Headache Relief

Description

Acetaminophen, 250 mg, is a non-opioid analgesic and antipyretic agent. Aspirin, 250 mg, is a nonsteroidal anti-inflammatory drug (NSAID) that provides analgesic, antipyretic, and anti-inflammatory effects. Caffeine, 65 mg, is a central nervous system stimulant that may enhance the analgesic effects of acetaminophen and aspirin. The formulation is presented in GELTABS dosage form, which offers a smooth and easy-to-swallow option.

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, 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. For adults and children aged 12 years and older, the prescribed dosage is 2 geltabs every 6 hours, with a maximum limit of 8 geltabs within a 24-hour period. It is essential to consume a full glass of water with each dose to ensure proper administration.

For children under 12 years of age, the use of this medication is not advised unless specifically directed by a healthcare professional.

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 another 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, as these may be early indicators of Reye's syndrome.

Allergy Alerts

This product contains acetaminophen, which may lead to severe skin reactions. Symptoms of such reactions can include skin reddening, blisters, and rash. Should any skin reaction occur, the use of the product must be discontinued, and medical assistance should be sought without delay.

Additionally, aspirin, another component of this product, may provoke a severe allergic reaction characterized by hives, facial swelling, shock, or asthma (wheezing). Immediate medical attention is warranted if any of these symptoms manifest.

Liver Warning

The presence of acetaminophen in this product necessitates caution, as severe liver damage can occur under certain conditions. Specifically, individuals should not exceed 4,000 mg of acetaminophen within a 24-hour period, should avoid concurrent use with other medications containing acetaminophen, and should limit alcohol consumption to fewer than three drinks per day while using this product.

Stomach Bleeding Warning

This product contains a nonsteroidal anti-inflammatory drug (NSAID), which carries a risk of severe stomach bleeding. The likelihood of this adverse effect is heightened in individuals aged 60 or older, those with a history of stomach ulcers or bleeding problems, and those taking anticoagulants or steroid medications. Caution is also advised for individuals using other NSAIDs, including aspirin, ibuprofen, or naproxen, and for those consuming three or more alcoholic drinks daily while using this product. It is crucial to adhere to the recommended dosage and duration of use to mitigate these risks.

Caffeine Warning

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

Emergency Medical Help

In the event of an overdose, immediate medical assistance should be sought, or contact a Poison Control Center (1-800-222-1222) without delay. Prompt medical attention is critical for both adults and children, even in the absence of noticeable signs or symptoms.

Discontinuation of Use

Patients should stop using this product and consult a healthcare provider if any of the following occur: an allergic reaction; signs of stomach bleeding such as feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain; ringing in the ears or loss of hearing; redness and swelling in a painful area; worsening pain lasting more than 10 days; fever that worsens or persists for more than three days; or the emergence of any new symptoms. These may indicate a serious condition requiring medical evaluation.

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. 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.

Severe skin reactions have been reported in patients using acetaminophen, which is an ingredient in this product. Symptoms may include skin reddening, blisters, and rash. If any of these symptoms occur, patients should discontinue use and seek medical assistance promptly.

Aspirin, another component of this product, may lead to severe allergic reactions. Symptoms of such reactions can include hives, facial swelling, shock, and asthma (wheezing). Patients experiencing any signs of an allergic reaction should stop using the product and seek immediate medical help.

The product contains acetaminophen, which poses a risk of severe liver damage if patients exceed 4,000 mg in 24 hours, use it in conjunction with other acetaminophen-containing medications, or consume three or more alcoholic drinks daily while using this product.

Additionally, the presence of an NSAID in this formulation raises the risk of severe stomach bleeding, particularly in patients aged 60 or older, those with a history of stomach ulcers or bleeding problems, or those taking anticoagulants, steroids, or other NSAIDs. The risk is further increased if patients consume three or more alcoholic drinks daily or exceed the recommended dosage.

