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Pain Relief Extra Strength

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This product has been discontinued

Active ingredient
Acetaminophen 500 mg
Other brand names
Dosage form
Tablet
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 ingredient
Acetaminophen 500 mg
Other brand names
Dosage form
Tablet
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
52904-446
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 provide temporary relief from minor aches and pains. It can help alleviate discomfort associated with various conditions, including the common cold, headaches, backaches, arthritis, toothaches, muscular aches, and menstrual cramps. Additionally, MM1 is effective in reducing fever, making it a versatile option for managing everyday pain and discomfort.

Uses

You can use this medication for the temporary relief of minor aches and pains that may arise from various conditions. This includes discomfort associated with the common cold, headaches, backaches, arthritis, toothaches, muscular aches, and menstrual cramps. Additionally, it can help reduce fever.

It's important to note that there are no reported teratogenic effects (which means it does not cause birth defects) or nonteratogenic effects associated with this medication. Always consult with a healthcare professional if you have any questions or concerns about its use.

Dosage and Administration

If you are an adult or a child aged 12 years and older, you can take 2 tablets of this medication every 4 to 6 hours as needed for relief. However, make sure not to exceed 8 tablets in a 24-hour period to avoid any potential health risks.

For children under 12 years of age, it’s important to avoid using this extra strength product, as it contains a higher dose than what is recommended for younger children. Taking too much can lead to serious health problems, so always consult with a healthcare professional for appropriate options for younger patients.

What to Avoid

There are no specific contraindications, controlled substance classifications, or concerns regarding abuse, misuse, or dependence associated with this medication. Additionally, there are no explicit instructions indicating that you should not take or use this medication. Always consult with your healthcare provider for personalized advice and to ensure this medication is appropriate for you.

Side Effects

This product contains acetaminophen, which can lead to severe liver damage if you exceed 8 tablets in 24 hours, take it with other acetaminophen-containing medications, or consume 3 or more alcoholic drinks daily while using it. It's important to avoid using this product alongside any other drugs that contain acetaminophen, whether they are prescription or over-the-counter.

You should consult a doctor before using this product if you have liver disease or are taking the blood-thinning medication warfarin. If your pain worsens or lasts longer than 10 days, if you experience a rare sensitivity reaction, if your fever worsens or lasts more than 3 days, or if new symptoms develop, stop using the product and seek medical advice.

Warnings and Precautions

This product contains acetaminophen, which can cause severe liver damage if you take more than 8 tablets in 24 hours, use it with other medications that also contain acetaminophen, or consume 3 or more alcoholic drinks daily while using it. It's important to avoid combining this product with any other acetaminophen-containing drugs, whether prescription or over-the-counter. If you're unsure about a medication, consult your doctor or pharmacist. Additionally, if you have liver disease or are taking the blood thinner warfarin, please ask your doctor before using this product.

You should stop using this product and call your doctor if your pain worsens or lasts longer than 10 days, if you experience a rare sensitivity reaction, if your fever worsens or lasts more than 3 days, if your symptoms do not improve, if new symptoms develop, or if you notice any redness or swelling. Always prioritize your health and seek medical advice when needed.

Overdose

Taking more than 8 tablets of this product in a 24-hour period can lead to severe liver damage. It's also important to avoid using this product alongside any other medications that contain acetaminophen, whether they are prescription or over-the-counter. Additionally, if you regularly consume 3 or more alcoholic drinks each day, using this product can significantly increase your risk of 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, seek immediate medical help. Always prioritize your health and safety by following the recommended dosage guidelines.

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. Using this extra strength product in younger children can lead to an overdose, which may result in serious health issues.

For those aged 12 and older, the recommended dosage is 2 tablets every 4 to 6 hours as needed, but be sure not to exceed 8 tablets in a 24-hour period. Always follow these guidelines to ensure your child's safety and well-being.

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 healthcare providers may not have tailored guidelines for elderly patients.

If you or a loved one is an older adult considering this medication, it’s important to discuss any potential risks and benefits with your healthcare provider. They can help determine the best approach based on individual health needs and circumstances.

Renal Impairment

If you have kidney issues, it's important to know that there are no specific guidelines provided for dosage adjustments, special monitoring, or safety considerations related to your condition. This means that the information available does not outline any particular changes you may need to make regarding your medication or treatment.

Always consult your healthcare provider for personalized advice and to ensure that your treatment plan is safe and effective for your kidney health. They can help you understand how your condition may affect your medications and what steps you should take.

Hepatic Impairment

If you have liver problems, it's important to be cautious when using this product, as it contains acetaminophen. Taking more than 8 tablets in a 24-hour period can lead to severe liver damage, which is the maximum daily amount you should not exceed. Additionally, avoid using this product alongside other medications that also contain acetaminophen, whether they are prescription or over-the-counter.

