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 associated with various conditions, including headache, arthritis, the common cold, 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 and not exceed the directed amount. Each dose should be accompanied by a full glass of water to ensure proper administration.

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

For children under 12 years of age, 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 should not use this product. Additionally, 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. Furthermore, individuals who have experienced an allergic reaction to this product or any of its components should refrain from its use.

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 may induce severe allergic reactions, which can manifest as shock, facial swelling, hives, or asthma symptoms such as wheezing. Similarly, acetaminophen may lead to severe skin reactions, including skin reddening, blisters, or rash. In the event of a skin reaction, it is crucial to discontinue use and seek medical assistance without delay.

This product contains acetaminophen, and caution is warranted due to the potential for severe liver damage. Such damage may occur if the user exceeds 4,000 mg of acetaminophen within a 24-hour period, combines it with other medications containing acetaminophen, or consumes three or more alcoholic drinks daily while using this product.

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

Caffeine is also present in the recommended dose of this product, which is comparable to the caffeine content of a cup of coffee. Users should 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.

Before using this product, individuals should consult a healthcare provider if they have liver disease, if the stomach bleeding warning applies, or if they have a history of stomach issues such as heartburn. Additional caution is advised for those with high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or those taking diuretics. It is also recommended to seek advice from a doctor or pharmacist if the user is 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, immediate medical attention is essential. Contact a Poison Control Center or seek emergency medical help right away, as prompt intervention is critical for both adults and children, even in the absence of noticeable symptoms.

Users should discontinue use and consult a healthcare professional if any allergic reactions occur, or if they experience signs of stomach bleeding such as feeling faint, vomiting blood, having bloody or black stools, or persistent stomach pain. Additional reasons to stop use include ringing in the ears, loss of hearing, worsening pain lasting more than 10 days, fever lasting more than 3 days, presence of redness or swelling, or the emergence of new symptoms, as these may indicate a serious condition.

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 not to use this product under these circumstances. If 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.

Severe allergic reactions may occur, particularly in patients sensitive to aspirin or acetaminophen. Symptoms of an allergic reaction to aspirin may include shock, facial swelling, hives, and asthma (wheezing). 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 attention immediately.

This product contains acetaminophen, which poses a risk of severe liver damage if patients exceed 4,000 mg in 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 increases the risk of severe stomach bleeding, particularly in patients aged 60 or older, those taking anticoagulants or steroid medications, individuals consuming three or more alcoholic drinks daily, and those with a history of stomach ulcers or bleeding problems. Patients should be cautioned against taking this product for longer than directed.

Common Adverse Reactions Patients may also experience less severe but notable reactions. The recommended dose of this product contains caffeine, which is comparable to that found in a cup of coffee. Excessive caffeine intake may lead to nervousness, irritability, sleeplessness, and, in some cases, rapid heartbeat.

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

Drug Interactions

There are currently no documented drug interactions associated with the use of this medication. Additionally, there is no information available regarding interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

Packaging & NDC

Below are the non-prescription pack sizes of 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 chicken pox or flu-like symptoms should not use this product due to the risk of Reye’s syndrome, a rare but serious illness. If changes in behavior accompanied by nausea and vomiting occur while using this product, it is important to consult a doctor, 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 tablets every 6 hours, with a maximum of 8 tablets 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 a Poison Control Center should be contacted. 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 and older, may have an increased risk of stomach bleeding when using this medication. It is essential for healthcare providers to exercise caution when prescribing to this population.

Before initiating treatment, it is advisable for healthcare providers to assess the medical history of geriatric patients, especially those with comorbid conditions such as high blood pressure, heart disease, liver cirrhosis, or kidney disease. Consultation with a physician is recommended in these cases to ensure the safe use of the medication and to consider any necessary dose adjustments or monitoring strategies.

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 explicitly directed by a physician, as it may pose risks to the developing fetus 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

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 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 4,000 mg of acetaminophen in a 24-hour period, avoid concurrent use with other medications containing acetaminophen, and limit alcohol consumption to fewer than three alcoholic drinks per day while using this product.

Prior to use, patients with known liver disease should consult a healthcare professional. Additionally, patients taking other medications or those under medical care for serious conditions, including liver cirrhosis, are advised to seek guidance from a doctor or pharmacist before using this product. Monitoring of liver function may be warranted in these patients to prevent potential adverse effects.

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 should be aware that the lack of immediate symptoms does not preclude the potential for serious adverse effects. Therefore, vigilance and timely intervention are essential in managing overdose situations effectively.

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

Postmarketing experience has indicated that acetaminophen may be associated with severe skin reactions. Reports have included instances of skin reddening, blisters, and rash. In the event of a skin reaction, it is advised to discontinue use and seek medical assistance immediately.

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 patients do not notice any signs or symptoms of overdose, they should not hesitate to seek help. This proactive approach can significantly impact the outcome in such situations.

Storage and Handling

The product is supplied in configurations that include specific NDC numbers, which can be found on the packaging. It should be stored at a controlled room temperature of 25°C (77°F), with permissible excursions between 15°C and 30°C (59°F and 86°F).

Healthcare professionals are advised to check the end flap of the packaging for the expiration date and lot number to ensure proper inventory management and product safety.

Additional Clinical Information

The medication is administered orally. Clinicians should advise patients who are pregnant or breastfeeding to consult a health professional prior to use. It is particularly crucial to avoid the use of aspirin after 20 weeks of pregnancy unless explicitly directed by a physician, as it may pose risks to the unborn child or lead to complications during delivery.

Drug Information (PDF)

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

View product document (PDF)