Aramark Extra Strength Acetaminophen

Description

Extra Strength Acetaminophen is formulated as a tablet dosage form, with a total of 100 tablets per package. This product is indicated as a pain reliever and fever reducer, providing temporary relief from minor aches and pains associated with conditions such as colds, headaches, toothaches, and muscular aches, as well as for the reduction of fever. The active ingredient is comparable to that found in Extra Strength Tylenol® (Registered Trademark of Johnson & Johnson). This product is manufactured for Aramark, located in Lenexa, KS 66219, and can be contacted at 866-362-2691. For complete product information, it is advised to retain the carton. Further details can be found on the website aramarkuniform.com.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with various conditions, including headache, toothaches, menstrual cramps, the common cold, muscular aches, and minor pain of arthritis. 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 older are instructed to take 2 tablets every 4 to 6 hours as needed. It is imperative that they do not exceed 8 tablets within a 24-hour period unless specifically directed by a healthcare professional.

This product is not recommended for use in children under 12 years of age.

Healthcare professionals should ensure that patients are aware of these guidelines to prevent potential overdose and to promote safe usage.

Contraindications

Use of this product is contraindicated in the following situations:

Patients with a history of allergic reactions to any pain reliever or fever reducer should not use this product, as it may pose a risk of severe allergic reactions. Additionally, the product should not be administered immediately before or after heart surgery due to potential complications associated with surgical recovery. Furthermore, individuals with a known allergy to this product or any of its ingredients are also contraindicated from use, as this may lead to serious adverse effects.

Warnings and Precautions

Acetaminophen has been associated with significant safety concerns that healthcare professionals must be aware of to ensure safe usage among patients.

Allergy Alert Acetaminophen may lead to severe skin reactions, which can manifest as skin reddening, blisters, or rash. In the event of any skin reaction, it is imperative to discontinue use immediately and seek medical attention without delay.

Liver Warning This product contains acetaminophen, and there is a risk of severe liver damage under certain conditions. Healthcare professionals should advise patients to avoid exceeding the maximum daily dosage of 8 tablets within a 24-hour period. Additionally, patients should be cautioned against consuming three or more alcoholic drinks daily while using this product. It is also critical to adhere to the recommended duration of use, as taking more than directed or for an extended period increases the risk of liver injury.

Emergency Medical Help In cases of suspected overdose, immediate medical assistance should be sought, or the local Poison Control Center should be contacted. Prompt intervention is essential for both adults and children, even in the absence of noticeable signs or symptoms.

Monitoring and Follow-Up Patients should be advised to stop taking acetaminophen and consult their healthcare provider if any of the following occur:

• Pain worsens or persists for more than 10 days.

• Symptoms of faintness are experienced.

• Fever intensifies or lasts longer than 3 days.

• Redness or swelling appears in the area of pain.

• Any new symptoms develop.

Regular monitoring and patient education regarding these warnings and precautions are crucial for minimizing risks associated with acetaminophen use.

Side Effects

Patients using this product should be aware of potential adverse reactions, which may vary in seriousness and frequency.

Severe allergic reactions have been reported, including instances of severe skin reactions characterized by symptoms such as skin reddening, blisters, and rash. In the event of a skin reaction, patients are advised to discontinue use immediately and seek medical attention.

There is a significant risk of severe liver damage associated with the use of this product, particularly if patients exceed the maximum recommended dosage of 8 tablets in 24 hours, consume 3 or more alcoholic drinks daily while using the product, or take it for longer than directed.

Patients should discontinue use and consult a healthcare professional if they experience worsening pain that lasts more than 10 days, feel faint, notice that a fever worsens or persists for more than 3 days, observe redness or swelling in the painful area, or develop any new symptoms.

It is recommended that patients with liver disease consult a doctor before using this product. Additionally, individuals under a doctor's care for any serious condition or those taking the blood-thinning medication Warfarin should seek advice from a healthcare professional or pharmacist prior to use.

Drug Interactions

Patients taking the anticoagulant Warfarin should consult with a healthcare professional prior to using this medication. The interaction between this drug and Warfarin may necessitate careful monitoring of coagulation parameters to ensure therapeutic efficacy and minimize the risk of adverse effects. Adjustments to the dosage of Warfarin may be required based on the clinical judgment of the healthcare provider.

Packaging & NDC

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

Pediatric Use

Pediatric patients under 12 years of age should not use this product. For adolescents aged 12 years and older, the recommended dosage is 2 tablets every 4 to 6 hours as needed. It is important not to exceed 8 tablets in a 24-hour period unless directed by a healthcare professional.

