Extra Pain Relief Acetaminophen, Aspirin (nsaid) and Caffeine

Description

The drug is identified by SPL code 34089-3 and is presented as a white to off-white, round, biconvex tablet, which is debossed with "A" on one side and "123" on the other. Each tablet contains 500 mg of Acetaminophen. The formulation includes several inactive ingredients: microcrystalline cellulose, croscarmellose sodium, stearic acid, povidone, magnesium stearate, talc, hypromellose, polyethylene glycol, titanium dioxide, iron oxide red, and iron oxide yellow.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with various conditions, including headache, sinusitis, cold, arthritis, muscular aches, toothache, and premenstrual and menstrual cramps.

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

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 tablets every 6 hours, with a maximum limit of 8 tablets within a 24-hour period. Each dose should be accompanied by a full glass of water to ensure proper administration.

For children under 12 years of age, the use of this medication is not advised unless specifically directed by a healthcare professional. It is essential to follow these guidelines to avoid potential overdose and ensure safe usage.

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 should not use this product due to the risk of severe allergic reactions.

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

The product should not be used for pain relief for more than 10 days unless directed by a healthcare provider, as prolonged use may lead to adverse effects. Similarly, it is contraindicated for use in managing fever for more than 3 days without medical supervision, to prevent potential complications.

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 skin reddening, blisters, or rash. In the event of a skin reaction, the use of the product should be discontinued, and medical assistance should be sought without delay.

This product contains acetaminophen, which poses a risk of severe liver damage if the following conditions are met: exceeding 8 tablets within a 24-hour period (the maximum daily amount), 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 formulation raises the risk of severe stomach bleeding, particularly in individuals who are 60 years or older, have a history of stomach ulcers or bleeding problems, are taking anticoagulants or steroid medications, are using other NSAIDs (such as aspirin, ibuprofen, or naproxen), consume three or more alcoholic drinks daily, or 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. Limiting the use of other caffeine-containing medications, foods, or beverages is recommended 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 before using this product if they have a history of stomach problems (such as heartburn), high blood pressure, heart disease, liver cirrhosis, kidney disease, are taking diuretics, have asthma, or have liver disease.

In the event of an accidental overdose, immediate medical attention is crucial. Patients should contact a Poison Control Center or seek emergency medical help right away, regardless of whether symptoms are present.

Patients should discontinue use and consult a healthcare provider if any of the following occur: signs of an allergic reaction, redness or swelling in the painful area, lack of improvement in symptoms, appearance of new symptoms, worsening pain or fever, signs of stomach bleeding (such as feeling faint, vomiting blood, having bloody or black stools, or persistent stomach pain), ringing in the ears or hearing loss, fever lasting more than three days, or pain lasting more than ten days.

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 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 symptoms could indicate the onset of Reye's syndrome.

Severe allergic reactions may occur, particularly in patients sensitive to aspirin or acetaminophen. Symptoms of an allergic reaction to aspirin may include hives, facial swelling, asthma (wheezing), and shock. For acetaminophen, severe skin reactions can manifest as skin reddening, blisters, or rash. If any of these symptoms occur, patients should discontinue use and seek medical assistance promptly.

The product contains acetaminophen, which poses a risk of severe liver damage if patients exceed the maximum daily dosage of 8 tablets within 24 hours, use it in conjunction with other acetaminophen-containing medications, or consume three or more alcoholic drinks daily while using the product.

Additionally, the presence of an NSAID in this product raises the risk of severe stomach bleeding, particularly in patients aged 60 or older, those with a history of stomach ulcers or bleeding problems, or those taking anticoagulants, steroids, or other NSAIDs. Patients who consume three or more alcoholic drinks daily or take the product for longer than directed are also at increased risk.

Caffeine is another component of this product, and patients are advised to limit the intake of other caffeine-containing medications, foods, or beverages. Excessive caffeine consumption may lead to nervousness, irritability, sleeplessness, and, in some cases, rapid heartbeat.

Patients should stop using the product and consult a doctor if they experience any signs of an allergic reaction, if the painful area becomes red or swollen, if symptoms do not improve, or if new symptoms appear. They should also seek medical attention if pain or fever persists or worsens, or if they notice signs of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or experiencing unrelenting stomach pain. Additionally, if patients experience ringing in the ears or a loss of hearing, they should consult a doctor before continuing use.

Before using this product, patients should consult a healthcare professional if they have a history of stomach problems, high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma, or if they are taking diuretics.

Drug Interactions

Patients taking anticoagulants or steroid medications may experience increased risks of adverse effects when co-administered with this drug. It is advisable to monitor for signs of bleeding or other complications and consider dosage adjustments as necessary.

Concomitant use of this drug with other nonsteroidal anti-inflammatory drugs (NSAIDs), including both prescription and nonprescription options such as aspirin, ibuprofen, and naproxen, may elevate the risk of gastrointestinal irritation or bleeding. Close monitoring of the patient's condition is recommended, and dosage adjustments should be considered based on clinical judgment.

Additionally, the use of this drug alongside any other products containing acetaminophen, whether prescription or nonprescription, may lead to an increased risk of hepatotoxicity. It is essential to monitor liver function and adjust dosages accordingly to mitigate potential risks.

