Acetaminophen/Aspirin/Caffeine

Description

No specific description details are 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. Each dose should be taken with a full glass of water to ensure proper administration.

For adults and children aged 12 years and older, the recommended dosage is 2 geltabs every 6 hours, with a maximum of 8 geltabs 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 is contraindicated in children due to the risk of accidental ingestion. Additionally, exceeding the recommended dosage may lead to serious health complications. In the event of an overdose, immediate medical assistance or contact with a Poison Control Center 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, 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.

Allergy Alerts Acetaminophen may lead to severe skin reactions, which can manifest as skin reddening, blisters, or rash. Should any skin reaction occur, the use of the product must be discontinued, and medical assistance should be sought without delay. Similarly, aspirin may provoke a severe allergic reaction characterized by hives, facial swelling, asthma (wheezing), or shock.

Liver and Stomach Bleeding Warnings This product contains acetaminophen, and taking more than 8 geltabs in a 24-hour period— the maximum daily amount— or combining it with other acetaminophen-containing medications, or consuming 3 or more alcoholic drinks daily while using this product, may result in severe liver damage. Additionally, the presence of an NSAID in this formulation poses a risk of severe stomach bleeding, particularly in individuals aged 60 or older, those with a history of stomach ulcers or bleeding problems, or those concurrently taking blood thinners, steroids, or other NSAIDs (including aspirin, ibuprofen, or naproxen). The risk is further heightened by the consumption of 3 or more alcoholic drinks daily or exceeding the recommended duration or dosage.

Caffeine Considerations The recommended dosage of this product contains approximately the same amount of caffeine as a 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.

Contraindications This product should not be used by individuals with a known allergy to acetaminophen, aspirin, or any other pain reliever/fever reducer, or in conjunction with any other drug containing acetaminophen (whether prescription or nonprescription). If there is uncertainty regarding the presence of acetaminophen in a medication, consultation with a healthcare provider or pharmacist is recommended.

Consultation Recommendations Healthcare professionals should be consulted prior to use if the patient has liver disease, a history of stomach bleeding, high blood pressure, heart disease, liver cirrhosis, kidney disease, or is taking diuretics or has asthma. Additionally, it is advisable to seek guidance from a doctor or pharmacist if the patient is on prescription medications for diabetes, gout, or arthritis, or is under medical care for any serious condition.

Discontinuation of Use If an allergic reaction occurs, the product should be discontinued immediately, and medical help should be sought. Patients should also stop using the product and consult a healthcare professional if they experience any signs of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or persistent stomach pain. Other concerning symptoms include ringing in the ears, loss of hearing, worsening pain, fever lasting more than three days, or the emergence of any new symptoms, as these may indicate a serious condition.

Pregnancy and Breastfeeding Pregnant or breastfeeding individuals should consult a healthcare professional before using this product. It is particularly crucial to avoid aspirin during the last trimester of pregnancy unless explicitly directed by a physician, as it may pose risks to the unborn child or lead to complications during delivery.

Overdose Precautions Taking more than the recommended dosage can result in serious health complications. In the event of an overdose, immediate medical attention should be sought, or contact with a Poison Control Center is advised.

Side Effects

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

Warnings associated with this product include the risk of Reye’s syndrome, particularly in children and teenagers who have or are recovering from chickenpox or flu-like symptoms. If patients exhibit changes in behavior accompanied by nausea and vomiting, they should consult a doctor immediately, as these symptoms may indicate the onset of this rare but serious illness.

Allergic reactions are also a concern. Patients may experience severe skin reactions due to acetaminophen, which can manifest as skin reddening, blisters, or rash. In such cases, it is imperative to discontinue use and seek medical assistance promptly. Additionally, aspirin may provoke severe allergic reactions, including hives, facial swelling, asthma (wheezing), or shock.

The product contains acetaminophen, and patients should be aware of the liver warning. Severe liver damage may occur if more than 8 geltabs are taken within 24 hours, particularly if combined with other acetaminophen-containing medications or if the patient consumes 3 or more alcoholic drinks daily while using this product.

Stomach bleeding is another serious risk associated with the nonsteroidal anti-inflammatory drug (NSAID) component of this product. The likelihood of severe stomach bleeding increases in patients aged 60 or older, those with a history of stomach ulcers or bleeding problems, individuals taking anticoagulants or steroid medications, and those consuming 3 or more alcoholic drinks daily while using the product. Patients should be vigilant for signs of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain.

Caffeine content in the recommended dose is comparable to that of 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.

Patients should stop using the product and consult a doctor if they experience any signs of an allergic reaction or any of the following symptoms: signs of stomach bleeding, ringing in the ears or loss of hearing, 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

Severe liver damage may occur if the maximum daily dosage of 8 geltabs is exceeded within a 24-hour period, particularly when used concurrently with other medications containing acetaminophen. It is essential to monitor total acetaminophen intake to prevent hepatotoxicity.

The risk of severe gastrointestinal bleeding is significantly increased when this product is used in conjunction with anticoagulants, steroids, or other nonsteroidal anti-inflammatory drugs (NSAIDs), including prescription and over-the-counter options such as aspirin, ibuprofen, and naproxen. Patients should be advised to exercise caution and consider alternative therapies or enhanced monitoring for signs of gastrointestinal bleeding when these medications are co-administered.

