Extra Strength Pain Relief

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 associated with various conditions, including headache, cold symptoms, arthritis, muscular aches, toothache, and premenstrual or 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 oral administration, adults and children aged 12 years and older are instructed to take 2 caplets every 6 hours, with a maximum limit of 8 caplets within a 24-hour period. It is essential to consume a full glass of water with each dose to ensure proper swallowing and absorption.

For children under 12 years of age, it is advised to consult a healthcare professional for appropriate dosing recommendations.

Contraindications

Use is contraindicated in patients with a history of allergic reactions to acetaminophen, aspirin, or any other pain reliever or fever reducer. Additionally, this product should not be used concurrently with any other medication containing acetaminophen, whether prescription or nonprescription. If there is uncertainty regarding the presence of acetaminophen in other medications, consultation with a healthcare professional is advised.

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 condition.

Allergy Alerts Acetaminophen may lead to severe skin reactions, which can manifest as skin reddening, blisters, or rash. In the event of a skin reaction, the use of this product should be discontinued immediately, and medical assistance should be sought. Similarly, aspirin can provoke a severe allergic reaction characterized by hives, facial swelling, or shock. Immediate medical attention is warranted if any of these symptoms occur.

Liver Warning This product contains acetaminophen, and severe liver damage may result from exceeding the maximum daily dosage of 8 caplets within a 24-hour period, using other medications that contain acetaminophen, or consuming three or more alcoholic drinks daily while using this product.

Stomach Bleeding Warning As this product contains a nonsteroidal anti-inflammatory drug (NSAID), there is a risk of severe stomach bleeding. The likelihood of this adverse effect increases in individuals who are 60 years of age or older, have a history of stomach ulcers or bleeding problems, are taking anticoagulants or steroid medications, are using other NSAIDs (including aspirin, ibuprofen, or naproxen), consume three or more alcoholic drinks daily, or exceed the recommended dosage or duration of use.

Caffeine Warning The recommended dosage of this product contains approximately the same amount of caffeine as a standard cup of coffee. It is advisable to limit the intake of other caffeine-containing medications, foods, or beverages while using this product, as excessive caffeine consumption may lead to symptoms such as nervousness, irritability, sleeplessness, and, in some cases, rapid heartbeat.

In the event of an overdose, immediate medical assistance should be sought, or contact a Poison Control Center at 1-800-222-1222. Prompt medical attention is crucial for both adults and children, even if no signs or symptoms are initially apparent.

When to Stop Taking the Product and Seek Medical Attention Users should discontinue use and contact a healthcare provider if an allergic reaction occurs. Additionally, medical help should be sought if any of the following symptoms indicative of stomach bleeding arise: feeling faint, experiencing bloody or black stools, vomiting blood, or having persistent stomach pain. Other concerning symptoms include ringing in the ears or loss of hearing, redness or swelling in a painful area, worsening pain lasting more than 10 days, fever that worsens or persists beyond three days, or the emergence of any new symptoms.

Side Effects

Patients using this product may experience a range of adverse reactions, some of which can be serious.

Serious Adverse Reactions 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. Patients should be advised to discontinue use and consult a doctor if they experience changes in behavior accompanied by nausea and vomiting, as these may be early signs of Reye’s syndrome.

Severe allergic reactions have been reported, particularly in relation to acetaminophen and aspirin. Symptoms of a severe skin reaction to acetaminophen may include skin reddening, blisters, and rash. If any of these symptoms occur, patients should stop use and seek medical help immediately. Aspirin may also cause severe allergic reactions, which can manifest as hives, facial swelling, or shock.

Patients with a history of asthma may experience wheezing. Additionally, the product contains acetaminophen, which poses a risk of severe liver damage if the maximum daily dosage of 8 caplets is exceeded, if used in conjunction with other acetaminophen-containing products, or if consumed with three or more alcoholic drinks daily.

The product also contains an NSAID, which may increase 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 should be cautioned against consuming three or more alcoholic drinks daily while using this product, as well as against taking more than directed or for longer than recommended.

Common Adverse Reactions Patients should be aware of the potential for nervousness, irritability, sleeplessness, and, occasionally, rapid heartbeat due to caffeine content in the product. It is advisable to limit the use of other caffeine-containing medications, foods, or beverages while taking this product.

Patients are advised to stop use and consult a doctor if they experience any signs of an allergic reaction, symptoms indicative of stomach bleeding (such as feeling faint, having bloody or black stools, vomiting blood, or experiencing persistent stomach pain), ringing in the ears or loss of hearing, redness or swelling in a painful area, worsening pain lasting more than 10 days, fever lasting more than 3 days, or any new symptoms. These may indicate a serious condition requiring medical attention.

