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Tendinitica Synergy

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This product has been discontinued

Active ingredient
Menthol 1.3 mg/50 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
April 2, 2016
Active ingredient
Menthol 1.3 mg/50 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
April 2, 2016
Manufacturer
PHYTOPIA CO. , LTD.
Registration number
part356
NDC root
70470-1139

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Drug Overview

PainAway is a topical product that combines natural ingredients, specifically peppermint oil and balsam Peru oil. It is designed to provide relief from pain when applied to the skin. By gently massaging it around the affected area, you may experience soothing effects that help alleviate discomfort.

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 use without concerns about these specific 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 much lower, at just 1 ml per day.

Always measure the dosage carefully to avoid taking too much. If you have any questions about how to use this medication or if you’re unsure about the right amount for you or your child, be sure to consult with a healthcare professional for guidance.

What to Avoid

You should only use this product externally and keep it out of reach of children to ensure safety. If you notice any rash while using it, stop immediately and consult your doctor. There are no specific contraindications, controlled substance classifications, or concerns about abuse or dependence associated with this product, but it's always best to use it as directed for your health and safety.

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 this 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 of overdose for this medication, general symptoms can include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these signs, or if you are unsure, seek medical help right away.

In case of an overdose, contact your local emergency services or go to the nearest hospital. It's always better to be safe and get checked by a healthcare professional if you have any concerns about your health. Remember, timely intervention can make a significant difference.

Pregnancy Use

When it comes to using this medication during pregnancy, there are no specific guidelines or safety concerns provided. It's important to consult with your healthcare provider if you are pregnant, planning to become pregnant, or breastfeeding. They can help you understand any potential risks and make informed decisions about your treatment options. Always prioritize open communication with your doctor to ensure the best care for you and your baby.

Lactation Use

If you are breastfeeding, it's important to talk to your healthcare professional before using this product. There is a possibility that it could be passed into your breast milk, so caution is advised. The safety of this product during breastfeeding has not been fully established, which means that you should be vigilant and monitor your baby for any unusual reactions if you decide to use it. Your health and your baby's well-being are the top priorities, so make sure to seek guidance from a medical expert.

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. This limit helps ensure their safety and effectiveness of the treatment. Always follow this guideline to avoid any potential risks associated with higher doses. If you have any questions or concerns about administering this medication, consult your child's healthcare provider for personalized advice.

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 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 important to have open conversations with your healthcare provider about any medications or tests you may be taking. In this case, there are no known drug interactions or laboratory test interactions reported. However, every individual is different, and your healthcare provider can help ensure that your treatment plan is safe and effective for you. Always share your complete list of medications and any lab tests you undergo to avoid any potential issues.

Storage and Handling

To ensure the best performance of your product, it's important to store it in a cool, dry place. Make sure to 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 should I use PainAway?

Apply PainAway on the skin and gently massage 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?

There are no contraindications 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 side effects of PainAway?

The provided text does not mention any specific side effects 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 Tendinitica Synergy (tendinitica). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Tendinitica Synergy.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

PainAway is a topical formulation that incorporates natural Peppermint and Balsam Peru Oil. The product is designed for the relief of pain and discomfort. It is presented in a dosage form suitable for external application. The effective date of this formulation is April 1, 2016. An image of the product is available in JPEG format, referenced as 70470-1117-PainAway.jpg.

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 limited to 1 mL per day.

Administration should be performed using an appropriate measuring device to ensure accurate dosing. It is advised that the medication be taken at the same time each day to maintain consistent therapeutic levels. Healthcare professionals should monitor patients for efficacy and any potential adverse effects, adjusting the dosage as necessary within the specified limits.

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.

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 intended 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 ensure safety.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there are no known interactions with laboratory tests. Therefore, no specific recommendations for dosage adjustments or monitoring are necessary at this time.

Packaging & NDC

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

Packaging configurations for Tendinitica 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

The safety of this medication during pregnancy has not been established. There are no available data regarding the use of this medication in pregnant patients, and therefore, the potential risks to fetal outcomes remain unknown. Healthcare professionals are advised to consider the lack of information and weigh the benefits against potential risks when prescribing this medication to women of childbearing potential. It is recommended that pregnant patients or those planning to become pregnant discuss their treatment options with their healthcare provider to ensure appropriate management and care.

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 safety of this product during lactation has not been established. It is recommended to monitor breastfed infants for any adverse reactions if the nursing mother uses this product.

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 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 toxicology experts for guidance on specific management protocols and interventions tailored to the situation.

Documentation of the incident, including the substance involved, estimated dose, and time of exposure, is crucial for effective management 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 compound in these areas.

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 occurs. 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 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 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 Tendinitica 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 Tendinitica 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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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.