Headache Relief

Description

This formulation is designed for headache relief and contains a combination of active ingredients comparable to those found in Excedrin® Extra Strength. The product features Acetaminophen, an analgesic and antipyretic; Aspirin, a nonsteroidal anti-inflammatory drug (NSAID) that also serves as a pain reliever; and Caffeine, which acts as a pain reliever aid. The dosage form is presented in GELTABS.

The product is distributed by Old East Main Co., located at 100 Mission Ridge, Goodlettsville, TN 37072. It is important to note that this product is not manufactured or distributed by GSK Consumer Healthcare, the distributor of Excedrin® Extra Strength. The packaging includes a tamper-evident safety seal; the product should not be used if the seal under the cap is broken or missing. Users are advised to retain the outer carton for complete warnings and product information.

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, with a maximum limit of 8 geltabs within a 24-hour period.

For children under 12 years of age, the use of this medication is not advised unless 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 indicators of this condition.

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 may occur under certain conditions. Specifically, this risk increases if more than 4,000 mg of acetaminophen is consumed within a 24-hour period, if it is taken concurrently with other medications containing acetaminophen, or if the individual consumes three or more alcoholic drinks daily while using this product.

Stomach Bleeding Warning This product also contains a nonsteroidal anti-inflammatory drug (NSAID), which may elevate the 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 advised for individuals using other NSAIDs (including aspirin, ibuprofen, or naproxen) or consuming three or more alcoholic drinks daily while using this product. It is also critical to adhere to the recommended dosage and duration of use.

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 during treatment, 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 crucial for both adults and children, even if no signs or symptoms are initially apparent.

Discontinuation of Use Patients are advised to stop using this product and consult a healthcare professional if any of the following occur: an allergic reaction, new symptoms, 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 hearing loss, worsening pain lasting more than 10 days, fever that worsens or persists for more than three days, or if the painful area becomes red or swollen. These symptoms may indicate a serious condition requiring medical evaluation.

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, it is essential to consult a healthcare professional, 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 presence of an NSAID in this product raises 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 consuming three or more alcoholic drinks daily while using this product and should adhere strictly to the recommended dosage.

Common Adverse Reactions Patients may also experience less severe but notable reactions. Caffeine, present in the recommended dose of this product, can lead to nervousness, irritability, sleeplessness, and, in some cases, rapid heartbeat. It is advisable to limit the intake of other caffeine-containing medications, foods, or beverages during treatment.

Patients should be instructed to stop using the product and consult a healthcare provider if they experience any new symptoms, signs of stomach bleeding (such as feeling faint, vomiting blood, having bloody or black stools, or persistent stomach pain), ringing in the ears, loss of hearing, worsening pain lasting more than 10 days, or a fever that worsens or lasts more than three days. Additionally, if a painful area becomes red or swollen, medical advice should be sought, as these could indicate serious conditions.

Drug Interactions

Taking this product concurrently with other medications containing acetaminophen, whether prescription or nonprescription, is not advised due to the potential for increased risk of adverse effects.

When this product is used in conjunction with anticoagulants or steroid medications, there is an elevated risk of severe gastrointestinal bleeding. Therefore, careful monitoring is recommended for patients receiving these combinations.

The concomitant use of this product with other nonsteroidal anti-inflammatory drugs (NSAIDs), including but not limited to aspirin, ibuprofen, and naproxen, also heightens the risk of severe stomach bleeding. It is advisable to avoid such combinations to mitigate this risk.

Additionally, the intake of caffeine-containing medications, foods, or beverages should be limited while using this product to prevent potential adverse interactions.

No specific laboratory test interactions 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.

Caution is advised for children and teenagers who have or are recovering from chickenpox or flu-like symptoms, as they are at risk for Reye's syndrome. If any changes in behavior accompanied by nausea and vomiting occur while using this product, a healthcare provider should be consulted, as these may be early signs of this rare but serious condition.

Geriatric Use

Elderly patients, particularly those aged 60 years 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. Additionally, dosage adjustments may be necessary for elderly patients, particularly if they are taking higher doses or using the product for an extended duration beyond the recommended guidelines.

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 concerning, as it may lead to adverse effects on fetal development and complications during delivery. Therefore, it is crucial that pregnant patients only use aspirin in the final three months of pregnancy if explicitly directed by a healthcare provider.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication if they are pregnant or breastfeeding. 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.

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 lack of immediate symptoms does not preclude the potential for serious health consequences. Therefore, it is essential to monitor the patient closely and provide supportive care as needed.

Management of an overdose may involve symptomatic treatment and monitoring of vital signs, as well as specific interventions based on the substance involved. It is recommended that healthcare providers follow established protocols for overdose management to ensure optimal patient outcomes.

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 provided regarding nonclinical toxicology or animal pharmacology and toxicology.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

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 temperature range of 20º to 25ºC (68º to 77ºF) to maintain its efficacy and stability. Proper storage conditions should be ensured to prevent exposure to extreme temperatures, which may compromise the product's integrity.

Additional Clinical Information

Patients should be informed 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 during the last trimester of pregnancy unless specifically directed by a physician, 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)