Extra Strength Headache Relief

Description

Acetaminophen Aspirin (NSAID) and Caffeine is a combination medication utilized for its analgesic and antipyretic properties. Each pouch contains two caplets, with a total of 25 pouches per package. This formulation is designed to provide effective relief from pain and reduce fever.

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 and menstrual cramps.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

Adults and children aged 12 years and older are instructed to take 2 caplets every 6 hours, with a maximum dosage of 8 caplets within a 24-hour period. It is essential to drink a full glass of water with each dose to ensure proper administration and absorption.

For children under 12 years of age, it is recommended to consult a physician for appropriate dosing guidance.

Healthcare professionals should advise patients not to exceed the recommended dosage, as outlined in the Overdose Warning section.

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.

Aspirin, a component of this product, has the potential to cause severe allergic reactions, which may manifest as hives, facial swelling, asthma (wheezing), or shock. Additionally, acetaminophen may lead to severe skin reactions, including skin reddening, blisters, and rash. Should any skin reaction occur, it is crucial to discontinue use immediately and seek medical assistance.

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 acetaminophen-containing medications, or consuming three or more alcoholic drinks daily while using this product. Furthermore, the product contains a nonsteroidal anti-inflammatory drug (NSAID), which may increase the risk of severe stomach bleeding, particularly in individuals who are 60 years or older, have a history of stomach ulcers or bleeding problems, 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.

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, in some cases, rapid heartbeat.

Healthcare professionals should advise patients to consult a physician prior to use if they have liver disease, if the stomach bleeding warning is applicable, if they have a history of stomach issues 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 seek medical advice before use. Additionally, it is important to consult a doctor or pharmacist if the patient is taking any other NSAID (whether prescription or nonprescription), a prescription medication for diabetes, gout, or arthritis, or any other drug, or if they are under medical care for any serious condition, including anticoagulants or steroid medications.

In the event of an overdose, immediate medical attention is essential. Patients should contact a Poison Control Center or seek emergency medical help without delay, even if no signs or symptoms are apparent. The Poison Control Center can be reached at 1(800) 222-1222.

Patients should discontinue use and contact a physician 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 that worsens or lasts more than 3 days, or any new symptoms. These may be indicative of a serious condition requiring medical evaluation.

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 allergic reactions may occur, particularly in patients sensitive to aspirin. Symptoms of such reactions can include hives, facial swelling, asthma (wheezing), and shock. Additionally, acetaminophen, one of the components of this product, may lead to severe skin reactions characterized by skin reddening, blisters, or rash. Patients should discontinue use and seek medical assistance promptly if any skin reactions occur.

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 this product.

As this product contains a nonsteroidal anti-inflammatory drug (NSAID), there is a 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 blood thinners, steroids, or other NSAIDs. The risk is also heightened if patients consume three or more alcoholic drinks daily or exceed the recommended duration or dosage of the product.

Patients should 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 use and seek medical attention 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 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, as these may signal a serious condition.

Before using this product, patients should consult a doctor if they have liver disease, a history of stomach problems (such as heartburn), high blood pressure, heart disease, liver cirrhosis, kidney disease, or if they are taking diuretics or have asthma. Additionally, patients should seek advice from a doctor or pharmacist if they are currently taking any other NSAIDs, prescription medications for diabetes, gout, or arthritis, or any other drugs, especially blood thinners or steroids.

Drug Interactions

Patients taking anticoagulants or steroid medications should exercise caution when using this product, as there may be an increased risk of bleeding or other adverse effects. It is advisable to monitor for signs of bleeding and consider dosage adjustments as necessary.

Concurrent use of this product with other nonsteroidal anti-inflammatory drugs (NSAIDs), including prescription and nonprescription options such as aspirin, ibuprofen, and naproxen, may heighten the risk of gastrointestinal irritation or bleeding. Patients are encouraged to limit the use of these medications and to consult with a healthcare provider regarding appropriate pain management strategies.

Additionally, the consumption of caffeine-containing medications, foods, or beverages should be limited while using this product. This precaution is recommended to avoid potential overstimulation or other adverse effects associated with excessive caffeine intake.

