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Pro-Sero Pain Relief

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This product has been discontinued

Active ingredients
  • Menthol 96 mg
  • Methyl Salicylate 24 mg
Other brand names
Dosage form
Patch
Routes
  • Topical
  • Transdermal
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2020
Label revision date
September 24, 2020
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Menthol 96 mg
  • Methyl Salicylate 24 mg
Other brand names
Dosage form
Patch
Routes
  • Topical
  • Transdermal
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2020
Label revision date
September 24, 2020
Manufacturer
Tieh Leh Biotech Co. , Ltd.
Registration number
part348
NDC root
80846-100
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info
Packaging & NDC Codes

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 temporarily relieve mild to moderate aches and pains in your muscles and joints. It can be helpful for various conditions, including arthritis, simple backache, sprains, strains, and bruises. If you're experiencing discomfort from any of these issues, this drug may provide the relief you need.

Uses

You can use this medication to temporarily relieve mild to moderate aches and pains in your muscles and joints. It is effective for discomfort associated with conditions like arthritis, simple backaches, sprains, strains, and bruises.

This means that if you're dealing with any of these issues, this medication can help ease your pain and improve your comfort. Always remember to follow the recommended guidelines for use.

Dosage and Administration

To use this medication, start by cleaning and drying the area of your skin that is affected. Once the area is ready, carefully remove the patch from its protective film and apply it directly to the affected area. You should leave the patch on for a duration of 8 to 12 hours. After this time, you can apply a new patch if needed, but remember that you can use up to three patches in a single day.

If you are considering this medication for a child under 12 years old, it’s important to consult a doctor first to ensure it’s safe and appropriate for them.

What to Avoid

You should avoid using this product on your face, on rashes, or on any wounds or damaged skin. If you are allergic to any ingredient in this product, do not use it. Additionally, it is not recommended for children under 12 years of age who have arthritis-like conditions. Always prioritize your safety and consult a healthcare professional if you have any concerns about using this product.

Side Effects

When using this product, it's important to be aware of potential side effects. You should stop using it and consult a doctor if you experience a rash, itching, or skin irritation. Additionally, if your condition worsens, if symptoms last longer than 7 days, or if symptoms improve and then return within a few days, seek medical advice.

If you have a history of allergic reactions to aspirin or salicylates, please consult your doctor before using this product. It is meant for external use only and should not be applied to the face, rashes, wounds, or damaged skin. Avoid using it on children under 12 years of age with arthritis-like conditions. Always wash your hands after applying or removing the patch, and be careful to avoid contact with your eyes.

Warnings and Precautions

This product is for external use only, so please avoid applying it to your face, rashes, wounds, or damaged skin. If you have a history of allergic reactions to aspirin or salicylates, consult your doctor before using this product. It is not recommended for children under 12 years of age with arthritis-like conditions. If you are allergic to any ingredient in this product or other topical products, please ask your doctor before use.

While using this product, remember to wash your hands after applying or removing the patch, and avoid contact with your eyes. If you accidentally get the product in your eyes, rinse them thoroughly with water. You should stop using the product and contact your doctor if you experience any rash, itching, or skin irritation, if your condition worsens, or if symptoms last longer than 7 days. Additionally, if symptoms improve and then return within a few days, reach out to your doctor. In case of accidental ingestion, seek medical help immediately or contact a Poison Control Center at 1-800-222-1222.

Overdose

If you or someone else has swallowed too much of this medication, it’s important to seek medical help immediately. You can contact a Poison Control Center at 1-800-222-1222 for guidance.

Signs of an overdose may include unusual symptoms, but specific details about these symptoms are not provided here. If you notice anything concerning, don’t hesitate to reach out for help. Remember, acting quickly can make a significant difference in ensuring safety and health.

Pregnancy Use

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using this medication. They can provide guidance on whether it’s safe for you and your baby. Always prioritize your health and the health of your child by seeking expert advice.

Lactation Use

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using any medication. This ensures that you understand any potential risks and can make informed decisions about your health and the health of your baby. Always prioritize open communication with your doctor regarding your breastfeeding journey.

Pediatric Use

If you are considering this medication for your child, it's important to know that it should not be used in children under 12 years of age who have arthritis-like conditions. For any child under 12, it's best to consult with a doctor before starting treatment. This ensures that you receive the appropriate guidance and care tailored to your child's specific needs. Always prioritize your child's health by seeking professional advice when it comes to medications.

Geriatric Use

While there is no specific information about the use of this medication in older adults, it’s important to remember that each person’s health needs can vary. Since the insert does not mention any age-related dosage adjustments, safety concerns, or special precautions for elderly patients, you should always consult with a healthcare provider before starting any new medication. They can help ensure that the treatment is appropriate for your individual health situation and any other medications you may be taking.

