Aspirin

Description

No description information is available for the drug.

Uses and Indications

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

Healthcare professionals are encouraged to inquire about additional uses for Safety Coated 81 mg Aspirin.

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

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 should 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 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 used in patients who have previously experienced an allergic reaction to this product or any of its ingredients.

In the event of an allergic reaction, immediate medical attention is required. Discontinue use and seek medical help if any signs of stomach bleeding occur, including feeling faint, bloody or black stools, vomiting blood, persistent stomach pain, worsening pain lasting more than 10 days, fever lasting more than 3 days, presence of redness or swelling, new symptoms, or symptoms such as ringing in the ears or loss of hearing.

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, 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, as these may be early signs of Reye's syndrome.

Aspirin may induce severe allergic reactions, which can manifest as hives, facial swelling, shock, or asthma symptoms such as wheezing. Healthcare professionals should be vigilant for these signs and advise patients to seek immediate medical attention if they experience any allergic reactions.

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 while using this product, or exceed the recommended dosage or duration of use.

General precautions should be taken for patients with a history of stomach problems, such as heartburn, as well as those with high blood pressure, heart disease, liver cirrhosis, or kidney disease. Patients on diuretics or those with asthma should also exercise caution when using this product.

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

Patients should be advised to discontinue use and contact their healthcare provider if they experience any signs of an allergic reaction or symptoms indicative of stomach bleeding. These symptoms include feeling faint, having bloody or black stools, vomiting blood, 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, if new symptoms arise, or if there is ringing in the ears or loss of hearing, medical attention should be sought promptly.

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 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 experience 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, a component of this product, may cause severe allergic reactions in some patients. Symptoms of such reactions can include hives, facial swelling, shock, and asthma (wheezing). Patients with a known allergy to aspirin should avoid this product.

This product contains a nonsteroidal anti-inflammatory drug (NSAID), which carries a warning for the potential of severe stomach bleeding. The risk of stomach bleeding is heightened 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, or use other medications containing NSAIDs (such as aspirin, ibuprofen, or naproxen). Additionally, patients who take this product for longer than directed or in higher doses than recommended are at increased risk.

Patients should seek immediate medical attention if they experience any signs of stomach bleeding, which may include feeling faint, having bloody or black stools, vomiting blood, 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, the presence of redness or swelling, the occurrence of new symptoms, or any ringing in the ears or loss of hearing.

Additional considerations for patients include a history of stomach problems such as heartburn, high blood pressure, heart disease, liver cirrhosis, kidney disease, or if they are taking diuretics. Patients with asthma, gout, diabetes, or arthritis should also exercise caution when using this product.

Drug Interactions

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

Packaging & NDC

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

Pediatric Use

Pediatric patients who have or are 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, a healthcare professional should be consulted, as these may be early signs of Reye's syndrome, a rare but serious condition.

For children under 12 years of age, it is advised to consult a doctor before use. For adolescents and adults aged 12 years and older, the recommended dosage is 4 to 8 tablets every 4 hours, with a maximum of 48 tablets in a 24-hour period unless otherwise directed by a healthcare provider.

Geriatric Use

Elderly patients, particularly those aged 60 and older, are at an increased risk of severe stomach bleeding when using this product, which contains a nonsteroidal anti-inflammatory drug (NSAID). This risk is further heightened in individuals with pre-existing conditions such as high blood pressure, heart disease, liver cirrhosis, or kidney disease.

Healthcare providers should exercise caution when prescribing this medication to geriatric patients, ensuring that they are closely monitored for any signs of gastrointestinal bleeding. It is advisable to consider alternative therapies or implement dose modifications based on the individual patient's health status and risk factors. Regular assessment of the patient's overall health and medication regimen is recommended to mitigate potential adverse effects associated with NSAID use in this population.

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 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 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 patients with reduced kidney function. Regular monitoring of renal function may be warranted in these patients, although specific guidelines are not outlined.

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 overdosage information, it is essential for healthcare professionals to remain vigilant regarding the potential for overdose with this medication. In cases where an overdose is suspected, immediate medical attention should be sought.

Healthcare providers are advised to monitor patients closely for any signs or symptoms that may arise from an overdose. Common symptoms may include, but are not limited to, severe drowsiness, confusion, respiratory distress, or any unusual physiological changes.

Management of an overdose should be tailored to the individual patient and may involve supportive care, including monitoring vital signs and providing symptomatic treatment as necessary. In cases of significant overdose, consultation with a poison control center or toxicology specialist is recommended to determine the most appropriate course of action.

It is crucial for healthcare professionals to educate patients about the importance of adhering to prescribed dosages and to provide guidance on what to do in the event of a suspected overdose.

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

No specific postmarketing experience details are available in the insert text. As such, there are no additional adverse events or rare case reports to summarize.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center in the event of an overdose. It is important to discuss any known allergies, particularly to aspirin or other pain relievers and fever reducers, as well as any previous allergic reactions to this product or its ingredients.

Patients should be informed to recognize the signs of an allergic reaction and to seek medical help promptly if such symptoms occur. Additionally, healthcare providers should instruct patients to be vigilant for signs of stomach bleeding, which may include feeling faint, experiencing bloody or black stools, vomiting blood, or having persistent stomach pain that does not improve. Patients should also be made aware that if their pain worsens or lasts more than 10 days, or if a fever persists or worsens beyond three days, they should seek medical attention. Any redness or swelling, the emergence of new symptoms, or symptoms such as ringing in the ears or loss of hearing should also prompt immediate consultation with a healthcare professional.

It is crucial to assess the patient's medical history, particularly for those with a history of stomach problems, such as heartburn, or conditions like high blood pressure, heart disease, liver cirrhosis, or kidney disease. Patients taking diuretics, those with asthma, gout, diabetes, or arthritis should be counseled on the specific risks associated with their conditions in relation to this product.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at room temperature, ensuring that it is kept away from excessive heat, particularly temperatures exceeding 40°C (104°F). Proper storage conditions are crucial to maintain the integrity and efficacy of the product.

Additional Clinical Information

The medication is administered orally, with specific dosing guidelines for different age groups. Adults and children aged 12 years and older are advised to take 4 to 8 tablets every 4 hours, not exceeding 48 tablets in a 24-hour period unless directed otherwise by a healthcare professional. For children under 12 years, consultation with a doctor is recommended prior to use.

Clinicians should counsel patients on the importance of consulting a healthcare professional if they are pregnant or breastfeeding. 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. Patients are also advised to drink a full glass of water with each dose.

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)