Extra Strength Headache, Extra Strength Headache, Circle K

Description

This formulation is designed for the relief of headaches and contains a combination of active ingredients. Each caplet includes 250 mg of acetaminophen, a pain reliever, and 250 mg of aspirin, a nonsteroidal anti-inflammatory drug (NSAID) that also serves as a pain reliever. Additionally, the formulation contains 65 mg of caffeine, which acts as a pain reliever aid. The product is presented in a dosage form of caplets, with a total of 50 caplets per package, identifiable by the Lil' Drug Store logo.

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 or menstrual cramps.

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

Dosage and Administration

Adults and children aged 12 years and older are instructed to take 2 caplets every 6 hours as needed. It is imperative that they do not exceed a total of 8 caplets within a 24-hour period. Each dose should be accompanied by a full glass of water to ensure proper administration.

For children under 12 years of age, it is recommended to consult a physician for appropriate dosing guidance.

Healthcare professionals should advise patients to adhere strictly to the recommended dosages and to be aware of the overdose warning associated with this medication.

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.

Aspirin, a component of this product, may lead to severe allergic reactions, which can manifest as hives, facial swelling, asthma (wheezing), or shock. Similarly, acetaminophen may cause severe skin reactions, including 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.

This product contains acetaminophen, which poses a risk of severe liver damage if the maximum daily dosage of 8 caplets is exceeded within a 24-hour period, if it is taken concurrently with other medications containing acetaminophen, or if consumed with three or more alcoholic drinks daily.

The presence of an NSAID in this product raises the potential for severe stomach bleeding, particularly in individuals aged 60 or older, those with a history of stomach ulcers or bleeding problems, and those taking blood thinners (anticoagulants) or steroid medications. The risk is also heightened for individuals consuming three or more alcoholic drinks daily or using the product for longer than directed.

Caffeine is also present in the recommended dose of this product, which is comparable to that found in 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 doctor prior to use if they have liver disease, if the stomach bleeding warning applies, or if they have a history of stomach problems such as heartburn. Additionally, individuals with high blood pressure, heart disease, liver cirrhosis, kidney disease, or those taking diuretics or who have asthma should seek medical advice before using this product.

Patients should also be encouraged to consult a doctor or pharmacist if they are taking any other NSAIDs (whether prescription or nonprescription), prescription medications for diabetes, gout, or arthritis, or if they are under medical care for any serious condition, including the use of blood thinners or steroid drugs.

In the event of an overdose, immediate medical assistance should be sought, or contact with a Poison Control Center (1-800-222-1222) is recommended. Prompt medical attention is crucial for both adults and children, even if no signs or symptoms are initially apparent.

Patients must discontinue use and contact a healthcare provider 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 the emergence of any new symptoms, as these may indicate a serious condition.

Side Effects

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

Reye's syndrome is a rare but serious illness that may occur in children and teenagers who have or are recovering from chicken pox or flu-like symptoms. Patients should not use this product if they fall into this category. If changes in behavior accompanied by nausea and vomiting occur, it is crucial to consult a doctor, as these symptoms could indicate the onset of Reye's syndrome.

Severe allergic reactions may occur with the use of this product, particularly due to aspirin. Symptoms of such reactions can include hives, facial swelling, asthma (wheezing), and shock. Additionally, acetaminophen may lead to severe skin reactions, which 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 the maximum daily dosage of 8 caplets within 24 hours, use it in conjunction with other acetaminophen-containing drugs, or consume three or more alcoholic drinks daily while using this product.

Furthermore, 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, are taking blood thinners or steroid medications, or are consuming three or more alcoholic drinks daily. The risk is also heightened if patients take other prescription or nonprescription NSAIDs, or exceed the recommended duration or 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 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 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. These may be signs of a serious condition requiring medical attention.

Drug Interactions

Co-administration of this medication with other drugs containing acetaminophen, whether prescription or nonprescription, should be approached with caution due to the potential for increased hepatotoxicity.

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

The concomitant use of this medication with other nonsteroidal anti-inflammatory drugs (NSAIDs), including but not limited to aspirin, ibuprofen, and naproxen, also heightens the risk of stomach bleeding. It is advisable to avoid such combinations unless specifically directed by a healthcare provider.

