Headache Relief

Description

This formulation contains the active ingredients acetaminophen (250 mg), aspirin (250 mg), and caffeine (65 mg). It is presented in a GELTABS dosage form. The product is manufactured by H-E-B® in San Antonio, TX 78204, with a commitment to quality. A tamper-evident safety seal is included; the product should not be used if the seal under the cap is broken or missing. 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 other medications, 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. If any changes in behavior accompanied by nausea and vomiting occur while using this product, it is imperative to consult a healthcare professional, as these symptoms may indicate the onset of this rare but serious illness.

Allergy Alerts Acetaminophen, a component of this product, has been associated with severe skin reactions. Symptoms may include skin reddening, blisters, and rash. Should any skin reaction occur, the use of this product must be discontinued immediately, and medical assistance should be sought without delay.

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

Liver Warning This product contains acetaminophen, and severe liver damage may occur 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 drinks daily while using this product.

Stomach Bleeding Warning As this product contains a nonsteroidal anti-inflammatory drug (NSAID), there is 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 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 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 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 (1-800-222-1222) without delay. Prompt medical attention is crucial for both adults and children, even in the absence of noticeable signs or symptoms.

Discontinuation and Consultation 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 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 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. If any of these symptoms develop, patients should stop using the product and seek medical assistance immediately. Aspirin may also cause severe allergic reactions characterized by hives, facial swelling, shock, or asthma (wheezing).

Patients should be aware of the risk of severe liver damage associated with acetaminophen, particularly if they exceed the recommended dosage of 4,000 mg in 24 hours, use other medications containing acetaminophen, or consume three or more alcoholic drinks daily while using this product.

The product contains an NSAID, which may increase 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. Patients should be vigilant for signs of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain.

Common Adverse Reactions Patients may also experience less severe but common adverse reactions. Caffeine, present in the recommended dose of this product, may lead to nervousness, irritability, sleeplessness, and, in some cases, rapid heartbeat. It is advisable to limit the intake of other caffeine-containing medications, foods, or beverages while using this product.

Patients are encouraged to stop use and consult a doctor if they experience any new symptoms, as these may indicate a serious condition. Additionally, they should seek medical advice if they experience ringing in the ears or loss of hearing, if a painful area becomes red and swollen, if pain persists for more than 10 days, or if fever worsens or lasts for more than three days.

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 for signs of bleeding is recommended in patients receiving this combination.

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 dosage adjustments or enhanced monitoring for patients taking these combinations.

No specific interactions with laboratory tests 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. If any changes in behavior accompanied by nausea and vomiting occur while using this product, it is essential to consult a doctor, as these may be early signs of this rare but serious illness.

For children under 12 years of age, the product should not be used unless directed by a doctor. In contrast, adults and children aged 12 years and older are advised to take 2 geltabs every 6 hours, with a maximum of 8 geltabs in a 24-hour period.

In the event of an overdose, it is crucial to seek medical help or contact a Poison Control Center (1-800-222-1222) immediately. Prompt medical attention is vital for both adults and children, even if no signs or symptoms are apparent.

Geriatric Use

Elderly patients, particularly those aged 60 and older, are at an increased risk of severe stomach bleeding when using this product, which contains a nonsteroidal anti-inflammatory drug (NSAID). This risk is further heightened in individuals with a history of stomach ulcers or bleeding problems, those who are concurrently using blood-thinning medications (anticoagulants) or steroid drugs, and patients taking other NSAIDs, whether prescription or over-the-counter, such as aspirin, ibuprofen, or naproxen.

Healthcare providers should exercise caution when prescribing this product to geriatric patients, especially if they consume three or more alcoholic drinks daily while using the medication. It is essential to monitor these patients closely for any signs of gastrointestinal bleeding and to consider dose modifications or alternative therapies as appropriate. Additionally, adherence to the recommended dosage and duration of treatment is critical to minimize the risk of adverse effects in this vulnerable population.

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, particularly in the later stages of pregnancy.

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, patients should avoid concurrent use of other medications containing acetaminophen and limit alcohol consumption to fewer than three alcoholic drinks per day while using this product.

Before initiating treatment, patients with liver disease, high blood pressure, heart disease, liver cirrhosis, or kidney disease are advised to consult a healthcare professional. Monitoring of liver function may be warranted in these patients to ensure safety and efficacy during treatment.

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 severity of symptoms may vary based on the amount ingested and the individual’s health status. Therefore, it is essential to monitor the patient closely and provide supportive care as needed.

Management of an overdose may involve symptomatic treatment and monitoring of vital signs. The healthcare provider should be prepared to implement appropriate interventions based on the clinical presentation of the patient.

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

No postmarketing experience details are available in the insert text.

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 20ºC and 25ºC (68ºF and 77ºF). Proper storage conditions must be maintained 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 instructed to take 2 geltabs every 6 hours, not exceeding 8 geltabs within a 24-hour period. For children under 12 years, use is not recommended unless directed by a healthcare professional.

Clinicians should counsel patients regarding the use of this medication during pregnancy and breastfeeding, advising them 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, due to potential risks to the unborn child and complications during delivery. In the event of an overdose, patients should seek immediate medical assistance or contact a Poison Control Center, 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.

View product document (PDF)