Headache Relief

Description

GOOD NEIGHBOR PHARMACY Extra Strength Headache Relief is formulated as analgesic caplets containing a combination of active ingredients: acetaminophen, aspirin (a nonsteroidal anti-inflammatory drug), and caffeine. Each bottle contains 100 caplets, and the product is identified by the National Drug Code (NDC) 46122-690-78.

The product features a tamper-evident safety seal, which must remain intact; it should not be used if the seal is broken or missing. It is important to note that this product is not manufactured or distributed by Haleon CH SARL, the owner of the registered trademark Excedrin® Extra Strength Headache.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with various conditions, including toothache, arthritis, muscular aches, headache, the common cold, 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 and not exceed the directed amount. Each dose should be taken with a full glass of water to ensure proper administration.

For adults and children aged 12 years and older, the recommended dosage is 2 caplets every 6 hours, with a maximum limit of 8 caplets within a 24-hour period.

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

Contraindications

Use is contraindicated in patients with a history of allergic reactions to any 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

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.

Aspirin may induce severe allergic reactions, which can manifest as shock, hives, facial swelling, or asthma (wheezing). Similarly, acetaminophen may lead to severe skin reactions, including skin reddening, blisters, or rash. In the event of a skin reaction, the product should be discontinued, and medical assistance should be sought without delay.

This product contains acetaminophen, which poses a risk of severe liver damage if the following conditions are met: exceeding 4,000 mg of acetaminophen within a 24-hour period, concurrent use with other medications containing acetaminophen, or consumption of three or more alcoholic drinks daily while using this product.

Additionally, the product contains a nonsteroidal anti-inflammatory drug (NSAID), which may increase the risk of severe stomach bleeding, particularly in individuals aged 60 or older, those with a history of stomach ulcers or bleeding problems, or those taking anticoagulants, steroids, or other NSAIDs (such as aspirin, ibuprofen, or naproxen). The risk is also heightened with excessive alcohol consumption or prolonged use beyond the recommended duration.

Caffeine is present in the recommended dose of this product, approximately equivalent to that found in a cup of coffee. Patients are advised to limit the intake of other caffeine-containing medications, foods, or beverages, as excessive caffeine consumption may lead to nervousness, irritability, sleeplessness, and, in some cases, rapid heartbeat.

Healthcare professionals should advise patients to consult a doctor prior to use if they have liver disease, if the stomach bleeding warning applies, or if they have a history of stomach issues such as heartburn. Additional caution is warranted for individuals with asthma, those taking diuretics, or those with high blood pressure, heart disease, liver cirrhosis, or kidney disease. Patients should also seek guidance from a healthcare provider or pharmacist if they are currently taking prescription medications for diabetes, gout, or arthritis.

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

Patients should discontinue use and contact a healthcare professional if any allergic reactions occur, or if they experience symptoms indicative of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or persistent stomach pain. Other reasons to stop use include ringing in the ears or loss of hearing, worsening pain lasting more than 10 days, fever that worsens or persists for more than 3 days, visible redness or swelling, or the emergence of any new symptoms.

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. If patients exhibit changes in behavior accompanied by nausea and vomiting while using this product, they should consult a doctor immediately, as these may be early signs of Reye's syndrome.

Severe allergic reactions to aspirin may manifest as shock, hives, facial swelling, or asthma (wheezing). Acetaminophen can also lead to severe skin reactions, including skin reddening, blisters, or rash. In the event of a skin reaction, patients are advised to discontinue use and seek medical assistance promptly.

The product contains acetaminophen, which poses a risk of severe liver damage if patients exceed 4,000 mg in 24 hours, use it in conjunction with other acetaminophen-containing medications, 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, particularly 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 cautious if they consume three or more alcoholic drinks daily or take the medication for longer than directed.

Common Adverse Reactions Patients may also experience less severe but common adverse reactions. The recommended dose of this product contains caffeine, which is comparable to that found in a cup of coffee. Excessive caffeine intake may lead to nervousness, irritability, sleeplessness, and, in some cases, rapid heartbeat.

Patients are advised to stop using the product 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, loss of hearing, worsening pain lasting more than 10 days, fever lasting more than 3 days, redness or swelling, or any new symptoms.

Precautions Before using this product, patients should consult a doctor if they have liver disease, if the stomach bleeding warning applies to them, or if they have a history of stomach problems such as heartburn. Patients with asthma, those taking diuretics, or individuals with high blood pressure, heart disease, liver cirrhosis, or kidney disease should also seek medical advice prior to use. Furthermore, patients taking prescription medications for diabetes, gout, or arthritis should consult a doctor or pharmacist before using this product.

Drug Interactions

Concurrent use of this medication with any other drug containing acetaminophen, whether prescription or nonprescription, is contraindicated due to the risk of acetaminophen overdose and associated hepatotoxicity.

The concomitant administration of this medication with other nonsteroidal anti-inflammatory drugs (NSAIDs), including but not limited to aspirin, ibuprofen, and naproxen, significantly increases the risk of severe gastrointestinal bleeding. Therefore, it is advised to avoid the use of multiple NSAIDs simultaneously.

