Headache Relief

Description

Acetaminophen, Aspirin (NSAID), and Caffeine are the active ingredients in this formulation. The product is packaged in a total of 25 pouches, with each pouch containing 2 caplets.

Uses and Indications

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

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

Dosage and Administration

Patients should adhere strictly to the recommended dosage. For adults and children aged 12 years and older, the prescribed dosage is 2 tablets every 6 hours, with a maximum limit of 8 tablets within a 24-hour period. It is essential that each dose is accompanied by a full glass of water to ensure proper administration and absorption.

For children under the age of 12, 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 other medications, consultation with a healthcare professional is advised.

Warnings and Precautions

Children and teenagers who have or are recovering from chickenpox or flu-like symptoms should not use this product. If any changes in behavior accompanied by nausea and vomiting occur during use, it is imperative to consult a physician, as these symptoms may indicate the onset of Reye's syndrome, a rare but serious condition.

Aspirin, a component of this product, has the potential to cause severe allergic reactions, which may manifest as hives, facial swelling, asthma (wheezing), or shock.

This product contains acetaminophen, and caution is warranted to prevent severe liver damage. The risk of liver injury increases if an adult exceeds 8 tablets within a 24-hour period, if a child takes more than 5 tablets in the same timeframe, if it is used concurrently with other acetaminophen-containing medications, or if the individual consumes 3 or more alcoholic drinks daily while using this product.

Additionally, this product contains a nonsteroidal anti-inflammatory drug (NSAID), which may lead to severe stomach bleeding. The risk is heightened in individuals who are 60 years of age or older, have a history of stomach ulcers or bleeding disorders, are taking anticoagulants or steroid medications, are using other NSAIDs (including aspirin, ibuprofen, or naproxen), consume 3 or more alcoholic beverages daily, or exceed the recommended dosage or duration of use.

The recommended dosage of this product contains approximately the same amount of caffeine as a standard cup of coffee. Therefore, it is advisable to limit the intake of other caffeine-containing medications, foods, or beverages while using this product, as excessive caffeine consumption may result in nervousness, irritability, sleeplessness, and, in some cases, rapid heartbeat.

Healthcare professionals should advise patients to consult a physician prior to use if they have liver disease, if the stomach bleeding warning is applicable, if they have not been adequately hydrated, if they have a history of gastrointestinal issues such as heartburn, or if they have conditions such as high blood pressure, heart disease, liver cirrhosis, or kidney disease. Patients taking diuretics, those with asthma, or individuals who have experienced significant fluid loss due to vomiting or diarrhea should also seek medical advice before use.

Furthermore, it is essential to consult a doctor or pharmacist before using this product if the patient is taking any other NSAIDs (whether prescription or over-the-counter), anticoagulants, steroid medications, or prescription drugs for diabetes, gout, or arthritis, or if they are under medical care for any serious condition.

In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center (1-800-222-1222) should be contacted. 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 physician if they experience any signs of an allergic reaction, such as hives or swelling, or if they exhibit symptoms indicative of stomach bleeding, including feeling faint, vomiting blood, passing bloody or black stools, experiencing persistent stomach pain, or noticing ringing in the ears or loss of hearing. Additional reasons to stop use include the presence of redness or swelling in a painful area, worsening pain lasting more than 10 days, a fever that worsens or persists for more than 3 days, or the emergence of any new symptoms.

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. 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 healthcare professional, as these may be early signs of Reye's syndrome.

Severe allergic reactions to aspirin can occur, presenting as hives, facial swelling, asthma (wheezing), or shock. 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 the maximum daily dosage is exceeded. Specifically, adults should not take more than 8 tablets in 24 hours, and children should not exceed 5 tablets in the same timeframe. The risk of liver damage increases when this product is taken with other medications containing acetaminophen or when consumed with three or more alcoholic drinks daily.

Additionally, the product contains a nonsteroidal anti-inflammatory drug (NSAID), which may lead to severe stomach bleeding. The likelihood of this adverse reaction is heightened in patients aged 60 or older, those with a history of stomach ulcers or bleeding problems, individuals taking anticoagulants or steroid medications, and those consuming three or more alcoholic drinks daily while using this product. Patients should also be cautious if they take other NSAIDs, whether prescription or over-the-counter, and should adhere strictly to the recommended dosage.

