Acetaminophen/Aspirin/Caffeine

Description

This product is identified by NDC 37835-531-01 and contains a formulation that compares to the active ingredients in Excedrin® Extra Strength, specifically Acetaminophen, Aspirin (NSAID), and Caffeine. It is classified as an Extra Strength pain reliever and is supplied in a dosage form of 100 caplets. This product is distributed by BI-MART, located in Eugene, OR 97402. It is important to note that this product is not manufactured or distributed by the owner of the registered trademark Excedrin® Extra Strength.

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 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

There are no specific contraindications listed for this product. However, it is essential to keep the product out of reach of children to prevent accidental ingestion. In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center (1-800-222-1222) should be contacted. Prompt medical attention is critical for both adults and children, even if no signs or symptoms are apparent.

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, as these may be early signs of Reye's syndrome.

Allergy Alerts Acetaminophen may lead to skin reactions, which can manifest as skin reddening, blisters, or rash. Should any skin reaction occur, the use of this product must be discontinued, and medical assistance should be sought without delay. Similarly, aspirin may provoke severe allergic reactions, including hives, facial swelling, asthma (wheezing), or shock. Immediate medical attention is warranted if any of these symptoms arise.

Liver Warning This product contains acetaminophen, and severe liver damage may occur 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 consumed with three or more alcoholic drinks daily while using this product.

Stomach Bleeding Warning As this product contains a nonsteroidal anti-inflammatory drug (NSAID), there is 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 taking anticoagulants or steroid medications. The risk is also heightened for individuals taking other NSAIDs (such as aspirin, ibuprofen, or naproxen), consuming three or more alcoholic drinks daily, or using the product for longer than directed.

Caffeine Warning 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 nervousness, irritability, sleeplessness, and occasional rapid heartbeat.

Contraindications This product should not be used by individuals who have previously experienced an allergic reaction to acetaminophen, aspirin, or any other pain reliever/fever reducer. It should also not be used in conjunction with any other medications 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 Required Healthcare professionals should be consulted prior to use if the patient has liver disease, if the stomach bleeding warning applies, or if there is a history of stomach problems such as heartburn. Additionally, individuals with high blood pressure, heart disease, liver cirrhosis, or kidney disease, as well as those taking diuretics or with asthma, should seek medical advice before use. Patients taking prescription medications for diabetes, gout, or arthritis, or any other serious condition, should also consult a healthcare provider or pharmacist before use.

Discontinuation of Use The product should be discontinued and medical advice sought if an allergic reaction occurs. Signs of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain, warrant immediate medical attention. Other concerning symptoms include ringing in the ears, loss of hearing, redness or swelling in a painful area, worsening pain lasting more than 10 days, fever that worsens or lasts more than three days, or the emergence of any new symptoms, as these may indicate a serious condition.

Pregnancy and Breastfeeding Consultation with a healthcare professional is essential before using this product during pregnancy or while breastfeeding. Aspirin should be avoided after 20 weeks of pregnancy unless specifically directed by a healthcare provider, as it may pose risks to the unborn child or lead to complications during delivery.

Overdose In the event of an overdose, immediate medical assistance should be sought or contact with a Poison Control Center (1-800-222-1222) is advised. Prompt medical attention is crucial for both adults and children, even if no signs or symptoms are immediately apparent.

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 chickenpox or flu-like symptoms. Patients should not use this product in such cases, and if changes in behavior accompanied by nausea and vomiting occur, medical consultation is advised as these may be early signs of Reye's syndrome.

Allergic reactions to acetaminophen and aspirin can occur. Symptoms of an allergic 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. Aspirin may cause severe allergic reactions characterized by hives, facial swelling, asthma (wheezing), and shock.

The product contains acetaminophen, which poses a risk of severe liver damage if patients exceed the maximum daily dosage of 8 caplets, use it in conjunction with other acetaminophen-containing medications, or consume three or more alcoholic drinks daily while using this product. Additionally, the presence of an NSAID in the formulation raises the risk of severe stomach bleeding, particularly in patients aged 60 or older, those with a history of stomach ulcers or bleeding problems, and individuals taking blood thinners or other NSAIDs. Patients should also be cautious if they consume three or more alcoholic drinks daily or take the medication for longer than directed.

Caffeine is also present in the recommended dose, which is comparable to that found in a cup of coffee. Patients 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 occasional rapid heartbeat.

