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 pediatric patients, and healthcare professionals should refer to the dosage chart to determine the appropriate dose based on the patient's weight or age. It is essential to adhere to the following guidelines for administration:

• The recommended dosing intervals are every 4 hours as needed while symptoms persist. However, the total number of doses should not exceed 5 doses within a 24-hour period.

• Treatment should not extend beyond 5 consecutive days unless directed by a physician.

• For optimal administration, tablets must be chewed or crushed completely before swallowing; they should not be swallowed whole.

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 (2-3 years): administer 1 chewable tablet.

• For patients weighing 36-47 lb (4-5 years): administer 1 ½ chewable tablets.

• For patients weighing 48-59 lb (6-8 years): administer 2 chewable tablets.

• For patients weighing 60-71 lb (9-10 years): administer 2 ½ chewable tablets.

• For patients weighing 72-95 lb (11 years): administer 3 chewable tablets.

Dosing should be adjusted as necessary based on clinical judgment and individual patient needs, and any deviations from the recommended dosing should be discussed with a healthcare provider.

Contraindications

Use of this product is contraindicated in the following situations:

• Co-administration with any other drug containing acetaminophen, whether prescription or nonprescription, is prohibited. If there is uncertainty regarding the presence of acetaminophen in another medication, consultation with a healthcare professional is advised.

• This product should not be administered to children with a known allergy to acetaminophen or any of the inactive ingredients contained in the formulation.

• Exceeding the recommended dosage is contraindicated.

Warnings and Precautions

This product contains acetaminophen, which poses a risk of severe liver damage if the maximum daily dosage is exceeded. Specifically, healthcare professionals should advise caregivers that no more than five doses should be administered within a 24-hour period. Additionally, caution is warranted when this product is used concurrently with other medications containing acetaminophen.

Severe skin reactions have been associated with acetaminophen use. Symptoms indicative of such reactions may include skin reddening, blisters, and rash. Should any of these symptoms manifest, 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 essential.

Healthcare professionals should inquire about the patient's medical history, particularly regarding liver disease, prior to recommending this product. Furthermore, it is advisable to consult a doctor or pharmacist if the patient is concurrently taking warfarin or any other blood-thinning medication.

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

Patients should be advised to discontinue use and consult a healthcare provider if any of the following occur: worsening pain lasting more than five days, fever that worsens or persists beyond three days, the emergence of new symptoms, or the presence of redness or swelling. These signs may indicate a serious underlying condition that requires further evaluation.

Side Effects

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

Severe liver damage may occur if the maximum daily amount of acetaminophen, which is more than 5 doses in 24 hours, is exceeded or if it is taken concurrently with other medications containing acetaminophen. Patients should also be alerted to the risk of severe skin reactions associated with acetaminophen, which may manifest as skin reddening, blisters, or rash. In the event of a skin reaction, it is imperative to discontinue use and seek medical assistance immediately.

Additionally, if a patient experiences a severe sore throat that persists for more than 2 days or is accompanied by fever, headache, rash, nausea, or vomiting, they should consult a healthcare professional promptly.

This product should not be used in conjunction with any other drug containing acetaminophen, whether prescription or nonprescription. Patients should verify the presence of acetaminophen in other medications with a doctor or pharmacist if uncertain. It is contraindicated for use in patients with a known allergy to acetaminophen or any inactive ingredients in the formulation.

Patients with liver disease should consult a doctor before using this product. Furthermore, those taking the blood-thinning medication warfarin should seek advice from a healthcare professional or pharmacist prior to use.

While using this product, it is crucial not to exceed the recommended dosage. Patients should discontinue use and consult a doctor if pain worsens or persists for more than 5 days, if fever worsens or lasts more than 3 days, if new symptoms arise, or if redness or swelling occurs, as these may indicate a serious condition.

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

Drug Interactions

Acetaminophen may interact with the anticoagulant warfarin. It is advisable for patients to consult a healthcare professional, such as a doctor or pharmacist, prior to using acetaminophen if they are concurrently taking warfarin. This interaction may necessitate careful monitoring of coagulation parameters to ensure therapeutic efficacy and safety.

