Extra Strength Headache Relief

Description

The product is presented in various carton sizes, specifically containing 50, 100, and 200 units per carton. Each carton is visually represented by images in JPEG format, which are referenced as "Carton 50ct.jpg," "Carton 100ct.jpg," and "Carton 200ct.jpg." The effective date for this labeling is June 18, 2024. The labeling is identified by the code 51945-4, which is part of the code system 2.16.840.1.113883.6.1.

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 administration guidelines. It is imperative not to exceed the directed dosage.

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. Each dose should be accompanied by a full glass of water to ensure proper hydration and absorption.

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

This product contains acetaminophen, which may lead to severe skin reactions. Symptoms such as skin reddening, blisters, or rash warrant immediate cessation of use and prompt medical attention. Additionally, aspirin, another component of this product, can provoke severe allergic reactions, including hives, facial swelling, asthma (wheezing), and shock.

Healthcare professionals should be aware of the liver warning associated with acetaminophen. Severe liver damage can occur if more than 8 caplets are taken within a 24-hour period, if other medications containing acetaminophen are used concurrently, or if the individual consumes 3 or more alcoholic drinks daily while using this product.

The presence of a nonsteroidal anti-inflammatory drug (NSAID) in this formulation raises the 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 patients using other NSAIDs (including aspirin, ibuprofen, or naproxen), consuming 3 or more alcoholic drinks daily, or exceeding the recommended duration or dosage of this product.

Caffeine is another component of this product, with a recommended dose containing approximately the same amount 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, in some cases, rapid heartbeat.

Healthcare professionals should instruct patients to discontinue use and seek medical advice if any allergic reactions occur. Signs of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain, should prompt immediate medical evaluation. Other concerning symptoms include ringing in the ears, loss of hearing, worsening pain, fever lasting more than 3 days, or the emergence of new symptoms, as these may indicate serious conditions.

In the event of an overdose, it is critical to seek emergency medical assistance or contact a Poison Control Center immediately at 1(800)222-1222. Prompt medical attention is essential for both adults and children, even if no signs or symptoms are initially 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. If patients experience changes in behavior accompanied by nausea and vomiting while using this product, they should consult a doctor immediately, as these symptoms could indicate the onset of Reye’s syndrome.

Severe skin reactions have been reported in patients using acetaminophen, which is an ingredient in this product. Symptoms may include skin reddening, blisters, and rash. If any of these reactions occur, patients should discontinue use and seek medical assistance promptly.

Aspirin, another component of this product, may lead to severe allergic reactions. Symptoms of such reactions can include hives, facial swelling, asthma (wheezing), and shock. Patients experiencing any signs of an allergic reaction should stop using the product and seek medical help immediately.

The product contains acetaminophen, which poses a risk of severe liver damage if patients exceed the maximum daily dosage of 8 caplets within 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 nonsteroidal anti-inflammatory drug (NSAID) present in this product may increase the risk of severe stomach bleeding, particularly in patients who are 60 years of age or older, have a history of stomach ulcers or bleeding problems, are taking blood thinners or steroids, or are using other NSAIDs. The risk is also heightened if patients consume three or more alcoholic drinks daily or take the medication for longer than directed.

Patients should also be cautious regarding caffeine intake, as the recommended dose of this product contains approximately the same amount of caffeine as a cup of coffee. Excessive caffeine consumption may lead to nervousness, irritability, sleeplessness, and, in some cases, rapid heartbeat.

Patients are advised to stop using the product and consult a doctor 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 experiencing persistent stomach pain), ringing in the ears or loss of hearing, redness or swelling in a painful area, worsening pain lasting more than 10 days, fever lasting more than 3 days, or any new symptoms. These could be indicative of a serious condition requiring medical attention.

Drug Interactions

This product contains acetaminophen; therefore, concurrent use with any other drug containing acetaminophen, whether prescription or nonprescription, is contraindicated to avoid the risk of acetaminophen overdose.

Additionally, this product includes a nonsteroidal anti-inflammatory drug (NSAID). The concomitant use of this NSAID with anticoagulants (blood thinners) or steroid medications increases the risk of severe gastrointestinal bleeding. Caution is advised when administering this product alongside other NSAIDs, including aspirin, ibuprofen, naproxen, or similar agents, as this may further elevate the risk of adverse effects.

No specific interactions with laboratory tests have been identified in the product insert.

