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Pain Relief Maximum Strength

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This product has been discontinued

Active ingredients
  • Aspirin 250 mg
  • Acetaminophen 250 mg
  • Caffeine 65 mg
Other brand names
Dosage form
Tablet, Coated
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2012
Label revision date
October 15, 2012
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Aspirin 250 mg
  • Acetaminophen 250 mg
  • Caffeine 65 mg
Other brand names
Dosage form
Tablet, Coated
Route
Oral
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 2012
Label revision date
October 15, 2012
Manufacturer
Select Corporation
Registration number
part343
NDC root
52904-468
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

MM1 is a medication designed to temporarily relieve minor aches and pains. It can help with discomfort associated with various conditions, including backaches, headaches, colds, toothaches, minor arthritis pain, and muscular aches. This makes it a versatile option for managing everyday pain and discomfort you might experience.

Uses

You can use this medication to temporarily relieve minor aches and pains that you might experience from various conditions. This includes discomfort from backaches, headaches, colds, toothaches, minor arthritis pain, and muscular aches.

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

Dosage and Administration

If you are an adult or a child aged 12 years and older, you can take 2 tablets whenever you need relief from pain, but make sure to wait at least 6 hours before taking another dose. It's important not to exceed 8 tablets in a 24-hour period unless your doctor advises otherwise.

For children under 12 years of age, it's best to consult a doctor before giving them this medication. Always follow your healthcare provider's instructions to ensure safe and effective use.

What to Avoid

There are no specific contraindications, controlled substance classifications, or risks of abuse, misuse, or dependence associated with this medication. This means that, based on the available information, there are no particular situations or conditions under which you should avoid using it. Always consult with your healthcare provider for personalized advice and to ensure that this medication is appropriate for your individual health needs.

Side Effects

It's important to be aware of potential side effects when using this medication. Children and teenagers should not use it for chickenpox or flu symptoms without consulting a doctor due to the risk of Reye's syndrome, a rare but serious illness linked to aspirin. If you are allergic to aspirin or any salicylate, you should avoid this product. Additionally, be cautious if you have liver issues, as taking more than 8 tablets in 24 hours, combining it with other acetaminophen-containing products, or consuming three or more alcoholic drinks daily can lead to severe liver damage.

This medication may also increase the risk of stomach bleeding, especially if you are over 60, have a history of stomach ulcers, or are taking blood thinners or other NSAIDs. If you experience ringing in the ears, loss of hearing, worsening pain or fever, or new symptoms, stop using the product and consult a doctor. Always follow the recommended dosage and consult your healthcare provider if you have asthma, stomach problems, or are taking other medications.

Warnings and Precautions

It's important to be aware of some key warnings and precautions when using this medication. If you are a child or teenager, do not use this medicine for chickenpox or flu symptoms without first consulting a doctor, as it may be linked to a serious condition called Reye's syndrome. Additionally, avoid this product if you are allergic to aspirin or any salicylate, or if you have had an allergic reaction to other pain relievers or fever reducers.

This medication contains acetaminophen, which can cause severe liver damage if you take more than 8 tablets in 24 hours, combine it with other acetaminophen-containing products, or consume 3 or more alcoholic drinks daily while using it. Be cautious if you are over 60, have a history of stomach ulcers or bleeding, or are taking blood thinners or other NSAIDs, as these factors can increase the risk of stomach bleeding. Always consult your doctor if you have asthma, stomach issues, or are on medications for blood thinning, diabetes, gout, or arthritis.

If you experience ringing in your ears, loss of hearing, worsening pain or fever, new symptoms, or any redness or swelling, stop using the product and contact your doctor. Always follow the recommended dosage and consult a healthcare professional if you have any questions or concerns.

Overdose

Taking more than 8 tablets of this medication in a 24-hour period can lead to severe liver damage. It's also important to be cautious if you are using other medications that contain acetaminophen, whether they are prescribed or available over the counter, as combining them can increase the risk of liver harm. Additionally, consuming 3 or more alcoholic drinks daily while using this product can also result in serious liver damage.

If you suspect an overdose, look out for signs such as nausea, vomiting, loss of appetite, confusion, or jaundice (yellowing of the skin or eyes). If you experience any of these symptoms or believe you have taken too much of the medication, seek immediate medical help. It's always better to be safe and get checked by a healthcare professional.

Pregnancy Use

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using any medication. This is to ensure the safety of both you and your baby.

Particularly, you should avoid using aspirin during the last three months of your pregnancy unless your doctor specifically advises you to do so. Taking aspirin at this stage can lead to potential issues for your unborn child or complications during delivery. Always prioritize open communication with your healthcare provider regarding any medications you may consider.