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, including children and teenagers, should not use this product if they have or are recovering from chicken pox or flu-like symptoms. It is important to monitor for any changes in behavior accompanied by nausea and vomiting, as these may indicate the onset of Reye's syndrome, a rare but serious condition.

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, consultation with a doctor is advised before use.

Geriatric Use

Elderly patients, particularly those aged 60 years 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 risk-benefit ratio is essential when treating this population to ensure optimal safety and efficacy.

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 the unborn child or 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 health 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 its use in lactating individuals.

Renal Impairment

Patients with renal impairment should consult a healthcare professional prior to use, particularly if they have high blood pressure, heart disease, liver cirrhosis, or kidney disease. It is essential for these patients to be monitored closely for any signs of adverse effects, including symptoms indicative of stomach bleeding such as feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain. Additionally, patients taking a diuretic should seek advice from a doctor or pharmacist before initiating treatment.

Hepatic Impairment

Patients with hepatic impairment should consult their healthcare provider prior to using this product. The presence of liver disease may increase the risk of adverse effects, particularly due to the acetaminophen content.

Severe liver damage may occur if patients exceed the maximum recommended dosage of 8 caplets within a 24-hour period. Additionally, caution is advised against the concurrent use of other medications containing acetaminophen, as this may further elevate the risk of liver injury.

Patients who consume 3 or more alcoholic drinks daily should also 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 compromised liver health to ensure safety and efficacy while 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, even in the absence of noticeable signs or symptoms. Healthcare professionals are advised to contact the Poison Control Center at 1(800) 222-1222 for guidance on managing the situation effectively.

The potential symptoms of overdose may vary, and vigilance is essential, as some individuals may not exhibit immediate reactions. Therefore, it is recommended that healthcare providers remain alert to any changes in the patient's condition and act swiftly to ensure appropriate care is administered.

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

Postmarketing experience has identified several adverse reactions associated with the use of the product. Severe allergic reactions, including hives, facial swelling, asthma (wheezing), and shock, have been reported in association with aspirin. Additionally, severe skin reactions linked to acetaminophen have been noted, which may manifest as skin reddening, blisters, and rash.

There is a risk of severe liver damage if the maximum daily dosage of acetaminophen is exceeded or if it is used concurrently with other medications containing acetaminophen. Furthermore, severe stomach bleeding has been reported, particularly in individuals over 60 years of age, those with a history of stomach ulcers or bleeding problems, and those taking blood thinners or other nonsteroidal anti-inflammatory drugs (NSAIDs). Symptoms indicative of stomach bleeding include feeling faint, vomiting blood, having bloody or black stools, and persistent stomach pain.

Excessive consumption of caffeine may lead to symptoms such as nervousness, irritability, sleeplessness, and, in some cases, rapid heart rate.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center at 1(800) 222-1222 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 symptoms such as faintness, vomiting blood, bloody or black stools, or persistent stomach pain occur, as these may indicate stomach bleeding. Additionally, they should stop use and seek medical advice if they notice ringing in the ears, loss of hearing, redness or swelling in a painful area, or if pain worsens or persists beyond 10 days. If fever intensifies or lasts more than 3 days, or if any new symptoms arise, patients should also be advised to contact their doctor.

Before initiating use, patients should be encouraged to discuss their medical history with their healthcare provider, particularly if they have liver disease, a history of stomach problems such as heartburn, high blood pressure, heart disease, liver cirrhosis, or kidney disease. Patients taking diuretics, those with asthma, or those on any other medications, including NSAIDs, prescription drugs for diabetes, gout, or arthritis, should also consult their healthcare provider prior to use. Furthermore, patients on blood thinners or steroid medications should seek guidance from their doctor or pharmacist before using this medication.

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 room temperature, maintaining a range of 20º to 25º C (68º to 77º F). Proper storage conditions are crucial to ensure the integrity and efficacy of the product.

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 advised 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 recommended to consult a doctor for appropriate dosing.

Clinicians should counsel patients regarding the use of this medication during pregnancy and breastfeeding. It is particularly important to avoid aspirin in the last trimester of pregnancy unless explicitly directed by a healthcare professional, 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)