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Pain Reliever 2

Last content change checked dailysee data sync status

This product has been discontinued

Active ingredients
  • Aspirin 250 mg
  • Acetaminophen 250 mg
  • Caffeine 65 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 2020
Label revision date
July 2, 2021
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Aspirin 250 mg
  • Acetaminophen 250 mg
  • Caffeine 65 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 2020
Label revision date
July 2, 2021
Manufacturer
Redicare LLC
Registration number
part343
NDC root
71105-174
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 that you may experience from various conditions. It can help with headaches, colds, toothaches, minor arthritis pain, muscular aches, menstrual cramps, and backaches. If you're looking for a way to ease discomfort from these common issues, this drug may be a suitable option for you.

Uses

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

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 who may be concerned about such risks.

Dosage and Administration

If you are an adult or a child aged 12 years and older, you should take 2 tablets every 6 hours as needed. Make sure to swallow the tablets with a full glass of water. It's important not to take more than 8 tablets in a 24-hour period to avoid any potential side effects.

If you have a child under 12 years old, it's best to consult a doctor before giving them this medication. They can provide guidance on the appropriate dosage for younger children. Always follow these instructions carefully to ensure safe and effective use of the medication.

What to Avoid

You should avoid using this medication if you are allergic to aspirin or if you have had an allergic reaction to any other pain reliever or fever reducer. It's important not to combine it with other pain relievers or fever reducers, including any products that contain acetaminophen. Additionally, do not use this medication for pain for more than 10 days or for fever for more than 3 days unless your doctor advises otherwise.

Be cautious about your overall caffeine intake, as using this medication with large amounts of caffeinated products is not recommended. Always follow the recommended dosage and never exceed it to prevent potential misuse or dependence (a condition where your body becomes reliant on a substance).

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. Additionally, this product 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.

This medication also includes a non-steroidal anti-inflammatory drug (NSAID), which may increase the risk of stomach bleeding, especially if you have a history of stomach ulcers, are over 60, or consume alcohol regularly. If you experience ringing in the ears, loss of hearing, persistent pain or fever, or any allergic reactions, stop using the product and consult a doctor. Always keep this medication out of reach of children, and seek immediate medical help in case of an overdose. If you are pregnant or breastfeeding, consult a healthcare professional before use, particularly during the last three months of pregnancy.

Warnings and Precautions

It's important to be aware of some serious warnings when using this medication. Children and teenagers should not use it for chickenpox or flu symptoms without consulting a doctor first, as it can lead to Reye’s syndrome, a rare but serious illness. Additionally, this product 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, as this medication also contains a non-steroidal anti-inflammatory drug (NSAID) that may increase the risk of stomach bleeding, especially if you have a history of stomach ulcers, are over 60, or drink alcohol regularly.

Before using this medication, consult your doctor if you have conditions like asthma, liver or kidney issues, high blood pressure, or stomach problems. It's also wise to check with a healthcare professional if you're taking other medications for blood thinning, diabetes, gout, or arthritis. If you suspect an overdose, seek emergency medical help immediately, even if you don't notice any symptoms. Lastly, stop using the medication and contact your doctor if you experience ringing in the ears, worsening pain or fever, new symptoms, or any signs of an allergic reaction, such as redness or swelling.

Overdose

If you suspect an overdose, it’s important to seek medical help immediately or contact a Poison Control Center. This is crucial for both adults and children, even if you don’t see any signs or symptoms of an overdose.

Signs of an overdose can vary, but they may include unusual drowsiness, confusion, or difficulty breathing. Always err on the side of caution and get help right away if you think an overdose has occurred. Your quick action can make a significant difference in ensuring safety and health.

Pregnancy Use

If you are pregnant or breastfeeding, it’s crucial 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 instructs 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 issues for your unborn child or complications during delivery. Always prioritize your health and your baby's well-being by seeking professional guidance.

