Headache Man

Description

This liquid formulation provides headache and pain relief, containing 650 mg of acetaminophen per dose. It functions as both a pain reliever and fever reducer. The product includes 1.1% alcohol and is flavored with organic lemon. The total volume of the solution is 1.7 fluid ounces (50 mL).

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with various conditions, including headache, sore throat, minor pain of arthritis, muscle aches, cold and flu symptoms, toothache, and premenstrual and menstrual cramps. Additionally, it is indicated for the temporary reduction of fever.

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

Dosage and Administration

Adults are advised to take one Headache Man One Shot™ every 4 to 6 hours, or as directed by a healthcare professional, while symptoms persist. It is important not to exceed a total of 6 Headache Man Shots™ within a 24-hour period.

The use of Headache Man One Shot™ is not recommended for children under 12 years of age.

Contraindications

Use of this product is contraindicated in patients who are concurrently taking any other medication that contains acetaminophen, whether prescription or non-prescription. The combination may lead to an increased risk of acetaminophen-related toxicity. If there is uncertainty regarding the presence of acetaminophen in other medications, consultation with a healthcare professional is advised.

Warnings and Precautions

This product contains acetaminophen, which poses a risk of severe liver damage if the following conditions are met: exceeding 6 bottles within a 24-hour period, concurrent use with other medications containing acetaminophen, or consumption of 3 or more alcoholic drinks daily while using this product.

Acetaminophen may also lead to severe skin reactions, which can manifest as skin reddening, blisters, or rash. In the event of a skin reaction, it is imperative to discontinue use immediately and seek medical assistance.

Healthcare professionals should advise patients to consult a doctor if they experience a sore throat that is severe, persists for more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting.

General precautions include advising patients to seek medical advice prior to use if they have a history of liver disease. Additionally, patients taking the anticoagulant warfarin should consult a doctor or pharmacist before using this product.

In cases of overdose, immediate medical attention is crucial. Patients should be instructed to contact a Poison Control Center (800-222-1222) or seek emergency medical help right away, even if no signs or symptoms are apparent.

Patients should also be advised to discontinue use and consult a doctor if any of the following occur: worsening pain lasting more than 10 days, worsening fever lasting more than 3 days, the emergence of new symptoms, or the presence of redness or swelling. These symptoms may indicate a serious underlying condition that requires medical evaluation.

Side Effects

Severe liver damage may occur in patients who exceed the maximum daily amount of six bottles within a 24-hour period, take the product in conjunction with other medications containing acetaminophen, or consume three or more alcoholic drinks daily while using this product.

Patients should be aware that acetaminophen may cause severe skin reactions, which can manifest as skin reddening, blisters, or rash. In the event of a skin reaction, it is imperative to discontinue use and seek medical assistance immediately.

In cases of severe sore throat that lasts more than two days, or if it is accompanied or followed by fever, headache, rash, nausea, or vomiting, patients are advised to consult a doctor promptly.

Patients should also stop use and consult a healthcare professional if pain worsens or persists for more than ten days, if fever worsens or lasts more than three days, if new symptoms arise, or if redness or swelling is observed, as these may indicate a serious condition.

It is recommended that patients with liver disease consult a doctor prior to use. Additionally, individuals taking the blood-thinning medication warfarin should seek advice from a doctor or pharmacist before using this product.

Drug Interactions

Patients should consult a healthcare professional prior to using this medication if they are concurrently taking warfarin, a blood-thinning agent. The combination may increase the risk of bleeding due to potential pharmacodynamic interactions.

Additionally, this medication should not be used in conjunction with any other products containing acetaminophen, whether prescription or over-the-counter. Co-administration may lead to an increased risk of acetaminophen-related toxicity. If there is uncertainty regarding the presence of acetaminophen in other medications, patients are advised to seek guidance from a healthcare provider.

Packaging & NDC

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

Pediatric Use

Pediatric patients under 12 years of age should not be administered this medication. Safety and efficacy have not been established in this population, and use is contraindicated. Healthcare professionals are advised to consider alternative treatments for pediatric patients within this age range.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any adverse effects or changes in therapeutic response, given the lack of targeted data for this population.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. The potential risks and benefits must be carefully weighed, as the effects on fetal outcomes and lactation are not fully established. It is essential for women of childbearing potential to seek medical advice to ensure safe use during pregnancy and lactation.

Lactation

Lactating mothers are advised to consult a healthcare professional prior to using this medication. There is currently no available data regarding the excretion of this drug in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

Renal Impairment

Patients with renal impairment have no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the drug insert. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the lack of data necessitates careful clinical judgment.

Hepatic Impairment

Patients with hepatic impairment should consult a healthcare professional prior to using this medication. It is essential for individuals with liver disease to receive appropriate guidance regarding the use of this product, as compromised liver function may affect the drug's metabolism and overall safety profile. Monitoring of liver function may be necessary to ensure the safe administration of the medication in this population.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center at 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 timely recognition and management of overdose situations can significantly impact patient outcomes. Therefore, it is essential to remain vigilant and proactive in addressing potential overdose cases.

Nonclinical Toxicology

No information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or toxicology.

Postmarketing Experience

No specific postmarketing experience details are provided in the insert text.

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 this medication in conjunction with any other drug that contains acetaminophen, whether prescription or non-prescription. If patients are uncertain about whether a drug contains acetaminophen, they should be encouraged to consult with a doctor or pharmacist for clarification.

Patients should be instructed to discontinue use and seek medical advice if their pain worsens or persists for more than 10 days. Similarly, if a fever worsens or lasts longer than 3 days, patients should stop using the medication and consult a healthcare professional. They should also be made aware that the emergence of new symptoms, or the presence of redness or swelling, warrants immediate medical consultation, as these may indicate a serious condition.

Additionally, it is important for patients to ask a doctor before using this medication if they have a history of liver disease. Patients taking the blood-thinning medication warfarin should also be advised to consult with a doctor or pharmacist prior to use to ensure safety and avoid potential interactions.

Storage and Handling

The product is supplied in a configuration that includes a neckband on the bottle. It is essential to inspect the neckband prior to use; the product should not be utilized if the neckband is broken or missing.

For optimal storage, the product must be maintained at a temperature range of 20-25°C (68-77°F). Proper handling and storage conditions are crucial to ensure the integrity and efficacy of the product.

Additional Clinical Information

The route of administration for the product is oral. Adults are advised to take one Headache Man One Shot™ every 4 to 6 hours, or as directed by a healthcare professional, with a maximum of 6 Headache Man Shots™ in a 24-hour period. The product is not recommended for children under 12 years of age.

Clinicians should counsel patients to consult a healthcare professional if they are pregnant or breastfeeding before use. It is important to keep the product out of reach of children. In the event of an overdose, patients should seek medical assistance or contact a Poison Control Center (800-222-1222) immediately, as prompt medical attention is crucial for both adults and children, even if no symptoms are apparent.

Drug Information (PDF)

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

View product document (PDF)