Pain Reliever

Description

Aspirin is a nonsteroidal anti-inflammatory drug (NSAID) indicated for the relief of pain. It is commonly utilized for its analgesic, antipyretic, and anti-inflammatory properties. The active ingredient, aspirin, is chemically known as acetylsalicylic acid. The molecular weight of aspirin is 180.16 g/mol, and its chemical formula is C9H8O4. Aspirin is available in a dosage form of 325 mg tablets. The tablets are typically white, round, and may be coated for ease of swallowing.

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 administration and absorption.

It is imperative that patients do not exceed a total of 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 prior to administration to determine appropriate dosing and safety.

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, administration in these patients is not recommended.

Warnings and Precautions

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

Reye’s Syndrome Children and teenagers who are experiencing or recovering from chickenpox or flu-like symptoms should not use this product. If any changes in behavior accompanied by nausea and vomiting occur during use, it is imperative to consult a healthcare professional, as these symptoms may indicate the onset of Reye’s syndrome, a rare but serious condition.

Allergy Alert Aspirin has the potential to cause severe allergic reactions. Symptoms may include hives, shock, facial swelling, and asthma (wheezing). Immediate medical attention should be sought if an allergic reaction occurs.

Stomach Bleeding Warning This product contains a nonsteroidal anti-inflammatory drug (NSAID), which may increase the risk of severe stomach bleeding. The likelihood of this adverse effect is heightened in individuals who:

• Are aged 60 years or older

• Have a history of stomach ulcers or bleeding disorders

• Are concurrently taking anticoagulants or steroid medications

• Are using other NSAIDs, whether prescription or over-the-counter (e.g., aspirin, ibuprofen, naproxen)

• Consume three or more alcoholic beverages daily while using this product

• Exceed the recommended dosage or duration of use

Stop Use and Consult a Doctor Patients should discontinue use and seek medical advice if any of the following occur:

• Signs of an allergic reaction

• Symptoms indicative of stomach bleeding, such as feeling faint, vomiting blood, or having bloody or black stools

• Worsening fever lasting more than three days

• Persistent stomach pain that does not improve

• Pain that worsens or lasts longer than ten days

• Presence of redness or swelling

• Emergence of any new symptoms

• Ringing in the ears or loss of hearing

These symptoms may signify a serious medical condition requiring immediate attention.

Emergency Medical Help In the event of an overdose, it is crucial to seek emergency medical assistance or contact a Poison Control Center immediately at 1-800-222-1222.

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 a significant risk of severe allergic reactions to aspirin, which may manifest as hives, shock, facial swelling, or asthma (wheezing). Patients should seek immediate medical attention if any signs of an allergic reaction occur.

This product contains a nonsteroidal anti-inflammatory drug (NSAID), which may lead to severe stomach bleeding. The risk of this adverse reaction 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 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 worsening fever lasting more than three days. Other concerning symptoms include persistent stomach pain, worsening pain lasting more than ten days, redness or swelling, the appearance of new symptoms, or ringing in the ears or loss of hearing, as these may indicate a serious condition.

Before using this product, patients should consult a doctor 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 important for patients taking diuretics or those with asthma to seek medical advice prior to use. Furthermore, patients taking prescription medications for diabetes, gout, or arthritis should consult a doctor or pharmacist before using this product.

Drug Interactions

Aspirin has been associated with several significant drug interactions that may increase the risk of adverse effects, particularly gastrointestinal bleeding.

Anticoagulants and Antiplatelet Agents Aspirin may enhance the risk of stomach bleeding when administered concurrently with anticoagulant medications. This interaction necessitates careful monitoring of patients receiving both aspirin and anticoagulants to mitigate the risk of gastrointestinal complications.

Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) The concomitant use of aspirin with other NSAIDs, including both prescription and nonprescription options such as ibuprofen and naproxen, is associated with an increased risk of stomach bleeding. It is advisable to avoid the simultaneous use of multiple NSAIDs to reduce this risk.

