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 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. Each dose should be accompanied by a full glass of water to ensure proper administration.

For adults and children aged 12 years and older, the recommended dosage is 2 geltabs every 6 hours. It is imperative not to exceed a total of 8 geltabs within a 24-hour period.

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 other medications, 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 signs 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 and Stomach Warnings

The presence of acetaminophen in this product necessitates caution due to the risk of severe liver damage. This risk is heightened if the user exceeds 4,000 mg of acetaminophen within a 24-hour period, concurrently uses other medications containing acetaminophen, or consumes three or more alcoholic drinks daily while using this product.

Furthermore, the product contains a nonsteroidal anti-inflammatory drug (NSAID), which may increase the likelihood of severe stomach bleeding. This risk is particularly pronounced in individuals aged 60 or older, those with a history of stomach ulcers or bleeding problems, users of blood-thinning medications or steroids, and those who consume three or more alcoholic drinks daily while using this product. Caution is also advised for individuals taking other prescription or nonprescription NSAIDs, including aspirin, ibuprofen, or naproxen, and for those who exceed the recommended dosage or duration of use.

Caffeine Considerations

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

Emergency Situations

In the event of an overdose, it is crucial to seek emergency medical assistance or contact a Poison Control Center (1-800-222-1222) immediately. Prompt medical attention is essential for both adults and children, even if no signs or symptoms are initially apparent.

Discontinuation and Consultation

Users should discontinue use and consult a healthcare professional 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 or 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, which may indicate a serious condition.

Side Effects

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

Serious Adverse Reactions 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, medical consultation is recommended as these may be early signs of Reye's syndrome.

Severe allergic reactions may occur, particularly in patients sensitive to acetaminophen or aspirin. Symptoms of a severe skin reaction to acetaminophen may include skin reddening, blisters, and rash. If any of these symptoms develop, patients should discontinue use and seek immediate medical attention. Similarly, aspirin may cause severe allergic reactions characterized by hives, facial swelling, shock, or asthma (wheezing).

Patients should be aware of the risk of severe liver damage associated with acetaminophen, particularly if they exceed 4,000 mg in 24 hours, use other products containing acetaminophen, or consume three or more alcoholic drinks daily while using this product.

The product contains an NSAID, which may increase the risk of severe stomach bleeding, especially in patients aged 60 or older, those with a history of stomach ulcers or bleeding problems, or those taking anticoagulants, steroids, or other NSAIDs. Patients should be cautioned against exceeding the recommended dosage or duration of use, as well as against consuming three or more alcoholic drinks daily while using this product.

Common Adverse Reactions Patients may experience symptoms related to 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 experiencing persistent stomach pain), ringing in the ears or loss of hearing, redness or swelling in a painful area, worsening pain lasting more than 10 days, fever lasting more than 3 days, or any new symptoms that may suggest a serious condition.

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 warranted 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 those under 12 years of age, should not use this product unless directed by a healthcare professional. It is important to note that children and teenagers who have or are recovering from chickenpox or flu-like symptoms are at risk for Reye's syndrome and should avoid this product. 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 Reye’s syndrome, a rare but serious condition.

For patients aged 12 years and older, the recommended dosage is 2 geltabs every 6 hours, with a maximum of 8 geltabs in a 24-hour period.

Geriatric Use

Elderly patients, particularly those aged 60 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 signs of gastrointestinal bleeding and to evaluate the necessity of dosage adjustments based on individual patient factors. Careful assessment of the benefits and risks is essential in this population to ensure safe and effective use of the medication.

Pregnancy

Pregnant patients and women 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 to the unborn child and may lead to complications during delivery. Therefore, it is crucial that aspirin is only used in these circumstances if explicitly directed by a physician.

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 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 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 severity of symptoms may vary based on the specific substance involved in the overdose. Therefore, a thorough assessment and monitoring of the patient are essential.

Management of an overdose may include supportive care and symptomatic treatment, tailored to the individual’s clinical presentation. Continuous evaluation and appropriate interventions should be initiated as necessary to mitigate potential complications associated with the overdose.

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 relevant information is available regarding non-teratogenic effects. Additionally, there is no relevant information provided concerning nonclinical toxicology or animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has shown that acetaminophen may be associated with severe skin reactions, including skin reddening, blisters, and rash. Additionally, postmarketing data indicate that aspirin may lead to severe allergic reactions, which can manifest as hives, facial swelling, shock, and asthma symptoms such as wheezing. These events have been reported voluntarily or identified through surveillance programs.

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 proactive approach can significantly impact the outcome in such 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 aged 12 years and older are advised to take 2 geltabs every 6 hours, with a maximum of 8 geltabs in a 24-hour period. For children under 12 years, use should only occur if directed by a healthcare professional.

Clinicians should counsel patients regarding the use of the medication during pregnancy and breastfeeding. It is particularly important to avoid aspirin use after 20 weeks of pregnancy unless specifically directed by a healthcare provider, 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)