Extra Strength Headache Relief

Description

The SPL code for this product is 34089-3. It is identified as the ES Headache Pouch, which is designed for the management of headache symptoms.

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

Patients should adhere strictly to the recommended dosage and administration guidelines. It is imperative not to exceed the directed dosage, as outlined in the Overdose warning section.

For adults and children aged 12 years and older, the recommended dosage is 2 tablets taken orally every 6 hours. The maximum allowable dosage is 8 tablets within a 24-hour period. Each dose should be accompanied by a full glass of water to ensure proper administration.

For children under 12 years of age, it is advised to consult a healthcare professional 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

The use of this product necessitates careful consideration of several warnings and precautions to ensure patient safety.

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 Acetaminophen has the potential to cause severe skin reactions, which may manifest as skin reddening, blisters, or rash. In the event of a skin reaction, the product should be discontinued immediately, and medical assistance should be sought. Additionally, aspirin may provoke a severe allergic reaction characterized by hives, facial swelling, asthma (wheezing), or shock.

Liver Warning This product contains acetaminophen, and severe liver damage may occur if the maximum daily dosage of 8 tablets is exceeded within a 24-hour period. Caution is advised when using other medications that contain acetaminophen or when 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 stomach bleeding. The likelihood of this adverse effect increases in individuals aged 60 or older, those with a history of stomach ulcers or bleeding problems, and those concurrently taking blood thinners (anticoagulants) or steroid medications. Patients should also be cautious if they are using other NSAIDs (including aspirin, ibuprofen, or naproxen) or consuming three or more alcoholic drinks daily while using this product. Extended use or higher dosages than recommended may further elevate this risk.

Caffeine Warning The recommended dosage of this product contains approximately the same amount of caffeine as a standard cup of coffee. Patients are advised to limit the intake of other caffeine-containing medications, foods, or beverages during treatment, as excessive caffeine consumption may lead to symptoms such as nervousness, irritability, sleeplessness, and, in some cases, rapid heartbeat.

Discontinuation and Consultation Patients should discontinue use and consult a healthcare professional if any of the following occur: an allergic reaction; signs 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 persists beyond three days; or the emergence of any new symptoms that may indicate a serious condition.

Emergency Medical Help Immediate medical assistance is required if an allergic reaction occurs.

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. Patients should be advised to discontinue use and consult a doctor if they experience changes in behavior accompanied by nausea and vomiting, as these may be early signs of Reye’s syndrome.

Severe skin reactions, including skin reddening, blisters, and rash, may occur due to acetaminophen. In the event of a skin reaction, patients should stop use immediately and seek medical assistance. Aspirin, another component of this product, may cause severe allergic reactions characterized by hives, facial swelling, asthma (wheezing), or shock, necessitating immediate medical attention.

Patients are also at risk for severe liver damage if they exceed the maximum daily dosage of 8 tablets within 24 hours, use other medications containing acetaminophen, or consume three or more alcoholic drinks daily while using this product.

Additionally, the nonsteroidal anti-inflammatory drug (NSAID) component may increase the risk of stomach bleeding, particularly in patients aged 60 or older, those with a history of stomach ulcers or bleeding problems, or those taking anticoagulants or steroids. The risk is further heightened with concurrent use of other NSAIDs or excessive alcohol consumption.

Common Adverse Reactions Patients should be aware of the potential for nervousness, irritability, sleeplessness, and, occasionally, rapid heartbeat due to caffeine, which is present in a quantity comparable to that of a cup of coffee in the recommended dose of this product.

Patients are advised to stop use and consult a doctor if they experience any signs of an allergic reaction, symptoms indicative of stomach bleeding (such as feeling faint, vomiting blood, or having bloody or black stools), ringing in the ears or loss of hearing, redness or swelling in a painful area, worsening pain lasting more than 10 days, fever persisting beyond 3 days, or any new symptoms that may suggest a serious condition.

Precautions 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, or kidney disease. Additionally, patients taking diuretics or those with asthma should seek medical advice prior to use. It is also recommended that patients discuss the use of this product with a healthcare provider if they are taking any other NSAIDs, prescription medications for diabetes, gout, or arthritis, or any other drugs, particularly anticoagulants or steroids.

Drug Interactions

Patients should consult a healthcare professional prior to using this product if they are concurrently taking any other medications, particularly those listed below.

Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) The concurrent use of this product with other NSAIDs, whether prescription or non-prescription (e.g., aspirin, ibuprofen, naproxen), may increase the risk of gastrointestinal bleeding. It is advisable to avoid the combination of these agents unless directed by a healthcare provider.

Anticoagulants and Steroids The use of blood-thinning medications (anticoagulants) or steroid drugs alongside this product heightens the risk of stomach bleeding. Close monitoring is recommended for patients on these medications.

Diabetes, Gout, or Arthritis Medications Patients taking prescription medications for diabetes, gout, or arthritis should seek medical advice before using this product, as interactions may occur that could affect treatment outcomes.

Acetaminophen Severe liver damage may result from the concomitant use of this product with other medications containing acetaminophen. Patients should be advised to avoid this combination to prevent potential hepatotoxicity.

Caffeine Patients are 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 heartbeat. Monitoring of caffeine intake is recommended to mitigate these effects.

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

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 any 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 tablets every 6 hours, with a maximum of 8 tablets in a 24-hour period. For children under 12 years of age, it is advised to consult a doctor before use.

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 should consult a healthcare professional before using this medication, particularly if they are in the later stages of pregnancy or breastfeeding. The use of aspirin during the last trimester is especially cautioned against, as it may pose risks to the unborn child and lead to complications during delivery. Therefore, it is imperative 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 have not been specifically addressed in the available data regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the lack of information necessitates careful clinical judgment and monitoring.

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 tablets within a 24-hour period. Additionally, patients must avoid concomitant use with 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 to fewer than 3 alcoholic drinks per day while using this product. Given the potential for increased susceptibility to liver damage, healthcare providers should assess liver function and consider appropriate dosage adjustments or alternative therapies for patients with significant hepatic impairment. Regular monitoring of liver function tests may be warranted to ensure patient safety.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222. Prompt medical intervention is crucial for both adults and children, even in the absence of noticeable signs or symptoms.

Healthcare professionals should be aware that the lack of immediate symptoms does not preclude the potential for serious health consequences. 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

Postmarketing experience has identified several adverse reactions associated with the use of acetaminophen and aspirin. Reports indicate that severe skin reactions, including skin reddening, blisters, and rash, have been observed in patients using acetaminophen. Additionally, severe allergic reactions have been reported in association with aspirin, including hives, facial swelling, asthma (wheezing), and shock. These events were reported voluntarily or through surveillance programs and are documented in the postmarketing safety database.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. Patients must be informed not to use the medication if they have a history of allergic reactions to acetaminophen, aspirin, or any other pain reliever or fever reducer.

It is essential to instruct patients not to use this medication in conjunction with any other drug containing acetaminophen, whether prescription or nonprescription. If patients are uncertain whether a drug contains acetaminophen, they should be encouraged to consult a doctor or pharmacist for clarification.

Patients should be advised to stop using the medication and seek medical attention immediately if they experience any signs of an allergic reaction. Additionally, they should be informed to discontinue use and consult a doctor if they notice any symptoms indicative of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, experiencing persistent stomach pain, or if they develop ringing in the ears or loss of hearing. Patients should also be cautioned to seek medical advice if pain worsens or lasts longer than 10 days, if fever intensifies or persists beyond 3 days, or if any new symptoms arise, as these may signal a serious condition.

Healthcare providers should recommend that patients consult a doctor before using the medication if they have liver disease or if the stomach bleeding warning is applicable to them. Patients with a history of stomach problems, such as heartburn, high blood pressure, heart disease, liver cirrhosis, or kidney disease should also be advised to seek medical guidance prior to use.

Furthermore, patients taking diuretics, those with asthma, or individuals on any other NSAID (whether prescription or nonprescription) should be encouraged to discuss their medication regimen with a doctor or pharmacist before using this product. It is also important to advise patients to consult a healthcare professional if they are taking prescription medications for diabetes, gout, or arthritis, or if they are under a doctor’s care for any serious condition. Lastly, patients should be reminded to inform their healthcare provider if they are taking any blood-thinning (anticoagulant) or steroid medications before using this product.

Storage and Handling

The product is supplied in configurations that include specific NDC numbers. It should be stored at a controlled room temperature of 20° to 25° C (68° to 77° F). Care should be taken to ensure that the storage environment maintains these temperature conditions to preserve the integrity of the product.

Additional Clinical Information

The route of administration for the medication is oral. Clinicians should advise patients who are pregnant or breastfeeding to consult a health professional prior to use. It is particularly crucial to avoid 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.

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)