Patients taking prescription medications for diabetes, gout, or arthritis should consult their healthcare provider prior to initiating therapy with this medication to ensure safe and effective use.

Additionally, individuals on anticoagulant therapy or steroid medications are advised to seek medical consultation before using this drug, as potential interactions may necessitate dosage adjustments or increased monitoring.

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

Pediatric patients under 12 years of age should consult a healthcare professional before using this product. It is contraindicated in children and teenagers who have or are recovering from chickenpox or flu-like symptoms 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 seek medical advice, as these may be early signs of Reye's syndrome, a rare but serious condition.

In the event of an accidental overdose, immediate medical assistance should be sought, or the Poison Control Center should be contacted without delay. Prompt medical attention is crucial for both children and adults, 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. 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 of treatment in geriatric patients is crucial to ensure their safety and well-being.

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 healthcare professional before using this medication. It is particularly important to avoid the use of aspirin at 20 weeks of gestation 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 its use 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 consult a healthcare professional prior to using this product. It is important to note that this product contains acetaminophen, which carries a risk of severe liver damage under certain conditions. Specifically, patients should be aware that exceeding 4,000 mg of acetaminophen within a 24-hour period, using other medications that also contain acetaminophen, or consuming three or more alcoholic beverages daily while using this product may significantly increase the risk of liver injury.

Due to the potential for compromised liver function to affect the metabolism of acetaminophen, careful consideration and monitoring are advised for patients with liver disease. Adjustments to dosage or additional monitoring may be necessary based on the severity of hepatic impairment.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. Prompt 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 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 provided regarding nonclinical toxicology or animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has identified several important safety considerations associated with the use of this product.

Severe skin reactions, including symptoms such as skin reddening, blisters, and rash, have been reported. In the event of a skin reaction, it is advised to discontinue use and seek medical assistance immediately.

The product contains acetaminophen, which carries a risk of severe liver damage if the following conditions are met: exceeding 4,000 mg of acetaminophen within a 24-hour period, consuming three or more alcoholic drinks daily while using the product, or using it concurrently with other medications that contain acetaminophen.

Additionally, the presence of an NSAID in this product raises concerns regarding the potential for severe stomach bleeding. The risk is heightened in individuals aged 60 or older, those taking other NSAIDs (both prescription and nonprescription), individuals consuming three or more alcoholic drinks daily, those with a history of stomach ulcers or bleeding problems, and those using blood thinners or steroid medications. Prolonged use or exceeding the recommended dosage may also increase this risk.

Users are advised to discontinue use and consult a healthcare professional if any signs of an allergic reaction occur, or if symptoms indicative of stomach bleeding arise, such as feeling faint, experiencing bloody or black stools, vomiting blood, persistent stomach pain, ringing in the ears, loss of hearing, redness or swelling, worsening pain lasting more than 10 days, fever lasting more than three days, or the emergence of new symptoms. These symptoms may indicate a serious condition requiring immediate medical attention.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center in the event of an overdose, as prompt medical attention is critical for both adults and children, even if no signs or symptoms are initially apparent.

Patients should be informed not to use this medication if they have a history of allergic reactions to any other pain reliever or fever reducer. It is also essential to instruct patients not to combine this medication with any other drug containing acetaminophen, whether prescription or nonprescription. If patients are uncertain about the presence of acetaminophen in their other medications, they should be encouraged to consult a doctor or pharmacist.

Patients must be advised to discontinue use and consult a doctor if they experience any signs of an allergic reaction or if they notice any of the following symptoms indicative of stomach bleeding: feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain. Additionally, they should be instructed to stop use and seek medical advice if they experience ringing in the ears, loss of hearing, worsening pain that lasts longer than 10 days, a fever that worsens or persists for more than 3 days, redness or swelling, or any new symptoms.

Healthcare providers should recommend that patients consult a doctor before using this medication if they have liver disease, a history of stomach problems such as heartburn, asthma, or if the stomach bleeding warning applies to them. Patients taking diuretics, or those with high blood pressure, heart disease, liver cirrhosis, or kidney disease should also be advised to seek medical guidance prior to use. Furthermore, patients should be encouraged to discuss their use of any prescription drugs for diabetes, gout, or arthritis with their healthcare provider or pharmacist before starting this medication.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available upon request. It should be stored at a controlled room temperature of 25°C (77°F), with permissible excursions between 15°C and 30°C (59°F to 86°F).

Healthcare professionals are advised to check the end flap of the packaging for the expiration date and lot number to ensure proper inventory management and product safety.

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 caplets every 6 hours, not exceeding 8 caplets within a 24-hour period. For children under 12 years, it is advised to consult a doctor for appropriate dosing.

Clinicians should counsel patients regarding the use of this medication during pregnancy and breastfeeding, emphasizing the importance of consulting a health professional before use. It is particularly critical to avoid aspirin after 20 weeks of pregnancy unless directed by a physician, due to potential risks to the unborn child and complications during delivery. In the event of an accidental overdose, patients should seek immediate medical assistance or contact a Poison Control Center, as prompt intervention is essential for both adults and children, regardless of the presence 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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