about this drug?

Nursing mothers should be aware of the potential for excretion in breast milk and the associated infant risk.

How should this drug be stored?

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

Are there any contraindications for this drug?

No contraindications are listed.

What should I do if I have more questions about this drug?

Consult your healthcare provider for more information and guidance.

Packaging Info

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

Packaging configurations for Plak Smacker Anti Cavity Fluoride.
Details

Drug Information (PDF)

This file contains official product information for Plak Smacker Anti Cavity Fluoride, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

The provided data does not specify the chemical name, physical characteristics, or inactive ingredients of the drug. Therefore, a detailed description cannot be formulated based on the available information. Further details are required to create a comprehensive description section.

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 2 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 physician. It is important to ensure that the product is not swallowed during use.

For children under 6 years of age, a pea-sized amount of the product should be used to minimize the risk of swallowing. Caregivers are advised to instruct these children in proper brushing and rinsing techniques. Additionally, supervision is recommended until the child is capable of brushing their teeth without assistance.

Contraindications

Use of this product is contraindicated in individuals who are unable to keep it out of reach of children. This precaution is necessary to prevent accidental ingestion or misuse by pediatric patients. No other contraindications have been identified.

Warnings and Precautions

It is imperative to keep this product out of the reach of children under 6 years of age. In the event that more than the recommended amount for brushing is accidentally ingested, immediate medical assistance should be sought, or contact a Poison Control Center without delay.

Additionally, general precautions should be observed to ensure the safety of children. This product should always be stored in a secure location, away from the reach of children, to prevent accidental ingestion or misuse.

Side Effects

Patients should be aware of the potential adverse reactions associated with the use of this product. It is crucial to keep the product out of the reach of children under 6 years of age. In the event that more than the recommended amount is accidentally swallowed, it is imperative to seek medical assistance or contact a Poison Control Center immediately.

Additionally, the product should always be stored safely to prevent accidental ingestion by children. Proper precautions should be taken to ensure that children do not have access to the product, as this can lead to serious health risks.

Drug Interactions

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

Packaging & NDC

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

Packaging configurations for Plak Smacker Anti Cavity Fluoride.
Details

Pediatric Use

Pediatric patients under 6 years of age should be kept out of reach, and if more than the recommended amount for brushing is accidentally swallowed, medical assistance or contact with a Poison Control Center is advised immediately. For children aged 2 years and older, it is recommended to brush teeth thoroughly, preferably after each meal or at least twice daily, or as directed by a dentist or physician.

To minimize the risk of swallowing, a pea-sized amount of toothpaste should be used for children under 6 years. It is essential to instruct these children in proper brushing and rinsing techniques. Additionally, supervision is necessary until the child is capable of brushing without assistance.

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 they may have altered pharmacokinetics and pharmacodynamics. Close monitoring is recommended to ensure safety and efficacy in this population.

Pregnancy

There is no specific information available 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.

Lactation

Nursing mothers should be aware of the potential for excretion of this product in breast milk. There is an associated risk to breastfed infants when this product is used during lactation. Healthcare professionals should consider these factors when advising lactating mothers on the use of this product.

Renal Impairment

There is no information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution and consider the lack of specific guidance when prescribing to patients with reduced kidney function.

Hepatic Impairment

There is no available information regarding the use of this medication in patients with hepatic impairment. Consequently, there are no dosage adjustments, special monitoring requirements, or precautions specified for individuals with compromised liver function. Healthcare professionals should exercise caution and consider the lack of data when prescribing this medication to patients with hepatic impairment.

Overdosage

In the event of an overdosage, immediate medical assistance is crucial. If an individual accidentally swallows more than the recommended amount used for brushing, it is imperative to seek medical help or contact a Poison Control Center without delay.

Healthcare professionals should be aware that timely intervention can significantly mitigate potential adverse effects associated with overdosage. Monitoring for symptoms related to the specific substance involved is essential, and appropriate management procedures should be initiated based on clinical judgment and established protocols.

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 reach of children to prevent accidental ingestion or misuse. It is important to emphasize the necessity of proper storage to ensure the safety of young individuals.

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, the tube should be kept tightly closed when not in use. Additionally, it is recommended to discard the product after opening if it is not used within a specified time frame, although this duration is not detailed in the provided information.

Additional Clinical Information

The product is administered via the dental route. Clinicians should advise patients to keep the product out of the reach of children under 6 years of age. In the event that more than the recommended amount for brushing is accidentally swallowed, immediate medical assistance or contact with a Poison Control Center is necessary. It is important to instruct children under 6 to use only a pea-sized amount to minimize swallowing and to supervise their brushing and rinsing habits until they are capable of doing so independently.

Drug Information (PDF)

This file contains official product information for Plak Smacker Anti Cavity Fluoride, 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 Plak Smacker Anti Cavity Fluoride, 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.