Aspirin 81 mg

Description

Procure is an adult low strength pain reliever containing Aspirin USP 81 mg, classified as a nonsteroidal anti-inflammatory drug (NSAID). Each bottle contains 300 enteric-coated tablets, designed to minimize gastrointestinal irritation. The formulation is comparable to the active ingredient found in the Aspirin Regimen BAYER®. The National Drug Code (NDC) for this product is 55681-402-03.

Uses and Indications

This drug is indicated for the relief of pain.

There are no teratogenic effects associated with this drug. Additionally, no nonteratogenic effects have been reported.

Dosage and Administration

Patients should take the medication with a full glass of water for optimal efficacy.

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.

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 potentially serious condition.

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

Healthcare professionals should advise patients to discontinue use and seek medical attention if any of the following occur:

• Signs of an allergic reaction, which require immediate medical intervention.

• Symptoms indicative of stomach bleeding, including feeling faint, experiencing bloody or black stools, vomiting blood, or persistent stomach pain.

• Worsening pain or pain that persists beyond 10 days.

• The presence of redness or swelling.

• The emergence of new symptoms.

• Symptoms such as ringing in the ears or loss of hearing, which may suggest a serious underlying condition.

Monitoring for these signs and symptoms is essential to ensure patient safety and to facilitate timely medical intervention when necessary.

Side Effects

Patients using this product should be aware of several potential adverse reactions. A serious warning includes the risk of Reye's syndrome, particularly 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 this rare but serious illness.

In addition to serious warnings, patients should discontinue use and seek medical attention if they experience an allergic reaction. Signs of an allergic reaction may include rash, itching, or difficulty breathing. Furthermore, patients should be vigilant for symptoms indicative of stomach bleeding, which may manifest as feeling faint, having bloody or black stools, vomiting blood, or experiencing persistent stomach pain. If any of these symptoms occur, it is crucial to seek medical help promptly.

Patients are also advised to stop using the product if pain worsens or persists for more than 10 days. Other concerning signs that warrant medical consultation include the presence of redness or swelling, the emergence of new symptoms, or the occurrence of ringing in the ears or loss of hearing, as these could indicate a serious underlying condition.

Drug Interactions

Patients should consult a healthcare professional prior to using this medication if they are concurrently taking prescription drugs for diabetes, gout, or arthritis, as these conditions may influence the medication's efficacy or safety profile.

Pharmacodynamic interactions are particularly significant with anticoagulants and steroid medications. The concomitant use of this medication with blood thinners (anticoagulants) or steroids increases the risk of severe gastrointestinal bleeding. Therefore, careful monitoring is advised for patients on these therapies.

Additionally, the risk of severe stomach bleeding is elevated when this medication is used alongside other nonsteroidal anti-inflammatory drugs (NSAIDs), including both prescription and over-the-counter options such as aspirin, ibuprofen, and naproxen. It is recommended that healthcare providers assess the necessity of dosage adjustments or enhanced monitoring for patients who are prescribed these combinations.

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

Packaging & NDC

Below are the non-prescription pack sizes of Aspirin 81 mg (aspirin enteric coated tablets 81 mg). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 12 years of age should consult a healthcare professional before using this product. It is contraindicated in children and teenagers who have or are recovering from chickenpox or flu-like symptoms due to the risk of Reye's syndrome.

Healthcare providers should be vigilant for changes in behavior accompanied by nausea and vomiting in pediatric patients using this product, as these symptoms may indicate the onset of Reye's syndrome, a rare but serious condition.

Geriatric Use

Elderly patients, particularly those aged 60 years and older, may have an increased risk of severe stomach bleeding. Healthcare providers should exercise caution when prescribing this medication to geriatric patients, considering the potential for heightened adverse effects.

It is advisable to closely monitor elderly patients for any signs of gastrointestinal bleeding and to evaluate the necessity of dosage adjustments based on individual patient factors. Careful assessment of the benefits and risks is essential when treating this population to ensure optimal safety and efficacy.

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 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 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 in lactating mothers.

Renal Impairment

There is no specific information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients to ensure safety and efficacy.

Hepatic Impairment

There is no information available regarding the use of this medication in patients with hepatic impairment. Consequently, there are no dosage adjustments, special monitoring requirements, or precautions specified for individuals with compromised liver function. Healthcare professionals should exercise caution and consider the overall clinical context when prescribing this medication to patients with liver problems, as the absence of specific guidance necessitates careful evaluation of potential risks and benefits.

Overdosage

In the event of an overdosage, it is important to note that there is no specific information available regarding the effects or management of such an occurrence as outlined in the provided sections of the Structured Product Labeling (SPL).

Healthcare professionals are advised to monitor the patient closely for any potential symptoms that may arise, despite the absence of documented overdosage data. Standard supportive care should be initiated as necessary, and symptomatic treatment should be provided based on the clinical presentation of the patient.

In the absence of specific antidotes or treatment protocols, it is recommended that healthcare providers consult local poison control centers or relevant medical authorities for guidance on managing suspected overdosage cases. Continuous assessment and supportive measures remain critical in ensuring patient safety and well-being.

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 reported voluntarily or through surveillance programs.

Allergic reactions have been documented, including manifestations such as hives, facial swelling, shock, and asthma (wheezing). Additionally, severe stomach bleeding has been reported, particularly in individuals aged 60 or older, those with a history of stomach ulcers or bleeding problems, and patients taking blood-thinning (anticoagulant) or steroid medications. The risk may also increase in individuals using other drugs containing prescription or nonprescription NSAIDs (e.g., aspirin, ibuprofen, naproxen), those consuming three or more alcoholic drinks daily while using this product, or those taking the medication for longer than directed.

Furthermore, cases of Reye's syndrome have been reported in children and teenagers who have or are recovering from chickenpox or flu-like symptoms. Early signs of Reye's syndrome may include changes in behavior accompanied by nausea and vomiting, indicating a rare but serious illness.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children and to seek immediate medical assistance or contact a Poison Control Center in the event of an overdose.

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. It is important for patients to stop using the medication and consult a doctor if they experience any signs of an allergic reaction, such as difficulty breathing or swelling of the face, lips, or throat. They should also seek medical help if they notice symptoms indicative of stomach bleeding, including feeling faint, having bloody or black stools, vomiting blood, or experiencing persistent stomach pain. Additionally, patients should be advised to discontinue use and consult a healthcare professional if their pain worsens or lasts longer than 10 days, if redness or swelling occurs, if new symptoms arise, or if they experience ringing in the ears or a loss of hearing, as these may signal a serious condition.

Healthcare providers should encourage patients to consult a doctor before using the medication if the warning regarding stomach bleeding applies to them, or if they have a history of stomach issues such as heartburn. Patients with high blood pressure, heart disease, liver cirrhosis, or kidney disease should also seek medical advice prior to use. Furthermore, those taking diuretics, individuals with asthma, or patients who have not been adequately hydrating or have lost significant fluids due to vomiting or diarrhea should be advised to consult a healthcare professional.

Lastly, patients should be instructed to speak with a doctor or pharmacist before using the medication if they are currently taking prescription drugs for diabetes, gout, or arthritis, any other medications, or if they are under a doctor's care for any serious condition.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. Currently, there are no specified storage or handling conditions outlined in the provided information. Therefore, it is recommended that healthcare professionals refer to the product's official labeling or consult with the manufacturer for any additional details regarding storage and handling requirements.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Aspirin 81 mg, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)