Acetaminophen/Aspirin/Caffeine

Description

This formulation provides extra strength headache relief through a combination of active ingredients. Each dosage unit contains 250 mg of acetaminophen, a pain reliever; 250 mg of aspirin, a nonsteroidal anti-inflammatory drug (NSAID) that also serves as a pain reliever; and 65 mg of caffeine, which acts as a pain reliever aid. This product is comparable to the active ingredients found in Excedrin® Extra Strength. It is distributed by Safrel Pharmaceuticals, LLC, located in Bridgewater, NJ 08807. Further information can be accessed at www.safrel.com.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with various conditions, including headache, cold, arthritis, muscular aches, sinusitis, 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. For adults and children aged 12 years and older, the prescribed dosage is 2 tablets every 6 hours, with a maximum limit of 8 tablets within a 24-hour period. It is essential to consume a full glass of water with each dose to ensure proper administration.

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. Concurrent use with any other drug containing acetaminophen, whether prescription or nonprescription, is also contraindicated; if there is uncertainty regarding the presence of acetaminophen in a medication, consultation with a healthcare professional is advised. Additionally, do not use if the imprinted safety seal under the cap is broken or missing.

Warnings and Precautions

Patients should be informed of the following warnings and precautions associated with the use of this product.

Reye's Syndrome Children and teenagers who are experiencing or recovering from chickenpox or flu-like symptoms should avoid using this product. If any changes in behavior accompanied by nausea and vomiting occur during use, it is imperative to consult a healthcare professional, as these symptoms may indicate the onset of Reye's syndrome, a rare but serious condition.

Allergy Alert Aspirin may induce severe allergic reactions, which can manifest as hives, shock, facial swelling, or asthma (wheezing). Patients should be advised to seek immediate medical attention if any signs of an allergic reaction occur.

Liver Warning This product contains acetaminophen, and severe liver damage may result from exceeding the maximum daily dosage of 8 tablets within a 24-hour period, using other medications that contain acetaminophen, or consuming 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. The likelihood of this adverse effect increases in patients who are 60 years of age or older, have a history of stomach ulcers or bleeding disorders, are taking anticoagulants or steroid medications, are using other NSAIDs (including aspirin, ibuprofen, or naproxen), consume three or more alcoholic drinks daily, or exceed the recommended dosage or duration of use.

Caffeine Warning The recommended dosage of this product contains approximately the same amount of caffeine as a cup of coffee. Patients should 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.

Discontinuation of Use Patients should stop using this product and consult a healthcare professional if they experience any signs of stomach bleeding, such as feeling faint, having bloody or black stools, vomiting blood, or experiencing persistent stomach pain. Additionally, any allergic reactions, new symptoms, ringing in the ears, loss of hearing, worsening pain lasting more than 10 days, or fever lasting more than 3 days warrant immediate medical attention. Redness or swelling in the painful area should also be evaluated by a healthcare provider.

Emergency Medical Help In the event of an overdose, it is crucial to seek emergency medical assistance or contact a Poison Control Center (1-800-222-1222) immediately. Prompt medical intervention is essential for both adults and children, even if no signs or symptoms are initially apparent.

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. If patients exhibit changes in behavior accompanied by nausea and vomiting while using this product, they should consult a doctor immediately, as these may be early signs of Reye's syndrome.

A severe allergic reaction to aspirin may manifest as hives, shock, facial swelling, or asthma (wheezing). Patients experiencing any of these symptoms should seek medical attention promptly.

This product contains acetaminophen, and severe liver damage may occur if patients exceed the maximum daily dosage of 8 tablets within 24 hours, 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 this product raises the risk of severe stomach bleeding, particularly in patients who are 60 years or older, have a history of stomach ulcers or bleeding problems, are taking blood thinners or steroids, consume three or more alcoholic drinks daily, or exceed the recommended duration or dosage.

Common Adverse Reactions Patients should be aware of the potential for stomach bleeding, which may present as feeling faint, having bloody or black stools, vomiting blood, or experiencing persistent stomach pain. If any of these symptoms occur, patients are advised to stop use and consult a doctor.

Other common adverse reactions may include ringing in the ears or loss of hearing, worsening pain lasting more than 10 days, or a fever that persists for more than three days. Patients should also seek medical advice if a painful area becomes red or swollen.

Precautions Patients with liver disease, a history of stomach problems (such as heartburn), high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma should consult a doctor before using this product. Additionally, those taking diuretics or prescription medications for diabetes, gout, or arthritis should also seek medical advice prior to use.

Caffeine is present in the recommended dose of this product, 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, or, occasionally, rapid heartbeat.

Drug Interactions

Co-administration of this medication with any other drug containing acetaminophen, whether prescription or nonprescription, is contraindicated due to the risk of acetaminophen overdose and associated hepatotoxicity.

