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Pain Free Plus

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This product has been discontinued

Active ingredients
  • Aspirin 250
  • Acetaminophen 250
  • Caffeine 65
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 2016
Label revision date
September 21, 2019
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Aspirin 250
  • Acetaminophen 250
  • Caffeine 65
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 2016
Label revision date
September 21, 2019
Manufacturer
Afassco Inc.
Registration number
part343
NDC root
51532-0560
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

You can use this medication for the temporary relief of various types of pain, including headaches, muscular aches, menstrual cramps, toothaches, minor arthritic pain, and discomfort from colds. It is designed to help alleviate these common pains, providing you with some comfort when you need it most.

Uses

You can use this medication for the temporary relief of various types of pain. It is effective for headaches, muscular aches, menstrual cramps, toothaches, minor arthritic pain, and even discomfort associated with colds. This means that if you're experiencing any of these common pains, this medication may help you feel better for a short period.

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

Dosage and Administration

You should take this medication orally, which means you will swallow it with a full glass of water. For adults, the recommended dosage is 2 tablets every 6 hours as needed. However, it’s important not to take more than 8 tablets in a 24-hour period to avoid potential side effects.

If you are giving this medication to a child under 12 years of age, it’s best to consult a doctor first to ensure it’s safe and appropriate for them. Always follow these guidelines to use the medication effectively and safely.

What to Avoid

It's important to keep this medication out of reach of children to ensure their safety. There are no specific contraindications, controlled substance classifications, or concerns regarding abuse, misuse, or dependence mentioned in the provided information. Always follow these guidelines to use the medication safely and effectively.

Side Effects

It's important to be aware of potential side effects when using this medication. If you are a child or teenager, consult a doctor before using it for chickenpox or flu symptoms, as it may be linked to Reye’s Syndrome, a rare but serious illness.

This product contains acetaminophen, which can lead to severe liver damage if you exceed 8 tablets in 24 hours, combine it with other acetaminophen-containing medications, or consume 3 or more alcoholic drinks daily while using it. Additionally, because it contains a nonsteroidal anti-inflammatory drug (NSAID), there is a risk of stomach bleeding, especially if you have a history of stomach ulcers, are taking blood thinners or steroids, are over 60 years old, consume alcohol heavily, or use other NSAIDs. Always follow the recommended dosage and consult your healthcare provider if you have concerns.

Warnings and Precautions

You should be aware of some important warnings and precautions when using this medication. First, if you are a child or teenager, do not use this medicine for chickenpox or flu symptoms without consulting a doctor first, as it may be linked to a serious condition called Reye’s Syndrome.

This product contains acetaminophen, which can lead to severe liver damage if you take more than 8 tablets in 24 hours, use it alongside other medications containing acetaminophen, or consume 3 or more alcoholic drinks daily while using it. Additionally, because this medication includes a nonsteroidal anti-inflammatory drug (NSAID), it may increase the risk of stomach bleeding, especially if you have a history of stomach ulcers, are taking blood thinners or steroids, are over 60 years old, or consume alcohol regularly.

If you experience symptoms like unusual tiredness, yellowing of the skin or eyes, or stomach pain, stop using the medication and call your doctor immediately. It’s also important to get emergency help if you notice signs of severe allergic reactions, such as difficulty breathing or swelling of the face and throat. Regular lab tests may be necessary to monitor your liver function while using this medication, so be sure to follow your healthcare provider's recommendations.

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 effects of an overdose for this medication, you should be aware of general signs that may indicate a problem. These can include unusual drowsiness, confusion, or difficulty breathing.

If you notice any of these symptoms or if you believe you have taken too much of the medication, seek medical help right away. Contact your healthcare provider or go to the nearest emergency room. It's always better to be safe and get checked out if you have any concerns about your health.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that the information available about this product does not specify any risks or contraindications related to its use during pregnancy. There are no special precautions or dosage modifications mentioned for pregnant individuals, which suggests that the product may be considered safe. However, always consult with your healthcare provider before using any medication to ensure it is appropriate for your specific situation.

Lactation Use

If you are breastfeeding, you can feel reassured that there are no specific warnings or recommendations regarding the use of this product while nursing. Additionally, there is no information available about whether this product is excreted in breast milk or any potential risks to your infant. Always consult with your healthcare provider if you have any concerns or questions about medications while breastfeeding.

Pediatric Use

It's important to be cautious when considering this medicine for your child. If your child has chicken pox or flu symptoms, you should consult a doctor before using this medication, as it can be linked to a rare but serious condition called Reye's Syndrome. This condition primarily affects children and teenagers and can have serious health implications.

For children under 12 years of age, it's essential to speak with a doctor before administering this medicine. Always prioritize your child's safety and well-being by seeking professional advice when it comes to their health.

