Aspirin

Description

The product is packaged in a blister containing 30 tablets. Each tablet is formulated for oral administration. The blister packaging ensures the integrity and stability of the tablets, providing protection from environmental factors.

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 are instructed to take 1 or 2 tablets orally 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 contraindicated and should not be administered.

It is recommended that the smallest effective dose be utilized to manage symptoms. Additionally, treatment duration should not exceed 10 days unless specifically directed 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 disorders, are concurrently using blood-thinning medications or steroids, are taking other NSAIDs (including aspirin, ibuprofen, or naproxen), consume three or more alcoholic beverages daily, or exceed the recommended dosage or duration of use.

Healthcare providers should advise patients to consult a physician 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 prescription medications for diabetes, gout, or arthritis should seek guidance from a healthcare professional before use.

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 provider 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 that worsens or lasts longer than 10 days. Additionally, any new symptoms, redness or swelling, or symptoms such as ringing in the ears or loss of hearing warrant immediate medical consultation.

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. Patients should be advised to discontinue use and consult a doctor if they experience changes in behavior accompanied by nausea and vomiting, as these may be early signs of Reye’s syndrome.

Aspirin may also cause severe allergic reactions in some patients, which can manifest as hives, facial swelling, asthma (wheezing), or shock. Individuals with a known allergy to aspirin or 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 anticoagulants or steroid medications, consume three or more alcoholic drinks daily, or exceed the recommended dosage or duration of use.

Patients should be instructed 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 persistent stomach pain, or noticing any new symptoms such as ringing in the ears or loss of hearing.

Additional precautions should be taken by patients with a history of stomach problems, high blood pressure, heart disease, liver cirrhosis, or kidney disease, as well as those taking diuretics or prescription medications for diabetes, gout, or arthritis.

In the event of an overdose, which may lead to liver damage, patients should seek immediate medical help or contact a Poison Control Center, as prompt medical attention is critical for both adults and children, even in the absence of noticeable symptoms.

Drug Interactions

Aspirin has the potential to cause severe gastrointestinal bleeding, particularly when co-administered with anticoagulants, corticosteroids, or other nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen or naproxen.

Patients are advised to consult a healthcare professional prior to using aspirin if they are currently prescribed medications for diabetes, gout, or arthritis. This precaution is essential to ensure safe and effective use of aspirin in conjunction with these conditions and their respective treatments. Monitoring for signs of gastrointestinal bleeding is recommended when aspirin is used in combination with the aforementioned drug classes.

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. If any changes in behavior accompanied by nausea and vomiting occur while using this product, it is important to consult a doctor, as these symptoms may indicate the onset of Reye’s syndrome, a rare but serious condition.

This product is contraindicated in children under 12 years of age.

Geriatric Use

Elderly patients, particularly those aged 60 and older, may have an increased risk of severe stomach bleeding when using this medication. It is essential for healthcare providers to exercise caution when prescribing to this population.

Before initiating treatment, it is advisable for healthcare providers to inquire about any history of stomach problems in geriatric patients, including conditions such as heartburn, high blood pressure, heart disease, liver cirrhosis, or kidney disease. Such medical histories may necessitate careful monitoring and potential dose adjustments to mitigate risks associated with the use of this medication in elderly patients.

Pregnancy

Pregnant patients 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 outcomes or complications during delivery. Therefore, it is essential that pregnant patients only use aspirin in this period if explicitly directed by a physician. Additionally, women who are breastfeeding should also seek medical advice prior to use.

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 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 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 medication, necessitating careful consideration of dosage and monitoring. It is essential to recognize that taking more than the recommended dose can lead to liver damage. In the event of an overdose, immediate medical assistance should be sought, and contacting a Poison Control Center is advised. Prompt medical attention is critical for both adults and children, even in the absence of noticeable signs or symptoms.

Due to the potential for increased risk of adverse effects in patients with compromised liver function, healthcare providers should closely monitor liver function parameters in these individuals. Adjustments to the dosage may be required based on the severity of hepatic impairment, and ongoing assessment of liver health is recommended to ensure patient safety.

Overdosage

In the event of an overdose, it is crucial to recognize that exceeding the recommended dosage may lead to significant liver damage. Healthcare professionals should advise patients to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222 without delay.

Recommended Actions Prompt medical attention is essential for both adults and children, even in the absence of noticeable signs or symptoms. The potential for serious health consequences necessitates a proactive approach to management.

Potential Symptoms While specific symptoms of overdose may not always be evident, vigilance is advised, as liver damage can occur silently. Healthcare providers should be prepared to assess and monitor for any signs of hepatic impairment in affected individuals.

Management Procedures Upon recognition of an overdose, healthcare professionals should initiate appropriate interventions, which may include supportive care and monitoring of liver function. The involvement of poison control experts can provide additional guidance on the management of overdose cases.

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 additional non-teratogenic effects or specific nonclinical toxicology details have been identified in the available data. Furthermore, there are no specific findings related to animal pharmacology and toxicology.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

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 controlled temperature range of 20° to 25°C (68° to 77°F) to maintain its integrity and efficacy. Proper storage conditions must be adhered to, ensuring that the product is kept in a suitable container that protects it from environmental factors. Special handling requirements should be followed to prevent any compromise to the product's quality.

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 professional. It is contraindicated for children under 12 years of age.

Clinicians should advise patients who are pregnant or breastfeeding to consult a healthcare professional before use. Special caution is warranted regarding the use of aspirin during the last trimester of pregnancy, 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, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)