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 the common cold, headache, 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 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 drug 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, a component of this product, may lead to severe allergic reactions, which can manifest as hives, shock, facial swelling, or asthma symptoms such as wheezing. Similarly, acetaminophen may cause severe skin reactions, including rash, blisters, and skin reddening. In the event of a skin reaction, 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, consuming three or more alcoholic drinks daily while using this product, or using other medications that contain acetaminophen concurrently.

Additionally, the product contains a nonsteroidal anti-inflammatory drug (NSAID), which may increase the risk of severe stomach bleeding, particularly in individuals aged 60 or older, those with a history of stomach ulcers or bleeding problems, or those taking anticoagulants, steroids, or other NSAIDs (including aspirin, ibuprofen, or naproxen). The risk is further heightened with excessive alcohol consumption or prolonged use beyond the recommended duration.

Caffeine is also present in the recommended dose of this product, approximately equivalent to that found in a cup of coffee. It is advisable to limit the intake of other caffeine-containing medications, foods, or beverages while using this product, as excessive caffeine 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, if they have a history of stomach issues such as heartburn, if they are taking diuretics, or if they have conditions such as high blood pressure, heart disease, liver cirrhosis, or kidney disease. Patients with asthma should also seek medical advice before use. Furthermore, it is recommended to consult a doctor or pharmacist if the patient is taking prescription medications for diabetes, gout, or arthritis.

In the event of an overdose, immediate medical assistance should be sought, or contact with a Poison Control Center is essential. Prompt medical attention is critical 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 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 or loss of hearing, worsening pain lasting more than 10 days, fever that worsens or persists for more than three days, redness or swelling, or the emergence of any new symptoms.

Side Effects

Patients using this product may experience a range of adverse reactions, some of which can be serious.

Serious adverse reactions include the risk of Reye’s syndrome, particularly in children and teenagers who have or are recovering from chickenpox or flu-like symptoms. If patients exhibit changes in behavior accompanied by nausea and vomiting, they should consult a doctor immediately, as these may be early signs of this rare but serious illness.

Allergic reactions can occur with the use of this product. Patients should be aware that aspirin may cause severe allergic reactions, which can manifest as hives, shock, facial swelling, or asthma (wheezing). Similarly, 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 carries a liver warning. Severe liver damage may occur if patients exceed 4,000 mg of acetaminophen in a 24-hour period, consume three or more alcoholic drinks daily while using the product, or take other medications containing acetaminophen concurrently.

Additionally, 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 blood thinners or steroid drugs, consume three or more alcoholic drinks daily, or use other NSAIDs.

Patients should also be cautious regarding 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 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, loss of hearing, worsening pain lasting more than 10 days, fever lasting more than 3 days, redness or swelling, or any new symptoms.

Before using this product, patients should consult a doctor if they have liver disease, 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 taking prescription medications for diabetes, gout, or arthritis should seek advice from a doctor or pharmacist prior to use.

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 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. Healthcare professionals should advise that if any changes in behavior accompanied by nausea and vomiting occur while using this product, a doctor should be consulted, as these may be early signs of this rare but serious illness.

For dosing, adults and children aged 12 years and older 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 recommended to consult a doctor before use.

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.

It is essential for geriatric patients to consult with a healthcare provider prior to using this product, particularly if they have pre-existing conditions such as high blood pressure, heart disease, liver cirrhosis, or kidney disease. Close monitoring and appropriate dose adjustments may be necessary to ensure safety and efficacy in this population.

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 the unborn child and complications during delivery. Therefore, it is crucial that pregnant patients only use aspirin under the guidance of a qualified 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 at 20 weeks of pregnancy or later unless specifically directed by a doctor, 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. Additionally, consumption of three or more alcoholic drinks daily while using this product is contraindicated, as it may exacerbate the risk of liver injury.

Patients with known liver disease, high blood pressure, heart disease, liver cirrhosis, or kidney disease are advised to consult a healthcare professional prior to use. Monitoring of liver function may be warranted in these patients to ensure safety and efficacy while using this product.

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 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 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 provided in the available data. Furthermore, there are no specific findings related to animal pharmacology and toxicology mentioned.

Postmarketing Experience

Postmarketing experience has identified rare cases of severe skin reactions associated with acetaminophen, including rash, blisters, and skin reddening. Additionally, reports of allergic reactions to aspirin have been documented, which may manifest as hives, shock, facial swelling, and asthma (wheezing). Instances of Reye's syndrome have been reported in children and teenagers who have used this product during or after chickenpox or flu-like symptoms.

Furthermore, postmarketing reports indicate occurrences of liver damage associated with the use of acetaminophen, particularly in cases of overdose or concurrent use with alcohol. There have also been reports of gastrointestinal bleeding linked to the use of NSAIDs, including aspirin, especially in patients with a history of ulcers or those concurrently using anticoagulants.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance 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 apparent.

Patients should be informed not to use this medication if they have a history of allergic reactions to any other pain reliever or fever reducer. It is also essential to counsel patients against using this medication in conjunction with any other drug containing acetaminophen, whether prescription or nonprescription. If patients are uncertain about the presence of acetaminophen in their medications, they should be encouraged to consult a doctor or pharmacist.

Patients must be instructed to discontinue use and consult a doctor if they experience any signs of an allergic reaction or if they notice any of the following symptoms indicative of stomach bleeding: feeling faint, having bloody or black stools, vomiting blood, or experiencing persistent stomach pain. Additionally, patients should be advised to stop use and seek medical advice if they experience ringing in the ears, loss of hearing, worsening pain that lasts longer than 10 days, a fever that worsens or persists for more than 3 days, redness or swelling, or any new symptoms.

Healthcare providers should recommend that patients consult a doctor before using this medication if they have liver disease, a history of stomach problems such as heartburn, or if the stomach bleeding warning applies to them. Patients taking diuretics, those with high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma should also be advised to seek medical guidance prior to use. Furthermore, patients taking prescription medications for diabetes, gout, or arthritis should be encouraged to discuss their current medications with a doctor or pharmacist before using this product.

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 25ºC (77ºF), with permissible excursions between 15°-30°C (59°-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. 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 after 20 weeks of pregnancy 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)