Geriatric Use

Elderly patients should consult a healthcare provider prior to use if they have liver disease. Additionally, it is advisable for geriatric patients to seek guidance from a doctor or pharmacist if they are under medical care for any serious condition.

For adults and children aged 12 years and older, the recommended dosage is 2 tablets every 4 to 6 hours as needed, with a maximum limit of 8 tablets in a 24-hour period unless otherwise directed by a healthcare professional. Careful monitoring of dosage and adherence to these guidelines is essential to ensure safety and efficacy in this population.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. The potential risks and benefits must be carefully weighed, as the effects on fetal outcomes and lactation are not fully established. It is essential for women of childbearing potential to seek medical advice to ensure the safety of both the mother and the developing fetus.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data regarding the excretion of this medication in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating mothers.

Renal Impairment

Patients with renal impairment have no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the text. Therefore, healthcare professionals should exercise caution and consider individual patient factors when prescribing to this population. Regular monitoring of renal function may be warranted to ensure safe and effective use of the medication in patients with reduced kidney function.

Hepatic Impairment

Patients with hepatic impairment should exercise caution when using this product, which contains acetaminophen. It is critical to adhere to the recommended dosage guidelines to prevent severe liver damage. The maximum daily amount is limited to 8 tablets within a 24-hour period.

Additionally, patients with compromised liver function should avoid consuming 3 or more alcoholic drinks daily while using this product, as this may further increase the risk of liver damage. It is also advised that patients do not exceed the recommended duration of use or dosage, as taking more than directed can lead to serious hepatic complications.

Monitoring of liver function may be warranted in patients with existing liver conditions or those who are at increased risk for hepatic impairment. Regular assessment of liver enzymes and overall liver health is recommended to ensure patient safety while using this product.

Overdosage

Severe liver damage may occur in patients who exceed the recommended dosage of this product. Specifically, the risk increases significantly if an individual consumes more than 8 tablets within a 24-hour period, which is established as the maximum daily amount. Additionally, concurrent consumption of 3 or more alcoholic drinks daily while using this product can further elevate the risk of liver injury.

Patients should also be cautioned against taking more of the product or using it for a longer duration than directed, as this can lead to serious health complications.

In the event of suspected overdosage, it is imperative to seek immediate medical attention. Healthcare professionals should monitor for symptoms indicative of liver damage, which may include jaundice, abdominal pain, nausea, vomiting, and confusion. Management of overdosage may involve supportive care and monitoring of liver function, as well as potential interventions based on the severity of the symptoms presented.

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

Postmarketing experience has identified several important safety considerations associated with the use of acetaminophen. Reports indicate that acetaminophen may lead to severe skin reactions, characterized by symptoms such as skin reddening, blisters, and rash. In the event of a skin reaction, it is advised to discontinue use and seek immediate medical assistance.

Additionally, there is a warning regarding the potential for severe liver damage, which may occur if the maximum daily dosage of 8 tablets is exceeded within a 24-hour period, if 3 or more alcoholic beverages are consumed daily while using the product, or if the medication is taken for a duration longer than directed.

Furthermore, there is an increased risk of heart attack or stroke associated with the use of acetaminophen beyond the recommended dosage or duration. In cases of overdose, it is crucial to obtain medical help or contact a Poison Control Center immediately, as prompt medical attention is essential for both adults and children, even in the absence of noticeable signs or symptoms.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. In the event of an overdose, patients must seek medical help or contact a Poison Control Center immediately, as prompt medical attention is critical for both adults and children, even if no signs or symptoms are apparent.

Patients should be informed not to use this medication if they have a history of allergic reactions to any other pain reliever or fever reducer, or if they have previously experienced an allergic reaction to this product or any of its ingredients. Additionally, it is important to counsel patients against using this medication right before or after heart surgery.

Patients should be instructed to stop using the medication and consult a doctor if their pain worsens or persists for more than 10 days, if they feel faint, if their fever worsens or lasts more than 3 days, if there is redness or swelling in the painful area, or if any new symptoms occur.

When using this product, patients should take it with food or milk if they experience stomach upset. It is crucial to inform patients that the risk of heart attack or stroke may increase if they exceed the recommended dosage or duration of use.

Healthcare providers should encourage patients to consult a doctor before using this medication if they have liver disease, are under a doctor’s care for any serious condition, or are taking the blood-thinning medication Warfarin.

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 protected from conditions that may compromise its quality. Special handling needs should be observed to ensure optimal storage conditions are maintained throughout the product's shelf life.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)