Aspirin

Description

The product is available in two National Drug Code (NDC) configurations: 17714-121-12, which contains 120 tablets, and 17714-121-06, which contains 240 tablets. Each tablet is formulated to deliver the specified active ingredients in a precise dosage form, ensuring consistent therapeutic efficacy. The appearance and specific characteristics of the tablets are designed to meet professional standards for pharmaceutical products.

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 beyond this indication.

Limitations of use include a recommendation against use for more than 10 days without prior consultation with a healthcare professional, as serious side effects may occur. There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

Patients should drink a full glass of water with each dose to ensure proper administration and absorption of the medication.

For adults and children aged 12 years and older, the recommended dosage is 4 to 8 tablets every 4 hours as needed for symptom relief. However, the total dosage should not exceed 48 tablets within a 24-hour period.

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

Contraindications

There are no contraindications associated with the use of this product. It is deemed safe for use in the absence of specific conditions or situations that would warrant avoidance.

Warnings and Precautions

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 imperative to consult a healthcare professional immediately.

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

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 problems, are taking anticoagulants or steroid medications, are using other NSAIDs (such as ibuprofen or naproxen), exceed the recommended dosage or duration of use, or consume three or more alcoholic beverages daily while using this product.

Patients should refrain from using this product if they have a known allergy to any other pain reliever or fever reducer. Prior to use, it is advisable for patients to consult a 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, use of diuretics, or asthma. Additionally, patients should seek guidance from a doctor or pharmacist if they are taking prescription medications for diabetes, gout, or arthritis, are on any other medications, or are under medical care for any serious condition.

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

Patients are advised to discontinue use and consult a healthcare professional if they experience any signs of stomach bleeding, which may include feeling faint, vomiting blood, passing bloody or black stools, experiencing persistent stomach pain, worsening pain lasting more than 10 days, fever that worsens or lasts more than 3 days, redness or swelling in the painful area, the emergence of new symptoms, or any ringing in the ears or loss of hearing.

For pregnant or breastfeeding individuals, it is crucial to consult a healthcare professional before use. Aspirin should particularly be avoided 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.

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 may be early signs of Reye’s syndrome.

Aspirin may also cause severe allergic reactions in some individuals. Symptoms of such reactions can include hives, asthma (wheezing), shock, and facial swelling. Patients with a known history of allergic reactions to any other pain reliever or fever reducer should not use this product.

The 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 blood-thinning medications or steroids, are using other NSAIDs (either prescription or nonprescription), exceed the recommended dosage or duration of use, or consume three or more alcoholic drinks daily while using this product.

Patients are advised to seek medical advice before using this product 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. Additionally, those taking diuretics or any prescription drugs for diabetes, gout, or arthritis should consult a healthcare professional prior to use.

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

For pregnant or breastfeeding patients, it is crucial to consult a healthcare professional before using this product. Aspirin should be avoided 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.

Drug Interactions

Patients are advised to consult a healthcare professional, such as a doctor or pharmacist, prior to using this medication if they are currently taking prescription drugs for diabetes, gout, or arthritis. This precaution is essential to ensure safe and effective use of the medication, as potential interactions may alter the therapeutic effects or increase the risk of adverse reactions.

Additionally, individuals should seek professional guidance before using this medication if they are taking any other drugs. This recommendation underscores the importance of evaluating all concurrent medications to prevent possible drug interactions that could compromise treatment outcomes.

No specific laboratory test interactions have been identified in the available data. Therefore, routine monitoring of laboratory tests is not indicated based on the information provided.

Packaging & NDC

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

Pediatric Use

Pediatric patients, particularly those under 12 years of age, should consult a healthcare professional before using this product. It is contraindicated in children and teenagers who have or are recovering from chickenpox or flu-like symptoms 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, a doctor should be consulted immediately, as these may be early signs of Reye’s syndrome.

For adolescents aged 12 years and older, the recommended dosage is 4 to 8 tablets every 4 hours as needed, not to exceed 48 tablets in a 24-hour period.

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 advised 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 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 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. Therefore, caution is recommended when considering the use of this medication while breastfeeding.

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 the dosing regimen 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. It is essential to assess liver function prior to initiating treatment. In patients with significant liver cirrhosis, dosage adjustments may be necessary to avoid potential toxicity.

Monitoring of liver function tests is recommended throughout the treatment course to ensure safety and efficacy. Patients with compromised liver function should be closely observed for any signs of adverse reactions, particularly those related to hepatic metabolism.

In cases where patients present with concurrent conditions such as high blood pressure, heart disease, or kidney disease, additional caution is warranted, and a thorough evaluation of the overall health status should be conducted to inform treatment decisions.

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, the following management procedures should be considered:

1. Assessment: Conduct a thorough assessment of the patient's clinical status, including vital signs and level of consciousness.

2. Supportive Care: Provide supportive care as needed, which may include airway management, oxygen supplementation, and intravenous fluids.

3. Consultation: Engage with a poison control center or a medical toxicologist for guidance on specific interventions and antidotes, if applicable.

4. Documentation: Document all findings, interventions, and the patient's response to treatment meticulously.

Healthcare professionals should remain vigilant and prepared to implement appropriate measures in the event of an overdose, even in the absence of specific guidelines.

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 relevant information is available regarding non-teratogenic effects. Additionally, there is no pertinent data provided in the nonclinical toxicology section or in the animal pharmacology and toxicology section.

Postmarketing Experience

Postmarketing experience has indicated that aspirin may be associated with severe allergic reactions, which can manifest as hives, asthma (wheezing), shock, and facial swelling. Additionally, there have been reports of gastrointestinal bleeding linked to aspirin use. Tinnitus and hearing loss have also been noted in patients taking aspirin. Some individuals have experienced anaphylactic reactions following aspirin administration. Furthermore, rare cases of Reye's syndrome have been reported in children and teenagers who received aspirin during viral infections.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. It is crucial to emphasize the importance of safety in the home environment, particularly for households with young children.

In the event of an overdose, healthcare providers should instruct patients to seek medical help immediately or contact a Poison Control Center. Patients should be made aware of the signs of overdose and the urgency of obtaining assistance to ensure their safety and well-being.

Storage and Handling

The product is supplied in a configuration that includes a tamper-evident safety seal. It is essential to ensure that the safety seal under the cap is intact; do not use the product if the seal is broken or missing.

For optimal storage, the product should be maintained at a temperature range of 15-30 °C (59-86 °F). Proper adherence to these storage conditions is crucial to ensure the integrity and efficacy 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 additional information is available regarding laboratory tests, abuse potential, or postmarketing experience.

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)