Headache Relief

Description

equate™ is a pain reliever formulation indicated for headache relief, containing active ingredients of acetaminophen, aspirin (a nonsteroidal anti-inflammatory drug), and caffeine. Each package contains 24 caplets, designed for extra strength efficacy. The product is distributed by Walmart Inc., located in Bentonville, AR 72716. A tamper evident warning is included, stating: "DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING." This product is not manufactured or distributed by Haleon CH SARL, the owner of the registered trademark Excedrin® Extra Strength Headache. The National Drug Code (NDC) for equate™ is 49035-433-08.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with various conditions, including headache, muscular aches, the common cold, arthritis, 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, a component of this product, may lead to severe allergic reactions, which can manifest as hives, facial swelling, shock, or asthma symptoms such as wheezing. Similarly, acetaminophen may cause severe skin reactions, including skin reddening, blisters, or rash. In the event of a skin reaction, users must discontinue use and seek medical assistance without delay.

This product contains acetaminophen, which poses a risk of severe liver damage if taken in conjunction with other acetaminophen-containing medications, exceeds 4,000 mg within a 24-hour period, or is consumed alongside three or more alcoholic drinks daily. 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 who take more than the recommended dosage or for an extended duration, individuals with a history of stomach ulcers or bleeding issues, and those concurrently using blood thinners, steroids, or other NSAIDs. Alcohol consumption of three or more drinks daily while using this product further elevates this risk.

Caffeine is also present in the recommended dosage of this product, approximately equivalent to that found in a cup of coffee. Users should limit the intake of other caffeine-containing medications, foods, or beverages to avoid potential side effects such as 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 high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma, as well as those taking diuretics. Patients should also seek guidance from a healthcare provider or pharmacist if they are on prescription medications for diabetes, gout, or arthritis.

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

Users must discontinue use and consult a healthcare professional if any allergic reactions occur, or if they experience signs of stomach bleeding, such as feeling faint, having bloody or black stools, vomiting blood, or persistent stomach pain. Additional reasons to stop use include ringing in the ears or hearing loss, the presence of redness or swelling, the emergence of new symptoms, worsening pain lasting more than 10 days, or a fever that persists or worsens beyond three days.

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 notice 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 aspirin or acetaminophen. Symptoms of an allergic reaction to aspirin can include hives, facial swelling, shock, and asthma (wheezing). For acetaminophen, severe skin reactions may manifest as skin reddening, blisters, or rash. In the event of any skin reaction, patients should stop use and seek medical assistance immediately.

This product contains acetaminophen, which poses a risk of severe liver damage if taken in conjunction with other acetaminophen-containing products, exceeds 4,000 mg in a 24-hour period, or is consumed with three or more alcoholic drinks daily.

Additionally, the presence of an NSAID in this product raises the risk of severe stomach bleeding, particularly in patients aged 60 or older, those who take the medication for longer than directed, individuals with a history of stomach ulcers or bleeding problems, and those concurrently using blood thinners or other NSAIDs. Patients should be vigilant for signs of stomach bleeding, such as feeling faint, experiencing bloody or black stools, vomiting blood, or having persistent stomach pain, and should seek medical attention if these symptoms occur.

Common Adverse Reactions Patients may also experience less severe but notable reactions. The recommended dose of this product contains caffeine, which can lead to nervousness, irritability, sleeplessness, and, in some cases, rapid heartbeat if consumed in excess alongside other caffeine-containing products.

Patients are advised to stop use and consult a doctor if they experience any new symptoms, if pain worsens or lasts longer than 10 days, or if fever persists or worsens after three days.

Precautions Before using this product, patients should consult a doctor 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, those taking diuretics or prescription medications for diabetes, gout, or arthritis should seek advice from a healthcare professional prior to use.

Drug Interactions

Co-administration of this product with other medications containing acetaminophen may result in severe liver damage. It is advisable to avoid the concurrent use of these agents 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 of patients on these combinations is recommended, and dosage adjustments may be necessary based on clinical judgment.

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 should be exercised, and alternative pain management strategies should be considered.

Patients are also advised to limit the intake of caffeine-containing medications, foods, or beverages while using this product. Excessive caffeine consumption may lead to symptoms such as nervousness, irritability, sleeplessness, and, in some cases, rapid heartbeat. Monitoring for these effects is recommended to ensure patient safety.

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 and caffeine). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients, particularly children and teenagers, should not use this product if they have or are recovering from chicken pox 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 important to consult a healthcare professional, as these symptoms may indicate the onset of Reye's syndrome.

