Aspirin

Description

Aspirin is a nonsteroidal anti-inflammatory drug (NSAID) indicated for the relief of pain and reduction of fever. Each coated tablet contains 325 mg of aspirin. The product is available in a package containing 100 coated tablets.

Uses and Indications

This drug is indicated for the temporary relief of various types of pain and discomfort, including headache, muscle pain, toothache, menstrual pain, and minor pain associated with arthritis. Additionally, it is effective in alleviating pain and fever associated with colds.

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 1 or 2 tablets every 4 hours, or alternatively, 3 tablets every 6 hours. The total daily dosage must not exceed 12 tablets within a 24-hour period.

For children under 12 years of age, it is advised to consult a healthcare professional 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

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

Aspirin has the potential to cause severe allergic reactions, which may manifest as hives, facial swelling, asthma (wheezing), or shock. Additionally, this product contains a nonsteroidal anti-inflammatory drug (NSAID), which can lead to severe stomach bleeding. The risk of such adverse effects is heightened in individuals who are 60 years of age or older, have a history of stomach ulcers or bleeding disorders, are taking anticoagulants or steroid medications, are using other NSAIDs (including aspirin, ibuprofen, or naproxen), consume three or more alcoholic beverages daily while using this product, or exceed the recommended dosage or duration of use.

Individuals should refrain from using this product if they have a known allergy to aspirin or any other pain reliever or fever reducer. It is advisable to consult a healthcare professional prior to use 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 a diagnosis of asthma. Furthermore, patients taking prescription medications for diabetes, gout, or arthritis should seek guidance from a doctor or pharmacist before using this product.

In the event of an overdose, immediate medical assistance should be sought, or contact a Poison Control Center at 1-800-222-1222.

Users should discontinue use and contact a healthcare provider if any of the following occur: signs of an allergic reaction, symptoms indicative of stomach bleeding (such as feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain), worsening pain lasting more than 10 days, presence of redness or swelling, fever that worsens or persists for more than three days, emergence of new symptoms, or occurrences of ringing in the ears or loss of hearing. These symptoms may signify a serious medical condition requiring prompt attention.

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. It is crucial for these individuals to avoid using this product. 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 may also cause severe allergic reactions in some patients. Symptoms of such reactions can include hives, facial swelling, asthma (wheezing), and shock. Patients experiencing any signs of an allergic reaction should seek medical help right away.

This product contains a nonsteroidal anti-inflammatory drug (NSAID), which may lead to 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 blood-thinning medications or steroids, are using other NSAIDs (including aspirin, ibuprofen, or naproxen), consume three or more alcoholic drinks daily while using this product, or take more of the product than directed or for an extended period.

Patients should discontinue use and consult a doctor if they experience any signs of stomach bleeding, which may include feeling faint, vomiting blood, having bloody or black stools, or experiencing stomach pain that does not improve. Additionally, if pain worsens or persists for more than 10 days, if redness or swelling occurs, if fever worsens or lasts for more than three days, if new symptoms arise, or if there is ringing in the ears or loss of hearing, medical advice should be sought.

Before using this product, patients should consult a doctor 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 seek medical advice prior to use.

For pregnant or breastfeeding patients, it is essential 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

Aspirin has several notable interactions that may impact patient safety and treatment efficacy.

Anticoagulants Aspirin may enhance the effects of blood-thinning medications, leading to an increased risk of severe gastrointestinal bleeding. It is advisable for healthcare providers to closely monitor patients who are concurrently using aspirin with anticoagulants to mitigate this risk.

Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) Concurrent use of aspirin with other NSAIDs, such as ibuprofen or naproxen, may further elevate the risk of stomach bleeding. Patients should be advised to avoid the combination of these medications unless specifically directed by a healthcare professional.

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 is to ensure that potential interactions are assessed and managed appropriately, as aspirin may affect the pharmacodynamics of these treatments.

In all cases, careful consideration of dosage adjustments and ongoing monitoring is recommended to ensure patient safety.

Packaging & NDC

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

Pediatric Use

Pediatric patients, particularly 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. Healthcare professionals are advised to consult a doctor if any changes in behavior accompanied by nausea and vomiting occur, as these may be early signs of Reye's syndrome.

