Headache Relief

Description

No description information is available for the drug.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with various conditions, including colds, headaches, arthritis, muscular aches, toothaches, 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 caplets every 6 hours, with a maximum limit of 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 any pain reliever or fever reducer. 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 a 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.

Aspirin may induce severe allergic reactions, which can manifest as hives, shock, facial swelling, or asthma symptoms such as wheezing. Similarly, acetaminophen has the potential to cause severe skin reactions, including rash, blisters, and skin reddening. In the event of a skin reaction, it is crucial to discontinue use and seek medical assistance without delay.

This product contains acetaminophen, and caution is warranted due to the risk of severe liver damage. Such damage may occur if more than 4,000 mg of acetaminophen is ingested within a 24-hour period, if three or more alcoholic beverages are consumed daily while using this product, or if it is taken concurrently with other medications containing acetaminophen.

The presence of an NSAID in this product raises the risk of severe stomach bleeding, particularly in individuals aged 60 or older, those with a history of stomach ulcers or bleeding problems, and those taking anticoagulants or steroid medications. The risk is also heightened for individuals taking other NSAIDs (including aspirin, ibuprofen, or naproxen), exceeding the recommended dosage, or consuming three or more alcoholic drinks daily while using this product.

Caffeine is also a component of the recommended dose, which is comparable to that found in a cup of coffee. Therefore, it is advisable to limit the intake of other caffeine-containing medications, foods, or beverages to avoid potential side effects such as 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, asthma, a history of stomach problems (such as heartburn), or if the stomach bleeding warning applies. Additionally, individuals taking diuretics, or those with high blood pressure, heart disease, liver cirrhosis, or kidney disease should seek medical advice. Patients on prescription medications for diabetes, gout, or arthritis should also consult a healthcare provider or pharmacist before use.

In the event of an overdose, immediate medical attention is essential. Patients should contact a Poison Control Center or seek emergency medical help right away, as prompt intervention is critical for both adults and children, even in the absence of noticeable signs or symptoms.

Patients are advised to discontinue use and contact 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, redness or swelling, worsening pain lasting more than 10 days, fever lasting more than 3 days, or any new symptoms that arise.

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 condition 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.

Aspirin, one of the components of this product, may cause severe allergic reactions, which can manifest as hives, shock, facial swelling, or asthma (wheezing). Additionally, acetaminophen may lead to severe skin reactions, including rash, blisters, and skin reddening. In the event of a skin reaction, patients are advised to discontinue use and seek medical assistance promptly.

The product contains acetaminophen, which poses a risk of severe liver damage if patients exceed 4,000 mg in a 24-hour period, consume three or more alcoholic drinks daily while using the product, or take other medications containing acetaminophen concurrently.

Furthermore, the presence of an NSAID in this product raises the risk of severe stomach bleeding, particularly in patients who are 60 years or older, have a history of stomach ulcers or bleeding problems, are taking anticoagulants or steroid drugs, or are using other NSAIDs. Patients should be cautious if they consume three or more alcoholic drinks daily while using this product or if they take it for longer than directed.

Caffeine is also included in the recommended dose, which is comparable to that found in a cup of coffee. Patients 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.

Patients are advised to stop using the product and seek medical attention 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 loss of hearing, redness or swelling, worsening pain lasting more than 10 days, fever lasting more than three days, or any new symptoms.

Before using this product, patients should consult a doctor if they have liver disease, asthma, a history of stomach problems (such as heartburn), are taking diuretics, or have high blood pressure, heart disease, liver cirrhosis, or kidney disease. Additionally, patients should seek advice from a doctor or pharmacist if they are taking prescription medications for diabetes, gout, or arthritis.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there are no known interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are necessary at this time.

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

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. Healthcare professionals are advised to consult a doctor if any changes in behavior accompanied by nausea and vomiting occur, as these may be early indicators of Reye's syndrome.

For dosing, adults and children aged 12 years and older are instructed 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 recommended to consult a doctor for appropriate dosing guidance.

