Pain and Fever

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 headache, sore throat, flu, toothache, and the common cold. Additionally, it is indicated for the temporary reduction of fever.

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

Dosage and Administration

This product is intended for use in accordance with the dosing chart provided below. Healthcare professionals should ensure that the correct dose is determined based on the patient's weight or age, as applicable.

For patients weighing under 24 pounds or under 2 years of age, it is advised to consult a physician before administration. For patients weighing between 24 to 35 pounds and aged 2 to 3 years, the recommended dose is 1 tablet. For those weighing 36 to 47 pounds and aged 4 to 5 years, the dose is 1 ½ tablets. Patients weighing 48 to 59 pounds and aged 6 to 8 years should receive 2 tablets. For individuals weighing 60 to 71 pounds and aged 9 to 10 years, the appropriate dose is 2 ½ tablets. Finally, for patients weighing 72 to 95 pounds and aged 11 years, the recommended dose is 3 tablets.

Tablets must be chewed or crushed completely before swallowing; they should not be swallowed whole. Dosing may be repeated every 4 hours as needed while symptoms persist, but should not exceed 5 doses within a 24-hour period. It is imperative to adhere strictly to these guidelines and not exceed the recommended dosage.

Contraindications

Use of this product is contraindicated in patients who are concurrently taking any other medication that contains acetaminophen, whether prescription or nonprescription. This is due to the potential risk of acetaminophen overdose, which can lead to serious liver damage. If there is uncertainty regarding the presence of acetaminophen in other medications, consultation with a healthcare professional is advised.

Warnings and Precautions

Severe liver damage may occur in children who take this product, which contains acetaminophen, if they exceed the maximum daily amount of 5 doses within a 24-hour period or if they use it concurrently with other medications containing acetaminophen. Healthcare professionals should advise caregivers to adhere strictly to dosing guidelines to mitigate the risk of liver injury.

Acetaminophen has been associated with severe skin reactions, which may manifest as skin reddening, blisters, or rash. In the event of any skin reaction, it is imperative to discontinue use immediately and seek medical assistance without delay.

In cases of severe sore throat that persists for more than 2 days, or if it is accompanied or followed by fever, headache, rash, nausea, or vomiting, healthcare providers should be consulted promptly to rule out serious underlying conditions.

Before administering this product, it is essential to consult a physician if the child has a history of liver disease. Additionally, caregivers should seek advice from a healthcare professional or pharmacist if the child is currently taking warfarin, a blood-thinning medication, to avoid potential interactions.

In the event of an overdose, immediate medical attention is crucial. Caregivers should contact a Poison Control Center or seek emergency medical help right away, as prompt intervention is vital for both adults and children, even in the absence of noticeable symptoms.

Healthcare professionals should instruct caregivers to discontinue use and consult a physician if the child experiences worsening pain lasting more than 5 days, a fever that worsens or persists beyond 3 days, the emergence of any new symptoms, or the presence of redness or swelling.

Side Effects

Patients using this product should be aware of several important warnings and potential adverse reactions.

Severe liver damage may occur in patients who exceed the maximum daily dosage of acetaminophen, which is more than 5 doses in a 24-hour period, or who take this product concurrently with other medications containing acetaminophen. Patients with pre-existing liver disease should consult a doctor before use.

There is also an allergy alert associated with acetaminophen, as it may lead to severe skin reactions. Symptoms of such reactions can include skin reddening, blisters, and rash. If any of these symptoms occur, patients are advised to discontinue use immediately and seek medical assistance.

In cases where a sore throat is severe, persists for more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting, patients should consult a doctor promptly.

Patients should stop using the product and seek medical advice if pain worsens or lasts longer than 5 days, if fever worsens or lasts more than 3 days, if any new symptoms appear, or if there is any redness or swelling.

Additionally, it is recommended that patients taking the blood-thinning medication warfarin consult 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 necessitate careful monitoring of coagulation parameters to avoid potential adverse effects related to increased bleeding risk. Adjustments to the dosage of either medication may be required based on clinical judgment and patient response.

Packaging & NDC

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

Pediatric Use

Pediatric patients under 24 lb (under 2 years) should consult a doctor before use. For those weighing 24-35 lb (2-3 years), the recommended dose is 1 tablet; for 36-47 lb (4-5 years), 1 1/2 tablets; for 48-59 lb (6-8 years), 2 tablets; for 60-71 lb (9-10 years), 2 1/2 tablets; and for 72-95 lb (11 years), 3 tablets.