Pediatric Use

It's important to be cautious when giving this medicine to children and teenagers, especially if they have chickenpox or flu symptoms. Before using it, you should consult a doctor about the risk of Reye’s syndrome, a rare but serious illness linked to aspirin use in young people.

For adults and children aged 12 and older, the recommended dosage is 2 tablets every 6 hours as needed, but you should not exceed 8 tablets in a 24-hour period. If your child is under 12 years old, it's essential to ask a doctor for guidance before administering this medication.

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 a higher chance of experiencing stomach bleeding when taking certain medications. This risk is something you should discuss with your healthcare provider, as they can help you understand your specific situation and any necessary precautions.

Always make sure to inform your doctor about your age and any other health conditions you may have, as this information can guide them in prescribing the safest and most effective treatment for you. Your health and safety are the top priority, so don't hesitate to ask questions or express any concerns you may have.

Renal Impairment

If you have kidney problems, it's important to consult your doctor before using this medication. Your healthcare provider can help determine if it's safe for you and may need to adjust your dosage or monitor your kidney function closely. Always prioritize your health by discussing any concerns with your doctor.

Hepatic Impairment

If you have liver problems, it's important to be cautious when using this product, which contains Acetaminophen. You should consult your doctor before using it. Severe liver damage can occur if you take more than 8 tablets in a 24-hour period, combine it with other medications that also contain acetaminophen, or consume 3 or more alcoholic drinks daily while using this product.

To protect your liver health, always follow your healthcare provider's advice regarding dosage and potential interactions with other medications or alcohol. Your safety is a priority, so don't hesitate to reach out to your doctor with any questions or concerns.

Drug Interactions

It's important to talk to your doctor or pharmacist before using this medication if you are taking any prescription drugs for blood thinning (anticoagulation), diabetes, gout, or arthritis. These medications can interact in ways that may affect your health. Additionally, you should avoid using this medication alongside other pain relievers or fever reducers, especially those containing acetaminophen, as well as large amounts of caffeinated products. Combining these can increase the risk of stomach bleeding, particularly if you are also on blood thinners or steroids.

Always ensure that your healthcare provider is aware of all the medications you are taking, as this will help them provide you with the safest and most effective care.

Storage and Handling

To ensure the safety and effectiveness of your product, always store it at a controlled room temperature between 15˚ to 30˚C (59˚ to 86˚F). It's important to keep it away from excessive heat and humidity, as these conditions can affect its quality.

When handling the product, be sure to check the packaging carefully. Do not use it if the packet is torn, cut, or opened, as this indicates that it may have been tampered with and could be unsafe. Following these guidelines will help you use the product safely and effectively.

Additional Information

You should take 2 tablets every 6 hours as needed if you are an adult or a child aged 12 years and older, making sure to drink a full glass of water. It's important not to exceed 8 tablets in a 24-hour period. If your child is under 12 years old, consult a doctor for the appropriate dosage.

If you are pregnant or breastfeeding, it's crucial to talk to a healthcare professional before using this medication. Avoid using aspirin during the last three months of pregnancy unless your doctor specifically advises it, as it can lead to issues for the unborn child or complications during delivery.

FAQ

What minor aches and pains does this drug relieve?

This drug temporarily relieves minor aches and pains associated with headaches, colds, toothaches, minor arthritis pain, muscular aches, menstrual cramps, and backaches.

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

Adults and children 12 years of age and older should take 2 tablets every 6 hours as needed, with a full glass of water, and should not exceed 8 tablets in any 24-hour period.

What should children under 12 do?

Children under 12 years should ask a doctor before use.

Are there any contraindications for using this drug?

Do not use this drug if you are allergic to aspirin, have had an allergic reaction to any other pain reliever, or if you are taking other pain relievers or products containing acetaminophen.

What should I do 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 are the warnings associated with this drug?

Warnings include the risk of Reye’s syndrome in children and teenagers, severe liver damage if exceeding the recommended dose, and the potential for stomach bleeding, especially in older adults or those with certain health conditions.

What should I do in case of overdose?

