Headache Formula

Description

exchange✓select™ is an extra strength headache formula designed to provide effective pain relief. The product contains a combination of active ingredients, including acetaminophen, aspirin (a nonsteroidal anti-inflammatory drug), and caffeine, which work synergistically to alleviate headache symptoms. Each package contains 100 caplets, ensuring a sufficient supply for users.

The product is manufactured for military exchanges and distributed by LNK International, Inc., located in Hauppauge, NY. It features a tamper-evident warning, indicating that it should not be used if the safety seal under the cap is broken or missing. For customer inquiries, a service contact number is provided: 1-800-426-9391. Additionally, a satisfaction guarantee is offered, ensuring customer confidence in the product's efficacy.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with various conditions, including headache, arthritis, the common cold, 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. 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 contraindicated. 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 shock, facial swelling, hives, or asthma symptoms such as wheezing. Similarly, acetaminophen may cause severe skin reactions, including skin reddening, blisters, or rash. In the event of a skin reaction, users must discontinue use and seek medical assistance 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, consuming three or more alcoholic drinks daily while using this product, or using other medications that contain acetaminophen concurrently.

Additionally, the product contains a nonsteroidal anti-inflammatory drug (NSAID), which may increase the risk of severe stomach bleeding. This risk is heightened in individuals aged 60 or older, those taking other NSAIDs (whether prescription or over-the-counter), individuals consuming three or more alcoholic drinks daily, those with a history of stomach ulcers or bleeding problems, and those taking anticoagulants or steroid medications. Users should also be cautious not to exceed the recommended dosage or duration of use.

Caffeine is present in the recommended dose of this product, approximately equivalent to that found in a cup of coffee. Users are advised to limit the intake of other caffeine-containing medications, foods, or beverages, as excessive caffeine consumption may lead to nervousness, irritability, sleeplessness, and, in some cases, rapid heartbeat.

Before using this product, individuals should consult a healthcare provider if they have liver disease, if the stomach bleeding warning applies, or if they have a history of stomach issues such as heartburn. Those with high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma, as well as individuals taking diuretics, should also seek medical advice prior to use. Furthermore, it is recommended to consult a doctor or pharmacist if taking prescription medications for diabetes, gout, or arthritis.

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

Users must discontinue use and contact a healthcare professional if any allergic reactions occur, if signs of stomach bleeding are observed (such as feeling faint, having bloody or black stools, vomiting blood, or experiencing persistent stomach pain), if there is ringing in the ears or loss of hearing, if redness or swelling develops, if pain worsens or lasts longer than 10 days, if fever intensifies or persists beyond three days, or if any new symptoms arise.

Side Effects

Patients using this product may experience a range of adverse reactions, some of which can be serious.

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 chickenpox or flu-like symptoms. Patients should be advised not to use this product under these circumstances. If changes in behavior accompanied by nausea and vomiting occur, it is essential to consult a healthcare professional, as these may be early signs of Reye's syndrome.

Severe allergic reactions may occur, particularly in patients sensitive to aspirin or acetaminophen. Symptoms of an allergic reaction to aspirin can include shock, facial swelling, hives, and asthma (wheezing). For acetaminophen, severe skin reactions may manifest as skin reddening, blisters, or rash. In the event of any skin reaction, patients should discontinue use and seek medical assistance immediately.

This product contains acetaminophen, and patients are at risk for severe liver damage if they exceed 4,000 mg of acetaminophen in 24 hours, consume three or more alcoholic drinks daily while using the product, or take other medications containing acetaminophen concurrently.

Additionally, the presence of an NSAID in this product raises the risk of severe stomach bleeding, particularly in patients aged 60 or older, those taking other NSAIDs, individuals with a history of stomach ulcers or bleeding problems, and those on blood thinners or steroids. Patients should be cautioned to adhere strictly to dosing instructions to minimize this risk.

Common Adverse Reactions:

Patients may also experience less severe but still concerning symptoms. It is recommended that patients stop use and consult a doctor if they experience any signs of stomach bleeding, such as feeling faint, having bloody or black stools, vomiting blood, or experiencing persistent stomach pain. Other symptoms warranting medical consultation include ringing in the ears, loss of hearing, redness or swelling, worsening pain lasting more than 10 days, fever lasting more than 3 days, or the emergence of any new symptoms.

Caffeine Considerations:

The recommended dose of this product contains approximately the same amount of caffeine as a cup of coffee. Patients should limit the use of other caffeine-containing medications, foods, or beverages, as excessive caffeine intake may lead to nervousness, irritability, sleeplessness, and, in some cases, rapid heartbeat.

Precautions:

Patients should consult a healthcare professional before using this product if they have liver disease, a history of stomach problems (such as heartburn), high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma. Additionally, those taking diuretics or prescription medications for diabetes, gout, or arthritis should seek advice prior to use.