Lactation Use

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using any medication. This is especially true for aspirin, which should be avoided during the last three months of pregnancy unless your doctor specifically advises you to take it. Using aspirin at this stage can lead to potential problems for your unborn child or complications during delivery. Always prioritize your health and your baby's well-being by seeking professional guidance.

Pediatric Use

If you have a child under 12 years old, it's important to consult a doctor before using this medicine. This is especially crucial if your child has chickenpox or flu symptoms. There is a risk of Reye's syndrome, a rare but serious illness that has been linked to the use of aspirin in children and teenagers. Always seek medical advice to ensure the safety and well-being of your child.

Geriatric Use

As you age, it's important to be aware of certain health risks associated with medications. If you are 60 years or older, there is an increased risk of stomach bleeding when taking certain drugs. This means that you should be especially cautious and discuss any concerns with your healthcare provider. They can help you understand the risks and determine the best treatment options for your needs. Always prioritize your safety and well-being by staying informed and seeking guidance when necessary.

Renal Impairment

If you have kidney problems, it's important to know that there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the usual recommendations for monitoring or safety considerations related to renal impairment (kidney issues) are not provided.

Always consult your healthcare provider for personalized advice and to ensure that any medications you take are safe and appropriate for your kidney health. They can help you understand how your condition may affect your treatment plan.

Hepatic Impairment

If you have liver problems, it's important to be cautious when using products that contain acetaminophen. Taking more than 8 tablets in a 24-hour period can lead to severe liver damage. Additionally, avoid using other medications that also contain acetaminophen, whether they are prescribed or available over the counter.

It's also crucial to limit alcohol consumption to less than three drinks per day while using this product, as drinking alcohol can increase the risk of liver damage. Always consult with your healthcare provider for personalized advice and to ensure your safety when using medications.

Drug Interactions

It's important to talk to your doctor or pharmacist before using this medication, especially if you're taking other drugs. You should avoid using it alongside any other pain relievers or fever reducers. If you're on prescription medications for blood thinning (anticoagulation), diabetes, gout, or arthritis, make sure to consult your healthcare provider first.

Be aware that combining this medication with blood thinners or steroids can increase the risk of stomach bleeding. Additionally, taking it with other products that contain acetaminophen, whether prescription or over-the-counter, can lead to severe liver damage. Always prioritize open communication with your healthcare team to ensure your safety and well-being.

Storage and Handling

To ensure the safety and effectiveness 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 the product protected from light to maintain its quality. Always remember to keep it out of reach of children to prevent any accidental ingestion or misuse. Once you open the product, be sure to discard it after use to avoid any potential safety issues.

Additional Information

You should take this medication orally. If you are pregnant or breastfeeding, it's important to consult a healthcare professional before using it. Specifically, avoid using aspirin during the last three months of pregnancy unless your doctor has specifically instructed you to do so, as it can lead to issues for the unborn child or complications during delivery.

FAQ

What is MM1 used for?

MM1 temporarily relieves minor aches and pains associated with backache, headaches, colds, toothache, minor arthritis pain, and muscular aches.

What is the recommended dosage for adults and children over 12?

Adults and children 12 years of age and older can take 2 tablets as needed for pain every 6 hours, not exceeding 8 tablets in 24 hours.

What should I do if I am under 12 years old?

If you are under 12 years old, consult a doctor before using MM1.

Are there any warnings for using MM1?

Yes, do not use MM1 if you are allergic to aspirin or any other salicylate, and consult a doctor if you have asthma, stomach problems, or are taking certain prescription drugs.

Can I use MM1 if I am pregnant or breastfeeding?

If you are pregnant or breastfeeding, ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless directed by a doctor.

What should I do if I experience side effects?

Stop using MM1 and consult a doctor if you experience ringing in the ears, loss of hearing, worsening pain or fever, new symptoms, or redness and swelling.

How should I store MM1?

Store MM1 at room temperature, between 20°C to 25°C (68°F to 77°F), protect it from light, and keep it out of reach of children.

Packaging Info

Below are the non-prescription pack sizes of Pain Relief Maximum Strength (acetaminophen, aspirin, caffeine). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Pain Relief Maximum Strength.
Details

Drug Information (PDF)

This file contains official product information for Pain Relief Maximum Strength, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

MM1 is identified by SPL Code 34089-3 and is provided in the form of a Pain Max packet.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with various conditions, including backache, headaches, colds, toothache, minor arthritis pain, and muscular aches.

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

Dosage and Administration

Adults and children 12 years of age and older may take 2 tablets as needed for pain every 6 hours. The total daily dosage should not exceed 8 tablets within a 24-hour period unless otherwise directed by a healthcare professional.

For children under 12 years of age, it is recommended to consult a doctor for appropriate dosing and administration guidance.

Contraindications

There are no contraindications associated with the use of this product. It is not classified as a controlled substance, and there are no known risks of abuse, misuse, or dependence. Additionally, there are no specific instructions indicating that the product should not be taken or used under any circumstances.