In case of overdose, get medical help or contact a Poison Control Center immediately, as prompt medical attention is critical.

What should I do if I experience side effects?

Stop use and ask a doctor if you experience ringing in the ears, loss of hearing, persistent pain or fever, new symptoms, or any allergic reactions.

Packaging Info

Below are the non-prescription pack sizes of Pain Reliever 2 (pain reliever). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Pain Reliever 2.
Details

Drug Information (PDF)

This file contains official product information for Pain Reliever 2, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

The product is identified by the SPL code 34089-3. No additional specific description details are provided in the available data.

Uses and Indications

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

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 every 6 hours as needed, accompanied by a full glass of water. It is imperative that the total dosage does not exceed 8 tablets within a 24-hour period.

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

Contraindications

Use is contraindicated in the following situations:

Patients with a known allergy to aspirin should not use this product. Additionally, concurrent use with any other pain reliever or fever reducer is contraindicated due to the potential for increased risk of adverse effects. Individuals who have previously experienced an allergic reaction to any pain reliever or fever reducer should also avoid this product.

The product should not be used for pain relief for more than 10 days or for fever for more than 3 days unless directed by a healthcare professional, as prolonged use may lead to complications. Concurrent use with any product containing acetaminophen is contraindicated to prevent the risk of overdose. Furthermore, the use of this product alongside large amounts of caffeinated products is not recommended due to potential interactions.

Exceeding the recommended dose is also contraindicated.

Warnings and Precautions

Children and teenagers should not use this medicine for chickenpox or flu symptoms without first consulting a healthcare professional regarding the risk of Reye’s syndrome, a rare but serious condition associated with aspirin use.

This product contains acetaminophen, which poses a risk of severe liver damage under certain conditions. Healthcare professionals should advise patients that liver damage may occur if they exceed 8 tablets in a 24-hour period, use this product in conjunction with other medications containing acetaminophen (whether prescription or over-the-counter), or consume 3 or more alcoholic drinks daily while using this product.

The presence of a non-steroidal anti-inflammatory drug (NSAID) in this formulation raises the potential for stomach bleeding. The risk is heightened in patients with a history of stomach ulcers or bleeding disorders, those taking anticoagulants or steroid medications, individuals aged 60 or older, those consuming 3 or more alcoholic drinks daily, and patients using other NSAIDs or exceeding the recommended dosage or duration of use.

Healthcare professionals should advise patients to consult a doctor prior to use if they have any of the following conditions: asthma, liver or kidney disease, high blood pressure, heart disease, stomach issues (including heartburn or painful stomach), gastric ulcers, bleeding disorders, or if they are taking diuretics. Additionally, patients should seek guidance if they are on prescription medications for anticoagulation, diabetes, gout, or arthritis, or if they have other concurrent medications or conditions.

In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center should be contacted. Prompt medical attention is crucial for both adults and children, even if no signs or symptoms are initially apparent.

Patients should discontinue use and contact a healthcare provider if they experience ringing in the ears or loss of hearing, if pain or fever persists or worsens, if new symptoms arise, or if any signs of an allergic reaction, such as redness or swelling, occur.

Side Effects

Patients using this product should be aware of several serious 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 is not used for chickenpox or flu symptoms in these populations without prior consultation with a healthcare provider.

The product contains acetaminophen, which poses a risk of severe liver damage if patients exceed 8 tablets in a 24-hour period, use it in conjunction with other medications containing acetaminophen, or consume 3 or more alcoholic drinks daily while using this product.

Additionally, the presence of a non-steroidal anti-inflammatory drug (NSAID) in this formulation raises the risk of stomach bleeding. This risk is heightened in patients with a history of stomach ulcers or bleeding problems, those taking blood-thinning medications or steroids, individuals aged 60 or older, and those who consume 3 or more alcoholic drinks daily. Patients should also be cautious if they are taking other NSAIDs or using the product for longer than directed.

