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Pain Relief Anti Inflammatory

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This product has been discontinued

Active ingredient
Ibuprofen 200 mg
Other brand names
Dosage form
Tablet
Route
Oral
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2012
Label revision date
October 15, 2012
Active ingredient
Ibuprofen 200 mg
Other brand names
Dosage form
Tablet
Route
Oral
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Marketed in the U.S.
Since 2012
Label revision date
October 15, 2012
Manufacturer
Select Corporation
Registration number
ANDA091239
NDC root
52904-486

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Drug Overview

MM1 is a medication designed to temporarily relieve minor aches and pains, including headaches, muscular aches, toothaches, backaches, and pain associated with arthritis, the common cold, and menstrual cramps. Additionally, it helps to reduce fever, making it a useful option for managing discomfort during various everyday ailments.

While the specific mechanism of action isn't detailed, MM1 is often associated with anti-inflammatory properties, which can contribute to its effectiveness in alleviating pain and discomfort. If you're experiencing any of these minor pains or fever, MM1 may provide the relief you need.

Uses

You can use this medication to temporarily relieve minor aches and pains caused by various conditions, including headaches, muscular aches, arthritis pain, toothaches, backaches, the common cold, and menstrual cramps. Additionally, it can help reduce fever for a short period.

This medication is designed to provide you with quick relief from discomfort, making it easier to go about your daily activities. Always remember to follow the recommended guidelines for use to ensure safety and effectiveness.

Dosage and Administration

If you are an adult or a child aged 12 years and older, you can take 1 tablet every 4 to 6 hours as needed while you have symptoms. If you find that 1 tablet isn’t enough to relieve your pain or fever, you may take 2 tablets instead. However, it’s important not to exceed 6 tablets in a 24-hour period unless your doctor advises you to do so.

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

You should be aware that this medication can cause severe allergic reactions, particularly if you are allergic to aspirin. Symptoms of such reactions may include hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, and blisters.

Additionally, this product contains a nonsteroidal anti-inflammatory drug (NSAID), which can lead to serious stomach bleeding. Your risk is higher if you are over 60, have a history of stomach ulcers or bleeding, take blood thinners or steroids, use other NSAIDs, consume three or more alcoholic drinks daily, or exceed the recommended dosage. If you notice signs of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain, you should stop using the medication and consult a doctor immediately.

Warnings and Precautions

You should be aware that ibuprofen can cause severe allergic reactions, especially if you are allergic to aspirin. Symptoms of an allergic reaction may include hives, facial swelling, wheezing, shock, skin reddening, rash, or blisters. If you experience any of these symptoms, stop using ibuprofen immediately and seek emergency medical help.

Ibuprofen can also lead to serious stomach bleeding, particularly if you are over 60, have a history of stomach ulcers or bleeding, take blood thinners or steroids, consume three or more alcoholic drinks daily, or use it for longer than directed. It's important to consult your doctor before using ibuprofen if you have any history of stomach problems, high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma. Additionally, if you are taking aspirin for heart conditions, check with your doctor, as ibuprofen may reduce its effectiveness.

If you notice signs of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or if your stomach pain worsens or lasts more than 10 days, stop taking ibuprofen and contact your doctor. Also, seek medical attention if you experience any new symptoms or if your fever worsens or lasts more than three days.

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, 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

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using any medication, including ibuprofen. This is particularly crucial during the last three months of pregnancy, as using ibuprofen during this time can lead to potential issues for your unborn child or complications during delivery. Always prioritize your health and the health of your baby by seeking guidance from your doctor.

Lactation Use

If you are pregnant or breastfeeding, it's important to consult with a healthcare professional before using any medication, including ibuprofen. During the last three months of pregnancy, you should avoid ibuprofen unless your doctor specifically advises you to take it, as it may pose risks to your unborn child or lead to complications during delivery.

Always prioritize your health and the health of your baby by seeking guidance from your healthcare provider regarding any medications you may consider while breastfeeding.