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.

It's always best to consult with your healthcare provider about your specific situation, as they can offer personalized advice and ensure that any medications you take are safe and effective for you.

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, you should avoid using other medications that also contain acetaminophen, whether they are prescribed or available over the counter.

It's also crucial to limit your alcohol intake to fewer than 3 drinks per day while using this product, as drinking more 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 be cautious when taking this product alongside other medications. If you are using any drugs that contain acetaminophen, whether prescribed or over-the-counter, it could lead to serious liver damage. Additionally, combining this product with blood thinners (anticoagulants) or steroids can increase your risk of stomach bleeding. The same applies if you take it with other nonsteroidal anti-inflammatory drugs (NSAIDs), as this may also heighten the risk of stomach bleeding.

Always discuss your current medications and any planned tests with your healthcare provider. They can help ensure that you use this product safely and avoid any harmful interactions. Your health and safety should always come first, so don't hesitate to ask questions or express concerns about your treatment plan.

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

For adults, the recommended dosage is 2 tablets taken with a full glass of water every 6 hours as needed, but you should not exceed 8 tablets in a 24-hour period. If you are giving this medication to a child under 12 years old, it’s important to consult a doctor for the appropriate dosage.

FAQ

What is this product used for?

This product is used for the temporary relief of pain from headaches, muscular aches, menstrual cramps, toothaches, minor arthritic pain, and colds.

What is the recommended dosage for adults?

Adults should take 2 tablets with a full glass of water every 6 hours as needed, not exceeding 8 tablets in a 24-hour period.

What should children under 12 do?

Children under 12 years of age should consult a doctor before use.

Are there any warnings for liver health?

Yes, this product contains Acetaminophen, and severe liver damage may occur if you take more than 8 tablets in 24 hours or consume 3 or more alcoholic drinks daily while using it.

What is the stomach bleeding warning?

This product contains a nonsteroidal anti-inflammatory drug (NSAID), which may cause stomach bleeding, especially if you have had ulcers, take blood thinners, or are over 60 years old.

Is there a warning regarding Reye's Syndrome?

Yes, children and teenagers should not use this medicine for chicken pox or flu symptoms without consulting a doctor about Reye’s Syndrome.

How should this product be stored?

Store at room temperature, 20°C to 25°C (68°F to 77°F), protect from light, and keep the container tightly closed.

Are there any contraindications for this product?

No specific contraindications are listed in the provided text.

Can this product be used during pregnancy?

There are no specific statements regarding the use of this product during pregnancy.

Is there any information about nursing mothers?

No specific warnings or recommendations regarding the use of this product in nursing mothers are provided.

Packaging Info

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

Packaging configurations for Pain Free Plus.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

No relevant information is available for SPL code 34089-3.

Uses and Indications

This drug is indicated for the temporary relief of pain associated with headaches, muscular aches, menstrual cramps, toothaches, minor arthritic pain, and colds.

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

Dosage and Administration

Adults are instructed to take 2 tablets orally with a full glass of water every 6 hours as needed. The total dosage must not exceed 8 tablets within a 24-hour period. For children under 12 years of age, it is essential to consult a doctor prior to administration.

Contraindications

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

Warnings and Precautions

Children and teenagers should not use this medicine for chicken pox or flu symptoms without prior consultation with a healthcare professional regarding the risk of Reye’s Syndrome. This rare but serious illness has been associated with the use of aspirin in this population.

This product contains Acetaminophen, which poses a risk of severe liver damage under certain conditions. Healthcare professionals should advise patients to avoid exceeding 8 tablets within a 24-hour period. Additionally, patients should not use this product concurrently with other medications containing acetaminophen, whether prescription or non-prescription. Consumption of 3 or more alcoholic drinks daily while using this product may also increase the risk of liver damage.

The presence of a nonsteroidal anti-inflammatory drug (NSAID) in this formulation raises concerns regarding stomach bleeding. The likelihood of this adverse effect is heightened in patients with a history of stomach ulcers or bleeding disorders, those taking anticoagulants or steroid medications, individuals aged 60 or older, and patients who consume 3 or more alcoholic drinks daily while using this product. Furthermore, the risk increases when this product is taken in conjunction with other NSAIDs or when used in higher doses or for extended periods beyond the recommended guidelines.

Healthcare professionals should monitor patients for signs of liver dysfunction and gastrointestinal bleeding, particularly in those identified as high-risk based on the aforementioned criteria.

Side Effects

Patients using this medication should be aware of several serious adverse reactions associated with its use. A warning regarding Reye's Syndrome is particularly important; children and teenagers should not use this medicine for chicken pox or flu symptoms without prior consultation with a healthcare provider, as Reye's Syndrome is a rare but serious illness linked to aspirin use in this population.