Patients should not use this product if they are allergic to aspirin or any other pain reliever/fever reducer, if they have experienced an allergic reaction to similar medications, or if they require pain relief for more than 10 days or fever relief for more than 3 days without medical advice. It is also advised to avoid concurrent use with other products containing acetaminophen or large amounts of caffeinated products.

Before using this product, patients should consult a healthcare provider if they have asthma, liver or kidney disease, high blood pressure, heart disease, stomach problems (such as heartburn or ulcers), bleeding disorders, or if they are taking diuretics, especially if the stomach bleeding warning applies to them.

While using this product, patients must adhere to the recommended dosage and should discontinue use and seek medical advice if they experience ringing in the ears, loss of hearing, persistent or worsening pain or fever, new symptoms, or signs of an allergic reaction such as redness or swelling.

For pregnant or breastfeeding individuals, it is essential to consult a healthcare professional before use. Aspirin should be avoided during the last three months of pregnancy unless specifically directed by a doctor, as it may cause complications for the unborn child or during delivery.

Patients should keep this product out of reach of children. In the event of an overdose, immediate medical assistance should be sought, as prompt attention is critical for both adults and children, even if no symptoms are apparent.

Drug Interactions

Patients should consult a healthcare professional prior to using this medication if they are concurrently taking prescription drugs for anticoagulation, diabetes, gout, or arthritis. The potential for adverse interactions necessitates careful consideration and monitoring.

Co-administration with other pain relievers or fever reducers is contraindicated. Additionally, the use of any products containing acetaminophen should be avoided to prevent the risk of overdose and associated complications.

Caution is advised regarding the consumption of large amounts of caffeinated products, as this may exacerbate side effects.

The risk of gastrointestinal bleeding may be increased in patients taking blood-thinning agents (anticoagulants) or steroid medications. Therefore, close monitoring and possible dosage adjustments may be warranted in these cases to mitigate risks.

No specific laboratory test interactions have been identified in the available data.

Packaging & NDC

Below are the non-prescription pack sizes of Pain Reliever 2 (pain reliever). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Pain Reliever 2.
Details

Pediatric Use

Children and teenagers should not use this medicine for chickenpox or flu symptoms without consulting a doctor regarding the risk of Reye’s syndrome, a rare but serious illness associated with aspirin use.

For dosing, adults and children 12 years of age and older are directed to take 2 tablets every 6 hours as needed, with a full glass of water, not to exceed 8 tablets in any 24-hour period. For children under 12 years, it is advised to consult a doctor before use.

Geriatric Use

Elderly patients, particularly those aged 60 years and older, may have an increased risk of stomach bleeding when using this medication. It is essential for healthcare providers to exercise caution when prescribing this treatment to geriatric patients.

Monitoring for signs and symptoms of gastrointestinal bleeding is recommended in this population. Additionally, healthcare providers should consider the overall health status and concurrent medications of elderly patients, as these factors may further influence the risk of adverse effects.

Dose adjustments may be necessary based on individual patient assessments, taking into account the potential for increased sensitivity to the medication in older adults.

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 trimester of pregnancy unless specifically directed by a physician, as it may pose risks to the unborn child and lead to complications during delivery.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication if they are pregnant or breastfeeding. It is particularly important to avoid the use of aspirin during the last three months of pregnancy unless specifically directed by a healthcare provider, 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.

Renal Impairment

Patients with renal impairment should consult a healthcare professional prior to use, particularly if they have a history of kidney problems. It is essential to assess renal function and consider potential dosing adjustments or monitoring requirements based on the degree of impairment.

Hepatic Impairment

Patients with hepatic impairment should exercise caution when using this product, which contains Acetaminophen. Severe liver damage may occur if patients exceed the recommended dosage of 8 tablets within a 24-hour period. Additionally, the risk of liver damage increases if this product is taken concurrently with other medications containing acetaminophen, whether prescription or non-prescription.

