Aspirin

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains, or as recommended by a healthcare professional.

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 of this product is contraindicated in the following situations:

Patients with a known allergy to aspirin or any other pain reliever or fever reducer should not use this product due to the risk of severe allergic reactions. Additionally, the product should not be used for at least 7 days following a tonsillectomy or oral surgery unless directed by a healthcare professional, as it may increase the risk of bleeding.

Aspirin use is also contraindicated during the last trimester of pregnancy unless specifically directed by a physician, as it may pose risks to the unborn child and lead to complications during delivery.

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 Reye’s syndrome, a rare but serious condition.

Aspirin may provoke severe allergic reactions, which can manifest as hives, facial swelling, asthma (wheezing), or shock. Healthcare professionals should be vigilant for these signs 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 meet any of the following criteria: those aged 60 years or older, individuals with a history of stomach ulcers or bleeding disorders, patients taking anticoagulants or steroid medications, those using other NSAIDs (including aspirin, ibuprofen, or naproxen), individuals consuming three or more alcoholic beverages daily while using this product, or those who exceed the recommended dosage or duration of use.

Healthcare professionals should advise patients to consult a doctor prior to use if they have a history of stomach problems, such as heartburn, or if they have conditions such as high blood pressure, heart disease, liver cirrhosis, or kidney disease. Additionally, patients taking diuretics or those with asthma should seek medical advice before using this product.

In the event of an accidental overdose, it is crucial to obtain emergency medical assistance or contact a Poison Control Center at 1-800-222-1222 immediately.

Patients should be instructed to discontinue use and contact their healthcare provider if they experience any signs of an allergic reaction, such as hives or swelling, or if they notice symptoms indicative of stomach bleeding, including feeling faint, vomiting blood, passing bloody or black stools, or experiencing persistent stomach pain. Furthermore, if pain worsens or lasts longer than 10 days, if redness or swelling occurs, if new symptoms arise, or if there is ringing in the ears or loss of hearing, patients should seek medical attention promptly.

Side Effects

Patients using this product may experience a range of adverse reactions, some of which can be serious.

Serious Adverse Reactions 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. Patients should be advised not to use this product under these circumstances. If changes in behavior accompanied by nausea and vomiting occur, it is essential to consult a healthcare professional, as these may be early signs of Reye’s syndrome.

Aspirin may also cause severe allergic reactions, which can manifest as hives, facial swelling, asthma (wheezing), or shock. Patients should be instructed to seek immediate medical attention if any signs of an allergic reaction occur.

This product contains a nonsteroidal anti-inflammatory drug (NSAID), which may lead to severe stomach bleeding. The risk of this adverse reaction 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 while using this product, or exceed the recommended dosage or duration of use.

Common Adverse Reactions Patients should be advised to stop using the product and consult a healthcare professional if they experience any signs of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain. Additionally, if pain worsens or lasts longer than 10 days, or if new symptoms arise, medical advice should be sought. Symptoms such as redness or swelling, as well as ringing in the ears or loss of hearing, should also prompt a consultation with a healthcare provider.

Precautions Patients should not use this product if they are allergic to aspirin or any other pain reliever or fever reducer. It is also contraindicated for use for at least 7 days following tonsillectomy or oral surgery unless directed by a healthcare professional.

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. Those taking diuretics or with a history of asthma should also seek medical advice prior to use.

Pregnancy and Breastfeeding It is crucial for patients who are pregnant or breastfeeding 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 the potential to induce severe allergic reactions, which may manifest as hives, facial swelling, asthma (wheezing), or shock. Clinicians should be vigilant for these symptoms in patients who are prescribed aspirin, particularly those with a history of allergies.

In terms of pharmacodynamic interactions, the concomitant use of aspirin with anticoagulants or steroid medications significantly increases the risk of severe gastrointestinal bleeding. This risk is further compounded when aspirin is taken alongside other nonsteroidal anti-inflammatory drugs (NSAIDs), including ibuprofen and naproxen. It is advisable to monitor patients closely for signs of gastrointestinal bleeding and consider dosage adjustments or alternative therapies as necessary.

Additionally, patients taking prescription medications for gout, diabetes, or arthritis should consult with their healthcare provider or pharmacist prior to initiating aspirin therapy. This precaution is essential to avoid potential drug interactions that could compromise treatment efficacy or safety.

Packaging & NDC

Below are the non-prescription pack sizes of Aspirin (aspirin 81 mg). 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, it is essential 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 4 to 8 tablets every 4 hours, not exceeding 48 tablets in a 24-hour period unless directed by a doctor. For children under 12 years of age, it is advised to consult a doctor for appropriate dosing recommendations.

This product should be kept out of reach of children. In the event of an accidental overdose, immediate medical assistance should be sought, or contact a Poison Control Center at 1-800-222-1222.

Geriatric Use

Elderly patients, particularly those aged 60 and older, may have an increased risk of severe stomach bleeding when using this product, which contains a nonsteroidal anti-inflammatory drug (NSAID). It is essential for healthcare providers to advise geriatric patients to consult a physician prior to use if they have a history of stomach bleeding.

Additionally, elderly patients with comorbid conditions such as high blood pressure, heart disease, liver cirrhosis, or kidney disease should seek medical advice before initiating treatment. Monitoring for potential adverse effects is crucial in this population, and dosage adjustments may be necessary based on individual health status and concurrent medications.

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 development or complications during delivery. Therefore, it is essential that pregnant patients only use aspirin in this period if specifically 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 doctor, 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 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 underlying conditions such as liver cirrhosis. It is essential for these patients to receive appropriate evaluation and monitoring of their liver function to ensure safe 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

Overdosage of this product can lead to significant adverse effects. Healthcare professionals should be aware that symptoms associated with 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 to do so by a doctor, as it may cause problems in the unborn child or complications during delivery. No non-teratogenic effects or additional nonclinical toxicology data were provided.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical help or contact a Poison Control Center at 1-800-222-1222 in the event of an accidental overdose. Patients should be informed not to use this product if they have a known allergy to aspirin or any other pain reliever or fever reducer.

It is important to instruct patients not to use this product for at least 7 days following a tonsillectomy or oral surgery unless directed by a healthcare professional. Providers should encourage patients to consult a doctor before use 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 be advised to seek medical guidance prior to using this product. Additionally, those taking diuretics or who have asthma should consult a healthcare provider before use. Patients should be reminded to ask a doctor or pharmacist before using this product if they are taking prescription medications for gout, diabetes, or arthritis.

Healthcare providers should instruct patients to discontinue use and consult a doctor if they experience any signs of an allergic reaction or if symptoms such as feeling faint, vomiting blood, having bloody or black stools, or persistent stomach pain occur, as these may indicate stomach bleeding. Patients should also be advised to stop use and seek medical advice if pain worsens or lasts more than 10 days, if redness or swelling is present, if new symptoms arise, or if they experience ringing in the ears or loss of hearing.

For patients who are pregnant or breastfeeding, it is crucial to recommend consulting a health professional before use. Providers should emphasize that aspirin should be avoided during the last 3 months of pregnancy unless specifically directed by a doctor, as it may pose risks to the unborn child or lead to complications during delivery.

Storage and Handling

The product is supplied in blister card packaging. It is essential to store the product at room temperature. Healthcare professionals should ensure that the blister card is intact and not damaged or tampered with prior to use, as compromised packaging may affect the product's integrity and safety.

Additional Clinical Information

No further data are available.

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)