Pain Relief Aspirin

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains, as well as for use as recommended by a healthcare professional. Due to its delayed 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 adhere strictly to the recommended dosage and administration guidelines.

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.

It is essential for patients to consume a full glass of water with each dose to ensure proper hydration and facilitate the medication's effectiveness.

For children under 12 years of age, the use of this medication is not advised unless specifically directed by a physician.

Contraindications

Use of this product is contraindicated in individuals with a known allergy to aspirin or any other pain reliever or fever reducer. Additionally, it should not be used in patients who have a history of allergic reactions to this product or any of its components.

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, shock, hives, and asthma-related 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 patients who are 60 years of age or older, those taking anticoagulants or steroid medications, individuals consuming three or more alcoholic beverages daily while using this product, and patients with a history of stomach ulcers or bleeding disorders. Additionally, the risk is heightened if the product is used in excess of the recommended dosage or duration, or if other NSAIDs (including prescription or nonprescription medications such as aspirin, ibuprofen, or naproxen) are concurrently administered.

Healthcare professionals should advise patients to consult a physician prior to using this product if they have a history of stomach issues, such as heartburn, or if they have conditions such as high blood pressure, heart disease, liver cirrhosis, or kidney disease. Patients with asthma or those taking diuretics should also seek medical advice before use. Furthermore, it is recommended that patients inform their healthcare provider or pharmacist if they are currently taking prescription medications for gout, diabetes, or arthritis.

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 contact their healthcare provider if they experience any signs of an allergic reaction, such as difficulty breathing or swelling. Additionally, they should seek medical attention if they notice any symptoms indicative of stomach bleeding, including bloody or black stools, faintness, vomiting blood, or persistent stomach pain. Other concerning symptoms that warrant medical consultation include ringing in the ears, hearing loss, worsening pain lasting more than 10 days, fever persisting beyond 3 days, visible redness or swelling, or the emergence of new symptoms, as these may signal a serious underlying condition.

Side Effects

Patients using this product should be aware of several serious adverse reactions associated with its use. Notably, Reye's syndrome is a rare but serious illness that can 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, there is a significant risk of severe allergic reactions to aspirin, which may manifest as facial swelling, shock, hives, or asthma (wheezing). Patients experiencing any signs of an allergic reaction should seek medical help right away.

This product contains a nonsteroidal anti-inflammatory drug (NSAID), which may lead to severe stomach bleeding. The risk of this adverse reaction is heightened in patients who are 60 years of age or older, those taking blood-thinning medications or steroids, individuals consuming three or more alcoholic drinks daily while using the product, patients with a history of stomach ulcers or bleeding problems, and those who exceed the recommended dosage or duration of use. Furthermore, concurrent use of other medications containing NSAIDs, such as aspirin, ibuprofen, or naproxen, may increase the likelihood of stomach bleeding.

Patients are advised to discontinue use and consult a doctor if they experience any signs of stomach bleeding, which may include bloody or black stools, faintness, vomiting blood, or persistent stomach pain. Other concerning symptoms warranting medical attention include ringing in the ears or loss of hearing, worsening pain lasting more than 10 days, fever that worsens or lasts more than three days, redness or swelling, or the emergence of new symptoms. These could indicate a serious condition requiring prompt evaluation.

Drug Interactions

Aspirin is associated with a significant risk of severe gastrointestinal bleeding, particularly when co-administered with anticoagulants or steroid medications. This interaction necessitates careful consideration of the patient's overall medication regimen to mitigate potential adverse effects.

Additionally, the concomitant use of aspirin with other nonsteroidal anti-inflammatory drugs (NSAIDs), including both prescription and over-the-counter options such as ibuprofen and naproxen, further elevates the risk of gastrointestinal bleeding. Clinicians should monitor patients closely and consider dosage adjustments or alternative therapies to minimize this risk.

For patients taking prescription medications for gout, diabetes, or arthritis, it is advisable to consult a healthcare provider to evaluate potential interactions and ensure safe and effective management of their conditions. Regular monitoring and assessment of the patient's response to therapy may be warranted in these cases.

