Aspirin

Description

The product is identified by the SPL Code 34089-3 and is packaged in a blister containing 30 tablets.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with various conditions, including headache, minor arthritis, common cold, menstrual cramps, muscular aches, backache, and toothache. Additionally, it is indicated for the temporary reduction of fever.

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

Dosage and Administration

Adults and children aged 12 years and older may take 1 or 2 tablets with a full glass of water every 4 hours as needed. The maximum dosage should not exceed 12 tablets within a 24-hour period, unless otherwise directed by a healthcare professional.

For children under 12 years of age, this medication is not recommended and should not be administered.

It is essential to adhere to the prescribed dosage and to use the smallest effective dose. Patients should not continue use for longer than 10 days unless specifically instructed by a healthcare provider.

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, asthma (wheezing), and shock. Healthcare professionals should be vigilant for these signs when prescribing or recommending this product.

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 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, or exceed the recommended dosage or duration of use.

Healthcare providers should advise patients to consult a doctor prior to use if any of the following conditions apply: a history of stomach problems such as heartburn, high blood pressure, heart disease, liver cirrhosis, kidney disease, or if they are taking diuretics. Additionally, patients should seek guidance from a doctor or pharmacist if they are currently taking prescription medications for diabetes, gout, or arthritis.

In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center should be contacted at 1-800-222-1222. Prompt medical attention is crucial for both adults and children, even if no signs or symptoms are initially apparent.

Patients should 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, experiencing persistent stomach pain, or if pain worsens or lasts longer than 10 days. Additional symptoms warranting medical consultation include the presence of redness or swelling, the emergence of any 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 adverse reactions associated with its use. Reye’s syndrome is a rare but serious illness that can 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.

Additionally, there is an allergy alert for this product, as aspirin may cause severe allergic reactions. Symptoms of such reactions can include hives, facial swelling, asthma (wheezing), and shock. Patients with known allergies to aspirin or other NSAIDs should avoid using this product.

The product contains a nonsteroidal anti-inflammatory drug (NSAID), which carries a warning for the potential of severe stomach bleeding. The risk of stomach bleeding is heightened 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 (including aspirin, ibuprofen, or naproxen), consume three or more alcoholic drinks daily, or exceed the recommended dosage or duration of use.

Patients are advised to stop using the product 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 persists for more than 10 days. Additional symptoms warranting medical consultation include the presence of redness or swelling, the appearance of any new symptoms, or experiencing ringing in the ears or loss of hearing.

Furthermore, an overdose of this product can lead to liver damage. Patients should seek immediate medical help or contact a Poison Control Center if they suspect an overdose, as prompt medical attention is crucial for both adults and children, even in the absence of noticeable signs or symptoms.

Drug Interactions

The concomitant use of anticoagulants or steroid medications may significantly elevate the risk of severe gastrointestinal bleeding. Healthcare professionals should exercise caution when prescribing these agents together and consider monitoring for signs of gastrointestinal distress.

The co-administration of nonsteroidal anti-inflammatory drugs (NSAIDs), including but not limited to aspirin, ibuprofen, and naproxen, also heightens the risk of severe stomach bleeding. It is advisable to evaluate the necessity of NSAID therapy in patients already receiving anticoagulants or steroids and to monitor for any adverse gastrointestinal effects.

Patients taking prescription medications for diabetes, gout, or arthritis should consult their healthcare provider prior to initiating treatment with the drug in question. This precaution is essential to ensure safe and effective management of their underlying conditions while minimizing the risk of potential drug interactions.

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

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 while using this product, a healthcare professional should be consulted, as these may be early signs of Reye’s syndrome.

This product is contraindicated in children under 12 years of age. For adults and children aged 12 years and older, the recommended dosage is 1 or 2 tablets taken with water every 4 hours as needed, with a maximum of 12 tablets in a 24-hour period, unless otherwise directed by a healthcare provider.

Geriatric Use

Elderly patients, particularly those aged 60 and older, are at an increased risk for severe stomach bleeding. Therefore, it is crucial for healthcare providers to exercise caution when prescribing this medication to geriatric patients.

Before initiating treatment, it is advisable to inquire about any history of gastrointestinal issues, including heartburn, as well as comorbid conditions such as high blood pressure, heart disease, liver cirrhosis, or kidney disease. These factors may necessitate closer monitoring or alternative therapeutic strategies.

