Headache Relief

Description

No description information is available for the drug.

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 drug 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 shock, facial swelling, hives, 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 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 this product, or using it concurrently with other medications containing acetaminophen.

Additionally, the product contains a nonsteroidal anti-inflammatory drug (NSAID), which may increase the risk of severe stomach bleeding. This risk is heightened in individuals aged 60 or older, those taking other NSAIDs (prescription or nonprescription), individuals consuming three or more alcoholic drinks daily, those with a history of stomach ulcers or bleeding problems, and those taking anticoagulants or steroid medications. Users should also be cautious not to exceed the recommended dosage or duration of use.

Caffeine is present in the recommended dose of this product, approximately equivalent to that found in a cup of coffee. Users 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.

Before using this product, individuals should consult a healthcare professional if they have liver disease, if the stomach bleeding warning applies, if they have a history of stomach issues such as heartburn, or if they have high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma. It is also advisable to seek guidance from a doctor or pharmacist if taking prescription medications for diabetes, gout, or arthritis.

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

Users must discontinue use and consult 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), if there is ringing in the ears or loss of hearing, if redness or swelling develops, if pain worsens or lasts longer than 10 days, if fever intensifies or lasts more than three days, or if any new symptoms appear.

Side Effects

Patients using this product should be aware of several serious and common adverse reactions associated with its use.

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. If patients experience changes in behavior accompanied by nausea and vomiting while using this product, they should consult a doctor immediately, as these symptoms could indicate the onset of Reye's syndrome.

Severe allergic reactions may occur, particularly in patients sensitive to aspirin. Symptoms of such reactions can include shock, facial swelling, hives, and asthma (wheezing). Additionally, acetaminophen may lead to severe skin reactions, characterized by 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 a 24-hour period, consume three or more alcoholic drinks daily while using the product, or take other medications containing acetaminophen concurrently.

Furthermore, 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 cautious if they consume three or more alcoholic drinks daily while using this product or take it for longer than directed.

Caffeine is also present in the recommended dose, which is comparable to that found in a cup of coffee. Patients should limit the intake of other caffeine-containing medications, foods, or beverages, as excessive caffeine may lead to nervousness, irritability, sleeplessness, and, in some cases, rapid heartbeat.

Patients are advised to stop use and consult a doctor if they experience any signs of an allergic reaction, symptoms indicative of stomach bleeding (such as feeling faint, bloody or black stools, vomiting blood, or persistent stomach pain), ringing in the ears or hearing loss, redness or swelling, worsening pain lasting more than 10 days, fever lasting more than 3 days, or any new symptoms.

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, patients taking diuretics or prescription medications for diabetes, gout, or arthritis should seek advice from a doctor or pharmacist prior to use.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there is no information available regarding interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Headache Relief (aspirin, acetaminophen, 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 essential 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, it is advised to consult a doctor before use.

This product should be kept out of reach of children. In the event of an overdose, immediate medical assistance should be sought, or a Poison Control Center should be contacted, as prompt medical attention is critical for both adults and children, even if no signs or symptoms are apparent.

Geriatric Use

Elderly patients may be at an increased risk for severe stomach bleeding when using this product, as it contains a nonsteroidal anti-inflammatory drug (NSAID). The likelihood of experiencing such adverse effects is notably higher in individuals aged 60 years and older.

It is essential for geriatric patients to consult with a healthcare provider prior to using this medication, particularly if they have pre-existing conditions such as high blood pressure, heart disease, liver cirrhosis, or kidney disease. Careful consideration and monitoring are advised to ensure the safe use of this product in the elderly 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 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 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. Patients are advised to avoid exceeding a maximum dosage of 4,000 mg of acetaminophen within a 24-hour period. Additionally, consumption of three or more alcoholic drinks daily while using this product may further increase the risk of liver damage. Caution should be exercised when considering the use of other medications that also contain acetaminophen, as this may lead to unintentional overdose and subsequent hepatic injury. Regular monitoring of liver function may be warranted in patients with compromised liver health to ensure safety and efficacy.

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 are advised to remain vigilant, as the absence of symptoms does not preclude the possibility of serious complications. Early recognition and management of an overdose can significantly influence patient outcomes. Therefore, it is essential to ensure that patients and caregivers are aware of the importance of timely medical evaluation in cases of suspected overdose.

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

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 or seek medical help right away, regardless of whether they observe any signs or symptoms. It is crucial for both adults and children to receive prompt medical attention in such situations to ensure their safety and well-being.

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 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. Clinicians should advise patients who are pregnant or breastfeeding to consult a health professional prior to use. It is particularly crucial to avoid the use of aspirin 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.

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)