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Giant Eagle Wintermint with Fluoride

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This product has been discontinued

Active ingredient
Sodium Fluoride 0.2 mg/1 mL
Other brand names
Dosage form
Mouthwash
Route
Oral
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2019
Label revision date
October 22, 2019
Active ingredient
Sodium Fluoride 0.2 mg/1 mL
Other brand names
Dosage form
Mouthwash
Route
Oral
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Marketed in the U.S.
Since 2019
Label revision date
October 22, 2019
Manufacturer
Apollo Health and Beauty Care Inc.
Registration number
part355
NDC root
63148-021

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Drug Overview

This medication is designed to help prevent dental cavities or decay. By using it, you can support your oral health and reduce the risk of developing cavities, which are small holes in your teeth caused by decay. Regular use can be an important part of maintaining a healthy smile.

Uses

You can use this product to help prevent dental cavities or decay. By incorporating it into your oral care routine, you can support your dental health and keep your teeth stronger. Regular use can be an effective way to maintain a healthy smile and reduce the risk of tooth decay.

Dosage and Administration

To use this mouth rinse effectively, you should follow a simple routine. For adults and children aged 6 years and older, rinse twice a day after brushing your teeth. Measure out 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, and you should avoid eating or drinking for 30 minutes after using it to allow the rinse to work properly.

If you're supervising a child aged 12 or younger, make sure to teach them good rinsing habits to help prevent swallowing the rinse. Always keep an eye on 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 using the rinse.

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 to avoid swallowing more than what is intended for rinsing. If you accidentally swallow a larger amount, seek medical help or contact a Poison Control Center right away. Your safety is a priority, so please use the product as directed.

Side Effects

If you accidentally swallow more of this product than intended for rinsing, it’s important to seek medical help or contact a Poison Control Center right away. This is a serious situation that requires prompt attention.

Please be aware that while using this product, you should monitor for any unusual reactions and consult your healthcare provider if you have concerns. Your safety is a priority, so don’t hesitate to reach out for assistance if needed.

Warnings and Precautions

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. This is crucial to ensure your safety and address any potential risks.

Currently, there are no specific general precautions or laboratory tests associated with this product. However, always use it as directed to avoid any unintended issues. If you have any concerns or experience unusual symptoms, don’t hesitate to reach out to your healthcare provider for guidance.

Overdose

If you accidentally swallow more of the product than intended for rinsing, 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

There is currently no specific information available about the use of GIANT EAGLE WINTERMINT WITH FLUORIDE (sodium fluoride mouthwash) during pregnancy. This means that safety concerns, dosage adjustments, or any special precautions for pregnant individuals have not been addressed in the drug insert.

If you are pregnant or planning to become pregnant, it is important to consult with your healthcare provider before using this mouthwash or any other medication. They can provide guidance tailored to your individual health needs and 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. This means that, based on the information available, it is considered safe for you to use without concerns about potential effects on your milk production or the nursing infant.

Additionally, there are no indications that this product is excreted in breast milk, which further supports its use during lactation. Always consult with your healthcare provider if you have any questions or concerns about medications while breastfeeding.

Pediatric Use

It's important to keep this product out of reach of children. If a 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 rinse can be used twice a day after brushing teeth. They should swish 10 mL of the rinse vigorously between their teeth for 1 minute and then spit it out, making sure not to swallow it. After rinsing, they should avoid eating or drinking for 30 minutes.

For children aged 12 and older, it's essential to teach them proper rinsing techniques to reduce the risk of swallowing. Always supervise younger children until they can use the rinse safely on their own. If your child is under 6 years old, consult 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, it’s always a good idea to discuss any medications with a healthcare provider, especially since older adults may have different health needs and may be taking other medications.

Since there are no dosage adjustments or special precautions mentioned for elderly patients, your healthcare provider can help determine the best approach for you, considering your overall health and any other medications you may be taking. 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 guidelines, dosage adjustments, or monitoring instructions to share for patients with kidney issues. If you have concerns about how your kidney health may affect your treatment, it's important to discuss this with your healthcare provider for personalized advice and recommendations.

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 (issues with liver function).

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 great to know that there are no reported drug interactions or laboratory test interactions with this medication. 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, and helps avoid any potential issues.

Always keep your healthcare provider informed about any changes in your health or new medications you may start. Open communication is key to managing your health effectively.

Storage and Handling

To ensure the best use of your product, store it at room temperature. While cold weather may cause the product to appear cloudy, rest assured that this does not impact its effectiveness in preventing cavities.

When handling the product, be mindful of its storage conditions to maintain its quality. Always keep it in a safe place, away from extreme temperatures, to ensure it remains effective for your dental health.

Additional Information

You should take this medication orally, using it twice a day after brushing your teeth. For adults and children aged 6 years and older, 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're supervising children, make sure to instruct those aged 12 and older on proper rinsing techniques to help prevent swallowing. 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 or decay.