Packaging & NDC

Below are the non-prescription pack sizes of Pain Relief Aspirin (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 unless directed by a healthcare professional. It is contraindicated in children and teenagers who have or are recovering from chickenpox or flu-like symptoms.

For patients 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 physician.

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 and older, are at an increased risk of severe stomach bleeding when using this product, which contains a nonsteroidal anti-inflammatory drug (NSAID). It is crucial for healthcare providers to assess the individual risk factors for stomach bleeding in geriatric patients prior to prescribing this medication.

Before initiating treatment, healthcare providers should advise elderly patients to consult with their physician if they have a history of stomach bleeding or if they have comorbid conditions such as high blood pressure, heart disease, liver cirrhosis, or kidney disease. These conditions may further elevate the risk of adverse effects associated with NSAID use.

Close monitoring of elderly patients is recommended to ensure safety and efficacy, and dosage adjustments may be necessary based on the patient's overall health status and concurrent medical conditions.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional before using this medication. It is particularly important to avoid the use of aspirin after 20 weeks of pregnancy unless specifically directed by a physician, as it may pose risks to the developing fetus and could 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 before using this medication. It is particularly important to avoid the use of aspirin at 20 weeks of gestation or later 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 its use during lactation.

Renal Impairment

Patients with renal impairment should consult a healthcare professional prior to use, particularly if they have conditions such as high blood pressure, heart disease, liver cirrhosis, or kidney disease. It is essential to assess renal function and consider potential dosing adjustments or monitoring requirements based on the severity of renal impairment.

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 without delay. Prompt intervention is crucial to mitigate potential adverse effects associated with the overdose.

Healthcare professionals should be aware that the specific symptoms of an overdose may vary depending on the substance involved. Therefore, a thorough assessment of the patient's condition is essential to determine the appropriate course of action.

Management of an overdose typically involves supportive care and symptomatic treatment. Continuous monitoring of the patient's vital signs and clinical status is recommended. In cases where the specific substance is known, targeted therapies may be employed as indicated.

It is essential for healthcare providers to remain vigilant and act swiftly in the management of overdose situations to ensure optimal patient outcomes.

Nonclinical Toxicology

It is especially important not to use aspirin at 20 weeks or later in pregnancy unless definitely directed to do so by a doctor, as it may cause problems in the unborn child or complications during delivery. No non-teratogenic effects have been specified. Additionally, there are no details provided regarding nonclinical toxicology or animal pharmacology and toxicology.

Postmarketing Experience

No specific postmarketing experience details are available in the extracted data. As such, there are no additional adverse events or rare case reports to summarize.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center in the event of an overdose. It is crucial to inform patients not to 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 should be instructed to discontinue use and consult a doctor if they experience any signs of an allergic reaction, and to seek medical help immediately in such cases. They should also be made aware of the signs of potential stomach bleeding, which include bloody or black stools, faintness, vomiting blood, or persistent stomach pain. If any of these symptoms occur, patients should stop using the product and contact their healthcare provider.

Furthermore, patients should be advised to stop use and consult a doctor if they experience ringing in the ears, a loss of hearing, worsening pain that lasts more than 10 days, or a fever that worsens or lasts more than 3 days. Any signs of redness or swelling, or the emergence of new symptoms should also prompt a consultation with a healthcare provider, as these may indicate a serious condition.

Patients should be encouraged to discuss their medical history with their healthcare provider before using the product, particularly if they have a history of stomach problems such as heartburn, high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma. It is also important for patients to inform their healthcare provider if they are taking a diuretic or any prescription medications for gout, diabetes, or arthritis prior to using this product.

Storage and Handling

The product is supplied in packaging that includes specific NDC numbers. It should be stored at a controlled room temperature of 25ºC (77ºF), with permissible excursions between 15ºC and 30ºC (59ºF to 86ºF). It is essential to adhere to the expiration date indicated on the package to ensure product efficacy and safety.

Additional Clinical Information

Patients are advised to consult with their doctor or healthcare provider prior to using this product for heart-related conditions. No further information is available regarding laboratory tests, abuse potential, route, method, or frequency of administration, or postmarketing experiences.

Drug Information (PDF)

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

View product document (PDF)