Pain Reliever

Description

This formulation contains 81 mg of a pain reliever. It is designed for the management of mild to moderate pain. The active ingredient is provided in a dosage form suitable for oral administration.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains, or as recommended by a healthcare professional. Due to its delayed action, this product is not suitable for the fast relief of headaches, fever, or other symptoms requiring immediate alleviation. Healthcare providers may consider other uses for Aspirin 81 mg based on individual patient needs.

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 healthcare provider for appropriate dosing recommendations.

Contraindications

Use is contraindicated in patients with a known allergy to aspirin or any other pain reliever or fever reducer. Additionally, individuals who have previously experienced an allergic reaction to this product or any of its ingredients should not use it, due to the risk of severe allergic responses.

Warnings and Precautions

Patients, particularly children and teenagers, should be cautioned against the use of this product if they have or are recovering from chickenpox or flu-like symptoms due to the risk of Reye’s syndrome. This rare but serious condition may present with changes in behavior accompanied by nausea and vomiting. If such symptoms occur, it is imperative to consult a healthcare professional immediately.

Aspirin, a component of this product, carries a risk of severe allergic reactions. Symptoms may include hives, facial swelling, asthma (wheezing), and shock. In the event of an allergic reaction, immediate medical attention is required.

This product contains a nonsteroidal anti-inflammatory drug (NSAID), which may increase the risk of stomach bleeding. The likelihood of this adverse effect is heightened in individuals who are 60 years of age or older, have a history of stomach ulcers or bleeding disorders, are taking anticoagulants or steroid medications, are using other NSAIDs (including aspirin, ibuprofen, or naproxen), consume three or more alcoholic beverages daily, or exceed the recommended dosage or duration of use.

Healthcare professionals should advise patients to discontinue use and seek medical advice if any of the following symptoms arise: signs of an allergic reaction, faintness, vomiting blood, bloody or black stools, worsening fever lasting more than three days, persistent stomach pain, worsening pain lasting more than ten days, presence of redness or swelling, new symptoms, or tinnitus or hearing loss.

In cases of overdose, it is critical to obtain emergency medical assistance or contact a Poison Control Center immediately at 1-800-222-1222.

Side Effects

Patients using this product should be aware of several serious and common adverse reactions associated with its use.

Reye’s syndrome is a rare but serious illness that may occur in children and teenagers who have or are recovering from chicken pox or flu-like symptoms. It is crucial for these individuals to avoid using 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 hives, facial swelling, asthma (wheezing), and shock. Patients experiencing any signs of an allergic reaction should seek medical help right away.

The product contains a nonsteroidal anti-inflammatory drug (NSAID), which may increase the risk of stomach bleeding. This risk is heightened in patients who are 60 years of age or older, have a history of stomach ulcers or bleeding problems, are taking blood-thinning medications or steroids, consume three or more alcoholic drinks daily while using the product, or take other medications containing NSAIDs, such as aspirin, ibuprofen, or naproxen. Patients should be advised to stop 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.

Patients are also advised to seek medical advice before using this product if they have a history of stomach problems, such as heartburn, or if they have high blood pressure, heart disease, liver cirrhosis, or kidney disease. Additionally, those taking diuretics or prescription medications for gout, diabetes, or arthritis should consult a doctor or pharmacist prior to use.

It is important for patients to monitor their health closely while using this product and to report any new or worsening symptoms, including fever lasting more than three days, pain persisting for more than ten days, redness or swelling, or any ringing in the ears or loss of hearing.

Drug Interactions

The concomitant use of aspirin with anticoagulants or steroid medications may elevate the risk of gastrointestinal bleeding. Healthcare professionals should exercise caution when prescribing these combinations and consider monitoring for signs of bleeding.

Additionally, the use of aspirin alongside other non-steroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen or naproxen, can further increase the risk of stomach bleeding. It is advisable for patients to consult their healthcare provider if they are concurrently taking any prescription medications for conditions such as gout, diabetes, or arthritis to ensure safe and effective management of their treatment regimen.

