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Amplify Relief Mm

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This product has been discontinued

Active ingredients
  • Menthol 1 g/10 g
  • Methyl Salicylate 3 g/10 g
Other brand names
Dosage form
Cream
Route
Topical
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2017
Label revision date
March 13, 2017
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Menthol 1 g/10 g
  • Methyl Salicylate 3 g/10 g
Other brand names
Dosage form
Cream
Route
Topical
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 2017
Label revision date
March 13, 2017
Manufacturer
International Brand Management, LLC
Registration number
part348
NDC root
69837-019
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 minor aches and pains in your muscles and joints. It can be helpful for various conditions, including simple backache, arthritis, strains, bruises, and sprains. By targeting these discomforts, it aims to provide you with some relief and improve your overall comfort.

Uses

You can use this medication to temporarily relieve minor aches and pains in your muscles and joints. It is effective for conditions such as simple backache, arthritis, strains, bruises, and sprains. This means if you're dealing with discomfort from any of these issues, this medication may help ease your pain and improve your mobility.

It's important to note that there are no reported teratogenic effects (which means it doesn't cause birth defects) associated with this medication, making it a safer option for those concerned about such risks.

Dosage and Administration

It's important to use this medication only as directed by your healthcare provider. If you are an adult or a child aged 12 years and older, you can apply it to the affected area up to 3 to 4 times a day. Make sure to follow the recommended frequency to ensure safety and effectiveness.

If the patient is a child under 12 years old, it's best to consult a doctor before use. They can provide guidance on the appropriate dosage and application for younger patients. Always prioritize safety and follow the advice of a healthcare professional.

What to Avoid

It's important to use this medication safely. Keep it out of reach of children to prevent accidental ingestion. If your condition worsens or symptoms last longer than 7 days, or if symptoms improve and then return within a few days, stop using the medication and consult your doctor. Additionally, if you experience excessive skin irritation, discontinue use and seek medical advice.

Be careful to avoid contact with your eyes or mucous membranes, and do not apply a tight bandage over the area where the medication is used. Following these guidelines will help ensure your safety while using this product.

Side Effects

You should be aware that this product is for external use only and should not be applied to wounds or damaged skin. It is also not recommended for use with a heating pad or on children under 12 years of age who have arthritis-like conditions. If you notice any redness over the affected area, it's best to consult a doctor before using the product.

If your condition worsens or symptoms last longer than 7 days, or if symptoms improve and then return within a few days, you should stop using the product and seek medical advice. Additionally, if you experience excessive skin irritation, discontinue use and consult a healthcare professional.

Warnings and Precautions

This product is for external use only, so please avoid applying it to wounds or damaged skin. Do not use it with a heating pad, and if you are considering using it on a child under 12 years old with arthritis-like conditions, consult a doctor first. If you notice any redness over the affected area, it's best to ask your doctor before proceeding.

If you accidentally swallow this product, seek emergency medical help or contact a Poison Control Center right away. You should also stop using the product and call your doctor if your condition worsens, if symptoms persist for more than 7 days, if symptoms clear up and then return within a few days, or if you experience excessive skin irritation.

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 considering the use of AMPLIFY RELIEF MM, a cream containing methyl salicylate and menthol, it's important to note that there is no specific information available about its safety or effects during pregnancy. This means that the drug insert does not provide guidance on whether it is safe to use while pregnant, how the dosage might need to be adjusted, or if there are any special precautions you should take.

If you are pregnant or planning to become pregnant, it is always best to consult with your healthcare provider before using any medication, including topical creams like AMPLIFY RELIEF MM. They can help you weigh the potential risks and benefits based on your individual situation.

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 it is generally considered safe for you to use without concerns about it affecting your breast milk or posing risks to your infant.

However, it's always a good idea to consult with your healthcare provider if you have any questions or concerns about medications while breastfeeding. They can provide personalized advice based on your situation.

Pediatric Use

If your child is under 12 years old and has arthritis-like conditions, it's important not to use this medication. For children in this age group, you should consult a doctor before use.

