Acetaminophen/Aspirin/Caffeine

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

Healthcare professionals should advise patients to 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 geltabs every 6 hours, with a maximum limit of 8 geltabs within a 24-hour period.

For children under 12 years of age, it is essential to consult a physician for appropriate dosing recommendations.

Contraindications

There are no contraindications listed for this product. However, it is important to note that taking more than the directed dosage can lead to serious health problems. In the event of an overdose, immediate medical assistance should be sought, or contact a Poison Control Center without delay.

Warnings and Precautions

Children and teenagers 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 product must be discontinued, and medical assistance sought without delay. Similarly, aspirin can provoke a severe allergic reaction characterized by hives, facial swelling, asthma (wheezing), or shock.

Liver Warning This product contains acetaminophen, and severe liver damage may result from exceeding the maximum daily dosage of 8 geltabs within 24 hours, using other medications containing acetaminophen, or consuming 3 or more alcoholic drinks daily while using this product.

Stomach Bleeding Warning As this product contains a nonsteroidal anti-inflammatory drug (NSAID), it may increase the risk of severe stomach bleeding. This risk is heightened in individuals aged 60 or older, those with a history of stomach ulcers or bleeding problems, users of blood thinners or steroid medications, individuals taking other NSAIDs (including aspirin, ibuprofen, or naproxen), and those consuming 3 or more alcoholic drinks daily while using the product. It is also important to adhere strictly to the recommended dosage.

Caffeine Warning The recommended dose of this product contains approximately the same amount of caffeine as 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.

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 professional is advised.

Consultation Required Before using this product, individuals with liver disease, a history of stomach problems (such as heartburn), high blood pressure, heart disease, liver cirrhosis, kidney disease, or those taking diuretics or with asthma should seek advice from a healthcare professional. Additionally, individuals taking prescription medications for diabetes, gout, or arthritis, or those under medical care for any serious condition, should consult a doctor or pharmacist prior to use.

Discontinuation of Use Users must stop using the product and seek medical attention if any allergic reactions occur. Signs of potential stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, persistent stomach pain, ringing in the ears, loss of hearing, worsening pain lasting more than 10 days, fever lasting more than 3 days, or the emergence of any new symptoms, warrant immediate medical evaluation as they may indicate a serious condition.

Pregnancy and Breastfeeding Consultation with a healthcare professional is essential before using this product if pregnant or breastfeeding. Aspirin should particularly be avoided during the last trimester of pregnancy unless specifically directed by a healthcare provider, as it may pose risks to the unborn child or lead to complications during delivery.

Safety Precautions This product should be kept out of reach of children. An overdose can lead to serious health complications; therefore, in the event of an overdose, immediate medical assistance or contact with a Poison Control Center is crucial.

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 chicken pox 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 crucial to consult a doctor, as these symptoms could indicate the onset of Reye’s syndrome.

Severe allergic reactions have been reported with the use of acetaminophen and aspirin, both of which are components of this product. Acetaminophen may cause severe skin reactions, which can manifest as skin reddening, blisters, or rash. If any skin reaction occurs, patients should discontinue use and seek medical assistance immediately. Aspirin may also lead to severe allergic reactions, including hives, facial swelling, asthma (wheezing), and shock.

The product contains acetaminophen, which poses a risk of severe liver damage if the maximum daily amount of 8 geltabs is exceeded within 24 hours, particularly when combined with other medications containing acetaminophen or when consuming three or more alcoholic drinks daily while using this product.

Additionally, this product contains a nonsteroidal anti-inflammatory drug (NSAID), which may increase the risk of severe stomach bleeding. This risk is heightened in patients aged 60 or older, those with a history of stomach ulcers or bleeding problems, individuals taking blood thinners or steroid medications, and those consuming three 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 is also present in the recommended dose of this product, which is comparable to the amount found in 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, persistent ringing in the ears or loss of hearing, worsening pain or swelling in a painful area, 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 adhere strictly to the recommended dosage to mitigate the risk of hepatotoxicity.

