Acetaminophen/Aspirin/Caffeine

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, 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 and not exceed the directed amount. 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 caplets every 6 hours, with a maximum limit of 8 caplets 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 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, 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.

Acetaminophen, one of the active ingredients, may lead to severe skin reactions, including symptoms such as skin reddening, blisters, and rash. Should any skin reaction manifest, the product must be discontinued, and medical assistance should be sought without delay. Additionally, aspirin may provoke a severe allergic reaction characterized by hives, facial swelling, asthma (wheezing), or shock. Immediate medical attention is warranted if such symptoms occur.

This product contains acetaminophen, and caution is advised due to the potential for severe liver damage. This risk is heightened if the maximum daily dosage of 8 caplets is exceeded within a 24-hour period, if it is taken concurrently with other medications containing acetaminophen, or if the individual consumes three or more alcoholic drinks daily while using this product.

Furthermore, the presence of a nonsteroidal anti-inflammatory drug (NSAID) in this formulation raises the risk of severe stomach bleeding. This risk is particularly pronounced in individuals aged 60 or older, those with a history of stomach ulcers or bleeding problems, and those taking anticoagulants or steroid medications. The risk is also increased for individuals consuming three or more alcoholic drinks daily, taking other NSAIDs, or using the product for longer than directed.

The recommended dosage of this product contains approximately the same amount of caffeine as a cup of coffee. Therefore, it is advisable to limit the intake of other caffeine-containing medications, foods, or beverages during treatment, as excessive caffeine consumption may lead to nervousness, irritability, sleeplessness, and, in some cases, rapid heartbeat.

Healthcare professionals should advise patients to consult a doctor prior to use if they have liver disease, if the stomach bleeding warning applies, or if they have a history of stomach problems such as heartburn. Additional caution is warranted for individuals with high blood pressure, heart disease, liver cirrhosis, kidney disease, those taking diuretics, or those with asthma.

In the event of an overdose, immediate medical assistance should be sought, or contact with a Poison Control Center (1-800-222-1222) is recommended. 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 healthcare provider if they experience any allergic reactions or any of the following signs indicative of stomach bleeding: feeling faint, vomiting blood, having bloody or black stools, experiencing persistent stomach pain, or if there is ringing in the ears or loss of hearing. Additionally, if pain worsens or lasts longer than 10 days, if fever persists or worsens beyond three days, if redness or swelling occurs, or if any new symptoms arise, medical consultation is advised as these may indicate a serious condition.

Side Effects

Patients using this product should be aware of several serious and common adverse reactions associated with its use.

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 not use this product under these circumstances. If changes in behavior accompanied by nausea and vomiting occur, it is crucial 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 acetaminophen or aspirin. Symptoms of a severe skin reaction to acetaminophen may include skin reddening, blisters, and rash. If any of these symptoms develop, patients should discontinue use and seek medical assistance immediately. Similarly, aspirin may provoke severe allergic reactions characterized by hives, facial swelling, asthma (wheezing), or shock, necessitating immediate medical attention.

Patients should also be aware of the risk of severe liver damage associated with acetaminophen. This risk is heightened if patients exceed the maximum daily dosage of 8 caplets within 24 hours, use other medications containing acetaminophen, or consume three or more alcoholic drinks daily while using this product.

The product contains a nonsteroidal anti-inflammatory drug (NSAID), which may lead to severe stomach bleeding. The likelihood of this adverse reaction increases in patients aged 60 or older, those with a history of stomach ulcers or bleeding problems, and individuals taking blood thinners, steroids, or other NSAIDs. Patients who consume three or more alcoholic drinks daily while using this product or take it for longer than directed are also at increased risk.

Common Adverse Reactions

Patients should limit the use of caffeine-containing medications, foods, or beverages while taking this product, as it contains a caffeine amount comparable to that of a cup of coffee. Excessive caffeine intake may result in nervousness, irritability, sleeplessness, and, in some cases, rapid heartbeat.

Monitoring and Consultation

Patients are advised to stop use and consult a healthcare provider if they experience any signs of an allergic reaction or symptoms indicative of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain. Additional symptoms warranting medical consultation include 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 any new symptoms, as these may indicate a serious condition.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there are no known 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 Acetaminophen, Aspirin and Caffeine. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients, particularly 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. If any changes in behavior accompanied by nausea and vomiting occur while using this product, it is essential to consult a healthcare professional, as these may be early signs of this rare but serious illness.

