Headache Relief

Description

Acetaminophen/Aspirin is a nonsteroidal anti-inflammatory drug (NSAID) formulated for pain relief, enhanced by the inclusion of caffeine as a pain reliever aid. This product is available in an extra strength dosage form, presented as caplets. The packaging features a tamper-evident safety seal; it is advised not to use the product if the printed safety seal under the cap is broken or missing. The product is distributed by Walgreens Co., located at 200 Wilmot Rd., Deerfield, IL 60015.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with various conditions, including headache, cold symptoms, arthritis, muscular aches, toothache, and premenstrual or menstrual cramps.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

Healthcare professionals should advise patients to adhere strictly to the recommended dosage and administration guidelines.

For adults and children aged 12 years and older, the recommended dosage is 2 caplets every 6 hours, with a maximum of 8 caplets within a 24-hour period. It is essential that each dose is accompanied by a full glass of water to ensure proper hydration and facilitate the medication's effectiveness.

For children under 12 years of age, it is advised to consult a physician for appropriate dosing recommendations.

Patients should be cautioned against exceeding the directed dosage to avoid potential adverse effects.

Contraindications

Use is contraindicated in patients with a history of allergic reactions to acetaminophen, aspirin, or any other pain reliever or fever reducer. Additionally, this product should not be used concurrently with any other medication containing acetaminophen, whether prescription or nonprescription. If there is uncertainty regarding the presence of acetaminophen in other medications, 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.

Allergy Alerts Acetaminophen may lead to severe skin reactions, which can manifest as skin reddening, blisters, or rash. In the event of a skin reaction, the use of this product should be discontinued, and medical assistance should be sought without delay. Additionally, aspirin may provoke a severe allergic reaction characterized by hives, facial swelling, shock, or asthma symptoms such as wheezing.

Liver Warning This product contains acetaminophen, and severe liver damage may occur if the maximum daily dosage of 8 caplets is exceeded within a 24-hour period, if it is taken concurrently with other medications containing acetaminophen, or if consumed with three or more alcoholic drinks 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, have a history of stomach ulcers or bleeding problems, are taking anticoagulants or steroid medications, or are using other NSAIDs (including aspirin, ibuprofen, or naproxen). The risk is also heightened with the consumption of three or more alcoholic drinks daily or if the product is taken for longer than directed.

Caffeine Warning The recommended dosage of this product contains 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 consumption may lead to symptoms such as nervousness, irritability, sleeplessness, and, in some cases, rapid heartbeat.

General Precautions Healthcare professionals should advise patients to consult a doctor before using this product if they have liver disease, if the stomach bleeding warning applies, if they have asthma, if they are taking diuretics, or if they have a history of stomach issues such as heartburn. Patients with high blood pressure, heart disease, liver cirrhosis, or kidney disease should also seek medical advice prior to use. Furthermore, it is recommended that patients consult a doctor or pharmacist if they are taking prescription medications for diabetes, gout, or arthritis, or if they are under medical care for any serious condition.

Emergency Medical Help In the event of an overdose, immediate medical assistance should be sought, or contact with a Poison Control Center is essential. Prompt medical attention is critical for both adults and children, even if no signs or symptoms are initially apparent.

Discontinuation of Use Patients should stop taking this product and contact a healthcare provider if they experience any allergic reactions, new symptoms, or any signs of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain. Additionally, if ringing in the ears or loss of hearing occurs, if pain worsens or lasts longer than 10 days, if fever intensifies or lasts more than three days, or if the painful area becomes red or swollen, medical attention should be sought, as these may indicate serious conditions.

Side Effects

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

Serious adverse reactions include the risk of Reye's syndrome, particularly 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, they should consult a healthcare professional immediately, as these may be early signs of this rare but serious illness.

Allergic reactions can also occur, with potential severe manifestations linked to both acetaminophen and aspirin. Symptoms of a severe skin reaction to acetaminophen may include skin reddening, blisters, and rash. In the event of such a reaction, patients are advised to discontinue use and seek medical assistance promptly. For aspirin, severe allergic reactions may present as hives, facial swelling, shock, or asthma symptoms such as wheezing.

The product contains acetaminophen, which poses a risk of severe liver damage if patients exceed the maximum daily dosage of 8 caplets within 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 the formulation raises 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 also be cautious if they consume three or more alcoholic drinks daily or take the medication for longer than directed.

Common adverse reactions may include symptoms related to caffeine intake, as the recommended dose contains approximately the same amount of caffeine as a cup of coffee. Excessive caffeine consumption can lead to nervousness, irritability, sleeplessness, and, in some cases, rapid heartbeat.

