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 and 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 caplets every 6 hours, with a maximum limit of 8 caplets within a 24-hour period. It is essential to take each dose with a full glass of water to ensure proper administration and absorption.

For children under 12 years of age, it is advised to consult a healthcare professional 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

Patients should be advised of the following warnings and precautions associated with the use of this product.

Reye's Syndrome Children and teenagers who are experiencing or recovering from chickenpox or flu-like symptoms should not use this product. If behavioral changes accompanied by nausea and vomiting occur during use, it is imperative to consult a physician, as these symptoms may indicate the onset of Reye's syndrome, a rare but serious condition.

Allergy Alerts Aspirin may induce severe allergic reactions, which can manifest as shock, facial swelling, hives, or asthma (wheezing). Acetaminophen may also lead to severe skin reactions, with symptoms including skin reddening, blisters, or rash. In the event of a skin reaction, the patient should discontinue use immediately and seek medical assistance.

Liver Warning This product contains acetaminophen, and severe liver damage may occur if the patient exceeds 4,000 mg of acetaminophen within a 24-hour period, uses other medications containing acetaminophen concurrently, or consumes three or more alcoholic beverages 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, particularly in individuals who are 60 years of age or older, take other NSAIDs (including aspirin, ibuprofen, or naproxen), consume three or more alcoholic drinks daily, have a history of stomach ulcers or bleeding disorders, are on anticoagulant or steroid medications, 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. Patients should limit the intake of other caffeine-containing medications, foods, or beverages while using this product, as excessive caffeine consumption may lead to nervousness, irritability, sleeplessness, and, in some cases, rapid heartbeat.

General Precautions Prior to use, patients should consult a healthcare professional if they have liver disease, if the stomach bleeding warning is applicable, if they have a history of gastrointestinal issues such as heartburn, or if they have conditions such as high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma. Additionally, patients taking diuretics should seek medical advice before use.

Emergency Medical Help In the event of an overdose, immediate medical attention should be sought, or the Poison Control Center should be contacted. Prompt intervention is crucial for both adults and children, even if no symptoms are immediately apparent.

Discontinuation and Consultation Patients should stop using the product and consult a physician 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 hearing loss; redness or swelling; worsening pain lasting more than 10 days; fever that worsens or persists for more than three days; or the emergence of any new symptoms.

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 doctor, 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 may include shock, facial swelling, hives, and asthma (wheezing). For acetaminophen, severe skin reactions can manifest as skin reddening, blisters, or rash. If any of these symptoms occur, patients should discontinue use and seek medical assistance immediately.

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, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain.

Common Adverse Reactions:

Patients may experience nervousness, irritability, sleeplessness, and occasionally rapid heartbeat due to caffeine, which is present in a quantity comparable to that of a cup of coffee. It is advisable to limit the intake of other caffeine-containing medications, foods, or beverages while using this product.

Patients are advised to stop use and consult a doctor if they experience any of the following: an allergic reaction, signs of stomach bleeding, 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.

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 healthcare professional 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 (acetaminophen, aspirin, 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, adults and children aged 12 years and older are advised 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 recommended to consult a doctor before use.

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 potential for heightened adverse effects.

It is advisable to closely monitor elderly patients for any signs of gastrointestinal bleeding and to evaluate the necessity of dosage adjustments based on individual patient factors. Careful assessment of the risk-benefit profile is essential in this population to ensure safe and effective use of the 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 healthcare 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 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 with compromised liver function should be aware that exceeding 4,000 mg of acetaminophen within a 24-hour period may lead to significant hepatic injury. Additionally, concurrent use of other medications containing acetaminophen is contraindicated, as this may further increase the risk of liver damage.

Furthermore, patients who consume three or more alcoholic beverages daily while using this product are at an elevated risk for severe liver damage. Therefore, careful consideration and monitoring of liver function are advised for patients with hepatic impairment to prevent potential adverse effects associated with acetaminophen use.

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, 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, 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 or additional nonclinical toxicology details are available in the provided data. Furthermore, there are no specific findings related to 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 (wheezing). 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 medical assistance immediately.

Warnings regarding liver damage have been highlighted, particularly with acetaminophen. Severe liver damage may occur if the daily dosage exceeds 4,000 mg, if used concurrently with other acetaminophen-containing products, or if combined with the consumption of three or more alcoholic drinks 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, individuals with a history of stomach ulcers or bleeding problems, and those using blood thinners or steroids. Additionally, prolonged use or exceeding the recommended dosage may elevate this risk.

Caffeine content in the recommended dose is comparable to that of a cup of coffee. Caution is advised regarding the concurrent use of other caffeine-containing products, as excessive caffeine intake may lead to nervousness, irritability, sleeplessness, and, in some cases, rapid heartbeat.

Users are advised to discontinue use and consult a healthcare professional if any of the following occur: signs of an allergic reaction, symptoms indicative of stomach bleeding (such as feeling faint, vomiting blood, or having bloody or black stools), ringing in the ears or hearing loss, redness or swelling, worsening pain lasting more than 10 days, fever persisting beyond three days, or the emergence of any new symptoms.

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 crucial for both adults and children, even if no signs or symptoms are 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 essential to caution 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 a doctor or pharmacist.

Patients must be instructed 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 stomach pain that does not improve. Additionally, patients should be advised to stop use and seek medical attention if they experience ringing in the ears, loss of hearing, redness, or swelling.

Healthcare providers should inform patients to stop using the medication and consult a doctor if their pain worsens or persists for more than 10 days, if their fever worsens or lasts for more than 3 days, or if any new symptoms arise.

Patients with liver disease, a history of stomach problems such as heartburn, high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma should be advised to consult a doctor before using this medication. Furthermore, patients taking diuretics or prescription medications for diabetes, gout, or arthritis should also be encouraged to seek guidance from a doctor or pharmacist prior to use.

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 15ºC and 30ºC (59ºF to 86ºF).

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 advised to take 2 caplets every 6 hours, with a maximum of 8 caplets in a 24-hour period. For children under 12 years, consultation with a doctor is recommended before use.

Clinicians should counsel patients regarding the use of this medication during pregnancy and breastfeeding. It is particularly important to avoid aspirin use after 20 weeks of pregnancy unless explicitly directed by a healthcare professional, 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)