Headache Relief

Description

DG® health Extra Strength Headache Relief is a formulation designed as a pain reliever and pain reliever aid. The product contains active ingredients including acetaminophen, aspirin (a nonsteroidal anti-inflammatory drug), and caffeine. It is packaged in a size of 100 caplets.

The product features a tamper-evident warning, indicating that it should not be used if the imprinted safety seal under the cap is broken or missing. It is important to note that this product is not manufactured or distributed by Haleon CH SARL, the owner of the registered trademark Excedrin® Extra Strength Headache. Distribution is handled by OLD EAST MAIN CO., located at 100 Mission Ridge, Goodlettsville, TN 37072.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with various conditions, including headache, arthritis, the common cold, 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

The use of this product necessitates careful consideration of several warnings and precautions to ensure patient safety.

Reye’s Syndrome Children and teenagers who are experiencing or recovering from chickenpox or flu-like symptoms should not use this product. If any changes in behavior accompanied by nausea and vomiting occur during use, it is imperative to consult a healthcare professional, as these symptoms may indicate the onset of Reye's syndrome, a rare but serious condition.

Allergy Alerts Aspirin may induce severe allergic reactions, which can manifest as shock, facial swelling, hives, or asthma (wheezing). Additionally, acetaminophen has the potential to cause severe skin reactions, including skin reddening, blisters, and rash. Should any skin reaction occur, the product must be discontinued immediately, and medical assistance should be sought.

Liver Warning This product contains acetaminophen, and severe liver damage may occur 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.

Stomach Bleeding Warning As this product contains a nonsteroidal anti-inflammatory drug (NSAID), there is a risk of severe stomach bleeding, particularly in individuals who are 60 years of age or older, those taking other NSAIDs (prescription or nonprescription), individuals with a history of stomach ulcers or bleeding problems, and those who consume three or more alcoholic drinks daily while using this product. Caution is also advised for patients taking blood thinners or steroid medications, as well as for those who exceed the recommended dosage or 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 while using this product, as excessive caffeine consumption may lead to nervousness, irritability, sleeplessness, and, in some cases, rapid heartbeat.

General Precautions Healthcare professionals should advise patients to consult a doctor prior to use if they have liver disease, if the stomach bleeding warning applies, or if they have a history of stomach issues such as heartburn. Additional caution is warranted for individuals with high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma, as well as for those taking diuretics. Patients should also seek guidance from a doctor or pharmacist if they are currently taking prescription medications for diabetes, gout, or arthritis.

Emergency Medical Help In the event of an overdose, immediate medical assistance should be sought, or contact with a Poison Control Center is recommended. Prompt medical attention is crucial for both adults and children, even if no signs or symptoms are initially apparent.

Discontinuation and Consultation Patients 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, 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 that worsens or lasts more than three days, or the emergence of any new symptoms.

Side Effects

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

Reye’s syndrome is a rare but serious condition that can 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 aspirin or acetaminophen. Symptoms of an allergic reaction to aspirin may include shock, facial swelling, hives, and asthma (wheezing). For acetaminophen, severe skin reactions can manifest as skin reddening, blisters, or rash. In the event of a skin reaction, patients should discontinue use and seek medical assistance immediately.

The product contains acetaminophen, which poses a risk of severe liver damage if patients exceed 4,000 mg in 24 hours, 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 aged 60 or older, those taking other NSAIDs, individuals with a history of stomach ulcers or bleeding problems, and those on blood thinners or steroids. Patients should be cautioned to avoid exceeding the recommended dosage or duration of use.

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 products to avoid potential side effects such as 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 hearing loss, redness or swelling, worsening pain lasting more than 10 days, fever lasting more than 3 days, or any new symptoms.

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

Drug Interactions

Taking this product concurrently with other medications containing acetaminophen, whether prescription or nonprescription, may result in severe liver damage. It is advisable to avoid the use of multiple acetaminophen-containing products to mitigate this risk.

The concomitant use of this product with other nonsteroidal anti-inflammatory drugs (NSAIDs), including aspirin, ibuprofen, and naproxen, may significantly increase the likelihood of severe stomach bleeding. Caution is recommended, and healthcare providers should consider alternative pain management strategies when prescribing this product alongside NSAIDs.