Patients are advised to stop using the product and consult a healthcare professional if they experience any signs of an allergic reaction, new symptoms, or any of the following signs of stomach bleeding: feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain. Additionally, if patients notice ringing in the ears, loss of hearing, worsening pain lasting more than 10 days, fever lasting more than 3 days, or if a painful area becomes red or swollen, they should seek medical attention, as these could indicate serious conditions.

Drug Interactions

Co-administration of this product with other medications containing acetaminophen, whether prescription or nonprescription, may result in severe liver damage. It is advised that healthcare professionals monitor liver function closely in patients using this combination.

The concomitant use of this product with anticoagulants or steroid medications increases the risk of severe gastrointestinal bleeding. Patients receiving such combinations should be monitored for signs of gastrointestinal bleeding and may require dosage adjustments or alternative therapies.

Additionally, the risk of severe stomach bleeding is elevated when this product is taken alongside other nonsteroidal anti-inflammatory drugs (NSAIDs), including but not limited to aspirin, ibuprofen, and naproxen. Caution is recommended, and healthcare providers should consider the necessity of monitoring for gastrointestinal complications in patients using these combinations.

No specific interactions with laboratory tests have been identified in the available data.

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, it is advised to consult a doctor before use.

Geriatric Use

Elderly patients may have an increased risk of severe stomach bleeding, particularly those aged 60 years and older. It is essential for healthcare providers to monitor these patients closely for any signs of gastrointestinal bleeding.

Additionally, caution is advised for geriatric patients with liver disease. Consultation with a healthcare professional is recommended prior to use, as liver function may be compromised in this population, potentially affecting drug metabolism and safety.

Furthermore, elderly patients with pre-existing conditions such as high blood pressure, heart disease, liver cirrhosis, or kidney disease should seek medical advice before initiating treatment. These conditions are more prevalent in the geriatric population and may necessitate dose adjustments or increased monitoring to ensure safety and efficacy.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional before using this medication. The use of aspirin during the last trimester of pregnancy is particularly cautioned against, as it may lead to adverse effects on the unborn child or complications during delivery. Therefore, it is essential that pregnant patients only use aspirin in this period if explicitly directed by a healthcare provider.

Lactation

Lactating mothers are advised to consult a health professional before using this medication. It is particularly important to avoid the use of aspirin during the last three months of pregnancy 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 its use in lactating individuals.

Renal Impairment

Patients with renal impairment should consult a healthcare professional prior to use, particularly if they have underlying 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 exercise caution when using this product, as it contains acetaminophen, which is associated with the risk of severe liver damage. The maximum recommended dosage is 8 caplets in a 24-hour period. Exceeding this dosage, using other medications that contain acetaminophen concurrently, or consuming 3 or more alcoholic drinks daily while using this product may significantly increase the risk of liver injury.

It is advised that patients with liver disease, high blood pressure, heart disease, liver cirrhosis, or kidney disease consult a healthcare professional prior to use. Monitoring of liver function may be warranted in these patients to ensure safety and efficacy while using this product.

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 observable signs or symptoms.

Healthcare professionals are advised to remain vigilant and proactive in managing potential overdose situations. The lack of immediate symptoms does not preclude the possibility of serious health consequences, and therefore, timely evaluation and treatment are essential.

Nonclinical Toxicology

It is especially important not to use aspirin during the last three months of pregnancy unless specifically directed by a healthcare professional, as it may lead to complications for the unborn child or during delivery. No relevant information is available regarding non-teratogenic effects. Additionally, there is no pertinent data provided in the nonclinical toxicology section or in the animal pharmacology and toxicology section.

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, as prompt medical attention is crucial for both adults and children. It is essential to emphasize that even in the absence of noticeable signs or symptoms, an overdose can still pose significant health risks, and timely intervention is vital.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at a controlled room temperature, specifically between 20º-25ºC (68º-77ºF). Proper storage conditions must be maintained to ensure the integrity and efficacy of the product.

Additional Clinical Information

Patients should be informed that the medication is administered orally. For adults and children 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. For children under 12 years, it is advised to consult a doctor for appropriate dosing.

Clinicians should counsel patients who are pregnant or breastfeeding to seek advice from a health professional before use. It is particularly important to avoid aspirin during the last trimester of pregnancy unless specifically directed by a physician, as it may pose risks to the unborn child or lead to complications during delivery. Additionally, patients should keep the medication out of reach of children and be aware that in the event of an overdose, immediate medical assistance or contact with a Poison Control Center is essential, 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)