Headache Relief, Extra Strength

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 colds, toothaches, arthritis, muscular aches, headaches, 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. For adults and children aged 12 years and older, the prescribed dosage is 2 caplets every 6 hours, with a maximum limit of 8 caplets within a 24-hour period. It is essential to take each dose with a full glass of water to ensure proper administration and absorption.

For children under 12 years of age, it is advised to consult a healthcare professional 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 medication containing acetaminophen, whether prescription or nonprescription, is prohibited. If there is uncertainty regarding the presence of acetaminophen in a 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, shock, or asthma symptoms such as wheezing. Additionally, 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 following conditions are met: exceeding 4,000 mg of acetaminophen within a 24-hour period, concurrent use with other medications containing acetaminophen, or consumption of three or more alcoholic drinks daily while using this product.

The presence of an NSAID in this formulation raises the risk of severe stomach bleeding, particularly in individuals who are taking other NSAIDs (prescription or nonprescription), have a history of stomach ulcers or bleeding issues, are on blood thinners or steroid medications, consume three or more alcoholic drinks daily, are aged 60 or older, or exceed the recommended dosage or duration of use.

Caffeine is also included in the recommended dose of this product, which is comparable to the caffeine content of a cup of coffee. It is advisable to limit the intake of other caffeine-containing medications, foods, or beverages during treatment, 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 is applicable, if they have a history of stomach issues such as heartburn, if they are taking diuretics, or if they have high blood pressure, heart disease, liver cirrhosis, or kidney disease. Additionally, individuals with asthma should seek medical advice before using this product. Patients should also consult a doctor or pharmacist if they are currently taking prescription medications for diabetes, gout, or arthritis.

In the event of an overdose, immediate medical attention is crucial. Patients should contact a Poison Control Center or seek emergency medical help right away, regardless of whether symptoms are present.

Patients are advised to discontinue use and contact a healthcare professional 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, worsening pain lasting more than 10 days, fever lasting more than 3 days, redness or swelling, or any new symptoms that arise.

Side Effects

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

Warnings Reye’s syndrome is a rare but serious illness that can occur in children and teenagers who have or are recovering from chickenpox or flu-like symptoms. These individuals should not use this product. If patients experience changes in behavior accompanied by nausea and vomiting while using this product, they should consult a doctor immediately, as these symptoms may indicate the onset of Reye's syndrome.

Allergy Alert Aspirin, one of the components of this product, may cause severe allergic reactions, which can manifest as hives, facial swelling, shock, or asthma (wheezing). Additionally, acetaminophen may lead to severe skin reactions, including skin reddening, blisters, and rash. If any skin reaction occurs, patients should discontinue use and seek medical assistance promptly.

Liver Warning This product contains acetaminophen, and severe liver damage may occur if patients exceed 4,000 mg of acetaminophen in a 24-hour period, use it in conjunction with other medications containing acetaminophen, or consume three or more alcoholic drinks daily while using this product.

Stomach Bleeding Warning As this product contains a nonsteroidal anti-inflammatory drug (NSAID), there is a risk of severe stomach bleeding. The likelihood of this adverse reaction increases in patients who take other NSAIDs (such as aspirin, ibuprofen, or naproxen), have a history of stomach ulcers or bleeding problems, are on blood-thinning medications or steroids, consume three or more alcoholic drinks daily, are aged 60 or older, or take the product for longer than directed.

Caffeine Warning The recommended dose of this product contains approximately the same amount of caffeine as a cup of coffee. Patients are advised 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.

Stop Use and Ask a Doctor If Patients should discontinue use and seek medical advice 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, worsening pain lasting more than 10 days, fever lasting more than three days, redness or swelling, or any new symptoms.

Ask a Doctor Before Use If Patients with liver disease, a history of stomach problems (such as heartburn), or those taking diuretics, have high blood pressure, heart disease, liver cirrhosis, or kidney disease, or have asthma should consult a doctor prior to using this product.

Ask a Doctor or Pharmacist Before Use If Patients who are taking prescription medications for diabetes, gout, or arthritis should seek advice from a healthcare professional before using this product.

