Headache Relief

Description

NDC 56062-934-12. This product contains acetaminophen, aspirin (a nonsteroidal anti-inflammatory drug), and caffeine, formulated for extra strength headache relief. It is presented in a dosage form of caplets, with a total of 100 caplets per container. The product is comparable to the active ingredients found in Excedrin® Extra Strength Headache. It is distributed by Publix Super Markets, Inc., located at 3300 Publix Corporate Parkway, Lakeland, FL 33811. The product is tamper evident; do not use if the imprinted safety seal under the cap is broken or missing. This product is not manufactured or distributed by Haleon CH SARL, the owner of the registered trademark Excedrin® Extra Strength Headache.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with various conditions, including headache, arthritis, the common cold, muscular aches, toothache, and premenstrual and 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 administration guidelines.

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. It is essential to take each dose with a full glass of water to ensure proper hydration and absorption.

For children under 12 years of age, it is advised to consult a healthcare professional for appropriate dosing recommendations.

Patients are cautioned not to exceed the directed dosage to avoid potential adverse effects.

Contraindications

Use is contraindicated in patients with a history of allergic reactions to any pain reliever or fever reducer. Additionally, concurrent use with any other medication containing acetaminophen, whether prescription or nonprescription, is contraindicated. If there is uncertainty regarding the presence of acetaminophen in a medication, 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.

Aspirin may induce severe allergic reactions, which can manifest as shock, facial swelling, hives, or asthma symptoms such as wheezing. Similarly, acetaminophen may lead to severe skin reactions, including skin reddening, blisters, or rash. In the event of a skin reaction, it is crucial to discontinue use and seek medical assistance without delay.

This product contains acetaminophen, which poses a risk of severe liver damage if the following conditions are met: exceeding 4,000 mg of acetaminophen within a 24-hour period, concurrent use with other medications containing acetaminophen, or consumption of 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 individuals aged 60 or older, those taking other NSAIDs (prescription or nonprescription), individuals with a history of stomach ulcers or bleeding problems, and those using blood thinners or steroids. The risk is also heightened if the product is taken in greater amounts or for longer durations than directed.

Caffeine is also a component of the recommended dose, which is comparable to the caffeine content of 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.

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 issues such as heartburn. Patients with high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma, as well as those taking diuretics, should also seek medical advice before using this product. Furthermore, individuals on prescription medications for diabetes, gout, or arthritis should consult a doctor or pharmacist before use.

In the event of an overdose, immediate medical attention is essential. Patients should contact a Poison Control Center or seek emergency medical help right away, as prompt intervention is critical for both adults and children, even in the absence of noticeable symptoms.

Users should discontinue use and contact a healthcare professional if they experience any signs of an allergic reaction, symptoms indicative of stomach bleeding (such as feeling faint, vomiting blood, having bloody or black stools, or persistent stomach pain), ringing in the ears or hearing loss, redness or swelling, worsening pain lasting more than 10 days, fever lasting more than 3 days, or any new symptoms that arise.

Side Effects

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

Reye’s syndrome is a rare but serious condition that may occur in children and teenagers who have or are recovering from chickenpox or flu-like symptoms. It is crucial for these individuals to avoid using this product. If patients exhibit changes in behavior accompanied by nausea and vomiting while using this product, they should consult a healthcare professional immediately, as these symptoms could indicate the onset of Reye's syndrome.

Severe allergic reactions may occur, particularly in patients with a known allergy to aspirin or acetaminophen. Symptoms of such reactions can include shock, facial swelling, hives, and asthma (wheezing). In the case of acetaminophen, severe skin reactions have been reported, characterized by skin reddening, blisters, and rash. Patients experiencing any skin reactions should discontinue use and seek medical assistance promptly.

The product contains acetaminophen, which poses a risk of severe liver damage if patients exceed 4,000 mg in 24 hours, use it in conjunction with other acetaminophen-containing medications, or consume three or more alcoholic drinks daily while using the product.

Additionally, the presence of an NSAID in this product raises the risk of severe stomach bleeding, particularly in patients aged 60 or older, those taking other NSAIDs, individuals with a history of stomach ulcers or bleeding problems, and those on blood thinners or steroids. 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 included 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 products to avoid potential side effects such as nervousness, irritability, sleeplessness, and, in some cases, rapid heartbeat.

Patients should stop using the product and consult a healthcare provider if they experience any allergic reactions, signs of stomach bleeding, ringing in the ears, loss of hearing, redness or swelling, worsening pain lasting more than 10 days, fever lasting more than 3 days, or any new symptoms.

Before using this product, patients should seek medical advice if they have liver disease, a history of stomach problems, high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma. It is also recommended to consult a healthcare professional if they are taking prescription medications for diabetes, gout, or arthritis.

Drug Interactions

The concomitant use of this product with other nonsteroidal anti-inflammatory drugs (NSAIDs), including both prescription and nonprescription medications such as aspirin, ibuprofen, and naproxen, may significantly increase the risk of severe gastrointestinal bleeding. Caution is advised when considering the use of multiple NSAIDs concurrently.

Additionally, the risk of severe stomach bleeding is heightened when this product is used in conjunction with anticoagulants or steroid medications. Healthcare professionals should evaluate the necessity of dosage adjustments or enhanced monitoring for patients receiving these combinations.