Pediatric Use

If your child is under 12 years old, it's important to consult a doctor before giving them this medication. For those aged 12 and older, you can administer 1 tablet every 4 to 6 hours as needed for symptoms. If one tablet isn't effective for pain or fever, you may give 2 tablets, but be sure not to exceed 6 tablets in a 24-hour period unless a doctor advises otherwise.

Always remember to keep this medication out of reach of children to ensure their safety.

Geriatric Use

As you age, it's important to be aware of certain health risks when taking medications. If you are 60 years or older, there is a higher chance of experiencing severe stomach bleeding. This risk is especially significant if you have conditions like high blood pressure, heart disease, liver cirrhosis (a liver condition), or kidney disease.

Before starting any new medication, it's wise to consult with your doctor, particularly if any of these warnings apply to you. Your healthcare provider can help ensure that your treatment is safe and appropriate for your specific health needs.

Renal Impairment

If you have kidney problems, it's important to consult your doctor before using this medication. This is especially crucial if you also have high blood pressure, heart disease, or liver cirrhosis, as these conditions can affect how your body processes the medication. Your healthcare provider can help determine if this treatment is safe for you and whether any adjustments are needed based on your kidney function. Always prioritize open communication with your doctor regarding your health conditions.

Hepatic Impairment

If you have liver problems, such as liver cirrhosis (a severe scarring of the liver), it's important to consult your doctor before using this medication. Your healthcare provider can help determine if it's safe for you, especially if you also have other conditions like high blood pressure or heart disease.

Always prioritize your health by discussing any existing liver issues with your doctor to ensure proper care and monitoring.

Drug Interactions

It's important to be aware of how certain medications can interact with each other. For instance, if you take ibuprofen, it may reduce the effectiveness of aspirin when used for preventing heart attacks or strokes. Additionally, combining ibuprofen with blood thinners (medications that help prevent blood clots) or steroids can raise the risk of stomach bleeding.

Moreover, using ibuprofen for longer than recommended can increase your chances of experiencing a heart attack or stroke. Always discuss any medications you are taking, including over-the-counter drugs like ibuprofen, with your healthcare provider 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 protect it from light and keep the container tightly closed when not in use. Always keep the product out of reach of children to prevent accidental ingestion or misuse. Once opened, please remember to discard the product to maintain safety and quality.

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 ibuprofen during the last three months of pregnancy unless your doctor has specifically instructed you to do so, as it may lead to issues for the unborn child or complications during delivery.

FAQ

What is MM1 used for?

MM1 temporarily relieves minor aches and pains due to headaches, muscular aches, arthritis, toothaches, backaches, the common cold, and menstrual cramps. It also temporarily reduces fever.

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

Adults and children 12 years and over should take 1 tablet every 4 to 6 hours while symptoms persist. If pain or fever does not respond to 1 tablet, you may take 2 tablets, but do not exceed 6 tablets in 24 hours unless directed by a doctor.

What should I do if I experience signs of stomach bleeding?

Stop use and ask a doctor if you feel faint, vomit blood, have bloody or black stools, or experience stomach pain that does not improve.

Are there any warnings associated with MM1?

Yes, MM1 may cause severe allergic reactions, especially in those allergic to aspirin. It also contains an NSAID, which can increase the risk of stomach bleeding, particularly in older adults or those with certain medical conditions.

Can I use MM1 if I am pregnant or breastfeeding?

If you are pregnant or breastfeeding, consult a health professional before use. It is especially important not to use MM1 during the last 3 months of pregnancy unless directed by a doctor.

What should I do if I have high blood pressure or heart disease?

Ask a doctor before using MM1 if you have high blood pressure, heart disease, liver cirrhosis, or kidney disease.

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 the container tightly closed and out of reach of children.

Packaging Info

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

Packaging configurations for Pain Relief Anti Inflammatory.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

The drug is classified as an anti-inflammatory agent, provided in a packet formulation. It is designed to deliver therapeutic effects aimed at reducing inflammation. The specific composition and dosage details are not provided, but the formulation is intended for professional use in managing inflammatory conditions.