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

Packaging & NDC

Below are the non-prescription pack sizes of Extra Pain Relief Acetaminophen, Aspirin (nsaid) and Caffeine (acetaminophen, aspirin, caffeine). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 12 years of age should not use this product unless directed by a healthcare professional. It is important to note that children and teenagers who have or are recovering from chickenpox or flu-like symptoms should avoid 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, a healthcare provider should be consulted immediately, as these may be early signs of Reye's syndrome.

In the event of an accidental overdose, it is crucial to seek medical assistance or contact a Poison Control Center promptly, as timely intervention is essential for both children and adults, even if no symptoms are apparent.

For patients aged 12 years and older, the recommended dosage is 2 tablets every 6 hours, with a maximum of 8 tablets in a 24-hour period.

Geriatric Use

Elderly patients, particularly those aged 60 years and older, are at an increased risk of severe stomach bleeding when using this product, which contains a nonsteroidal anti-inflammatory drug (NSAID). This risk is further heightened in individuals with a history of stomach ulcers or bleeding problems, those who are concurrently using blood-thinning medications (anticoagulants) or steroid drugs, and patients taking other NSAIDs, whether prescription or over-the-counter, such as aspirin, ibuprofen, or naproxen.

Healthcare providers should exercise caution when prescribing this product to geriatric patients, especially if they consume three or more alcoholic drinks daily while using the medication. It is essential to monitor these patients closely for any signs of gastrointestinal bleeding and to consider dose adjustments or alternative therapies as necessary. Additionally, patients should be advised to adhere strictly to the recommended dosage and duration of use to minimize the risk of adverse effects.

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 fetal development or complications during delivery. Therefore, it is essential that pregnant patients only use aspirin under the guidance of a physician, especially in the later stages of pregnancy.

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, 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 individuals.

Renal Impairment

Patients with renal impairment should consult their healthcare provider prior to use, particularly if they have a history of 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 exercise caution when using this product, as it contains acetaminophen, which is associated with the risk of severe liver damage. It is critical that patients do not exceed the maximum daily dosage of 8 tablets within a 24-hour period. Additionally, patients must avoid concomitant use with other medications containing acetaminophen, as this can further increase the risk of liver injury.

Patients with compromised liver function, including those with liver cirrhosis, should consult a healthcare professional prior to use. It is also advisable for patients to discuss their medical history, particularly if they have high blood pressure, heart disease, or kidney disease, as these conditions may influence the safety and efficacy of the product. Furthermore, patients are advised against consuming three or more alcoholic drinks daily while using this product, as alcohol can exacerbate the potential for liver damage. Regular monitoring of liver function may be warranted in patients with existing liver disease to ensure safety during treatment.

Overdosage

In the event of an accidental overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. Prompt medical attention is crucial for both adults and children, even in the absence of noticeable signs or symptoms.

Healthcare professionals are advised to remain vigilant and proactive in managing potential overdose situations. Early intervention can significantly impact the outcome, underscoring the importance of swift action in these scenarios.

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 events associated with the use of this product, reported voluntarily or through surveillance programs.

Severe allergic reactions have been noted with aspirin, which may manifest as hives, facial swelling, asthma (wheezing), or shock. Acetaminophen has been associated with severe skin reactions, including skin reddening, blisters, and rash.

Warnings regarding liver damage have been issued, indicating that severe liver injury may occur if the maximum daily dosage of more than 8 tablets is exceeded within 24 hours, if used concurrently with other acetaminophen-containing products, or if consumed with three or more alcoholic drinks daily.

The product contains a nonsteroidal anti-inflammatory drug (NSAID), which may increase the risk of severe stomach bleeding, particularly in individuals aged 60 or older, those with a history of stomach ulcers or bleeding disorders, and those taking anticoagulants, steroids, or other NSAIDs. The risk is also heightened with excessive alcohol consumption or prolonged use beyond the recommended duration.

Caffeine content in the recommended dose is comparable to that of a cup of coffee. Users are advised to limit the intake of other caffeine-containing products to avoid potential side effects such as nervousness, irritability, sleeplessness, and, in some cases, rapid heartbeat.

Patients are instructed to discontinue use and seek medical advice if an allergic reaction occurs, if the painful area becomes red or swollen, if symptoms do not improve, or if new symptoms arise. Additional signs warranting medical consultation include persistent or worsening pain or fever, symptoms indicative of stomach bleeding (such as feeling faint, vomiting blood, or having bloody or black stools), and any occurrence of ringing in the ears or hearing loss.

In cases of accidental overdose, immediate medical assistance or contact with a Poison Control Center is essential, as prompt intervention is critical for both adults and children, even in the absence of noticeable symptoms.

Patient Counseling

Healthcare providers should advise patients about the importance of seeking immediate medical assistance in the event of an accidental overdose. Patients should be informed to contact a Poison Control Center or seek medical help right away, as prompt medical attention is critical for both adults and children. It is essential to emphasize that even if no signs or symptoms are apparent, medical evaluation is necessary to ensure safety and appropriate care.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It should be stored at a controlled room temperature of 20° to 25°C (68° to 77°F). Care should be taken to ensure that the product is kept within this temperature range to maintain its integrity and efficacy.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

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