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Rheumatica Synergy

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This product has been discontinued

Active ingredient
Menthol 7 mg/50 mL
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 7 mg/50 mL
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
part356
NDC root
70470-1130

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

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Drug Overview

PainAway is a topical product that combines natural peppermint and balsam Peru oil. It is designed to be applied directly to the skin, where you can gently massage it around areas experiencing pain. This soothing application helps to alleviate discomfort by utilizing the natural properties of its ingredients.

Uses

You can use this product by applying it directly to your skin and gently massaging it around the area that is painful. This method helps to target discomfort effectively.

It's important to note that there are no teratogenic effects (which means it does not cause birth defects) or nonteratogenic effects associated with this product. This makes it a safer option for those concerned about potential risks.

Dosage and Administration

When using this medication, it's important to follow the recommended dosage to ensure safety and effectiveness. For adults, the maximum amount you should take is 5 milliliters (ml) per day. If you are giving this medication to a child, the maximum dosage is 1 ml per day.

Make sure to measure the dosage accurately to avoid taking too much. While the specific method of taking or applying the medication isn't detailed, it's essential to follow any additional instructions provided by your healthcare professional or on the medication packaging. Always consult with your doctor if you have any questions or concerns about how to use this medication properly.

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 any rash while using the product, stop using it immediately and consult your doctor. Additionally, keep this product out of reach of children to prevent any accidental misuse.

While there are no specific contraindications or concerns about abuse, misuse, or dependence associated with this product, always prioritize safety and follow the usage instructions carefully.

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, make sure to keep this product out of reach of children to ensure their safety.

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.

It's important to keep this product out of reach of children to prevent accidental ingestion or misuse. Always prioritize safety when using any medication or treatment.

Overdose

If you suspect an overdose, it's important to stay calm and take immediate action. While there is no specific information available about the signs or symptoms of an overdose for this medication, general signs may include unusual drowsiness, confusion, or difficulty breathing.

If you notice any of these symptoms or have concerns about a possible overdose, seek medical help right away. It's always better to err on the side of caution when it comes to your health. Remember, if you are ever in doubt, contacting a healthcare professional is the best course of action.

Pregnancy Use

When it comes to using this medication during pregnancy, there are no specific guidelines or safety concerns mentioned. It's important to consult with your healthcare provider if you are pregnant, planning to become pregnant, or breastfeeding. They can provide personalized advice based on your health needs and the latest information available. Always prioritize open communication with your doctor to ensure the best outcomes for you and your baby.

Lactation Use

If you are breastfeeding or planning to breastfeed, it's important to talk to your healthcare professional before using this product. There is a possibility that the ingredients could be passed into your breast milk, so caution is recommended.

Additionally, the effects on your nursing infant have not been thoroughly studied. Therefore, it's essential to weigh the potential risks against the benefits of using this product while breastfeeding.

Pediatric Use

When giving this medication to your child, it's important to remember that the maximum dosage for children is 1 milliliter (ml) per day. Always ensure you do not exceed this limit to keep your child safe. If you have any questions or concerns about the appropriate use of this medication for your child, consult 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 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 differently due to your liver health.

Always consult your healthcare provider for personalized advice and to discuss any concerns you may have regarding your liver function and how it relates to your treatment. They can help ensure that your medication is safe and effective for you.

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

The medication is administered topically, meaning it is applied directly to the skin. There are no additional details available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experiences. If you have any specific questions or concerns about using this medication, it's best to consult your healthcare provider for personalized advice.

FAQ

What is PainAway?

PainAway is a topical product containing natural Peppermint and Balsam Peru Oil, designed for pain relief.

How do I use PainAway?

Apply PainAway on the skin and gently massage it around the painful area.

What is the maximum dosage for adults and children?

Adults can use a maximum of 5ml per day, while children should not exceed 1ml per day.

Are there any contraindications for PainAway?

No contraindications are listed for PainAway.

Is PainAway safe to use during pregnancy?

The provided text does not mention any specific information regarding the use of PainAway during pregnancy.

Can nursing mothers use PainAway?

Nursing mothers should consult a healthcare professional before using PainAway, as there is a potential for excretion in breast milk.

What precautions should I take when using PainAway?

PainAway is for external use only. Stop use and consult a doctor if a rash occurs, and keep it out of reach of children.

Are there any known drug interactions with PainAway?

No drug interactions information is found for PainAway.

How should I store PainAway?

Protect PainAway from excessive heat and direct sunlight.

Packaging Info

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

Packaging configurations for Rheumatica Synergy.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

PainAway is formulated with natural Peppermint and Balsam Peru Oil. The product is presented in an image/jpeg format, with a reference value of 70470-1117-PainAway.jpg. The effective time for this formulation is noted as April 1, 2016.

Uses and Indications

This drug is indicated for topical application to the skin, with gentle massage around the painful area to alleviate discomfort.

There are no teratogenic effects associated with this drug, and no nonteratogenic effects have been reported.

Dosage and Administration

For adults, the recommended dosage is a maximum of 5 mL per day. In pediatric patients, the maximum dosage is 1 mL per day.

Healthcare professionals should ensure that the administration adheres to these specified maximum dosages to avoid potential adverse effects. The route and method of administration have not been specified; therefore, practitioners should follow standard protocols for the delivery of the medication as appropriate for the formulation and patient population.

Contraindications

Use of this product is contraindicated for external use only. Patients should discontinue use and consult a healthcare professional if a rash occurs. Additionally, the product must be kept out of reach of children to prevent accidental ingestion or misuse.

Warnings and Precautions

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 reach of children to prevent accidental ingestion or misuse.

Side Effects

Patients should be aware that the 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, the product should be kept out of reach of children to prevent accidental ingestion or misuse.

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 Rheumatica Synergy (rheumatica). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Rheumatica Synergy.
Details

Pediatric Use

Pediatric patients are advised to limit the dosage to a maximum of 1 mL per day. This dosage recommendation is applicable to children, ensuring safety and efficacy in this population. Careful adherence to this limit is essential to avoid potential adverse effects.

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

Pregnant patients should be aware that the safety of this medication during pregnancy has not been established. There are no specific data regarding the potential risks or fetal impacts associated with its use in pregnant individuals. Healthcare professionals are advised to consider the lack of information when prescribing this medication to women of childbearing potential and to discuss the potential risks and benefits with their patients. It is essential to exercise caution and to monitor any pregnant patients closely if this medication is deemed necessary.

Lactation

Nursing mothers should consult a healthcare professional before using this product. There is a potential for excretion in breast milk; therefore, caution is advised when administering to nursing mothers. The effects on the nursing infant are not well studied; thus, the risks versus benefits should be considered.

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 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 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 maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

Additionally, it is recommended to consult local poison control centers or relevant toxicology resources for guidance on specific management protocols and antidotes, if applicable.

Documentation of the incident, including the amount and timing of the substance taken, 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 these contexts.

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 their healthcare provider if a rash develops during treatment. Additionally, it is important to emphasize the necessity of keeping the product out of reach of children to prevent accidental ingestion or misuse.

Storage and Handling

This product should be protected from excessive heat and direct sunlight to maintain its integrity and efficacy. It is essential to store the product in a cool, dry place, away from sources of heat and light. Proper handling and storage conditions are crucial to ensure the product remains effective throughout its shelf life.

Additional Clinical Information

The route of administration for the product is topical. There are no additional details available regarding laboratory tests, abuse information, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Rheumatica 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 Rheumatica 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.

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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.