Uses and Indications

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

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

Dosage and Administration

Adults and children aged 12 years and over are instructed to take 1 tablet every 4 to 6 hours as needed while symptoms persist. In cases where pain or fever does not adequately respond to 1 tablet, a dose of 2 tablets may be administered. It is imperative that the total dosage does not exceed 6 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 guidance.

Contraindications

There are no contraindications associated with the use of this product. It is deemed safe for use in the absence of specific conditions or situations that would warrant avoidance.

Warnings and Precautions

Ibuprofen may cause severe allergic reactions, particularly in individuals with a known allergy to aspirin. Symptoms of such reactions can include hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, and blisters. In the event of an allergic reaction, it is imperative to discontinue use immediately and seek medical assistance.

This product contains a nonsteroidal anti-inflammatory drug (NSAID), which carries a risk of severe stomach bleeding. The likelihood of this adverse effect is increased in patients who are 60 years of age or older, have a history of stomach ulcers or bleeding disorders, are taking anticoagulants or steroid medications, consume three or more alcoholic beverages daily while using this product, or exceed the recommended dosage or duration of use. Additionally, ibuprofen should not be used in individuals who have previously experienced an allergic reaction to any pain reliever or fever reducer, or immediately before or after heart surgery.

Healthcare professionals should advise patients to consult a physician prior to using ibuprofen if they have experienced serious side effects from pain relievers or fever reducers, have a history of stomach issues such as heartburn, or have conditions such as high blood pressure, heart disease, liver cirrhosis, or kidney disease. Patients with asthma or those taking diuretics should also seek medical advice before use. It is important to inform patients that ibuprofen may diminish the cardioprotective effects of aspirin when taken concurrently for heart attack or stroke prevention. Furthermore, patients under medical supervision for serious conditions or those taking other medications should consult their healthcare provider before using ibuprofen.

To mitigate gastrointestinal discomfort, ibuprofen should be taken with food or milk. Patients should be cautioned that exceeding the recommended dosage or duration of use may increase the risk of heart attack or stroke.

Patients should be instructed to discontinue use and contact their healthcare provider if they experience any signs of stomach bleeding, which may include feeling faint, vomiting blood, having bloody or black stools, persistent stomach pain, worsening pain lasting more than 10 days, fever lasting more than 3 days, redness or swelling in the painful area, or the emergence of any new symptoms.

In the case of an allergic reaction, patients must stop using ibuprofen and seek emergency medical help immediately.

Side Effects

Patients may experience a range of adverse reactions associated with the use of this product. Serious adverse reactions include severe allergic reactions, particularly in individuals with a known allergy to aspirin. Symptoms of such reactions may manifest as hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, or blisters.

Additionally, this product contains a nonsteroidal anti-inflammatory drug (NSAID), which carries a warning for the potential risk of severe stomach bleeding. The likelihood of experiencing stomach bleeding is increased in patients who are aged 60 or older, have a history of stomach ulcers or bleeding problems, are taking anticoagulant or steroid medications, are using other NSAIDs (including aspirin, ibuprofen, or naproxen), consume three or more alcoholic drinks daily while using this product, or exceed the recommended dosage or duration of use.

Patients should be vigilant for signs of stomach bleeding and are advised to discontinue use and consult a healthcare professional if they experience any of the following symptoms: feeling faint, vomiting blood, having bloody or black stools, persistent stomach pain that does not improve, worsening pain lasting more than 10 days, fever that worsens or lasts more than three days, redness or swelling in the painful area, or the emergence of any new symptoms.

Drug Interactions

The concomitant use of ibuprofen with aspirin may diminish the cardioprotective effects of aspirin when utilized for the prevention of heart attack or stroke. It is advisable to avoid the simultaneous administration of these medications to ensure optimal therapeutic outcomes.

When ibuprofen is used in conjunction with anticoagulants or steroid medications, there is an increased risk of gastrointestinal bleeding. Clinicians should exercise caution and consider monitoring patients closely for signs of bleeding, particularly in those with additional risk factors.

