Excedrin Extra Strength, Excedrin Extra Strength, Cvp Health, Excedrin Extra ...

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 individuals 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 other 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 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.

This product contains acetaminophen, which has the potential to cause severe skin reactions. Symptoms may include skin reddening, blisters, and rash. Should any skin reaction occur, the user must discontinue use immediately and seek medical assistance.

Severe liver damage may result from the consumption of this product if the user exceeds the maximum daily dosage of 8 caplets within a 24-hour period, combines it with other medications containing acetaminophen, or consumes three or more alcoholic drinks daily while using this product.

Additionally, 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 duration or dosage.

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

Before using this product, individuals should consult a physician if they have liver disease, if the stomach bleeding warning applies, if they have a history of stomach issues such as heartburn, or if they have high blood pressure, heart disease, liver cirrhosis, or kidney disease. Additionally, those taking diuretics or who have asthma should seek medical advice prior to use. It is also recommended to consult a doctor or pharmacist if the user is taking prescription medications for diabetes, gout, or arthritis, or if they are under medical care for any serious condition.

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, as prompt intervention is essential for both adults and children, even in the absence of noticeable signs or symptoms.

Users must discontinue use and consult a physician if any allergic reaction occurs, or if they experience signs of stomach bleeding, which may include feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain. Additional symptoms warranting medical attention include 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 lasts more than three days, or the emergence of any new symptoms, as these may indicate a serious condition.

Side Effects

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

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. If patients experience changes in behavior accompanied by nausea and vomiting while using this product, they should consult a doctor immediately, as these symptoms could indicate the onset of Reye's syndrome.

Severe skin reactions may occur due to acetaminophen, with symptoms including skin reddening, blisters, and rash. In the event of a skin reaction, patients are advised to discontinue use and seek medical assistance promptly. Additionally, aspirin may provoke severe allergic reactions characterized by hives, facial swelling, asthma (wheezing), and shock.

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.

Furthermore, the presence of an 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, individuals taking anticoagulants or steroid drugs, and those consuming three or more alcoholic drinks daily. Patients should also be cautious if they take other NSAIDs, whether prescription or nonprescription, or if they exceed the recommended duration or dosage.

Caffeine is also a component of this product, and patients are advised to limit the intake of other caffeine-containing medications, foods, or beverages. Excessive caffeine consumption may lead to nervousness, irritability, sleeplessness, and, in some cases, rapid heartbeat.

Patients should stop using the product and seek medical attention if they experience any signs of an allergic reaction or symptoms indicative of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain. Other concerning symptoms include ringing in the ears, loss of hearing, redness or swelling in a painful area, worsening pain lasting more than 10 days, fever lasting more than 3 days, or the emergence of any new symptoms.

Before using this product, patients should 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 if they are taking diuretics or have asthma.

Patients with a known allergy to acetaminophen, aspirin, or any other pain reliever or fever reducer should not use this product. It is also important to avoid concurrent use with any other medications containing acetaminophen, whether prescription or nonprescription. If there is uncertainty regarding the presence of acetaminophen in other medications, patients should seek guidance from a healthcare professional.

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 Excedrin Extra Strength, Excedrin Extra Strength, Cvp Health, Excedrin Extra Strength, Travel Basix (acetaminophen, aspirin, and caffeine). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Children and teenagers who have or are 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 important to consult a doctor, as these symptoms may indicate an early sign of Reye's syndrome.

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.

This product should be kept out of reach of children. In the event of an overdose, immediate medical assistance should be sought, or contact a Poison Control Center right away. Quick medical attention is critical for both adults and children, even if no signs or symptoms are immediately 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 when treating elderly patients with this medication.

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 fetal outcomes 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 if they are pregnant or breastfeeding. It is particularly important to avoid the use of aspirin during the last three months of pregnancy unless specifically directed by a healthcare provider, 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.

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 consult a healthcare professional prior to using this product. It is important to note that this product contains acetaminophen, which carries a risk of severe liver damage under certain conditions.

Patients with compromised liver function must be particularly cautious not to exceed the maximum daily dosage of 8 caplets within a 24-hour period. Additionally, the concurrent use of other medications containing acetaminophen should be avoided to prevent the risk of exceeding safe acetaminophen levels.

Furthermore, patients who consume three or more alcoholic drinks daily should refrain from using this product, as this may significantly increase the risk of liver damage. Regular monitoring of liver function may be warranted in patients with existing liver disease to ensure safety and efficacy while using this product.

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 observable 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 during the last three months of pregnancy unless specifically directed by a healthcare professional, as it may lead to complications for the unborn child or during delivery. No specific non-teratogenic effects have been identified in the available data. Additionally, there are no details regarding nonclinical toxicology or animal pharmacology and toxicology provided in the current information.

Postmarketing Experience

No postmarketing experience details are available for SPL code 90375-7.

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 critical for patients to seek medical help or contact a Poison Control Center immediately, as prompt medical attention is essential for both adults and children, even if no signs or symptoms are initially apparent.

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 medication in conjunction with any other drug 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 any of the following symptoms indicative of stomach bleeding: feeling faint, vomiting blood, having bloody or black stools, experiencing stomach pain that does not improve, noticing ringing in the ears or loss of hearing, observing redness or swelling in a painful area, or if pain worsens or persists for more than 10 days. They should also seek medical attention if a fever worsens or lasts for more than 3 days, or if any new symptoms arise, as these could indicate a serious condition.

Patients should be advised to consult a doctor before using this medication if they have liver disease, a history of stomach problems such as heartburn, or if the stomach bleeding warning applies to them. Furthermore, they should seek medical advice if they have high blood pressure, heart disease, liver cirrhosis, or kidney disease, or if they are taking a diuretic. Patients with asthma should also be encouraged to consult a doctor prior to use. Lastly, patients taking prescription medications for diabetes, gout, or arthritis, or any other drugs, should discuss their current medications with a doctor or pharmacist before using this medication, especially if they are under care for any serious condition.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at a controlled room temperature of 20° to 25°C (68° to 77°F) to maintain its integrity and efficacy. Proper storage conditions should be ensured to prevent exposure to extreme temperatures.

Additional Clinical Information

Adults and children aged 12 years and over 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, consultation with a doctor is recommended before administration.

Clinicians should counsel patients on the importance of consulting a health professional if they are pregnant or breastfeeding. It is particularly crucial to avoid aspirin during the last trimester of pregnancy unless specifically directed by a physician, as it may pose risks to the unborn child or lead to complications during delivery. Additionally, patients should be informed to keep the medication out of reach of children and to seek immediate medical assistance or contact a Poison Control Center in the event of an overdose, as prompt attention is essential for both adults and children, even in the absence of noticeable symptoms.

Drug Information (PDF)

This file contains official product information for Excedrin Extra Strength, Excedrin Extra Strength, Cvp Health, Excedrin Extra Strength, Travel Basix, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)