Extra Strenght Headache Relief

Description

24/7 for Life By 7-ELEVEN is an extra strength formulation indicated for headache relief. The product contains a combination of active ingredients, including acetaminophen, aspirin (a nonsteroidal anti-inflammatory drug), and caffeine, which collectively function as a pain reliever and fever reducer. This formulation is comparable to EXCEDRIN® EXTRA STRENGTH. Each package contains 6 caplets.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with various conditions, including headache, cold, arthritis, muscular aches, sinusitis, toothache, and premenstrual and menstrual cramps.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

Patients should take the medication with a full glass of water to ensure proper absorption.

For adults and children aged 12 years and older, the recommended dosage is 2 caplets every 6 hours, with a maximum 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 acetaminophen, aspirin, or any other pain reliever/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 have or are recovering from chickenpox or flu-like symptoms should not use this product. If behavioral changes accompanied by nausea and vomiting occur during use, it is imperative to consult a physician, as these symptoms may indicate the onset of Reye's syndrome, a rare but serious condition.

Aspirin, a component of this product, has the potential to cause severe allergic reactions, which may manifest as hives, facial swelling, asthma (wheezing), or shock. Additionally, acetaminophen may lead to severe skin reactions, including skin reddening, blisters, or rash. Should any skin reaction occur, it is crucial to discontinue use immediately and seek medical assistance.

This product contains acetaminophen, and severe liver damage may result from exceeding the maximum daily dosage of 8 caplets within 24 hours, using it concurrently with other acetaminophen-containing medications, or consuming three or more alcoholic drinks daily while using this product. Furthermore, this product contains a nonsteroidal anti-inflammatory drug (NSAID), which may increase the risk of severe stomach bleeding, particularly in individuals who are 60 years or older, have a history of stomach ulcers or bleeding problems, are taking anticoagulants or steroid medications, are using other NSAIDs (including aspirin, ibuprofen, or naproxen), consume three or more alcoholic drinks daily, or exceed the recommended duration or dosage.

The recommended dosage of this product contains approximately the same amount of caffeine as 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 consumption may lead to nervousness, irritability, sleeplessness, and, in some cases, rapid heartbeat.

Healthcare professionals should advise patients to consult a physician 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, or if they have high blood pressure, heart disease, liver cirrhosis, or kidney disease. Patients should also seek medical advice if they are taking diuretics or have asthma. Additionally, it is important to consult a doctor or pharmacist before use if the patient is taking any other NSAID (whether prescription or nonprescription), a prescription medication for diabetes, gout, or arthritis, or any other drug, or if they are under a physician's care for any serious condition, including anticoagulants or steroid medications.

In the event of an overdose, immediate medical attention is essential. Patients should contact a Poison Control Center or seek emergency medical help without delay, even if no signs or symptoms are apparent. The Poison Control Center can be reached at 1(800) 222-1222.

Patients should discontinue use and contact a physician 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 hearing loss, redness or swelling in a painful area, worsening pain lasting more than 10 days, fever lasting more than 3 days, or any new symptoms, as these may signify a serious condition.

Side Effects

Patients using this product should be aware of several potential adverse reactions, which can range from serious to common.

Serious adverse reactions include Reye's syndrome, which 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, a rare but serious illness.

Allergic reactions may also occur, with aspirin potentially causing severe responses such as hives, facial swelling, asthma (wheezing), and shock. Acetaminophen, another component of this product, may lead to severe skin reactions characterized by skin reddening, blisters, or rash. 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 the maximum daily dosage of 8 caplets within 24 hours, use other medications containing acetaminophen concurrently, or consume three or more alcoholic drinks daily while using this product.

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, take blood-thinning medications or steroids, use other NSAIDs, or consume three or more alcoholic drinks daily. Patients should also be cautious not to exceed the recommended duration or dosage.

Caffeine is another component of this product, and patients should limit their intake of other caffeine-containing medications, foods, or beverages. Excessive caffeine consumption may lead to nervousness, irritability, sleeplessness, and, in some cases, rapid heartbeat.

Patients are advised to stop use 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 or swelling in a painful area, worsening pain lasting more than 10 days, fever lasting more than 3 days, or any new symptoms. These could signify a serious condition requiring medical attention.

Drug Interactions

Taking other medications that contain acetaminophen, whether prescription or nonprescription, may elevate the risk of severe liver damage. It is advisable to monitor total daily acetaminophen intake to avoid exceeding recommended limits.

