Aramark Aspirin

Description

Aspirin is a pharmaceutical product manufactured by Aramark, located at Lenexa, KS 66219. Each box contains 100 tablets. The active ingredient is comparable to that of BAYER® (Registered Trademark of Bayer Corp.). For complete product information, it is advised to retain the carton. For inquiries, the manufacturer can be contacted at (913) 269-9611.

Uses and Indications

This drug is indicated for the temporary relief of minor pain associated with various conditions, including headache, menstrual pain, minor pain of arthritis, muscle pain, pain and fever associated with colds, and toothache. 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 12 years of age and older are instructed to take 2 tablets every 4 to 6 hours as needed. The total daily dosage must not exceed 12 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 prior to administration to determine the appropriate dosage and administration guidelines.

Contraindications

There are no contraindications listed for this product. It is deemed safe for use across various patient populations, with no specific conditions or situations identified that would warrant avoidance.

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.

Allergy Alert This product is contraindicated in individuals with a known allergy to aspirin or any other salicylate. It should also not be used by those who have experienced an allergic reaction to any other pain reliever or fever reducer.

Stomach Bleeding Warning This medication contains nonsteroidal anti-inflammatory drugs (NSAIDs), which may increase the risk of stomach bleeding. The likelihood of this adverse effect is heightened in patients who meet any of the following criteria:

• Are aged 60 years or older

• Have a history of stomach ulcers or bleeding disorders

• Are concurrently taking anticoagulants or steroid medications

• Are using other NSAIDs (including aspirin, ibuprofen, naproxen, or similar agents)

• Exceed the recommended dosage or duration of use.

General Precautions This product should not be used in conjunction with any other pain reliever or fever reducer. Prior to use, patients should consult a healthcare provider if they have any of the following conditions:

• Upset stomach or stomach pain

• History of ulcers

• Bleeding disorders

• High blood pressure

• Heart or kidney disease

• Have taken a diuretic

• Are aged 60 years or older.

Additionally, patients should seek advice from a doctor or pharmacist before using this medication if they are taking any other NSAIDs, whether prescription or over-the-counter, or if they are on anticoagulant or steroid therapy.

Emergency Medical Help In the event of an overdose, immediate medical assistance should be sought, or contact a Poison Control Center without delay. Timely intervention is crucial for both adults and children, even in the absence of noticeable symptoms.

Discontinuation of Use Patients should discontinue use and consult a healthcare provider if they experience any of the following:

• Ringing in the ears or loss of hearing

• Persistent or worsening pain or fever

• Onset of new symptoms

• Presence of redness or swelling

• Symptoms of gastrointestinal bleeding, such as feeling faint, vomiting blood, or passing bloody or black stools.

Side Effects

Patients using this medication should be aware of several important 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 not be used for chickenpox or flu symptoms in these age groups without prior consultation with a healthcare provider.

Allergic reactions may occur in patients who are allergic to aspirin or any other salicylate. Individuals with a history of allergic reactions to other pain relievers or fever reducers should also avoid this medication.

Stomach bleeding is a significant risk associated with the use of this product, which contains nonsteroidal anti-inflammatory drugs (NSAIDs). The likelihood of experiencing stomach bleeding increases in patients who are 60 years of age or older, have a history of stomach ulcers or bleeding problems, are taking blood thinners (anticoagulants) or steroid medications, are using other NSAIDs (such as aspirin, ibuprofen, or naproxen), or exceed the recommended dosage or duration of use.

Patients should not use this medication in conjunction with any other pain reliever or fever reducer.

Before using this medication, patients should consult a healthcare provider if they have any of the following conditions: upset stomach or stomach pain, ulcers, bleeding problems, high blood pressure, heart or kidney disease, have taken a diuretic, or are 60 years of age or older. Additionally, patients taking any other NSAID (whether prescription or nonprescription) or blood thinners should seek advice from a doctor or pharmacist prior to use.

