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. This medication 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

Patients should adhere strictly to the recommended dosage. Each dose should be accompanied by 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. It is imperative not to exceed 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 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 another 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, as these may be early indicators of this condition.

Allergy Alerts This product contains acetaminophen, which may lead to severe skin reactions. Symptoms can include skin reddening, blisters, and rash. Should any skin reaction occur, the user must discontinue use and seek medical assistance without delay. Additionally, aspirin, another component of this product, may provoke a severe allergic reaction characterized by hives, facial swelling, shock, or asthma (wheezing). Immediate medical attention is warranted if such symptoms arise.

Liver Warning The presence of acetaminophen in this product necessitates caution, as severe liver damage may occur under certain conditions. Users should not exceed 8 caplets within a 24-hour period, which is the maximum daily dosage. Caution is also advised when using other medications containing acetaminophen or when consuming three or more alcoholic drinks daily while using this product.

Stomach Bleeding Warning This product contains a nonsteroidal anti-inflammatory drug (NSAID), which may increase the risk of severe stomach bleeding. The likelihood of this adverse effect is heightened in individuals aged 60 or older, those with a history of stomach ulcers or bleeding problems, and those concurrently taking blood thinners, steroids, or other NSAIDs (including aspirin, ibuprofen, or naproxen). Users should also avoid consuming three or more alcoholic drinks daily while using this product and should adhere strictly to the recommended dosage to minimize risks.

Caffeine Warning The recommended dosage of this product contains approximately the same amount of caffeine as a standard 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.

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

Discontinuation of Use Users should stop using this product and consult a healthcare professional if any of the following occur: an allergic reaction, new symptoms, 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 loss of hearing, worsening pain lasting more than 10 days, fever that worsens or lasts more than 3 days, or if the painful area becomes red or swollen. These symptoms may indicate a serious condition requiring medical evaluation.

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 illness 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 skin reactions have been reported in patients using acetaminophen, which may manifest as skin reddening, blisters, or rash. If any of these symptoms occur, patients are advised to discontinue use and seek medical assistance promptly.

Aspirin, another component of this product, may lead to severe allergic reactions in some individuals. Symptoms can include hives, facial swelling, shock, and asthma (wheezing). Patients experiencing any signs of an allergic reaction should seek immediate medical attention.

The product contains acetaminophen, which poses a risk of severe liver damage if patients exceed the maximum daily dosage of 8 caplets, 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 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 blood thinners or other NSAIDs. Patients should be cautious if they consume three or more alcoholic drinks daily or take the medication for longer than directed.

Patients should also be aware of the caffeine content in this product, which is comparable to that found in a cup of coffee. Excessive caffeine intake may lead to nervousness, irritability, sleeplessness, and, in some cases, rapid heartbeat. It is advisable to limit the use of other caffeine-containing medications, foods, or beverages while taking this product.

Patients are instructed 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 or 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. These symptoms could signify a serious condition requiring medical evaluation.

Drug Interactions

Co-administration of this product with other medications containing acetaminophen, whether prescription or nonprescription, may result in severe liver damage. It is advisable to avoid the concurrent use of these agents to mitigate the risk of hepatotoxicity.

In terms of pharmacodynamic interactions, the concomitant use of this product with anticoagulants or steroid medications significantly increases the risk of severe gastrointestinal bleeding. Close monitoring of patients receiving these combinations is recommended, and consideration should be given to dosage adjustments or alternative therapies.

Additionally, the risk of severe stomach bleeding is also heightened when this product is taken alongside other nonsteroidal anti-inflammatory drugs (NSAIDs), including but not limited to aspirin, ibuprofen, and naproxen. Caution is warranted, and healthcare providers should evaluate the necessity of using multiple NSAIDs concurrently.

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, 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 of age, it is advised 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 associated with the use of this medication. It is essential for healthcare providers to exercise caution when prescribing this treatment to geriatric patients.

Monitoring for signs of gastrointestinal bleeding is advised, and dosage adjustments may be necessary based on the individual patient's health status and concurrent medications. Careful assessment of the risks versus benefits should be conducted to ensure the safety of elderly patients receiving this therapy.

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 fetal development 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 the use of this medication in lactating mothers.

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 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 the maximum daily dosage of 8 caplets within a 24-hour period. Additionally, patients should avoid concomitant use with other medications containing acetaminophen and limit alcohol consumption to fewer than 3 drinks per day while using this product.

Before initiating treatment, patients with a history of 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 observable signs or symptoms.

Healthcare professionals should be aware that the lack of immediate symptoms does not preclude the potential for serious health consequences. Therefore, vigilance and timely action are essential in managing overdose situations effectively.

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 specific non-teratogenic effects have been identified in the available data. Additionally, there are no details regarding nonclinical toxicology or animal pharmacology and toxicology provided in the current information.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients about 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, as timely intervention can be critical in managing overdose situations effectively.

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 20ºC and 25ºC (68ºF and 77ºF). Proper storage conditions are crucial to maintain the integrity and efficacy of the product.

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, not exceeding 8 caplets within a 24-hour period. For children under 12 years, consultation with a doctor is recommended before use.

Clinicians should counsel patients on important safety information. Pregnant or breastfeeding individuals should seek advice from a health professional prior to use, particularly noting that aspirin should generally be avoided during the last trimester of pregnancy unless specifically directed by a physician due to potential risks to the fetus and complications during delivery. Additionally, it is crucial to keep the medication out of reach of children. In the event of an overdose, immediate medical assistance or contact with a Poison Control Center is essential, as prompt attention is vital 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.

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