Before using this product, please consult your doctor if you have liver disease. It's also wise to check with your doctor or pharmacist if you are taking warfarin, a medication that helps thin your blood, to ensure your safety. Your health is important, so always seek professional advice when it comes to managing your medications.

Drug Interactions

It's important to talk to your doctor or pharmacist before using this medication, especially if you are taking warfarin, a blood-thinning drug. Combining these can increase your risk of bleeding, so your healthcare provider can help ensure your safety.

Additionally, avoid using this medication alongside any other products that contain acetaminophen, whether they are prescription or over-the-counter. Taking multiple medications with acetaminophen can lead to serious health issues, including liver damage. Always discuss your current medications and any tests with your healthcare provider to avoid potential interactions and ensure your treatment is safe and effective.

Storage and Handling

To ensure the safety and effectiveness of your product, store it at room temperature. This helps maintain its quality and performance. Additionally, it's important to keep the product out of reach of children to prevent any accidental misuse or ingestion. By following these simple guidelines, you can help ensure safe handling and storage.

Additional Information

You should take this medication orally. For adults and children aged 12 and older, the recommended dosage is 2 tablets every 4 to 6 hours as needed, but do not exceed 8 tablets in a 24-hour period.

If you are pregnant or breastfeeding, it's important to consult a healthcare professional before using this medication. Additionally, make sure to keep it out of reach of children to ensure their safety.

FAQ

What is MM1 used for?

MM1 is used for the temporary relief of minor aches and pains associated with conditions like the common cold, headache, backache, arthritis, toothache, muscular aches, menstrual cramps, and for the reduction of fever.

What is the recommended dosage for adults and children 12 years and older?

Adults and children 12 years and older should take 2 tablets every 4 to 6 hours as needed, without exceeding 8 tablets in 24 hours.

Can children under 12 use MM1?

No, children under 12 years of age should not use this extra strength product as it may lead to an overdose and serious health problems.

What should I do if I have liver disease?

If you have liver disease, you should ask a doctor before using MM1, as it contains acetaminophen which can cause severe liver damage.

What are the warnings associated with MM1?

Warnings include the risk of severe liver damage if you take more than 8 tablets in 24 hours, use with other acetaminophen-containing drugs, or consume 3 or more alcoholic drinks daily while using this product.

What should I do if my symptoms do not improve?

You should stop using MM1 and consult a doctor if your pain worsens or lasts more than 10 days, if fever worsens or lasts more than 3 days, or if new symptoms occur.

Is it safe to use MM1 during pregnancy or breastfeeding?

If you are pregnant or breastfeeding, you should ask a health professional before using MM1.

How should I store MM1?

Store MM1 at room temperature and keep it out of reach of children.

Packaging Info

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

Packaging configurations for Pain Relief Extra Strength.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

The Pain ES Packet is a medical product designed for the management of pain. It is associated with an effective time of October 15, 2012. The product is represented in a media type of image/jpeg, with the reference file named Pain ES Packet.jpg.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with various conditions, including common cold, headache, backache, arthritis, toothache, muscular aches, and menstrual cramps. Additionally, it is indicated for the reduction of fever.

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

Dosage and Administration

Adults and children 12 years of age and older are instructed to take 2 tablets orally every 4 to 6 hours as needed. The maximum allowable dosage is 8 tablets within a 24-hour period.

For children under 12 years of age, the use of this extra strength product is contraindicated, as it may result in an overdose that could lead to serious health complications.

Contraindications

There are no contraindications listed for this product. It is important to evaluate each patient's individual circumstances and medical history when considering its use.

Warnings and Precautions

Severe liver damage may occur with the use of this product, which contains acetaminophen. Healthcare professionals should advise patients that the risk of liver injury increases significantly if they exceed the maximum daily dosage of 8 tablets within a 24-hour period, use this product concurrently with other medications containing acetaminophen, or consume 3 or more alcoholic beverages daily while using this product.

It is imperative that patients do not use this product in conjunction with any other drug containing acetaminophen, whether prescription or nonprescription. If patients are uncertain about the presence of acetaminophen in their medications, they should be encouraged to consult a healthcare provider or pharmacist for clarification.

Patients with a history of liver disease should be advised to seek medical consultation prior to using this product. Additionally, those taking the anticoagulant warfarin should also consult with a healthcare professional before use, as potential interactions may occur.

Patients should be instructed to discontinue use and seek medical advice if any of the following occur: pain worsens or persists for more than 10 days; a rare sensitivity reaction is experienced; fever intensifies or lasts longer than 3 days; symptoms do not improve; new symptoms arise; or if there is any redness or swelling.

