Headache Relief

Description

This formulation is designed for extra strength headache relief, containing a combination of active ingredients comparable to those found in Excedrin® Extra Strength. Each GELTAB contains 250 mg of acetaminophen, a pain reliever, and 250 mg of aspirin, a nonsteroidal anti-inflammatory drug (NSAID), along with 65 mg of caffeine, which acts as a pain reliever aid. The product is packaged in tamper-evident containers, and users are advised not to use the product if the printed safety seal under the cap is broken or missing. For complete warnings and product information, the outer carton should be retained. This product is distributed by Target Corporation, located in Minneapolis, MN 55403.

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, 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 indicators of Reye's syndrome.

Allergy Alerts

This product contains acetaminophen, which may lead to severe skin reactions. Symptoms of such reactions can include skin reddening, blisters, and rash. In the event of a skin reaction, the use of the product should be discontinued, and medical assistance should be sought without delay.

Additionally, aspirin, another component of this product, may provoke severe allergic reactions characterized by hives, facial swelling, shock, or asthma (wheezing). Immediate medical attention is warranted if any of these symptoms occur.

Liver Warning

The presence of acetaminophen in this product necessitates caution, as severe liver damage may result from exceeding 4,000 mg of acetaminophen within a 24-hour period, using other medications containing acetaminophen concurrently, or 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 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 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

Healthcare professionals should advise patients to stop using this product and seek medical advice 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. These may indicate a serious condition requiring further evaluation.

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 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 allergic 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. Similarly, aspirin may cause severe allergic reactions characterized by hives, facial swelling, shock, or asthma (wheezing).

Patients should also be aware of the potential for severe liver damage associated with acetaminophen. This risk increases significantly if patients exceed 4,000 mg of acetaminophen in a 24-hour period, use other medications containing acetaminophen, or consume three or more alcoholic drinks daily while using this product.

The product contains a nonsteroidal anti-inflammatory drug (NSAID), which may lead to severe stomach bleeding. The risk is heightened in patients aged 60 or older, those with a history of stomach ulcers or bleeding problems, and individuals taking blood thinners, steroids, or other NSAIDs. Patients who consume three or more alcoholic drinks daily while using this product or who take it for longer than directed are also at increased risk.

Common Adverse Reactions

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

Monitoring and Consultation

Patients are advised to stop use and consult a healthcare provider 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, loss of hearing, or if a painful area becomes red and swollen. Additionally, if pain worsens or lasts longer than 10 days, or if fever persists or worsens beyond three days, patients should seek medical attention. Any new symptoms that arise should also prompt consultation with a healthcare professional, as they may indicate a serious condition.

Drug Interactions

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

The concomitant use of this product with anticoagulants or steroid medications increases the risk of severe gastrointestinal bleeding. Close monitoring for signs of gastrointestinal bleeding is recommended in patients receiving these combinations.

Additionally, the risk of severe stomach bleeding is elevated when this product is taken alongside other nonsteroidal anti-inflammatory drugs (NSAIDs), including but not limited to aspirin, ibuprofen, and naproxen. Caution should be exercised, and alternative pain management strategies should be considered to reduce the likelihood of adverse effects.

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. For those aged 12 years and older, the recommended dosage is 2 geltabs every 6 hours, with a maximum of 8 geltabs in a 24-hour period.

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

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 bleeding or gastrointestinal distress. Additionally, dosage adjustments may be necessary based on the individual patient's health status and concurrent medications. Careful assessment of the risks versus benefits is essential when treating elderly patients with this medication.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional before using this medication. It is particularly important to avoid the use of aspirin after 20 weeks of pregnancy unless specifically directed by a physician, as it may pose risks to the developing fetus and lead to complications during delivery. Healthcare providers should carefully evaluate the potential benefits and risks when considering the use of this medication in pregnant patients.

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, avoid concurrent use with 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 known 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 timely recognition and management of overdose situations can significantly impact patient outcomes. Therefore, it is essential to remain vigilant and proactive in addressing potential overdose cases.

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 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 text.

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 temperature range of 20º to 25ºC (68º to 77ºF) to maintain its efficacy and stability. Proper storage conditions should be ensured to prevent exposure to extreme temperatures, which may compromise the product's integrity.

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 geltabs 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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