Aspirin

Uses and Indications

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

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. 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 patients 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), exceed the recommended dosage or duration of use, or consume three or more alcoholic beverages daily while using this product.

Healthcare professionals should advise patients to consult a doctor prior to use if any of the following conditions apply: a history of stomach problems such as heartburn, high blood pressure, heart disease, liver cirrhosis, kidney disease, or if they are taking diuretics or have asthma. Additionally, patients should seek guidance from a doctor or pharmacist if they are currently taking prescription medications for gout, diabetes, or arthritis.

In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center (1-800-222-1222) should be contacted without delay.

Patients should be instructed to discontinue use and contact a healthcare provider if they experience any signs of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain. Immediate medical attention is also warranted if an allergic reaction occurs, if pain worsens or persists beyond 10 days, if fever intensifies or lasts more than 3 days, if there is ringing in the ears or loss of hearing, if redness or swelling develops, or if any new symptoms arise.

Side Effects

Patients using this product should be aware of several serious adverse reactions and warnings 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 that these individuals do not use 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 should seek immediate medical attention if they experience any signs of an allergic reaction.

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

Patients are advised to stop using the product 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 persistent stomach pain. They should also seek medical help if an allergic reaction occurs, if pain worsens or lasts more than 10 days, if fever worsens or lasts more than 3 days, if there is ringing in the ears or loss of hearing, if redness or swelling is present, or if any new symptoms arise.

Before using this product, patients should consult a doctor if any of the following apply: they have a history of stomach problems such as heartburn, high blood pressure, heart disease, liver cirrhosis, or kidney disease; they are taking a diuretic; or they have asthma. Furthermore, patients should ask a doctor or pharmacist before use if they are taking prescription medications for gout, diabetes, or arthritis.

Drug Interactions

The product contains a nonsteroidal anti-inflammatory drug (NSAID), which is associated with an increased risk of severe gastrointestinal bleeding. This risk is particularly heightened in patients who are concurrently using anticoagulants or steroid medications. Additionally, the concomitant use of other NSAIDs, whether prescription or over-the-counter (such as aspirin, ibuprofen, or naproxen), may further elevate this risk.

Patients taking prescription medications for gout, diabetes, or arthritis should consult with a healthcare professional prior to using this product. Furthermore, individuals with pre-existing conditions such as high blood pressure, heart disease, liver cirrhosis, or kidney disease are advised to seek medical advice before initiating treatment with this NSAID. Monitoring and potential dosage adjustments may be necessary based on the clinical judgment of the healthcare provider.

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, should not use this product if they have or are recovering from chicken pox or flu-like symptoms due to the risk of Reye's syndrome. If any changes in behavior accompanied by nausea and vomiting occur during use, it is essential to consult a healthcare professional, as these may be early signs of Reye's syndrome.

For dosing, 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 advised to consult a doctor for appropriate dosing recommendations.

This product should be kept out of reach of children. In the event of an 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, are at an increased risk of severe stomach bleeding when using this product, which contains a nonsteroidal anti-inflammatory drug (NSAID). Therefore, caution is advised when prescribing this medication to geriatric patients.

Before initiating treatment, healthcare providers should assess the patient's medical history, especially for conditions such as high blood pressure, heart disease, liver cirrhosis, or kidney disease. It is recommended that elderly patients consult with their healthcare provider prior to use to ensure safe administration and to discuss any potential risks associated with their existing health conditions.

Monitoring for adverse effects, particularly gastrointestinal complications, is essential in this population to mitigate the risk of serious outcomes.

Pregnancy

Pregnant patients should consult a healthcare professional before using this medication, particularly if they are in the later stages of pregnancy or breastfeeding. The use of aspirin during the last trimester is particularly cautioned against, as it may pose risks to the unborn child and lead to 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 while breastfeeding.

Renal Impairment

Patients with renal impairment should consult a healthcare professional prior to use, particularly if they have comorbid 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 degree 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 medical guidance to assess the potential risks and benefits associated with the use of this medication. Monitoring of liver function may be necessary to ensure safety and efficacy in this population. Adjustments to dosage or treatment regimens may be required based on the severity of hepatic impairment, and healthcare providers should evaluate each case individually.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance. Healthcare professionals are advised to contact a Poison Control Center at 1-800-222-1222 for guidance on managing the situation effectively.

Prompt intervention is crucial to mitigate potential adverse effects associated with overdose. Symptoms may vary depending on the substance involved, and healthcare providers should be prepared to assess and manage these symptoms accordingly.

Management procedures may include supportive care and symptomatic treatment, tailored to the specific clinical presentation of the patient. Continuous monitoring and evaluation are essential to ensure patient safety and to address any complications that may arise during the course of treatment.

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 non-teratogenic effects have been specified in the available data. Additionally, there are no details provided regarding nonclinical toxicology or animal pharmacology and toxicology.

Postmarketing Experience

No specific postmarketing experience details are available. As such, there are no additional adverse events or rare case reports to summarize at this time.

Patient Counseling

Patients should be advised to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222 in the event of an overdose.

Healthcare providers should instruct patients to 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 persistent stomach pain.

Patients should also be informed to stop use and seek medical attention if they notice any signs of an allergic reaction, and to do so immediately if such a reaction occurs. Additionally, they should be counseled to stop use and consult a doctor if their pain worsens or persists beyond 10 days, or if their fever intensifies or lasts more than 3 days.

It is important to advise patients to seek medical advice if they experience ringing in the ears, loss of hearing, redness, swelling, or any new symptoms.

Patients should be encouraged 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. Furthermore, they should be advised to seek medical guidance if they have high blood pressure, heart disease, liver cirrhosis, or kidney disease, or if they are taking a diuretic.

Lastly, patients should be reminded to consult a doctor or pharmacist before use if they are currently taking a prescription medication for gout, diabetes, or arthritis.

Storage and Handling

The product is supplied in a configuration that includes a tamper-evident seal. It is essential to inspect the safety seal under the cap; do not use the product if the seal is broken or missing.

Storage conditions require the product to be maintained at a temperature of 25ºC (77ºF), with permissible excursions between 15ºC and 30ºC (59ºF to 86ºF). For optimal integrity, it is advised to keep the product in its original container.

The expiration date and lot number can be found on the end flap of the packaging, and it is important to check these details prior to use.

Additional Clinical Information

Patients should be advised to consult a healthcare professional if they are pregnant or breastfeeding before using the medication. 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.

In the event of an overdose, patients are urged to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222.

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)