Aspirin

Description

This product is available in two National Drug Code (NDC) configurations: 17714-010-01, which contains 100 tablets, and 17714-010-03, which contains 300 tablets. Each tablet is formulated to deliver the specified active ingredients in a precise dosage form, ensuring consistent therapeutic efficacy. The appearance and specific characteristics of the tablets are designed to meet professional standards for pharmaceutical products.

Uses and Indications

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

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, with a maximum limit of 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 listed for this product. However, in the event of an overdose, it is imperative to seek medical assistance or contact a Poison Control Center immediately.

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 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 signs of Reye’s syndrome.

Aspirin may induce severe allergic reactions, which can manifest as hives, asthma (wheezing), shock, or facial swelling. Individuals with a known allergy to any other pain reliever or fever reducer should refrain from using this product.

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 (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.

Healthcare professionals should advise patients to seek medical consultation 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, patients taking diuretics or those with asthma should also consult a healthcare provider prior to use. It is recommended that patients inform their doctor or pharmacist if they are taking prescription medications for diabetes, gout, or arthritis, or any other drugs, or if they are under medical care for any serious condition.

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

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, 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, consultation with a healthcare professional is essential before use. It is particularly critical 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.

Side Effects

Patients using this product should be aware of several serious 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 may be early signs of Reye’s syndrome.

Aspirin may also cause severe allergic reactions in some patients, 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 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 (either prescription or nonprescription), exceed the recommended dosage or duration of use, or consume three or more alcoholic drinks daily while using this product.

Patients are advised to 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 should 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 worsens or lasts 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 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

The concomitant use of anticoagulants or steroid medications may elevate the risk of severe gastrointestinal bleeding. Healthcare professionals should exercise caution when prescribing these agents together, and patients should be monitored for signs of gastrointestinal distress.

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 risk of severe stomach bleeding when taken alongside anticoagulants or steroids. It is advisable for patients to consult with their healthcare provider prior to initiating NSAID therapy if they are already on anticoagulant or steroid treatment.

Patients taking prescription medications for diabetes, gout, or arthritis should seek guidance from a healthcare professional before using this medication. Furthermore, it is recommended that individuals consult their doctor before using this medication if they are on any other prescription drugs 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 stomach problems, high blood pressure, heart disease, liver cirrhosis, or kidney disease.

Before initiating treatment, healthcare providers should inquire about the presence of any of these conditions in elderly patients, as they may necessitate a more thorough evaluation or consideration of alternative therapies. Monitoring for signs of gastrointestinal bleeding is advised in this population to ensure patient safety and to mitigate potential complications.

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 explicitly 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 mothers.

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 avoid potential adverse effects and to 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 a history of high blood pressure, heart disease, or kidney disease should be evaluated for potential interactions and contraindications related to their hepatic condition. It is crucial to tailor treatment plans based on the severity of hepatic impairment to optimize outcomes while minimizing risks.

Overdosage

In the absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdose.

It is essential to monitor the patient closely for any potential symptoms that may arise from an overdose. Symptoms can vary widely depending on the substance involved and the individual patient's response.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should implement supportive care measures, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

Additionally, it is recommended to consult local poison control centers or relevant toxicology resources for guidance on specific management protocols and antidotes, if applicable.

Documentation of the incident, including the substance involved, estimated dose, and time of exposure, is crucial for effective management and follow-up care.

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 details 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 aspirin. Reports indicate that gastrointestinal bleeding may occur, particularly in patients with a history of ulcers or those concurrently using anticoagulants. Allergic reactions, including cases of anaphylaxis, have also been documented in some patients. Additionally, renal impairment has been observed, especially in individuals with pre-existing kidney conditions or dehydration.

Other adverse reactions reported include tinnitus and hearing loss, which appear to be more prevalent with high doses or prolonged use of aspirin. These events have been reported voluntarily or through surveillance programs, contributing to the overall understanding of the safety profile of aspirin.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental ingestion. It is important to emphasize the potential risks associated with overdose. Patients should be instructed to seek medical help or contact a Poison Control Center immediately in the event of an overdose. This information is crucial for ensuring patient safety and promoting responsible use of the medication.

Storage and Handling

The product is supplied in a configuration that ensures tamper evidence; it should not be used if the imprinted safety seal under the cap is broken or missing.

For optimal storage, the product must be kept at a temperature range of 15-30 °C (59-86 °F). It is essential to avoid exposure to excessive heat or humidity to maintain product integrity.

Additional Clinical Information

The medication is administered orally. 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 specifically 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)