Extra Strength Headache Relief

Description

Acetaminophen, Aspirin (NSAID), and Caffeine are combined in this formulation to provide effective pain relief. Each component plays a role in alleviating discomfort, with acetaminophen serving as an analgesic, aspirin functioning as a nonsteroidal anti-inflammatory drug (NSAID), and caffeine acting as a pain reliever aid. The product is available in a dosage form of 80 softgels, designed for convenient administration. This formulation is comparable to the active ingredients found in 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. For adults and children aged 12 years and older, the prescribed dosage is 2 softgels every 6 hours, with a maximum of 8 softgels within a 24-hour period. It is essential to take each dose with a full glass of water to ensure proper administration and absorption.

For children under 12 years of age, it is advised to consult a healthcare professional before use to determine the appropriate dosage.

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 have or are recovering from chickenpox or flu-like symptoms should not use this product. If behavioral changes accompanied by nausea and vomiting occur during use, it is imperative to consult a physician, as these symptoms may indicate the onset of Reye's syndrome, a rare but serious condition.

Acetaminophen, a component of this product, has the potential to cause severe skin reactions. Symptoms may include skin reddening, blisters, or rash. Should any skin reaction occur, the use of the product must be discontinued immediately, and medical assistance should be sought.

This product contains acetaminophen, and severe liver damage may result from exceeding the maximum daily dosage of 8 caplets within a 24-hour period, using it concurrently with other medications containing acetaminophen, or consuming three or more alcoholic drinks daily while using this product.

Additionally, the product contains a nonsteroidal anti-inflammatory drug (NSAID), which may lead to severe stomach bleeding. The risk of such an event is heightened in individuals 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 duration or dosage of the product.

The recommended dosage of this product contains approximately the same amount of caffeine as a standard 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 symptoms such as nervousness, irritability, sleeplessness, and, in some cases, rapid heartbeat.

Healthcare professionals should advise patients to consult a physician prior to use if they have liver disease, if the warning regarding stomach bleeding applies, or if they have a history of gastrointestinal issues such as heartburn. Patients with high blood pressure, heart disease, liver cirrhosis, kidney disease, or those taking diuretics or who have asthma should also seek medical advice before using this product. Furthermore, patients should inform their healthcare provider if they are taking prescription medications for diabetes, gout, or arthritis, or any other drugs, particularly if they are under care for a serious medical condition.

In the event of an overdose, immediate medical attention is crucial. Patients should contact a Poison Control Center or seek emergency medical help without delay, as prompt intervention is essential for both adults and children, even in the absence of noticeable symptoms.

Patients are advised to discontinue use and consult a physician if they experience any allergic reactions, signs 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 in a painful area, worsening pain lasting more than 10 days, fever that worsens or persists for more than three days, or any new symptoms, 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 symptoms could indicate the onset of Reye's syndrome.

Severe allergic reactions may occur, particularly in response 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. Aspirin may provoke severe allergic reactions characterized by hives, facial swelling, asthma (wheezing), or shock, necessitating prompt medical attention.

This 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 concurrently 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 with a history of stomach ulcers or bleeding problems, or those taking anticoagulants, steroids, or other NSAIDs. The risk is further heightened if patients consume three or more alcoholic drinks daily or exceed the recommended duration or dosage.

Common Adverse Reactions

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

Patients are advised to stop use and consult 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 experiencing persistent stomach pain), ringing in the ears or loss of hearing, or if a painful area becomes red or swollen. Furthermore, if pain persists for more than 10 days, fever worsens or lasts for more than three days, or any new symptoms arise, patients should seek medical evaluation, as these may signal a serious condition.

Drug Interactions

Taking this product concurrently with other medications containing acetaminophen, whether prescription or nonprescription, may result in severe liver damage. It is advisable to avoid the use of multiple acetaminophen-containing products to mitigate this risk.

The concomitant use of this product with anticoagulants or steroid medications significantly increases the likelihood of severe gastrointestinal bleeding. Close monitoring of patients on these combinations 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. Excessive caffeine consumption may lead to symptoms such as nervousness, irritability, sleeplessness, and, in some cases, rapid heart rate. Monitoring for these effects is recommended to ensure patient safety.

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

Packaging & NDC

Below are the non-prescription pack sizes of Extra Strength Headache Relief (acetaminophen, aspirin, and caffeine). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients, particularly children and teenagers, should not use this product if they have or are recovering from chicken pox or flu-like symptoms due to the risk of Reye's syndrome. Healthcare professionals should advise parents and caregivers to consult a doctor if their child experiences changes in behavior accompanied by nausea and vomiting, 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 softgels every 6 hours, with a maximum of 8 softgels in a 24-hour period. For children under 12 years of age, it is recommended to seek medical advice before use.

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 signs of gastrointestinal bleeding and to evaluate the necessity of dosage adjustments based on individual health status and concurrent medications. Careful assessment of the risk-benefit ratio is essential in this population to ensure safe and effective treatment.

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 and complications during delivery. Therefore, it is essential that pregnant patients only use aspirin in this period if explicitly directed by a healthcare provider.

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 doctor, 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 should consult their healthcare provider prior to use, particularly if they have a history of 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 their healthcare provider 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 should not exceed 8 caplets in a 24-hour period, as this is the maximum daily dosage. Additionally, patients must avoid concurrent use with other medications that contain acetaminophen, as this can further increase the risk of liver injury.

Furthermore, patients who consume three or more alcoholic drinks daily should exercise caution when using this product, as alcohol can exacerbate the potential for liver damage. Regular monitoring of liver function may be warranted in patients with existing liver disease or those who are at increased risk for hepatic impairment.

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, even in the absence of observable signs or symptoms.

Healthcare professionals should be aware that the lack of immediate symptoms does not preclude the potential for serious adverse effects. Therefore, vigilance and timely action are essential in managing overdose situations effectively.

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

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, 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 about the contents of a medication, they should be encouraged to consult a doctor or pharmacist.

Patients must be instructed to discontinue use and consult a healthcare professional if they experience any signs of an allergic reaction or if they notice symptoms indicative of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain. Additionally, they should stop use and seek medical advice if they experience ringing in the ears, loss of hearing, redness or swelling in the painful area, or if their pain worsens or persists beyond 10 days. If a fever worsens or lasts more than 3 days, or if any new symptoms arise, patients should also be advised to contact their doctor, as these may signal a serious condition.

Patients should be encouraged to consult their healthcare provider 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. It is also important for patients to discuss their use of diuretics, asthma, or any prescription medications for diabetes, gout, or arthritis with their doctor or pharmacist prior to use. Lastly, patients should be reminded to inform their healthcare provider if they are under care for any serious condition or are taking any other medications.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available upon request. It should be stored at a temperature range of 20° to 25° C (68° to 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 and prevent contamination. Proper adherence to these storage and handling guidelines is crucial for preserving the quality of the product.

Additional Clinical Information

The medication is administered orally. For adults and children aged 12 years and older, the recommended dosage is 2 softgels every 6 hours, with a maximum of 8 softgels in a 24-hour period. For children under 12 years, it is advised to consult a doctor regarding appropriate dosing.

Clinicians should counsel patients to seek advice from a health professional if they are pregnant or breastfeeding. It is particularly crucial 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.

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