Aspirin

Description

The product is identified by the National Drug Code (NDC) 54738-128-36 and is available in a count of 36 units. Further details regarding its chemical composition, dosage form, and other specifications are not provided in the extracted facts.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains.

Limitations of Use: This medication should not be used for more than 10 days without consulting a healthcare professional, as serious side effects may occur. For other uses, patients are advised to seek guidance from their doctor.

Dosage and Administration

Patients should drink a full glass of water with each dose.

For adults and children aged 12 years and older, the recommended dosage is 4 to 8 tablets every 4 hours as needed while symptoms persist. However, the total daily dosage should not exceed 48 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

There are no contraindications associated with the use of this product. It is deemed safe for use in the absence of specific conditions or situations that would warrant avoidance.

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 physician, as these may be early indicators of this rare but serious condition.

Aspirin may provoke severe allergic reactions, which can manifest as hives, asthma (wheezing), shock, or facial swelling. Healthcare professionals should be vigilant for these symptoms and advise patients accordingly.

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 children with a history of stomach ulcers or bleeding disorders, those taking anticoagulants or steroid medications, or those using other NSAIDs (such as ibuprofen or naproxen). Additionally, exceeding the recommended dosage or duration of use heightens this risk.

The product should not be administered if the child has a known allergy to any other pain reliever or fever reducer, or if it has been less than 7 days since a tonsillectomy or oral surgery.

Before using this product, it is essential to consult a healthcare provider if any of the following conditions apply:

• The child has a history of stomach problems, including heartburn.

• The child has not been adequately hydrated or has experienced significant fluid loss due to vomiting or diarrhea.

• The child has high blood pressure, heart disease, liver cirrhosis, or kidney disease.

• The child is taking diuretics or has asthma.

• The child is on prescription medications for diabetes, gout, or arthritis.

• The child is under medical supervision for any serious health condition.

If the child exhibits any signs of stomach bleeding, such as feeling faint, vomiting blood, passing bloody or black stools, experiencing persistent stomach pain, or if pain worsens or lasts longer than 5 days, it is crucial to discontinue use and seek medical advice. Additionally, any new symptoms, redness or swelling in the painful area, or symptoms such as ringing in the ears or hearing loss warrant immediate consultation with a healthcare professional.

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

For pregnant or breastfeeding individuals, it is advisable to consult a healthcare professional prior to use. Special caution is warranted during the last trimester of pregnancy, as aspirin may pose risks to the unborn child or lead to complications during delivery.

Side Effects

Patients using this product should be aware of several serious warnings and potential adverse reactions.

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. It is crucial that these individuals do not use this product. If patients exhibit 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.

Aspirin may also cause severe allergic reactions in some patients, which can manifest as hives, asthma (wheezing), shock, or facial swelling. Patients with a history of allergic reactions to 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 have a history of stomach ulcers or bleeding problems, those taking blood-thinning medications or steroids, and those using other NSAIDs (such as ibuprofen or naproxen). Additionally, patients who take more of the product or use it for a longer duration than directed are at higher risk.

Patients should seek medical advice before using this product if they have a history of stomach problems, such as heartburn, or if the stomach bleeding warning applies to them. Other conditions that warrant consultation include dehydration from vomiting or diarrhea, high blood pressure, heart disease, liver cirrhosis, kidney disease, or if they are taking diuretics or prescription medications for diabetes, gout, or arthritis.

Patients are advised to discontinue use 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 that require medical attention include worsening pain lasting more than five days, the appearance of new symptoms, redness or swelling in the painful area, or ringing in the ears or loss of hearing.

For pregnant or breastfeeding patients, it is essential to consult a healthcare professional before use. Aspirin should particularly be avoided 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.

Drug Interactions

Aspirin is associated with significant risks of gastrointestinal bleeding, particularly in pediatric patients with certain predisposing factors. The following interactions and considerations should be noted:

Pharmacodynamic Interactions:

Aspirin may increase the risk of severe stomach bleeding in children, especially in those who have a history of stomach ulcers or bleeding disorders. The risk is further heightened when aspirin is co-administered with anticoagulants or steroid medications. Additionally, concurrent use of other nonsteroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen or naproxen, can exacerbate this risk.

Clinical Considerations:

Before administering aspirin, it is advisable to consult a healthcare professional if the child is currently taking any prescription medications for diabetes, gout, or arthritis. Furthermore, it is essential to seek guidance if the child is under medical supervision for any serious health condition or is taking any other medications. Monitoring for signs of gastrointestinal bleeding is recommended in patients receiving aspirin, particularly those with the aforementioned risk factors.

