Aspirin 325 mg

Description

This product contains Aspirin, a nonsteroidal anti-inflammatory drug (NSAID), at a strength of 325 mg per tablet. It is available in a dosage form of enteric-coated tablets, designed to minimize gastrointestinal irritation. The product is packaged in a bottle containing 125 tablets. The National Drug Code (NDC) for this formulation is 41250-681-02. This formulation is comparable to the active ingredient found in Regular Strength Ecotrin®. The product is marketed under the Meijer® brand.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with various conditions, including headache, muscle pain, toothache, menstrual pain, colds, and minor pain of arthritis. 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

Patients should take the medication with a full glass of water for optimal efficacy.

For adults and children aged 12 years and older, the recommended dosage is 1 to 2 tablets every 4 hours as needed for symptom relief. It is important not to exceed 12 tablets within a 24-hour period unless specifically 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 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 have or are recovering from chickenpox or flu-like symptoms should not use this product. If changes in behavior accompanied by nausea and vomiting occur while using this product, it is imperative to consult a physician, as these symptoms may indicate the onset of Reye's syndrome, a rare but serious condition.

Aspirin may induce severe allergic reactions, which can manifest as hives, facial swelling, asthma (wheezing), or shock. This product contains a nonsteroidal anti-inflammatory drug (NSAID), which carries the risk of severe stomach bleeding. The likelihood of such an event 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.

Individuals should refrain from using this product if they are allergic to aspirin or any other pain reliever or fever reducer. Prior to use, it is advisable to consult a healthcare professional if any of the following conditions apply: a history of stomach bleeding, existing stomach issues such as heartburn, high blood pressure, heart disease, liver cirrhosis, kidney disease, use of diuretics, or a diagnosis of asthma. Additionally, consultation with a doctor or pharmacist is recommended for those taking prescription medications for diabetes, gout, or arthritis.

In the event of an overdose, immediate medical assistance should be sought, or contact a Poison Control Center at 1-800-222-1222.

Users should discontinue use and contact a healthcare provider if any of the following occur: signs of an allergic reaction, symptoms indicative of stomach bleeding (such as feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain), worsening pain lasting more than 10 days, presence of redness or swelling, fever that worsens or persists for more than three days, emergence of new symptoms, or occurrences of 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 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 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, are using other NSAIDs (including aspirin, ibuprofen, or naproxen), 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 persistent stomach pain. Additionally, if pain worsens or lasts longer than 10 days, if redness or swelling occurs, if fever worsens or lasts more than three days, if new symptoms arise, or if there is ringing in the ears or loss of hearing, medical advice should be sought.

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. Patients taking diuretics or those with asthma should also seek medical advice prior to use.

It is important to note that this product should not be used by individuals who are allergic to aspirin or any other pain reliever or fever reducer.

Drug Interactions

Aspirin has notable interactions with various drug classes, particularly concerning its pharmacodynamic effects.

Anticoagulants and Steroids Aspirin may significantly increase the risk of severe gastrointestinal bleeding when co-administered with anticoagulants or steroid medications. It is advisable to monitor patients closely for signs of bleeding and consider dosage adjustments or alternative therapies as necessary.

Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) Concurrent use of aspirin with other NSAIDs, whether prescription or nonprescription, such as ibuprofen or naproxen, is contraindicated. This combination may elevate the risk of adverse effects, including gastrointestinal complications. Patients should be advised against using multiple NSAIDs simultaneously.

Diabetes, Gout, and Arthritis Medications Patients taking prescription medications for diabetes, gout, or arthritis should consult a healthcare provider prior to initiating aspirin therapy. This consultation is essential to evaluate potential interactions and to determine appropriate management strategies.

Packaging & NDC

Below are the non-prescription pack sizes of Aspirin 325 mg (aspirin). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients, particularly children and teenagers, should not use this product if they have or are recovering from chicken pox or flu-like symptoms. For children under 12 years of age, it is advised to consult a doctor before use.

In patients aged 12 years and older, the recommended dosage is 1 to 2 tablets every 4 hours as needed, with a maximum of 12 tablets in a 24-hour period unless otherwise directed by a healthcare professional.

Healthcare providers should be vigilant for changes in behavior accompanied by nausea and vomiting, as these may indicate the onset of Reye's syndrome, a rare but serious condition.

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 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 should consult a healthcare professional prior to use, particularly if they have 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 may experience altered pharmacokinetics of the drug due to compromised liver function. It is essential to assess liver function prior to initiating therapy and to monitor liver parameters throughout treatment.

In patients with liver cirrhosis, dosage adjustments may be necessary to mitigate the risk of adverse effects. Close monitoring of blood pressure and heart function is also recommended, particularly in those with concurrent conditions such as high blood pressure or heart disease.

Due to the potential for increased sensitivity to the drug in this population, healthcare providers should exercise caution and consider the overall clinical status of patients with hepatic impairment when determining the appropriate therapeutic regimen.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. Healthcare professionals should advise patients or caregivers to call the Poison Control Center at 1-800-222-1222 for guidance.

Prompt intervention is crucial in managing overdose situations, as symptoms may vary depending on the substance involved. Therefore, a thorough assessment of the patient's condition is essential to determine the appropriate course of action.

Management procedures may include supportive care and symptomatic treatment, tailored to the specific symptoms presented. Continuous monitoring of the patient's vital signs and clinical status is recommended to ensure safety and effectiveness of the treatment provided.

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 associated with the use of the product. Reports of allergic reactions have been documented, including hives, facial swelling, asthma (wheezing), and shock. Additionally, cases of stomach bleeding have been noted, particularly in patients who are older, have a history of stomach ulcers or bleeding problems, or are concurrently taking certain medications. Serious gastrointestinal bleeding has also been reported, especially in individuals with identified risk factors. Other adverse reactions that have been reported include tinnitus and hearing loss.

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 immediately or contact a Poison Control Center at 1-800-222-1222.

Patients must be cautioned against using this medication if they have a known allergy to aspirin or any other pain reliever or fever reducer. It is important for healthcare providers to inform patients to stop using the medication and consult a doctor if they experience any signs of an allergic reaction, which may require immediate medical attention. Additionally, patients should be made aware of the signs of stomach bleeding, including feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain. They should also be advised to seek medical advice if their pain worsens or lasts longer than 10 days, if redness or swelling occurs, if fever worsens or lasts more than 3 days, if new symptoms develop, or if they experience 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 should also seek medical advice prior to use. Furthermore, those taking diuretics or who have asthma should be advised to discuss their situation with a healthcare professional.

Lastly, patients should be encouraged to consult a doctor or pharmacist before using this medication if they are currently taking prescription drugs for diabetes, gout, or arthritis to ensure safe and effective use.

Storage and Handling

The product is supplied in a carton that contains essential information and warnings. It should be stored in a dry place at a temperature range of 20-25°C (68-77°F) to ensure optimal stability and efficacy. It is recommended to retain the carton for reference to complete product details.

Additional Clinical Information

The route of administration for the medication is oral. 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 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.

Drug Information (PDF)

This file contains official product information for Aspirin 325 mg, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)