Aspirin

Description

No relevant information is available for SPL code 34089-3.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains, as recommended by a healthcare professional. Due to its delayed action, this product is not suitable for the immediate relief of headaches or other symptoms requiring prompt alleviation.

Healthcare professionals are encouraged to inquire about additional uses for this medication.

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

Dosage and Administration

Patients are advised to take the medication with a full glass of water for optimal efficacy.

For adults and children aged 12 years and older, the recommended dosage is 4 to 8 tablets every 4 hours. The total daily dosage should 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 recommended to consult a physician for appropriate dosing guidance.

Contraindications

There are no specific contraindications listed for this product. However, it is essential to keep the product out of reach of children to prevent accidental ingestion. In the event of an overdose, immediate medical assistance should be sought, or contact with a Poison Control center is advised.

Warnings and Precautions

The use of this product necessitates careful consideration of several warnings and precautions to ensure patient safety.

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 can provoke severe allergic reactions, which may manifest as hives, facial swelling, asthma (wheezing), or shock. Patients with a known allergy to aspirin or any other pain reliever or fever reducer should not use this product.

Stomach Bleeding Warning This product contains a nonsteroidal anti-inflammatory drug (NSAID), which carries a risk of severe stomach bleeding. The likelihood of this adverse effect increases in individuals 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, 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.

General Precautions Prior to using this product, patients should consult a healthcare provider if they have a history of stomach issues, such as heartburn, or if they have conditions including high blood pressure, heart disease, liver cirrhosis, or kidney disease. Additionally, individuals taking diuretics or those with asthma should seek medical advice before use. It is also advisable to consult a doctor or pharmacist if the patient is on prescription medications for gout, diabetes, or arthritis.

Signs to Discontinue Use Patients should immediately stop taking this product and contact a healthcare professional if they experience any signs of an allergic reaction or any of the following symptoms indicative of stomach bleeding:

• Feeling faint

• Vomiting blood

• Presence of bloody or black stools

• Persistent stomach pain that does not improve

• Worsening pain lasting more than 10 days

• Redness or swelling

• Fever that worsens or lasts more than three days

• Onset of new symptoms

• Ringing in the ears or loss of hearing.

Emergency Medical Help In the event of an overdose, it is crucial to seek emergency medical assistance or contact Poison Control immediately. Timely medical intervention is essential for both adults and children, even if no signs or symptoms are initially apparent.

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 symptoms could indicate the onset of Reye’s syndrome.

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

This 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 anticoagulants or steroid medications, consume three or more alcoholic drinks daily, or use other NSAIDs concurrently. Patients should be advised to take this product only as directed and to avoid prolonged use.

Common adverse reactions may include signs of stomach bleeding, which necessitate immediate medical attention. Patients should stop using the product and seek medical help if they experience symptoms such as feeling faint, vomiting blood, having bloody or black stools, or experiencing stomach pain that does not improve. Additional symptoms warranting cessation of use and consultation with a healthcare provider include worsening pain lasting more than 10 days, redness or swelling, fever that worsens or lasts more than three days, the emergence of new symptoms, or ringing in the ears or loss of hearing.

Patients are encouraged to consult a doctor before using this product if they have a history of stomach problems, high blood pressure, heart disease, liver cirrhosis, or kidney disease, or if they are taking diuretics. Additionally, those on prescription medications for gout, diabetes, or arthritis should seek advice from a healthcare professional prior to use.

Drug Interactions

Aspirin has the potential to cause severe gastrointestinal bleeding, particularly when used concurrently with anticoagulants or steroid medications. This risk is further elevated in patients who are also taking other nonsteroidal anti-inflammatory drugs (NSAIDs), including but not limited to ibuprofen and naproxen.

Patients are advised to consult with a healthcare professional, such as a doctor or pharmacist, prior to initiating aspirin therapy if they are currently prescribed medications for gout, diabetes, or arthritis. This precaution is essential to ensure safe and effective use of aspirin in the context of their overall medication regimen.

Packaging & NDC

Below are the non-prescription pack sizes of Aspirin 81mg. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 12 years of age should consult a healthcare professional before using this product. It is contraindicated in children and teenagers who have or are recovering from chickenpox or flu-like symptoms due to the risk of Reye’s syndrome.

Healthcare providers should be vigilant for changes in behavior accompanied by nausea and vomiting in pediatric patients, as these may indicate the onset of Reye’s syndrome, a rare but serious condition.

This product should be kept out of reach of children. In the event of an overdose, immediate medical assistance should be sought, and contacting a Poison Control center is advised. Prompt medical attention is essential for both adults and children, even if no signs or symptoms are initially apparent.

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 assess the individual risk factors of geriatric patients before prescribing this medication.

Patients with a history of stomach problems, such as heartburn, should be closely monitored. Additionally, those with comorbid conditions, including high blood pressure, heart disease, liver cirrhosis, or kidney disease, may require careful evaluation and potential dosage adjustments.

The use of diuretics in elderly patients also necessitates caution, as it may influence the safety profile of the medication. Furthermore, patients with asthma should be advised to consult their healthcare provider prior to use, given the potential for adverse effects.

In summary, healthcare providers should exercise heightened vigilance when prescribing this medication to elderly patients, considering their unique health profiles and the associated risks.

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 the unborn child or complications during delivery. Therefore, it is essential that pregnant patients only use aspirin in this period if explicitly directed by a physician.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. It is particularly important to avoid the use of aspirin during the last three months of pregnancy unless explicitly 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 should consult a healthcare professional prior to use, particularly if they have conditions such as high blood pressure, heart disease, liver cirrhosis, or kidney disease. It is essential to assess renal function and consider potential dosing adjustments or monitoring requirements based on the severity of renal impairment.

Hepatic Impairment

Patients with hepatic impairment may experience altered pharmacokinetics of the medication 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 concurrent conditions such as high blood pressure, heart disease, or kidney disease should be evaluated for potential interactions and the overall impact on treatment outcomes. It is advisable to consult with a healthcare professional to determine the most appropriate management strategy for patients with hepatic impairment.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. Prompt intervention is crucial for both adults and children, regardless of whether any signs or symptoms are initially apparent.

Healthcare professionals should be aware that the absence of symptoms does not preclude the possibility of serious complications arising from an overdose. Therefore, it is essential to monitor the patient closely and provide appropriate medical care as needed.

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 reported voluntarily or through surveillance programs. These include gastrointestinal bleeding, allergic reactions such as anaphylaxis, and Reye's syndrome in children and teenagers recovering from chickenpox or flu-like symptoms. Additionally, asthma exacerbation and other serious skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, have been noted. Reports of liver damage, renal impairment, hemolytic anemia, and thrombocytopenia have also been documented. Furthermore, other rare but serious adverse events have been reported.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental ingestion.

In the event of an overdose, it is crucial for patients to seek medical help or contact Poison Control immediately. Healthcare providers should emphasize that prompt medical attention is essential for both adults and children, even if no signs or symptoms of overdose are apparent.

Storage and Handling

The product is supplied in a configuration that ensures optimal usability. It should be stored at room temperature, specifically within the range of 20 to 25°C (68 to 77°F). Care should be taken to avoid exposure to excessive heat, cold, and humidity, as these conditions may compromise the integrity of the product. After each use, it is essential to close the cap tightly to maintain the product's quality and effectiveness.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Aspirin 81mg, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)