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Heb

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Active ingredient
Sodium Fluoride 0.15 g/100 g
Other brand names
Dosage form
Paste, Dentifrice
Route
Dental
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2012
Label revision date
August 8, 2025
Active ingredient
Sodium Fluoride 0.15 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 2012
Label revision date
August 8, 2025
Manufacturer
HEB
Registration number
M021
NDC root
37808-167

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

This medication is designed to help protect your teeth against cavities, which are small holes that can form in your teeth due to decay. By using this product, you can support your dental health and reduce the risk of developing cavities, contributing to a 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 (which refers to effects that do not cause harm during pregnancy) associated with this product. This makes it a safe option for many 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. If your child is under 2 years old, it's best to consult with a dentist or doctor for guidance on their dental care.

When brushing, remember not to swallow the toothpaste. For children under 6, use only a pea-sized amount to help minimize swallowing. It's also a good idea to supervise your child's brushing until they develop good habits on their own. This way, you can ensure they are brushing effectively and safely.

What to Avoid

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

While there are no specific contraindications or concerns about abuse, misuse, or dependence associated with this product, always use it as directed to ensure your safety and well-being.

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 what is typically 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, seek medical help or contact a Poison Control Center immediately.

Always use this product as directed. If you experience any unusual symptoms or reactions, stop using it and call your doctor for advice. Your safety 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 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 know that the safety of HEB HEBUDDY fluoride paste during pregnancy has not been established. There may be potential risks to your fetus, and further studies are needed to fully understand these risks. Therefore, it is crucial to consult your healthcare provider before using this product to discuss any concerns and receive personalized advice.

Currently, there are no specific dosage modifications recommended for pregnant individuals. Always seek guidance from your healthcare provider to ensure the best care for you and 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. If your 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, encourage them to brush their teeth thoroughly, ideally after each meal or at least twice a day, following the advice of a dentist or doctor.

When brushing for children under 6, use only a pea-sized amount to help minimize swallowing. Always supervise their brushing until they develop good habits. If your child is under 2 years old, it's best to consult with 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. If you or a loved one is an older adult, be sure to discuss any potential risks or concerns with your healthcare provider. They can help determine the best approach, considering factors like overall health and any other medications being taken.

Always keep in mind that older adults may have different responses to medications, so regular check-ins with your doctor are essential to ensure safety and effectiveness.

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 plan is safe and effective for your specific situation. They can help monitor your kidney health and make any necessary adjustments to your medications.

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 like you.

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your liver health. They can provide guidance based on your individual situation.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications or tests you may be taking. While there are no specific drug interactions or laboratory test interactions noted for this medication, your healthcare provider can help ensure that everything you are taking works well together and is safe for you. Always share your complete list of medications and any health conditions you have to receive the best care possible.

Storage and Handling

To ensure the best performance and safety of your product, store it in a cool, dry place. This helps maintain its effectiveness and prevents any potential damage. When you're not using the tube, make sure to keep it capped. This protects the contents from contamination and preserves their quality. Following these simple storage and handling tips will help you use the product safely and effectively.

Additional Information

This medication is administered through the dental route, meaning it is used in the mouth, typically for oral care. It's important to keep this product out of reach of children under 6 years old. If a child accidentally swallows more than what is used for brushing, seek medical help or contact a Poison Control Center immediately. For children under 6, use only a pea-sized amount to minimize swallowing, and supervise their brushing until they develop good habits. If your child is under 2 years old, consult a dentist or doctor before use.

FAQ

What is the main use of this drug?

This drug helps protect against cavities.

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.

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 for children under 6 years of age?

Keep out of reach of children under 6 years of age and supervise their brushing until good habits are established.

Is this drug safe to use during pregnancy?

The safety of this drug during pregnancy has not been established; consult a healthcare provider if pregnant or planning to become pregnant.

What should I do if my child is under 2 years old?

Consult a dentist or doctor before use for children under 2 years of age.

How should I store this drug?

Store in a cool dry place and keep the tube capped when not in use.

Packaging Info

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

Packaging configurations for Heb.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

No description information is available for the specified drug.

Uses and Indications

This drug is indicated for the protection against dental cavities.

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

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 under 2 years of age, it is recommended to consult a dentist or doctor prior to use.

To minimize the risk of swallowing, a pea-sized amount of toothpaste should be used for children under 6 years of age. It is essential to supervise children's brushing until proper oral hygiene habits are established. Additionally, users should be instructed not to swallow the toothpaste during brushing.

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. In the event that more than the recommended amount used for brushing is accidentally swallowed, immediate medical assistance should be sought, or contact with a Poison Control Center is advised without delay.

Healthcare professionals should ensure that caregivers are aware of these critical warnings to promote safe usage and prevent potential harm.

Side Effects

Patients should be aware of the following warnings associated with the use of this product. It is crucial 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 used for brushing is accidentally swallowed, it is imperative 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

There are currently no documented drug interactions associated with this medication. Additionally, there are no known interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are necessary at this time.

Packaging & NDC

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

Packaging configurations for Heb.
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, immediate medical assistance or contact with a Poison Control Center is advised.

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. To minimize the risk of swallowing, a pea-sized amount of the product should be used for children under 6 years. It is important to supervise children's brushing until they have established good oral hygiene habits.

For children under 2 years of age, consultation with a dentist or doctor is recommended 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

The safety of HEB HEBUDDY fluoride paste during pregnancy has not been established. Pregnant patients or those planning to become pregnant should consult a healthcare provider prior to use, as there may be potential risks to the fetus. Further studies are needed to determine the safety profile of this product in pregnant individuals. Currently, no specific dosage modifications are provided for pregnant individuals; therefore, personalized advice from a healthcare provider is recommended.

Lactation

There are no specific warnings or recommendations regarding nursing mothers or lactation in the provided text. Therefore, healthcare professionals should consider the absence of data when advising lactating mothers about the use of this medication. It is advisable to monitor breastfed infants for any potential effects, although no specific information is available.

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

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 data does not preclude the need for careful evaluation and monitoring in this population.

Overdosage

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

Healthcare professionals should be aware that prompt intervention can mitigate potential adverse effects associated with overdosage. Monitoring for symptoms may be necessary, although specific symptoms related to overdosage are not detailed in the provided information.

Management procedures should include supportive care and symptomatic treatment as required. It is essential to follow established protocols for handling cases of overdosage to ensure patient safety and effective care.

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

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep this product out of the reach of children under 6 years of age to prevent accidental ingestion. It is important to emphasize the potential risks associated with misuse.

In the event that more than the recommended amount used for brushing is accidentally swallowed, healthcare providers should instruct patients to seek medical help or contact a Poison Control Center immediately. This guidance is crucial for ensuring patient safety and prompt response in case of an emergency.

Storage and Handling

The product is supplied in a tube format, with specific storage and handling requirements to ensure its integrity and efficacy. It should be stored in a cool, dry place to maintain optimal conditions. Additionally, it is essential to keep the tube capped when not in use to prevent contamination and preserve the product's quality.

Additional Clinical Information

The product is administered via the dental route. Clinicians should advise patients to keep the product out of 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. For children under 6, it is recommended to use a pea-sized amount to minimize swallowing, and caregivers should supervise brushing until proper habits are established. Additionally, consultation with a dentist or doctor is advised for children under 2 years of age.

Drug Information (PDF)

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