Aramark Pain-Free Extra Strength

Description

Pain-Free® Extra Strength Maximum Strength Pain Reliever is formulated as a tablet dosage form, available in packaging options of 100 tablets, 250 tablets, and 2-tablet packets. Manufactured by Aramark in Lenexa, KS, this product is indicated for the temporary relief of fever and various types of pain, including sinusitis, headache, toothache, muscular aches, backache, menstrual discomfort, minor arthritis pain, as well as discomfort associated with colds and flu. The active ingredient is comparable to that found in EXCEDRIN Migraine® (Registered Trademark of GlaxoSmithKline). For complete product information, it is advised to retain the carton. For inquiries, contact Aramark at (913) 269-9611 or visit their website at aramarkuniform.com.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with various conditions, including backache, headaches, colds, toothache, minor arthritis pain, muscular aches, and menstrual cramps. Additionally, it provides temporary relief of fever and pain related to sinusitis, headache, toothache, muscular aches, backache, menstrual discomfort, minor arthritis pain, and colds and flu.

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

Dosage and Administration

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

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

Contraindications

Use of this product is contraindicated in the following situations:

• Concurrent use with any other pain reliever or fever reducer is prohibited due to the potential for increased risk of adverse effects.

• The product should not be used for pain relief for more than 10 days or for fever reduction for more than 3 days unless specifically directed by a healthcare professional, to prevent complications associated with prolonged use.

• Individuals with a history of allergic reactions to any other pain reliever or fever reducer should not use this product, as it may trigger a similar allergic response.

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, a rare but serious condition associated with aspirin use.

Individuals with a known allergy to aspirin or any other salicylate should refrain from using this product. Additionally, those who have experienced allergic reactions to other pain relievers or fever reducers should also avoid this medication.

This product contains acetaminophen, which poses a risk of severe liver damage if the following conditions are met: exceeding 8 tablets within a 24-hour period, concurrent use with other medications containing acetaminophen (both prescription and nonprescription), or consumption of 3 or more alcoholic beverages daily while using this product.

The presence of nonsteroidal anti-inflammatory drugs (NSAIDs) in this formulation raises the potential for stomach bleeding. The risk is heightened in individuals who are 60 years of age or older, have a history of stomach ulcers or bleeding disorders, are taking anticoagulants or steroid medications, are using other NSAIDs (such as aspirin, ibuprofen, or naproxen), or exceed the recommended dosage or duration of use.

Healthcare professionals are advised to consult with a doctor or pharmacist before combining this medication with other drugs if there is any uncertainty regarding potential interactions.

In the event of an overdose, immediate medical assistance should be sought, or a Poison Control Center should be contacted. Timely intervention is crucial for both adults and children, even in the absence of noticeable symptoms.

Patients should discontinue use and consult a healthcare provider if they experience any of the following: ringing in the ears or hearing loss, persistent or worsening pain or fever, the emergence of new symptoms, or the presence of redness or swelling.

Side Effects

Patients using this medication may experience a range of adverse reactions, which can be categorized by seriousness and frequency.

Serious adverse reactions include the risk of Reye’s Syndrome, particularly in children and teenagers using the medication for chicken pox or flu symptoms. It is crucial that these patients consult a doctor prior to use due to the association of Reye’s Syndrome with aspirin, a component of this medication. Additionally, severe liver damage may occur if patients exceed the recommended dosage of more than 8 tablets in 24 hours, use other medications containing acetaminophen concurrently, or consume three or more alcoholic drinks daily while using this product. The use of nonsteroidal anti-inflammatory drugs (NSAIDs) in this product also raises the risk of stomach bleeding, especially in patients aged 60 or older, those with a history of stomach ulcers or bleeding problems, and individuals taking anticoagulants, steroids, or other NSAIDs.

Common adverse reactions may include ringing in the ears or loss of hearing, which necessitates discontinuation of the medication and consultation with a healthcare provider. Patients should also seek medical advice if pain or fever persists or worsens, if new symptoms arise, or if redness or swelling is observed.

Patients with a history of upset stomach, stomach pain, gastric ulcers, or bleeding problems should consult a doctor before using this medication. Additionally, individuals with asthma or those taking prescription medications for anticoagulation, gout, diabetes, or arthritis should seek guidance from a healthcare professional or pharmacist prior to use.

Drug Interactions

Patients should consult a healthcare professional before using this medication in conjunction with other drugs, particularly if they are currently prescribed medications for anticoagulation, gout, diabetes, or arthritis.