Patients with compromised liver function are advised to consult a healthcare professional prior to use, particularly if they have a history of liver problems. Furthermore, individuals who consume three or more alcoholic drinks daily should avoid using this product, as this may further exacerbate the risk of liver injury. Monitoring of liver function may be warranted in patients with hepatic impairment to ensure safety and prevent potential adverse effects.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. Prompt medical attention is crucial for both adults and children, even in the absence of noticeable signs or symptoms.

Healthcare professionals should be aware that the lack of immediate symptoms does not preclude the potential for serious adverse effects. Therefore, vigilance and timely intervention are essential in managing overdose cases effectively.

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 specific non-teratogenic effects have been identified in the available data. Additionally, there are no details regarding nonclinical toxicology or animal pharmacology and toxicology provided in the current information.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center in the event of an overdose, as prompt medical attention is critical for both adults and children, even if no signs or symptoms are present.

Patients should be informed not to use this product if they have a known allergy to aspirin or any other pain reliever or fever reducer. It is important to emphasize that this product should not be used in conjunction with any other pain reliever or fever reducer, nor with any product containing acetaminophen. Additionally, patients should avoid using this product alongside large amounts of caffeinated products.

Patients should be cautioned against using this product for pain for more than 10 days or for fever for more than 3 days unless directed by a healthcare provider. They should also be instructed to stop use and consult a doctor if they experience ringing in the ears, loss of hearing, persistent or worsening pain or fever, new symptoms, or any signs of an allergic reaction, such as redness or swelling.

When using this product, patients must not exceed the recommended dose. Healthcare providers should encourage patients to consult a doctor before use if they have a history of asthma, liver or kidney disease, high blood pressure, heart disease, stomach problems (including heartburn or an upset stomach), gastric ulcers, or bleeding problems. Furthermore, patients taking diuretics or those for whom the stomach bleeding warning applies should also seek medical advice prior to use.

Lastly, patients should be advised to consult a doctor or pharmacist before using this product if they are taking prescription medications for anticoagulation, diabetes, gout, or arthritis, or if they are taking other drugs or have other medical conditions.

Storage and Handling

The product is supplied in tamper-evident packaging. Healthcare professionals should ensure that no packets are used if they are torn, cut, or opened, as this may compromise the integrity of the product.

For optimal storage, the product should be maintained at a controlled room temperature between 15˚ to 30˚C (59˚ to 86˚F). It is essential to avoid exposure to excessive heat and humidity to preserve the product's efficacy and safety.

Additional Clinical Information

Adults and children aged 12 years and older are advised to take 2 tablets every 6 hours as needed, accompanied by a full glass of water, without exceeding 8 tablets in a 24-hour period. For children under 12 years, consultation with a doctor is recommended prior to administration.

Clinicians should counsel patients to seek professional advice if they are pregnant or breastfeeding. It is particularly crucial to avoid the use of aspirin during the last three months of pregnancy unless specifically directed by a healthcare provider, 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 Reliever 2, 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 Reliever 2, retrieved by a validated AI data-extraction workflow.

All FDA-listed dosage forms and strengths are shown in the Packaging & NDC Codes section above. Regulatory status appears in the Summary Information panel above and was verified in the FDA National Drug Code directory and the NSDE NDC Directory daily file.

Note: an automated daemon monitors NSDE checksums; when the record for this NDC changes, the new file is pulled instantly and this page is refreshed.

No human clinician has reviewed this version.

Learn more in our Editorial Policy

Last AI update:

Primary FDA sources:

Orange Book data shown on this page are limited to Regulatory Status (Rx), Established Pharmacologic Class (EPC), and Mechanism of Action (MoA).

Regulatory data notice: Information on this page is reproduced verbatim from FDA public databases (NSDE, Orange Book, Purple Book, DailyMed SPL). NDA/ANDA drugs are FDA-approved, BLA biologics are FDA-licensed. Inclusion alone does not guarantee current market availability or imply FDA endorsement.

Medical disclaimer: This AI-generated content is provided for educational purposes only and does not constitute medical advice. Always consult a licensed healthcare professional for diagnosis or treatment decisions.