Aspirin

Description

Aspirin 81 mg is presented in the form of peach-colored tablets. Each tablet contains 81 mg of aspirin as the active ingredient. The formulation is designed for oral administration.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains. It is essential for patients to consult their healthcare provider for any additional uses beyond this indication. The use of this drug should not exceed 10 days without medical consultation, as serious side effects may occur with prolonged use.

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

Dosage and Administration

Patients should take the medication with a full glass of water to ensure proper administration and absorption.

For adults and children aged 12 years and older, the recommended dosage is 4 to 8 tablets every 4 hours. The total daily dosage must not exceed 48 tablets within a 24-hour period unless otherwise directed by a healthcare professional.

For children under 12 years of age, it is advised to consult a physician for appropriate dosing recommendations.

Contraindications

Use is contraindicated in individuals with a known allergy to aspirin or any other pain reliever or fever reducer. Due to the potential for severe allergic reactions, administration in these patients is not recommended.

Warnings and Precautions

Patients should be advised of the following warnings and precautions associated with the use of this product.

Reye's Syndrome Children and teenagers who are experiencing or recovering from chickenpox or flu-like symptoms should avoid using this product. If any changes in behavior accompanied by nausea and vomiting occur during use, it is imperative to consult a healthcare professional, as these symptoms may indicate the onset of Reye's syndrome, a rare but serious condition.

Allergy Alert Aspirin has the potential to cause severe allergic reactions. Healthcare professionals should be vigilant for signs of an allergic response, which may include hives, facial swelling, shock, or asthma symptoms such as wheezing.

Stomach Bleeding Warning This product contains a nonsteroidal anti-inflammatory drug (NSAID), which may increase the risk of severe stomach bleeding. The risk 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 anticoagulant medications

• Are using other NSAIDs, whether prescription or over-the-counter (e.g., aspirin, ibuprofen, naproxen)

• Consume three or more alcoholic beverages daily while using this product

• Exceed the recommended dosage or duration of use

Monitoring Parameters Patients should be closely monitored for signs of stomach bleeding, which may include feeling faint, the presence of bloody or black stools, vomiting blood, or persistent stomach pain. If any of these symptoms occur, patients should discontinue use and seek medical attention immediately.

Additional Precautions Patients should also be advised to stop taking the product and consult a healthcare provider if:

• Pain worsens or persists beyond 10 days

• Fever worsens or lasts more than 3 days

• Redness or swelling occurs in the affected area

• New symptoms develop

• Ringing in the ears or hearing loss is experienced

Emergency Medical Help In the event of an overdose, it is crucial to seek emergency medical assistance or contact a Poison Control Center without delay.

Side Effects

Patients using this product should be aware of several serious 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.

Additionally, this product may cause severe allergic reactions in some individuals, which can manifest as hives, facial swelling, shock, or asthma symptoms such as wheezing.

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 anticoagulant medications, are using other NSAIDs (including aspirin, ibuprofen, or naproxen), consume three or more alcoholic drinks daily while using the product, or exceed the recommended dosage or duration of use.

Patients are advised to stop using the product and seek medical attention if they experience any signs of stomach bleeding, which may include feeling faint, having bloody or black stools, vomiting blood, or experiencing persistent stomach pain. Other reasons to consult a doctor include worsening pain lasting more than 10 days, fever lasting more than 3 days, the presence of redness or swelling in the painful area, the emergence of new symptoms, or experiencing ringing in the ears or loss of hearing.

Before using this product, patients should consult a doctor if they have a history of stomach problems such as heartburn, high blood pressure, heart disease, liver cirrhosis, or kidney disease, are taking diuretics, have asthma, or have not been adequately hydrating. Furthermore, it is advisable to seek guidance from a doctor or pharmacist if patients are taking prescription medications for diabetes, gout, or arthritis, are using any other drugs, or are under medical care for any serious condition.

Drug Interactions

Aspirin has the potential to interact with various drug classes, particularly those that affect hemostasis and gastrointestinal integrity.

Anticoagulants and Antiplatelet Agents Aspirin may significantly increase the risk of severe gastrointestinal bleeding when co-administered with anticoagulant medications. Healthcare professionals should closely monitor patients on anticoagulants for signs of bleeding and consider dosage adjustments as necessary.

Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) The concomitant use of aspirin with other NSAIDs, whether prescription or nonprescription (such as ibuprofen or naproxen), heightens the risk of stomach bleeding. It is advisable to avoid the simultaneous use of multiple NSAIDs to mitigate this risk.

Diabetes, Gout, and Arthritis Medications Patients taking prescription medications for diabetes, gout, or arthritis should consult their healthcare provider prior to initiating aspirin therapy. This consultation is crucial to ensure safe use and to evaluate the need for any dosage adjustments or enhanced monitoring for potential adverse effects.

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 any changes in behavior accompanied by nausea and vomiting occur while using this product, a healthcare professional should be consulted, as these may be early signs of Reye's syndrome.

For dosing, adults and children aged 12 years and over are directed to take 4 to 8 tablets every 4 hours, with a maximum of 48 tablets in 24 hours unless otherwise directed by a doctor. For children under 12 years of age, consultation with a healthcare professional is recommended prior to use.

Geriatric Use

Elderly patients, particularly those aged 60 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 stomach problems, high blood pressure, heart disease, liver cirrhosis, or kidney disease.

Before initiating treatment, healthcare providers should inquire about the presence of any of these conditions in elderly patients, as they may necessitate closer monitoring or alternative therapeutic strategies. The potential for adverse effects, such as gastrointestinal bleeding, should be carefully weighed against the benefits of treatment in this population.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to use. 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 its use in lactating individuals.

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 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

Overdosage of this product can lead to significant adverse effects. Healthcare professionals should be aware that symptoms associated with an overdose may include nausea, vomiting, and abdominal pain.

In the event of an overdose, it is imperative to seek immediate medical attention. Prompt intervention is crucial to mitigate potential harm and manage the symptoms effectively.

Nonclinical Toxicology

It is especially important not to use 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 details regarding nonclinical toxicology or animal pharmacology and toxicology provided in the current information.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions associated with the use of the product. These include gastrointestinal bleeding, allergic reactions such as anaphylaxis, Reye's syndrome in children and teenagers recovering from chickenpox or flu-like symptoms, asthma exacerbation, renal impairment, hepatic impairment, skin reactions including rash and urticaria, as well as tinnitus and hearing loss.

Additionally, safety updates from postmarketing experience indicate an increased risk of gastrointestinal bleeding in patients over 60 years of age or those with a history of ulcers or bleeding disorders. Caution is advised for patients concurrently taking anticoagulants or other nonsteroidal anti-inflammatory drugs (NSAIDs).

Patient Counseling

Patients should be advised to keep this medication out of reach of children to prevent accidental ingestion. In the event of an overdose, it is crucial to seek medical assistance or contact a Poison Control Center immediately.

Patients must be informed not to use this medication if they have a known allergy to aspirin or any other pain reliever or fever reducer. They should be instructed to stop use and consult a healthcare provider if they experience any signs of stomach bleeding, which may include feeling faint, having bloody or black stools, vomiting blood, or experiencing stomach pain that does not improve.

Healthcare providers should counsel patients to seek medical advice if their pain worsens or persists for more than 10 days, or if their fever worsens or lasts more than 3 days. Patients should also be made aware that the presence of redness or swelling in the painful area, the appearance of any new symptoms, or the occurrence of ringing in the ears or loss of hearing warrants immediate consultation with a healthcare professional.

It is important to advise patients to consult a doctor before use 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. Patients taking diuretics or those with asthma should also be encouraged to seek medical advice prior to using this medication. Additionally, patients who have not been adequately hydrating should be cautioned.

Patients should be reminded to consult a doctor or pharmacist before use if they are currently taking prescription medications for diabetes, gout, or arthritis, or if they are taking any other drugs. Those under a doctor's care for any serious condition should also be advised to discuss the use of this medication with their healthcare provider.

Storage and Handling

The product is supplied in packaging that includes specific NDC numbers. It should be stored at a controlled room temperature of 25°C (77°F). Temporary excursions are permissible between 15°C and 30°C (59°F to 86°F). It is essential to adhere to the expiration date indicated on the package to ensure product efficacy and safety.

Additional Clinical Information

The medication is administered orally. Clinicians should advise patients who are pregnant or breastfeeding to consult a health professional prior to use. It is particularly crucial to avoid aspirin during 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. No further information is available regarding laboratory tests, abuse potential, or postmarketing experiences.

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)