Regular monitoring of liver function may be warranted in patients using this product, particularly in those with pre-existing liver conditions or those consuming alcohol.

Side Effects

Severe liver damage may occur in patients taking this product containing acetaminophen if they exceed the maximum daily amount of 8 tablets within a 24-hour period, use it concurrently with other drugs containing acetaminophen, or consume 3 or more alcoholic drinks daily while using this product. Patients are advised not to use this product in conjunction with any other drug containing acetaminophen, whether prescription or nonprescription.

Patients with liver disease should consult a doctor prior to use. Additionally, individuals taking the blood-thinning medication warfarin should seek advice from a healthcare professional before using this product.

Patients are instructed to discontinue use and consult a doctor if any of the following occur: pain worsens or persists for more than 10 days; a rare sensitivity reaction manifests; fever worsens or lasts more than 3 days; symptoms do not improve; new symptoms arise; or if redness or swelling is observed.

Drug Interactions

Patients should consult a healthcare professional prior to using this medication if they are concurrently taking warfarin, a blood-thinning agent. The combination may increase the risk of bleeding due to potential pharmacodynamic interactions.

Additionally, this medication should not be used in conjunction with any other products containing acetaminophen, whether prescription or over-the-counter. Co-administration may lead to an increased risk of acetaminophen-related hepatotoxicity. Monitoring for signs of liver damage is advised in patients who may inadvertently exceed the recommended acetaminophen dosage.

Packaging & NDC

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

Packaging configurations for Pain Relief Extra Strength.
Details

Pediatric Use

Children under 12 years of age should not use this extra strength product, as it may lead to an overdose that could result in serious health problems. For adults and children aged 12 years and older, the recommended dosage is 2 tablets every 4 to 6 hours as needed, with a maximum of 8 tablets in a 24-hour period.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any potential adverse effects or changes in efficacy, given the lack of targeted data for this population.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. It is important to assess the potential risks and benefits, as well as any available data regarding fetal outcomes and maternal health. Healthcare providers can offer guidance tailored to individual circumstances, ensuring the safety of both the patient and the developing fetus or nursing infant.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is no specific data available regarding the excretion of this medication in 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 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 should exercise caution when using this product, as it contains acetaminophen, which is associated with the risk of severe liver damage. The maximum recommended dosage is 8 tablets within a 24-hour period; exceeding this limit may lead to significant hepatic injury.

It is imperative that patients with liver disease consult a healthcare professional prior to using this product. Additionally, patients taking anticoagulants such as warfarin should seek advice from a doctor or pharmacist before use, as potential interactions may necessitate monitoring or dosage adjustments.

Due to the risks associated with acetaminophen, careful consideration and monitoring of liver function are advised in patients with compromised liver health.

Overdosage

In cases of overdosage, it is critical to recognize the potential for severe liver damage associated with the use of this product. The maximum recommended daily dosage is 8 tablets within a 24-hour period. Exceeding this limit significantly increases the risk of hepatic injury.

Additionally, the concomitant use of this product with other medications containing acetaminophen, whether prescription or nonprescription, poses a serious risk for liver damage. Healthcare professionals should advise patients against combining these substances to mitigate the risk of overdose.

Furthermore, the consumption of three or more alcoholic beverages daily while using this product can also lead to severe liver damage. It is essential for healthcare providers to counsel patients on the dangers of alcohol use in conjunction with this medication.

In the event of suspected overdosage, immediate medical attention is warranted. Healthcare professionals should monitor liver function and consider appropriate management strategies, which may include supportive care and specific interventions as guided by clinical protocols.

Nonclinical Toxicology

If pregnant or breastfeeding, it is advised to consult a health professional prior to use. No non-teratogenic effects have been specified in the available data. Additionally, there are no details provided regarding nonclinical toxicology or animal pharmacology and toxicology.

Postmarketing Experience

Reports of side effects have been received through voluntary submissions and surveillance programs. Healthcare professionals and patients are encouraged to report any adverse events to the designated contact number, 888-952-0050. This information contributes to the ongoing monitoring of the product's safety profile.

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 potential risks associated with improper access to the medication, ensuring that patients understand the necessity of safeguarding it in their home environment.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at room temperature to maintain its integrity and efficacy. Additionally, it should be kept out of reach of children to ensure safety. Special handling requirements are not specified; however, standard precautions should be observed during storage and handling.

Additional Clinical Information

Patients aged 12 years and older are advised to take 2 tablets orally every 4 to 6 hours as needed, with a maximum of 8 tablets in a 24-hour period. Clinicians should counsel patients to consult a health professional if they are pregnant or breastfeeding and to ensure that the medication is kept out of reach of children.

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

Drug Information (PDF)

This file contains official product information for Pain Relief Extra 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 Extra 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.

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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.