Pain and Fever

Description

No description information is available for the 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

The recommended dosage of this product is determined primarily by the patient's weight; however, age may be used as an alternative if weight is not available. Healthcare professionals should refer to the dosage chart below to identify the appropriate dose. It is imperative to adhere strictly to the recommended dosages and not exceed the maximum frequency of administration.

Patients should chew or crush the tablets completely before swallowing; whole tablets should not be swallowed. Dosing may be repeated every 4 hours as needed while symptoms persist, but it is essential not to administer more than 5 doses within a 24-hour period.

Dosage Chart:

• For patients weighing under 24 lb or under 2 years of age, consultation with a doctor is advised.

• For patients weighing 24-35 lb or aged 2-3 years, the recommended dose is 1 chewable tablet.

• For patients weighing 36-47 lb or aged 4-5 years, the recommended dose is 1 ½ chewable tablets.

• For patients weighing 48-59 lb or aged 6-8 years, the recommended dose is 2 chewable tablets.

• For patients weighing 60-71 lb or aged 9-10 years, the recommended dose is 2 ½ chewable tablets.

• For patients weighing 72-95 lb or aged 11 years, the recommended dose is 3 chewable tablets.

Dosing may also be adjusted as directed by a healthcare professional.

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 severe 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 with the use of this product, which contains acetaminophen. Healthcare professionals should advise caregivers that exceeding five doses within a 24-hour period, which constitutes the maximum daily amount, or concomitant use with other medications containing acetaminophen can significantly increase the risk of liver injury.

Acetaminophen is also associated with the potential for severe skin reactions. Symptoms indicative of such reactions may include skin reddening, blisters, and rash. In the event of any skin reaction, it is imperative to discontinue use immediately and seek medical assistance.

In cases of severe sore throat, particularly if it persists for more than two days or is accompanied by fever, headache, rash, nausea, or vomiting, prompt consultation with a healthcare provider is recommended.

Healthcare professionals should exercise caution and recommend that caregivers consult a physician prior to use if the child has a history of liver disease. Additionally, it is advisable to seek guidance from a doctor or pharmacist if the child is concurrently taking the anticoagulant warfarin, as interactions may occur.

In the event of an overdose, immediate medical attention is crucial. Caregivers should be instructed to contact a Poison Control Center or seek emergency medical help without delay, regardless of the presence of symptoms.

Patients should be advised to discontinue use and consult a healthcare provider if any of the following occur: pain worsens or persists beyond five days, fever intensifies or lasts more than three days, redness or swelling is observed, or any new symptoms develop.

Side Effects

Severe adverse reactions associated with this product include the potential for severe liver damage, particularly in patients who exceed the maximum daily dosage of five doses within a 24-hour period or who concurrently use other medications containing acetaminophen.

Patients may also experience severe skin reactions, which can 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.

Additionally, a warning is issued for patients experiencing a severe sore throat that persists for more than two days or is accompanied by fever, headache, rash, nausea, or vomiting; such individuals should consult a healthcare professional without delay.

Common adverse reactions warranting medical consultation include worsening pain that lasts beyond five days, fever that persists for more than three days, the presence of redness or swelling, or the emergence of any new symptoms.

Patients with a history of liver disease should seek medical advice prior to using this product. Furthermore, it is advisable for patients taking the anticoagulant warfarin to consult with a healthcare provider or pharmacist before use.

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 should not exceed the recommended dosage. The appropriate dose can be determined using the weight-based chart provided below; if weight is not available, age may be used as a guide. Tablets must be chewed or crushed completely before swallowing and should not be swallowed whole. Dosing may be repeated every 4 hours as needed, but should not exceed 5 doses in a 24-hour period.

Weight (lb) Age (yr) Dose (chewable tablets)

• Under 24: Under 2 years - Ask a doctor

• 24-35: 2-3 years - 1 tablet

• 36-47: 4-5 years - 1 1/2 tablets

• 48-59: 6-8 years - 2 tablets

• 60-71: 9-10 years - 2 1/2 tablets

• 72-95: 11 years - 3 tablets

Healthcare professionals should advise caregivers to consult a doctor before use if the child has liver disease or is taking the blood-thinning medication warfarin. It is essential to keep the medication out of reach of children. In the event of an overdose, immediate medical assistance should be sought, and contacting a Poison Control Center is advised. Prompt medical attention is critical for both children and adults, even if no signs or symptoms are present.

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 may be taking to avoid potential acetaminophen overdose, which can have serious implications for both maternal and fetal health.

In cases where the pregnant patient has a history of liver disease, consultation with a healthcare professional is strongly 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 to assess the safety and potential interactions.

Patients should be instructed to discontinue use and consult a healthcare provider if symptoms worsen or persist beyond the recommended duration: pain that lasts more than 5 days, fever that lasts more than 3 days, or the presence of redness or swelling. The emergence of any new symptoms should also prompt immediate medical advice. These precautions are vital to ensure the safety and well-being of both the patient and the developing fetus.

Lactation

There is no specific information available regarding the use of this medication in nursing mothers or any lactation considerations. Healthcare professionals should exercise caution and consider the potential risks and benefits when prescribing this medication to lactating mothers. Further research may be necessary to fully understand the implications for breastfed infants.

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 patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment and monitoring of these patients.

Hepatic Impairment

Patients with hepatic impairment should be closely monitored when considering the use of this product, which contains acetaminophen. It is important to note that severe liver damage may occur if the maximum daily amount of more than 5 doses in 24 hours is exceeded, or if the patient is concurrently taking other medications that contain acetaminophen.

Prior to administration, it is recommended that a healthcare professional 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, regardless of whether any signs or symptoms are apparent.

Healthcare professionals are advised to remain vigilant, as the absence of symptoms does not preclude the possibility of serious complications. Early recognition and management of an overdose can significantly influence patient outcomes. Therefore, it is essential to ensure that patients and caregivers are aware of the importance of timely medical evaluation in cases of suspected overdose.

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 in these areas limits the understanding of the compound's potential effects in nonclinical settings.

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. In such instances, it is crucial to obtain medical help or contact a Poison Control Center without delay. Prompt medical attention is essential for both adults and children, even if no signs or symptoms are initially observed.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center in the event of an overdose. It is essential to emphasize that prompt medical attention is critical for both adults and children, even if no signs or symptoms are initially 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 any other medications they are taking, 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 worsens or lasts longer than three days. Additionally, patients should be informed to stop use and consult a doctor if they notice any redness or swelling, or if any new symptoms develop.

It is important for healthcare providers to remind patients to consult a doctor before using this medication if their child has liver disease. Furthermore, patients should 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 should not be used 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 25°C (77°F), with permissible excursions between 15°C and 30°C (59°F to 86°F). It is essential to avoid high humidity during storage. For reference, the expiration date and lot number can be found on the end flap of the packaging.

Additional Clinical Information

Patients should be informed that 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. Prompt medical attention is crucial for both adults and children, even if no signs or symptoms are initially apparent.

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.

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