For dosing, adults and children aged 12 years and older are directed to take 2 caplets every 6 hours, with a maximum of 8 caplets in a 24-hour period. For children under 12 years of age, it is advised to consult a doctor before use.

Geriatric Use

Elderly patients, particularly those aged 60 and older, may have an increased risk of stomach bleeding associated with the use of this medication. It is essential for healthcare providers to exercise caution when prescribing this treatment to geriatric patients, taking into account their age and potential comorbidities.

Before initiating therapy, healthcare providers should inquire about the presence of high blood pressure, heart disease, liver cirrhosis, or kidney disease in elderly patients. These conditions may necessitate careful monitoring and consideration of dosage adjustments to ensure safety and efficacy. Regular assessment of the patient's health status is recommended to mitigate risks associated with the use of this medication in the geriatric 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 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 its use in lactating individuals.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available data regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the lack of information necessitates careful clinical judgment and monitoring of these patients.

Hepatic Impairment

Patients with hepatic impairment should be closely monitored when using this product, which contains acetaminophen. It is important to note that severe liver damage may occur if patients exceed the maximum daily dosage of 8 caplets within a 24-hour period. Additionally, patients should avoid concomitant use with other medications containing acetaminophen, as this can further increase the risk of liver injury.

Patients with compromised liver function are also advised to limit alcohol consumption to fewer than 3 alcoholic drinks per day while using this product, as alcohol can exacerbate the potential for liver damage. Regular assessment of liver function may be warranted in these patients to ensure safety and efficacy during treatment.

Overdosage

There is currently no specific information available regarding overdosage for this medication. Healthcare professionals are advised to monitor patients closely for any signs of adverse effects or symptoms that may arise from excessive dosing.

In the event of suspected overdosage, it is recommended that healthcare providers initiate supportive care and symptomatic treatment as necessary. Patients should be evaluated for potential complications, and appropriate interventions should be implemented based on the clinical presentation.

For further guidance, healthcare professionals should refer to established protocols and consult relevant toxicology resources.

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

Postmarketing experience has identified several adverse reactions associated with the use of acetaminophen and aspirin. Reports indicate occurrences of severe skin reactions, which include skin reddening, blisters, and rash in patients receiving acetaminophen. Additionally, severe allergic reactions have been reported in association with aspirin, manifesting as hives, facial swelling, asthma (wheezing), and shock. These events were reported voluntarily or through surveillance programs and are documented in the postmarketing safety database.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222 in the event of an overdose, as prompt medical attention is crucial 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 history of allergic reactions to acetaminophen, aspirin, or any other pain reliever or fever reducer. It is essential to avoid concurrent use with any other medications 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 must be instructed to discontinue use and consult a doctor if they experience any signs of an allergic reaction or if they notice any of the following symptoms indicative of stomach bleeding: feeling faint, vomiting blood, having bloody or black stools, experiencing persistent stomach pain, or if they develop ringing in the ears or loss of hearing. Additionally, they should seek medical advice if pain worsens or lasts longer than 10 days, if fever intensifies or persists beyond 3 days, if redness or swelling occurs, or if any new symptoms arise, as these may signal a serious condition.

Healthcare providers should recommend that patients consult a doctor before using this medication if they have liver disease, a history of stomach problems such as heartburn, high blood pressure, heart disease, liver cirrhosis, or kidney disease. Patients taking diuretics, those with asthma, or those on prescription medications for diabetes, gout, or arthritis should also be advised to seek medical guidance prior to use. Furthermore, patients should be encouraged to discuss any other medications they are taking or any serious health conditions they are managing with their healthcare provider or pharmacist, especially if they are using any products that contain aspirin, acetaminophen, or other pain relievers or fever reducers.

Storage and Handling

The product is supplied in a configuration that includes an NDC number for identification. 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 to 86°F).

To ensure product integrity, the cap must be closed tightly after each use. Additionally, the product should not be utilized if the printed seal under the cap is missing or damaged, as this may compromise safety and efficacy.

Additional Clinical Information

The medication is administered orally, with specific dosing guidelines for different age groups. Adults and children aged 12 years and older are advised to take 2 caplets every 6 hours, with a maximum of 8 caplets in a 24-hour period. For children under 12 years, consultation with a doctor is recommended before use.

Clinicians should counsel patients regarding the use of this medication during pregnancy and breastfeeding. It is particularly important to avoid aspirin in the last three months of pregnancy unless explicitly directed by a healthcare professional, 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 Acetaminophen, Aspirin and Caffeine, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)