ADD CONDITION

items per page

Hyvee

Last content change checked dailysee data sync status

This product has been discontinued

Active ingredient
Sodium Fluoride 0.5 mg/1 mL
Other brand names
Dosage form
Liquid
Route
Oral
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2015
Label revision date
November 30, 2015
Active ingredient
Sodium Fluoride 0.5 mg/1 mL
Other brand names
Dosage form
Liquid
Route
Oral
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Marketed in the U.S.
Since 2015
Label revision date
November 30, 2015
Manufacturer
HYVEE INC.
Registration number
part355
NDC root
42507-554

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 drug is designed to help prevent dental cavities, which are small holes in your teeth caused by decay. By using this medication, you can take an important step towards maintaining your oral health and keeping your teeth strong.

Uses

You can use this product to help prevent dental cavities, which are small 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. Regular use can be an effective way to maintain a healthy smile.

Dosage and Administration

After you brush your teeth with toothpaste, you can use this mouth rinse once a day. Take 10 mL of the rinse and swish it vigorously between your teeth for one minute before spitting it out. It's important not to swallow the rinse. After using it, avoid eating or drinking for 30 minutes to allow the rinse to work effectively.

If you're supervising a child aged 6 years or older, make sure they can use the rinse properly. For children under 6 years old, it's best to consult a dentist or doctor before using the rinse.

What to Avoid

It's important to be aware of specific instructions regarding the use of this product. While there are no listed contraindications, controlled substance classifications, or risks of abuse or dependence, you should take care when using it.

If you accidentally swallow more than what is intended for rinsing, seek medical help or contact a Poison Control Center right away. Your safety is a priority, so please follow these guidelines closely.

Side Effects

It's important to keep this product out of reach of children. If you accidentally swallow more than what is intended for rinsing, seek medical help or contact a Poison Control Center right away.

Be aware that while using this product, you may experience some side effects. If you notice any unusual reactions, it's best to consult with a healthcare professional.

Warnings and Precautions

It's important to keep this product out of reach of children to prevent accidental ingestion. If you or someone else accidentally swallows more than what is intended for rinsing, seek medical help or contact a Poison Control Center right away.

Always use this product as directed, and if you have any concerns or experience unusual symptoms, 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 intended for rinsing, it’s important to seek medical help right away or contact a Poison Control Center. Acting quickly can help ensure your safety.

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

There is no specific information available regarding the use of this medication during pregnancy. The insert does not mention any safety concerns, dosage changes, or special precautions for pregnant individuals. Additionally, there are no contraindications (conditions that would prevent use) noted for pregnancy, and no information is provided about potential risks to the fetus.

If you are pregnant or planning to become pregnant, it is always best to consult with your healthcare provider before starting any new medication to ensure it is 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 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 about any concerns you may have regarding your health and breastfeeding.

Pediatric Use

It's important to keep this product out of reach of children. If your child accidentally swallows more than the amount used for rinsing, seek medical help or contact a Poison Control Center right away.

For children aged 6 years and older, the recommended use is once a day after brushing their teeth. They should swish 10 mL of the rinse between their teeth for 1 minute and then spit it out. Make sure they do not swallow the rinse and avoid eating or drinking for 30 minutes after using it. Always supervise younger children until they can use the rinse safely on their own. For children under 6 years old, it's best to 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 if you or a loved one is an older adult considering this medication, it’s important to consult with a healthcare provider. 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

It appears that there is no specific information regarding renal impairment (kidney problems) in the provided text. Therefore, there are no dosage adjustments, special monitoring, or safety considerations to discuss for patients with kidney issues. If you have kidney problems, it's always best to consult your healthcare provider for personalized advice and guidance regarding your medications and treatment options. They can provide you with the most accurate and relevant information based on your individual health needs.

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.

However, it's always best to discuss your individual health situation with your healthcare provider, as they can offer personalized advice and ensure that any medications you take are safe for your liver health.

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 lab tests you undergo, as this helps in managing your health effectively.

Storage and Handling

To ensure the best performance of your product, store it at room temperature. If you notice any cloudiness during cold weather, don’t worry; this does not affect its antiseptic properties, meaning it will still work effectively.

Handle the product with care, and always follow any additional safety instructions provided. Proper storage and handling will help maintain its quality and effectiveness.

Additional Information

You should take this medication orally, once a day, after brushing your teeth with toothpaste. To use it, vigorously swish 10 mL of the rinse between your teeth for 1 minute, then spit it out. Remember not to swallow the rinse, and avoid eating or drinking for 30 minutes after using it.

If you have children, supervise them while using this product until they can do so independently. For children under 6 years old, it's important to consult a dentist or doctor before use.

FAQ

What is the primary use of this drug?

This drug aids in the prevention of dental cavities.

How should adults and children 6 years of age and older use this drug?

Use once a day after brushing your teeth with toothpaste. Vigorously swish 10 mL of rinse between your teeth for 1 minute and then spit it out.

What precautions should I take after using the rinse?