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 consult a doctor if they experience any signs of an allergic reaction, symptoms indicative of stomach bleeding (such as feeling faint, vomiting blood, having bloody or black stools, or persistent stomach pain), ringing in the ears or loss of hearing, redness and swelling in a painful area, worsening pain lasting more than 10 days, fever lasting more than 3 days, or any new symptoms. These could be indicative of a serious condition requiring medical attention.

Drug Interactions

Co-administration of this product with other medications containing acetaminophen, whether prescription or nonprescription, is not recommended due to the potential for increased risk of adverse effects.

When used concurrently with anticoagulants or steroid medications, there is an elevated risk of severe gastrointestinal bleeding. It is advisable to monitor patients closely for signs of bleeding and consider dosage adjustments as necessary.

The concomitant use of this product with other nonsteroidal anti-inflammatory drugs (NSAIDs), including aspirin, ibuprofen, and naproxen, also heightens the risk of stomach bleeding. Clinicians should exercise caution and may need to adjust dosages or implement additional monitoring for patients receiving these combinations.

No specific interactions with laboratory tests have been identified in the available data.

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 under 12 years of age should not use this product unless directed by a healthcare professional. For adolescents aged 12 years and older, the recommended dosage is 2 geltabs every 6 hours, with a maximum of 8 caplets in a 24-hour period.

Healthcare professionals should be aware that children and teenagers who have or are recovering from chicken pox or flu-like symptoms should avoid using 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 important to consult a doctor, as these symptoms may indicate the onset of Reye’s syndrome, a rare but serious condition.

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 who are concurrently using blood-thinning medications (anticoagulants) or steroid drugs, 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, especially if they consume three or more alcoholic drinks daily while using the medication. It is essential to monitor these patients closely for any signs of gastrointestinal bleeding and to consider dose modifications or alternative therapies as appropriate. Additionally, patients should be advised to adhere strictly to the recommended dosage and duration of use to minimize the risk of adverse effects.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional before using this medication. It is particularly important to avoid the use of aspirin after 20 weeks of pregnancy unless specifically directed by a physician, as it may pose risks to the developing fetus and lead to complications during delivery. Healthcare providers should carefully evaluate the potential benefits and risks when considering the use of this medication in pregnant patients.

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, nor should they use this product in conjunction with other medications containing acetaminophen. Additionally, consumption of three or more alcoholic drinks daily while using this product may further increase the risk of liver damage.

Before initiating treatment, 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 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 timely recognition and management of overdose situations can significantly impact patient outcomes. Therefore, it is essential to remain vigilant and proactive in addressing potential overdose cases.

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 non-teratogenic effects have been specified. Additionally, there are no details provided regarding nonclinical toxicology or animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions associated with the use of the medications. Reports indicate occurrences of severe skin reactions, which include skin reddening, blisters, and rash linked to acetaminophen. Additionally, severe allergic reactions have been reported in association with aspirin, manifesting as hives, facial swelling, shock, and asthma (wheezing). These events were reported voluntarily or through surveillance programs and are documented for ongoing safety monitoring.

Patient Counseling

Healthcare providers should advise patients on 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. It is crucial to emphasize that prompt medical attention is necessary for both adults and children, even if they do not exhibit any signs or symptoms of overdose. This information is vital for ensuring patient safety and effective management of potential overdose situations.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at a controlled room temperature, specifically between 20ºC and 25ºC (68ºF and 77ºF). Proper storage conditions are crucial to maintain the integrity and efficacy of the product.

Additional Clinical Information

Patients should be aware that the medication is administered orally. For adults and children aged 12 years and older, the recommended dosage is 2 geltabs every 6 hours, with a maximum of 8 caplets in a 24-hour period. For children under 12 years, use is not advised unless directed by a healthcare professional.

Clinicians should counsel patients who are pregnant or breastfeeding to consult a health professional before use. It is particularly important to avoid aspirin after 20 weeks of pregnancy unless specifically directed by a doctor, as it may pose risks to the unborn child or lead to complications during delivery. In the event of an overdose, patients should seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222, as prompt attention is crucial for both adults and children, even in the absence 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)