Pain Reliever

Description

No relevant information is available for SPL code 34089-3.

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 intended for the fast relief of headaches or other symptoms requiring immediate 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 for optimal efficacy.

For adults and children aged 12 years and older, the recommended dosage is 4 to 8 tablets every 4 hours as needed for symptom relief. It is important not to exceed a total of 48 tablets within a 24-hour period unless specifically directed by a healthcare professional.

For children under 12 years of age, it is advised to consult a doctor 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 this rare but serious illness.

Aspirin may provoke severe allergic reactions, which can manifest as hives, shock, facial swelling, or asthma symptoms such as wheezing. Healthcare professionals should be vigilant for these signs and advise patients to seek immediate medical attention if they occur.

This product contains a nonsteroidal anti-inflammatory drug (NSAID), which carries a risk of severe stomach bleeding. The likelihood of this adverse effect is increased 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 while using this product, or exceed the recommended dosage or duration of use.

Healthcare providers should advise patients to consult a physician prior to using this product if they have asthma, if the stomach bleeding warning applies to them, if they have a history of gastrointestinal issues such as heartburn, or if they have conditions such as high blood pressure, heart disease, liver cirrhosis, or kidney disease. Additionally, patients taking diuretics or any prescription medications for diabetes, gout, or arthritis should seek guidance from their healthcare provider or pharmacist before use.

In the event of an overdose, it is crucial to obtain emergency medical assistance or contact a Poison Control Center (1-800-222-1222) immediately. Prompt medical intervention is essential for both adults and children, even in the absence of noticeable symptoms.

Patients should discontinue use and contact their healthcare provider if they experience any signs of stomach bleeding, including feeling faint, having bloody or black stools, vomiting blood, or experiencing persistent stomach pain. Immediate medical attention is also warranted if an allergic reaction occurs, if there is ringing in the ears or loss of hearing, if pain worsens or persists beyond 10 days, if fever intensifies or lasts more than 3 days, if redness or swelling appears in the affected area, or if new symptoms arise, as these may indicate a serious condition.

Side Effects

Patients using this product should be aware of several serious 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 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 Reye's syndrome.

Additionally, aspirin may cause severe allergic reactions, which can manifest as hives, shock, facial swelling, or asthma (wheezing). Patients should be vigilant for these symptoms and seek medical attention if they occur.

This 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 are 60 years of age or older, have a history of stomach ulcers or bleeding problems, are taking anticoagulants or steroid medications, 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, including feeling faint, having bloody or black stools, vomiting blood, or experiencing persistent stomach pain.

Common adverse reactions may include ringing in the ears or loss of hearing, worsening pain lasting more than 10 days, fever lasting more than three days, redness or swelling in the painful area, or the emergence of new symptoms. Patients are encouraged to seek medical help if any of these occur.

Before using this product, patients should consult a doctor if they have asthma, a history of stomach problems such as heartburn, high blood pressure, heart disease, liver cirrhosis, or kidney disease. It is also advisable to seek medical advice if they are taking diuretics or any prescription drugs for diabetes, gout, or arthritis, or if they are under a doctor's care for any serious condition.

Drug Interactions

Aspirin has several important drug interactions that should be considered to ensure patient safety and efficacy of treatment.

Pharmacodynamic Interactions

Aspirin may lead to severe allergic reactions, which can manifest as hives, shock, facial swelling, and asthma symptoms such as wheezing. Patients should be monitored for any signs of an allergic response, particularly if they have a history of allergies to nonsteroidal anti-inflammatory drugs (NSAIDs).

Pharmacokinetic Interactions

The concomitant use of aspirin with anticoagulants or steroid medications significantly increases the risk of severe gastrointestinal bleeding. It is advisable to assess the necessity of dosage adjustments or enhanced monitoring for patients who are prescribed these medications alongside aspirin.

Additionally, caution is warranted when aspirin is used in patients taking prescription medications for diabetes, gout, or arthritis. Consultation with a healthcare provider is recommended prior to initiating aspirin therapy in these cases to evaluate potential interactions and adjust treatment plans accordingly.

Special Populations

Aspirin is contraindicated in children and teenagers who have or are recovering from chickenpox or flu-like symptoms due to the associated risk of Reye's syndrome. This population should be carefully evaluated to avoid the use of aspirin in these circumstances.