Patients should not use this product if they have a history of allergic reactions to acetaminophen, aspirin, or any other pain reliever/fever reducer, or if they are taking any other medications containing acetaminophen. It is recommended that patients consult a healthcare professional before use if they have liver disease, a history of stomach problems, high blood pressure, heart disease, liver cirrhosis, kidney disease, or if they are taking diuretics or have asthma.

Patients should stop using the product and seek medical advice if they experience any signs of an allergic reaction, symptoms indicative of stomach bleeding (such as feeling faint, vomiting blood, or having bloody or black stools), ringing in the ears, loss of hearing, worsening pain, or any new symptoms. These may indicate a serious condition.

For pregnant or breastfeeding patients, it is crucial to consult a healthcare professional before use. Aspirin should be avoided after 20 weeks of pregnancy unless specifically directed by a doctor, as it may pose risks to the unborn child or lead to complications during delivery.

Drug Interactions

Co-administration of this product with other medications containing acetaminophen, whether prescription or nonprescription, may result in severe liver damage. It is advisable to avoid the concurrent use of these agents to mitigate this risk.

The concomitant use of this product with anticoagulants or steroid medications may significantly increase the risk of severe gastrointestinal bleeding. Close monitoring for signs of bleeding is recommended, and dosage adjustments may be necessary based on clinical judgment.

Additionally, the use of this product alongside other nonsteroidal anti-inflammatory drugs (NSAIDs), including aspirin, ibuprofen, and naproxen, may elevate the risk of stomach bleeding. Caution is warranted, and healthcare providers should consider alternative pain management strategies or adjust dosages accordingly.

Patients are also advised to limit the intake of caffeine-containing medications, foods, or beverages while using this product to prevent excessive caffeine consumption, which could lead to adverse effects.

No specific laboratory test interactions have been identified in the available data.

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

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 pediatric patients experience changes in behavior accompanied by nausea and vomiting while using this product, it is important to consult a healthcare professional, 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 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, are at an increased risk for severe stomach bleeding. This heightened risk necessitates careful consideration and monitoring when prescribing medications that may contribute to gastrointestinal complications.

Additionally, severe liver damage may occur in geriatric patients who exceed the maximum daily dosage or who concurrently use other medications containing acetaminophen. This risk underscores the importance of adhering to recommended dosages and being vigilant about potential drug interactions.

It is advisable for healthcare providers to consult with elderly patients regarding their medical history, especially if they have a history of stomach problems, high blood pressure, heart disease, liver cirrhosis, or kidney disease. These conditions are more prevalent in the geriatric population and may influence the safety and efficacy of treatment options. Regular monitoring and appropriate dose modifications may be necessary to ensure the well-being of elderly patients.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to use. The use of aspirin is particularly cautioned against after 20 weeks of pregnancy, as it may pose risks to the developing fetus and lead to complications during delivery. It is essential for healthcare providers to evaluate the necessity of aspirin in these circumstances and to consider alternative treatments when appropriate.

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 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 using this product. It is important to note that this product contains acetaminophen, which carries a risk of severe liver damage. Patients with compromised liver function must be particularly cautious, as exceeding the maximum daily dosage of 8 caplets within a 24-hour period can lead to significant hepatic injury.

Additionally, the risk of liver damage is heightened when acetaminophen is taken in conjunction with other medications containing acetaminophen or when consuming three or more alcoholic beverages daily while using this product. Therefore, careful monitoring of liver function and adherence to recommended dosages is essential for patients with liver disease.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222. Prompt medical 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 health consequences. Therefore, it is essential to monitor the patient closely and provide comprehensive care as needed.

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

No specific postmarketing experience details have been reported. As such, there are no additional adverse events or rare case reports to summarize at this time.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental ingestion. It is essential to emphasize the importance of seeking immediate medical assistance in the event of an overdose. Patients should be informed to contact a Poison Control Center at 1-800-222-1222 or seek medical help right away, regardless of whether they observe any signs or symptoms. Quick medical attention is critical for both adults and children in such situations.

Storage and Handling

The product is supplied in a configuration that includes an NDC number for identification. It should be stored at a temperature range of 20°-25°C (68°-77°F) to ensure optimal stability and efficacy. After each use, it is essential to close the cap tightly to maintain the integrity of the product. Users are advised not to use the product if the printed seal under the cap is missing or damaged, as this may compromise safety and effectiveness.

Additional Clinical Information

The medication is administered orally. Clinicians should counsel patients to consult a health professional if they are pregnant or breastfeeding before use. It is particularly critical to avoid the use of aspirin at 20 weeks of gestation or later unless specifically 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 Acetaminophen, Aspirin, and Caffeine, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)