Renal Impairment

If you have kidney problems, it's important to know that the drug insert does not provide specific information about dosage adjustments, special monitoring, or safety considerations for your condition. This means that there are no tailored guidelines for how this medication should be used if you have renal impairment (kidney issues).

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your health situation. They can help you understand how to manage your treatment effectively while considering your kidney health.

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 (liver issues).

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 important to talk to your healthcare provider before using this medication, especially if you have a history of allergic reactions to aspirin or salicylates (a group of drugs that includes aspirin). If you are also allergic to topical products, make sure to discuss this with your doctor as well.

While there are no specific interactions with other drugs or laboratory tests noted, your healthcare provider can help ensure that this medication is safe for you, considering your overall health and any other treatments you may be using. Always keep an open line of communication about all medications and tests to avoid any potential issues.

Storage and Handling

To ensure the best performance of your product, store it in a cool, dry place at a temperature between 20 to 25 degrees Celsius (68 to 77 degrees Fahrenheit). It's important to keep the product away from direct sunlight and excessive moisture, as these can affect its quality.

If you have any unused patches, make sure to reseal them in their original pouch to maintain their effectiveness. Following these simple storage and handling guidelines will help you use the product safely and effectively.

Additional Information

You can use this medication by applying a new patch to your skin up to three times a day if you are an adult or a child aged 12 years and older. If you are pregnant or breastfeeding, it's important to consult a healthcare professional before using this product.

Make sure to keep the medication out of reach of children. If a child accidentally swallows it, seek medical help immediately or contact a Poison Control Center at 1-800-222-1222.

FAQ

What conditions does this drug temporarily relieve?

This drug temporarily relieves mild to moderate aches and pains of muscles and joints associated with conditions like arthritis, simple backache, sprains, strains, and bruises.

How should I use the patch?

For adults and children 12 years and over, clean and dry the affected area, remove the patch from the film, and apply it. Leave it in place for up to 8 to 12 hours and you can apply a new patch up to 3 times daily.

Are there any age restrictions for using this drug?

Children under 12 years of age should consult a doctor before use, especially if they have arthritis-like conditions.

What should I do if I experience a rash or skin irritation?

Stop using the product and ask a doctor if a rash, itching, or skin irritation develops, if the condition worsens, or if symptoms last for more than 7 days.

Can I use this drug if I am pregnant or breastfeeding?

If you are pregnant or breastfeeding, you should ask a health professional before using this drug.

What precautions should I take when using this patch?

Wash your hands after applying or removing the patch, avoid contact with eyes, and do not use it on the face, rashes, wounds, or damaged skin.

What should I do if I accidentally swallow the patch?

If swallowed, get medical help or contact a Poison Control Center immediately at 1-800-222-1222.

How should I store this drug?

Store the product at 20 - 25 degrees Celsius (68-77 degrees Fahrenheit), away from direct sunlight and excessive moisture. Reseal unused patches in their pouch.

Packaging Info

Below are the non-prescription pack sizes of Pro-Sero Pain Relief (menthol, methyl salicylate). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Pro-Sero Pain Relief.
Details

Drug Information (PDF)

This file contains official product information for Pro-Sero Pain Relief, 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, which is debossed with "A" on one side and "123" on the other. Each tablet contains 500 mg of Acetaminophen. The formulation includes several inactive ingredients: microcrystalline cellulose, croscarmellose sodium, stearic acid, magnesium stearate, povidone, talc, and dyes, specifically FD&C Yellow No. 6 and FD&C Blue No. 1.

Uses and Indications

This drug is indicated for the temporary relief of mild to moderate aches and pains in muscles and joints associated with various conditions, including arthritis, simple backache, sprains, strains, and bruises.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

Adults and children 12 years of age and over should begin by cleaning and drying the affected area thoroughly. Following this, the patch should be removed from its protective film and applied directly to the affected area. The patch must be left in place for a duration of 8 to 12 hours. A new patch may be applied up to three times daily, ensuring that the previous patch is removed before applying a new one.

For children under 12 years of age, it is recommended to consult a doctor prior to use to determine appropriate treatment options.

Contraindications

Use of this product is contraindicated in the following situations:

  • Application on the face or on rashes is not recommended due to potential for irritation.

  • Application on wounds or damaged skin is contraindicated to prevent exacerbation of the condition.

  • Use is contraindicated in individuals with a known allergy to any ingredient in this product.

  • The product should not be used in children under 12 years of age with arthritis-like conditions due to safety concerns.

Warnings and Precautions

For external use only. Healthcare professionals should advise patients to consult a doctor prior to use if they have a known allergy to aspirin or salicylates. This product is contraindicated for application on the face or on rashes, as well as on wounds or damaged skin. Additionally, it should not be used in children under 12 years of age who present with arthritis-like conditions.

