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Menthol

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This product has been discontinued

Active ingredient
Menthol 20 mg/500 mg
Other brand names
Dosage form
Oil
Route
Topical
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2016
Label revision date
October 24, 2016
Active ingredient
Menthol 20 mg/500 mg
Other brand names
Dosage form
Oil
Route
Topical
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Marketed in the U.S.
Since 2016
Label revision date
October 24, 2016
Manufacturer
PHYTOPIA CO. , LTD.
Registration number
part346
NDC root
70470-1113

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Drug Overview

Gout is a type of arthritis that can cause sudden and severe pain, often in the joints. This medication is designed to help relieve the discomfort associated with gout. It works by targeting the painful areas, providing relief through its soothing properties.

You can apply this medication directly to the skin around the affected joint, gently massaging it in for maximum effect. It's important to follow the recommended dosage, which is a maximum of 5ml per day for adults, to ensure safe and effective use.

Uses

If you're dealing with gout, this medication can help relieve your symptoms. Gout is a type of arthritis that causes sudden and severe pain, often in the joints. This drug works by providing a synergistic effect, meaning it enhances the effectiveness of other treatments you may be using for gout.

It's important to note that this medication does not have any teratogenic effects, which means it won't cause harm to a developing fetus if you're pregnant. Additionally, there are no reported nonteratogenic effects, indicating that it is generally safe in terms of other potential side effects. Always consult with your healthcare provider for personalized advice and treatment options.

Dosage and Administration

You should apply this medication directly to your skin, focusing on the areas where you feel pain. For adults, the maximum amount you can use in one day is 5 milliliters (ml). When applying, gently massage the medication into the skin around the painful area to help it work effectively.

Remember, you should not exceed the 5 ml limit in a single day. This ensures that you use the medication safely and effectively. Always follow these guidelines to get the best results from your treatment.

What to Avoid

It's important to use this product safely and effectively. Remember, it is for external use only, so do not apply it internally. If you notice a rash while using the product, stop using it immediately and consult your doctor. To ensure safety, keep the product out of reach of children and protect it from excessive heat and direct sunlight.

By following these guidelines, you can help ensure a positive experience with the product. If you have any questions or concerns, don't hesitate to reach out to a healthcare professional for advice.

Side Effects

When using this product, it's important to remember that it is for external use only. If you notice a rash, you should stop using it and consult your doctor. Additionally, keep the product out of reach of children and protect it from excessive heat and direct sunlight to ensure its effectiveness.

Warnings and Precautions

This product is intended for external use only, so please avoid applying it to any areas that are not meant for topical treatment. If you notice a rash or any unusual skin reaction while using the product, stop using it immediately and consult your doctor for further advice.

To ensure safety, keep this product out of reach of children. Additionally, be sure to store it in a cool place, away from excessive heat and direct sunlight, to maintain its effectiveness.

Overdose

If you suspect an overdose, it's important to stay calm and take immediate action. While the specific signs of an overdose are not detailed, common symptoms can include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these signs or feel concerned, seek medical help right away.

In case of an overdose, contact your local emergency services or go to the nearest hospital. It's crucial to provide them with as much information as possible about the substance taken and the amount, if known. Remember, acting quickly can make a significant difference in your health and safety.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that the information provided does not specify any safety concerns related to the use of this medication during pregnancy. There are no dosage modifications recommended for pregnant individuals, and no special precautions are mentioned.

While this may suggest that the medication is considered safe, it's always best to consult with your healthcare provider before starting any new treatment. They can provide personalized advice based on your specific health needs and circumstances.

Lactation Use

If you are breastfeeding or planning to breastfeed, it's important to be aware that there is no specific information available regarding the effects of this medication on nursing mothers or lactation (the process of producing milk). Since there are no guidelines or data provided, it’s advisable to consult with your healthcare provider to discuss any potential risks or concerns related to your situation. They can help you make informed decisions about your health and your baby's well-being.

Pediatric Use

It's important to keep this medication out of reach of children. This precaution helps prevent accidental ingestion, which can be dangerous. Always store it in a safe place where children cannot access it, ensuring their safety at all times. If you have any concerns or questions about the medication, don't hesitate to reach out to your healthcare provider for guidance.

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

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 the drug insert does not provide specific information regarding dosage adjustments, special monitoring, or precautions for your condition. This means that there are no established guidelines for how this medication may affect you if you have liver impairment.

Before starting any new medication, including this one, you should discuss your liver health with your healthcare provider. They can help determine the best approach for your treatment and ensure your safety.

Drug Interactions

It's great to know that there are no known 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 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, it's important to store it in a cool, dry place. Protect it from excessive heat and direct sunlight, as these conditions can damage the product.

When handling the product, always do so with care to maintain its integrity. Following these simple guidelines will help ensure that your product remains safe and effective for use.

Additional Information

You should apply this medication topically, which means you will put it directly on your skin. The maximum amount you can use in a day is 5 milliliters. When applying, gently massage the medication around the area where you feel pain. Make sure to follow this guideline to ensure safe and effective use.

FAQ

What is the maximum dosage for adults?

The maximum dosage for adults is 5ml per day.

