Aspirin

Description

Aspirin Delayed Release Tablets, USP, contain 81 mg of aspirin in an enteric-coated formulation. The tablets are yellow in appearance, designed to delay the release of the active ingredient until it reaches the intestine, thereby minimizing gastric irritation.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains, as recommended by a healthcare professional. Due to its delayed release action, this product is not suitable for the immediate relief of headaches or other symptoms requiring prompt alleviation.

Limitations of Use: There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

Patients should take the medication with a full glass of water to ensure proper administration and absorption.

For adults and children aged 12 years and older, the recommended dosage is 4 to 8 tablets every 4 hours. The total daily dosage must not exceed 48 tablets within a 24-hour period unless otherwise directed by a healthcare professional.

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 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 Reye's syndrome, a rare but serious condition.

Aspirin may provoke severe allergic reactions in some individuals. Symptoms of such reactions can include facial swelling, asthma (wheezing), shock, and hives. Healthcare professionals should be vigilant for these signs and advise patients to seek immediate medical attention if they occur.

Before initiating treatment, it is essential for patients to consult their healthcare provider 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, kidney disease, or asthma. Additionally, patients taking diuretics should also seek medical advice prior to use. Furthermore, individuals on prescription medications for gout, diabetes, or arthritis should discuss their current medications with their doctor or pharmacist before using this product.

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

Patients are advised to discontinue use and contact their healthcare provider if they experience any signs of an allergic reaction or any of the following symptoms indicative of stomach bleeding: feeling faint, vomiting blood, passing bloody or black stools, experiencing persistent stomach pain, worsening pain lasting more than 10 days, presence of redness or swelling, occurrence of new symptoms, or experiencing ringing in the ears or loss of hearing.

Side Effects

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

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. It is crucial that these individuals do not use this product. If patients experience changes in behavior accompanied by nausea and vomiting while using this product, they should consult a doctor immediately, as these symptoms could indicate the onset of Reye's syndrome.

Aspirin may also cause severe allergic reactions in some patients. Symptoms of such reactions can include facial swelling, asthma (wheezing), shock, and hives. Patients should stop using the product and seek medical attention if any signs of an allergic reaction occur.

Additionally, patients are advised to discontinue use and consult a doctor if they experience any signs of stomach bleeding, which may manifest as feeling faint, vomiting blood, having bloody or black stools, or experiencing stomach pain that does not improve. Other concerning symptoms include worsening pain lasting more than 10 days, the presence of redness or swelling, the emergence of new symptoms, or ringing in the ears or loss of hearing.

Before using this product, patients should consult their doctor if they have a history of stomach problems such as heartburn, or if they have high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma. It is also recommended that patients taking diuretics or prescription medications for gout, diabetes, or arthritis seek advice from their doctor or pharmacist prior to use.

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.

Additionally, the concurrent administration of nonsteroidal anti-inflammatory drugs (NSAIDs), including but not limited to aspirin, ibuprofen, and naproxen, can further increase the likelihood of severe stomach bleeding. It is advisable to evaluate the necessity of NSAID therapy in patients already receiving anticoagulants or steroids.

Patients who are prescribed medications for gout, diabetes, or arthritis should consult their healthcare provider to assess potential interactions and the need for dosage adjustments or enhanced monitoring.

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

Pediatric patients, particularly those under 12 years of age, should not use this product without consulting a doctor. It is important to note that children and teenagers who have or are recovering from chicken pox or flu-like symptoms are at risk for Reye's syndrome and should avoid this medication. If any 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, a rare but serious condition.

For dosing, adults and children aged 12 years and older may take 4 to 8 tablets every 4 hours, with a maximum of 48 tablets in a 24-hour period unless otherwise directed by a physician. For children under 12 years, medical advice is necessary before administration.

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 assess this risk when prescribing medications that may exacerbate this condition. Geriatric patients should be advised to consult their doctor prior to use if they fall within this age group and if the stomach bleeding warning is applicable.