Packaging & NDC

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

Pediatric Use

Pediatric patients, particularly children and teenagers, should not use this product if they have or are recovering from chicken pox or flu-like symptoms due to the risk of Reye's syndrome. It is important to consult a healthcare professional if any changes in behavior accompanied by nausea and vomiting occur, as these may be early indicators of Reye's syndrome.

For children under 12 years of age, it is advised to seek medical guidance before use. The recommended dosing for adults and children aged 12 years and older is 4 to 8 tablets every 4 hours as needed for symptom relief, with a maximum limit of 48 tablets in a 24-hour period unless otherwise directed by a healthcare provider.

Geriatric Use

Elderly patients, particularly those aged 60 and older, are at an increased risk for severe stomach bleeding. This heightened risk necessitates careful consideration and monitoring when prescribing medications that may contribute to gastrointestinal complications.

Healthcare providers should advise geriatric patients to consult with their physician if they have a history of stomach issues, such as heartburn, or if they fall within the age group where the stomach bleeding warning is applicable. It is essential to evaluate the patient's overall health status and any potential contraindications before initiating treatment, ensuring that appropriate precautions are taken to mitigate risks associated with gastrointestinal bleeding.

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 the unborn child 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 before 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

Patients with renal impairment should consult a healthcare professional prior to use, particularly if they have comorbid conditions such as high blood pressure, heart disease, liver cirrhosis, or kidney disease. Additionally, caution is advised for patients who are taking a diuretic, as this may further impact renal function and necessitate closer monitoring.

Hepatic Impairment

Patients with hepatic impairment should consult a healthcare professional prior to use, particularly if they have conditions such as liver cirrhosis. It is essential for these patients to receive appropriate evaluation and monitoring of their liver function to ensure safe use of the medication. Adjustments to dosage may be necessary based on the severity of hepatic impairment, and ongoing assessment of liver function is recommended throughout the treatment period.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222. Prompt medical intervention is crucial for both adults and children, even in the absence of noticeable signs or symptoms.

Healthcare professionals should be aware that the timely recognition and management of overdose situations can significantly impact patient outcomes. Therefore, it is essential to remain vigilant and proactive in addressing potential overdose cases.

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

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 (1-800-222-1222) in the event of an overdose, as prompt medical attention is crucial for both adults and children, even if no signs or symptoms are apparent.

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 to instruct patients to discontinue use and consult a doctor if they experience any signs of stomach bleeding, which may include feeling faint, having bloody or black stools, vomiting blood, experiencing persistent stomach pain, or if an allergic reaction occurs.

Patients should also be advised to seek medical help immediately if they notice ringing in the ears or experience a loss of hearing. Additionally, they should stop using the medication and consult a doctor if their pain worsens or persists for more than 10 days, if their fever intensifies or lasts longer than 3 days, if there is redness or swelling in the painful area, or if any new symptoms arise, as these may indicate a serious condition.

It is essential for healthcare providers to recommend that patients consult a doctor before using the medication if they have asthma, a history of stomach problems such as heartburn, or if the stomach bleeding warning applies to them. Patients with high blood pressure, heart disease, liver cirrhosis, or kidney disease should also be advised to seek medical guidance prior to use. Furthermore, patients taking diuretics or prescription medications for diabetes, gout, or arthritis should consult a doctor or pharmacist before using this medication. Lastly, patients under a doctor's care for any serious condition should be encouraged to discuss their use of this medication with their healthcare provider.

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, maintaining a range of 15-30ºC (59-86ºF). Proper storage conditions are crucial to ensure the integrity and efficacy of the product.

Additional Clinical Information

Patients should be advised to take the medication with a full glass of water. For adults and children aged 12 years and older, the recommended dosage is 4 to 8 tablets every 4 hours as needed, with a maximum of 48 tablets in a 24-hour period unless otherwise directed by a physician. For children under 12 years, consultation with a doctor is recommended before administration.

Clinicians should counsel patients who are pregnant or breastfeeding to seek advice from a health professional prior to use. It is particularly important to avoid aspirin during the last trimester of pregnancy unless specifically instructed by a doctor, due to potential risks to the unborn child and complications during delivery. In the event of an overdose, patients should seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222, as prompt attention is crucial for both adults and children, even in the absence of symptoms.

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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