For those aged 12 and older, you can apply the medication to the affected area, but be sure to limit applications to no more than 3 to 4 times a day. Always follow your healthcare provider's guidance to ensure safe and effective 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, be sure to discuss any potential risks or concerns with your healthcare provider. They can help determine the best approach for your individual health needs, especially since older adults may have different responses to medications compared to younger individuals. Always keep an open line of communication with your doctor about any changes in health or medication effects.

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. This means that there are no tailored recommendations for how your kidney condition might affect the use of this medication.

Always consult your healthcare provider for personalized advice and to ensure that any treatment plan is safe and effective for your specific situation. They can help you understand how your kidney health may influence your medication and what steps to take for your safety.

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 important to have open conversations with your healthcare provider about any medications you are taking. In this case, there are no specific drug interactions or laboratory test interactions noted, which means that the medication is generally considered safe to use alongside other treatments or tests. However, every individual is different, and your healthcare provider can help ensure that your overall treatment plan is safe and effective for you. Always share your complete list of medications and any lab tests you may undergo to avoid any potential issues.

Storage and Handling

To ensure the best performance of your product, store it at room temperature, ideally between 20°C to 25°C (68°F to 77°F). It's important to keep it away from light and never freeze it, as this can damage the product. When you're not using the tube, make sure to keep it tightly closed to maintain its integrity.

Once you open the tube, please remember to discard it after use to ensure safety and effectiveness. Following these guidelines will help you handle the product safely and effectively.

Additional Information

You should apply this medication topically to the affected area, using it no more than 3 to 4 times a day if you are an adult or a child aged 12 years and older. If the patient is under 12 years old, it's important to consult a doctor before use. Always follow the recommended application guidelines for safe and effective treatment.

FAQ

What is the primary use of this drug?

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

How should I apply this drug?

Adults and children 12 years of age and older should apply it to the affected area no more than 3 to 4 times daily. For children under 12 years, consult a doctor.

Are there any warnings I should be aware of?

Yes, this product is for external use only. Avoid using it on wounds or damaged skin, with a heating pad, or on children under 12 years with arthritis-like conditions.

What should I do if I experience excessive skin irritation?

Stop using the product and consult a doctor if excessive skin irritation occurs.

What should I do if I accidentally swallow this product?

If swallowed, seek emergency medical help or contact a Poison Control Center immediately.

Can I use this product if I am pregnant or nursing?

There are no specific warnings or recommendations regarding the use of this product during pregnancy or while nursing.

How should I store this drug?

Store at room temperature, between 20°C to 25°C (68°F to 77°F), protect from light, and do not freeze. Keep the tube tightly closed when not in use.

Packaging Info

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

Packaging configurations for Amplify Relief Mm.
Details

Drug Information (PDF)

This file contains official product information for Amplify Relief Mm, 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 the SPL code 34089-3. Specific details regarding the chemical name, physical characteristics, inactive ingredients, formulation, or composition are not provided in the available information.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with muscles and joints. Specifically, it is effective for conditions such as simple backache, arthritis, strains, bruises, and sprains.

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

Dosage and Administration

The medication should be used only as directed. For adults and children aged 12 years and older, it is recommended to apply the product to the affected area no more than 3 to 4 times daily. For children under 12 years of age, it is advised to consult a physician before use.

Contraindications

There are no specific contraindications listed for this product. However, it is advised to keep the product out of reach of children to prevent accidental ingestion.

Patients should discontinue use and consult a healthcare professional if any of the following occur: worsening of the condition, persistence of symptoms beyond 7 days, recurrence of symptoms after initial resolution within a few days, or excessive skin irritation.

Additionally, contact with eyes or mucous membranes should be avoided, and the product should not be applied with tight bandaging.

Warnings and Precautions

For external use only. This product should not be applied to wounds or damaged skin, nor should it be used in conjunction with a heating pad. It is contraindicated for use in children under 12 years of age who present with arthritis-like conditions. Healthcare professionals are advised to recommend that patients consult a physician prior to use if there is any redness present over the affected area.

In the event of accidental ingestion, immediate medical assistance should be sought, or the local Poison Control Center should be contacted without delay.

