Headache Relief

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 other pain reliever or fever reducer. Additionally, concurrent use with any other medication containing acetaminophen, whether prescription or nonprescription, is prohibited. 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. If any changes in behavior accompanied by nausea and vomiting occur while using this product, it is imperative to consult a healthcare professional, as these may be early signs of this rare but serious condition.

Aspirin, a component of this product, may lead to severe allergic reactions, which can manifest as shock, hives, facial swelling, 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, it is crucial to discontinue use immediately and seek medical assistance.

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 with a history of stomach ulcers or bleeding problems, or those taking anticoagulants, steroids, or other NSAIDs (including aspirin, ibuprofen, or naproxen). The risk is also heightened with excessive alcohol consumption or prolonged use beyond the recommended duration.

Caffeine is another component of this product, with a recommended dose containing approximately the same amount of caffeine as a cup of coffee. It is advisable to limit the intake of other caffeine-containing medications, foods, or beverages while using this product, as excessive caffeine 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 if they are taking prescription medications for diabetes, gout, or arthritis.

In the event of an overdose, immediate medical attention is essential. Patients should contact a Poison Control Center or seek emergency medical help without delay, as prompt intervention is critical for both adults and children, even in the absence of noticeable symptoms.

Patients are advised to discontinue use and consult a healthcare professional 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 or hearing loss, worsening pain lasting more than 10 days, fever lasting 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. Patients should be advised to discontinue use and consult a doctor if they experience changes in behavior accompanied by nausea and vomiting, 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 should stop use immediately and seek medical assistance.

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 increases 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 cautioned against exceeding the recommended dosage or duration of use.

Common Adverse Reactions Patients should be aware of the potential for nervousness, irritability, sleeplessness, and, occasionally, rapid heartbeat due to caffeine content in the recommended dose, which is comparable to that of a cup of coffee.

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

Drug Interactions

Taking this product concurrently with other medications containing acetaminophen, whether prescription or nonprescription, may result in severe liver damage. It is advisable to avoid the use of multiple acetaminophen-containing products simultaneously.

This product contains an NSAID (Aspirin), which may heighten the risk of severe gastrointestinal bleeding, particularly when used in conjunction with other NSAIDs (such as aspirin, ibuprofen, or naproxen) or with anticoagulant medications and steroid drugs. Caution is recommended, and monitoring for signs of gastrointestinal bleeding should be considered in patients using these combinations.

Additionally, the use of caffeine-containing medications, foods, or beverages should be limited while taking this product. Excessive caffeine intake may lead to symptoms such as nervousness, irritability, sleeplessness, and, in some cases, rapid heartbeat.

Patients are advised to consult with a healthcare professional before using this product if they are currently taking prescription medications for diabetes, gout, or arthritis, as interactions may occur that could affect treatment outcomes.

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. It is important for healthcare professionals to advise that if any changes in behavior accompanied by nausea and vomiting occur during the use of this product, a doctor should be consulted immediately, as these may be early signs of Reye's syndrome, a rare but serious condition.

For children under 12 years of age, it is recommended to consult a doctor before use. In the event of an overdose, it is crucial to seek medical help or contact a Poison Control Center immediately, as prompt medical attention is essential for both adults and children, even if no signs or symptoms are initially apparent.

Geriatric Use

Elderly patients, particularly those aged 60 and older, are at an increased risk of severe stomach bleeding when using this product, which contains a nonsteroidal anti-inflammatory drug (NSAID). This risk is further heightened in individuals with a history of stomach ulcers or bleeding problems, those who are concurrently using blood-thinning medications (anticoagulants) or steroid drugs, and patients taking other NSAIDs, whether prescription or over-the-counter, such as aspirin, ibuprofen, or naproxen.

Additionally, the risk of gastrointestinal complications may be exacerbated by the consumption of three or more alcoholic drinks daily while using this product. It is crucial for healthcare providers to monitor elderly patients closely for signs of gastrointestinal bleeding and to consider dose adjustments or alternative therapies as necessary. Patients should be advised to adhere strictly to the recommended dosage and duration of use to minimize potential adverse effects.

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 the unborn child and complications during delivery. Therefore, it is crucial that pregnant patients only use aspirin under the guidance of a healthcare provider, particularly in the later stages of pregnancy.

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 the 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 in a 24-hour period, nor should they use this product in conjunction with other medications containing acetaminophen. Additionally, consumption of three or more alcoholic drinks daily while using this product may further increase the risk of liver damage.

Before initiating treatment, patients with 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 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 non-teratogenic effects have been specified. Additionally, there are no details provided regarding nonclinical toxicology or animal pharmacology and toxicology.

Postmarketing Experience

No specific postmarketing experience details are available. As such, there are no additional adverse events or rare case reports to summarize at this time.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical help 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 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 important to instruct patients not to use 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 advised to stop using the medication 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 instructed to seek medical advice if they experience ringing in the ears or loss of hearing, if their pain worsens or persists for more than 10 days, if their fever worsens or lasts for more than 3 days, if redness or swelling occurs, or if any new symptoms arise.

Healthcare providers should recommend that patients consult a doctor before using this medication if they have liver disease, if the warning regarding stomach bleeding applies to them, if they have a history of stomach problems such as heartburn, if they have asthma, if they are taking a diuretic, or if they have high blood pressure, heart disease, liver cirrhosis, or kidney disease. Furthermore, patients should be advised to speak with a doctor or pharmacist before use if they are taking a prescription drug for diabetes, gout, or arthritis.

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 tracking and usage. Special handling requirements are not specified; however, adherence to the recommended storage conditions is essential for maintaining product integrity.

Additional Clinical Information

Patients should be advised to consult a healthcare professional if they are pregnant or breastfeeding before using the medication. It is particularly crucial to avoid the use of aspirin after 20 weeks of pregnancy unless specifically 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, immediate medical assistance should be sought, or a Poison Control Center should be contacted without delay. Prompt medical attention is essential for both adults and children, even if no signs or symptoms are apparent.

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)