Headache Relief

Description

NDC 83324-063-24. QC® Quality Choice Extra Strength is a pain reliever formulated for headache relief, containing acetaminophen, aspirin (NSAID), and caffeine as active ingredients. Each package contains 24 coated tablets. This product is comparable to the active ingredients in Excedrin® Extra Strength. It is distributed by CDMA, Inc., Novi, MI 48375. The product features a tamper-evident safety seal; do not use if the seal under the cap is broken or missing. For more information, visit www.qualitychoice.com or contact customer service at 800-935-2362. This product is not manufactured or distributed by Haleon CH SARL, the owner of the registered trademark Excedrin® Extra Strength.

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, toothache, muscular aches, 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 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 tablets every 6 hours, with a maximum limit of 8 tablets 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 of this product is contraindicated in the following situations:

Patients with a history of allergic reactions to acetaminophen, aspirin, or any other pain reliever or fever reducer should not use this product. 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 other medications, consultation with a healthcare professional is advised. Furthermore, individuals who have experienced an allergic reaction to this product or any of its components should refrain from its use.

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 symptoms may indicate the onset of this rare but serious illness.

Aspirin, a component of this product, may lead to severe allergic reactions, which can manifest as hives, facial swelling, shock, 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 who take more than the recommended dosage or for an extended duration, have a history of stomach ulcers or bleeding issues, are on anticoagulant or steroid medications, are aged 60 or older, or consume three or more alcoholic drinks daily while using this product.

Caffeine is also a component of the recommended dose, which is comparable to the caffeine content of a cup of coffee. It is advisable to limit the intake of other caffeine-containing medications, foods, or beverages during the use of this product, as excessive caffeine consumption 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 asthma, a history of stomach problems such as heartburn, are taking diuretics, or have conditions such as high blood pressure, heart disease, liver cirrhosis, or kidney disease. This is particularly important if the patient has a history of stomach bleeding or liver disease.

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

Patients should 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, bloody or black stools, vomiting blood, or persistent stomach pain), ringing in the ears or hearing loss, new or worsening symptoms, redness or swelling, pain lasting more than ten days, or fever lasting more than three days. These symptoms may signify a serious condition requiring prompt medical evaluation.

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 not to use this product under these circumstances. If changes in behavior accompanied by nausea and vomiting occur, it is essential 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 hives, facial swelling, shock, 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.

Patients should also be aware of the risk of severe liver damage associated with acetaminophen, particularly if they exceed 4,000 mg in 24 hours, use other products containing acetaminophen, or consume three or more alcoholic drinks daily while using this product.

The product contains an NSAID, which may increase the risk of severe stomach bleeding. This risk is heightened in patients who take more than the recommended dose, have a history of stomach ulcers or bleeding problems, are on anticoagulant or steroid medications, are aged 60 or older, or consume three or more alcoholic drinks daily while using this product.

Common Adverse Reactions Patients may experience symptoms related to caffeine intake, as the recommended dose of this product contains approximately the same amount of caffeine as a cup of coffee. Excessive caffeine consumption may lead to nervousness, irritability, sleeplessness, and, in some cases, rapid heartbeat.

Patients are advised to stop using the product and consult a doctor if they experience any signs of an allergic reaction, symptoms indicative of stomach bleeding (such as feeling faint, having bloody or black stools, vomiting blood, or experiencing persistent stomach pain), ringing in the ears, loss of hearing, new symptoms, redness or swelling, worsening pain lasting more than 10 days, or a fever that worsens or lasts more than three days. These symptoms could indicate a serious condition requiring medical attention.

Drug Interactions

Concurrent use of this medication with any other drug containing acetaminophen, whether prescription or nonprescription, is contraindicated due to the risk of acetaminophen overdose and potential hepatotoxicity.

Pharmacodynamic interactions are significant when this medication is used alongside anticoagulants or steroid drugs. The concomitant use of these agents increases the risk of severe gastrointestinal bleeding. Healthcare professionals should exercise caution and consider alternative therapies or enhanced monitoring for patients requiring both treatments.