Caution is also warranted regarding the concurrent use of caffeine-containing medications, foods, or beverages. Excessive caffeine intake may lead to adverse effects such as nervousness, irritability, insomnia, and, in some cases, tachycardia. It is advisable to limit caffeine consumption while using this product.

Patients should consult with a healthcare professional before using this product if they are currently taking prescription medications for diabetes, gout, or arthritis, or if they are under medical supervision for any serious health condition. This precaution is necessary to ensure safe and effective use of the product in the context of their overall treatment plan.

Packaging & NDC

Below are the non-prescription pack sizes of Acetaminophen 250mg Aspirin 250mg Caffeine 65mg. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients aged 12 years and older may take 2 geltabs every 6 hours, with a maximum of 8 geltabs in a 24-hour period. For children under 12 years, it is advised to consult a doctor before use.

Caution is warranted for children and teenagers who have or are recovering from chickenpox or flu-like symptoms, as they 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, a doctor should be consulted, as these may be early signs of this rare but serious illness.

It is important to keep this product out of reach of children.

Geriatric Use

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

Additionally, the risk of gastrointestinal complications may be exacerbated by the consumption of three or more alcoholic drinks daily while using this product. It is essential for healthcare providers to closely monitor elderly patients for signs of gastrointestinal bleeding and to consider appropriate dose adjustments or alternative therapies when necessary.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to use. The use of aspirin during the last trimester of pregnancy is particularly cautioned against unless specifically directed by a physician, as it may pose risks to the developing fetus and lead to complications during delivery. It is essential for healthcare providers to weigh the potential benefits against the 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 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 its use in lactating individuals.

Renal Impairment

Patients with renal impairment should consult a healthcare professional 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, 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 geltabs within a 24-hour period. Additionally, patients should avoid concurrent use of other medications containing acetaminophen and limit alcohol consumption to fewer than 3 drinks per day while using this product.

Prior to use, patients with liver disease or a history of liver cirrhosis should consult a healthcare professional. The same applies to individuals with a history of stomach problems, such as heartburn, as well as those with high blood pressure or heart disease. Monitoring of liver function may be warranted in patients with compromised liver function to prevent potential adverse effects.

Overdosage

In cases of overdosage, severe liver damage may occur if an individual consumes more than 8 geltabs within a 24-hour period, which is the maximum recommended daily dosage. This risk is further heightened when the product is taken in conjunction with other medications containing acetaminophen or when the individual consumes 3 or more alcoholic beverages daily while using this product.

Healthcare professionals should be vigilant in monitoring patients for symptoms indicative of liver damage, which may include jaundice, abdominal pain, nausea, vomiting, and confusion. Immediate medical attention is warranted in the event of suspected overdosage.

Management of acetaminophen overdosage typically involves the administration of N-acetylcysteine (NAC) as an antidote, which is most effective when given within 8 hours of ingestion. Supportive care should also be provided as necessary, including monitoring of liver function tests and symptomatic treatment. It is crucial for healthcare providers to assess the patient's overall clinical status and to initiate appropriate interventions promptly to mitigate the risk of severe hepatic injury.

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 important safety information related to the use of this product.

Severe skin reactions associated with acetaminophen have been reported, with symptoms including skin reddening, blisters, and rash. In the event of a skin reaction, it is advised to discontinue use and seek medical assistance immediately.

Aspirin has been linked to the potential for severe allergic reactions, which may manifest as hives, facial swelling, asthma (wheezing), or shock. Users are cautioned to stop use and consult a healthcare professional if any allergic reactions occur.

The product contains acetaminophen, and there is a risk of severe liver damage if the maximum daily dosage of 8 geltabs is exceeded within a 24-hour period, particularly when combined with other acetaminophen-containing medications or when consuming three or more alcoholic drinks daily.

Additionally, the presence of an NSAID in this product raises concerns regarding severe stomach bleeding, especially in individuals aged 60 or older, those with a history of stomach ulcers or bleeding problems, and those taking anticoagulants, steroids, or other NSAIDs. The risk is further heightened with excessive alcohol consumption or prolonged use beyond the recommended duration.

Caffeine content is comparable to that of a standard cup of coffee, and 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.

Users are encouraged to seek medical attention if they experience signs of stomach bleeding, including feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain. Other concerning symptoms include ringing in the ears, loss of hearing, worsening pain, fever lasting more than three days, or the emergence of any new symptoms, as these may indicate serious conditions.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental ingestion. It is crucial to emphasize the importance of adhering to the recommended dosage, as taking more than directed can lead to serious health problems. In the event of an overdose, patients should be instructed to seek medical help immediately or contact a Poison Control Center for assistance.

Storage and Handling

The product is supplied in a configuration that includes specific NDC numbers, which are essential for identification and inventory management. It is crucial to store the product at room temperature, maintaining a range between 20-25 ºC (68-77 ºF). Care should be taken to avoid exposure to excessive heat, cold, and humidity, as these conditions may compromise the integrity of the product. After each use, the cap must be closed tightly to ensure proper sealing and to maintain the product's efficacy.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Acetaminophen 250mg Aspirin 250mg Caffeine 65mg, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)