Extra Strength Pain Reliever

Description

The product contains Acetaminophen, Aspirin, and Caffeine as active ingredients, providing temporary relief from pain, fever, and inflammation. It is designed to soothe muscle aches and minor arthritis pain. The quality comfort caplets are formulated and packaged for workplace use, adhering to ANSI Z308.1-2021 standards. Each caplet is sealed in tamper-evident packets to ensure safety and convenience. The product is available in a package containing 50 caplets, with 2 caplets per packet.

Uses and Indications

This drug is indicated for the temporary relief of fever and minor aches and pains associated with various conditions, including headache, colds, muscular aches, menstrual discomfort, toothaches, and minor arthritis pain. It provides temporary relief from pain, fever, and inflammation, effectively soothing muscle aches and minor arthritis pain.

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

Dosage and Administration

For adults, the recommended dosage is 2 tablets taken with water every 6 hours while symptoms persist. The total daily dosage should not exceed 8 tablets within a 24-hour period, unless otherwise directed by a healthcare professional.

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

Contraindications

Use of this product is contraindicated in the following situations:

• Patients with a known allergy to aspirin.

• Concurrent use with any other pain reliever or fever reducer.

• Individuals with a history of allergic reactions to any other pain reliever or fever reducer.

• Use for pain exceeding 10 days or for fever exceeding 3 days, unless directed by a healthcare professional.

• Concurrent use with any product containing acetaminophen, whether prescription or nonprescription.

• If there is uncertainty regarding the presence of acetaminophen in a drug, consultation with a doctor or pharmacist is advised.

Warnings and Precautions

Children and teenagers who have or are recovering from chickenpox or flu-like symptoms should not use this product. If behavioral changes accompanied by nausea and vomiting occur during use, it is imperative to consult a physician, as these symptoms may indicate the onset of Reye's Syndrome, a rare but serious condition.

Aspirin, a component of this product, has the potential to cause severe allergic reactions, which may manifest as hives, facial swelling, asthma (wheezing), or shock.

This product contains acetaminophen, and caution is warranted due to the risk of severe liver damage. Such damage may occur if the user exceeds the maximum daily dosage of 8 tablets within a 24-hour period, combines this product with other medications containing acetaminophen, or consumes three or more alcoholic drinks daily while using this product.

Additionally, this product includes a nonsteroidal anti-inflammatory drug (NSAID), which carries 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 disorders, 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.

The recommended dosage of this product contains approximately the same amount of caffeine as a standard cup of coffee. Therefore, 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.

Healthcare professionals should advise patients to consult a physician prior to use if any of the following conditions apply: a history of stomach bleeding, liver disease, high blood pressure, heart disease, liver cirrhosis, asthma, or kidney disease. Additionally, patients taking diuretics or prescription medications for anticoagulation, diabetes, gout, or arthritis should seek guidance from a healthcare provider or pharmacist before using this product.

In the event of an overdose, immediate medical assistance should be sought, 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.

Patients should discontinue use and contact a physician if they experience any signs of stomach bleeding, including feeling faint, vomiting blood, having bloody or black stools, experiencing persistent stomach pain, or if they notice ringing in the ears or loss of hearing. Furthermore, if pain or fever persists or worsens, new symptoms arise, or redness or swelling is observed, medical advice should be sought.

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 condition 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.

Aspirin, a component of this product, may cause severe allergic reactions in some individuals. Symptoms of such reactions can include hives, facial swelling, asthma (wheezing), and shock. Patients should seek immediate medical attention if they experience any of these symptoms.

The product contains acetaminophen, which can lead to severe liver damage if patients exceed the maximum daily dosage of 8 tablets within 24 hours, take it in conjunction with other medications containing acetaminophen, or consume three or more alcoholic drinks daily while using this product.

Additionally, the nonsteroidal anti-inflammatory drug (NSAID) present in this product may increase the risk of severe stomach bleeding, particularly in patients who are 60 years or older, have a history of stomach ulcers or bleeding problems, are taking anticoagulants or steroid medications, consume three or more alcoholic drinks daily, or use other NSAIDs concurrently. Patients should be vigilant for signs of stomach bleeding, which may include feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain. If any of these symptoms occur, patients should stop use and consult a doctor.

Patients are advised to limit the intake of caffeine-containing medications, foods, or beverages while using this product, as excessive caffeine may lead to nervousness, irritability, sleeplessness, and, in some cases, rapid heartbeat.

Before using this product, patients should consult a doctor if they have liver disease, high blood pressure, heart disease, liver cirrhosis, asthma, kidney disease, or a history of stomach problems such as heartburn. It is also recommended to seek advice from a healthcare professional if taking prescription medications for anticoagulation, diabetes, gout, or arthritis.

Drug Interactions

Co-administration of this medication with other pain relievers or fever reducers is contraindicated. Additionally, the use of this medication alongside any product containing acetaminophen, whether prescription or nonprescription, is not recommended due to the potential for increased risk of adverse effects.

The concomitant use of this medication with anticoagulants (blood thinners) or steroid drugs significantly elevates the risk of severe gastrointestinal bleeding. Therefore, it is imperative that healthcare providers assess the patient's medication regimen for these interactions.

Patients are advised to consult with a healthcare professional prior to using this medication if they are currently prescribed anticoagulants, or if they are being treated for diabetes, gout, or arthritis. This precaution is essential to ensure safe and effective use of the medication.

