Headache Relief

Description

EQUAL INE® is a formulation designed for extra strength headache relief, containing active ingredients comparable to those found in Excedrin® Extra Strength Headache. Each caplet includes acetaminophen, aspirin (a nonsteroidal anti-inflammatory drug), and caffeine, functioning as a pain reliever and pain reliever aid. The product is packaged in a bottle containing 100 caplets, with an actual size representation provided.

The National Drug Code (NDC) for this product is 41163-334-12. It is important to note that the product is tamper evident; consumers should not use it if the imprinted safety seal under the cap is broken or missing. EQUAL INE® is distributed by UNFI, located in Providence, RI 02908, USA, and is not manufactured or distributed by Haleon CH SARL, the owner of the registered trademark Excedrin® Extra Strength Headache. The product is backed by a 100% quality guarantee.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with various conditions, including headache, arthritis, the common cold, 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 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, facial swelling, hives, or asthma symptoms such as wheezing. Similarly, acetaminophen may lead to severe skin reactions, including skin reddening, blisters, or rash. In the event of a skin reaction, it is crucial to discontinue use and seek medical assistance 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 presence of an NSAID in this product raises the risk of severe stomach bleeding, particularly in individuals aged 60 or older, those taking other NSAIDs (prescription or nonprescription), individuals with a history of stomach ulcers or bleeding problems, and those on blood thinners or steroids. The risk is also heightened if the product is taken in greater amounts or for longer durations than directed.

Caffeine is also a component of the recommended dose, which is comparable to that found in a cup of coffee. Users should 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 is applicable, or if they have a history of stomach issues such as heartburn. Patients with high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma, as well as those taking diuretics, should also seek medical advice before using this product. Furthermore, individuals on prescription medications for diabetes, gout, or arthritis should consult a doctor or pharmacist before use.

In the event of an overdose, immediate medical attention is essential. Patients should contact a Poison Control Center or seek emergency medical help right away, regardless of whether symptoms are present.

Users should discontinue use and contact a healthcare professional if any allergic reactions occur, if symptoms of stomach bleeding arise (such as feeling faint, having bloody or black stools, vomiting blood, or experiencing persistent stomach pain), or if they experience ringing in the ears, loss of hearing, redness or swelling, worsening pain lasting more than 10 days, fever lasting more than 3 days, or any new symptoms.

Side Effects

Patients using this product may experience a range of adverse reactions, some of which may be serious.

Serious Adverse Reactions:

Reye’s syndrome is a rare but serious condition 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 healthcare professional if they notice changes in behavior accompanied by nausea and vomiting, as these may be early signs of Reye's syndrome.

Severe allergic reactions to aspirin can occur, presenting symptoms such as shock, facial swelling, hives, and asthma (wheezing). Patients experiencing any signs of an allergic reaction should seek immediate medical attention.

Acetaminophen, another component of this product, may lead to severe skin reactions, including skin reddening, blisters, and rash. If any skin reaction occurs, patients should stop using the product and seek medical help 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 the 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 taking other NSAIDs, individuals with a history of stomach ulcers or bleeding problems, and those on blood thinners or steroids. Patients should be vigilant for signs of stomach bleeding, such as feeling faint, having bloody or black stools, vomiting blood, or experiencing persistent stomach pain.

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 limit the use of other caffeine-containing medications, foods, or beverages while using this product.

Patients should stop using the product and consult a healthcare professional if they experience any of the following: ringing in the ears or loss of hearing, redness or swelling, worsening pain lasting more than 10 days, fever lasting more than three days, or any new symptoms.

Precautions:

Before using this product, patients should consult a healthcare professional if they have liver disease, a history of stomach problems (such as heartburn), high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma. Additionally, patients taking diuretics or prescription medications for diabetes, gout, or arthritis should seek advice from a doctor or pharmacist prior to use.

Drug Interactions

Concurrent use of nonsteroidal anti-inflammatory drugs (NSAIDs) significantly increases the risk of severe gastrointestinal bleeding. This risk is particularly pronounced when combining the drug with other NSAIDs, including both prescription and over-the-counter options such as aspirin, ibuprofen, and naproxen.

