Aspirin

Description

No description information is available for the specified drug.

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 formulation, this product is not intended for the rapid alleviation of headaches or other symptoms requiring immediate relief.

Limitations of Use: There are no known 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 caplets every 4 hours as needed. It is imperative that the total daily dosage does not exceed 48 caplets within a 24-hour period unless specifically directed by a healthcare professional.

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

Contraindications

Use of this product is contraindicated in individuals with a known allergy to aspirin or any other pain reliever or fever reducer. Additionally, it should not be administered to patients who have a history of allergic reactions to this product or any of its components.

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 hives, shock, facial swelling, and asthma-related wheezing. Immediate medical attention is required if an allergic reaction occurs.

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 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.

Healthcare professionals should advise patients to consult a physician prior to using this product if any of the following conditions apply: a history of stomach problems such as heartburn, high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or if they are currently taking a diuretic. Additionally, patients should seek guidance from a doctor or pharmacist if they are on prescription medications for gout, diabetes, or arthritis.

Patients must be instructed to seek emergency medical assistance if they experience any signs of an allergic reaction. Furthermore, they should discontinue use and contact their healthcare provider if they notice any symptoms indicative of stomach bleeding, such as vomiting blood, passing bloody or black stools, feeling faint, experiencing persistent stomach pain, or if they develop ringing in the ears or hearing loss. Other concerning signs include worsening pain lasting more than 10 days, fever persisting beyond three days, redness or swelling, or the emergence of new symptoms, as these may signal a serious underlying condition.

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 symptoms could indicate the onset of Reye's syndrome.

Additionally, there is an allergy alert associated with this product. Aspirin may cause severe allergic reactions, which can manifest as hives, shock, facial swelling, or asthma symptoms such as wheezing. Patients experiencing any signs of an allergic reaction should seek medical attention promptly.

This 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 anticoagulants or steroid medications, are using other NSAIDs (including aspirin, ibuprofen, or naproxen), consume three or more alcoholic drinks daily while using this product, or exceed the recommended dosage or duration of use.

Patients are advised to stop using the product and consult a doctor if they experience any signs of stomach bleeding, which may include vomiting blood, having bloody or black stools, feeling faint, or experiencing persistent stomach pain. Other symptoms that warrant medical attention include ringing in the ears or loss of hearing, worsening pain that lasts more than 10 days, fever that worsens or lasts more than 3 days, redness or swelling, or the emergence of new symptoms, as these could indicate a serious condition.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there is no information available regarding interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Aspirin Delayed Release 81mg. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Children and teenagers who have or are recovering from chickenpox or flu-like symptoms should not use this product due to the risk of Reye's syndrome, a rare but serious illness. If pediatric patients experience changes in behavior accompanied by nausea and vomiting while using this product, it is important to consult a doctor, as these symptoms may indicate the onset of Reye's syndrome.

For dosing, adults and children aged 12 years and older are directed to take 4 to 8 caplets every 4 hours, with a maximum of 48 caplets in a 24-hour period unless otherwise directed by a healthcare professional. For children under 12 years of age, it is advised to consult a doctor 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 exercise caution when prescribing medications that may exacerbate this risk in this population.

Before initiating treatment, healthcare providers should inquire about the patient's history of stomach problems, including but not limited to heartburn, high blood pressure, heart disease, liver cirrhosis, or kidney disease. If any of these conditions are present, a thorough evaluation and discussion regarding the potential risks and benefits of the medication should be conducted.

Monitoring for signs of gastrointestinal bleeding is advised in geriatric patients, especially those with pre-existing conditions that may heighten their susceptibility. Adjustments to dosage or alternative therapeutic options may be necessary based on individual patient assessments.

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 if they are pregnant or breastfeeding. 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.

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 dosing 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 medication 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 hepatic impairment. It is advisable to consult with a healthcare professional to determine the most appropriate treatment plan for patients with these comorbidities.

Overdosage

In the event of an overdosage, it is imperative to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222. Prompt medical attention is crucial for both adults and children, even in the absence of noticeable signs or symptoms.

Healthcare professionals should be aware that the lack of immediate symptoms does not preclude the potential for serious health consequences. Therefore, it is essential to monitor the patient closely and provide supportive care as necessary.

Management of overdosage may involve symptomatic treatment and supportive measures tailored to the specific circumstances of the patient. Continuous assessment and intervention may be required to address any emerging complications.

Nonclinical Toxicology

It is especially important not to use aspirin during the last three months of pregnancy unless definitely directed to do so by a doctor, as it may cause problems in the unborn child or complications during delivery. No relevant information regarding non-teratogenic effects, nonclinical toxicology, or animal pharmacology and toxicology has been extracted.

Postmarketing Experience

No specific postmarketing experience details have been reported in the available data. As such, there are no additional adverse events or rare case reports to summarize at this time.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. Patients should be informed not to use the product if they have a known allergy to aspirin or any other pain reliever or fever reducer. It is crucial to emphasize that individuals with a history of allergic reactions to this product or any of its ingredients should also refrain from use.

Patients should be instructed to stop using the medication and seek medical attention immediately if they experience any signs of an allergic reaction. Additionally, they should be made aware of the symptoms indicative of stomach bleeding, which include vomiting blood, having bloody or black stools, feeling faint, or experiencing persistent stomach pain. If any of these symptoms occur, patients should be advised to contact their healthcare provider.

Healthcare providers should also inform patients to discontinue use and consult a doctor if they experience ringing in the ears, a loss of hearing, worsening pain that lasts more than 10 days, or a fever that persists beyond 3 days. Patients should be cautioned to seek medical advice if they notice any redness or swelling or if new symptoms arise, as these may indicate a serious condition.

Before initiating treatment, patients should be encouraged to consult their healthcare provider if they have a history of stomach problems, such as heartburn, or if the stomach bleeding warning applies to them. It is also important to discuss any existing conditions, including high blood pressure, heart disease, liver cirrhosis, or kidney disease, as well as asthma. Patients taking diuretics or prescription medications for gout, diabetes, or arthritis should be advised to consult their doctor or pharmacist prior to use.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It should be stored at room temperature, within the range of 15-30°C (59-86°F). Care should be taken to ensure that the product is kept in a suitable container to maintain its integrity. No special handling requirements are noted; however, standard precautions should be observed to ensure optimal storage conditions.

Additional Clinical Information

The product is administered orally. Clinicians should advise patients to consult with their doctor or healthcare provider prior to using this product for heart-related conditions. No further information is available regarding laboratory tests, abuse potential, or postmarketing experiences.

Drug Information (PDF)

This file contains official product information for Aspirin Delayed Release 81mg, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

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