Headache Relief

Description

CVP® HEALTH is a formulation designed for extra strength headache relief, containing a combination of active ingredients: acetaminophen, aspirin (a nonsteroidal anti-inflammatory drug), and caffeine. The product is presented in the form of coated tablets, with a total of 24 tablets per package.

The product is subject to a tamper evident warning, indicating that it should not be used if the imprinted safety seal under the cap is broken or missing. It is important to note that this product is not manufactured or distributed by GSK Consumer Healthcare SARL, the owner of the registered trademark Excedrin® Extra Strength. CVP® HEALTH is distributed by Consumer Value Products, Inc., located at P.O. Box 6115, Temple, Texas 76502. For additional information, the product can be found online at CVPproducts.com.

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, toothache, muscular aches, 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 and not exceed the directed amount. Each dose should be taken with a full glass of water to ensure proper administration.

For adults and children aged 12 years and older, the recommended dosage is 2 tablets every 6 hours, with a maximum limit of 8 tablets within a 24-hour period.

For children under 12 years of age, it is advised to consult a physician for appropriate dosing recommendations.

Contraindications

Use of this product is contraindicated in the following situations:

Patients with a history of allergic reactions to acetaminophen, aspirin, or any other pain reliever or fever reducer should not use this product due to the risk of severe allergic reactions.

Concurrent use with any other medication containing acetaminophen, whether prescription or nonprescription, is contraindicated. If there is uncertainty regarding the presence of acetaminophen in other medications, consultation with a healthcare professional is advised.

Additionally, individuals who have previously experienced an allergic reaction to this product or any of its components should refrain from its use to prevent potential adverse effects.

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. Similarly, acetaminophen may cause severe skin reactions, including skin reddening, blisters, or rash. In the event of a skin reaction, the product should 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.

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 who take more than the recommended dosage or for an extended duration, have a history of stomach ulcers or bleeding issues, are on anticoagulant or steroid medications, are aged 60 or older, or consume three or more alcoholic drinks daily while using this product.

Caffeine is also present in the recommended dosage, which 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 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 asthma, a history of stomach issues such as heartburn, are taking diuretics, or have conditions such as high blood pressure, heart disease, liver cirrhosis, or kidney disease. Patients with liver disease or those for whom the stomach bleeding warning is applicable should also seek medical advice before use. Furthermore, individuals taking prescription medications for diabetes, gout, or arthritis, or any other serious conditions, should consult a healthcare provider or pharmacist before using this product.

In the event of an accidental 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, loss of hearing, new or worsening symptoms, redness or swelling, pain lasting more than 10 days, or fever lasting more than three days. These symptoms may indicate a serious condition requiring prompt medical evaluation.

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 to discontinue use and consult a doctor if they experience changes in behavior accompanied by nausea and vomiting, 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 hives, facial swelling, shock, and asthma (wheezing). For acetaminophen, severe skin reactions may manifest as skin reddening, blisters, or rash. In the event of a skin reaction, patients should stop use and seek medical assistance immediately.

Patients should also be aware of the risk of severe liver damage associated with acetaminophen, particularly if they exceed 4,000 mg in 24 hours, use other products containing acetaminophen, or consume three or more alcoholic drinks daily while using this product.

Additionally, the product contains an NSAID, which may increase the risk of severe stomach bleeding. This risk is heightened in patients who take more than the recommended dose, have a history of stomach ulcers or bleeding problems, are on anticoagulant or steroid medications, are aged 60 or older, or consume three or more alcoholic drinks daily while using this product.

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 use 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 persistent stomach pain), ringing in the ears or loss of hearing, new symptoms, redness or swelling, worsening pain lasting more than 10 days, or a fever that worsens or lasts more than three days. These symptoms could indicate a serious condition requiring medical attention.

Drug Interactions

Co-administration of this medication with any other drug containing acetaminophen, whether prescription or nonprescription, is contraindicated due to the risk of acetaminophen overdose and associated hepatotoxicity.

