Aspirin

Description

E/C Aspirin is available in two NDC configurations: 54738-111-01, which contains 325 mg of enteric-coated aspirin in a bottle of 100 tablets, and 54738-111-03, which contains the same dosage in a larger bottle of 1000 tablets. The enteric coating is designed to protect the active ingredient from degradation in the stomach, allowing for targeted release in the intestines.

Uses and Indications

This drug is indicated for the temporary relief of various types of pain, including headache, menstrual pain, muscle pain, toothache, minor pain associated with arthritis, and pain and fever related to colds.

There are no teratogenic or nonteratogenic effects mentioned in the available data.

Dosage and Administration

Patients should take the medication orally, with each dose accompanied by a full glass of water. For adults and children aged 12 years and older, the recommended dosage is 1 to 2 tablets every 4 hours as needed for symptom relief, with a maximum limit of 12 tablets within a 24-hour period. For children under 12 years of age, it is advised to consult a physician for appropriate dosing recommendations.

Contraindications

There are no contraindications associated with the use of this product. It is deemed safe for use in the absence of specific conditions or situations that would warrant avoidance.

Warnings and Precautions

Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product due to the risk of Reye’s syndrome, a rare but serious illness. If changes in behavior accompanied by nausea and vomiting occur while using this product, it is imperative to consult a healthcare professional immediately, as these may be early signs of this condition.

Aspirin may induce severe allergic reactions, which can manifest as hives, asthma (wheezing), shock, or facial swelling. Healthcare professionals should be vigilant for these symptoms and advise patients to seek immediate medical attention if they occur.

This product contains a nonsteroidal anti-inflammatory drug (NSAID), which carries a risk of severe stomach bleeding. The likelihood of this adverse effect is increased in individuals who are 60 years of age or older, have a history of stomach ulcers or bleeding problems, are taking anticoagulants or steroid medications, are using other NSAIDs (either prescription or over-the-counter), exceed the recommended dosage or duration of use, or consume three or more alcoholic beverages daily while using this product.

Patients should refrain from using this product if they have a known allergy to any other pain reliever or fever reducer. Prior to use, it is advisable for patients to consult a healthcare provider if any of the following conditions apply: a history of stomach bleeding, existing stomach problems such as heartburn, high blood pressure, heart disease, liver cirrhosis, kidney disease, use of diuretics, or asthma. Additionally, patients should seek guidance from a doctor or pharmacist if they are taking prescription medications for diabetes, gout, or arthritis, are on any other medications, or are under medical care for any serious health condition.

In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center should be contacted without delay.

Patients are advised to discontinue use and consult a healthcare professional if they experience any signs of stomach bleeding, which may include feeling faint, vomiting blood, passing bloody or black stools, experiencing persistent stomach pain, or if pain worsens or lasts longer than 10 days. Additionally, if fever worsens or lasts more than three days, if redness or swelling occurs in the painful area, if any new symptoms arise, or if there is ringing in the ears or loss of hearing, medical advice should be sought promptly.

For pregnant or breastfeeding individuals, it is crucial to consult a healthcare professional before using this product. Aspirin should be avoided during the last three months of pregnancy unless specifically directed by a physician, as it may pose risks to the unborn child or lead to complications during delivery.

Side Effects

Patients using this product should be aware of several serious and common adverse reactions associated with its use.

Reye’s syndrome is a rare but serious illness that may occur in children and teenagers who have or are recovering from chickenpox or flu-like symptoms. If patients experience changes in behavior accompanied by nausea and vomiting while using this product, they should consult a doctor immediately, as these may be early signs of Reye’s syndrome.

Aspirin may also cause severe allergic reactions in some patients. Symptoms of such reactions can include hives, asthma (wheezing), shock, and facial swelling. Patients with a known history of allergic reactions to any other pain reliever or fever reducer should not use this product.

The product contains a nonsteroidal anti-inflammatory drug (NSAID), which carries a risk of severe stomach bleeding. The likelihood of this adverse reaction is increased in patients who are 60 years of age or older, have a history of stomach ulcers or bleeding problems, are taking blood-thinning medications or steroids, are using other NSAIDs (either prescription or nonprescription), exceed the recommended dosage or duration of use, or consume three or more alcoholic drinks daily while using this product.

Patients are advised to seek medical advice before using this product if they have a history of stomach problems, such as heartburn, or if they have high blood pressure, heart disease, liver cirrhosis, or kidney disease. Additionally, those taking diuretics or any prescription drugs for diabetes, gout, or arthritis should consult a healthcare professional prior to use.

Patients should discontinue use and seek medical attention if they experience any signs of stomach bleeding, which may include feeling faint, vomiting blood, having bloody or black stools, experiencing stomach pain that does not improve, or if pain worsens or lasts more than 10 days. Other concerning symptoms include a fever that worsens or lasts more than three days, redness or swelling in the painful area, the appearance of any new symptoms, or ringing in the ears or loss of hearing.

For pregnant or breastfeeding patients, it is crucial to consult a healthcare professional before using this product. Aspirin should be avoided 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.

Drug Interactions

Patients are advised to consult a healthcare professional, such as a doctor or pharmacist, prior to using this medication if they are currently taking prescription drugs for diabetes, gout, or arthritis. This precaution is essential to ensure safe and effective use, as potential interactions may alter the therapeutic effects or increase the risk of adverse reactions.

Additionally, individuals should seek guidance from a healthcare professional before using this medication in conjunction with any other drugs. This recommendation underscores the importance of evaluating all concurrent medications to prevent possible interactions that could compromise treatment outcomes.