Warnings and Precautions

Patients should be informed of the following warnings and precautions associated with the use of this medication.

Reye's Syndrome Children and teenagers must not use this medication for chickenpox or flu symptoms without prior consultation with a healthcare professional regarding the risk of Reye's syndrome, a rare but serious condition linked to aspirin use.

Allergy Alert This medication is contraindicated in individuals with a known allergy to aspirin or any other salicylate. It should not be used by anyone who has previously experienced an allergic reaction to any pain reliever or fever reducer.

Liver Warning This product contains acetaminophen, which can lead to severe liver damage if the following conditions are met:

  • More than 8 tablets are taken within a 24-hour period.

  • It is used concurrently with other medications containing acetaminophen, whether prescription or over-the-counter. Healthcare professionals should be consulted if there is uncertainty regarding the use of other medications.

  • The patient consumes 3 or more alcoholic beverages daily while using this product.

Stomach Bleeding Warning This medication contains nonsteroidal anti-inflammatory drugs (NSAIDs), which may increase the risk of stomach bleeding. The risk is heightened in patients who:

  • Are aged 60 years or older.

  • Have a history of stomach ulcers or bleeding disorders.

  • Are taking anticoagulants or steroid medications.

  • Are using other NSAIDs (such as aspirin, ibuprofen, or naproxen).

  • Exceed the recommended dosage or duration of use.

Contraindications This medication should not be used in the following circumstances:

  • If the patient is allergic to aspirin or any other pain reliever or fever reducer.

  • For pain lasting more than 10 days or fever persisting for more than 3 days unless directed by a healthcare provider.

  • In conjunction with any other product containing acetaminophen.

Consultation Required Patients should seek medical advice before using this medication if they have:

  • Asthma.

  • Stomach issues, including heartburn, upset stomach, or abdominal pain.

  • Gastric ulcers.

  • Bleeding disorders.

  • Are taking prescription medications for anticoagulation, diabetes, gout, or arthritis.

Dosage Adherence Patients must adhere to the recommended dosage and should not exceed the prescribed amount.

Discontinuation of Use Patients should stop using this medication and consult a healthcare professional if any of the following occur:

  • Ringing in the ears or loss of hearing.

  • Pain or fever persists or worsens.

  • New symptoms develop.

  • Redness or swelling is observed.

Side Effects

Patients using this medication should be aware of several important warnings and potential adverse reactions.

Reye's syndrome is a rare but serious illness associated with aspirin use, particularly in children and teenagers. Therefore, it is crucial that this medicine not be used for chickenpox or flu symptoms in these populations without prior consultation with a healthcare provider.

An allergy alert is also present; patients should not use this product if they are allergic to aspirin or any other salicylate, or if they have previously experienced an allergic reaction to any pain reliever or fever reducer.

Severe liver damage may occur due to the acetaminophen content in this product, particularly if patients exceed 8 tablets in 24 hours, use it in conjunction with other acetaminophen-containing medications, or consume three or more alcoholic drinks daily while using this product.

Additionally, the nonsteroidal anti-inflammatory drugs (NSAIDs) in this formulation may increase the risk of stomach bleeding. This risk is heightened in patients aged 60 or older, those with a history of stomach ulcers or bleeding problems, individuals taking anticoagulants or steroid medications, and those using other NSAIDs. Patients are advised to adhere strictly to the recommended dosage and duration of use.

Patients should not use this medication if they have a known allergy to aspirin, if they are taking any other pain reliever or fever reducer, or if they have experienced an allergic reaction to any such medications in the past. Furthermore, it is recommended that patients refrain from using this product for pain for more than 10 days or for fever for more than 3 days unless directed by a healthcare professional.

Before using this product, patients should consult a doctor if they have asthma, stomach problems (such as heartburn, upset stomach, or stomach pain), gastric ulcers, or bleeding problems. It is also advisable to seek guidance from a healthcare provider or pharmacist if the patient is taking prescription medications for anticoagulation, diabetes, gout, or arthritis.

Patients should be vigilant for certain symptoms while using this product. They should discontinue use and consult a doctor if they experience ringing in the ears or loss of hearing, if pain or fever persists or worsens, if new symptoms arise, or if redness or swelling occurs.

Drug Interactions

Patients should consult a healthcare professional before using this medication in conjunction with other drugs, particularly if they are uncertain about potential interactions.

Co-administration with other pain relievers or fever reducers is contraindicated. The risk of adverse effects, including stomach bleeding, is heightened when this medication is taken alongside anticoagulants or steroid medications. Therefore, careful monitoring is advised for patients on blood thinners or steroids.

Additionally, patients taking prescription medications for anticoagulation, diabetes, gout, or arthritis should seek guidance from a healthcare provider prior to use.