It is essential to keep this product out of reach of children. In the event of an overdose, immediate medical assistance should be sought, or contact a Poison Control Center without delay. 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, are at an increased risk of severe stomach bleeding when using this product, which contains a nonsteroidal anti-inflammatory drug (NSAID). This risk is further heightened in individuals with a history of stomach ulcers or bleeding problems, those concurrently using blood thinners (anticoagulants) or steroid medications, and patients taking other NSAIDs, whether prescription or over-the-counter, such as aspirin, ibuprofen, or naproxen.

Healthcare providers should exercise caution when prescribing this product to geriatric patients, ensuring that they do not exceed the recommended dosage or duration of use. Additionally, it is advisable to monitor these patients closely, especially if they consume three or more alcoholic drinks daily while using this medication, as this can further elevate the risk of gastrointestinal complications.

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 gestation 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 be closely monitored when using this product, as it contains acetaminophen, which poses a risk of severe liver damage. It is critical that patients do not exceed 4,000 mg of acetaminophen in a 24-hour period, as exceeding this dosage can lead to significant hepatic injury. Additionally, patients should avoid consuming three or more alcoholic drinks daily while using this product, as this can further increase the risk of liver damage.

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. This precaution is essential to ensure safe use and to determine any necessary dosage adjustments or additional monitoring requirements based on individual liver function.

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, regardless of whether any signs or symptoms are apparent.

Healthcare professionals should be aware that the absence of symptoms does not preclude the possibility of serious complications arising from an overdose. Therefore, it is essential to monitor the patient closely and provide appropriate care as needed.

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 or additional nonclinical toxicology details are available in the provided data. Furthermore, there are no specific findings related to animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has shown that acetaminophen may be associated with severe skin reactions. Reported symptoms include rash, blisters, and skin reddening. Additionally, postmarketing data indicate that aspirin may lead to severe allergic reactions, which can manifest as hives, shock, facial swelling, and asthma symptoms such as wheezing.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical help or contact a Poison Control Center in the event of an overdose, as prompt medical attention is critical for both adults and children, even if no signs or symptoms are initially present.

Patients should be informed not to use this medication if they have ever experienced an allergic reaction to any other pain reliever or fever reducer. It is also important to counsel patients against using this medication in conjunction with any other drug that contains acetaminophen, whether prescription or nonprescription. If patients are uncertain whether a drug contains acetaminophen, they should be encouraged to consult a doctor or pharmacist.

Patients should be instructed to stop using the medication and seek medical advice if they experience any signs of an allergic reaction. Immediate medical attention is necessary if symptoms such as feeling faint, having bloody or black stools, vomiting blood, or experiencing persistent stomach pain occur, as these may indicate stomach bleeding.

Additionally, patients should be advised to discontinue use and consult a doctor if they experience ringing in the ears, loss of hearing, redness, or swelling. They should also be informed to seek medical advice if their pain worsens or lasts longer than 10 days, if their fever worsens or persists for more than 3 days, or if any new symptoms arise.

Before initiating treatment, patients should be encouraged to consult a doctor if they have liver disease, asthma, or if the warning regarding stomach bleeding applies to them. Those with a history of stomach problems, such as heartburn, or who are taking a diuretic should also seek medical advice prior to use. Furthermore, patients with high blood pressure, heart disease, liver cirrhosis, or kidney disease should be advised to consult a doctor before using this medication. Lastly, patients taking prescription drugs for diabetes, gout, or arthritis should be encouraged to speak with a doctor or pharmacist before use.

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 tracking and usage. Special handling requirements are not specified; however, adherence to the recommended storage conditions is essential for maintaining product integrity.

Additional Clinical Information

The medication is administered orally. Clinicians should advise patients who are pregnant or breastfeeding to consult a health professional prior to use. It is particularly crucial to avoid the use of aspirin at 20 weeks of gestation or later unless specifically 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)