Headache Relief

Description

This formulation contains Acetaminophen at a dosage of 250 mg, Aspirin (a nonsteroidal anti-inflammatory drug) at 250 mg, and Caffeine at 65 mg. The product is presented in GELTAB form. It is important to note that this product is not manufactured or distributed by GlaxoSmithKline Consumer Healthcare Holdings (US) LLC, the distributor of 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 geltabs every 6 hours, with a maximum limit of 8 geltabs within a 24-hour period. It is essential to consume a full glass of water with each dose to ensure proper administration.

For children under 12 years of age, the use of this medication is not advised unless specifically directed by a healthcare professional.

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 another 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.

Allergy Alerts

Acetaminophen, one of the active ingredients in this product, has been associated with severe skin reactions. Symptoms may include skin reddening, blisters, or rash. Should any of these symptoms manifest, the use of the product must be discontinued, and medical assistance should be sought without delay.

Similarly, aspirin may provoke a severe allergic reaction characterized by hives, facial swelling, shock, or asthma symptoms such as wheezing. Immediate medical attention is warranted if any of these reactions occur.

Liver Warning

This product contains acetaminophen, and there is a significant risk of severe liver damage if the following conditions are met: adults consume more than 4,000 mg of acetaminophen within a 24-hour period, use other medications containing acetaminophen concurrently, or consume three or more alcoholic beverages daily while using this product.

Stomach Bleeding Warning

As this product contains a nonsteroidal anti-inflammatory drug (NSAID), it carries a risk of severe stomach bleeding. The likelihood of this adverse effect increases 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 dosage or duration of use.

Caffeine Warning

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.

Emergency Medical Help

In the event of an overdose, immediate medical assistance should be sought, or contact a Poison Control Center at 1-800-222-1222. Prompt medical attention is crucial for both adults and children, even if no signs or symptoms are initially apparent.

Discontinuation of Use

Users should stop using this product 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 and swelling in a painful area; worsening pain lasting more than 10 days; fever that worsens or persists for more than three days; or the emergence of any new symptoms, which may indicate a serious condition.

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 not to use this product under these circumstances. If changes in behavior accompanied by nausea and vomiting occur, medical consultation is recommended as these may be early signs of Reye's syndrome.

Severe allergic reactions may occur, particularly in patients sensitive to acetaminophen or aspirin. Symptoms of a severe skin reaction to acetaminophen may include skin reddening, blisters, and rash. In the case of an allergic reaction, patients should discontinue use and seek immediate medical attention. Aspirin may also provoke severe allergic reactions, which can manifest as hives, facial swelling, shock, or asthma symptoms such as wheezing.

Patients should be aware of the risk of severe liver damage associated with acetaminophen, particularly if they exceed 4,000 mg in 24 hours, use other products containing acetaminophen, or consume 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, especially in patients aged 60 or older, those with a history of stomach ulcers or bleeding problems, or those taking anticoagulants, steroids, or other NSAIDs.

Common Adverse Reactions Patients may experience symptoms related to 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 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 persistent stomach pain), ringing in the ears or loss of hearing, redness and swelling in a painful area, worsening pain lasting more than 10 days, fever lasting more than 3 days, or any new symptoms that arise, as these may indicate a serious condition.

Drug Interactions

Co-administration of this product with other drugs containing acetaminophen, whether prescription or nonprescription, should be approached with caution due to the potential for cumulative effects.

When used concurrently with anticoagulants or steroid medications, there is an increased risk of gastrointestinal bleeding. Therefore, careful monitoring of patients is advised, and dosage adjustments may be necessary based on clinical judgment.

The concomitant use of this product with other nonsteroidal anti-inflammatory drugs (NSAIDs), such as aspirin, ibuprofen, or naproxen, also heightens the risk of stomach bleeding. It is recommended to avoid the use of multiple NSAIDs simultaneously.

Additionally, the intake of caffeine-containing medications, foods, or beverages should be limited while using this product to prevent potential adverse effects.

No specific laboratory test interactions 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, a healthcare professional should be consulted, as these may be early signs of Reye’s syndrome.

For children under 12 years of age, the product should not be used unless directed by a doctor. For adults and children aged 12 years and older, the recommended dosage is 2 geltabs every 6 hours, with a maximum of 8 caplets in a 24-hour period.

Geriatric Use

Elderly patients, particularly those aged 60 years and older, may have an increased risk of stomach bleeding. It is essential for healthcare providers to exercise caution when prescribing medications that may exacerbate this risk in this population.

Monitoring for signs of gastrointestinal bleeding is advised, and dosage adjustments may be necessary based on the individual patient's health status and concurrent medications. Careful assessment of the benefits and risks is crucial when treating geriatric patients to ensure their safety and well-being.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional before using this medication. The use of aspirin during pregnancy, particularly at 20 weeks gestation or later, is associated with potential risks. Specifically, it may lead to adverse effects on the unborn child or complications during delivery. Therefore, it is crucial that pregnant patients only use aspirin under the guidance of a healthcare provider if deemed necessary.

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 the use of this medication 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 exercise caution when using this product, as it contains acetaminophen, which is associated with the risk of severe liver damage. It is critical that patients do not exceed 4,000 mg of acetaminophen within a 24-hour period. Additionally, the concurrent use of other medications containing acetaminophen should be avoided to prevent potential overdose.

Patients with compromised liver function, including those with liver disease, liver cirrhosis, or other significant hepatic conditions, are advised to consult a healthcare professional prior to using this product. Furthermore, individuals who consume three or more alcoholic drinks daily should also seek medical advice before use, as alcohol can exacerbate the risk of liver damage associated with acetaminophen.

Monitoring of liver function may be warranted in patients with existing liver conditions or those at risk for hepatic impairment. Regular assessment of liver enzymes and overall liver health is recommended to ensure safe use of this product in these populations.

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, it is essential to monitor the patient closely and provide supportive care as necessary.

Management of an overdose may involve symptomatic treatment and monitoring of vital signs, as well as specific interventions based on the substance involved. It is recommended that healthcare providers follow established protocols for overdose management to ensure optimal patient outcomes.

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

Postmarketing experience has revealed that acetaminophen may be associated with severe skin reactions, which can manifest as symptoms including skin reddening, blisters, and rash. Additionally, postmarketing data indicate that aspirin may lead to severe allergic reactions, potentially presenting with hives, facial swelling, shock, and asthma (wheezing).

Patient Counseling

Healthcare providers should advise patients on the importance of seeking immediate medical assistance in the event of an overdose. Patients should be informed to contact a Poison Control Center at 1-800-222-1222 without delay. It is crucial to emphasize that prompt medical attention is necessary for both adults and children, even if they do not exhibit any signs or symptoms of overdose. This proactive approach can significantly impact the outcome in such situations.

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, specifically between 20º-25ºC (68º-77ºF). Proper storage conditions must be maintained to ensure the integrity and efficacy of the product.

Additional Clinical Information

Patients should be informed that the medication is administered orally. For adults and children aged 12 years and older, the recommended dosage is 2 geltabs every 6 hours, with a maximum of 8 caplets in a 24-hour period. For children under 12 years, use is not advised unless directed by a healthcare professional.

Clinicians should counsel patients who are pregnant or breastfeeding to consult a health professional before use. It is particularly important to avoid aspirin after 20 weeks of pregnancy unless specifically directed by a doctor, as it may pose risks to the unborn child or lead to complications during delivery. In the event of an overdose, patients should seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222, as prompt attention is crucial for both adults and children, even in the absence 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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