Aspirin

Description

Aspirin Pain Reliever/Fever Reducer is formulated in its original strength and is provided in a dosage form of two tablets. This medication is indicated for the relief of pain and reduction of fever.

Uses and Indications

This drug is indicated for the temporary relief of various types of pain and discomfort, including headache, muscle pain, toothache, menstrual pain, and minor pain associated with arthritis. Additionally, it is effective in alleviating pain and fever associated with colds.

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 1 or 2 tablets every 4 hours, or 3 tablets every 6 hours. The total daily dosage must not exceed 12 tablets within a 24-hour period.

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

Contraindications

Use is contraindicated in individuals with a known allergy to aspirin or any other pain reliever or fever reducer. Due to the potential for severe allergic reactions, administration in these patients is not recommended.

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 this rare but serious condition.

Aspirin may provoke severe allergic reactions in some individuals. Symptoms of such reactions can include hives, facial swelling, wheezing, and shock. Immediate medical attention should be sought if any of these symptoms 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 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 doctor prior to using this product if they have a history of stomach problems, such as heartburn, or if they have conditions such as high blood pressure, heart disease, liver cirrhosis, or kidney disease. Additionally, patients taking diuretics or those with asthma should seek medical advice before use. It is also recommended that patients on prescription medications for gout, diabetes, or arthritis consult with a healthcare provider or pharmacist before using this product.

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

Patients should discontinue use and contact a healthcare professional if they experience any signs of an allergic reaction or any of the following symptoms indicative of 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. Additional symptoms warranting medical attention include redness or swelling, fever lasting more than three days, the emergence of new symptoms, or any ringing in the ears or loss of hearing.

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 chickenpox 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 doctor 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, asthma (wheezing), and shock. Patients should seek immediate medical attention if they experience any signs of an allergic reaction.

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, 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 feeling faint, vomiting blood, having bloody or black stools, or experiencing stomach pain that does not improve. Additional symptoms warranting medical attention include pain that worsens or lasts more than 10 days, the presence of redness or swelling, fever lasting more than three days, the emergence of new symptoms, or ringing in the ears or loss of hearing.

Patients should not use this product if they are allergic to aspirin or any other pain reliever or fever reducer. It is recommended that patients consult a doctor before use 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, patients taking diuretics or those with asthma should seek medical advice prior to use. Consultation with a doctor or pharmacist is also advised for patients taking prescription medications for gout, diabetes, or arthritis.

Drug Interactions

Aspirin has the potential to cause severe gastrointestinal bleeding, particularly when used concurrently with certain classes of medications.

Anticoagulants and Antiplatelet Agents The concomitant use of aspirin with blood-thinning medications (anticoagulants) may significantly increase the risk of gastrointestinal bleeding. It is advisable to monitor patients closely for signs of bleeding and consider dosage adjustments as necessary.

Corticosteroids Co-administration of aspirin with steroid drugs can also elevate the risk of severe stomach bleeding. Healthcare providers should evaluate the necessity of aspirin therapy in patients receiving corticosteroids and monitor for gastrointestinal complications.

Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) The use of aspirin alongside other NSAIDs, whether prescription or nonprescription (such as ibuprofen or naproxen), may further heighten the risk of gastrointestinal bleeding. Caution is recommended, and healthcare professionals should assess the overall NSAID burden on the patient.

Other Considerations Patients taking prescription medications for gout, diabetes, or arthritis should consult with a healthcare provider or pharmacist prior to initiating aspirin therapy. This is to ensure safe use and to evaluate potential interactions that may necessitate monitoring or dosage adjustments.

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 any changes in behavior accompanied by nausea and vomiting occur, it is essential 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 1 or 2 tablets every 4 hours or 3 tablets every 6 hours, with a maximum of 12 tablets in a 24-hour period. For children under 12 years of age, 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. This risk is further heightened in individuals with a history of stomach ulcers or bleeding disorders. It is essential for healthcare providers to exercise caution and consider the patient's medical history when prescribing treatment.

Geriatric patients with a history of stomach problems, including heartburn, high blood pressure, heart disease, liver cirrhosis, or kidney disease, should consult their healthcare provider prior to initiating therapy. Such conditions may necessitate closer monitoring or alternative treatment strategies.

Additionally, elderly patients may exhibit increased sensitivity to side effects. Therefore, healthcare providers should be vigilant in monitoring these patients for any adverse reactions and consider potential dose adjustments as necessary to ensure safety and efficacy.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to use. 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. 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 should consult a healthcare professional prior to use, particularly if they have comorbid conditions such as high blood pressure, heart disease, liver cirrhosis, or kidney disease. It is essential to assess renal function and consider potential dosing adjustments or monitoring requirements based on the severity of renal impairment.

Hepatic Impairment

Patients with hepatic impairment should consult a healthcare professional prior to use, particularly if they have conditions such as liver cirrhosis. It is essential for these patients to receive appropriate evaluation and monitoring of their liver function to ensure safe and effective use of the medication. Adjustments to dosage may be necessary based on the severity of hepatic impairment, and ongoing assessment of liver function is recommended throughout the treatment period.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. Prompt intervention is crucial to mitigate potential adverse effects associated with the overdose.

Healthcare professionals should be vigilant for symptoms that may arise from an overdose, although specific symptoms are not detailed in the provided information. The management of an overdose typically involves supportive care and symptomatic treatment, tailored to the individual patient's needs.

It is essential for healthcare providers to remain alert and prepared to implement appropriate management strategies in response to an overdose situation, ensuring the safety and well-being of the patient.

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

No postmarketing experience details are available in the insert text.

Patient Counseling

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

Patients must be informed not to use this medication if they have a known allergy to aspirin or any other pain reliever or fever reducer. They should be counseled to stop use and consult a doctor if they experience any signs of an allergic reaction, and to seek medical assistance right away in such cases.

Healthcare providers should discuss the signs of potential stomach bleeding with patients, advising them to stop use and contact a doctor if they experience symptoms such as feeling faint, vomiting blood, having bloody or black stools, or experiencing stomach pain that does not improve. Patients should also be made aware that pain persisting for more than 10 days, the presence of redness or swelling, a fever lasting more than 3 days, the occurrence of new symptoms, or any ringing in the ears or loss of hearing should prompt them to seek medical advice.

It is important for healthcare providers to recommend that patients consult a doctor before using this medication 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. Patients taking diuretics or those with asthma should also be encouraged to seek medical advice prior to use.

Additionally, patients should be advised to consult a doctor or pharmacist before using this medication if they are currently taking prescription drugs for gout, diabetes, or arthritis.

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, maintaining a range of 15° to 30°C (59° to 86°F). Proper storage conditions are crucial to ensure the integrity and efficacy of the product.

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.

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