Headache Relief

Description

Best Choice Extra Strength Headache Relief is a formulation designed as a pain reliever and pain reliever aid. The product contains three active ingredients: acetaminophen, aspirin (a nonsteroidal anti-inflammatory drug), and caffeine. It is packaged in a bottle containing 100 tablets. The product features a tamper-evident safety seal, and it should not be used if the seal under the cap is broken or missing. Best Choice Extra Strength Headache Relief is distributed by Associated Wholesale Grocers, Inc., located in Kansas City, Kansas 66106. For additional product information, customers may visit the website at www.bestchoicebrand.com or contact customer service at 1-844-292-1112.

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 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 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, 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.

Aspirin may induce severe allergic reactions, which can manifest as shock, facial swelling, hives, or asthma symptoms such as wheezing. Similarly, acetaminophen may lead to severe skin reactions, including skin reddening, blisters, or rash. In the event of a skin reaction, the use of the product should be discontinued, and medical assistance should be sought without delay.

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 taking other NSAIDs (prescription or nonprescription), anticoagulants, or steroid medications, individuals with a history of stomach ulcers or bleeding problems, and those who consume three or more alcoholic drinks daily while using this product. It is also important to adhere to the recommended dosage and duration of use to minimize risks.

Caffeine is present in the recommended dose of this product, approximately equivalent to that found in a cup of coffee. Users should 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.

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 considerations include high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or if they are taking a diuretic.

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

Patients should discontinue use and contact a healthcare provider if they experience any allergic reactions, signs 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 the emergence of new symptoms, as these may indicate a serious condition.

Side Effects

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

Warnings Reye’s syndrome is a rare but serious illness that may occur in children and teenagers who have or are recovering from chicken pox 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 essential to consult a doctor, as these may be early signs of Reye's syndrome.

An allergy alert is warranted for both aspirin and acetaminophen, as they may cause severe allergic reactions. Symptoms of an allergic reaction to aspirin may include shock, facial swelling, hives, and asthma (wheezing). For acetaminophen, severe skin reactions can occur, presenting as skin reddening, blisters, or rash. If any skin reaction occurs, patients should stop use and seek medical help immediately.

Liver and Stomach Bleeding Warnings This product contains acetaminophen, and severe liver damage may occur if patients exceed 4,000 mg of acetaminophen in 24 hours, use it in conjunction with other drugs containing acetaminophen, or consume three or more alcoholic drinks daily while using this product. Additionally, the product contains an NSAID, which may increase the risk of severe stomach bleeding, particularly in patients aged 60 or older, those taking other NSAIDs (prescription or nonprescription), blood thinners, or steroid drugs, individuals with a history of stomach ulcers or bleeding problems, and those who take more than directed or for an extended period.

Caffeine Warning The recommended dose of this product contains approximately the same amount of caffeine as a cup of coffee. Patients are advised to limit the use of other caffeine-containing medications, foods, or beverages while taking this product, as excessive caffeine intake may lead to nervousness, irritability, sleeplessness, and, occasionally, rapid heart rate.

Stop Use and Consult a Doctor Patients should stop use and seek medical advice if an allergic reaction occurs. Additionally, they should consult a doctor if they experience any signs of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or experiencing stomach pain that does not improve. Other symptoms warranting medical consultation include ringing in the ears or loss of hearing, worsening pain lasting more than 10 days, fever that worsens or lasts more than three days, redness or swelling, or the emergence of new symptoms, as these could indicate a serious condition.

Drug Interactions

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

The concomitant administration of this product with other nonsteroidal anti-inflammatory drugs (NSAIDs), including aspirin, ibuprofen, and naproxen, increases the risk of severe gastrointestinal bleeding. Caution is advised when using this product alongside anticoagulants or steroid medications, as these combinations also elevate the risk of serious stomach bleeding.

Patients are advised to limit the intake of caffeine-containing medications, foods, or beverages while using this product. Excessive caffeine consumption may lead to adverse effects such as nervousness, irritability, insomnia, and, in some cases, tachycardia.

Prior to initiating therapy with this product, individuals taking prescription medications for diabetes, gout, or arthritis should consult with a healthcare professional to assess potential interactions and necessary adjustments in therapy.

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 and 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, it is advised to consult a doctor before use.

This product should be kept out of reach of children. In the event of an accidental overdose, immediate medical assistance should be sought, or contact a Poison Control Center right away, as prompt medical attention is critical for both adults and children, even if no signs or symptoms are apparent.

Geriatric Use

Elderly patients may be at an increased risk for severe stomach bleeding when using this product, as it contains a nonsteroidal anti-inflammatory drug (NSAID). The likelihood of experiencing such adverse effects is notably higher in individuals aged 60 years and older.

Healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to closely monitor these patients for any signs of gastrointestinal bleeding and to consider appropriate dose adjustments based on individual patient factors.

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 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 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 per day while using this product may further increase the risk of liver damage.

Before using this product, 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 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 are advised to remain vigilant and proactive in managing potential overdose situations. Early intervention can significantly impact the outcome, making it essential to act swiftly and follow established protocols for overdose management.

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 have been identified in the available data. Additionally, there are no details regarding nonclinical toxicology or animal pharmacology and toxicology provided in the text.

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 the event of a skin reaction, it is advised to discontinue use and seek medical assistance immediately.

The product contains acetaminophen, which carries 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 concerns regarding severe stomach bleeding. The risk is heightened in individuals aged 60 or older, those taking other NSAIDs (including aspirin, ibuprofen, or naproxen), patients on blood thinners or steroids, individuals consuming three or more alcoholic drinks daily, those with a history of stomach ulcers or bleeding problems, and those who exceed the recommended dosage or duration of use.

Caffeine content is comparable to that of a cup of coffee, and users are advised to limit the intake of other caffeine-containing products to avoid potential side effects such as nervousness, irritability, sleeplessness, and, occasionally, rapid heartbeat.

Users are instructed to discontinue use and consult a healthcare professional if any signs of an allergic reaction occur or if symptoms indicative of stomach bleeding arise, including feeling faint, vomiting blood, having bloody or black stools, experiencing persistent stomach pain, or noticing ringing in the ears or hearing loss. Additional symptoms warranting medical attention include worsening pain or fever lasting more than three days, redness or swelling, and the emergence of new symptoms.

In cases of accidental overdose, immediate medical help or contact with a Poison Control Center is essential, as prompt attention is critical 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, regardless of whether they observe any signs or symptoms. It is crucial for both adults and children to receive prompt medical attention to mitigate potential risks associated with overdose.

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 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, consultation with a doctor is recommended before administration.

Clinicians should counsel patients regarding the use of this medication during pregnancy and breastfeeding. It is crucial to seek advice from a health professional if pregnant, particularly after 20 weeks of gestation, due to potential risks to the unborn child and complications during delivery. In the event of an accidental overdose, patients must 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)