Extra Strength Pain Reliever

Description

No description information is available for the specified drug.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains.

There are no teratogenic effects associated with this drug, nor are there any nonteratogenic effects noted.

Dosage and Administration

Patients should adhere strictly to the recommended dosage. For adults and children aged 12 years and older, the prescribed dosage is 2 caplets every 6 hours, with a maximum of 8 caplets within a 24-hour period. It is essential to take each dose with a full glass of water to ensure proper administration and absorption.

For children under the age of 12, it is advised to consult a physician for appropriate dosing recommendations.

Contraindications

Use of this product is contraindicated in the following situations:

• Patients with a history of allergic reactions to acetaminophen, aspirin, or any other pain reliever or fever reducer.

• Concurrent use with any other medication containing acetaminophen, whether prescription or nonprescription. If there is uncertainty regarding the presence of acetaminophen in a medication, consultation with a healthcare professional is advised.

• Individuals who have previously experienced an allergic reaction 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, a rare but serious illness. If any changes in behavior accompanied by nausea and vomiting occur while using this product, it is imperative to consult a healthcare professional immediately.

Aspirin, a component of this product, may lead to severe allergic reactions, which can manifest as hives, facial swelling, asthma (wheezing), or shock. Similarly, acetaminophen may cause severe skin reactions, including rash, skin reddening, and blisters. In the event of a skin reaction, discontinuation of the product and immediate medical assistance are necessary.

This product contains acetaminophen, which poses a risk of severe liver damage if the following conditions are met: exceeding 4,000 mg of acetaminophen within a 24-hour period, concurrent use with other medications containing acetaminophen, or consumption of three or more alcoholic drinks daily while using this product.

The presence of an NSAID in this product raises the potential for severe stomach bleeding, particularly in individuals with a history of stomach ulcers or bleeding problems, those taking anticoagulants or steroid medications, or those using other NSAIDs (including aspirin, ibuprofen, or naproxen). The risk is also heightened for individuals aged 60 or older, those consuming three or more alcoholic drinks daily, or those who exceed the recommended dosage or duration of use.

Caution is advised regarding caffeine intake, as the recommended dose of this product contains approximately the same amount of caffeine as a cup of coffee. It is advisable to limit the use of other caffeine-containing medications, foods, or beverages to avoid potential side effects such as nervousness, irritability, sleeplessness, and, in some cases, rapid heartbeat.

Healthcare professionals should advise patients to consult a doctor prior to use if they have liver disease, a history of stomach problems (such as heartburn), high blood pressure, heart disease, liver cirrhosis, kidney disease, or if they are taking diuretics or have asthma. Additionally, patients should seek guidance from a doctor or pharmacist if they are currently taking prescription medications for diabetes, gout, or arthritis, or if they are under medical care for any serious condition.

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

Patients should discontinue use and contact a healthcare provider if they experience any signs of an allergic reaction or symptoms indicative of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain. Additional symptoms warranting medical attention include ringing in the ears or loss of hearing, redness or swelling in a painful area, worsening pain lasting more than 10 days, fever persisting beyond three days, or the emergence of new symptoms that may suggest a serious condition.

Side Effects

Patients using this product should be aware of several serious adverse reactions and warnings 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. Patients should not use this product under these circumstances. If changes in behavior accompanied by nausea and vomiting occur while using this product, it is crucial to consult a healthcare professional, as these symptoms could indicate the onset of Reye’s syndrome.

Severe allergic reactions to aspirin may manifest as hives, facial swelling, asthma (wheezing), or shock. Additionally, acetaminophen may lead to severe skin reactions, including rash, skin reddening, and blisters. Should any skin reaction occur, patients are advised to discontinue use immediately and seek medical assistance.

The product contains acetaminophen, which poses a risk of severe liver damage if patients exceed 4,000 mg in a 24-hour period, use it in conjunction with other medications containing acetaminophen, or consume three or more alcoholic drinks daily while using this product.

Furthermore, the presence of an NSAID in this product raises the risk of severe stomach bleeding, particularly in patients with a history of stomach ulcers or bleeding problems, those taking anticoagulants or steroid medications, individuals aged 60 or older, and those consuming three or more alcoholic drinks daily while using this product. Patients should also be cautious not to exceed the recommended dosage or duration of use.

Lastly, the recommended dose of this product contains approximately the same amount of caffeine as a cup of coffee. Patients are advised to limit the intake of other caffeine-containing medications, foods, or beverages, as excessive caffeine consumption may lead to nervousness, irritability, sleeplessness, and, in some cases, rapid heartbeat.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there are no known interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are necessary at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Extra Strength Pain Reliever (acetaminophen, aspirin and caffeine). 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, it is essential to consult a healthcare professional, as these may be early signs of Reye’s syndrome.

For dosing, adults and children aged 12 years and older are directed to take 2 caplets every 6 hours, with a maximum of 8 caplets in a 24-hour period. For children under 12 years of age, it is advised to consult a doctor before use.

This product should be kept out of reach of children. In the event of an accidental overdose, immediate medical assistance should be sought, or contact a Poison Control Center (1-800-222-1222). Prompt medical attention is critical for both adults and children, even if no signs or symptoms are immediately apparent.

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 exercise caution when prescribing medications that may exacerbate this risk in this population.

Monitoring for signs of gastrointestinal bleeding is advised, and dosage adjustments may be necessary based on the individual patient's health status and concurrent medications. Careful assessment of the benefits and risks is crucial when treating geriatric patients to ensure their safety and well-being.

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 unborn child and 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 pregnancy 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 the use of this medication during lactation.

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 should be closely monitored when using this product, which contains acetaminophen. It is important to note that severe liver damage may occur if patients exceed the following limits:

• More than 4,000 mg of acetaminophen in a 24-hour period.

• Concurrent use with other medications that also contain acetaminophen.

• Consumption of three or more alcoholic drinks daily while using this product.

Due to the potential for increased risk of liver toxicity, patients with compromised liver function should be advised to adhere strictly to the recommended dosage and to avoid the aforementioned risk factors. Regular assessment of liver function may be warranted in these patients to ensure safety and prevent adverse effects.

Overdosage

There is currently no specific information available regarding overdosage for this medication. Healthcare professionals are advised to monitor patients closely for any signs of adverse effects or symptoms that may arise from excessive dosing.

In the event of suspected overdosage, it is recommended that healthcare providers initiate supportive care and symptomatic treatment as necessary. Patients should be evaluated for potential complications, and appropriate interventions should be implemented based on clinical judgment.

For further guidance, healthcare professionals may refer to established protocols for managing drug overdosage or consult a poison control center.

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 specific non-teratogenic effects or additional nonclinical toxicology details are available in the provided data. Furthermore, there are no specific findings related to animal pharmacology and toxicology.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

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 accidental overdose, patients should be instructed to seek medical help immediately or contact a Poison Control Center at 1-800-222-1222. It is crucial to emphasize that prompt medical attention is necessary for both adults and children, even if no signs or symptoms are apparent.

Additionally, healthcare providers should counsel patients who are pregnant or breastfeeding to consult a health professional before using this medication. It is particularly important to inform patients that aspirin should not be used at 20 weeks of pregnancy or later unless specifically directed by a doctor, as it may pose risks to the unborn child or lead to complications during delivery.

Storage and Handling

The product is supplied in various configurations, with specific NDC numbers available for identification. It should be stored at a temperature range of 20° to 25°C (68° to 77°F), with permissible excursions between 15° and 30°C (59° to 86°F). To ensure product integrity, it is essential to close the cap tightly after each use. Proper adherence to these storage and handling guidelines is crucial for maintaining the quality and efficacy of the product.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)