Do not swallow the rinse and avoid eating or drinking for 30 minutes after rinsing.

What should I do if a child under 6 years of age needs to use this drug?

Consult a dentist or doctor before use.

Are there any contraindications for this drug?

No contraindications are listed for this drug.

What should I do if more than the recommended amount is swallowed?

Get medical help or contact a Poison Control Center immediately.

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

No specific information regarding pregnancy use is provided in the insert.

How should this drug be stored?

Store at room temperature. Cold weather may cloud the product, but its antiseptic properties are not affected.

Is there any information about drug interactions?

No specific drug interactions are mentioned in the provided text.

What should I do if I have concerns about using this drug while nursing?

There are no specific warnings or recommendations regarding nursing mothers in the provided text.

Packaging Info

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

Packaging configurations for Hyvee.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

The product is identified by the SPL code 34089-3. No specific description details are provided in the text.

Uses and Indications

This drug is indicated for the prevention of dental cavities. It is intended for use in individuals at risk of developing dental caries.

Dosage and Administration

Adults and children aged 6 years and older are instructed to use the rinse once daily, following the brushing of teeth with toothpaste. The recommended method involves vigorously swishing 10 mL of the rinse between the teeth for a duration of 1 minute, after which the solution should be expectorated. It is imperative that the rinse is not swallowed. Additionally, patients should refrain from eating or drinking for 30 minutes post-rinsing to ensure optimal efficacy.

For children under 6 years of age, it is advised to consult a dentist or physician prior to use. Caregivers should supervise the administration of the rinse to ensure safety and proper technique until the child is capable of using it independently.

Contraindications

There are no contraindications listed for this product. However, it is important to note that if more than the recommended amount used for rinsing is accidentally swallowed, immediate medical assistance should be sought 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 to prevent accidental ingestion. In the event that more than the recommended amount used for rinsing 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 of the situation.

Side Effects

Patients should be advised to keep this product out of reach of children. In the event that more than the recommended amount for rinsing is accidentally swallowed, it is imperative to seek medical assistance or contact a Poison Control Center immediately.

Drug Interactions

There are currently no specific drug interactions identified for the medication. Additionally, no interactions with laboratory tests have been reported. Therefore, no dosage adjustments or monitoring recommendations are necessary at this time.

Packaging & NDC

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

Packaging configurations for Hyvee.
Details

Pediatric Use

Pediatric patients should be supervised during the use of this product, particularly those under 6 years of age. For children aged 6 years and older, the recommended dosage is 10 mL of rinse, to be used once daily after brushing teeth with toothpaste. Patients should vigorously swish the rinse between their teeth for 1 minute and then spit it out, ensuring that the rinse is not swallowed. It is advised that children do not eat or drink for 30 minutes following the use of the rinse.

For children under 6 years of age, consultation with a dentist or doctor is recommended prior to use. Care should be taken to keep the product out of reach of children. In the event that more than the recommended amount is accidentally swallowed, medical assistance should be sought immediately, or contact a Poison Control Center.

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 this medication during pregnancy. The prescribing information does not indicate any safety concerns, dosage modifications, or special precautions for pregnant patients. Additionally, there are no stated contraindications for use during pregnancy. Furthermore, there is no available data concerning potential risks to the fetus. Healthcare professionals should consider the lack of information when prescribing this medication to women of childbearing potential and weigh the benefits against any unknown risks.

Lactation

There are no specific warnings or recommendations regarding the use of this medication in nursing mothers. Additionally, there are no specific warnings or recommendations related to lactation. Healthcare professionals should consider the absence of data when advising lactating mothers about the use of this medication.

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 individual patient's liver status when prescribing this medication.

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 rinsing 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. Continuous assessment of the patient's condition is advised to ensure appropriate interventions are implemented based on the severity of symptoms presented.

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 question. Further studies may be necessary to elucidate these aspects of nonclinical toxicology.

Postmarketing Experience

No postmarketing experience details are available in the provided text.

Patient Counseling

Healthcare providers should advise patients that if more than the recommended amount used for rinsing is accidentally swallowed, they should seek medical help or contact a Poison Control Center immediately. It is important for patients to understand the potential risks associated with accidental ingestion and to act promptly in such situations.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at room temperature to maintain its integrity.

In colder weather conditions, the product may exhibit cloudiness; however, this does not impact its antiseptic properties. Care should be taken to avoid exposure to extreme temperatures to ensure optimal performance.

Additional Clinical Information

Patients should administer the product orally, using 10 mL of rinse once daily after brushing their teeth with toothpaste. The rinse should be vigorously swished between the teeth for 1 minute before being spat out, and it is important not to swallow the rinse. Patients are advised to refrain from eating or drinking for 30 minutes following the rinse.

Clinicians should ensure that children are supervised during use until they are capable of using the product without assistance. For children under 6 years of age, consultation with a dentist or doctor is recommended. No additional information is available regarding laboratory tests, abuse potential, or postmarketing experience.

Drug Information (PDF)

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