Additionally, the use of this medication in conjunction with other nonsteroidal anti-inflammatory drugs (NSAIDs), including but not limited to aspirin, ibuprofen, and naproxen, is associated with an elevated risk of severe stomach bleeding. It is advisable to avoid the combination of these medications to mitigate this risk.

Patients taking prescription medications for diabetes, gout, or arthritis should consult with their healthcare provider or pharmacist prior to initiating therapy with this medication. This precaution is essential to ensure safe and effective use, as potential interactions may necessitate dosage adjustments or increased monitoring.

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 tablets every 6 hours, with a maximum of 8 tablets in a 24-hour period. For children under 12 years, a doctor should be consulted for appropriate dosing recommendations.

This product should be kept out of reach of children. In the event of an accidental 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 initially apparent.

Geriatric Use

Elderly patients, particularly those aged 60 and older, may have an increased risk of severe stomach bleeding. It is essential for healthcare providers to exercise caution when prescribing this medication 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 treatment.

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 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 within a 24-hour period, avoid concurrent use with other medications containing acetaminophen, and limit alcohol consumption to fewer than three alcoholic drinks per day while using this product.

Prior to use, patients with known liver disease, including liver cirrhosis, should consult a healthcare professional. Additionally, individuals with high blood pressure, heart disease, or kidney disease should also seek medical advice before using this product. Monitoring of liver function may be warranted in patients with compromised liver function to prevent potential adverse effects.

Overdosage

In the event of an accidental overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. Prompt medical attention 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 adverse effects. Therefore, vigilance and timely intervention are essential in managing overdose situations effectively.

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 relevant information regarding non-teratogenic effects is provided in the insert. Additionally, there is no relevant information available concerning nonclinical toxicology or animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has identified several important safety considerations associated with the use of this product.

Severe skin reactions, including symptoms such as skin reddening, blisters, and rash, have been reported in association with acetaminophen. In the event of a skin reaction, it is advised to discontinue use and seek medical assistance immediately.

Additionally, there is a risk of severe liver damage if the product is used inappropriately. This risk is heightened when exceeding 4,000 mg of acetaminophen within a 24-hour period, using other medications that contain acetaminophen, or consuming three or more alcoholic drinks daily while using this product.

The presence of an NSAID in this formulation raises concerns regarding severe stomach bleeding. The likelihood of such an event increases with prolonged use, higher dosages than recommended, a history of stomach ulcers or bleeding disorders, concurrent use of anticoagulants or steroids, age over 60, or the use of other NSAIDs, including aspirin, ibuprofen, or naproxen. Alcohol consumption of three or more drinks daily while using this product also elevates the risk.

Users are advised to discontinue use and consult a healthcare professional if any signs of an allergic reaction occur, or if symptoms indicative of stomach bleeding arise, such as feeling faint, experiencing bloody or black stools, vomiting blood, persistent stomach pain, tinnitus, new symptoms, redness or swelling, worsening pain lasting more than 10 days, or fever lasting more than three days.

In cases of accidental overdose, it is critical to seek medical help or contact a Poison Control Center immediately, as prompt medical attention is essential for both adults and children, even in the absence of noticeable signs or symptoms.

Patient Counseling

Healthcare providers should advise patients about the importance of seeking immediate medical assistance in the event of an accidental overdose. Patients should be informed to contact a Poison Control Center or seek medical help right away, as prompt medical attention is critical for both adults and children. It is essential to emphasize that even if no signs or symptoms are apparent, medical evaluation is necessary to ensure safety and appropriate care.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available upon request. 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, with specific dosing guidelines for different age groups. Adults and children aged 12 years and older are instructed to take 2 tablets every 6 hours, with a maximum of 8 tablets in a 24-hour period. For children under 12 years, it is advised to consult a doctor for appropriate dosing.

Clinicians should counsel patients regarding the use of this medication during pregnancy and breastfeeding, emphasizing the importance of consulting a health professional before use. It is particularly critical to avoid aspirin after 20 weeks of pregnancy unless directed by a physician, due to potential risks to the unborn child and complications during delivery. In the event of an accidental overdose, patients should seek immediate medical assistance or contact a Poison Control Center, as prompt intervention is essential 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.

View product document (PDF)