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Amerfresh Clear

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This product has been discontinued

Active ingredient
Sodium Fluoride 0.22 g/100 g
Other brand names
Dosage form
Paste, Dentifrice
Route
Dental
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 1996
Label revision date
March 16, 2011
Active ingredient
Sodium Fluoride 0.22 g/100 g
Other brand names
Dosage form
Paste, Dentifrice
Route
Dental
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Marketed in the U.S.
Since 1996
Label revision date
March 16, 2011
Manufacturer
Amercare Products Inc
Registration number
part355
NDC root
51460-5010

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

Drug Overview

AMERFRESH® is a fluoride gel toothpaste designed to help protect your teeth against cavities. Fluoride is a mineral that strengthens tooth enamel, making it more resistant to decay. By using AMERFRESH®, you can support your oral health and maintain a brighter, healthier smile.

Uses

You can use this product to help protect against cavities, which are small holes in your teeth caused by decay. It's important to maintain good oral hygiene, and this product can be a helpful part of your routine to keep your teeth healthy.

Additionally, there are no concerns regarding teratogenic effects (which means it does not cause birth defects) or nonteratogenic effects associated with this product. This makes it a safe option for most users.

Dosage and Administration

To keep your teeth healthy, it's important to brush them thoroughly. If you are an adult or a child aged 6 years and older, you should brush your teeth after each meal or at least twice a day. If your dentist or physician has given you specific instructions, be sure to follow those as well.

For children aged 2 to 6 years, use only a small amount of toothpaste—about the size of a pea. It's essential to supervise their brushing and rinsing to help prevent them from swallowing the toothpaste. If your child is under 2 years old, it's best to consult with a dentist or physician for guidance on how to care for their teeth.

What to Avoid

It's important to keep this product out of the reach of children under 6 years old to ensure their safety. If a child accidentally swallows more than what is typically used for brushing, seek medical help or contact a poison control center right away. This precaution helps prevent any potential harm. Always use the product as directed to ensure safe and effective use.

Side Effects

It's important to keep this product out of the reach of children under 6 years old. If a child accidentally swallows more than what is typically used for brushing, seek medical help or contact a poison control center right away.

Please be aware of these precautions to ensure safety while using the product.

Warnings and Precautions

It's important to keep this product out of the 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 right away.

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 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 can vary, 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 considering the use of AMERFRESH CLEAR - sodium fluoride paste 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 potential risks and benefits of using this product while pregnant have not been clearly established.

If you are pregnant or planning to become pregnant, it is always best to consult with your healthcare provider before using any dental products, including fluoride pastes. They can provide personalized advice based on your health needs and circumstances.

Lactation Use

If you are breastfeeding or planning to breastfeed, it's important to consult your physician before using this product. There is a possibility that it may be excreted in breast milk, which means it could potentially affect your nursing infant. Since the effects on infants who are breastfed have not been thoroughly studied, it's best to exercise caution. Always prioritize your health and your baby's well-being by discussing any concerns with your healthcare provider.

Pediatric Use

It's important to keep this product out of the reach of children under 6 years old. If your child accidentally swallows more than the amount used for brushing, seek medical help or contact a poison control center right away.

For children aged 6 and older, encourage them to brush their teeth thoroughly, ideally after each meal or at least twice a day, following the guidance of a dentist or physician. If your child is between 2 and 6 years old, use only a pea-sized amount of the product and supervise their brushing and rinsing to help prevent swallowing. For children under 2 years, consult with a dentist or physician 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 and benefits with your healthcare provider. They can help determine the best approach based on individual health needs and circumstances.

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 determine the best approach for managing your health, especially if you have concerns about your kidneys.

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 you may have regarding your liver health and medication use. They can help ensure that you receive the safest and most effective treatment based on your individual needs.

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. Your safety and well-being are the top priority, so don't hesitate to ask questions or express any concerns you may have.

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

For effective use of this product, you should brush your teeth thoroughly, ideally after each meal or at least twice a day, unless your dentist or physician advises otherwise. If you are supervising a child aged 2 to 6 years, use only a pea-sized amount of the product and ensure they rinse properly to avoid swallowing. For children under 2 years, it's best to consult a dentist or physician before use.

FAQ

What is AMERFRESH®?

AMERFRESH® is a fluoride gel toothpaste that helps protect against cavities.

How should adults and children 6 years of age and older use AMERFRESH®?

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

What is the recommended usage for children aged 2 to 6 years?

Use only a pea-sized amount and supervise the child's brushing and rinsing to minimize swallowing.

What should I do if a child under 2 years needs to use AMERFRESH®?

Consult a dentist or physician before use.

Are there any contraindications for using AMERFRESH®?

No contraindications are listed for AMERFRESH®.

What precautions should I take regarding children and AMERFRESH®?

Keep AMERFRESH® out of the reach of children under 6 years of age. If more than the amount used for brushing is accidentally swallowed, seek medical help or contact a poison control center immediately.

Is there any information about the use of AMERFRESH® during pregnancy?

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

What should nursing mothers know about AMERFRESH®?

Nursing mothers should consult a physician before using this product, as there is potential for excretion in breast milk.

How should AMERFRESH® be stored?

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

Packaging Info

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

Packaging configurations for Amerfresh Clear.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

AMERFRESH® is a fluoride gel toothpaste formulated for oral hygiene. It is presented in a net weight of 6.4 ounces (181 grams). The product is designed to provide effective fluoride delivery for the prevention of dental caries.

Uses and Indications

This drug is indicated for the protection against cavities.

There are no teratogenic effects associated with this drug, nor are there any nonteratogenic effects mentioned.

Dosage and Administration

Adults and children aged 6 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 2 to 6 years, a pea-sized amount of the product should be used. It is essential that an adult supervises the child's brushing and rinsing to minimize the risk of swallowing.

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 due to the risk of accidental ingestion. In the event of accidental swallowing of an amount greater than that used for brushing, immediate medical assistance or contact with a poison control center is advised.

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 intervention.

Side Effects

Patients should be advised to keep this product out of the reach of children under 6 years of age. 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.

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

Packaging configurations for Amerfresh Clear.
Details

Pediatric Use

Pediatric patients under 6 years of age should be kept out of reach of the product. In the event that 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 6 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 physician.

For children aged 2 to 6 years, only a pea-sized amount should be used, and adult supervision is necessary during brushing and rinsing to minimize the risk of swallowing.

For infants and children under 2 years of age, consultation with a dentist or physician is recommended 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 AMERFRESH CLEAR - sodium fluoride paste, 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 and consider the lack of data when advising women of childbearing potential regarding the use of this product during pregnancy. It is recommended that the potential benefits be weighed against any unknown risks to fetal outcomes.

Lactation

Lactating mothers should consult a physician before using this product. There is a potential for excretion in breast milk, and the effects on nursing infants are not well studied; therefore, caution is advised.

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 complications associated with overdosage. 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 seeking assistance from medical professionals or poison control centers.

Nonclinical Toxicology

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

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 the reach of children under 6 years of age to prevent accidental ingestion. It is important to emphasize that if more than the recommended amount used for brushing is accidentally swallowed, patients should seek medical help or contact a poison control center immediately. This guidance is crucial for ensuring the safety and well-being of patients, particularly in households with young children.

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

Patients aged 6 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 2 to 6 years, only a pea-sized amount should be used, and adult supervision is recommended during brushing and rinsing to minimize the risk of swallowing. For children under 2 years of age, consultation with a dentist or physician is recommended prior to use.

No additional information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Amerfresh Clear, 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 Amerfresh Clear, 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.