Additionally, the product contains acetaminophen, which carries a significant risk of severe liver damage. This risk is heightened if patients exceed 8 tablets in a 24-hour period, use other medications containing acetaminophen (whether prescription or non-prescription), or consume 3 or more alcoholic drinks daily while taking this product.

The use of this medication also involves a risk of stomach bleeding, as it contains a nonsteroidal anti-inflammatory drug (NSAID). The likelihood of experiencing stomach bleeding increases in patients who have a history of stomach ulcers or bleeding problems, are taking anticoagulants or steroid medications, are aged 60 or older, consume 3 or more alcoholic drinks daily, use other NSAIDs concurrently, or take the medication for longer than directed.

Patients should be monitored for these serious adverse reactions and advised to seek medical attention if they experience any concerning symptoms.

Drug Interactions

Taking this product concurrently with other medications containing acetaminophen, whether prescription or non-prescription, may result in severe liver damage. It is advisable to avoid the use of multiple acetaminophen-containing products to mitigate this risk.

The concomitant use of this product with anticoagulants or steroid medications may elevate the risk of gastrointestinal bleeding. Clinicians should consider monitoring patients closely for signs of bleeding and may need to adjust dosages accordingly.

Additionally, co-administration with other nonsteroidal anti-inflammatory drugs (NSAIDs) can further increase the likelihood of stomach bleeding. Caution is recommended, and healthcare providers should evaluate the necessity of NSAID therapy in patients using this product.

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

Packaging & NDC

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

Packaging configurations for Pain Free Plus.
Details

Pediatric Use

Pediatric patients, particularly children and teenagers, should not use this medicine for chicken pox or flu symptoms without prior consultation with a healthcare professional regarding the risk of Reye's Syndrome. Reye's Syndrome is a rare but serious illness that has been associated with aspirin use in this population.

For children under 12 years of age, it is advised to consult a doctor before administration of this medication.

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, particularly in those with comorbidities or polypharmacy. Regular follow-up and reassessment of therapy are advised to ensure safety and efficacy in geriatric patients.

Pregnancy

There are no specific statements regarding the use of this product during pregnancy. The available data does not indicate any contraindications or risks associated with the use of this product in pregnant patients. Additionally, no dosage modifications for pregnant individuals are provided. The insert does not include any special precautions regarding the use of this product during pregnancy. Healthcare professionals should consider the absence of specific data when advising women of childbearing potential and pregnant patients.

Lactation

There are no specific warnings or recommendations regarding the use of this product in nursing mothers. Additionally, there is no information available about the potential for excretion in breast milk or any associated risks to breastfed infants.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available data regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the lack of information necessitates careful clinical judgment and monitoring.

Hepatic Impairment

Patients with hepatic impairment should be closely monitored when using this product, which contains acetaminophen. It is important to note that severe liver damage may occur if patients exceed the recommended dosage of more than 8 tablets in a 24-hour period.

Additionally, patients should be advised against the concurrent use of other medications containing acetaminophen, whether prescription or non-prescription, as this may further increase the risk of liver damage.

Patients with compromised liver function should also be cautioned about the consumption of alcohol. Specifically, the intake of 3 or more alcoholic drinks per day while using this product is not recommended, as it may exacerbate the risk of hepatic injury.

Regular monitoring of liver function is advised for patients with hepatic impairment to ensure safety and efficacy while using this product.

Overdosage

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

It is essential to monitor the patient closely for any potential symptoms that may arise, as the clinical presentation can vary depending on the substance involved and the individual patient's response. Common symptoms of overdose may include, but are not limited to, altered mental status, cardiovascular instability, respiratory distress, and gastrointestinal disturbances.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should initiate supportive care, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs. The use of activated charcoal may be considered if the patient presents within a suitable timeframe and if the ingestion was recent.

Furthermore, specific antidotes or treatments may be indicated based on the substance involved in the overdose. Consultation with a poison control center or a medical toxicologist is recommended to guide the management of the patient effectively.

Overall, vigilance and prompt intervention are critical in managing cases of suspected overdose, even in the absence of detailed information regarding specific overdosage effects.

Nonclinical Toxicology

No teratogenic or non-teratogenic effects have been reported in the available nonclinical studies. Additionally, there is no information regarding animal pharmacology and toxicology. The absence of data limits the assessment of potential risks associated with the compound in these areas.

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 to ensure the safety of young children.

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

Patients are advised on the route, method, and frequency of administration for the medication. For adults, the recommended dosage is 2 tablets taken with a full glass of water every 6 hours as needed, with a maximum limit of 8 tablets within a 24-hour period. For children under 12 years of age, it is essential to consult a doctor before administration.

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

Drug Information (PDF)

This file contains official product information for Pain Free Plus, 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 Free Plus, 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.