Aspirin

Description

The product contains aspirin as the active ingredient, comparable to that found in ECOTRIN® Tablets. It is classified as a nonsteroidal anti-inflammatory drug (NSAID) and is indicated for pain relief. The formulation is available in a regular strength dosage form, packaged in a container of 300 tablets.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with various conditions, including headache, minor arthritis pain, toothache, menstrual pain, and colds. It may also be used as recommended by a healthcare professional.

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

Dosage and Administration

Adults and children 12 years of age and over are instructed to take 1 to 2 tablets every 4 hours as needed while symptoms persist. Each dose should be accompanied by a full glass of water to ensure proper hydration and absorption.

It is imperative that patients do not exceed 12 tablets within a 24-hour period unless specifically directed by a healthcare professional.

For children under 12 years of age, it is recommended to consult a doctor for appropriate dosing guidance.

Contraindications

Use is contraindicated in individuals with a history of allergic reactions to aspirin or any other pain reliever or fever reducer. Due to the potential for severe allergic responses, such patients should avoid this product.

Warnings and Precautions

Patients should be informed of the following warnings and precautions associated with the use of this product.

Warnings

Reye’s syndrome is a serious condition that can occur in children and teenagers who have or are recovering from chickenpox or flu-like symptoms. The use of this product in these populations is contraindicated. 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.

An allergy alert is warranted, as aspirin may induce severe allergic reactions. Symptoms may include hives, shock, facial swelling, and asthma (wheezing). Immediate medical attention should be sought if any of these symptoms occur.

This product contains a nonsteroidal anti-inflammatory drug (NSAID), which carries a risk of 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 (including aspirin, ibuprofen, or naproxen), consume three or more alcoholic beverages daily, or exceed the recommended dosage or duration of use.

General Precautions

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 diabetes, gout, or arthritis.

Emergency Medical Help

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

Discontinuation of Use

Patients are advised to discontinue use and contact a healthcare professional if they experience any signs of an allergic reaction or any of the following symptoms indicative of potential stomach bleeding: feeling faint, vomiting blood, having bloody or black stools, experiencing persistent stomach pain, or if pain worsens or lasts longer than 10 days. Additionally, any new symptoms, redness or swelling, or symptoms such as ringing in the ears or loss of hearing should prompt immediate medical consultation, as these may signify a serious condition.

Side Effects

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

Reye’s syndrome is a rare but serious illness that may occur in children and teenagers who have or are recovering from chicken pox or flu-like symptoms. It is crucial for these individuals to avoid using this product. If patients exhibit changes in behavior accompanied by nausea and vomiting while using this product, they should consult a healthcare professional immediately, as these symptoms could indicate the onset of Reye’s syndrome.

Aspirin, the active ingredient in this product, may also provoke severe allergic reactions in some patients. Symptoms of such reactions can include hives, shock, facial swelling, and asthma (wheezing). Patients experiencing any signs of an allergic reaction should seek medical attention promptly.

Additionally, this product contains a nonsteroidal anti-inflammatory drug (NSAID), which carries a risk of 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 anticoagulants or steroid medications, consume three or more alcoholic drinks daily while using this product, or exceed the recommended dosage or duration of 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, or experiencing persistent stomach pain that worsens or lasts more than 10 days. Other concerning symptoms include the presence of redness or swelling, the appearance of any new symptoms, or experiencing ringing in the ears or loss of hearing.

Before using this product, patients should seek medical advice 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. It is also recommended that patients taking diuretics or prescription medications for diabetes, gout, or arthritis consult with a healthcare professional prior to use.

Drug Interactions

Aspirin has been identified to interact with various drug classes, particularly anticoagulants and corticosteroids, leading to an increased risk of gastrointestinal bleeding. This risk is further amplified when aspirin is co-administered with other nonsteroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen or naproxen.

Healthcare professionals are advised to exercise caution and consider monitoring patients closely for signs of gastrointestinal bleeding when aspirin is prescribed alongside these medications. Additionally, patients taking prescription medications for diabetes, gout, or arthritis should consult their healthcare provider prior to initiating aspirin therapy to ensure safe and effective use.

No specific interactions with laboratory tests have been reported 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 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, a rare but serious illness. If any changes in behavior accompanied by nausea and vomiting occur while using this product, a healthcare professional should be consulted, as these may be early signs of Reye’s syndrome.

For dosing, adults and children aged 12 years and older are directed to take 1 to 2 tablets every 4 hours while symptoms persist. For children under 12 years of age, it is advised to consult a doctor before use.

Geriatric Use

Elderly patients, particularly those aged 60 years and older, may have an increased risk of stomach bleeding. Healthcare providers should exercise caution when prescribing this medication to geriatric patients, considering the potential for heightened adverse effects.

It is advisable to monitor these patients closely for any signs of gastrointestinal bleeding and to evaluate the necessity of dosage adjustments based on individual patient factors. Careful assessment of the risk-benefit ratio is essential in this population to ensure safe and effective use of the 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 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 its use in lactating individuals.

Renal Impairment

Patients with renal impairment have no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the text. Therefore, healthcare professionals should exercise caution and consider individual patient factors when prescribing to this population. Regular assessment of renal function may be warranted to ensure safe and effective use of the medication in patients with reduced kidney function.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there are no established dosage adjustments, special monitoring requirements, or precautions outlined for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population. Regular monitoring of liver function may be prudent in these cases, although specific parameters are not defined in the available information.

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 initiate supportive care, which may include maintaining airway patency, ensuring adequate ventilation, and monitoring vital signs.

If available, the use of specific antidotes or treatments should be considered based on the substance involved and the clinical presentation. Consultation with a poison control center or a medical toxicologist may provide additional guidance on the management of overdose cases.

Documentation of the incident, including the substance, amount ingested, and time of ingestion, is crucial for effective management and treatment planning.

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 the product. Reports have included allergic reactions, such as hives, shock, and facial swelling. Additionally, instances of stomach bleeding have been noted, particularly in individuals over 60 years of age, those with a history of stomach ulcers or bleeding problems, and patients taking anticoagulants or other nonsteroidal anti-inflammatory drugs (NSAIDs). Symptoms indicative of stomach bleeding may include feeling faint, vomiting blood, having bloody or black stools, and experiencing persistent stomach pain.

Furthermore, cases of tinnitus (ringing in the ears) and loss of hearing have also been reported. It is advised that individuals seek medical assistance immediately if any of these symptoms occur.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center at 1(800)222-1222 in the event of an overdose. It is crucial to inform patients that they should not use this medication if they have a history of allergic reactions to aspirin or any other pain reliever or fever reducer.

Patients should be instructed to discontinue use and consult a doctor if they experience any signs of an allergic reaction or any of the following symptoms indicative of stomach bleeding: 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. Additionally, they should seek medical attention if redness or swelling occurs, any new symptoms appear, or if they experience ringing in the ears or a loss of hearing.

Healthcare providers should encourage patients to consult a doctor before using this medication 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, as well as those taking diuretics or who have asthma, should also be advised to seek medical guidance prior to use.

Furthermore, patients taking prescription medications for diabetes, gout, or arthritis should be encouraged to discuss their current medications with a doctor or pharmacist before starting this treatment.

Storage and Handling

The product is supplied with a tamperevident feature; it should not be used if the printed inner seal beneath the cap is missing or broken.

Storage conditions require that the product be kept below 25°C (77°F) to maintain its integrity and efficacy. Proper handling is essential to ensure the product remains safe for use.

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 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.

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)