Severe liver damage may occur if this medication is used concurrently with other products containing acetaminophen, whether prescription or nonprescription. It is crucial to avoid such combinations to mitigate the risk of hepatotoxicity.

Packaging & NDC

Below are the non-prescription pack sizes of Pain Relief Maximum Strength (acetaminophen, aspirin, caffeine). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Pain Relief Maximum Strength.
Details

Pediatric Use

Pediatric patients under 12 years of age should consult a healthcare professional prior to use. It is important to note that children and teenagers are advised against using this medication for chickenpox or flu symptoms without prior consultation due to the risk of Reye's syndrome, a rare but serious illness associated with aspirin use.

Geriatric Use

Elderly patients, particularly those aged 60 years and older, may have an increased risk of stomach bleeding. Healthcare providers should exercise caution when prescribing this medication to geriatric patients, considering the potential for heightened adverse effects.

It is advisable to monitor these patients closely for any signs of gastrointestinal bleeding and to evaluate the necessity of dosage adjustments based on individual patient factors. Careful assessment of the benefits and risks is essential when treating elderly patients with this medication.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to use. It is particularly important to avoid the use of aspirin during the last three months of pregnancy unless specifically directed by a physician, as it may pose risks to the unborn child and lead to complications during delivery. Healthcare providers should carefully consider these factors when advising women of childbearing potential regarding the use of this medication.

Lactation

Lactating mothers are advised to consult a healthcare professional before using this medication while breastfeeding. It is particularly important to avoid the use of aspirin during the last three months of pregnancy unless specifically directed by a doctor, as it may pose risks to the unborn child or lead to complications during delivery. There is no specific data provided regarding the excretion of this medication in breast milk or its effects on breastfed infants.

Renal Impairment

Patients with renal impairment have no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the text. Therefore, healthcare professionals should exercise caution and consider individual patient factors when prescribing to this population. Regular assessment of renal function may be warranted to ensure safe and effective use of the medication in patients with reduced kidney function.

Hepatic Impairment

Patients with hepatic impairment should be closely monitored when using this product, which contains acetaminophen. Severe liver damage may occur if patients exceed the recommended dosage of more than 8 tablets in a 24-hour period. Additionally, patients must avoid concomitant use with other medications containing acetaminophen, whether prescription or nonprescription, as this can further increase the risk of liver injury.

It is also critical for patients with compromised liver function to limit alcohol consumption. Specifically, the intake of 3 or more alcoholic drinks per day while using this product may significantly heighten the risk of severe liver damage. Therefore, healthcare providers should assess liver function and provide appropriate counseling regarding the safe use of this product in patients with hepatic impairment. Regular monitoring of liver function tests may be warranted to ensure patient safety.

Overdosage

In cases of overdosage, significant health risks are associated with the consumption of this product.

Risk of Severe Liver Damage Healthcare professionals should be aware that severe liver damage may occur if a patient ingests more than 8 tablets within a 24-hour period. This risk is compounded when the product is taken concurrently with other medications containing acetaminophen, whether they are prescription or nonprescription.

Additionally, patients who consume three or more alcoholic drinks daily while using this product are at an increased risk for severe liver damage.

Recommended Actions In the event of suspected overdosage, it is imperative to seek immediate medical attention. Healthcare providers should monitor liver function and consider appropriate interventions based on the severity of the symptoms presented. Prompt recognition and management of acetaminophen overdosage are crucial to mitigate potential liver injury.

Nonclinical Toxicology

It is especially important to avoid the use of aspirin during the last three months of pregnancy unless specifically directed by a healthcare professional, as it may lead to complications for the unborn child or during delivery. No non-teratogenic effects have been explicitly stated in the available data. Additionally, there are no specific findings related to animal pharmacology and toxicology provided in the extracted information.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental ingestion or misuse. It is important to emphasize the necessity of proper storage and handling to ensure safety. Patients should be informed about the potential risks associated with unauthorized access to the medication by children.

Storage and Handling

The product is supplied in a configuration that ensures optimal handling and storage. It should be stored at room temperature, specifically within the range of 20°C to 25°C (68°F to 77°F). It is essential to protect the product from light to maintain its integrity. Additionally, the product must be kept out of reach of children to ensure safety. Once opened, the product should be discarded to prevent any potential degradation or contamination.

Additional Clinical Information

The medication is administered orally. Clinicians should advise patients who are pregnant or breastfeeding to consult a health professional prior to use. It is particularly critical to avoid aspirin during the last three months of pregnancy unless specifically directed by a physician, as it may pose risks to the unborn child or lead to complications during delivery.

Drug Information (PDF)

This file contains official product information for Pain Relief Maximum Strength, 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 Pain Relief Maximum Strength, 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.