Aspirin

Description

The product is identified by the National Drug Code (NDC) 17714-009-36 and is available in a count of 36 units.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains. It is essential for patients to consult their healthcare provider for any additional uses beyond this indication.

Limitations of Use: This drug should not be used for more than 10 days without consulting a healthcare professional, as serious side effects may occur with prolonged use.

Dosage and Administration

Administer the medication only under adult supervision. Dosing should primarily be based on the patient's weight; if weight is not available, age may be used as a secondary guide. The medication may be repeated every 4 hours as long as symptoms persist, with a maximum of 5 doses within a 24-hour period. It is recommended that the patient drinks water with each dose to aid in administration.

For patients aged 12 years and older, the recommended dosage is 4 to 8 tablets every 4 hours while symptoms last, not exceeding 48 tablets in a 24-hour period.

For children under 12 years, dosing is as follows:

• For children weighing 77 to 83 lbs (ages 11 to under 12), the dose is 4 to 6 tablets.

• For children weighing 66 to 76 lbs (ages 9 to under 11), the dose is 4 to 5 tablets.

• For children weighing 46 to 65 lbs (ages 6 to under 9), the dose is 4 tablets.

• For children weighing 36 to 45 lbs (ages 4 to under 6), the dose is 3 tablets.

• For children weighing 32 to 35 lbs (ages 3 to under 4), the dose is 2 tablets.

• For children weighing under 32 lbs (under 3 years of age), it is advised to consult a doctor for appropriate dosing.

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, 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 immediately.

Aspirin may induce 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 poses a risk of severe stomach bleeding. The likelihood of this adverse effect is increased in children who have a history of stomach ulcers or bleeding problems, are taking anticoagulants or steroid medications, are using other NSAIDs (such as ibuprofen or naproxen), or exceed the recommended dosage or duration of use. Additionally, this product should not be administered to children who have previously experienced an allergic reaction to any pain reliever or fever reducer, or within 7 days following tonsillectomy or oral surgery.

Healthcare professionals should advise caregivers to consult a doctor prior to use if any of the following conditions apply: a history of stomach problems (e.g., heartburn), dehydration due to insufficient fluid intake or significant fluid loss from vomiting and diarrhea, high blood pressure, heart disease, liver cirrhosis, kidney disease, use of diuretics, asthma, concurrent prescription medications for diabetes, gout, or arthritis, or if the child is under medical supervision for any serious condition.

In the event of an overdose, immediate medical assistance should be sought, or contact with a Poison Control Center is recommended.

Caregivers should be instructed to discontinue use and consult a healthcare professional if the child exhibits any signs of stomach bleeding, including feeling faint, vomiting blood, passing bloody or black stools, experiencing persistent stomach pain, worsening pain lasting more than 5 days, the emergence of new symptoms, redness or swelling in the painful area, or experiencing ringing in the ears or hearing loss.

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

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, whether prescription or nonprescription. 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 known to interact with various classes of medications, particularly anticoagulants and corticosteroids. When administered concurrently with blood-thinning agents, there is an increased risk of gastrointestinal bleeding. This risk is further amplified in patients who are also taking nonsteroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen or naproxen, whether they are prescription or over-the-counter formulations.

Healthcare professionals should exercise caution when prescribing aspirin alongside these medications. It is advisable to monitor patients closely for signs of gastrointestinal bleeding and consider dosage adjustments or alternative therapies as necessary to mitigate this risk.

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, a healthcare professional should be consulted immediately.

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 had an allergic reaction to any pain reliever or fever reducer, or if they have undergone tonsillectomy or oral surgery within the past 7 days.

Before administering this product, it is important to consult a healthcare provider if the child has a history of stomach issues, has not been adequately hydrated, has experienced significant fluid loss due to vomiting or diarrhea, or has pre-existing conditions such as high blood pressure, heart disease, liver cirrhosis, or kidney disease. Additionally, consultation is recommended if the child is taking diuretics or has asthma.

For pediatric dosing, the following guidelines apply based on weight and age:

• 77 – 83 lbs / 11 to under 12 years: 4 – 6 tablets

• 66 – 76 lbs / 9 to under 11 years: 4 - 5 tablets

• 46 – 65 lbs / 6 to under 9 years: 4 tablets

• 36 – 45 lbs / 4 to under 6 years: 3 tablets

• 32 – 35 lbs / 3 to under 4 years: 2 tablets

• Under 32 lbs / under 3 years: consult a doctor

For children under 12 years, it is advised to seek medical advice before use.

Geriatric Use

There is no specific information available regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy.

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 outcomes 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 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 is recommended throughout the treatment course. Additionally, patients with concurrent conditions such as high blood pressure or heart disease should be evaluated for potential drug interactions and overall treatment safety.

It is advised that healthcare providers consider the patient's complete medical history, including any renal impairment, when determining the appropriate therapeutic regimen. Regular follow-up and assessment of liver function are crucial to ensure patient safety and efficacy of the treatment.

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 substance involved and the clinical presentation. 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 definitely directed to do so by a doctor, as it may cause problems in the unborn child or complications during delivery. No relevant information is available regarding non-teratogenic effects, nonclinical toxicology, or animal pharmacology and toxicology.

Postmarketing Experience

No specific postmarketing experience details are available in the insert text. As such, there are no additional adverse events or rare case reports to summarize.

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 includes a tamper-evident safety seal. It is imperative that the product is not used if the safety seal under the cap is broken or missing.

For optimal storage, the product should be maintained at a temperature range of 15-30 °C (59-86 °F). Proper adherence to these storage conditions is essential to ensure the integrity and efficacy of the product.

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

View product document (PDF)