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 Reliever (acetaminophen, aspirin, and caffeine). 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. It is important for healthcare professionals to advise parents or guardians to consult a doctor if their child exhibits changes in behavior accompanied by nausea and vomiting, as these symptoms may indicate the onset of Reye's Syndrome, a rare but serious condition. For children under 12 years of age, a consultation with a healthcare provider is recommended prior to use.

Geriatric Use

Elderly patients, particularly those aged 60 and older, are at an increased risk for severe stomach bleeding. This risk necessitates careful consideration when prescribing medications that may exacerbate this condition. It is advised that healthcare providers inquire about any history of stomach ulcers or bleeding problems in geriatric patients prior to initiating treatment.

The recommended dosage for adults should not exceed 8 tablets within a 24-hour period, unless otherwise directed by a healthcare professional. Geriatric patients should be closely monitored for any adverse effects, especially those related to gastrointestinal bleeding.

Additionally, it is crucial for healthcare providers to assess the medication regimens of elderly patients who are taking blood thinners (anticoagulants) or steroid drugs. Consultation with a physician is recommended before the use of such medications in this population to ensure safety and efficacy.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to use. 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 and lead to complications during delivery.

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 specifically directed by a doctor, 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

Patients with renal impairment should consult their healthcare provider prior to use, particularly if they have a history of kidney disease. It is essential to assess renal function and consider potential dosing adjustments or monitoring requirements based on the degree of impairment.

Hepatic Impairment

Patients with hepatic impairment should exercise caution when using this product, which contains acetaminophen. Severe liver damage may occur if patients exceed the maximum daily dosage of 8 tablets within a 24-hour period. Additionally, the risk of liver damage increases if acetaminophen is taken concurrently with other medications containing acetaminophen or if patients consume 3 or more alcoholic drinks daily while using this product.

It is essential for patients with liver disease, including liver cirrhosis, to consult a healthcare professional prior to use. Furthermore, individuals with high blood pressure, heart disease, asthma, or kidney disease should also seek medical advice before using this product to ensure safe administration and monitoring of liver function.

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 for both adults and children, even in the absence of noticeable signs or symptoms.

Healthcare professionals should be aware that the lack of immediate symptoms does not preclude the potential for serious adverse effects. Therefore, monitoring and evaluation should be conducted as soon as possible to ensure patient safety and appropriate management.

Nonclinical Toxicology

It is especially important to avoid the use of 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 detailed findings regarding nonclinical toxicology or animal pharmacology and toxicology provided in the current information.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions associated with the use of the product. Reports have included allergic reactions such as hives, facial swelling, asthma (wheezing), and shock. There is a risk of severe liver damage, particularly when the product is taken in excess or in conjunction with other acetaminophen-containing products.

Severe stomach bleeding has also been reported, especially in individuals over 60 years of age, those with a history of stomach ulcers or bleeding problems, and those concurrently using anticoagulants or other nonsteroidal anti-inflammatory drugs (NSAIDs). Symptoms indicative of stomach bleeding may include feeling faint, vomiting blood, having bloody or black stools, and experiencing stomach pain that does not improve.

Additionally, cases of ringing in the ears or loss of hearing have been noted. New symptoms, as well as redness or swelling, may also develop following use of the product. It is essential for individuals to seek medical attention in the event of an overdose, as prompt intervention is necessary for both adults and children.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children. In the event of an overdose, patients must seek medical help or contact a Poison Control Center immediately, as prompt medical attention is critical for both adults and children, even if no signs or symptoms are apparent.

Patients should be informed not to use this medication if they have a known allergy to aspirin or any other pain reliever/fever reducer. It is also important to counsel patients against using this product in conjunction with any other pain reliever or fever reducer, as well as any product 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 not to use this medication for pain for more than 10 days or for fever for more than 3 days unless directed by a healthcare provider. They should also be advised to stop use and consult a doctor if they experience any signs of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or experiencing stomach pain that does not improve. Additional symptoms that warrant medical consultation include ringing in the ears, loss of hearing, persistent or worsening pain or fever, new symptoms, or the presence of redness or swelling.

When using this product, patients must not exceed the recommended dose. Healthcare providers should inquire whether the stomach bleeding warning applies to the patient and advise them to consult a doctor before use if they have liver disease, high blood pressure, heart disease, liver cirrhosis, asthma, or kidney disease. Patients taking diuretics or those with a history of stomach problems, such as heartburn, should also be encouraged to seek medical advice prior to use. Furthermore, patients should be advised to consult a doctor or pharmacist if they are taking prescription medications for anticoagulation, diabetes, gout, or arthritis.

Storage and Handling

The product is supplied in packets that must not be used if opened or torn. It should be stored at room temperature, specifically within the range of 68º to 77ºF (20º to 25ºC). Care should be taken to avoid exposure to excessive heat and humidity to maintain product integrity.

Additional Clinical Information

The medication is administered orally, with adults advised to take 2 tablets with water every 6 hours while symptoms persist, not exceeding 8 tablets in a 24-hour period unless directed otherwise by a physician. For children under 12 years, consultation with a doctor is recommended prior to use.

Clinicians should counsel patients on the importance of consulting a health professional if they are pregnant or breastfeeding. It is particularly crucial to avoid aspirin during the last three months of pregnancy unless specifically directed by a doctor, as it may pose risks to the unborn child or lead to complications during delivery. Patients should also be informed to keep the medication out of reach of children and to seek immediate medical assistance or contact a Poison Control Center in the event of an overdose, as prompt attention is essential for both adults and children, even in the absence of noticeable symptoms.

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.

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