Additionally, the use of blood thinners (anticoagulants) or steroid medications in conjunction with this product may elevate the risk of stomach bleeding. Monitoring for gastrointestinal symptoms is advised, and dosage adjustments may be necessary based on the clinical scenario.

Patients are also advised to limit the intake of caffeine-containing medications, foods, or beverages while using this product. Excessive caffeine consumption can lead to adverse effects such as nervousness, irritability, sleeplessness, and, in some cases, rapid heartbeat.

No specific laboratory test interactions have been identified for this product.

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. If any changes in behavior accompanied by nausea and vomiting occur while using this product, it is essential to consult a healthcare professional, as these symptoms may indicate an early sign of Reye's syndrome.

For dosing, it is advised that children under 12 years should consult a doctor before use. For patients aged 12 years and older, the recommended dosage is 2 caplets every 6 hours, with a maximum of 8 caplets in a 24-hour period.

Geriatric Use

Elderly patients, particularly those aged 60 years and older, may have an increased risk of stomach bleeding associated with the use of this medication. Healthcare providers should exercise caution when prescribing this treatment to geriatric patients, considering the potential for heightened adverse effects.

It is advisable to monitor these patients closely for any signs of gastrointestinal bleeding and to evaluate the necessity of dosage adjustments based on individual patient factors. Careful assessment of the risk-benefit profile is essential in this population to ensure safe and effective use of the medication.

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 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 consult a healthcare professional prior to using this product. It is important to note that this product contains acetaminophen, which carries a risk of severe liver damage under certain conditions. Specifically, patients should be aware that exceeding 4,000 mg of acetaminophen within a 24-hour period may lead to significant hepatic injury. Additionally, the concurrent consumption of three or more alcoholic beverages daily while using this product can further increase the risk of liver damage.

Patients with compromised liver function should also avoid the use of other medications containing acetaminophen to prevent cumulative dosing that could exacerbate the risk of hepatotoxicity. Regular monitoring of liver function may be warranted in patients with existing liver disease 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 attention is crucial for both adults and children, even in the absence of noticeable signs or symptoms.

Healthcare professionals should be aware that early intervention can significantly impact the outcome of an overdose situation. Therefore, it is essential to remain vigilant and proactive in managing 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 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 identified several important safety considerations associated with the use of this product.

Severe skin reactions, including symptoms such as skin reddening, blisters, and rash, have been reported. In the event of a skin reaction, it is advised to discontinue use and seek medical assistance immediately.

The product contains acetaminophen, which carries 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 the product, or using it concurrently with other medications that contain acetaminophen.

Additionally, the presence of an NSAID in this product raises the potential for severe stomach bleeding. The risk is heightened in individuals aged 60 or older, those taking other NSAIDs (either prescription or nonprescription), individuals consuming three or more alcoholic drinks daily, those with a history of stomach ulcers or bleeding problems, and patients on blood thinners or steroid medications. Prolonged use or exceeding the recommended dosage may also increase this risk.

Users are advised to discontinue use and consult a healthcare professional if any allergic reactions occur or if symptoms indicative of stomach bleeding arise, such as feeling faint, experiencing bloody or black stools, vomiting blood, 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 the emergence of any new symptoms.

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 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 essential to caution patients against using this medication in conjunction with any other drug containing 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 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 attention if they experience ringing in the ears, loss of hearing, redness or swelling, worsening pain that lasts more than 10 days, or a fever that worsens or lasts more than 3 days. They should also be encouraged to consult a doctor if any new symptoms arise.

It is important for healthcare providers to recommend that patients consult a doctor before using this medication if they have liver disease, a history of stomach problems such as heartburn, high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma. Patients taking diuretics or prescription medications for diabetes, gout, or arthritis should also be advised to seek guidance from a doctor or pharmacist prior to use.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for reference. 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 inventory management and product safety.

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 caplets every 6 hours, with a maximum of 8 caplets in a 24-hour period. For children under 12 years, it is advised to consult a doctor for appropriate dosing.

Clinicians should counsel patients who are pregnant or breastfeeding to seek advice from a health professional before use. It is particularly crucial to avoid aspirin use 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. In the event of an overdose, patients must seek immediate medical assistance or contact a Poison Control Center, as timely intervention is essential for both adults and children, regardless of the presence 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)