Aspirin

Description

This product is available in tablet form, with the following National Drug Codes (NDC): 54738-559-12 for a bottle containing 120 tablets, 54738-559-25 for a bottle containing 240 tablets, and 54738-559-03 for a bulk supply of 1000 tablets. Each tablet is formulated to deliver the specified active ingredients in a consistent dosage. The appearance and specific characteristics of the tablets are defined by the formulation standards.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains. It is essential for patients to consult their healthcare provider for any additional uses beyond this indication. The use of this drug should not exceed 10 days without prior consultation with a healthcare professional, as serious side effects may occur with prolonged use.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

Patients should take the medication orally, ensuring to drink a full glass of water with each dose. For adults and children aged 12 years and older, the recommended dosage is 4 to 8 tablets every 4 hours as needed while symptoms persist, with a maximum limit of 48 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 deemed safe for use in the absence of specific conditions or situations that would warrant avoidance.

Warnings and Precautions

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 imperative to consult a healthcare professional immediately, as these may be early signs of this condition.

Aspirin may induce 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 problems, are taking anticoagulants or steroid medications, are using other NSAIDs (such as ibuprofen or naproxen), 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 problems (such as heartburn), high blood pressure, heart disease, liver cirrhosis, kidney disease, use of diuretics, or 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 care for any serious condition.

In the event of an overdose, immediate medical assistance should be sought, or a Poison Control Center should be contacted without delay.

Patients are advised to discontinue use and consult a healthcare professional if they experience any signs of stomach bleeding, which may include feeling faint, vomiting blood, having bloody or black stools, experiencing persistent stomach pain, or if pain worsens or lasts longer than 10 days. Additionally, if fever worsens or lasts more than three days, if redness or swelling occurs in the painful area, if any new symptoms arise, or if there is ringing in the ears or loss of hearing, medical advice should be sought.

For pregnant or breastfeeding individuals, it is crucial 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 physician, as it may pose risks to the unborn child or lead to complications during delivery.

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 can occur in children and teenagers who have or are recovering from chickenpox or flu-like symptoms. Patients should not use this product if they fall into this category. If any changes in behavior accompanied by nausea and vomiting occur while using this product, it is crucial 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, asthma (wheezing), shock, or facial swelling. Patients with a 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 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 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 seek medical attention 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 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 essential to consult a healthcare professional before using this product. Special caution is advised during the last three months of pregnancy, as aspirin 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 alongside the drug in question.

Additionally, the concurrent administration of nonsteroidal anti-inflammatory drugs (NSAIDs), including both prescription and over-the-counter options such as ibuprofen and naproxen, is associated with an increased likelihood of severe stomach bleeding. It is advisable for patients to consult with their healthcare provider prior to initiating therapy with this drug if they are currently using any NSAIDs.

Patients taking prescription medications for diabetes, gout, or arthritis should also seek guidance from a healthcare professional before using this drug. This recommendation extends to any other medications the patient may be taking, emphasizing the importance of thorough medication reconciliation to mitigate potential interactions.

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

Pediatric patients, particularly those 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, a rare but serious illness. If any changes in behavior accompanied by nausea and vomiting occur while using this product, a doctor should be consulted immediately, as these may be early signs of Reye’s syndrome.

For adolescents aged 12 years and older, the recommended dosage is 4 to 8 tablets every 4 hours as needed, not to exceed 48 tablets in a 24-hour period.

Geriatric Use

Elderly patients, particularly those aged 60 years 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 stomach problems, 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 gastrointestinal complications. Close monitoring of these patients is advised to ensure safety and to mitigate potential adverse effects associated with the use of this medication.

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 the unborn child 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 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 may experience altered pharmacokinetics of the drug. It is essential to assess liver function prior to initiating treatment and to monitor liver parameters throughout the course of therapy.

In patients with significant 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 hepatic impairment should be evaluated for the presence of comorbid conditions such as high blood pressure, heart disease, or kidney disease, as these may further complicate treatment and necessitate additional precautions.

Overdosage

In the absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution and consider general principles of management for suspected cases of drug overdosage.

Recommended Actions In the event of an overdosage, it is essential to assess the patient's clinical status promptly. Healthcare providers should initiate supportive care and monitor vital signs closely. The management of overdosage may include the following steps:

1. Assessment: Evaluate the patient's symptoms and history of exposure to the drug.

2. Supportive Care: Provide symptomatic treatment as necessary, which may include intravenous fluids, oxygen supplementation, or other interventions based on the patient's condition.

3. Consultation: Engage with a poison control center or a medical toxicologist for guidance on specific management strategies tailored to the drug involved.

Potential Symptoms While specific symptoms of overdosage are not detailed, healthcare professionals should remain vigilant for signs of toxicity that may arise from excessive dosing of any medication. Symptoms can vary widely depending on the pharmacological properties of the drug and may include, but are not limited to, neurological, cardiovascular, or gastrointestinal manifestations.

In summary, due to the lack of specific overdosage information, healthcare professionals should rely on established protocols for managing suspected overdosage cases, ensuring that patient safety remains the top priority.

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 revealed that aspirin may lead to severe allergic reactions, which can manifest as hives, asthma (wheezing), shock, and facial swelling. Additionally, there have been reports indicating that aspirin may be associated with severe stomach bleeding, particularly in certain populations. The risk of stomach bleeding is heightened in individuals who are 60 years of age or older, those with a history of stomach ulcers or bleeding problems, and patients concurrently using blood-thinning (anticoagulant) or steroid medications. Furthermore, the risk increases for individuals taking other nonsteroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen or naproxen, or for those who exceed the recommended dosage or duration of use. Consumption of three or more alcoholic drinks daily while using aspirin may also elevate the risk of stomach bleeding.

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 ensures tamper evidence. It is essential to inspect the safety seal under the cap; the product should not be used if the seal is broken or missing.

For optimal storage, the product must be maintained at a temperature range of 15-30 °C (59-86 °F). Proper handling and storage conditions are crucial to ensure the integrity and efficacy of the product.

Additional Clinical Information

The route of administration for the medication is oral. Clinicians should advise patients who are pregnant or breastfeeding to consult a health 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 additional information is available regarding laboratory tests, abuse potential, or postmarketing experience.

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)