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

Packaging & NDC

Below are the non-prescription pack sizes of Pain Reliever (aspirin). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Children and teenagers who have or are 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 essential 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, not exceeding 48 tablets in a 24-hour period unless 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 stomach bleeding. It is essential for healthcare providers to assess this risk when prescribing treatment to geriatric patients.

Before initiating therapy, healthcare providers should inquire about any history of stomach problems, including but not limited to heartburn, high blood pressure, heart disease, liver cirrhosis, or kidney disease. Such conditions may necessitate additional caution or monitoring during treatment.

Healthcare providers are advised to discuss the stomach bleeding warning with elderly patients and recommend consulting a physician prior to use if this warning is applicable. This proactive approach can help mitigate potential adverse effects and ensure safer management of therapy in the geriatric population.

Pregnancy

Pregnant patients should consult a healthcare professional before using this medication, particularly if they are in the later stages of pregnancy or breastfeeding. The use of aspirin during the last trimester 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 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 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 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 considered as part of standard clinical practice.

Overdosage

In the absence of specific information regarding overdosage in the provided sections of the Structured Product Labeling (SPL), healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdosage.

Healthcare providers should monitor patients 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, it is recommended that healthcare professionals initiate supportive care and symptomatic treatment as necessary.

Management procedures should include the following steps:

1. Assessment: Conduct a thorough assessment of the patient's clinical status, including vital signs and level of consciousness.

2. Supportive Care: Provide supportive care tailored to the patient's needs, which may include intravenous fluids, oxygen supplementation, or other interventions as indicated.

3. Consultation: Consider consulting a poison control center or a medical toxicologist for guidance on specific management strategies based on the substance involved and the severity of symptoms.

Due to the lack of specific overdosage information, it is imperative for healthcare professionals to remain vigilant and utilize their clinical judgment in managing any suspected cases of overdosage.

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

No specific postmarketing experience details have been reported in the available data. As such, there are no additional adverse events or rare case reports to summarize at this time.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222 in the event of an overdose. It is crucial to inform patients that they should not use this product if they have a known allergy to aspirin or any other pain reliever or fever reducer. Additionally, patients should be cautioned against using the product if they have previously experienced an allergic reaction to it or any of its ingredients.

Patients must be instructed to discontinue use and consult a doctor if they experience any signs of an allergic reaction. They should also seek medical help immediately if they notice symptoms indicative of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or if their fever worsens or persists for more than three days. Other concerning symptoms include persistent stomach pain, worsening pain lasting more than ten days, the presence of redness or swelling, the emergence of new symptoms, or experiencing ringing in the ears or loss of hearing.

Healthcare providers should encourage patients to consult a doctor before using the product if they have a history of stomach problems, such as heartburn, or if the stomach bleeding warning applies to them. It is also important to advise patients to seek medical advice if they have high blood pressure, heart disease, liver cirrhosis, or kidney disease. Patients taking diuretics or those with asthma should also be encouraged to discuss their conditions with a healthcare provider prior to use. Furthermore, patients should be advised to consult a doctor or pharmacist if they are currently taking prescription medications for gout, diabetes, or arthritis.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at room temperature, ensuring that it is kept away from excessive heat. Temperatures should not exceed 40°C (104°F) to maintain the integrity of the product. Proper storage conditions are crucial for preserving the quality and efficacy of the product.

Additional Clinical Information

The medication is administered orally, with specific dosing guidelines for different age groups. Adults and children aged 12 years and older are advised to take 4 to 8 tablets every 4 hours, not exceeding 48 tablets in a 24-hour period unless directed by a physician. For children under 12 years, consultation with a doctor is recommended prior to use.

Clinicians should counsel patients regarding the use of this medication during pregnancy and breastfeeding. It is particularly important to avoid aspirin in the last trimester of pregnancy unless explicitly directed by a healthcare professional, 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 Pain Reliever, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

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