Aspirin 81 mg

Description

Reliable-1 is an adult low strength pain reliever containing Aspirin USP at a dosage of 81 mg per tablet. This nonsteroidal anti-inflammatory drug (NSAID) is enteric coated to minimize gastrointestinal irritation. Each bottle contains 120 tablets. The product is formulated to compare to the active ingredient in the Aspirin Regimen BAYER®. The National Drug Code (NDC) for this product is 69168-066-02.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains. Due to its delayed action, it is not suitable for the fast relief of headaches or other symptoms requiring immediate alleviation. Healthcare professionals are encouraged to consult with patients regarding additional potential uses for enteric-coated 81 mg Aspirin.

There are no teratogenic or nonteratogenic effects associated with this product.

Dosage and Administration

Patients are advised to 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 should 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 essential to consult a healthcare provider 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 may be early indicators of this rare but serious condition.

Healthcare professionals should advise patients to seek medical guidance before using this product 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, or kidney disease. Additionally, caution is warranted for patients taking diuretics, those with asthma, individuals who have not been adequately hydrating, or those who have experienced significant fluid loss due to vomiting or diarrhea.

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

Patients should discontinue use and consult a healthcare provider if they experience any signs of an allergic reaction, such as difficulty breathing or swelling of the face, lips, or throat. Furthermore, they should seek medical attention if they notice symptoms indicative of stomach bleeding, including feeling faint, passing bloody or black stools, vomiting blood, or experiencing persistent stomach pain. If pain worsens or lasts longer than 10 days, if redness or swelling occurs, if new symptoms arise, or if there is ringing in the ears or a loss of hearing, patients should also stop taking the product and contact their doctor.

Side Effects

Patients using this product should be aware of several potential adverse reactions, which can range from serious to common.

Serious adverse reactions include the risk of Reye's syndrome, particularly in children and teenagers who have or are recovering from chickenpox or flu-like symptoms. It is crucial for patients to consult a doctor if they observe changes in behavior accompanied by nausea and vomiting, as these may be early signs of this rare but serious illness.

Patients should also stop using the product and seek medical attention if they experience any signs of an allergic reaction, which may require immediate intervention. Additionally, symptoms indicative of stomach bleeding, such as feeling faint, having bloody or black stools, vomiting blood, or experiencing persistent stomach pain, warrant urgent medical consultation.

Other serious concerns include worsening pain that lasts more than 10 days, the presence of redness or swelling, the emergence of new symptoms, and auditory disturbances such as ringing in the ears or loss of hearing.

It is essential for patients to monitor their health closely while using this product and to communicate any concerning symptoms to their healthcare provider promptly.

Drug Interactions

Aspirin has several notable drug interactions that may increase the risk of adverse effects, particularly gastrointestinal bleeding.

Anticoagulants and NSAIDs Aspirin may significantly enhance the risk of severe stomach bleeding when used concurrently with anticoagulant medications or other nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen or naproxen. It is advisable to avoid the concomitant use of these agents unless under the supervision of a healthcare professional.

Diabetes, Gout, and Arthritis Medications Patients taking prescription medications for diabetes, gout, or arthritis should consult a healthcare provider prior to using aspirin, as potential interactions may occur that could affect the efficacy or safety of these treatments.

Risk Factors for Gastrointestinal Bleeding The risk of gastrointestinal bleeding is notably increased in individuals aged 60 years or older, those with a history of stomach ulcers or bleeding disorders, individuals consuming three or more alcoholic beverages daily, or those who exceed the recommended dosage of aspirin. Monitoring and caution are advised in these populations.

Diuretics and Comorbid Conditions Patients on diuretics or those with high blood pressure, heart disease, liver cirrhosis, or kidney disease should seek medical advice before using aspirin. These conditions may interact with aspirin, necessitating careful consideration of the benefits and risks involved.

Packaging & NDC

Below are the non-prescription pack sizes of Aspirin 81 mg (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 while using this product, it is important to consult a doctor, as these may be early signs of Reye's syndrome.

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 doctor. For children under 12 years of age, consultation with a doctor is advised before use.

Geriatric Use

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

Monitoring for signs and symptoms of gastrointestinal bleeding is recommended in this population. Additionally, healthcare providers should consider the overall health status and concurrent medications of elderly patients, as these factors may further influence the risk of adverse effects.

Dose adjustments may be necessary based on individual patient assessments, and careful evaluation of the benefits versus risks should guide treatment decisions in geriatric patients.

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 pose risks to the unborn child and lead to 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. It is particularly important to avoid the use of aspirin during the last three months of pregnancy unless explicitly 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 its use in lactating mothers.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

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 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 implement supportive care measures, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

If available, specific antidotes or treatments should be administered as indicated based on the substance involved. Consultation with a poison control center or a medical toxicologist is recommended for guidance on the appropriate management of overdose cases.

Documentation of the incident, including the amount and timing of the substance taken, is crucial for effective treatment and follow-up care.

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 provided regarding nonclinical toxicology or animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions associated with the use of aspirin. These include gastrointestinal bleeding, allergic reactions such as anaphylaxis, Reye's syndrome in children and teenagers recovering from chickenpox or flu-like symptoms, asthma exacerbation, tinnitus (ringing in the ears), and hearing loss.

Additionally, safety updates from postmarketing experience indicate an increased risk of gastrointestinal bleeding in patients over 60 years of age or those with a history of stomach ulcers or bleeding problems. Caution is advised for patients taking anticoagulants or other nonsteroidal anti-inflammatory drugs (NSAIDs), as well as for those consuming three or more alcoholic drinks daily while using aspirin.

Patient Counseling

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

Patients must be informed not to use the medication if they have a known allergy to aspirin or any other pain reliever or fever reducer. They should be counseled to stop use and consult a doctor if they experience any signs of an allergic reaction, such as difficulty breathing or swelling of the face or throat, and to seek medical assistance right away. Additionally, patients should be made aware of the signs of stomach bleeding, which include feeling faint, having bloody or black stools, vomiting blood, or experiencing persistent stomach pain. They should also be advised to discontinue use 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.

Before initiating treatment, healthcare providers should encourage patients to consult a doctor if any of the following apply: they have a history of stomach problems, such as heartburn; they have high blood pressure, heart disease, liver cirrhosis, or kidney disease; they are taking a diuretic; they have asthma; they have not been adequately hydrating; or they have experienced significant fluid loss due to vomiting or diarrhea.

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

Storage and Handling

The product is supplied in accordance with the National Drug Code (NDC) specifications. It should be stored at a controlled room temperature of 25°C (77°F), with permissible excursions between 15°C and 30°C (59°F and 86°F). It is essential to adhere to the use by expiration date indicated on the package to ensure product efficacy and safety.

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)