No specific laboratory test interactions have been identified in the available data. However, ongoing monitoring and communication with healthcare providers are recommended to ensure comprehensive management of the patient's health status while on this medication.

Packaging & NDC

Below are the non-prescription pack sizes of Aspirin. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product due to the risk of Reye’s syndrome, a rare but serious illness. If changes in behavior accompanied by nausea and vomiting occur while using this product, it is important to consult a doctor, as these may be early signs of Reye’s syndrome.

For dosing, adults and children aged 12 years and older may take 1-2 tablets every 4 hours as needed, not exceeding 12 tablets in a 24-hour period. For children under 12 years of age, it is advised to consult a doctor before use.

Geriatric Use

Elderly patients, particularly those aged 60 years and older, are at an increased risk for severe stomach bleeding. It is essential for healthcare providers to exercise caution when prescribing this medication to geriatric patients, especially if they have a history of gastrointestinal issues or other relevant medical conditions.

Before initiating treatment, healthcare providers should inquire about any history of stomach problems, including but not limited to heartburn, high blood pressure, heart disease, liver cirrhosis, or kidney disease. Such conditions may necessitate a more thorough evaluation and consideration of alternative therapies or dosage adjustments to mitigate the risk of adverse effects. Regular monitoring of these patients is advised to ensure safety and efficacy throughout the course of treatment.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional before using this medication. The use of aspirin during the last trimester of pregnancy is particularly cautioned against, as it may lead to adverse effects on fetal outcomes or complications during delivery. Therefore, it is essential that pregnant patients only use aspirin in this period if explicitly directed by a healthcare provider.

Lactation

Lactating mothers are advised to consult a health professional before using this medication. 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 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 the use of this medication while breastfeeding.

Renal Impairment

Patients with renal impairment may require careful consideration regarding dosing adjustments and monitoring. In individuals with reduced kidney function, particularly those with high blood pressure, heart disease, liver cirrhosis, or kidney disease, it is essential to assess renal function prior to initiating treatment. Regular monitoring of renal parameters is recommended to ensure safety and efficacy. Adjustments to the dosing regimen may be necessary based on the degree of renal impairment to mitigate the risk of adverse effects and optimize therapeutic outcomes.

Hepatic Impairment

Patients with hepatic impairment may experience altered pharmacokinetics of the drug due to compromised liver function. It is essential to assess liver function prior to initiating treatment and to monitor liver parameters throughout the course of therapy.

In patients with liver cirrhosis, dosage adjustments may be necessary to mitigate the risk of adverse effects. Close monitoring of liver function tests, including alanine aminotransferase (ALT), aspartate aminotransferase (AST), and bilirubin levels, is recommended to ensure patient safety and therapeutic efficacy.

Additionally, patients with a history of high blood pressure, heart disease, or kidney disease should be evaluated for potential interactions and contraindications related to their hepatic condition. It is crucial to tailor treatment plans based on the severity of hepatic impairment to optimize outcomes while minimizing risks.

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 initiate supportive care, which may include monitoring vital signs, providing symptomatic treatment, and ensuring the patient's safety.

If available, consultation with a poison control center or a medical toxicologist is recommended to guide the management of the overdose effectively.

Documentation of the incident, including the substance involved, the amount taken, and the time of ingestion, is crucial for appropriate treatment and follow-up care.

Nonclinical Toxicology

It is especially important not to use aspirin during the last three months of pregnancy unless definitely directed to do so by a doctor, as it may cause problems in the unborn child or complications during delivery. No relevant information is available regarding non-teratogenic effects. Additionally, there is no relevant information provided concerning nonclinical toxicology or animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has indicated that aspirin may lead to severe allergic reactions, which can manifest as hives, asthma (wheezing), shock, and facial swelling. Additionally, there have been reports of stomach bleeding associated with aspirin use, particularly among patients aged 60 years or older, those with a history of stomach ulcers or bleeding problems, individuals taking blood-thinning (anticoagulant) or steroid medications, users of other prescription or nonprescription NSAIDs, those exceeding the recommended dosage, or individuals consuming three or more alcoholic drinks daily while using this product. Furthermore, adverse reactions reported in the postmarketing experience include tinnitus (ringing in the ears) and hearing loss.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. It is crucial to emphasize the importance of safety in the home environment, particularly for households with young children.

In the event of an overdose, healthcare providers should instruct patients to seek medical help immediately or contact a Poison Control Center. Patients should be made aware of the signs of overdose and the urgency of obtaining assistance to ensure their safety and well-being.

Storage and Handling

The product is supplied in a configuration that includes a tamper-evident seal. It is essential to inspect the safety seal under the cap; do not use the product if the seal is broken or missing.

For optimal storage, the product should be maintained at a temperature range of 15-30 °C (59-86 °F). It is crucial to avoid exposure to excessive heat or humidity to ensure the integrity and efficacy of the product. Proper handling and storage conditions are vital for maintaining product quality.

Additional Clinical Information

The medication is administered orally, with the recommended dosage for adults and children aged 12 years and older being 1-2 tablets every 4 hours as needed, not exceeding 12 tablets in a 24-hour period. For children under 12 years, it is advised to consult a doctor for appropriate dosing.

Clinicians should counsel patients regarding the use of this medication during pregnancy or breastfeeding, emphasizing the importance of consulting a health professional before use. It is particularly critical to avoid aspirin in the last trimester of pregnancy unless specifically directed by a physician, 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 Aspirin, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)