Aspirin

Description

Aspirin Delayed Release Tablets, USP contain 81 mg of aspirin per tablet. These tablets are formulated for delayed release, allowing for a gradual release of the active ingredient. Aspirin, chemically known as acetylsalicylic acid, is a nonsteroidal anti-inflammatory drug (NSAID) used for its analgesic, antipyretic, and anti-inflammatory properties. The tablets are designed to provide a specific dosage form that facilitates the management of various conditions as directed by healthcare professionals.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains, as well as for use as recommended by a healthcare professional. Due to its delayed release action, this product is not suitable for the immediate relief of headaches or other symptoms requiring prompt alleviation.

Limitations of Use: 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 4 to 8 tablets every 4 hours. The total daily dosage must not exceed 48 tablets within a 24-hour period unless otherwise directed by a healthcare professional.

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.

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 Reye's syndrome, a rare but serious condition.

Aspirin may provoke severe allergic reactions in some individuals. Symptoms of such reactions can include facial swelling, asthma (wheezing), shock, and hives. Healthcare professionals should be vigilant for these signs and advise patients to seek immediate medical attention if they occur.

Before initiating treatment, it is essential for patients to consult their 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, or asthma. Additionally, patients taking diuretics or prescription medications for gout, diabetes, or arthritis should also seek guidance from their doctor or pharmacist prior to use.

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

Patients are advised to discontinue use and contact their healthcare provider if they experience any signs of an allergic reaction or any of the following symptoms indicative of stomach bleeding: feeling faint, vomiting blood, passing bloody or black stools, experiencing persistent stomach pain, or if pain worsens or lasts longer than 10 days. Furthermore, any new symptoms, redness or swelling, or occurrences of ringing in the ears or loss of hearing should prompt immediate consultation with a healthcare professional.

Side Effects

Patients using this product should be aware of several serious and common adverse reactions.

Warnings 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. These individuals should 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 may indicate the onset of Reye's syndrome.

Additionally, an allergy alert is warranted, as aspirin may cause severe allergic reactions. Symptoms of such reactions can include facial swelling, asthma (wheezing), shock, and hives. Patients should stop using the product and seek medical assistance if any signs of an allergic reaction occur.

Stop Use and Consult a Doctor Patients are advised to discontinue use and consult a doctor if they experience any signs of stomach bleeding, which may manifest as feeling faint, vomiting blood, having bloody or black stools, or experiencing stomach pain that does not improve. Other concerning symptoms include worsening pain lasting more than 10 days, the presence of redness or swelling, the emergence of new symptoms, or ringing in the ears or loss of hearing.

Precautions Before using this product, patients should consult their doctor if they have a history of stomach problems, such as heartburn, or if they have high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma. Additionally, patients taking diuretics or prescription medications for gout, diabetes, or arthritis should seek advice from their doctor or pharmacist prior to use.

Drug Interactions

Aspirin has the potential to cause severe gastrointestinal bleeding, particularly when co-administered with anticoagulants or other nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen or naproxen. This interaction necessitates careful consideration of the concomitant use of these medications.

In patients who are prescribed medications for gout, diabetes, or arthritis, it is advisable to consult a healthcare professional prior to initiating aspirin therapy. This is to ensure that any potential interactions are adequately managed and to determine the appropriateness of dosage adjustments or enhanced monitoring based on the individual patient's medication regimen.

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, 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 over may take 4 to 8 tablets every 4 hours, not exceeding 48 tablets in a 24-hour period unless directed by a doctor. For children under 12 years of age, consultation with a healthcare professional is advised before use.

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 assess this risk when considering treatment options for geriatric patients. Patients should be advised to consult their physician prior to use if they fall within this age group and if the stomach bleeding warning is applicable.

In addition to age-related risks, safety considerations for elderly patients include a history of gastrointestinal issues, such as heartburn, as well as comorbid conditions like high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma. These factors are particularly relevant in the geriatric population and warrant careful evaluation and monitoring during treatment.

Healthcare providers should remain vigilant in assessing the overall health status of elderly patients and consider appropriate dose modifications or alternative therapies as necessary to mitigate potential risks.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional before using this medication. It is particularly important to avoid the use of aspirin during the last trimester of pregnancy unless specifically directed by a physician, as it may pose risks to the developing fetus and lead to complications during delivery. Healthcare providers should carefully evaluate the potential benefits and risks when considering the use of this medication in pregnant patients.

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 the use of this medication while breastfeeding.

Renal Impairment

There is no specific information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in this patient population.

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 amount and timing of the substance taken, is crucial for effective treatment and follow-up care.

Nonclinical Toxicology

It is especially important not to use aspirin during the last three months of pregnancy unless directed to do so by a doctor, as it may cause problems in the unborn child or complications 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 identified several adverse reactions associated with the use of the product. Reports indicate occurrences of gastrointestinal bleeding, particularly in patients with a history of ulcers or those concurrently using anticoagulants. Additionally, allergic reactions, including cases of anaphylaxis, have been documented. Other serious side effects reported include liver damage and renal impairment. These events have been reported voluntarily or through surveillance programs, contributing to the ongoing assessment of the product's safety profile.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children and to seek immediate medical assistance or contact a Poison Control Center in the event of an overdose.

Patients should be informed not to use the medication if they have a known allergy to aspirin or any other pain reliever or fever reducer. They should be instructed to stop use and consult a doctor if they experience any signs of an allergic reaction, and to seek medical help right away in such cases.

It is important for patients to be aware of the signs of stomach bleeding and to discontinue use and consult a doctor if they experience any of the following: feeling faint, vomiting blood, having bloody or black stools, experiencing stomach pain that does not improve, having pain that worsens or lasts more than 10 days, noticing redness or swelling, developing new symptoms, or experiencing ringing in the ears or loss of hearing.

Healthcare providers should encourage patients to ask their doctor before use if the warning regarding stomach bleeding applies to them, especially if they have a history of stomach problems such as heartburn. Additionally, patients should be advised to consult their doctor before use if they have high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma.

Patients taking a diuretic should also be encouraged to seek medical advice before using the medication. Furthermore, it is recommended that patients consult their doctor or pharmacist if they are taking a prescription drug for gout, diabetes, or arthritis.

Storage and Handling

This product is supplied in a configuration that includes a printed safety seal under the cap. It is essential to inspect this seal prior to use; the product should not be utilized if the seal is torn or missing.

For optimal storage, the product should be kept at room temperature. Care should be taken to ensure that the storage environment maintains this temperature range to preserve the integrity of the product.

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)