Patients are advised to discontinue use and consult a healthcare provider if they experience any of the following symptoms: ringing in the ears or loss of hearing, persistent or worsening pain or fever, new symptoms, redness or swelling, or if they feel faint, vomit blood, or have bloody or black stools, as these may indicate stomach bleeding.

Drug Interactions

Concurrent use of this medication with other pain relievers or fever reducers is contraindicated. The combination may increase the risk of adverse effects and should be avoided.

Patients are advised to consult a healthcare professional, such as a doctor or pharmacist, prior to using this medication if they are currently taking any other nonsteroidal anti-inflammatory drugs (NSAIDs), whether prescription or nonprescription. This precaution is essential to prevent potential pharmacodynamic interactions that could lead to increased side effects or diminished therapeutic efficacy.

Additionally, individuals taking anticoagulants (blood thinners) or steroid medications should seek guidance from a healthcare provider before initiating treatment with this medication. The interaction between these drug classes may necessitate careful monitoring or dosage adjustments to mitigate the risk of bleeding or other complications.

Packaging & NDC

Below are the non-prescription pack sizes of Aramark Aspirin (aspirin). 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 are directed to take 2 tablets every 4 to 6 hours as needed, with a maximum of 12 tablets in 24 hours or as directed by a healthcare professional. For children under 12 years of age, consultation with a doctor is required before use.

Geriatric Use

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

Before initiating treatment, it is advisable for elderly patients to consult with their healthcare provider to assess the appropriateness of the medication, considering their age and any potential risks associated with its use. Monitoring for signs of gastrointestinal bleeding should be a priority in this population, given the heightened susceptibility.

Healthcare providers should remain vigilant and consider dose adjustments or alternative therapies as necessary to ensure the safety and well-being of elderly patients.

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. Healthcare providers should carefully consider the potential fetal impacts and weigh the benefits against the risks when advising pregnant patients.

Lactation

Lactating mothers are advised to consult a health 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 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 a history of heart or kidney disease. Additionally, it is advisable for patients to seek guidance from a doctor or pharmacist if they are concurrently taking anticoagulant or steroid medications. Monitoring and appropriate dosing adjustments may be necessary to ensure safety and efficacy in this population.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there are no established dosage adjustments, special monitoring requirements, or precautions outlined for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population. Regular monitoring of liver function may be prudent in these cases, although specific parameters are not defined in the available information.

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 relevant toxicology resources for guidance on specific management protocols and antidotes, if applicable.

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 aspirin during the last three months of pregnancy unless specifically 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 associated with the use of the product. Reports of gastrointestinal bleeding have been noted, particularly in patients with a history of ulcers or those concurrently using anticoagulants. Additionally, allergic reactions, including anaphylaxis, have been documented in individuals with a known allergy to aspirin or other salicylates. Reye's syndrome, a rare but serious condition, has been reported in children and teenagers who used aspirin for the treatment of chicken pox or flu symptoms. These events were reported voluntarily or through surveillance programs and do not imply a causal relationship.

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 exhibit any signs or symptoms of overdose. This proactive approach can help ensure safety and effective management in case of an emergency.

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 aged 12 years and older are advised to take 2 tablets orally every 4 to 6 hours as needed, with a maximum of 12 tablets in a 24-hour period unless otherwise directed by a healthcare professional. For children under 12 years of age, consultation with a doctor is recommended prior to administration.

Clinicians should counsel patients on the importance of consulting a health professional if they are pregnant or breastfeeding. It is particularly crucial to avoid aspirin during the last trimester of pregnancy unless specifically instructed by a doctor, as it may pose risks to the unborn child or lead to complications during delivery. Additionally, patients should be reminded to keep the medication out of reach of children and to seek immediate medical assistance or contact a Poison Control Center in the event of an overdose, as prompt attention is essential for both adults and children, even in the absence of symptoms.

Drug Information (PDF)

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

View product document (PDF)