Co-administration with other pain relievers or fever reducers is contraindicated. The use of this medication alongside any other nonsteroidal anti-inflammatory drugs (NSAIDs), such as aspirin, ibuprofen, or naproxen, is not recommended due to the increased risk of adverse effects.

There is a significant risk of stomach bleeding associated with this medication, particularly in patients who are concurrently taking blood thinners (anticoagulants) or steroid medications. Therefore, careful monitoring is advised for individuals on these therapies.

Packaging & NDC

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

Pediatric Use

Children and teenagers should not use this medicine for chicken pox or flu symptoms without consulting a doctor due to the risk of Reye’s Syndrome, a rare but serious illness associated with aspirin.

For dosing, adults and children aged 12 years and older may take 2 tablets as needed for pain every 6 hours, with a maximum of 8 tablets in 24 hours unless otherwise directed by a physician. For children under 12 years of age, consultation with a doctor is required before use.

Geriatric Use

Elderly patients, particularly those aged 60 and older, are at an increased risk of stomach bleeding when using this product, which contains nonsteroidal anti-inflammatory drugs (NSAIDs). The risk is further heightened in individuals with a history of stomach ulcers or bleeding problems, as well as those concurrently taking anticoagulants, steroid medications, or other NSAIDs such as aspirin, ibuprofen, or naproxen.

Healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is essential to monitor these patients closely for any signs of gastrointestinal bleeding, especially if they have a history of related issues or are on multiple medications that may exacerbate this risk. Additionally, dosage adjustments may be necessary for elderly patients to minimize potential adverse effects, and they should be advised to adhere strictly to the recommended dosing guidelines to avoid prolonged use or higher dosages than directed.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to use. It is particularly important to avoid the use of aspirin during the last three months of pregnancy unless specifically directed by a physician, as it may pose risks to the unborn child and lead to complications during delivery.

Lactation

Lactating mothers are advised to consult a healthcare professional before using this medication while breastfeeding. It is particularly important to avoid the use of aspirin during the last three months of pregnancy unless specifically directed by a doctor, as it may pose risks to the unborn child or lead to complications during delivery. There is no specific data provided regarding the excretion of this medication in breast milk or its effects on breastfed infants. Therefore, caution is recommended when considering its use in 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 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 avoid concomitant use of other medications containing acetaminophen, whether prescription or nonprescription, as this can further increase the risk of liver damage.

Patients with compromised liver function are also advised to limit alcohol consumption. Specifically, the intake of 3 or more alcoholic drinks per day while using this product may significantly heighten the risk of severe liver damage. Therefore, careful consideration of liver function and adherence to recommended guidelines is essential for patients with hepatic impairment to prevent adverse effects.

Overdosage

In cases of overdosage, severe liver damage may occur under specific circumstances. It is critical for healthcare professionals to be aware of the following risk factors associated with acetaminophen use.

Risk Factors for Severe Liver Damage

Severe liver damage can result from the ingestion of more than 8 tablets within a 24-hour period. Additionally, the concomitant use of other medications containing acetaminophen, whether prescription or nonprescription, significantly increases the risk of hepatotoxicity. Furthermore, the consumption of three or more alcoholic drinks daily while using this product can exacerbate the potential for liver injury.

Recommended Actions

In the event of suspected overdosage, immediate medical attention is essential. Healthcare providers should assess the patient's condition and consider the administration of activated charcoal if the ingestion occurred within a suitable timeframe. Monitoring liver function tests and providing supportive care are critical components of management. In cases of severe toxicity, the use of N-acetylcysteine as an antidote should be initiated as soon as possible to mitigate liver damage.

Conclusion

Healthcare professionals must remain vigilant regarding the risks associated with acetaminophen overdosage and ensure that patients are educated on the safe use of this medication, including the importance of adhering to recommended dosages and avoiding alcohol consumption during treatment.

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 detailed findings regarding nonclinical toxicology or animal pharmacology and toxicology provided in the current information.

Postmarketing Experience

No postmarketing experience details are available for the product associated with SPL code 90375-7.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental ingestion. It is essential to emphasize the importance of seeking immediate medical assistance or contacting a Poison Control Center in the event of an overdose. Patients should be informed that prompt medical attention is critical for both adults and children, even if they do not observe any signs or symptoms of overdose. This proactive approach can help ensure the safety and well-being of all patients.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It should be stored at a controlled room temperature of 20-25°C (68-77°F). Care must be taken to avoid exposure to excessive heat, specifically temperatures exceeding 40°C (104°F), to maintain product integrity. Proper container requirements should be adhered to, ensuring that the product is kept in suitable conditions to prevent degradation. Special handling needs should be observed to ensure the product remains within the recommended temperature range throughout its storage and handling processes.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

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