Safety concerns include a liver warning indicating that severe liver damage may occur if more than 5 doses are taken in 24 hours, which is the maximum daily amount. An allergy alert is also present, as acetaminophen may cause severe skin reactions, including skin reddening, blisters, and rash. If any skin reaction occurs, use should be stopped immediately, and medical help should be sought. Additionally, if a sore throat is severe, persists for more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting, a doctor should be consulted promptly.

Precautions include consulting a doctor before use if the child has liver disease or is taking the blood-thinning drug warfarin. Use should be stopped and a doctor consulted if pain worsens or lasts more than 5 days, fever worsens or lasts more than 3 days, any new symptoms appear, or redness or swelling is present.

Administration instructions specify that the medication should not be given more than directed. Tablets should be chewed or crushed completely before swallowing; they should not be swallowed whole. Doses may be repeated every 4 hours while symptoms persist, but should not exceed 5 doses in 24 hours.

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 potential adverse effects or changes in efficacy, given the lack of targeted data for this population.

Pregnancy

Pregnant patients should be advised against the concurrent use of this medication with any other drug containing acetaminophen, whether prescription or nonprescription. It is essential for healthcare providers to inquire about all medications the patient is taking to avoid potential overdose and associated risks.

In cases where the patient has a history of liver disease, consultation with a healthcare professional is recommended prior to use. Additionally, if the patient is taking anticoagulants such as warfarin, it is crucial to seek guidance from a doctor or pharmacist before administration, as interactions may pose significant risks.

In the event of an overdose, immediate medical assistance should be sought, and contacting a Poison Control Center is advised. Prompt intervention is critical for both adults and children, regardless of the presence of symptoms.

Healthcare providers should carefully weigh the benefits and risks of this medication in pregnant patients, considering the potential for adverse fetal outcomes associated with misuse or overdose.

Lactation

Nursing mothers should consult a doctor before using this product. There is a potential for excretion of acetaminophen in breast milk. Caution is advised when administering this medication to nursing mothers due to the potential risk to the infant.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the drug insert regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients to ensure safety and efficacy.

Hepatic Impairment

Patients with hepatic impairment should be closely monitored when using this product, as it contains acetaminophen, which is associated with the risk of severe liver damage. It is critical to adhere to the maximum daily dosage of 5 doses within a 24-hour period to mitigate the risk of hepatotoxicity.

Before administration, it is advised that healthcare providers be consulted if the patient has a history of liver disease. This precaution is essential to ensure the safety and efficacy of the treatment in individuals with compromised liver function.

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 comprehensive care as needed.

Nonclinical Toxicology

No teratogenic or non-teratogenic effects have been reported in the available nonclinical studies. Additionally, there is no information regarding animal pharmacology and toxicology. The absence of data limits the assessment of potential risks associated with the use of the compound in question.

Postmarketing Experience

Acetaminophen has been associated with severe skin reactions, as reported in postmarketing surveillance. Symptoms of these reactions may include skin reddening, blisters, and rash. In the event of a skin reaction, it is advised to discontinue use immediately and seek medical assistance.

Additionally, cases of overdose have been reported. It is crucial to obtain medical help or contact a Poison Control Center without delay, as prompt medical attention is essential for both adults and children, even in the absence of noticeable signs or symptoms.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center in the event of an overdose, emphasizing that 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 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 with a doctor or pharmacist for clarification.

Healthcare providers should instruct patients to discontinue use and consult a doctor if their pain worsens or persists for more than five days. Similarly, patients should be advised to stop using the medication and seek medical advice if their fever intensifies or lasts longer than three days. They should also be informed to stop use and contact a healthcare professional if any new symptoms arise or if there is any redness or swelling.

Additionally, it is important for healthcare providers to recommend that patients consult a doctor before using this medication if their child has liver disease. Patients should also be advised to speak with a doctor or pharmacist prior to use if their child is currently taking the blood-thinning medication warfarin.

Storage and Handling

The product is supplied in tamper-evident packaging. It is essential to refrain from using the product if the outer package is opened or if the blister is torn or broken.

Storage conditions require the product to be maintained at a temperature of 25ºC (77ºF), with permissible excursions between 15ºC and 30ºC (59ºF to 86ºF). It is important to avoid high humidity during storage.

For tracking purposes, the expiration date and lot number can be found on the end flap of the packaging.

Additional Clinical Information

The medication is administered orally, with a recommended repeat dose every 4 hours as needed for symptom relief, not to exceed 5 doses within a 24-hour period. Clinicians should counsel patients 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 crucial for both adults and children, even in the absence of noticeable symptoms.

Drug Information (PDF)

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

View product document (PDF)