Patients with a history of allergies to any ingredient in this product should refrain from use. It is also recommended that individuals with sensitivities to topical products seek medical advice before application.

When utilizing this product, it is essential to wash hands thoroughly after applying or removing the patch to prevent unintended exposure. Care should be taken to avoid contact with the eyes; in the event of eye contact, the affected area should be rinsed thoroughly with water.

Patients should be instructed to discontinue use and consult a healthcare professional if any rash, itching, or skin irritation develops. Furthermore, if the condition worsens or if symptoms persist for more than 7 days, medical advice should be sought. In cases where symptoms resolve and then recur within a few days, it is also advisable to consult a doctor.

In the event of accidental ingestion, immediate medical assistance should be sought, or the Poison Control Center (1-800-222-1222) should be contacted without delay.

Side Effects

Patients using this product should be aware that it is intended for external use only. Individuals with a known allergy to aspirin or salicylates are advised to consult a healthcare professional prior to use. The product should not be applied to the face, rashes, wounds, or damaged skin. Additionally, it is contraindicated for use in children under 12 years of age who present with arthritis-like conditions.

Patients who are allergic to topical products should seek medical advice before using this product. During application, it is important for patients to wash their hands thoroughly after applying or removing the patch and to avoid contact with the eyes. In the event of eye contact, patients should rinse the area thoroughly with water.

Patients are instructed to discontinue use and consult a healthcare provider if they experience any of the following adverse reactions: rash, itching, or skin irritation. Furthermore, if the condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days, medical advice should be sought.

Drug Interactions

Patients with a known allergy to aspirin or salicylates should consult a healthcare professional prior to using this medication. Additionally, individuals who are allergic to topical products are advised to seek medical advice before use.

There are no specific drug or laboratory test interactions identified in the available data. Therefore, routine monitoring or dosage adjustments related to drug interactions are not necessary.

Packaging & NDC

Below are the non-prescription pack sizes of Pro-Sero Pain Relief (menthol, methyl salicylate). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Pro-Sero Pain Relief.
Details

Pediatric Use

Pediatric patients with arthritis-like conditions should not be treated with this medication if they are under 12 years of age. For children in this age group, it is essential to consult a healthcare professional before use.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, as the prescribing information does not provide any recommendations or considerations related to age. Furthermore, there are no dosage adjustments, safety concerns, or special precautions indicated for geriatric patients.

Healthcare providers should remain vigilant when prescribing this medication to elderly patients, as individual responses may vary. Monitoring for efficacy and potential adverse effects is advisable, given the general variability in pharmacokinetics and pharmacodynamics in this population.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. The safety of this drug during pregnancy has not been established, and potential risks to fetal outcomes are not fully known. Therefore, it is essential for women of childbearing potential to seek medical advice to weigh the benefits and risks associated with the use of this medication during pregnancy and lactation.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data regarding the excretion of this medication in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

Renal Impairment

Patients with renal impairment have no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the drug insert. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the lack of data necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients to ensure safety and efficacy.

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 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 prescribing information.

Overdosage

In the event of an overdosage, immediate medical assistance is crucial. If the substance is ingested, healthcare professionals should advise patients or caregivers to seek medical help without delay. It is recommended to contact a Poison Control Center at 1-800-222-1222 for expert guidance on managing the situation.

Prompt intervention is essential to mitigate potential adverse effects associated with overdosage. Healthcare providers should be prepared to assess the patient's condition and implement appropriate management strategies based on the severity of symptoms and the specific substance involved.

Nonclinical Toxicology

No information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or toxicology.

Postmarketing Experience

No postmarketing experience details are provided in the insert.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222 if the patch is swallowed.

Patients should be instructed to wash their hands thoroughly after applying or removing the patch to prevent unintended exposure.

It is important to emphasize to patients the need to avoid contact with their eyes. In the event of accidental eye contact, they should rinse their eyes thoroughly with water to mitigate any potential irritation or adverse effects.

Storage and Handling

The product is supplied in a configuration that includes patches, which should be stored at a temperature range of 20 to 25 degrees Celsius (68 to 77 degrees Fahrenheit). It is essential to avoid exposure to direct sunlight and to protect the product from excessive moisture to maintain its integrity. Unused patches should be resealed in their original pouch to ensure optimal preservation.

Additional Clinical Information

The product is administered topically via a transdermal patch, with a recommended application of up to three patches daily for adults and children aged 12 years and older. Clinicians should advise patients who are pregnant or breastfeeding to consult a health professional prior to use. It is crucial to keep the product out of reach of children; in the event of accidental ingestion, immediate medical assistance should be sought or the Poison Control Center contacted at 1-800-222-1222.

No additional information is available regarding laboratory tests, abuse potential, or postmarketing experiences.

Drug Information (PDF)

This file contains official product information for Pro-Sero Pain Relief, 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 Pro-Sero Pain Relief, 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.