Caffeine is another component of this product, and patients should limit their intake of other caffeine-containing medications, foods, or beverages. Excessive caffeine consumption may result in nervousness, irritability, sleeplessness, and, in some cases, rapid heartbeat.

Patients are advised to discontinue use and consult a healthcare provider if they experience any signs of an allergic reaction, symptoms indicative of stomach bleeding (such as feeling faint, vomiting blood, or having bloody or black stools), or if they notice any new or worsening symptoms.

Before using this product, patients should consult a doctor if they have liver disease, a history of stomach problems, high blood pressure, heart disease, liver cirrhosis, kidney disease, or if they are taking diuretics. Additionally, those who have lost significant fluids due to vomiting or diarrhea or have asthma should seek medical advice prior to use.

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 should be carefully considered when this medication is used alongside other nonsteroidal anti-inflammatory drugs (NSAIDs), whether prescription or nonprescription. It is advisable for patients to consult a healthcare professional prior to use if they are currently taking any NSAID to mitigate the risk of additive adverse effects.

Additionally, caution is warranted when this medication is used in conjunction with anticoagulants or steroid medications. Patients are advised to seek medical guidance before initiating therapy if they are on blood thinners or steroids, as these combinations may increase the risk of bleeding or other complications.

Patients taking prescription medications for diabetes, gout, or arthritis should also consult a healthcare provider before using this medication. This is to ensure safe and effective management of their underlying conditions while minimizing the risk of potential drug interactions.

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

Pediatric patients, particularly children and teenagers, should not use this product if they have or are recovering from chicken pox or flu-like symptoms due to the risk of Reye's syndrome. It is important to consult a healthcare professional if any changes in behavior accompany nausea and vomiting, as these may indicate the onset of Reye's syndrome.

For children under 12 years of age, it is advised to seek medical guidance before use. For those aged 12 years and older, the recommended dosage is 2 tablets every 6 hours, with a maximum of 8 tablets within a 24-hour period. Caution is warranted, as exceeding 5 tablets in a 24-hour period may lead to severe liver damage.

Geriatric Use

Elderly patients, particularly those aged 60 years and older, may have an increased risk of severe stomach bleeding. Healthcare providers should exercise caution when prescribing this medication to geriatric patients, considering the potential for heightened adverse effects.

It is advisable to closely monitor elderly patients for any signs of gastrointestinal bleeding and to evaluate the necessity of dosage adjustments based on individual patient factors. Careful assessment of the risk-benefit ratio is essential in this population to ensure safe and effective use of the medication.

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 physician.

Lactation

Lactating mothers are advised to consult a health professional prior to 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 while breastfeeding.

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 consult a healthcare professional prior to using this product, particularly if they have a history of liver disease. The formulation contains acetaminophen, which poses a risk of severe liver damage under certain conditions.

For adults, the maximum recommended dosage is 8 tablets within a 24-hour period. Exceeding this limit may significantly increase the risk of liver injury. In pediatric patients, the maximum dosage is limited to 5 tablets in a 24-hour period.

Additionally, patients should be cautious when using this product in conjunction with other medications that contain acetaminophen, as this can lead to unintentional overdose and subsequent liver damage.

Consumption of 3 or more alcoholic beverages daily while using this product is also contraindicated, as it may exacerbate the risk of liver toxicity. Regular monitoring of liver function may be warranted in patients with compromised liver function who require acetaminophen, and healthcare providers should evaluate the necessity of alternative pain management strategies in these individuals.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222. 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 comprehensive care as needed.

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 to keep the medication out of reach of children to prevent accidental ingestion. It is essential to emphasize the importance of seeking immediate medical assistance in the event of an overdose. Patients should be informed to contact a Poison Control Center at 1-800-222-1222 without delay. Quick medical attention is critical for both adults and children, even if no signs or symptoms of overdose are apparent.

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). Temporary excursions are permissible between 15-30 °C (59-86 °F). Proper storage conditions are essential 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 instructed to take 2 tablets every 6 hours, with a maximum of 8 tablets within a 24-hour period. For children under 12 years, it is recommended to consult a doctor for appropriate dosing.

Clinicians should advise patients who are pregnant or breastfeeding to seek guidance from a health professional prior to use. It is particularly critical to avoid aspirin during the last trimester of pregnancy unless explicitly directed by a physician, as it may pose risks to the unborn child or lead to complications during delivery.

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)