Pharmacodynamic interactions are significant when this medication is used concurrently with anticoagulants or steroid drugs. The risk of severe gastrointestinal bleeding is increased in patients taking these agents. Therefore, careful monitoring for signs of gastrointestinal bleeding is advised in such cases.

Additionally, the concomitant use of this medication with other nonsteroidal anti-inflammatory drugs (NSAIDs), including but not limited to aspirin, ibuprofen, and naproxen, also heightens the risk of severe stomach bleeding. It is recommended that patients avoid using multiple NSAIDs simultaneously.

Patients taking prescription medications for diabetes, gout, or arthritis should consult with a healthcare professional, such as a doctor or pharmacist, prior to initiating this medication to ensure safe and effective use.

Packaging & NDC

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

Pediatric Use

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, a rare but serious illness. If changes in behavior accompanied by nausea and vomiting occur while using this product, it is important to consult a doctor, 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 tablets every 6 hours, with a maximum of 8 tablets in a 24-hour period. For children under 12 years, it is advised to consult a doctor before use.

This product should be kept out of reach of children. In the event of an accidental overdose, immediate medical assistance should be sought, or contact a Poison Control Center right away, as prompt medical attention is critical for both adults and children, even if no signs or symptoms are apparent.

Geriatric Use

Elderly patients, particularly those aged 60 years and older, may have an increased risk of stomach bleeding. Healthcare providers should exercise caution when prescribing this medication to geriatric patients, considering the heightened susceptibility to gastrointestinal complications.

It is advisable to monitor these patients closely for any signs of gastrointestinal bleeding and to evaluate the necessity of dosage adjustments based on individual patient factors. Careful assessment of the risk-benefit ratio is essential in this population to ensure safe and effective use of the medication.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional before using this medication. The use of aspirin is particularly cautioned against after 20 weeks of pregnancy, as it may pose risks to the unborn child and lead to complications during delivery. It is essential for healthcare providers to evaluate the potential benefits and risks before prescribing this medication to pregnant women.

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 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 exercise caution when using this product, as it contains acetaminophen, which is associated with the risk of severe liver damage. It is critical that patients do not exceed 4,000 mg of acetaminophen within a 24-hour period, avoid concurrent use with other medications containing acetaminophen, and limit alcohol consumption to fewer than three alcoholic drinks per day while using this product.

Before initiating treatment, patients with liver disease, including those with liver cirrhosis, should consult a healthcare professional. Monitoring of liver function may be warranted in these patients to ensure safety and efficacy. Adjustments to dosage or additional precautions may be necessary based on the severity of hepatic impairment.

Overdosage

In the event of an accidental overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. Prompt medical attention is crucial for both adults and children, even in the absence of noticeable signs or symptoms.

Healthcare professionals should be aware that the severity of symptoms may vary, and early intervention can significantly impact the outcome. 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 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 indicated that acetaminophen may be associated with severe skin reactions. Reports have included instances of skin reddening, blisters, and rash. In the event of a skin reaction, it is advised to discontinue use immediately and seek medical assistance.

Patient Counseling

Healthcare providers should advise patients on the importance of seeking immediate medical assistance in the event of an accidental overdose. Patients should be informed to contact a Poison Control Center or seek medical help right away, as prompt medical attention is critical for both adults and children. It is essential to emphasize that even if no signs or symptoms are apparent, medical evaluation is necessary to ensure safety and appropriate care.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available upon request. 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

The medication is administered orally, with specific dosing guidelines for different age groups. Adults and children aged 12 years and older are instructed to take 2 tablets every 6 hours, with a maximum of 8 tablets in a 24-hour period. For children under 12 years, consultation with a healthcare provider is recommended before administration.

Clinicians should counsel patients regarding the use of this medication during pregnancy and breastfeeding. It is crucial to seek advice from a health professional if pregnant, particularly after 20 weeks, as aspirin may pose risks to the unborn child or lead to complications during delivery. In the event of an accidental overdose, patients must seek immediate medical assistance or contact a Poison Control Center, as prompt intervention is essential for both adults and children, regardless of the presence of symptoms.

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.

View product document (PDF)