Additionally, it is crucial for elderly patients to discuss their medical history with their healthcare provider before initiating treatment, especially if they have comorbid conditions such as high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma. These conditions may necessitate careful monitoring and potential dosage adjustments to ensure safety and efficacy in this population.

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 unless specifically directed by a physician, as it may pose risks to the developing fetus and lead to complications during delivery. Healthcare providers should carefully evaluate the potential benefits and risks when considering the use of this medication in pregnant patients.

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 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 the use of this medication while breastfeeding.

Renal Impairment

Patients with renal impairment have no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the text. Therefore, healthcare professionals should exercise caution and consider individual patient factors when prescribing to this population. Regular assessment of renal function may be warranted to ensure safe and effective use of the medication in patients with reduced kidney function.

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 context of overdosage, it is important to note that there is no specific information available regarding overdosage in the provided sections of the Structured Product Labeling (SPL).

Healthcare professionals are advised to exercise caution and consider standard management protocols for suspected overdosage cases. In the absence of specific symptoms or recommended actions, it is prudent to monitor the patient closely for any adverse effects and to provide supportive care as necessary.

In cases of suspected overdosage, it is recommended to contact a poison control center or seek expert consultation for further guidance on management strategies.

Nonclinical Toxicology

It is especially important not to use aspirin during the last three months of pregnancy unless directed to do so by a doctor, as it may cause problems in the unborn child or complications 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 reported voluntarily or through surveillance programs. These include allergic reactions, with some cases of anaphylaxis. Gastrointestinal bleeding has also been noted among the reported events. Hepatic reactions, characterized by elevated liver enzymes, and renal impairment have been documented. Additionally, instances of asthma exacerbation and skin reactions, such as rash and urticaria, have been observed.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children. In the event of an overdose, patients should seek medical help or contact a Poison Control Center immediately.

Patients must be informed not to use this medication if they are allergic to aspirin or any other pain reliever or fever reducer. They should be instructed to stop use and consult a doctor if they experience any signs of an allergic reaction, and to seek medical assistance right away.

It is important for healthcare providers to discuss the signs of potential stomach bleeding with patients. They should instruct patients to stop use and contact a doctor if they experience any of the following symptoms: feeling faint, vomiting blood, having bloody or black stools, experiencing stomach pain that does not improve, noticing that pain worsens or lasts more than 10 days, observing redness or swelling, developing new symptoms, or experiencing ringing in the ears or a loss of hearing.

Healthcare providers should encourage patients to consult their doctor before using this medication if the warning regarding stomach bleeding applies to them. Additionally, patients with a history of stomach problems, such as heartburn, should be advised to seek medical advice prior to use.

Patients with high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma should also be encouraged to discuss their medical history with their healthcare provider before using this medication. Furthermore, patients taking a diuretic or any prescription drugs for gout, diabetes, or arthritis should be advised to consult their doctor or pharmacist before use.

Storage and Handling

This product is supplied in a configuration that includes a printed safety seal under the cap. It is essential to ensure that this seal is intact before use; do not use the product if the seal is torn or missing.

For optimal storage, the product should be kept at room temperature. It is important to keep the product out of reach of children to prevent accidental ingestion. Once opened, the product must be discarded to ensure safety and efficacy.

Additional Clinical Information

Patients should be informed that the route of administration for the medication is oral. For adults and children aged 12 years and older, the recommended dosage is 4 to 8 tablets every 4 hours, with a maximum of 48 tablets in a 24-hour period unless otherwise directed by a healthcare professional. For children under 12 years, consultation with a doctor is advised before use.

Clinicians should counsel patients regarding the use of this medication during pregnancy and breastfeeding. It is crucial to seek advice from a healthcare professional if pregnant, particularly in the last trimester, as aspirin may pose risks to the unborn child or lead to complications during delivery. Additionally, patients should be made aware that aspirin may not be suitable for everyone, and a discussion with a doctor is recommended before starting an aspirin regimen.

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)