Furthermore, prolonged use of ibuprofen or exceeding the recommended dosage may elevate the risk of cardiovascular events, such as heart attack or stroke. It is essential to adhere to prescribed dosages and duration of therapy to mitigate these risks. Regular assessment of the patient's cardiovascular status may be warranted in those requiring long-term ibuprofen therapy.

Packaging & NDC

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

Packaging configurations for Pain Relief Anti Inflammatory.
Details

Pediatric Use

Children under 12 years of age should consult a doctor before use. For adults and children aged 12 years and older, the recommended dosage is 1 tablet every 4 to 6 hours as needed while symptoms persist. If pain or fever does not adequately respond to 1 tablet, 2 tablets may be administered. However, the total dosage must not exceed 6 tablets in a 24-hour period unless directed by a healthcare professional. It is essential to keep this medication out of reach of children to prevent accidental ingestion.

Geriatric Use

Elderly patients, particularly those aged 60 and older, are at an increased risk for severe stomach bleeding. It is essential for healthcare providers to exercise caution when prescribing this medication to geriatric patients, especially in the presence of risk factors such as high blood pressure, heart disease, liver cirrhosis, or kidney disease.

Before initiating treatment, healthcare providers should inquire about the presence of these conditions and consider the potential implications of the stomach bleeding warning. Close monitoring of elderly patients is advised to ensure safety and to mitigate any adverse effects associated with the use of this medication.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional before using this medication. It is particularly important to avoid the use of ibuprofen during the last trimester of pregnancy unless specifically directed by a physician, as it may pose risks to the developing fetus and lead to complications during delivery.

Lactation

Lactating mothers are advised to consult a health professional before using this medication. It is particularly important to avoid the use of ibuprofen 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 available regarding the excretion of this medication in breast milk or its effects on breastfed infants. Therefore, caution is recommended when considering its use in lactating individuals.

Renal Impairment

Patients with renal impairment should consult a healthcare professional prior to use, particularly if they have conditions such as high blood pressure, heart disease, liver cirrhosis, or kidney disease. It is essential to assess renal function and consider potential dosing adjustments or monitoring requirements based on the severity of renal impairment.

Hepatic Impairment

Patients with hepatic impairment should consult a healthcare professional prior to use, particularly if they have conditions such as liver cirrhosis. It is essential for these patients to receive appropriate evaluation and monitoring of their liver function to ensure safe use of the medication. Adjustments to dosage may be necessary based on the severity of hepatic impairment, and ongoing assessment of liver function is recommended throughout the treatment period.

Overdosage

In the absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdose.

It is essential to monitor the patient closely for any potential symptoms that may arise from an overdose. Symptoms can vary widely depending on the substance involved and the individual patient's response.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should implement supportive care measures, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

Additionally, it is recommended to consult local poison control centers or toxicology experts for guidance on specific management strategies tailored to the substance involved.

Documentation of the incident, including the amount and timing of the substance taken, is crucial for effective treatment and follow-up care.

Nonclinical Toxicology

It is especially important not to use ibuprofen during the last three months of pregnancy unless definitely directed to do so by a doctor, as it may cause problems in the unborn child or complications during delivery. 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

Postmarketing experience has identified several adverse reactions reported voluntarily or through surveillance programs. These include allergic reactions such as hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, and blisters. Additionally, cases of stomach bleeding have been noted, particularly in patients aged 60 years or older, those with a history of stomach ulcers or bleeding problems, individuals taking blood thinners or steroids, those consuming three or more alcoholic drinks daily, or patients exceeding the recommended dosage.

Furthermore, there is an observed increase in the risk of heart attack or stroke associated with the use of ibuprofen at higher doses or for durations longer than recommended.

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 a container that must be kept tightly closed to maintain its integrity. 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 exposure to ensure its efficacy. Additionally, the product should be kept out of reach of children, and any unused portion should be discarded after opening to prevent potential safety risks.

Additional Clinical Information

The route of administration for the medication is oral. Clinicians should advise patients who are pregnant or breastfeeding to consult a health professional prior to use. It is particularly crucial to avoid ibuprofen 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 Anti Inflammatory, 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 Anti Inflammatory, 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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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.