Patients are also advised to limit the intake of caffeine-containing medications, foods, or beverages while using this product. Excessive caffeine consumption may lead to adverse effects such as nervousness, irritability, insomnia, and, in some cases, tachycardia.

Before initiating therapy with this product, individuals taking prescription medications for diabetes, gout, or arthritis should consult with a healthcare provider or pharmacist to ensure safe and effective use.

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

Packaging & NDC

Below are the non-prescription pack sizes of Headache Relief (acetaminophen, aspirin, 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 changes in behavior accompanied by nausea and vomiting occur while using this product, it is important to consult a doctor, as these may be early signs of Reye's syndrome.

For dosing, adults and children aged 12 years and over 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, it is advised to consult a doctor for appropriate dosing recommendations.

Geriatric Use

Elderly patients, particularly those aged 60 years and older, may have an increased risk of stomach bleeding. Healthcare providers should exercise caution when prescribing this medication to geriatric patients, considering the heightened susceptibility to gastrointestinal complications.

It is advisable to monitor these patients closely for any signs of gastrointestinal bleeding and to evaluate the necessity of dosage adjustments based on individual patient factors. Careful assessment of the risk-benefit ratio is essential in this population to ensure safe and effective use of the medication.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional before using this medication. It is particularly important to avoid the use of aspirin after 20 weeks of pregnancy unless specifically directed by a physician, as it may pose risks to the developing fetus and lead to complications during delivery. Healthcare providers should carefully evaluate the potential benefits and 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 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 its use during lactation.

Renal Impairment

Patients with renal impairment should consult a healthcare professional prior to use, particularly if they have conditions such as high blood pressure, heart disease, liver cirrhosis, or kidney disease. It is essential to assess renal function and consider potential dosing adjustments or monitoring requirements based on the severity of renal 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 under certain conditions. Specifically, patients with compromised liver function should be aware that exceeding 4,000 mg of acetaminophen within a 24-hour period may lead to significant hepatic injury.

Additionally, concurrent use of other medications containing acetaminophen should be avoided to prevent cumulative dosing that could exacerbate the risk of liver damage. Patients who consume three or more alcoholic beverages daily while using this product are also at an increased risk for severe liver damage. Therefore, careful consideration and monitoring of liver function are advised for patients with hepatic impairment when using this product.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. Prompt medical intervention is crucial for both adults and children, regardless of whether any signs or symptoms are apparent.

Healthcare professionals are advised to remain vigilant, as the absence of symptoms does not preclude the possibility of serious complications. Early recognition and management of an overdose can significantly influence patient outcomes. Therefore, it is essential to ensure that patients and caregivers are aware of the importance of timely medical evaluation in cases of suspected overdose.

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 relevant information is available regarding non-teratogenic effects. Additionally, there is no relevant information provided concerning nonclinical toxicology or animal pharmacology and toxicology.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center in the event of an overdose, emphasizing that prompt medical attention is crucial for both adults and children, even if no signs or symptoms are initially apparent.

Patients should be informed not to use this medication if they have a history of allergic reactions to any other pain reliever or fever reducer. It is important to instruct patients to avoid using this medication in conjunction with any other products containing acetaminophen, whether prescription or nonprescription. If patients are uncertain about the presence of acetaminophen in other medications, they should be encouraged to consult a doctor or pharmacist.

Patients should be counseled to discontinue use and seek medical advice if they experience any signs of an allergic reaction. Additionally, they should be made aware of the symptoms indicative of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain, and advised to stop use and consult a doctor if these occur.

Healthcare providers should also inform patients to stop using the medication and seek medical attention if they experience ringing in the ears, loss of hearing, redness, or swelling. Patients should be advised to consult a doctor if their pain worsens or persists for more than 10 days, if their fever intensifies or lasts longer than 3 days, or if any new symptoms arise.

It is essential to recommend that patients consult a doctor before using this medication if they have liver disease, a history of stomach problems such as heartburn, or if the stomach bleeding warning applies to them. Patients with high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma should also be advised to seek medical guidance prior to use. Furthermore, patients taking diuretics or prescription medications for diabetes, gout, or arthritis should be encouraged to discuss their current medications with a doctor or pharmacist before using this product.

Storage and Handling

The product is supplied in configurations that include specific NDC numbers, which can be found on the packaging. 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).

Healthcare professionals are advised to check the end flap of the packaging for the expiration date and lot number to ensure proper inventory management and product safety.

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 instructed to take 2 caplets every 6 hours, with a maximum of 8 caplets in a 24-hour period. For children under 12 years, it is advised to consult a doctor for appropriate dosing.

Clinicians should counsel patients regarding the use of the medication during pregnancy and breastfeeding, emphasizing the importance of consulting a health professional before use. It is particularly critical to avoid aspirin after 20 weeks of pregnancy unless directed by a doctor, due to potential risks to the unborn child and complications during delivery. In the event of an overdose, patients should seek immediate medical assistance or contact a Poison Control Center, as prompt attention is essential for both adults and children, regardless of the presence of symptoms.

Drug Information (PDF)

This file contains official product information for Headache Relief, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

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