Diabetes, Gout, and Arthritis Medications Caution is warranted when aspirin is used alongside prescription medications for diabetes, gout, or arthritis. The potential for adverse effects may be heightened, and careful patient monitoring is recommended to ensure safety and efficacy.

No specific laboratory test interactions have been identified in the available data.

Packaging & NDC

Below are the non-prescription pack sizes of Pain Reliever (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 any changes in behavior accompanied by nausea and vomiting occur 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 1 to 2 tablets every 4 hours as needed while symptoms persist. For children under 12 years of age, it is advised to consult a doctor for appropriate dosing recommendations.

Geriatric Use

Elderly patients, defined as those aged 65 and older, may experience an increased risk of severe stomach bleeding, particularly if they are also 60 years of age or older. It is advisable for healthcare providers to inquire about the presence of any stomach bleeding warnings before prescribing this medication to geriatric patients.

Additionally, elderly patients may have a heightened susceptibility to stomach ulcers and bleeding complications. This necessitates careful monitoring and consideration of the patient's overall gastrointestinal health when initiating treatment.

Furthermore, it is important to note that geriatric patients may exhibit reduced kidney function, which can significantly impact the metabolism and clearance of the drug. As a result, dose adjustments may be required to ensure safety and efficacy in this population.

Lastly, increased sensitivity to side effects is a common concern among elderly patients. Healthcare providers should remain vigilant for any adverse reactions and adjust treatment protocols accordingly to mitigate potential risks.

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 development and 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 explicitly 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 may not have specific dosage adjustments, special monitoring, or safety considerations outlined in the prescribing information. Therefore, healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the lack of detailed guidance necessitates careful clinical judgment and individualized patient assessment. Regular monitoring of renal function is advisable to ensure patient safety and therapeutic efficacy.

Hepatic Impairment

There is no information available regarding the use of this medication in patients with hepatic impairment. Consequently, there are no dosage adjustments, special monitoring requirements, or precautions specified for individuals with compromised liver function. Healthcare professionals should exercise clinical judgment when considering the use of this medication in patients with liver problems, as the absence of specific guidance necessitates careful evaluation of the patient's overall health status and liver function.

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 implement supportive care measures, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

If available, specific antidotes or treatments should be administered as indicated based on the substance involved. Consultation with a poison control center or a medical toxicologist may be beneficial for guidance on management strategies tailored to the specific situation.

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 details 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. These include allergic reactions such as hives, shock, facial swelling, and asthma (wheezing). Additionally, severe stomach bleeding has been noted, particularly in individuals aged 60 or older, those with a history of stomach ulcers or bleeding problems, individuals taking blood thinning or steroid medications, those consuming three or more alcoholic drinks daily, or those exceeding the recommended dosage.

Furthermore, there have been reports of Reye’s syndrome in children and teenagers who have or are recovering from chickenpox or flu-like symptoms.

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, which may require urgent medical attention. Additionally, they should be made aware of the signs of potential stomach bleeding, including feeling faint, vomiting blood, having bloody or black stools, or experiencing worsening fever lasting more than three days. Patients should also report persistent stomach pain, worsening pain lasting more than ten days, any redness or swelling, the appearance of new symptoms, or symptoms such as ringing in the ears or loss of hearing, as these may indicate a serious condition.

Healthcare providers should encourage patients to consult with 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 seek medical advice prior to use.

Furthermore, patients taking prescription medications for diabetes, gout, or arthritis should be advised to consult with a doctor or pharmacist before using this medication to ensure safety and avoid potential interactions.

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 a controlled temperature range of 20–25°C (68–77°F) to maintain its integrity and efficacy. Proper storage conditions must be adhered to, ensuring that the product is kept within the specified temperature limits to prevent degradation.

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.

Drug Information (PDF)

This file contains official product information for Pain Reliever, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)