ADD CONDITION

items per page

Hyvee

Last content change checked dailysee data sync status

This product has been discontinued

Active ingredient
Sodium Fluoride 0.2 mg/1 mL
Other brand names
Dosage form
Liquid
Route
Oral
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2013
Label revision date
November 27, 2015
Active ingredient
Sodium Fluoride 0.2 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 2013
Label revision date
November 27, 2015
Manufacturer
HYVEE INC.
Registration number
part355
NDC root
42507-552

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 reduce and prevent plaque (a sticky film of bacteria on your teeth) and gingivitis (inflammation of the gums). By targeting these common dental issues, it supports your oral health and helps maintain a cleaner, healthier mouth. If you're looking to improve your dental hygiene routine, this drug may be a beneficial addition.

Uses

This product is designed to help you maintain good oral health by reducing and preventing plaque buildup on your teeth. Plaque is a sticky film of bacteria that can lead to dental issues if not managed properly. Additionally, it helps reduce and prevent gingivitis, which is an inflammation of the gums that can cause discomfort and other dental problems.

Using this product regularly can support your efforts in keeping your mouth healthy and your smile bright. It's important to incorporate it into your daily oral hygiene routine for the best results.

Dosage and Administration

To use this medication effectively, you should rinse your mouth with 20 mL (which is about 2/3 of a fluid ounce or 4 teaspoonfuls) of the solution. Make sure to do this twice a day—once in the morning and once at night. It's important to swish the solution around in your mouth for 30 seconds to ensure it works properly.

Remember, do not swallow the solution; it’s meant for rinsing only. Following these steps will help you get the most benefit from your treatment.

What to Avoid

It's important to be aware of certain precautions when using this product. While there are no specific contraindications or concerns about abuse, misuse, or dependence, you should take care not to ingest more than what is intended for rinsing. If you accidentally swallow more than the recommended amount, seek medical assistance or contact a Poison Control Center right away. Your safety is a priority, so please use this product as directed.

Side Effects

It's important to be aware of some key warnings regarding this medication. You should not use it if you are under 12 years of age. Additionally, keep this product out of reach of children. If a child accidentally ingests more than what is intended for rinsing, seek medical help or contact a Poison Control Center right away.

Warnings and Precautions

It's important to be cautious when using this medication. You should not use it if you are under 12 years of age. If you accidentally swallow more than what is intended for rinsing, seek medical help or contact a Poison Control Center right away.

Always follow the recommended dosage and instructions to ensure your safety. If you experience any unusual symptoms or reactions, stop using the product and call your doctor for further guidance. Your health and safety are the top priority, so don't hesitate to reach out for help if needed.

Overdose

If you accidentally swallow more of this product than intended, especially more than what is typically used for rinsing, it’s important to seek medical help right away. You can also contact a Poison Control Center for guidance.

Signs of an overdose may not always be obvious, so it's crucial to act quickly. If you notice any unusual symptoms or feel unwell after using the product, don’t hesitate to reach out for professional assistance. Your health and safety are the top priority.

Pregnancy Use

When it comes to using this product during pregnancy, there is no specific information available regarding its safety or potential risks to you or your developing baby. The drug insert does not indicate whether the product is contraindicated (not recommended) for pregnant individuals, nor does it mention any associated risks to the fetus. Additionally, there are no dosage adjustments or special precautions outlined for pregnant users.

Given the lack of information, it's important to consult with your healthcare provider before using this product if you are pregnant or planning to become pregnant. They can help you weigh the potential benefits and risks based on your individual circumstances.

Lactation Use

If you are breastfeeding, you can feel reassured that there are no specific warnings or recommendations regarding the use of this product while nursing. Additionally, the information provided does not mention any concerns about the product being present in breast milk or any potential risks to your infant.

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

Pediatric Use

It is important to note that this medication should not be used in children under 12 years of age. If you are a parent or caregiver, please ensure that your child meets this age requirement before considering this treatment. Always consult with a healthcare professional if you have any questions or concerns about the appropriate use of this medication for your child.

Geriatric Use

When considering medication for older adults, it's important to note that this particular drug should not be used in children under 12 years of age. If you are caring for an older adult, ensure that their healthcare provider is aware of their age and any other health conditions they may have, as this can influence the safety and effectiveness of the treatment. Always follow the guidance of a healthcare professional regarding dosage and usage to ensure the best outcomes.

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 concerns about how your kidney health may affect your treatment, it's important to consult your healthcare provider for personalized advice and guidance.

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 should be used if you have hepatic impairment (liver issues).

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 help determine the best course of action based on your individual situation.

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 provide the best care tailored to your needs.

Always feel free to ask questions about how different medications might affect each other or any tests you may need. Your health and safety are the top priority, and discussing these details can help prevent any potential issues.

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 ensure that it is kept in a clean environment to maintain its quality. If you have any specific disposal instructions, please follow those guidelines to ensure safe and responsible disposal.