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 aged 2 to 11 years are recommended for use of this medication. Dosing varies by weight: for children under 24 lb (under 2 years), consultation with a doctor is advised. 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.

The maximum dosage should not exceed 5 doses in a 24-hour period, and the medication should not be administered for more than 5 days unless directed by a healthcare professional.

Caution is advised regarding liver health, as severe liver damage may occur if the maximum daily amount is exceeded or if the child is taking other medications containing acetaminophen. Consultation with a doctor is also recommended if the child has liver disease or is taking the anticoagulant warfarin.

Pediatric patients may experience severe skin reactions, including symptoms such as skin reddening, blisters, or rash. If any skin reaction occurs, use should be discontinued immediately, and medical assistance should be sought.

In cases of severe sore throat that persists for more than 2 days or is accompanied by fever, headache, rash, nausea, or vomiting, prompt consultation with a healthcare provider is necessary.

Geriatric Use

There is no specific information available regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population.

Pregnancy

Pregnant patients should be advised against using this product if they are allergic to acetaminophen or any of the inactive ingredients contained within. It is essential for healthcare providers to assess the potential risks associated with the use of this product in pregnant patients, particularly in those with pre-existing liver disease, as this may exacerbate underlying conditions.

Additionally, caution is warranted if the pregnant patient is concurrently taking warfarin or other blood-thinning medications, as interactions may pose risks to both maternal and fetal health. Due to the absence of directions or complete warnings for adult use, healthcare professionals should carefully evaluate the necessity and safety of this product in pregnant patients, ensuring that all potential risks are communicated effectively.

Lactation

There are no specific warnings or recommendations regarding the use of this product by lactating mothers. Additionally, there is no information available concerning the potential for excretion in breast milk or any effects on 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 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 a healthcare professional be consulted if the patient has a history of liver disease. This precaution is essential to ensure the safe use of the product and to evaluate the need for any dosage adjustments or additional monitoring based on the severity of the hepatic impairment.

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 initially apparent.

Healthcare professionals should be aware that the absence of symptoms does not preclude the possibility of serious complications. Therefore, it is essential to monitor the patient closely and provide appropriate care as needed.

Nonclinical Toxicology

No teratogenic or non-teratogenic effects have been reported in the available data. Additionally, there is no information regarding nonclinical toxicology or animal pharmacology and toxicology provided in the insert.

Postmarketing Experience

Postmarketing experience has identified that acetaminophen may be associated with severe skin reactions. Reports indicate that symptoms can include 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 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 instructed not to exceed the recommended dosage of the medication. It is important for healthcare providers to inquire about any existing liver disease in children before recommending use. Additionally, patients should be advised to consult a doctor or pharmacist if their child is currently taking the blood-thinning medication warfarin.

Healthcare providers should inform patients to discontinue use and consult a doctor if pain worsens or persists for more than five days, if fever intensifies or lasts longer than three days, if new symptoms arise, or if there is any redness or swelling, as these may indicate a serious condition.

Patients must be cautioned against using this medication in conjunction with any other products containing acetaminophen, whether prescription or nonprescription. If patients are uncertain about the presence of acetaminophen in other medications, they should be encouraged to seek clarification from a doctor or pharmacist.

Finally, healthcare providers should ensure that patients are aware that this medication should not be used if their child has a known allergy to acetaminophen or any of the inactive ingredients contained in the product.

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 25°C (77°F), with permissible excursions between 15°C and 30°C (59°F to 86°F). It is important 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

The medication is administered orally, with specific instructions for patients to chew or crush the tablets completely before swallowing, as whole tablets should not be swallowed. Dosing should be repeated every 4 hours as needed, with a maximum of 5 doses within a 24-hour period. Patients should not use the medication for more than 5 consecutive days unless directed by a healthcare professional.

No additional information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experiences.

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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