Drug Interactions

Patients should consult a healthcare professional prior to using this medication if they are concurrently taking prescription drugs for diabetes, gout, or arthritis, as these conditions may influence the drug's efficacy or safety profile.

Co-administration with other nonsteroidal anti-inflammatory drugs (NSAIDs), including both prescription and over-the-counter options such as aspirin, ibuprofen, or naproxen, may significantly increase the risk of severe gastrointestinal bleeding. Therefore, it is advised to avoid the use of this medication in conjunction with any other NSAID.

Additionally, this medication should not be used alongside any other products containing acetaminophen, whether prescription or nonprescription, to prevent the risk of acetaminophen overdose and associated adverse effects.

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

Packaging & NDC

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

Pediatric Use

Pediatric patients, particularly children and teenagers who have or are recovering from chicken pox or flu-like symptoms, should not use this product due to the risk of Reye’s syndrome. Healthcare professionals should be vigilant for changes in behavior accompanied by nausea and vomiting in pediatric patients, as these symptoms may indicate the onset of Reye's syndrome, necessitating immediate consultation with a physician.

For dosing, adults and children aged 12 years and older are advised 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 consult a doctor for appropriate dosing guidance.

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). Therefore, caution is advised when prescribing this medication to geriatric patients.

It is essential for healthcare providers to assess the overall health status of elderly patients prior to initiating treatment. Patients with a history of high blood pressure, heart disease, liver cirrhosis, or kidney disease should consult with their healthcare provider before using this product. Monitoring for potential adverse effects is recommended to ensure patient safety and to manage any complications that may arise during 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.

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, 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 during lactation.

Renal Impairment

Patients with renal impairment should consult a healthcare professional prior to use, particularly if they have underlying 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 be closely monitored when using this product, which contains acetaminophen. Severe liver damage may occur if patients exceed the recommended dosage of 4,000 mg of acetaminophen within a 24-hour period. Additionally, patients should be advised against consuming three or more alcoholic drinks daily while using this product, as this may further increase the risk of liver damage.

It is essential for patients with known liver disease to consult a healthcare professional prior to using this product. Healthcare providers should evaluate liver function and consider potential interactions with other medications containing acetaminophen to ensure patient safety.

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 should be aware that the lack of immediate symptoms does not preclude the potential for serious health consequences. 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 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 events associated with the use of this product, reported voluntarily or through surveillance programs.

Severe allergic reactions have been noted with aspirin, which may manifest as shock, facial swelling, hives, or asthma (wheezing). Acetaminophen has been associated with severe skin reactions, including symptoms such as skin reddening, blisters, and rash. In the event of a skin reaction, it is advised to discontinue use and seek medical assistance immediately.

Warnings regarding liver damage have been highlighted, indicating that severe liver injury may occur if acetaminophen is taken in excess of 4,000 mg within a 24-hour period, consumed concurrently with three or more alcoholic drinks daily, or used alongside other medications containing acetaminophen.

The product also contains a nonsteroidal anti-inflammatory drug (NSAID), which may increase the risk of severe stomach bleeding, particularly in individuals aged 60 or older, those taking other NSAIDs, individuals consuming three or more alcoholic drinks daily, or those with a history of stomach ulcers or bleeding issues. Additionally, concurrent use of blood thinners or steroid medications, as well as exceeding the recommended dosage or duration of use, may elevate this risk.

Caffeine content in the recommended dose 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 symptoms such as nervousness, irritability, sleeplessness, and, in some cases, rapid heartbeat.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center in the event of an overdose, as prompt medical attention is crucial 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 a history of allergic reactions to any other pain reliever or fever reducer. It is also important to counsel patients against using this medication in conjunction with any other drug that contains acetaminophen, whether prescription or nonprescription. If patients are uncertain about the presence of acetaminophen in their medications, they should be encouraged to consult a doctor or pharmacist.

Patients should be instructed to discontinue use and consult a doctor if they experience any signs of an allergic reaction or if they notice symptoms indicative of stomach bleeding, such as feeling faint, having bloody or black stools, vomiting blood, or experiencing persistent stomach pain. Additionally, they should be advised to stop use and seek medical advice if they experience ringing in the ears, loss of hearing, redness or swelling, worsening pain that lasts more than 10 days, or a fever that worsens or persists for more than 3 days. Patients should also be encouraged to report any new symptoms that arise.

Before initiating treatment, patients should be advised 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. Furthermore, patients with high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma should seek medical advice prior to use. Those taking diuretics or prescription medications for diabetes, gout, or arthritis should also be encouraged to discuss their current medications with a doctor or pharmacist before using this product.

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 tracking and usage. Special handling requirements are not specified; however, maintaining the recommended storage conditions is essential for product integrity.

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 doctor, as it may pose risks to the unborn child or lead to complications during delivery. In the event of an overdose, patients must seek immediate medical assistance or contact a Poison Control Center, as prompt intervention is essential for both adults and children, even in the absence of noticeable symptoms.

Drug Information (PDF)

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

View product document (PDF)