Aspirin 325 mg

Description

Aspirin USP is a nonsteroidal anti-inflammatory drug (NSAID) with a molecular weight of 180.16 g/mol and a chemical formula of C9H8O4. Each tablet contains 325 mg of aspirin, serving as an effective pain reliever and fever reducer. The product is packaged in a bottle containing 100 tablets. This formulation is comparable to the active ingredient in Genuine Bayer® Aspirin 325 mg. The National Drug Code (NDC) for this product is 69618-016-01.

Uses and Indications

This drug is indicated for the temporary relief of various types of pain and discomfort, including headache, menstrual pain, minor pain associated with arthritis, muscle pain, toothache, and pain and fever related to colds.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

Patients should take the medication orally, ensuring to drink a full glass of water with each dose. For adults and children aged 12 years and older, the recommended dosage is 1 to 2 tablets every 4 hours as needed while symptoms persist, with a maximum limit of 12 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

Use is contraindicated in individuals with a history of allergic reactions to any other pain reliever or fever reducer. Due to the potential for severe allergic responses, such patients should not be administered this product.

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, 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, as these may be early indicators of Reye's syndrome.

Healthcare professionals should advise patients to seek medical guidance before using this product 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, or kidney disease. Additionally, patients taking diuretics or those with asthma should also consult a doctor prior to use.

Patients should be encouraged to discuss their current medications with a healthcare provider, particularly if they are taking prescription drugs for diabetes, gout, or arthritis, are under care for any serious condition, or are using any other medications. This precaution is essential to avoid potential drug interactions and ensure safe use.

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

Patients are advised to discontinue use and contact a healthcare professional if they experience any signs of stomach bleeding, which may include feeling faint, vomiting blood, passing bloody or black stools, or experiencing persistent stomach pain. Additionally, if pain worsens or lasts longer than 10 days, if fever intensifies or persists beyond 3 days, if there is redness or swelling in the painful area, or if any new symptoms arise, medical consultation is necessary. Patients should also report any occurrences of ringing in the ears or loss of hearing, as these may indicate a serious condition.

Side Effects

Patients should be aware of the potential adverse reactions associated with this product. Serious adverse reactions include the risk of Reye's syndrome, particularly 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 healthcare professional immediately, as these symptoms may indicate the onset of Reye's syndrome, a rare but serious illness.

Additionally, patients are advised to discontinue use and seek medical attention if they notice any signs of stomach bleeding. These signs include feeling faint, vomiting blood, having bloody or black stools, or experiencing stomach pain that does not improve. Patients should also be vigilant for worsening pain that lasts more than 10 days, a fever that persists for more than 3 days, redness or swelling in the painful area, the appearance of any new symptoms, or symptoms such as ringing in the ears or loss of hearing. These could signify a serious condition requiring prompt medical evaluation.

Drug Interactions

Taking aspirin concurrently with anticoagulants or steroid medications may elevate the risk of gastrointestinal bleeding. It is advisable for patients to consult with a healthcare professional prior to initiating aspirin therapy if they are currently prescribed any anticoagulant or steroid medication.

Additionally, the concomitant use of aspirin with other nonsteroidal anti-inflammatory drugs (NSAIDs), including ibuprofen and naproxen, can further increase the risk of stomach bleeding. Patients should be cautioned against using multiple NSAIDs simultaneously without medical guidance.

Patients who are receiving treatment for diabetes, gout, or arthritis should seek advice from a healthcare provider or pharmacist before using aspirin, as potential interactions may necessitate dosage adjustments or increased monitoring.

For individuals under medical supervision for serious health conditions or those taking other medications, it is recommended to consult a healthcare professional prior to the use of aspirin to ensure safety and efficacy.

No specific laboratory test interactions have been identified in the provided information.

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

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 older may take 1-2 tablets every 4 hours while symptoms persist, with a maximum of 12 tablets in a 24-hour period. For children under 12 years of age, it is advised to consult a doctor for appropriate dosing guidance.

This product should be kept out of reach of children. In the event of an overdose, immediate medical assistance or contact with a Poison Control center is necessary.

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 gastrointestinal issues, such as heartburn, or underlying conditions including high blood pressure, heart disease, liver cirrhosis, or kidney disease.

Before initiating treatment, healthcare providers should inquire about the presence of any of these risk factors in elderly patients. Close monitoring for signs of gastrointestinal bleeding is recommended in this population to ensure patient safety and to mitigate potential adverse effects.

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 the unborn child 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 healthcare 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 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 mothers.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

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 in the provided sections of the Summary of Product Characteristics (SPL), healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdosage.

Recommended Actions In the event of an overdosage, it is essential for healthcare providers to assess the patient's clinical status and initiate appropriate supportive care. Monitoring of vital signs and symptomatic treatment should be prioritized.

Potential Symptoms While specific symptoms of overdosage are not detailed, healthcare professionals should remain vigilant for any unusual or severe reactions that may arise, given the variability in individual responses to medication.

Management Procedures Healthcare professionals are encouraged to consult local poison control centers or relevant toxicology resources for guidance on the management of overdosage. In cases where the substance is known to have a specific antidote or requires particular interventions, these should be implemented promptly.

In summary, due to the lack of detailed overdosage information, a cautious and supportive approach is recommended, with an emphasis on monitoring and symptomatic management.

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 associated with the use of the product. Severe allergic reactions have been reported, which may manifest as hives, facial swelling, asthma (wheezing), and shock. Additionally, cases of stomach bleeding have been noted, particularly in individuals aged 60 or older, those with a history of stomach ulcers or bleeding problems, and patients taking anticoagulant or steroid medications. The risk may also increase in individuals using other nonsteroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen or naproxen, or those consuming three or more alcoholic drinks daily while using this product.

Patients are advised to discontinue use and seek medical consultation if they experience signs of stomach bleeding, which include feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain.

Patient Counseling

Healthcare providers should advise patients to keep the 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 Poison Control immediately.

Patients must be informed not to use the medication if they have ever experienced an allergic reaction to any other pain reliever or fever reducer. It is essential to counsel patients to stop using the medication 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. Additionally, patients should be made aware that worsening pain lasting more than 10 days, a fever that worsens or lasts more than 3 days, redness or swelling in the painful area, the appearance of any new symptoms, or symptoms such as ringing in the ears or loss of hearing could indicate a serious condition and warrant immediate medical attention.

Patients should be encouraged to consult a doctor before using the medication if the warning regarding stomach bleeding applies to them. It is also important to discuss their medical history, particularly if they have a history of stomach problems such as heartburn, high blood pressure, heart disease, liver cirrhosis, or kidney disease. Patients taking diuretics, those with asthma, or those under a doctor's care for any serious condition should also be advised to seek medical guidance prior to use.

Furthermore, patients should be counseled to consult a doctor or pharmacist before using the medication if they are taking any prescription drugs for diabetes, gout, or arthritis, or if they are taking any other medications. This ensures a comprehensive understanding of potential interactions and safety considerations.

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 325 mg, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

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