Symptom checker
Select audience type

Switch between content for healthcare professionals (PRO) and general audience (GEN).

ADD CONDITION

items per page

Maesa - Hey Human

Last content change checked dailysee data sync status

This product has been discontinued

Active ingredient
Sodium Fluoride 0.25 g/96 g
Other brand names
Dosage form
Paste, Dentifrice
Route
Buccal
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2021
Label revision date
April 19, 2021
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Sodium Fluoride 0.25 g/96 g
Other brand names
Dosage form
Paste, Dentifrice
Route
Buccal
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2021
Label revision date
April 19, 2021
Manufacturer
Nutrix International, LLC.
Registration number
part355
NDC root
73333-200
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info
Packaging & NDC Codes

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 protect against cavities, which are small holes in your teeth caused by decay. By using this product, you can support your dental health and reduce the risk of developing cavities. It's a helpful tool in maintaining a healthy smile and overall oral hygiene.

Uses

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

Rest assured, there are no known teratogenic effects (which means it does not cause birth defects) or nonteratogenic effects associated with this product. This makes it a safe option for maintaining your dental hygiene.

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. If you're helping a child between 2 and 6 years old, use only a pea-sized amount of toothpaste to reduce the chance of swallowing it. It's also essential to supervise their brushing and rinsing until they develop good habits.

For children under 2 years of age, it's best to consult a dentist or physician before starting any dental care routine. This ensures that you’re taking the right steps for their dental health at such a young age.

What to Avoid

There are no specific contraindications, controlled substance classifications, or risks of abuse, misuse, or dependence associated with this medication. This means that, based on the available information, there are no particular situations or conditions under which you should avoid using it. Always consult with your healthcare provider for personalized advice and to ensure that this medication is appropriate for your individual health needs.

Side Effects

It's important to keep this product out of 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.

Always be aware of how to use this product safely to avoid any potential risks.

Warnings and Precautions

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

Always use this product as directed and be aware of any unusual reactions. If you experience any concerning symptoms or side effects, stop using the product and call your doctor for further guidance. 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 intended for brushing your teeth, it’s important to seek medical help immediately or contact a Poison Control Center. Overdosing can lead to serious health issues, so don’t hesitate to reach out for assistance.

Signs of an overdose may not be obvious, but if you experience any unusual symptoms after swallowing too much, it’s crucial to get help right away. Always prioritize your safety and well-being by acting quickly in these situations.

Pregnancy Use

When it comes to using this medication during pregnancy, there is no specific information available regarding its safety, dosage adjustments, or any special precautions you should take. This means that the potential risks and benefits have not been clearly established for pregnant individuals.

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 potential risks and make informed decisions that are best for you and your baby.

Lactation Use

If you are breastfeeding, you can feel reassured that there are no specific warnings or recommendations against using this product while nursing. Currently, there is no information available about whether this product is passed into breast milk or if it poses any risk to your infant.

As always, it's a good idea to consult with your healthcare provider if you have any concerns or questions about using medications while breastfeeding.

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 between 2 and 6 years old, use only a pea-sized amount of the product to help minimize swallowing. Make sure to supervise their brushing and rinsing until they develop good habits. If your child is under 2 years old, it's best to consult 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 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

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 there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the standard recommendations apply, and there are no special monitoring or precautions outlined for patients with liver impairment.

Always consult your healthcare provider for personalized advice and to ensure that any medications you take are safe for your liver health. They can provide guidance based on your individual situation and any other health considerations you may have.

Drug Interactions

It's great to know that there are no reported interactions between this medication and other drugs or laboratory tests. However, it's still very important to discuss all medications you are taking, including over-the-counter drugs and supplements, with your healthcare provider. This ensures that your treatment is safe and effective.

Always keep your healthcare provider informed about any changes in your health or new medications you may start. Open communication helps prevent any potential issues and supports your overall well-being.

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

No further information is available.

FAQ

What is the primary use of this drug?

This drug helps protect against cavities.

What should adults and children 2 years and older do when using this drug?

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

How should children aged 2 to 6 use this drug?

To minimize swallowing, use only a pea-size amount and supervise their brushing and rinsing until good habits are established.

What should I do if a child under 2 years needs this drug?

Consult a dentist or physician before use.

Are there any warnings for this drug?

Keep it out of reach of children under 6 years of age. If more than the recommended amount is accidentally swallowed, seek medical help or contact a Poison Control Center immediately.

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

No specific information regarding pregnancy use or safety concerns is provided.

What should nursing mothers know about this drug?

There are no specific warnings or recommendations regarding its use by nursing mothers.

How should this drug be stored?

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

Packaging Info

Below are the non-prescription pack sizes of Maesa - Hey Human (clean mint rush). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Maesa - Hey Human.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

The provided information 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 data. Further information is required to create a comprehensive description.

Uses and Indications

This drug is indicated for the protection against cavities.

There are no teratogenic effects associated with this drug. Additionally, no nonteratogenic effects have been reported.

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 2 to 6 years, it is recommended to use only a pea-sized amount of the product to minimize the risk of swallowing. Caregivers should supervise the brushing and rinsing process until proper oral hygiene habits are established.

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

Contraindications

There are no contraindications associated with the use of this product. It is deemed safe for use in the absence of specific conditions or situations that would warrant caution.

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 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 care.

Side Effects

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

These precautions are essential to ensure the safety and well-being of patients, particularly young children who may be more susceptible to adverse effects from improper use.

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 Maesa - Hey Human (clean mint rush). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Maesa - Hey Human.
Details

Pediatric Use

Pediatric patients should be kept out of reach of children under 6 years of age. 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 physician.

In children aged 2 to 6 years, to minimize the risk of swallowing, only a pea-size amount of product should be used. Caregivers should supervise children's brushing and rinsing until good oral hygiene habits are established.

For children under 2 years of age, consultation with a dentist or physician is advised 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 this drug 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 using this medication.

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 in breast milk or any associated risks to breastfed infants.

Renal Impairment

Patients with renal impairment may not have specific dosage adjustments, special monitoring, or safety considerations outlined in the prescribing information. Therefore, healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the lack of detailed guidance necessitates careful clinical judgment and individualized patient assessment. Regular monitoring of renal function is advisable to ensure patient safety and therapeutic efficacy.

Hepatic Impairment

There is no information available 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 clinical judgment when considering the use of this medication in patients with liver problems, as the absence of specific guidance necessitates careful evaluation of the patient's overall health status and liver function.

Overdosage

In the event of an overdosage, it is critical to seek immediate medical assistance or contact a Poison Control Center if more than the recommended amount for brushing is accidentally ingested.

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

Management procedures should include assessing the patient's condition and providing supportive care as necessary. It is important to follow established protocols for the treatment of overdosage, which may involve decontamination and symptomatic treatment based on the clinical presentation.

In all cases of suspected overdosage, timely communication with poison control and adherence to local guidelines will facilitate optimal patient outcomes.

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

Adverse reactions have been reported voluntarily or through surveillance programs. Healthcare professionals and patients are encouraged to report any adverse reactions to Hey Humans c/o Report Reaction LLC, PO Box 22, Plainsboro, NJ 08536-0222. This information contributes to the ongoing monitoring of the safety profile of the product.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental ingestion or misuse. It is important to emphasize the necessity of safeguarding the medication to ensure the safety of young individuals.

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

No further data are available.

Drug Information (PDF)

This file contains official product information for Maesa - Hey Human, 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 Maesa - Hey Human, 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.