Pharmacodynamic interactions are significant when this medication is used concurrently with anticoagulants or steroid drugs. The risk of severe gastrointestinal bleeding is markedly increased in patients taking these agents. Therefore, careful monitoring for signs of gastrointestinal bleeding is advised in such cases.

Additionally, the concomitant use of this medication with other nonsteroidal anti-inflammatory drugs (NSAIDs), including but not limited to aspirin, ibuprofen, and naproxen, also elevates the risk of severe stomach bleeding. It is recommended that healthcare providers assess the necessity of NSAID therapy in patients receiving this medication.

Patients who are on prescription medications for diabetes, gout, or arthritis should consult with their healthcare provider or pharmacist prior to initiating this medication to ensure safe and effective use.

Packaging & NDC

Below are the non-prescription pack sizes of Extra Strength Headache Relief. 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, a healthcare professional should be consulted, as these may be early signs of this rare but serious condition.

For children under 12 years of age, it is advised to consult a doctor before use. For adolescents aged 12 years and older, the recommended dosage is 2 tablets every 6 hours, with a maximum of 8 tablets in a 24-hour period.

Geriatric Use

Elderly patients may be at an increased risk for severe stomach bleeding when using this product, as it contains a nonsteroidal anti-inflammatory drug (NSAID). The likelihood of experiencing such adverse effects is notably higher in individuals aged 60 years and older.

It is essential for geriatric patients to consult with a healthcare provider prior to using this medication, particularly if they have pre-existing conditions such as high blood pressure, heart disease, liver cirrhosis, or kidney disease. Close monitoring and appropriate dose adjustments may be necessary to ensure safety and efficacy in this 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 fetal development or complications during delivery. Therefore, it is essential that pregnant patients only use aspirin in the final three months of pregnancy if explicitly directed by a healthcare provider.

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, 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

There is no specific information regarding renal impairment, dosage adjustments, special monitoring, or safety considerations for patients with reduced kidney function. Healthcare professionals should exercise caution and consider individual patient factors when prescribing to patients with renal impairment, as the absence of detailed guidance necessitates careful clinical judgment.

Hepatic Impairment

Patients with hepatic impairment should exercise caution when using this product, which contains acetaminophen. It is critical to adhere to the maximum daily dosage of 8 tablets within a 24-hour period to avoid the risk of severe liver damage.

Additionally, patients must avoid concomitant use of other medications that contain acetaminophen, as this can further increase the risk of hepatotoxicity. Consumption of three or more alcoholic drinks per day while using this product is also contraindicated, as it may exacerbate liver damage.

Monitoring of liver function is recommended for patients with compromised liver function who are prescribed this product. Regular assessment of liver enzymes may be warranted to ensure patient safety and to mitigate the risk of potential adverse effects related to hepatic impairment.

Overdosage

In the absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdose.

It is essential to monitor the patient closely for any potential symptoms that may arise, as the clinical presentation can vary depending on the substance involved. Common symptoms of overdose may include, but are not limited to, respiratory depression, altered mental status, cardiovascular instability, and gastrointestinal disturbances.

In the event of an overdose, immediate medical intervention is recommended. Healthcare providers should initiate supportive care, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs. The use of activated charcoal may be considered if the patient presents within a suitable timeframe and is deemed appropriate based on clinical judgment.

Furthermore, it is crucial to consult local poison control centers or toxicology experts for guidance on specific management protocols and antidotes, if applicable. Continuous assessment and supportive measures should be maintained until the patient stabilizes or further treatment is determined.

In summary, while specific overdosage information is not available, healthcare professionals should remain vigilant and prepared to implement standard overdose management strategies in any suspected cases.

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 relevant information is available regarding non-teratogenic effects. Additionally, there is no pertinent data provided in the nonclinical toxicology section or in the animal pharmacology and toxicology information.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients on 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 without delay. It is crucial to emphasize that prompt medical attention is necessary for both adults and children, even if they do not exhibit any signs or symptoms of overdose. This proactive approach can significantly impact the outcome 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 controlled room temperature of 25°C (77°F), with permissible excursions between 15-30°C (59-86°F).

It is essential to ensure that the product is kept in its original container to maintain its integrity. Additionally, the product features a tamper-evident safety seal; therefore, it must not be used if the safety seal under the cap is broken or missing. Proper handling and storage conditions are crucial to ensure the product's efficacy and safety.

Additional Clinical Information

The medication is administered orally, with the recommended dosage for adults and children aged 12 years and older being 2 tablets every 6 hours, not to exceed 8 tablets in a 24-hour period. For children under 12 years, it is advised to consult a doctor before use.

Clinicians should counsel patients to seek advice from a health professional if they are pregnant or breastfeeding. It is particularly crucial to avoid aspirin during the last trimester of pregnancy 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 Extra Strength Headache Relief, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)