Aspirin

Description

The product is identified by the National Drug Code (NDC) 17714-011-01 and is available in a dosage form of 100 tablets.

Uses and Indications

This drug is indicated for the temporary relief of various types of pain, including headache, menstrual pain, muscle pain, toothache, minor pain associated with arthritis, and 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 orally, with each dose accompanied by a full glass of water. For adults and children aged 12 years and older, the recommended dosage is 1 to 2 tablets every 4 hours as needed for symptom relief, not to 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

There are no contraindications associated with the use of this product. It is not classified as a controlled substance, and there are no known risks of abuse, misuse, or dependence.

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 may be early indicators of this rare but serious condition.

Aspirin may provoke severe allergic reactions, which can manifest as hives, asthma (wheezing), shock, or facial swelling. Healthcare professionals should be vigilant for these symptoms 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 are 60 years of age or older, have a history of stomach ulcers or bleeding disorders, are concurrently using blood-thinning medications or steroids, are taking other NSAIDs (either prescription or over-the-counter), exceed the recommended dosage or duration of use, or consume three or more alcoholic beverages daily while using this product.

Patients should refrain from using this product if they have a known allergy to any other pain reliever or fever reducer. Prior to use, it is advisable for patients to consult a healthcare provider if any of the following conditions apply: a history of stomach bleeding, existing stomach issues such as heartburn, high blood pressure, heart disease, liver cirrhosis, kidney disease, use of diuretics, or a diagnosis of asthma. Additionally, patients should seek guidance from a doctor or pharmacist if they are taking prescription medications for diabetes, gout, or arthritis, are on any other medications, or are under medical supervision for any serious health condition.

In the event of an overdose, immediate medical assistance should be sought, or contact with a Poison Control Center is recommended.

Patients should discontinue use and contact a healthcare professional if they experience any signs of stomach bleeding, which may include feeling faint, vomiting blood, passing bloody or black stools, experiencing persistent stomach pain, worsening pain lasting more than 10 days, a fever that worsens or lasts more than 3 days, redness or swelling in the painful area, the emergence of 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 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 may also cause severe allergic reactions in some patients. Symptoms of such reactions can include hives, asthma (wheezing), shock, and facial swelling. Patients with a known history of allergic reactions to any other pain reliever or fever reducer should not use this product.

The 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 (such as ibuprofen or naproxen), exceed the recommended dosage or duration of use, or consume three or more alcoholic drinks daily while using this product.

Patients should seek medical advice before using this product 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. Additionally, those taking diuretics or prescription medications for diabetes, gout, or arthritis should consult a healthcare professional prior to use.

Patients are advised 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, experiencing stomach pain that does not improve, or if pain worsens or persists for more than 10 days. Other concerning symptoms include a fever that worsens or lasts more than three days, redness or swelling in the painful area, the appearance of any new symptoms, or ringing in the ears or loss of hearing.

For pregnant or breastfeeding patients, it is crucial to seek advice from a healthcare professional before using this product. Aspirin should particularly 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

The concomitant use of anticoagulants or steroid medications may significantly elevate the risk of severe gastrointestinal bleeding. Healthcare professionals should exercise caution when prescribing these agents together.

Additionally, the use of nonsteroidal anti-inflammatory drugs (NSAIDs), including both prescription and over-the-counter options such as ibuprofen and naproxen, can further increase the likelihood of severe stomach bleeding. It is advisable for patients to consult with their healthcare provider prior to initiating NSAID therapy if they are concurrently using anticoagulants or steroids.

Patients taking prescription medications for diabetes, gout, or arthritis should seek guidance from a healthcare professional before starting any new medication. Furthermore, it is recommended that individuals consult with their doctor prior to using any other medications to ensure safety and efficacy.

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

Packaging & NDC

Below are the non-prescription pack sizes of Aspirin. 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 changes in behavior accompanied by nausea and vomiting occur while using this product, it is important 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 1-2 tablets every 4 hours as needed, not exceeding 12 tablets in a 24-hour period. For children under 12 years of age, it is advised to consult a doctor for appropriate dosing recommendations.

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 exercise caution when prescribing this medication to geriatric patients, especially if they have a history of gastrointestinal issues, including heartburn, or comorbid conditions such as high blood pressure, heart disease, liver cirrhosis, or kidney disease.

Before initiating treatment, healthcare providers should inquire about any relevant medical history that may heighten the risk of stomach bleeding in elderly patients. Close monitoring for signs of gastrointestinal bleeding is advised, and dosage adjustments may be necessary based on the individual patient's 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 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 specifically 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 may require careful consideration regarding dosing adjustments and monitoring. In individuals with reduced kidney function, particularly those with high blood pressure, heart disease, liver cirrhosis, or kidney disease, it is essential to assess renal function prior to initiating treatment. Regular monitoring of renal parameters is recommended to ensure safety and efficacy. Adjustments to the dosing regimen may be necessary based on the degree of renal impairment to mitigate the risk of adverse effects and optimize therapeutic outcomes.

Hepatic Impairment

Patients with hepatic impairment may experience altered pharmacokinetics of the drug 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 carefully, as these factors may further complicate the management of therapy in the context of hepatic impairment.

Overdosage

In the absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution when administering the medication. It is essential to monitor patients closely for any signs of adverse effects or symptoms that may arise from excessive dosing.

In the event of suspected overdosage, immediate medical attention should be sought. Healthcare providers should implement supportive measures as necessary, which may include symptomatic treatment and monitoring of vital signs.

Due to the lack of detailed overdosage information, it is recommended that healthcare professionals refer to established clinical guidelines and protocols for managing overdose situations relevant to the specific medication in question. Additionally, contacting a poison control center may provide further guidance on appropriate management strategies.

Continued vigilance and patient assessment are crucial in mitigating potential risks associated with overdosage.

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 indicated that aspirin may lead to severe allergic reactions, which can manifest as hives, asthma (wheezing), shock, and facial swelling. Additionally, reports have highlighted the potential for severe stomach bleeding associated with aspirin use, particularly in individuals aged 60 years or older, those with a history of stomach ulcers or bleeding problems, and patients concurrently using blood-thinning (anticoagulant) or steroid medications. The risk may also be elevated in individuals taking other nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen or naproxen, those who exceed the recommended dosage or duration of use, and individuals consuming three or more alcoholic beverages daily while using aspirin.

Furthermore, there have been reports of symptoms consistent with Reye’s syndrome in children and teenagers who have or are recovering from chickenpox or flu-like symptoms following aspirin use.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. It is crucial to emphasize the importance of safety in the home environment, particularly for households with young children.

In the event of an overdose, healthcare providers should instruct patients to seek medical help immediately or contact a Poison Control Center. Patients should be made aware of the signs of overdose and the urgency of obtaining assistance to ensure their safety and well-being.

Storage and Handling

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

For optimal storage, the product should be kept at a temperature range of 15-30 °C (59-86 °F). It is important to avoid exposure to excessive heat or humidity to maintain the integrity of the product. Proper handling and storage conditions are crucial to ensure the product's efficacy and safety.

Additional Clinical Information

The medication is administered orally, with the recommended dosage for adults and children aged 12 years and older being 1-2 tablets every 4 hours as needed, not exceeding 12 tablets in a 24-hour period. For children under 12 years, it is advised to consult a doctor for appropriate dosing.

Clinicians should counsel patients to seek professional advice if they are pregnant or breastfeeding prior to use. It is particularly crucial to avoid aspirin during the last trimester of pregnancy unless specifically directed by a healthcare provider, as it may pose risks to the fetus or lead to complications during delivery.

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)