The concomitant use of blood thinners (anticoagulants) or steroid medications increases the risk of severe gastrointestinal bleeding. Additionally, the use of other nonsteroidal anti-inflammatory drugs (NSAIDs), whether prescription or over-the-counter, such as aspirin, ibuprofen, or naproxen, further elevates this risk. Patients should be closely monitored for signs of gastrointestinal bleeding if these medications are used together.

Caution is advised regarding the intake of caffeine-containing medications, foods, or beverages while using this product. Excessive caffeine consumption may lead to adverse effects, including nervousness, irritability, insomnia, and, in some cases, tachycardia.

Patients are encouraged to 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 ensures safe and effective use while minimizing potential interactions.

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

Adults and pediatric patients aged 12 years and older are advised to take 2 geltabs every 6 hours, with a maximum of 8 geltabs in a 24-hour period. For children under 12 years of age, it is recommended 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 healthcare professional should be consulted, as these may be early signs of this rare but serious condition.

It is essential 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 anticoagulants or steroid medications, and patients using other nonsteroidal anti-inflammatory drugs (NSAIDs), including both prescription and over-the-counter 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 geriatric patients for signs of gastrointestinal bleeding and to consider appropriate dose adjustments or alternative therapies when necessary. Careful assessment of the patient's overall medication regimen and alcohol consumption is advised to mitigate potential risks associated with the use of this product in the elderly population.

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 the unborn child or complications during delivery. Therefore, it is essential for healthcare providers to evaluate the risks and benefits before recommending this medication to pregnant women, especially in the later stages of pregnancy.

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 consult a healthcare professional prior to use of this medication, particularly if they have a history of liver disease, liver cirrhosis, or other significant medical conditions such as high blood pressure, heart disease, or kidney disease.

Due to the potential for altered drug metabolism and increased risk of adverse effects in individuals with compromised liver function, careful consideration and monitoring are advised. Patients with a history of stomach problems, including heartburn, should also seek medical advice before initiating treatment.

It is essential for healthcare providers to evaluate liver function and consider any necessary dosage adjustments or additional monitoring requirements based on the severity of hepatic impairment.

Overdosage

In cases of overdosage, severe liver damage may occur if an individual ingests 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 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 overdosage should involve prompt assessment and supportive care. It is crucial to monitor liver function tests and consider the administration of N-acetylcysteine as an antidote, particularly if the overdosage is identified within a critical time frame. Continuous evaluation and supportive measures should be implemented based on the patient's clinical status.

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 text.

Postmarketing Experience

Postmarketing experience has identified several important safety considerations associated with the use of this product.

Severe skin reactions have been reported in association with acetaminophen use, with symptoms including skin reddening, blisters, and rash. Users are advised to discontinue use and seek medical assistance immediately if such reactions occur.

Aspirin has been associated with the potential for severe allergic reactions, which may manifest as hives, facial swelling, asthma (wheezing), or shock.

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 used concurrently with other acetaminophen-containing medications or in conjunction with the consumption of three or more alcoholic drinks daily.

Additionally, the presence of an NSAID in this formulation raises concerns regarding the risk of severe stomach bleeding. This risk is heightened 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 also increased with the consumption of three or more alcoholic drinks daily or if the product is taken in higher doses or for extended periods beyond the recommended guidelines.

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 medications, foods, or beverages to avoid potential side effects such as nervousness, irritability, sleeplessness, and, in some cases, rapid heartbeat.

Patients are encouraged to discontinue use and consult a healthcare professional if any signs of an allergic reaction occur, or if symptoms indicative of stomach bleeding arise, including feeling faint, vomiting blood, having bloody or black stools, experiencing persistent stomach pain, or noticing any new or worsening symptoms. These may indicate a serious condition requiring immediate medical attention.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion.

Providers must emphasize the importance of adhering to the recommended dosage. Patients should be informed that taking more than the directed amount can lead to serious health complications. In the event of an overdose, it is crucial for patients to seek medical assistance immediately or contact a Poison Control Center for guidance.

Storage and Handling

The product is supplied in a configuration that ensures optimal usability. It should be stored at room temperature, specifically 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, it is essential to close the cap tightly to maintain the product's quality and effectiveness.

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)