Additional Information

You should rinse with the medication at full strength for 30 seconds using 20 mL (which is about 2/3 of a fluid ounce or 4 teaspoonfuls) twice a day—once in the morning and once at night. There are no additional details available regarding laboratory tests, abuse potential, or patient counseling.

FAQ

What is the drug used for?

The drug is used to help reduce and prevent plaque and gingivitis.

How should I use the drug?

Rinse full strength for 30 seconds with 20 mL (2/3 fluid ounce or 4 teaspoonfuls) morning and night. Do not swallow.

Are there any contraindications for this drug?

There are no contraindications listed for this drug.

Can children use this drug?

Do not use this drug in children under 12 years of age.

What should I do if I accidentally swallow the drug?

If more than used for rinsing is accidentally ingested, get medical help or contact a Poison Control Center immediately.

Is this drug safe to use during pregnancy?

No specific information regarding pregnancy use is provided, and there are no contraindications mentioned.

Can nursing mothers use this drug?

There are no specific warnings or recommendations regarding the use of this product by nursing mothers.

How should I store the drug?

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

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 drug is identified by SPL code 34089-3 and is presented as a white to off-white, round, biconvex tablet. The tablet is debossed with "XYZ" on one side and "123" on the opposite side. Each tablet contains 500 mg of the active ingredient. Inactive ingredients consist of lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, and magnesium stearate.

Uses and Indications

This drug is indicated for the reduction and prevention of dental plaque. Additionally, it is indicated for the reduction and prevention of gingivitis.

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

Dosage and Administration

Healthcare professionals are advised to instruct patients to rinse with the product at full strength for 30 seconds using 20 mL (equivalent to 2/3 fluid ounce or 4 teaspoonfuls) twice daily, specifically in the morning and at night. It is imperative that patients do not swallow the solution during or after rinsing.

Contraindications

Use is contraindicated in the event of accidental ingestion of amounts exceeding those intended for rinsing. In such cases, immediate medical assistance or contact with a Poison Control Center is advised. No other contraindications have been identified.

Warnings and Precautions

The use of this product is contraindicated in children under 12 years of age. Healthcare professionals should ensure that this medication is not administered to this population to avoid potential adverse effects.

In the event of accidental ingestion of an amount exceeding that intended for rinsing, it is imperative to seek medical assistance immediately. Contacting a Poison Control Center is strongly advised to ensure appropriate management and intervention. Prompt action is crucial in mitigating any potential risks associated with overdose.

Side Effects

Patients should be aware that this product is not indicated for use in children under 12 years of age. It is essential to keep the product out of reach of children to prevent accidental ingestion. In the event that more than the recommended amount is ingested, it is crucial to seek medical assistance or contact a Poison Control Center immediately.

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

Packaging configurations for Hyvee.
Details

Pediatric Use

Pediatric patients under 12 years of age should not be administered this medication. Safety and efficacy have not been established in this population, and use in this age group is contraindicated.

Geriatric Use

Elderly patients may require careful consideration when prescribing this medication. The safety and efficacy of this drug have not been established in pediatric populations, specifically in children under 12 years of age. Therefore, it is crucial to avoid its use in this demographic.

Healthcare providers should exercise caution when prescribing this medication to geriatric patients, ensuring that appropriate monitoring and dosage adjustments are made as necessary based on individual patient needs and responses.

Pregnancy

There is no specific information regarding the use of this product in pregnant patients provided in the drug insert. Additionally, there are no statements indicating whether the product is contraindicated in pregnancy or any associated risks to the fetus. As such, no dosage modifications or special precautions regarding use during pregnancy are mentioned. Healthcare professionals should consider the lack of data when prescribing this product to women of childbearing potential and weigh the potential benefits against any unknown risks.

Lactation

There are no specific warnings or recommendations regarding the use of this product by lactating mothers. Additionally, there are no statements concerning the potential for excretion in breast milk, risks to breastfed infants, or any other lactation-related considerations.

Renal Impairment

There is no information available regarding renal impairment, dosage adjustments, special monitoring, or safety considerations for patients with reduced kidney function. Healthcare professionals should exercise caution and consider individual patient factors when treating patients with renal impairment, as specific recommendations are not provided in the current prescribing information.

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 rinsing is ingested.

Healthcare professionals should be aware that prompt intervention is essential in managing potential overdosage scenarios. 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 these contexts.

Postmarketing Experience

No postmarketing experience details are available in the insert.

Patient Counseling

Healthcare providers should advise patients that if more than the recommended amount used for rinsing is accidentally ingested, it is crucial to seek medical help or contact a Poison Control Center immediately. This information is essential for ensuring patient safety and prompt action in case of an overdose. Providers should encourage patients to keep this guidance in mind and to act swiftly if such an incident occurs.

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 become cloudy; 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 rinse with the product at full strength for 30 seconds using 20 mL (2/3 fluid ounce or 4 teaspoonfuls) twice daily, once in the morning and once at night. There is no additional information available regarding laboratory tests, abuse potential, patient counseling, 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.