Patients taking prescription medications for diabetes, gout, or arthritis should consult their healthcare provider prior to initiating therapy with this medication to ensure safe and effective use. Additionally, those on diuretics are encouraged to seek medical advice to assess potential interactions and necessary monitoring.

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

Packaging & NDC

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

Pediatric Use

Pediatric patients under 12 years of age should consult a healthcare professional before using this product. It is contraindicated in children and teenagers who have or are recovering from chickenpox or flu-like symptoms due to the risk of Reye's syndrome, a rare but serious condition. If any changes in behavior accompanied by nausea and vomiting occur, medical advice should be sought immediately, as these may be early signs of Reye's syndrome.

For dosing, patients aged 12 years and older may take 2 caplets every 6 hours, with a maximum of 8 caplets in a 24-hour period. In cases of overdose, prompt medical attention is essential for both adults and pediatric patients, even if no signs or symptoms are immediately apparent.

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 adjustments or alternative therapies as necessary. 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. The use of aspirin during the last trimester of pregnancy is particularly cautioned against, as it may lead to adverse effects on fetal outcomes or complications during delivery. Therefore, it is essential that pregnant patients only use aspirin in this period if explicitly directed by a healthcare provider.

Lactation

Lactating mothers are advised to consult a health professional before using this medication. 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. Therefore, caution is recommended when considering the use of this medication while breastfeeding.

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 with compromised liver function should be aware that exceeding 8 caplets within a 24-hour period, which is the maximum daily dosage, may lead to significant hepatic injury.

Additionally, concurrent use of other medications containing acetaminophen should be avoided to prevent cumulative dosing that could exacerbate the risk of liver damage. Patients are also advised against consuming 3 or more alcoholic beverages daily while using this product, as this can further increase the likelihood of adverse hepatic effects. Regular monitoring of liver function may be warranted in patients with existing liver disease 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, and early recognition and management are essential to mitigate potential complications. It is recommended that healthcare providers remain vigilant and prepared to assess the situation thoroughly, as timely treatment can significantly influence outcomes in overdose cases.

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 regarding nonclinical toxicology or animal pharmacology and toxicology provided in the current information.

Postmarketing Experience

Postmarketing experience has indicated that acetaminophen may be associated with severe skin reactions. These reactions can manifest as symptoms including skin reddening, blisters, and rash. In the event of a skin reaction, it is advised that users discontinue use of the product and seek medical assistance promptly.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental ingestion. Patients should be informed not to use the medication if they have ever experienced an allergic reaction to acetaminophen, aspirin, or any other pain reliever or fever reducer. It is important to instruct patients not to use 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 stop use and seek medical attention immediately if they experience any signs of an allergic reaction. Additionally, they should be made aware of the signs of stomach bleeding, which include feeling faint, vomiting blood, having bloody or black stools, or experiencing stomach pain that does not improve. If patients notice ringing in the ears or loss of hearing, they should also stop use and consult a doctor.

Patients should be advised to discontinue use and seek medical advice if the painful area becomes red or swollen, if pain worsens or persists for more than 10 days, or if fever worsens or lasts for more than 3 days. They should be informed to contact a doctor if any new symptoms arise, as these may indicate a serious condition.

Before using the medication, patients should be encouraged to consult a doctor if they have liver disease, a history of stomach problems such as heartburn, or if the stomach bleeding warning applies to them. Patients with high blood pressure, heart disease, liver cirrhosis, or kidney disease should also seek medical advice prior to use. Those taking diuretics, have asthma, or are on any other NSAID (whether prescription or nonprescription) should consult a doctor or pharmacist before use.

Furthermore, patients should be advised to speak with a doctor or pharmacist if they are taking prescription medications for diabetes, gout, or arthritis, or if they are under a doctor’s care for any serious condition. Lastly, patients taking blood thinning (anticoagulant) or steroid drugs should also seek guidance from a healthcare professional before using this medication.

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 20° to 25°C (68° to 77°F) to maintain its efficacy and stability. Proper storage conditions must be adhered to, ensuring that the product is kept within this temperature range at all times.

Additional Clinical Information

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 to seek advice from a health professional if they are pregnant or breastfeeding. It is particularly crucial to avoid the use of 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.

Drug Information (PDF)

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

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