The concomitant use of blood thinners (anticoagulants) or steroid medications may heighten the risk of gastrointestinal bleeding. Patients should be closely monitored for signs of bleeding and may require dosage adjustments based on clinical judgment.

The use of other nonsteroidal anti-inflammatory drugs (NSAIDs), including aspirin, ibuprofen, and naproxen, whether prescription or nonprescription, can also increase the risk of stomach bleeding. Caution is recommended, and healthcare providers should consider alternative pain management strategies if necessary.

Additionally, it is recommended to limit the intake of caffeine-containing medications, foods, or beverages while using this product to prevent excessive caffeine consumption. Monitoring caffeine intake may be beneficial to avoid potential adverse effects associated with high levels of caffeine.

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

Packaging & NDC

Below are the non-prescription pack sizes of Extra Strenght Headache Relief (acetaminophen, aspirin, caffeine). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients, particularly children and teenagers, should not use this product if they have or are recovering from chicken pox or flu-like symptoms due to the risk of Reye's syndrome. It is important for healthcare professionals to advise caregivers to consult a doctor if any changes in behavior accompanied by nausea and vomiting occur, as these may be early signs of Reye's syndrome.

For dosing, adults and children aged 12 years and older are instructed 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 seek medical advice before administration.

Geriatric Use

Elderly patients may have an increased risk of severe stomach bleeding, particularly those aged 60 years and older. Therefore, caution is advised when prescribing this medication to this population.

Additionally, it is important for healthcare providers to consult with a physician if the elderly patient has a history of liver disease, as this condition may pose significant concerns in this age group.

Before initiating treatment, healthcare providers should also inquire about the presence of high blood pressure, heart disease, liver cirrhosis, or kidney disease, as these conditions are more prevalent among geriatric patients and may necessitate careful monitoring or dosage adjustments.

Pregnancy

Pregnant patients and women 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 outcomes or complications during delivery. Therefore, it is crucial that aspirin is only used in this period if explicitly directed by a physician.

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 high blood pressure, heart disease, liver cirrhosis, or kidney disease. It is also advisable for patients taking diuretics to seek guidance from a doctor or pharmacist before initiating treatment. Additionally, those under medical supervision for any serious condition, including kidney disease, should discuss their treatment options with their healthcare provider to ensure safety and efficacy.

Hepatic Impairment

Patients with hepatic impairment should consult their healthcare provider prior to using this product. The presence of liver disease may increase the risk of adverse effects, particularly due to the acetaminophen content.

Severe liver damage may occur if patients exceed the maximum recommended dosage of 8 caplets within a 24-hour period. Additionally, caution is advised against the concurrent use of other medications containing acetaminophen, as this may further elevate the risk of liver injury.

Patients are also advised to limit alcohol consumption to fewer than 3 alcoholic drinks per day while using this product, as alcohol can exacerbate the potential for liver damage. Regular monitoring of liver function may be warranted in patients with compromised liver function 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 without delay. Prompt medical intervention is crucial for both adults and children, even in the absence of noticeable signs or symptoms. Healthcare professionals are advised to utilize the Poison Control Center hotline at 1(800) 222-1222 for guidance and support in managing the situation effectively.

Timely action can significantly influence the outcome of an overdose scenario, underscoring the importance of vigilance and readiness to respond.

Nonclinical Toxicology

It is especially important not to use aspirin during the last three months of 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 have been identified in the available data. Additionally, there are no specific details regarding nonclinical toxicology or animal pharmacology and toxicology provided in the current information.

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 or seek medical help right away, emphasizing that quick medical attention is critical for both adults and children. It is essential to communicate that this action should be taken even if no signs or symptoms of overdose are apparent. Patients can reach the Poison Control Center at 1(800) 222-1222 for guidance.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available upon request. It should be stored at a controlled room temperature of 20º to 25º C (68º to 77º F). Care should be taken to ensure that the product is kept within this temperature range to maintain its integrity and efficacy.

Additional Clinical Information

The route of administration for the medication is oral. Clinicians should advise patients who are pregnant or breastfeeding to consult a health professional prior to use. It is particularly crucial 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. No additional information is available regarding laboratory tests, abuse potential, or postmarketing experiences.

Drug Information (PDF)

This file contains official product information for Extra Strenght Headache Relief, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

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