Packaging & NDC

Below are the non-prescription pack sizes of Extra Strength 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 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 essential 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.

This product should be kept out of reach of children. In the event of an overdose, immediate medical assistance should be sought, or contact a Poison Control Center right away, as prompt medical attention is critical for both adults and children, even if no signs or symptoms are apparent.

Geriatric Use

Elderly patients, particularly those aged 60 and older, may have an increased risk of severe stomach bleeding. Healthcare providers should exercise caution when prescribing this medication to geriatric patients, considering the potential for heightened adverse effects.

It is advisable to closely monitor elderly patients for any signs of gastrointestinal bleeding and to evaluate the necessity of dosage adjustments based on individual patient factors. Careful assessment of the benefits and risks 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 prior to use. The use of aspirin during the last trimester of pregnancy is particularly cautioned against, as it may pose risks to the unborn child and lead to complications during delivery. Therefore, it is essential that pregnant patients only use aspirin in this period if explicitly directed by a physician.

Lactation

Lactating mothers are advised to consult a healthcare 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 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 while breastfeeding.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

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 of 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. Specifically, the intake of 3 or more alcoholic drinks per day while using this product may significantly heighten the risk of liver damage. Therefore, careful consideration of liver function and adherence to the recommended dosage guidelines is essential to minimize the potential for adverse effects in this patient population.

Overdosage

In cases of overdosage, significant health risks are associated with the consumption of this product beyond the recommended limits.

Maximum Daily Dosage Taking more than 8 caplets within a 24-hour period is associated with the potential for severe liver damage. It is crucial for healthcare professionals to monitor patients for signs of liver impairment in individuals who exceed this dosage.

Drug Interactions The concomitant use of this product with other medications containing acetaminophen can also lead to severe liver damage. Healthcare providers should assess a patient's medication history to identify any potential interactions that may increase the risk of hepatotoxicity.

Alcohol Consumption Patients who consume 3 or more alcoholic drinks daily while using this product are at an elevated risk for severe liver damage. It is advisable for healthcare professionals to counsel patients on the dangers of alcohol consumption during treatment and to consider alternative therapies if necessary.

In the event of suspected overdosage, immediate medical attention is recommended. Monitoring liver function tests and providing supportive care are essential components of management.

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 detailed findings regarding nonclinical toxicology or animal pharmacology and toxicology provided in the current information.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical help or contact a Poison Control Center at 1(800)222-1222 in the event of an overdose. It is crucial to emphasize that quick medical attention is necessary 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 ever experienced an allergic reaction to acetaminophen, aspirin, or any other pain reliever or fever reducer. Additionally, they should be cautioned against using this medication in conjunction with any other drug that contains acetaminophen, whether prescription or nonprescription. If patients are uncertain whether a drug contains acetaminophen, they should be encouraged to consult a doctor or pharmacist.

Healthcare providers should instruct patients to discontinue use and seek medical advice if they experience any signs of an allergic reaction. Immediate medical assistance should be sought in such cases.

Patients should also be made aware of the signs of potential stomach bleeding, which include feeling faint, vomiting blood, having bloody or black stools, experiencing persistent stomach pain, ringing in the ears, loss of hearing, redness or swelling in a painful area, worsening pain lasting more than 10 days, fever worsening or lasting more than 3 days, or the appearance of any new symptoms. These symptoms may indicate a serious condition, and patients should be advised to stop use and consult a doctor if they occur.

Before initiating treatment, healthcare providers should recommend that patients consult a doctor if they have liver disease, if the warning regarding stomach bleeding applies to them, if they have a history of stomach problems such as heartburn, or if they have high blood pressure, heart disease, liver cirrhosis, or kidney disease. Patients taking diuretics or those with asthma should also be encouraged to seek medical advice prior to use.

Finally, patients should be advised to consult a doctor or pharmacist before using this medication if they are currently taking a prescription drug for diabetes, gout, or arthritis, any other medication, or if they are under a doctor’s care for any serious condition.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at a controlled temperature range of 20º to 25º C (68º to 77º F) to maintain its efficacy and stability. Proper storage conditions must be adhered to, ensuring that the product is kept within the specified temperature limits to prevent degradation.

Additional Clinical Information

The medication is administered orally. For adults and children aged 12 years and older, the recommended dosage is 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 to seek advice from a health professional if they are pregnant or breastfeeding. It is particularly important to avoid the use of 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)