Extra Strength 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 are advised to take the medication with a full glass of water to ensure proper administration and absorption.

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 recommended to consult a physician for appropriate dosing guidance.

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 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, another ingredient, can lead to severe skin reactions characterized by 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 tablets within a 24-hour period, using it concurrently with other acetaminophen-containing medications, or consuming three or more alcoholic drinks daily while using this product. Furthermore, the product includes 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, 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. Therefore, 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 is applicable, 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 recommended 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 loss of hearing, redness or swelling in a painful area, worsening pain lasting more than 10 days, fever that worsens or lasts more than 3 days, or any new symptoms. These may be indicative of a serious condition requiring medical evaluation.

Side Effects

Patients using this product should be aware of several serious and common adverse reactions associated with its use.

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. 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.

Severe allergic reactions may occur, particularly in patients with a history of allergies to aspirin or acetaminophen. Symptoms of such reactions can include hives, facial swelling, asthma (wheezing), and shock. Patients experiencing any signs of an allergic reaction should stop use and seek medical help right away. Additionally, acetaminophen may cause severe skin reactions, which can manifest as skin reddening, blisters, or rash. If any skin reaction occurs, patients should discontinue use and seek immediate medical attention.

The product contains acetaminophen, and patients should be cautious as severe liver damage may occur if they exceed the maximum daily dosage of 8 tablets in 24 hours, use it in conjunction with other medications containing acetaminophen, 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, take blood thinners or steroid drugs, use other NSAIDs, or consume three or more alcoholic drinks daily. Patients should be vigilant for signs of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain, and should seek medical attention if these symptoms occur.

Patients should also be aware of the caffeine content in the recommended dose, which is comparable to that of a cup of coffee. Excessive caffeine intake may lead to nervousness, irritability, sleeplessness, and, in some cases, rapid heartbeat. Therefore, it is advisable to limit the use of other caffeine-containing medications, foods, or beverages while taking this product.

Patients are advised to stop use and consult a doctor if they experience ringing in the ears or loss of hearing, if a painful area becomes red or swollen, if pain persists or worsens beyond 10 days, if fever worsens or lasts more than 3 days, or if any new symptoms appear.

This product should not be used by individuals who have previously experienced an allergic reaction to acetaminophen, aspirin, or any other pain reliever or fever reducer. Patients should consult a doctor before use if they have liver disease, a history of stomach problems, high blood pressure, heart disease, liver cirrhosis, kidney disease, or if they are taking diuretics or have asthma. Additionally, patients should seek advice from a doctor or pharmacist if they are taking any other NSAIDs, prescription medications for diabetes, gout, or arthritis, or any other drugs, or if they are under a doctor's care for any serious condition.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there is no information available regarding 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 Extra Strength 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. Healthcare professionals are advised to consult a doctor if any changes in behavior accompanied by nausea and vomiting occur, as these may be early indicators of Reye's syndrome.

For dosing recommendations, adults and children aged 12 years and older may take 2 caplets every 6 hours, with a maximum of 8 caplets in a 24-hour period. For children under 12 years, it is essential to consult a doctor for appropriate dosing guidance.

In the event of an overdose, prompt medical attention is critical for both adults and pediatric patients, even if no signs or symptoms are immediately apparent.

Geriatric Use

Elderly patients, particularly those aged 60 years 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 any signs of gastrointestinal bleeding and to evaluate the necessity of dosage adjustments based on individual patient factors. Careful assessment of the risk-benefit ratio 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 the last trimester of pregnancy is particularly cautioned against, as it may lead to adverse effects on fetal development and 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 healthcare 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 its use in lactating individuals.

Renal Impairment

Patients with renal impairment should consult their healthcare provider prior to use, particularly if they have a history of 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 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 in this formulation.

Severe liver damage may occur if patients exceed the maximum recommended dosage of 8 tablets 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 hepatotoxicity.

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. Quick intervention is crucial for both adults and children, even in the absence of noticeable signs or symptoms. Healthcare professionals are advised to call the Poison Control Center at 1(800) 222-1222 for guidance on managing the situation.

Prompt recognition and management of overdose symptoms can significantly impact patient outcomes. Therefore, vigilance in monitoring for any potential adverse effects is essential, and appropriate medical protocols should be followed to ensure patient safety.

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 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 adverse reactions reported voluntarily or through surveillance programs. These include allergic reactions such as hives, facial swelling, asthma (wheezing), and shock associated with aspirin. Severe skin reactions linked to acetaminophen have also been reported, characterized by skin reddening, blisters, and rash. Additionally, there is a risk of severe liver damage with excessive use of acetaminophen.

The use of nonsteroidal anti-inflammatory drugs (NSAIDs), including aspirin, may lead to severe stomach bleeding, particularly in individuals over 60 years of age or those with a history of stomach ulcers or bleeding problems. Symptoms of overdose may manifest as signs of liver damage and gastrointestinal bleeding.

Other reported experiences include tinnitus or hearing loss, localized pain accompanied by redness or swelling, and instances of pain that worsens or persists beyond 10 days. Furthermore, reports indicate that fever may worsen or last more than 3 days, and new symptoms may appear during treatment.

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 crucial 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 using the medication 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 discontinue use and consult a doctor.

Healthcare providers should inform patients to stop using the medication 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. Patients should be advised to report any new symptoms, as these may indicate a serious condition.

Before initiating treatment, healthcare providers should recommend that patients consult a doctor if they have liver disease, a history of stomach problems such as heartburn, high blood pressure, heart disease, liver cirrhosis, or kidney disease. Patients taking a diuretic, those with asthma, or those on any other medication should also be encouraged to seek medical advice prior to use. Furthermore, patients should be advised to consult a doctor or pharmacist if they are taking any other drug containing an NSAID, or if they are on prescription medications for diabetes, gout, or arthritis. Lastly, patients should be reminded to discuss any use of blood-thinning (anticoagulant) or steroid medications with their healthcare provider 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 room temperature, maintaining a range of 20º to 25º C (68º to 77º F). Proper storage conditions are crucial to ensure the integrity and efficacy of the product.

Additional Clinical Information

The medication is administered orally, with specific dosing guidelines for different age groups. Adults and children aged 12 years and older are advised to take 2 caplets every 6 hours, not exceeding 8 caplets within a 24-hour period. For children under 12 years, consultation with a doctor is recommended before use.

Clinicians should counsel patients regarding the use of this medication during pregnancy and breastfeeding. It is particularly important to avoid aspirin in the last trimester of pregnancy unless explicitly directed by a healthcare professional, 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 Relief, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)