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 Headache Relief, Extra Strength (acetaminophen, aspirin, caffeine tablet, film coated). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients, particularly those under 12 years of age, should not use this product without consulting a healthcare professional. 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 illness. If any changes in behavior accompanied by nausea and vomiting occur while using this product, a doctor should be consulted immediately, as these may be early signs of Reye's syndrome.

For dosing, adults and children aged 12 years and older are directed to take 2 caplets every 6 hours, with a maximum of 8 caplets in a 24-hour period. For children under 12 years, a healthcare provider should be consulted for appropriate dosing recommendations.

Geriatric Use

Elderly patients, particularly those aged 60 years and older, may have an increased risk of stomach bleeding. It is essential for healthcare providers to exercise caution when prescribing this medication to geriatric patients.

Monitoring for signs of gastrointestinal bleeding is recommended, and dosage adjustments may be necessary based on the individual patient's health status and concurrent medications. Careful assessment of the risks versus benefits should be conducted to ensure the safety of elderly patients receiving this treatment.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare 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 developing fetus and lead to complications during delivery. Healthcare providers should carefully evaluate the potential benefits and risks when considering the use of this medication in pregnant patients.

Lactation

Lactating mothers are advised to consult a health professional prior to 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 comorbid 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 degree 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 4,000 mg of acetaminophen within a 24-hour period 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 three or more alcoholic beverages daily while using this product, as this may further increase the likelihood of adverse hepatic effects.

Monitoring of liver function may be warranted in patients with existing liver disease or those who are at increased risk for hepatic impairment.

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, regardless of whether any signs or symptoms are apparent.

Healthcare professionals should be aware that the absence of symptoms does not preclude the possibility of serious complications. Therefore, it is essential to monitor the patient closely and provide appropriate care as needed.

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 non-teratogenic effects have been specified. Additionally, there are no details provided regarding nonclinical toxicology or animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions reported voluntarily or through surveillance programs. Allergic reactions, including hives, facial swelling, shock, and asthma (wheezing), have been associated with aspirin use. Severe skin reactions, such as skin reddening, blisters, and rash, have been reported in connection with acetaminophen.

Additionally, there have been reports of severe liver damage associated with acetaminophen, particularly in cases of overdose or when used concurrently with other acetaminophen-containing products. Incidents of severe stomach bleeding have been noted with the use of NSAIDs, including aspirin, especially in patients with a history of stomach ulcers or bleeding problems. Furthermore, cases of nervousness, irritability, sleeplessness, and rapid heartbeat have been associated with excessive caffeine intake from the product.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. In the event of an overdose, it is crucial to seek medical help or contact a Poison Control Center immediately, as prompt medical attention is essential 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 ever experienced an allergic reaction to any other pain reliever or fever reducer. Additionally, they should not use this product 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 must be instructed to stop use and seek medical advice if they experience any signs of an allergic reaction. Immediate medical assistance should be sought in such cases. Furthermore, they should discontinue use and consult a doctor if they notice any signs of stomach bleeding, which may include feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain. Other concerning symptoms include ringing in the ears, worsening pain lasting more than 10 days, a fever that worsens or lasts more than 3 days, visible redness or swelling, or the emergence of any new symptoms.

Healthcare providers should recommend that patients consult a doctor before using this medication if they have liver disease or if the stomach bleeding warning is applicable to them. Patients with a history of stomach problems, such as heartburn, should also seek medical advice prior to use. Additionally, those taking a diuretic, or who have high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma, should be advised to consult a doctor before using this medication. Lastly, patients taking prescription drugs for diabetes, gout, or arthritis should be encouraged to discuss their medications with a doctor or pharmacist before use.

Storage and Handling

The product is supplied in configurations that include specific NDC numbers, which can be found on the packaging. 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 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. Additionally, patients should be reminded to keep the medication out of reach of children and to seek immediate medical assistance or contact a Poison Control Center in the event of an overdose, as prompt attention is essential for both adults and children, even in the absence of symptoms.

Drug Information (PDF)

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

View product document (PDF)