For dosing recommendations, adults and children aged 12 years and older may take 1 or 2 tablets every 4 hours or 3 tablets every 6 hours, with a maximum of 12 tablets in a 24-hour period. For children under 12 years, it is essential to consult a doctor for appropriate dosing guidance.

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 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, it is advisable for healthcare providers to consult with the patient’s physician to assess the appropriateness of the medication in light of these risk factors. Close monitoring for signs of gastrointestinal bleeding should be considered in this population to ensure patient safety and to mitigate potential adverse effects.

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 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 mothers.

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 for these patients to receive appropriate evaluation and monitoring of their liver function to ensure safe and effective use of the medication. Adjustments to dosage may be necessary based on the severity of hepatic impairment, and ongoing assessment of liver function is recommended throughout the treatment period.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. Healthcare professionals should advise patients or caregivers to call the Poison Control Center at 1-800-222-1222 for guidance.

Prompt intervention is crucial in managing overdose situations, as timely medical help can significantly influence outcomes. Symptoms of overdose may vary depending on the substance involved and the individual’s health status. Therefore, a thorough assessment and monitoring of the patient are essential.

Management procedures should include supportive care and symptomatic treatment as necessary. Healthcare providers are encouraged to follow established protocols for overdose management, which may involve the administration of activated charcoal, intravenous fluids, or other interventions based on the clinical presentation.

It is vital for healthcare professionals to remain vigilant and prepared to address potential complications arising from an overdose, ensuring that appropriate measures are taken swiftly to mitigate risks to the patient’s health.

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 hives, facial swelling, asthma (wheezing), and shock. Additionally, cases of stomach bleeding have been noted, particularly in patients aged 60 or older, those with a history of stomach ulcers or bleeding problems, individuals taking blood-thinning (anticoagulant) or steroid medications, and patients using other drugs containing prescription or nonprescription NSAIDs. Increased risk is also associated with the consumption of three or more alcoholic drinks daily while using this product, as well as prolonged use beyond the recommended duration.

Signs indicative of stomach bleeding that necessitate immediate medical attention include feelings of faintness, vomiting blood, the presence of bloody or black stools, and persistent stomach pain. Furthermore, the emergence of new symptoms such as ringing in the ears or loss of hearing may suggest serious underlying conditions that warrant consultation with a healthcare professional.

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, patients should be instructed to seek medical help immediately or contact a Poison Control Center at 1-800-222-1222.

Patients must be informed not to use the medication if they have a known allergy to aspirin or any other pain reliever or fever reducer. They should be counseled to stop use and consult a doctor if they experience any signs of an allergic reaction, which requires immediate medical attention. Additionally, patients should be made aware of the signs of stomach bleeding, including feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain. They should also be advised to seek medical advice if their pain worsens or lasts longer than 10 days, if redness or swelling occurs, if fever worsens or lasts more than 3 days, if new symptoms develop, or if they experience ringing in the ears or loss of hearing, as these may indicate a serious condition.

Healthcare providers should encourage patients to consult a doctor before using the medication if they have a history of stomach problems, such as heartburn, or if the stomach bleeding warning applies to them. Patients with high blood pressure, heart disease, liver cirrhosis, or kidney disease should also seek medical advice prior to use. Furthermore, those taking diuretics or who have asthma should be advised to consult a healthcare professional before starting the medication.

Lastly, patients should be reminded to ask a doctor or pharmacist before use if they are currently taking prescription medications for diabetes, gout, or arthritis to ensure safe and effective use of the medication.

Storage and Handling

The product is supplied in a carton that contains essential information and warnings. It is important to store the product in a dry place, maintaining a temperature range of 20°-25°C (68°-77°F) to ensure its stability and efficacy. The carton should be retained for reference to complete product information and any necessary warnings.

Additional Clinical Information

The medication is administered orally. Clinicians should advise patients who are pregnant or breastfeeding to consult a healthcare professional prior to use. It is particularly crucial to avoid aspirin during the last trimester of pregnancy unless explicitly 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)