Drug Interactions

Co-administration of this product with other medications containing acetaminophen, whether prescription or nonprescription, may result in severe liver damage. It is advisable to avoid the concurrent use of these agents to mitigate this risk.

The concomitant use of this product with anticoagulants or steroid medications significantly increases the risk of severe gastrointestinal bleeding. Close monitoring of patients is recommended when these drugs are used together, and dosage adjustments may be necessary based on clinical judgment.

Additionally, the risk of gastrointestinal bleeding is heightened when this product is taken alongside other nonsteroidal anti-inflammatory drugs (NSAIDs), including but not limited to aspirin, ibuprofen, and naproxen. Caution is warranted, and alternative pain management strategies should be considered to reduce the potential for adverse effects.

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

Packaging & NDC

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

Pediatric Use

Pediatric patients under 12 years of age should consult a healthcare professional before use. The product is contraindicated in children and teenagers who have or are recovering from chickenpox or flu-like symptoms due to the risk of Reye’s syndrome. If behavioral changes accompanied by nausea and vomiting occur while using this product, it is essential to seek medical advice, as these may indicate the onset of Reye’s syndrome, a rare but serious condition.

In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center (1-800-222-1222) should be contacted. Prompt medical attention is crucial for both adults and children, even if no signs or symptoms are apparent.

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

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). 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 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 explicitly 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 while breastfeeding.

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. Severe liver damage may occur if patients exceed the maximum daily dosage of 8 caplets 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.

It is also advised that patients with compromised liver function limit their alcohol intake to fewer than 3 alcoholic drinks per day while using this product. Due to the potential for increased susceptibility to acetaminophen-related hepatotoxicity, careful consideration of liver function is essential in this patient population. Regular assessment of liver function may be warranted to ensure patient safety and to mitigate the risk of severe adverse effects.

Overdosage

In cases of overdosage, severe liver damage may occur under specific circumstances. It is critical for healthcare professionals to be aware of the following conditions that can lead to significant hepatic injury.

Maximum Daily Dosage Taking more than 8 caplets within a 24-hour period exceeds the maximum recommended daily dosage and poses a risk for severe liver damage.

Concurrent Use with Acetaminophen The risk of liver damage is further heightened when this product is used in conjunction with other medications containing acetaminophen. Healthcare providers should advise patients to avoid combining these substances to mitigate the risk of overdose.

Alcohol Consumption Consumption of three or more alcoholic drinks daily while using this product can also lead to severe liver damage. It is essential for healthcare professionals to counsel patients on the dangers of alcohol use during treatment.

Recommended Actions In the event of suspected overdosage, immediate medical attention is warranted. Healthcare professionals should monitor liver function and consider appropriate interventions based on the severity of the symptoms presented. Early recognition and management are crucial to prevent irreversible liver damage.

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 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 overdose, patients must be instructed to seek medical help immediately or contact a Poison Control Center at 1-800-222-1222, as prompt medical attention is crucial for both adults and children, even if no signs or symptoms are present.

Patients should be cautioned against using the medication if they have a history of allergic reactions to acetaminophen, aspirin, or any other pain reliever or fever reducer. It is important to inform patients not to use this medication in conjunction with any other drug containing acetaminophen, whether prescription or nonprescription. If patients are uncertain whether a drug contains acetaminophen, they should be encouraged to consult a doctor or pharmacist.

Patients should be instructed to stop using the medication and seek medical advice if they experience any signs of an allergic reaction or if they notice symptoms indicative of stomach bleeding, such as feeling faint, having bloody or black stools, vomiting blood, or experiencing persistent stomach pain. Additionally, patients should be advised to discontinue use and consult a doctor if they experience ringing in the ears, loss of hearing, redness or swelling in a painful area, worsening pain lasting more than 10 days, or a fever that worsens or lasts more than 3 days. They should also be informed to seek medical attention if any new symptoms arise, as these may indicate a serious condition.

Before initiating use, patients should be encouraged to consult a doctor if they have liver disease, if the stomach bleeding warning applies to them, or if they have a history of stomach problems such as heartburn. Furthermore, patients with high blood pressure, heart disease, liver cirrhosis, or kidney disease should also seek medical advice prior to use. Those taking diuretics or who have asthma should be advised to consult a doctor before using the medication. Lastly, patients should be encouraged to speak with a doctor or pharmacist if they are taking prescription medications for diabetes, gout, or arthritis, or if they are under a doctor’s care for any serious condition.

Storage and Handling

The product is supplied in a configuration that includes specific NDC numbers, which should be referenced for accurate identification. It is essential to store the product at a controlled room temperature of 20° to 25°C (68° to 77°F) to maintain its integrity and efficacy.

After each use, the cap must be closed tightly to prevent contamination and ensure the product remains effective. Proper handling and storage conditions are crucial for preserving the quality of the product throughout its shelf life.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

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