Bioelectro Extra Strength Headache Relief

Description

No description information is available for the specified 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 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 acetaminophen, aspirin, or any pain reliever/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 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.

Acetaminophen, a component of this product, has been associated with severe skin reactions, which may manifest as reddening, blisters, or rash. Should any skin reactions occur, the use of the product must be discontinued immediately, and a healthcare professional should be consulted. Additionally, aspirin may provoke severe allergic reactions, including hives, facial swelling, asthma (wheezing), or shock.

This product contains acetaminophen, and severe liver damage may occur if the following conditions are met: exceeding 8 caplets in 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.

Furthermore, this product contains a nonsteroidal anti-inflammatory drug (NSAID), which may lead to severe stomach bleeding. The risk of such an event 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.

The recommended dose 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 result in 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, kidney disease, or asthma. Additionally, patients should seek medical advice if they are taking diuretics, any other NSAIDs (whether prescription or nonprescription), anticoagulants, steroid medications, or prescription drugs for diabetes, gout, or arthritis, or if they are under a physician's care for any serious condition.

In the event of an overdose, immediate medical assistance should be sought, or contact with a Poison Control Center (1-800-222-1222) is recommended. Prompt medical attention is crucial, even in the absence of symptoms.

Patients should discontinue use and contact a healthcare provider if they experience any allergic reactions, signs of stomach bleeding (such as feeling faint, vomiting blood, having bloody or black stools, or persistent stomach pain), ringing in the ears or hearing loss, redness or swelling in a painful area, worsening pain lasting more than 10 days, fever that worsens or lasts more than three days, or any new symptoms.

Side Effects

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

Serious adverse reactions include the risk of Reye's syndrome, particularly in children and teenagers who have or are recovering from chickenpox or flu-like symptoms. If patients exhibit 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, a rare but serious condition.

Severe allergic reactions may occur, particularly in patients with a history of allergies to acetaminophen, aspirin, or other pain relievers/fever reducers. Such reactions can manifest as hives, facial swelling, asthma (wheezing), or shock. Patients experiencing any signs of an allergic reaction should stop use and seek medical attention promptly.

The product contains acetaminophen, which poses a risk of severe liver damage if patients exceed the maximum daily dosage of 8 caplets within 24 hours, use it in conjunction with other acetaminophen-containing medications, or consume three or more alcoholic drinks daily while using this product.

Additionally, the presence of a nonsteroidal anti-inflammatory drug (NSAID) in this product raises the risk of severe stomach bleeding, particularly in patients aged 60 or older, those with a history of stomach ulcers or bleeding problems, and individuals taking blood thinners or other NSAIDs. Patients should be vigilant for signs of stomach bleeding, such as feeling faint, vomiting blood, or having bloody or black stools, and should seek medical help if these symptoms occur.

Common adverse reactions may include gastrointestinal discomfort, and patients are advised to limit the use of caffeine-containing products while taking this medication, as excessive caffeine can lead to nervousness, irritability, sleeplessness, and occasionally rapid heartbeat.

Patients should discontinue use and consult a doctor if they experience any new symptoms, if pain worsens or persists for more than 10 days, if fever worsens or lasts for more than three days, or if they notice ringing in the ears or loss of hearing.

Before using this product, patients with liver disease, a history of stomach problems, high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma should consult a doctor. It is also advisable for patients taking diuretics or any other medications, particularly those containing NSAIDs or blood thinners, to seek medical advice prior to use.

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

Pediatric Use

Pediatric patients, including 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 signs of Reye's syndrome.

For dosing, adults and children aged 12 years and older are instructed 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, may have an increased risk of severe stomach bleeding when using this medication. It is essential for healthcare providers to exercise caution when prescribing to this population.

Before initiating treatment, it is advisable for healthcare providers to assess the patient's medical history, especially in those with pre-existing conditions such as high blood pressure, heart disease, liver cirrhosis, or kidney disease. Consultation with a physician is recommended to evaluate the appropriateness of the medication in these cases, ensuring that potential risks are adequately managed and monitored.

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 the unborn child or 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 health professional prior to using this medication. It is particularly important to avoid the use of aspirin during the last three months of pregnancy unless explicitly 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 while breastfeeding.

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 use. It is important to note that severe liver damage may occur if patients exceed 8 caplets within a 24-hour period, particularly when combined with other medications containing acetaminophen or when consuming 3 or more alcoholic drinks daily while using this product. Therefore, careful consideration and monitoring of liver function are advised for patients with compromised liver function to prevent potential adverse effects.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222. Prompt medical intervention is crucial, even in the absence of symptoms, as the effects of an overdose may not be immediately apparent.

Healthcare professionals should be aware that timely management can significantly influence patient outcomes. Therefore, it is essential to monitor the patient closely and provide supportive care as needed.

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

No postmarketing experience details are available in the insert text.

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 for patients to seek medical help or contact a Poison Control Center immediately at 1-800-222-1222, as prompt medical attention is essential even if no symptoms are present.

Patients should be informed not to use this medication if they have ever experienced an allergic reaction to acetaminophen, aspirin, or any other pain reliever or fever reducer. Additionally, they should not use this product in conjunction with any other medication 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 using the medication and seek medical advice if they experience any signs of an allergic reaction or if they notice symptoms indicative of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain. They should also be advised to discontinue use and consult a doctor if they experience ringing in the ears, loss of hearing, redness or swelling in a painful area, worsening pain lasting more than 10 days, or a fever that worsens or lasts more than 3 days. Any new symptoms that arise should prompt a discussion with a healthcare provider.

Before using this medication, patients should be encouraged to consult a doctor if they have liver disease, a history of stomach problems (such as heartburn), high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma. They should also seek medical advice if they are taking a diuretic, any other NSAID (whether prescription or nonprescription), blood-thinning medications (anticoagulants), steroid drugs, or prescription medications for diabetes, gout, or arthritis. It is important for patients to inform their healthcare provider about any other medications they are taking or if they are under a doctor's care for any serious condition.

Storage and Handling

The product is supplied in a configuration that includes specific NDC numbers, which should be referenced for accurate identification. It is essential to store the product at room temperature, maintaining a temperature range of 20-25°C (68°-77°F).

After each use, the cap must be closed tightly to ensure the integrity of the product. Users are advised to read all product information thoroughly before use and to retain the carton for future reference regarding drug facts.

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 on important safety information. Pregnant or breastfeeding individuals should seek advice from a health professional prior to use, particularly noting that aspirin should generally be avoided during the last trimester of pregnancy unless specifically directed by a physician, due to potential risks to the fetus and complications during delivery. Additionally, the medication should be kept out of reach of children, and in the event of an overdose, immediate medical assistance should be sought or the Poison Control Center contacted at 1-800-222-1222, as prompt attention is crucial even if symptoms are not present.

Drug Information (PDF)

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

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