The concomitant administration of anticoagulants or steroid medications also elevates the risk of severe stomach bleeding. Healthcare professionals should exercise caution and consider monitoring for gastrointestinal complications in patients receiving these combinations.

Additionally, the use of acetaminophen in excess of 4,000 mg within a 24-hour period, particularly when combined with other acetaminophen-containing products, poses a risk of severe liver damage. It is advisable to adhere to recommended dosing guidelines and to avoid overlapping acetaminophen sources.

Patients taking prescription medications for diabetes, gout, or arthritis should consult with a healthcare provider or pharmacist prior to initiating therapy with this drug, as potential interactions may necessitate dosage adjustments or increased monitoring.

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, 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 caplets every 6 hours, with a maximum of 8 caplets 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 and older, may have an increased risk of severe stomach bleeding when using this medication. It is essential for healthcare providers to exercise caution when prescribing to this population.

Before initiating treatment, it is advisable for healthcare providers to assess the patient's medical history, especially in those with pre-existing conditions such as high blood pressure, heart disease, liver cirrhosis, or kidney disease. Consultation with a physician is recommended to evaluate the appropriateness of the medication in these cases, ensuring that potential risks are adequately managed.

Monitoring for adverse effects, particularly gastrointestinal complications, is crucial in geriatric patients to ensure their safety and well-being during treatment.

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 fetal outcomes or complications during delivery. Therefore, it is crucial that pregnant patients only use aspirin under the guidance of a qualified 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 comorbid 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 degree 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 without delay. Prompt medical attention 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 adverse effects. Therefore, vigilance and timely intervention are essential in managing overdose cases 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 adverse events associated with the use of this product, reported voluntarily or through surveillance programs.

Severe allergic reactions have been noted with aspirin use, which may manifest as shock, facial swelling, hives, or asthma symptoms such as wheezing. Additionally, acetaminophen has been associated with severe skin reactions, including skin reddening, blisters, and rash. In cases of skin reactions, it is advised to discontinue use and seek immediate medical attention.

Warnings regarding liver damage have been highlighted, indicating that severe liver injury may occur if acetaminophen is taken in excess of 4,000 mg within a 24-hour period, in conjunction with other acetaminophen-containing products, or while consuming three or more alcoholic beverages daily.

The use of this product, which contains a nonsteroidal anti-inflammatory drug (NSAID), has been linked to an increased risk of severe stomach bleeding. This risk is heightened in individuals aged 60 or older, those taking other NSAIDs (prescription or nonprescription), individuals 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 elevate this risk.

Caffeine content in the recommended dose of this product is comparable to that found in a cup of coffee. It is advised 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.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center in the event of an overdose, emphasizing that 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 important to counsel patients against using this medication in conjunction with any other drug that contains acetaminophen, whether prescription or nonprescription. If patients are uncertain about the contents of a medication, they should be encouraged to consult with a doctor or pharmacist.

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

Before initiating use, patients should be advised to consult a doctor if they have liver disease, a history of stomach problems (such as heartburn), or if the stomach bleeding warning applies to them. Furthermore, patients with high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma should also seek medical advice prior to use. Lastly, patients taking a diuretic or any prescription medication for diabetes, gout, or arthritis should be encouraged to discuss their current medications with a doctor or pharmacist before using this product.

Storage and Handling

The product is supplied in configurations that include specific NDC numbers, which can be found on the packaging. It is essential to store the product at a controlled room temperature of 25°C (77°F). Temporary excursions are permissible within the range of 15° to 30°C (59° to 86°F).

Healthcare professionals should refer to the end flap of the packaging for the expiration date and lot number to ensure proper tracking and usage. Special handling requirements are not specified; however, standard precautions for storage should be observed to maintain product integrity.

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, consultation with a healthcare provider is recommended before use.

Clinicians should counsel patients regarding the use of the medication during pregnancy and breastfeeding, advising them to consult a health professional prior to use. It is particularly important to avoid aspirin use after 20 weeks of pregnancy unless explicitly directed by a physician, 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, as prompt intervention is crucial 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.

View product document (PDF)