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 changes in behavior accompanied by nausea and vomiting occur while using this product, a healthcare professional should be consulted immediately, as these may be early signs of Reye’s syndrome.

The risk of severe stomach bleeding is increased in pediatric patients with a history of stomach ulcers or bleeding problems, those taking anticoagulants or steroid medications, or those using other nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen or naproxen. Caution is advised if the child has not been adequately hydrated or has lost significant fluids due to vomiting or diarrhea. Additionally, children with high blood pressure, heart disease, liver cirrhosis, or kidney disease, as well as those taking diuretics or with a history of asthma, should be evaluated by a healthcare provider before use.

This product should not be administered to children who have previously experienced an allergic reaction to any pain reliever or fever reducer, nor should it be given for at least 7 days following tonsillectomy or oral surgery.

For children under 12 years of age, it is recommended to consult a doctor before use. Furthermore, parents or guardians should seek advice from a healthcare professional if the child is taking prescription medications for diabetes, gout, or arthritis, or if the child is under care for any serious medical condition.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any adverse effects or changes in therapeutic response, given the lack of targeted data for this population.

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 physician.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication if they are pregnant or breastfeeding. It is particularly important to avoid the use of aspirin during the last three months of pregnancy unless specifically directed by a healthcare provider, 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.

Renal Impairment

Patients with renal impairment may require careful consideration regarding dosing adjustments and monitoring. In particular, those with reduced kidney function, such as children with high blood pressure, heart disease, liver cirrhosis, or kidney disease, should be evaluated for potential alterations in drug clearance. It is essential to assess renal function prior to initiating therapy and to monitor renal parameters regularly throughout treatment to ensure safety and efficacy. Adjustments to dosing regimens may be necessary based on the degree of renal impairment to mitigate the risk of adverse effects.

Hepatic Impairment

Patients with hepatic impairment may experience altered pharmacokinetics of the drug due to compromised liver function. It is essential to assess the severity of liver impairment before initiating treatment.

In patients with liver cirrhosis, dosage adjustments may be necessary to avoid potential toxicity. Close monitoring of liver function tests, including alanine aminotransferase (ALT), aspartate aminotransferase (AST), and bilirubin levels, is recommended throughout the treatment period.

Additionally, patients with concurrent conditions such as high blood pressure, heart disease, or kidney disease should be evaluated for potential interactions and the overall impact on treatment efficacy and safety. Regular follow-up and reassessment of liver function are crucial to ensure optimal therapeutic outcomes in this patient population.

Overdosage

In the absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdose.

It is essential to monitor the patient closely for any potential symptoms that may arise from an overdose. Symptoms can vary widely depending on the substance involved and the individual patient's response.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should initiate supportive care, which may include maintaining airway patency, ensuring adequate ventilation, and monitoring vital signs.

If available, the use of antidotes or specific treatments should be considered based on the clinical scenario and the substance involved. Consultation with a poison control center or a medical toxicologist may provide additional guidance on the management of overdose cases.

Documentation of the incident, including the substance, amount ingested, and time of ingestion, is crucial for effective management and treatment planning.

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 aspirin. These include gastrointestinal bleeding, allergic reactions (notably anaphylaxis), Reye's syndrome in children and teenagers recovering from chickenpox or flu-like symptoms, asthma exacerbation, stomach ulcers, renal impairment, hepatic impairment, and skin reactions such as rash and urticaria.

Reports indicate that gastrointestinal bleeding has been particularly noted in patients with a history of ulcers or those concurrently using anticoagulants or other nonsteroidal anti-inflammatory drugs (NSAIDs). Additionally, there have been rare instances of severe allergic reactions, including anaphylaxis, in patients taking aspirin.

Cases of Reye's syndrome have been documented in children and teenagers who received aspirin during viral infections. Postmarketing surveillance has also suggested that some patients may experience exacerbation of asthma following aspirin use. Furthermore, renal and hepatic impairment has been reported, especially in individuals with pre-existing conditions. Skin reactions, including rash and urticaria, have also been observed in the postmarketing setting.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. It is crucial to emphasize the importance of safety in the home environment, particularly for households with young children.

In the event of an overdose, healthcare providers should instruct patients to seek medical help immediately or contact a Poison Control Center. Patients should be made aware of the signs of overdose and the urgency of obtaining assistance to ensure their safety and well-being.

Storage and Handling

The product is supplied in a configuration that ensures tamper evidence; it should not be used if the imprinted safety seal under the cap is broken or missing.

For optimal storage, the product must be maintained at a temperature range of 15-30 °C (59-86 °F). Proper handling and storage conditions are essential to preserve the integrity and efficacy of the product.

Additional Clinical Information

The medication is administered orally. 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 trimester 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, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)