In managing elderly patients, the smallest effective dose should be utilized to minimize potential adverse effects. Additionally, treatment duration should not exceed 10 days unless specifically directed by a healthcare provider, to further reduce the risk of complications associated with prolonged use.

Pregnancy

Pregnant patients should consult a healthcare professional before using this medication, particularly if they are in the later stages of pregnancy or breastfeeding. The use of aspirin during the last trimester is particularly cautioned against, as it may pose risks to the unborn child and lead to 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 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 high blood pressure, heart disease, liver cirrhosis, or kidney disease. It is important to monitor for any signs of stomach bleeding, as this risk may be increased in individuals with reduced kidney function. If any symptoms of stomach bleeding occur, patients are advised to discontinue use and seek medical attention.

Hepatic Impairment

Patients with hepatic impairment may experience altered pharmacokinetics of the medication, necessitating careful consideration of dosage adjustments and monitoring. It is essential to evaluate liver function prior to initiating treatment and to monitor liver enzymes regularly throughout the course of therapy.

In patients with liver cirrhosis or significant liver dysfunction, the risk of adverse effects, including potential liver damage, may be heightened, particularly in cases of overdose. Therefore, it is crucial to adhere strictly to the recommended dosing guidelines. In the event of an overdose, immediate medical attention should be sought, and contacting a Poison Control Center is advised. Prompt intervention is critical for both adults and children, regardless of the presence of overt symptoms.

Healthcare providers should exercise caution and consider the overall health status of patients with hepatic impairment, including any coexisting conditions such as high blood pressure, heart disease, or kidney disease, which may further complicate treatment. Regular assessment of liver function is recommended to ensure patient safety and therapeutic efficacy.

Overdosage

Taking more than the recommended dose of the medication may lead to significant liver damage. In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222.

Prompt medical attention is crucial for both adults and children, even in the absence of noticeable signs or symptoms. Healthcare professionals should be aware that early intervention can be vital in mitigating potential complications associated with overdose.

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 medication. Reports include gastrointestinal bleeding, which may occur without warning and can be fatal, as well as gastrointestinal complications such as ulcers and perforations. Allergic reactions have also been documented, including severe cases of anaphylaxis and shock.

In pediatric populations, there is a noted potential for Reye's syndrome, particularly in children and teenagers recovering from viral infections. Additional adverse events reported include tinnitus, hearing loss, asthma exacerbation, and various skin reactions such as hives and rashes.

Liver damage has been observed in cases of overdose. Monitoring for signs of gastrointestinal bleeding is recommended, especially in patients with pre-existing risk factors.

Patient Counseling

Healthcare providers should advise patients about the potential risks associated with overdose, emphasizing that taking more than the recommended dose may lead to liver damage. 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. It is crucial to stress that prompt medical attention is necessary for both adults and children, even if no signs or symptoms are apparent.

Patients should be informed not to use the medication if they have a known allergy to aspirin or any other pain reliever or fever reducer. Healthcare providers should encourage 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, experiencing persistent stomach pain, or if pain worsens or lasts longer than 10 days. Additionally, patients should be advised to seek medical attention if they notice redness or swelling, any new symptoms, or if they experience ringing in the ears or loss of hearing.

It is important for healthcare providers to ask patients about their medical history, particularly if the stomach bleeding warning applies to them. Patients with a history of stomach problems, such as heartburn, should be advised to consult a doctor before using the medication. Furthermore, patients with high blood pressure, heart disease, liver cirrhosis, or kidney disease should also be encouraged to seek medical advice prior to use. Lastly, patients taking a diuretic or any prescription drugs for diabetes, gout, or arthritis should be advised to consult with their doctor or pharmacist before using this medication.

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 temperature range of 15° to 30°C (59° to 86°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. For adults and children aged 12 years and older, the recommended dosage is 1 or 2 tablets taken with water every 4 hours as needed, with a maximum of 12 tablets in a 24-hour period unless otherwise directed by a healthcare provider. It is contraindicated for children under 12 years of age.

Clinicians should counsel patients regarding the use of this medication during pregnancy or breastfeeding, advising them to consult a health professional before use. Special caution is warranted in the last trimester of pregnancy, as aspirin may pose risks to the unborn child or lead to complications during delivery.

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)