How should I apply this medication?

You should apply it on the skin and gently massage around the painful area.

Is this medication safe to use during pregnancy?

No specific information regarding safety during pregnancy is provided, but no teratogenic effects are mentioned.

Are there any contraindications for this medication?

There are no contraindications listed for this medication.

What should I do if I experience a rash?

You should stop use and ask your doctor if a rash occurs.

Is this medication for external use only?

Yes, this medication is for external use only.

How should I store this product?

You should protect this product from excessive heat and direct sun.

What should I do if I keep this product out of reach of children?

Always keep this product out of reach of children to ensure safety.

Packaging Info

Below are the non-prescription pack sizes of Gout Reliever Synergy. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Gout Reliever Synergy.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

This formulation exhibits a synergistic effect in the relief of gout symptoms. It is designed to target the underlying mechanisms associated with gout, providing a comprehensive approach to management. The active components work in concert to alleviate pain and inflammation, enhancing overall therapeutic efficacy.

Uses and Indications

This drug is indicated for the relief of gout symptoms through its synergistic effects.

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

Dosage and Administration

For adults, the recommended dosage is a maximum of 5 mL per day. The product should be applied topically to the skin, specifically around the area of pain. It is advised to gently massage the application site to enhance absorption and efficacy.

Healthcare professionals should ensure that the total daily application does not exceed 5 mL.

Contraindications

The product is contraindicated for external use only. It should not be used if a rash occurs; in such cases, discontinue use and consult a healthcare professional. Additionally, the product must be kept out of reach of children to prevent accidental ingestion or misuse. It is also advised to protect the product from excessive heat and direct sunlight to maintain its efficacy.

Warnings and Precautions

This product is intended for external use only. Healthcare professionals should advise patients to discontinue use and consult a physician if a rash develops during treatment.

It is imperative to keep this product out of the reach of children to prevent accidental ingestion or misuse. Additionally, the product should be stored in a cool, dry place, protected from excessive heat and direct sunlight to maintain its efficacy and safety.

Side Effects

Patients should be aware that this product is for external use only. In the event of a rash occurring, it is advised to discontinue use and consult a healthcare professional. Additionally, it is important to keep this product out of reach of children to prevent accidental ingestion or misuse. Care should be taken to protect the product from excessive heat and direct sunlight to maintain its efficacy and safety.

Drug Interactions

No drug interactions or drug and laboratory test interactions have been identified for this product. Therefore, no specific recommendations for dosage adjustments or monitoring are necessary at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Gout Reliever Synergy. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Gout Reliever Synergy.
Details

Pediatric Use

Pediatric patients should be advised to keep this medication out of reach of children. Safety and efficacy in pediatric populations have not been established, and caution is advised when administering this medication to children.

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

The available data regarding the use of this medication during pregnancy is limited. There are no specific safety concerns outlined in the prescribing information that would contraindicate its use in pregnant patients. Additionally, no dosage modifications for pregnant individuals are recommended, and no special precautions regarding the use of this medication during pregnancy have been specified.

Healthcare professionals should consider the potential benefits and risks when prescribing this medication to women of childbearing potential. As with any medication, it is advisable to assess the individual circumstances of each patient, including the potential impact on fetal outcomes.

Lactation

There is no specific information available regarding the use of this medication in nursing mothers or lactation considerations. Healthcare professionals should exercise caution when prescribing this medication to lactating mothers, as the effects on breastfed infants are not well characterized. It is advisable to weigh the potential benefits against any unknown risks when considering treatment options for lactating patients.

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

Patients with hepatic impairment have not been specifically studied in relation to this medication. Consequently, there are no established dosage adjustments, special monitoring requirements, or precautions 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 regarding 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 prescribing information.

Overdosage

In the absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdose.

It is essential to monitor the patient closely for any potential symptoms that may arise from an overdose. Symptoms can vary widely depending on the substance involved and the individual patient's response.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should implement supportive care measures, which may include monitoring vital signs, providing symptomatic treatment, and ensuring the patient's safety.

If available, consultation with a poison control center or a medical toxicologist is recommended to guide further management and intervention strategies.

Documentation of the incident, including the substance involved, the amount taken, and the time of ingestion, is crucial for effective treatment and follow-up 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 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 insert text.

Patient Counseling

Healthcare providers should advise patients that the product is intended for external use only. Patients should be instructed to discontinue use and consult a healthcare professional if a rash occurs. It is important to emphasize the necessity of keeping the product out of reach of children to prevent accidental ingestion or misuse. Additionally, patients should be informed to protect the product from excessive heat and direct sunlight to maintain its efficacy and safety.

Storage and Handling

This product is supplied in packaging that ensures its integrity during storage and handling. It is essential to protect the product from excessive heat and direct sunlight to maintain its efficacy and safety. Proper storage conditions should be observed to prevent degradation.

Additional Clinical Information

The product is administered topically, with a maximum dosage of 5 ml per day for adults. Patients are instructed to apply the medication to the skin and gently massage it around the painful area to ensure proper absorption and effectiveness.

No additional information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Gout Reliever Synergy, 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 Gout Reliever Synergy, 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.