Aspirin

Description

The product is identified by the National Drug Code (NDC) 49638-481-36. Further details regarding its chemical composition, dosage form, and inactive ingredients are not provided in the extracted facts.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains. It is essential for patients to consult their healthcare provider for any additional uses. The use of this drug should not exceed 10 days without medical consultation, as serious side effects may occur with prolonged 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 of this product is contraindicated in individuals with a known allergy to aspirin or any other pain reliever or fever reducer.

Additionally, the product should not be used if the safety seal under the cap is torn or missing, as this may indicate tampering or contamination.

Due to the variability in individual health conditions, it is recommended that patients consult with their healthcare provider prior to initiating an aspirin regimen to ensure its appropriateness for their specific medical circumstances.

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 is not suitable for everyone; therefore, it is essential for patients to discuss their medical history and any potential contraindications with their healthcare provider before initiating an aspirin regimen.

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 consult a physician if they experience any signs of an allergic reaction, which requires urgent medical attention. Additionally, the following symptoms warrant immediate medical consultation due to the potential for serious complications such as 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. Other concerning signs include the presence of redness or swelling, a fever that worsens or persists beyond three days, the emergence of new symptoms, or any ringing in the ears or loss of hearing.

Side Effects

Patients should be aware of the potential for serious adverse reactions associated with this product. Notably, 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. It is crucial that these individuals do 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 could indicate the onset of Reye's syndrome.

In addition to the serious risks, patients should discontinue use and seek medical attention if they experience any signs of an allergic reaction. Immediate medical help is warranted in such cases. Furthermore, patients should be vigilant for signs of stomach bleeding, which may manifest as feeling faint, vomiting blood, or having bloody or black stools. Other concerning symptoms include persistent stomach pain that does not improve, worsening pain lasting more than 10 days, redness or swelling, fever that worsens or lasts more than 3 days, the emergence of new symptoms, or any ringing in the ears or loss of hearing. These symptoms necessitate prompt medical evaluation to ensure patient safety.

Drug Interactions

Aspirin has the potential to cause severe gastrointestinal bleeding, particularly when co-administered with anticoagulant medications. This interaction necessitates careful consideration and monitoring of patients who are prescribed blood thinners, as the risk of bleeding complications may be significantly elevated.

Additionally, patients taking prescription medications for diabetes, gout, or arthritis should consult a healthcare professional prior to initiating aspirin therapy. This is crucial to ensure that any potential interactions or contraindications are adequately addressed.

The risk of stomach bleeding is further increased in patients who are concurrently using other non-steroidal anti-inflammatory drugs (NSAIDs), including but not limited to ibuprofen and naproxen. It is advisable for healthcare providers to evaluate the necessity of combining these medications and to monitor patients closely for any signs of gastrointestinal distress or bleeding.

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 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, consultation with a doctor 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 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 any relevant medical history that may heighten the risk of gastrointestinal complications. Close monitoring of these patients is recommended to ensure safety and to mitigate potential adverse effects associated with the use of this 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 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 healthcare provider, 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

There is no information available regarding renal impairment, dosage adjustments, special monitoring, or safety considerations for patients with reduced kidney function. Healthcare professionals should exercise caution and consider individual patient factors when treating patients with renal impairment, as specific guidelines or recommendations are not provided.

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 and symptomatic treatment as necessary. This may include monitoring vital signs, providing respiratory support, and administering intravenous fluids if indicated.

Additionally, healthcare professionals should consider contacting a poison control center for guidance on specific management protocols and interventions tailored to the substance involved in the overdose.

Documentation of the incident, including the amount and timing of the substance taken, 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 detailed findings regarding nonclinical toxicology or animal pharmacology and toxicology provided in the current information.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions reported voluntarily or through surveillance programs. Severe allergic reactions have been noted, which may manifest as facial swelling, asthma (wheezing), shock, and hives. Additionally, cases of stomach bleeding have been reported, particularly among individuals aged 60 or older, those with a history of stomach ulcers or bleeding problems, patients taking blood-thinning (anticoagulant) or steroid medications, individuals using other drugs containing prescription or non-prescription NSAIDs, and those consuming three or more alcoholic drinks daily while using this product, or taking it for longer than directed.

Reports of Reye's syndrome have been documented in children and teenagers who have or are recovering from chickenpox or flu-like symptoms. Furthermore, new symptoms occurring during use have included ringing in the ears or loss of hearing.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children to prevent accidental ingestion. In the event of an overdose, patients should be instructed to seek medical help immediately or contact a Poison Control Center for assistance.

Patients should also be informed not to use the product if the printed safety seal under the cap is torn or missing, as this may indicate that the product has been tampered with.

It is important for healthcare providers to emphasize that aspirin is not suitable for everyone. Patients should be encouraged to discuss their individual health circumstances with their doctor before starting any aspirin regimen to ensure it is appropriate for their specific needs.

Storage and Handling

The product is supplied in packaging that includes specific NDC numbers. It should be stored at a controlled room temperature of 25°C (77°F), with permissible excursions between 15°C and 30°C (59°F to 86°F). It is essential to adhere to the expiration date indicated on the package to ensure product efficacy and safety.

Additional Clinical Information

No further data are available.

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)