How should adults and children 6 years and older use this mouthwash?

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

Consult a dentist or doctor before use.

Are there any specific instructions for children 12 years of age?

Instruct children 12 years of age in good rinsing habits to minimize swallowing.

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

Get medical help or contact a Poison Control Center immediately.

Are there any contraindications or risks associated with this drug?

No contraindications, abuse risks, or dependence concerns are listed for this drug.

How should this product be stored?

Store at room temperature. Cold weather may cloud the product but will not affect its anticavity properties.

Is there any information regarding the use of this product during pregnancy or lactation?

No specific warnings or recommendations regarding use during pregnancy or lactation are provided.

What precautions should be taken when using this mouthwash?

Keep out of reach of children and supervise their use until they can rinse without assistance.

Packaging Info

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

Packaging configurations for Giant Eagle Wintermint with Fluoride.
Details

Drug Information (PDF)

This file contains official product information for Giant Eagle Wintermint with Fluoride, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

No relevant information is available for SPL code 34089-3, and therefore, a detailed description cannot be provided.

Uses and Indications

This drug is indicated for the prevention of dental cavities or decay. 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 twice daily, following brushing 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. Patients should refrain from eating or drinking for 30 minutes following the rinsing procedure to ensure optimal efficacy.

For children aged 12 years and older, it is essential to instruct them in proper rinsing techniques to minimize the risk of swallowing the rinse. Supervision may be required for younger children until they demonstrate the ability to use the rinse without assistance. For children under 6 years of age, consultation with a dentist or physician is recommended prior to use.

Contraindications

Use is contraindicated if more than the recommended amount for rinsing is accidentally swallowed. In such cases, seek medical assistance or contact a Poison Control Center immediately.

Warnings and Precautions

In the event that more than the recommended amount used for rinsing is accidentally ingested, it is imperative to seek immediate medical assistance or contact a Poison Control Center. This action is crucial to ensure the safety and well-being of the patient.

Currently, there are no specific general precautions or laboratory tests associated with the use of this product. Healthcare professionals should remain vigilant and monitor for any adverse effects, although no additional instructions regarding discontinuation of use or consultation with a physician are provided at this time.

Side Effects

Patients should be aware that if more than the recommended amount used for rinsing is accidentally swallowed, it is imperative to seek medical assistance or contact a Poison Control Center immediately. This warning highlights the potential seriousness of ingesting excessive amounts of the product, underscoring the importance of adhering to the usage guidelines to prevent adverse outcomes.

Drug Interactions

There are no known drug interactions associated with the use of this medication. Additionally, there are no reported interactions between this drug and laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug interactions.

Packaging & NDC

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

Packaging configurations for Giant Eagle Wintermint with Fluoride.
Details

Pediatric Use

Pediatric patients should be instructed to keep the product out of reach of children. In the event that more than the recommended amount for rinsing is accidentally swallowed, medical assistance should be sought or a Poison Control Center contacted immediately.

For children aged 6 years and older, the recommended usage is twice daily after brushing teeth with toothpaste. Patients should vigorously swish 10 mL of the rinse between their teeth for 1 minute and then spit it out. It is important that the rinse is not swallowed, and patients should refrain from eating or drinking for 30 minutes following rinsing.

Children aged 12 years and older should be instructed in proper rinsing techniques to minimize the risk of swallowing the rinse. Supervision is advised for younger children 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 prior to use.

Geriatric Use

There is no specific information available 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. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy, given the lack of targeted data for this population.

Pregnancy

There is no specific information regarding the use of GIANT EAGLE WINTERMINT WITH FLUORIDE - sodium fluoride mouthwash 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 mouthwash during pregnancy. It is recommended that pregnant patients consult their healthcare provider for personalized guidance.

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 of this product in breast milk or its effects on breastfed infants.

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

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 intended for rinsing is accidentally 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 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

This product is supplied in various package configurations, with specific NDC numbers available for identification. It is important to note that exposure to cold weather may cause cloudiness in the product; however, this does not impact its anticavity properties.

For optimal storage, the product should be maintained at room temperature. Care should be taken to avoid exposure to extreme temperatures to ensure the integrity of the formulation.

Additional Clinical Information

Patients aged 6 years and older are instructed to use the oral rinse twice daily, following brushing with toothpaste. The recommended method involves vigorously swishing 10 mL of the rinse between the teeth for one minute before spitting it out. Patients should avoid swallowing the rinse and refrain from eating or drinking for 30 minutes after use.

Clinicians should counsel patients, particularly children aged 12 years and younger, on proper rinsing techniques to minimize the risk of swallowing. Supervision may be necessary for younger children until they can use the rinse independently. For children under 6 years of age, consultation with a dentist or doctor is advised.

Drug Information (PDF)

This file contains official product information for Giant Eagle Wintermint with Fluoride, 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 Giant Eagle Wintermint with Fluoride, 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

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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.