Headache Relief

Description

370R Extra Strength Headache Relief Caplets are presented in a dosage form of caplets, with a total count of 275 caplets per container. The product is designed for the relief of headache symptoms. Label images associated with this product include the primary label (370R_Extra Strength Headache Relief Caplets_LBL), the front label (370R_Extra Strength Headache Relief Caplets 275ct_LBL), and the information front cover (370R_Extra Strength Headache Relief Caplets_IFC).

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 should adhere strictly to the recommended dosage. The medication is to be administered orally, with each dose accompanied by a full glass of water.

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 before administration.

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. If any changes in behavior accompanied by nausea and vomiting occur while using this product, it is imperative to consult a healthcare professional, as these symptoms may indicate the onset of this rare but serious illness.

Allergy Alerts Acetaminophen, a component of this product, has been associated with severe skin reactions. Symptoms may include skin reddening, blisters, and rash. Should any skin reaction occur, the use of the product must be discontinued immediately, and medical assistance should be sought without delay.

Aspirin, another ingredient, may provoke a severe allergic reaction characterized by hives, facial swelling, asthma (wheezing), or shock. Immediate medical attention is warranted if any of these symptoms manifest.

Liver Warning This product contains acetaminophen, which poses a risk of severe liver damage if the following conditions are met: exceeding 8 caplets within a 24-hour period (the maximum daily amount), concurrent use with other medications containing acetaminophen, or consumption of three or more alcoholic drinks daily while using this product.

Stomach Bleeding Warning As this product contains a nonsteroidal anti-inflammatory drug (NSAID), it may increase the risk of severe stomach bleeding. The likelihood of this adverse effect is heightened in individuals who are 60 years of age 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 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. 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 symptoms such as nervousness, irritability, sleeplessness, and, in some cases, rapid heartbeat.

In the event of an overdose, immediate medical assistance should be sought, or contact a Poison Control Center (1-800-222-1222) without delay. Prompt medical attention is crucial for both adults and children, even if no signs or symptoms are initially apparent.

When to Seek Medical Attention Users should discontinue the product and consult a healthcare provider if any of the following occur: an allergic reaction, signs 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 that worsens or persists for more than 3 days, or the emergence of any new symptoms. These may indicate a serious medical condition requiring immediate evaluation.

Side Effects

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

Serious Adverse Reactions

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 under these circumstances. 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, particularly in patients sensitive to acetaminophen or aspirin. Symptoms of a severe skin reaction to acetaminophen may include skin reddening, blisters, and rash. If any of these symptoms develop, patients should discontinue use and seek medical assistance immediately. Similarly, aspirin may provoke severe allergic reactions characterized by hives, facial swelling, asthma (wheezing), or shock.

Patients should also be aware of the risk of severe liver damage associated with acetaminophen. This risk is heightened if patients exceed the maximum daily dosage of 8 caplets within 24 hours, use other medications containing acetaminophen, or consume three or more alcoholic drinks daily while using this product.

The product contains an NSAID, which may lead to severe stomach bleeding, particularly in patients aged 60 or older, those with a history of stomach ulcers or bleeding problems, or those taking anticoagulants, steroids, or other NSAIDs. The risk of stomach bleeding is also increased with excessive alcohol consumption or prolonged use beyond the recommended duration.

Common Adverse Reactions

Patients may experience symptoms related to 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 using the product 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 could signify a serious condition requiring medical attention.

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 anticoagulants or steroid medications significantly increases the risk of severe gastrointestinal bleeding. Close monitoring for signs of gastrointestinal bleeding is recommended in patients receiving these combinations.

Additionally, the use of other nonsteroidal anti-inflammatory drugs (NSAIDs), including aspirin, ibuprofen, and naproxen, either by prescription or over-the-counter, heightens the risk of stomach bleeding. Caution should be exercised, and the use of multiple NSAIDs should be avoided.

Patients are also advised to limit the intake of caffeine-containing medications, foods, or beverages while using this product to prevent excessive caffeine consumption.

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

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 under 12 years of age should consult a healthcare professional before use. The product 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 behavioral changes accompanied by nausea and vomiting occur while using this product, medical consultation is advised, as these may be early signs of Reye’s syndrome.

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

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 may be at an increased risk for severe stomach bleeding when using this product, as it contains a nonsteroidal anti-inflammatory drug (NSAID). The likelihood of experiencing such adverse effects is notably higher in individuals aged 60 years and older.

Healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to closely monitor these patients for any signs of gastrointestinal bleeding and to consider appropriate dose adjustments or alternative therapies as necessary to mitigate risks.

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.

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 have not been specifically addressed in the available data regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the lack of information necessitates careful clinical judgment and monitoring.

Hepatic Impairment

Patients with hepatic impairment should be closely monitored when using this product, which contains acetaminophen. Severe liver damage may occur if patients exceed the maximum daily dosage of 8 caplets within a 24-hour period. Additionally, patients must avoid concomitant use with other medications containing acetaminophen, as this can further increase the risk of liver injury.

It is also important for patients with compromised liver function to limit alcohol consumption. Specifically, the intake of 3 or more alcoholic drinks per day while using this product is contraindicated, as it may exacerbate the risk of severe liver damage. Regular assessment of liver function is recommended for patients with hepatic impairment to ensure safe use of this medication.

Overdosage

In cases of overdosage, significant health risks are associated with the consumption of this product.

Risk of Severe Liver Damage Taking more than 8 caplets within a 24-hour period, which is the maximum recommended daily dosage, can lead to severe liver damage. Healthcare professionals should be vigilant in assessing patients who may have exceeded this limit.

Additionally, the concomitant use of this product with other medications containing acetaminophen poses a further risk of severe liver damage. It is crucial for healthcare providers to inquire about all medications a patient is taking to prevent potential interactions that could exacerbate liver toxicity.

Furthermore, patients who consume three or more alcoholic drinks daily while using this product are at an increased risk of severe liver damage. Healthcare professionals should advise patients on the dangers of alcohol consumption in conjunction with this medication.

Recommended Actions In the event of suspected overdosage, immediate medical attention is warranted. Healthcare providers should initiate appropriate management procedures, which may include monitoring liver function tests and providing supportive care as necessary. It is essential to educate patients on the importance of adhering to the recommended dosage and the potential risks associated with overdosage.

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

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental ingestion. It is essential to emphasize the importance of seeking immediate medical assistance in the event of an overdose. Patients should be informed to contact a Poison Control Center at 1-800-222-1222 without delay. Quick medical attention is critical for both adults and children, even if no signs or symptoms of overdose are apparent.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available upon request. It should be stored at a temperature range of 20° to 25°C (68° to 77°F), with permissible excursions between 15° and 30°C (59° to 86°F). It is essential to adhere to the expiration date indicated on the package to ensure product efficacy and safety.

Additional Clinical Information

No further data are available.

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.

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