For dosing, children under 12 years of age should seek medical advice before use. For those aged 12 years and older, the recommended dosage is 2 caplets every 6 hours, with a maximum of 8 caplets in a 24-hour period.

Geriatric Use

Elderly patients may be at an increased risk for certain adverse effects when using this product. The presence of a nonsteroidal anti-inflammatory drug (NSAID) in the formulation raises concerns regarding severe stomach bleeding, particularly in individuals aged 60 years and older. Therefore, careful monitoring for gastrointestinal symptoms is advised in this population.

Additionally, the product contains acetaminophen, which poses a risk of severe liver damage if the dosage exceeds 4,000 mg within a 24-hour period. This risk is notably heightened in older adults, necessitating strict adherence to recommended dosing guidelines and vigilant assessment of liver function.

Healthcare providers should also advise elderly patients to consult a physician prior to use if they have pre-existing conditions such as high blood pressure, heart disease, liver cirrhosis, or kidney disease, as these conditions are more prevalent in geriatric patients and may influence the safety and efficacy of the 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 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 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 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 be aware that this product contains acetaminophen, which carries a risk of severe liver damage. The risk is heightened if patients take this product in conjunction with other medications containing acetaminophen, exceed a total daily dose of 4,000 mg of acetaminophen, or consume three or more alcoholic drinks daily while using this product.

It is advised that patients with liver disease consult a healthcare professional prior to using this product. Additionally, individuals with high blood pressure, heart disease, liver cirrhosis, or kidney disease should also seek medical advice before use to ensure safety and appropriate management of their conditions. Monitoring of liver function may be warranted in these patients to prevent potential adverse effects.

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 intervention is crucial for both adults and children, regardless of whether any signs or symptoms are apparent.

Healthcare professionals should be aware that the absence of symptoms does not preclude the possibility of serious complications arising from an overdose. Therefore, it is essential to monitor the patient closely and provide appropriate care as needed.

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 specific details regarding nonclinical toxicology or animal pharmacology and toxicology provided in the text.

Postmarketing Experience

Reports from postmarketing surveillance have identified several adverse events associated with the use of aspirin and acetaminophen. Severe allergic reactions, including hives, facial swelling, shock, and asthma (wheezing), have been documented in patients using aspirin. Additionally, acetaminophen has been linked to severe skin reactions, characterized by skin reddening, blisters, and rash.

Liver damage cases have also been reported in patients taking acetaminophen, particularly in instances of exceeding the recommended dosage or concurrent alcohol consumption. Furthermore, there have been reports of stomach bleeding in patients using nonsteroidal anti-inflammatory drugs (NSAIDs), especially among individuals over 60 years of age or those with a history of stomach ulcers or bleeding disorders.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical help 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 ever experienced an allergic reaction to any other pain reliever or fever reducer. It is also essential to counsel patients against using this medication in conjunction with any other drug containing acetaminophen, whether prescription or nonprescription. If patients are uncertain whether a drug contains acetaminophen, they should be encouraged to consult a doctor or pharmacist.

Patients should be instructed to stop using the medication and consult a doctor if they experience any signs of an allergic reaction, such as difficulty breathing or swelling of the face, lips, or throat. Additionally, they should seek medical attention if they notice any signs of stomach bleeding, including feeling faint, having bloody or black stools, vomiting blood, or experiencing persistent stomach pain.

Healthcare providers should also inform patients to discontinue use and consult a doctor if they experience ringing in the ears, loss of hearing, redness, or swelling. Patients should be advised to seek medical advice if any new symptoms arise, if pain worsens or persists for more than 10 days, or if fever worsens or lasts for more than 3 days.

Before initiating treatment, patients should be encouraged 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 prescription medications for diabetes, gout, or arthritis should be advised to consult a doctor or pharmacist before using this medication.

Storage and Handling

The product is supplied in configurations that include specific NDC numbers, which can be found on the packaging. It should be stored at a controlled room temperature of 25ºC (77ºF), with permissible excursions between 15°-30°C (59°-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 the recommended dosage for adults and children aged 12 years and older being 2 caplets every 6 hours, not to exceed 8 caplets in a 24-hour period. For children under 12 years, it is advised to consult a doctor for appropriate dosing.

Clinicians should counsel patients to seek advice from a health professional if they are pregnant or breastfeeding, particularly emphasizing the risks associated with aspirin use after 20 weeks of pregnancy, which may lead to complications for both the unborn child and during delivery. In the event of an overdose, immediate medical assistance or contact with a Poison Control Center is crucial, as timely intervention is necessary 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)