Patients should be instructed to discontinue use and contact their healthcare provider if any of the following occur: the condition worsens or symptoms persist beyond 7 days; symptoms resolve only to reappear within a few days; or if excessive skin irritation develops. Monitoring for these adverse effects is essential to ensure patient safety and effective management of their condition.

Side Effects

Patients using this product should be aware that it is for external use only. It is contraindicated for application on wounds or damaged skin, and should not be used in conjunction with a heating pad. Additionally, it is not recommended for use in children under 12 years of age who have arthritis-like conditions.

Patients are advised to seek medical advice prior to use if there is redness over the affected area.

In the event that the condition worsens or symptoms persist for more than 7 days, patients should discontinue use and consult a healthcare professional. Furthermore, if symptoms resolve and then recur within a few days, or if excessive skin irritation occurs, it is imperative to stop use and seek medical attention.

Drug Interactions

There are no specific drug interactions or laboratory test interactions identified in the available data. Therefore, no recommendations for dosage adjustments or monitoring are necessary at this time.

Packaging & NDC

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

Packaging configurations for Amplify Relief Mm.
Details

Pediatric Use

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

For adolescents aged 12 years and older, the recommended application is to the affected area no more than 3 to 4 times daily.

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 information available regarding the use of AMPLIFY RELIEF MM - methyl salicylate, menthol cream during pregnancy. Consequently, the safety of this product in pregnant patients has not been established, and there are no specific dosage modifications or special precautions recommended for use in this population. Healthcare professionals should exercise caution and consider the lack of data when advising women of childbearing potential regarding the use of this product during pregnancy.

Lactation

There are no specific warnings or recommendations regarding the use of this product by lactating mothers. Additionally, there are no known concerns related to the potential for excretion in breast milk or associated risks for breastfed infants.

Renal Impairment

Patients with renal impairment may not have specific dosage adjustments, special monitoring, or safety considerations outlined in the prescribing information. Therefore, healthcare professionals should exercise caution when prescribing to this population, as the absence of detailed guidance necessitates careful clinical judgment regarding the use of the medication in individuals with reduced kidney function. Regular monitoring of renal function is advisable to ensure patient safety and therapeutic efficacy.

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, as the clinical presentation can vary depending on the substance involved and the individual patient's response. Common symptoms of overdose may include, but are not limited to, altered mental status, cardiovascular instability, respiratory distress, and gastrointestinal disturbances.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should initiate supportive care, which may include maintaining airway patency, providing supplemental oxygen, and ensuring adequate circulation. The use of activated charcoal may be considered if the patient presents within a suitable timeframe and is deemed appropriate based on clinical judgment.

Furthermore, it is crucial to consult local poison control centers or relevant toxicology resources for guidance on specific management protocols and antidotes, if applicable. Continuous monitoring and supportive care remain the cornerstone of managing overdose situations until the patient stabilizes or further interventions are deemed necessary.

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

Postmarketing experience has identified the following adverse reaction: excessive skin irritation. This event has been reported voluntarily and through surveillance programs.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children to prevent accidental ingestion. In the event of swallowing, patients should seek medical assistance or contact a Poison Control Center immediately.

Patients should be instructed to stop using the product and consult a doctor if any of the following occur: the condition worsens or symptoms persist for more than 7 days; symptoms resolve and then recur within a few days; or if excessive skin irritation develops.

While using this product, patients should be cautioned to avoid contact with the eyes and mucous membranes. Additionally, they should be informed not to apply a tight bandage over the area of application.

Storage and Handling

The product is supplied in a tube format, with specific handling and storage requirements to ensure its integrity and efficacy. It should be stored at room temperature, within the range of 20°C to 25°C (68°F to 77°F). It is essential to protect the product from light exposure to maintain its quality. Freezing is not permitted, as it may compromise the formulation.

To preserve the product's effectiveness, the tube must be kept tightly closed when not in use. Additionally, it is important to discard the product after opening to prevent any potential degradation or contamination.

Additional Clinical Information

The medication is administered topically, with the recommended application frequency for adults and children aged 12 years and older being no more than 3 to 4 times daily to the affected area. For children under 12 years of age, it is advised to consult a doctor regarding the appropriate use. 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 Amplify Relief Mm, 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 Amplify Relief Mm, 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.