Aspirin

Description

Aspirin is a nonsteroidal anti-inflammatory drug (NSAID) with the chemical name acetylsalicylic acid. Its molecular formula is C9H8O4, and it has a molecular weight of 180.16 g/mol. Aspirin is typically presented in a tablet dosage form, characterized by its white to off-white appearance. The drug exhibits analgesic, antipyretic, and anti-inflammatory properties, making it widely used for the management of pain, fever, and inflammation.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains, as well as for other uses 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 advised to consult with patients regarding any additional uses of this medication. 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

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, and contacting a Poison Control center is advised. Prompt medical attention is critical for both adults and children, even if no signs or symptoms are apparent.

Warnings and Precautions

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

Aspirin may provoke severe allergic reactions in some individuals. Symptoms of such reactions can include hives, facial swelling, asthma (wheezing), and shock. Therefore, individuals with known allergies to aspirin or any other pain reliever or fever reducer should refrain from using this product. Additionally, those who have previously experienced an allergic reaction to this product or any of its components should avoid its use.

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 (including aspirin, ibuprofen, or naproxen), consume three or more alcoholic beverages daily, or exceed the recommended dosage or duration of use.

Healthcare professionals should advise patients to consult a doctor prior to using this product if any of the following conditions apply: a history of stomach bleeding, heartburn, high blood pressure, heart disease, liver cirrhosis, kidney disease, or if they are taking diuretics or have asthma. Furthermore, it is advisable to seek guidance from a doctor or pharmacist if the patient is currently taking prescription medications for gout, diabetes, or arthritis.

In the event of an overdose, immediate medical assistance should be sought, or contact with Poison Control is recommended. Timely medical intervention is crucial for both adults and children, even in the absence of noticeable signs or symptoms.

Patients should discontinue use and contact a healthcare provider if they experience any signs of an allergic reaction or any of the following symptoms indicative of stomach bleeding: feeling faint, vomiting blood, passing bloody or black stools, experiencing persistent stomach pain, worsening pain lasting more than ten days, presence of redness or swelling, fever that worsens or lasts more than three days, new symptoms, or any ringing in the ears or loss of hearing.

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 chicken pox or flu-like symptoms. Patients should not use this product if they exhibit changes in behavior accompanied by nausea and vomiting, as these may be early signs of Reye’s syndrome.

Aspirin may cause severe allergic reactions, which can 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.

This product contains a nonsteroidal anti-inflammatory drug (NSAID), which carries a warning for the potential of severe stomach bleeding. The risk of stomach bleeding is heightened 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 consult a healthcare professional before using this product if they have a history of stomach problems such as heartburn, high blood pressure, heart disease, liver cirrhosis, or kidney disease, or if they are taking diuretics or prescription medications for gout, diabetes, or arthritis.

Patients are advised to stop using the product and seek medical attention if they experience any signs of an allergic reaction or symptoms indicative of stomach bleeding, including feeling faint, vomiting blood, having bloody or black stools, experiencing persistent stomach pain, or if pain worsens or lasts more than 10 days. Additional symptoms warranting medical consultation include redness or swelling, fever lasting more than three days, the emergence of 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 use. 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.

In the event of an overdose, patients should seek medical help or contact a Poison Control center immediately, as prompt medical attention is essential for both adults and children, even if no signs or symptoms are initially apparent.

Drug Interactions

Patients taking anticoagulants or steroid medications should exercise caution when using this drug, as there may be an increased risk of bleeding or other adverse effects. It is advisable for these patients to consult with a healthcare professional prior to initiating therapy.

Concurrent use of this drug with other nonsteroidal anti-inflammatory drugs (NSAIDs), including prescription and over-the-counter options such as aspirin, ibuprofen, and naproxen, may elevate the risk of gastrointestinal complications. Patients are encouraged to seek medical advice before combining these medications.

Additionally, individuals who are on prescription medications for gout, diabetes, or arthritis should consult their healthcare provider or pharmacist prior to using this drug to ensure safe and effective treatment.

No specific interactions with laboratory tests have been identified in the available data.

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

Geriatric Use

Elderly patients, particularly those aged 60 and older, may have an increased risk of severe stomach bleeding. It is essential for healthcare providers to assess this risk before prescribing treatment, especially in patients with a history of stomach problems, such as heartburn.

Additionally, caution is advised for geriatric patients with comorbid conditions, including high blood pressure, heart disease, liver cirrhosis, or kidney disease. The use of diuretics in these patients may further complicate their clinical management and should be carefully monitored.

Patients with asthma also require special consideration, as their respiratory condition may influence the safety and efficacy of the treatment. Healthcare providers should engage in thorough discussions with elderly patients regarding these risks and consider appropriate dose modifications or alternative therapies as necessary.

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 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 in lactating individuals.

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 should consult a healthcare professional prior to use, particularly if they have conditions such as liver cirrhosis. It is essential to assess liver function and consider potential dosage adjustments or monitoring requirements based on the severity of hepatic impairment. Close monitoring of liver function tests may be warranted to ensure safety and efficacy in this patient population.

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 are advised to remain vigilant, as the absence of symptoms does not preclude the possibility of serious complications. 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 detailed findings 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. Reports of allergic reactions have included symptoms such as hives, facial swelling, asthma (wheezing), and shock. Additionally, stomach bleeding has been noted, particularly in patients aged 60 or older, those with a history of stomach ulcers or bleeding problems, individuals taking blood thinners or steroid medications, users of other NSAIDs, those consuming three or more alcoholic drinks daily, or patients exceeding the recommended dosage.

Changes in behavior accompanied by nausea and vomiting may indicate the onset of Reye’s syndrome, a rare but serious condition, especially in children and teenagers recovering from chickenpox or flu-like symptoms. Immediate medical attention is advised if an allergic reaction occurs or if symptoms indicative of stomach bleeding arise, such as feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain.

Furthermore, the emergence of new symptoms, including ringing in the ears or loss of hearing, should prompt a consultation with a healthcare professional. It is crucial to avoid the use of aspirin during the last three months of pregnancy unless specifically directed by a healthcare provider, due to potential risks to the unborn child and complications during delivery.

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, it is crucial for patients to seek medical help or contact a Poison Control Center 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 includes specific NDC numbers, which should be referenced for accurate identification. It is essential to store the product 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, the cap must be closed tightly to ensure proper sealing and to maintain the product's quality.

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)