Childrens Pain and Fever

Description

Children’s Pain & Fever ACETAMINOPHEN is an oral suspension formulation containing 160 mg of acetaminophen per 5 mL. It is indicated for the relief of pain and reduction of fever in children aged 2 to 11 years. The product is characterized by the absence of added alcohol, aspirin, ibuprofen, and parabens. It features a strawberry flavor to enhance palatability. The total volume of the product is 4 fluid ounces (118 mL), and a dosage cup is included for accurate administration.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with headache, toothache, sore throat, influenza, 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 ensure that the dosage is administered according to the following guidelines.

Prior to administration, the product must be shaken well. The provided dose cup should be utilized to measure the correct dosage. The appropriate dose can be determined using the dosage chart based on the patient's weight or age, as outlined below.

For patients weighing under 24 lb or under 2 years of age, it is advised to consult a physician for appropriate dosing recommendations. For those weighing between 24-35 lb (ages 2-3 years), the recommended dose is 5 mL. For patients weighing 36-47 lb (ages 4-5 years), the dose is 7.5 mL. For those weighing 48-59 lb (ages 6-8 years), the dose is 10 mL. For patients weighing 60-71 lb (ages 9-10 years), the recommended dose is 12.5 mL, and for those weighing 72-95 lb (age 11 years), the dose is 15 mL.

Dosing may be repeated every 4 hours as needed while symptoms persist, but it is critical not to exceed 5 doses within a 24-hour period. Healthcare professionals should ensure that patients do not receive more than the directed amount.

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 other medications, 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.

Warnings and Precautions

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

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.

Healthcare providers should be vigilant regarding sore throat symptoms. If a sore throat is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, prompt consultation with a physician is recommended.

Before administering this product, it is advisable to consult a physician if the child has a history of liver disease. Furthermore, healthcare professionals should inquire about the use of anticoagulants, such as warfarin, as interactions may occur.

In cases of overdose, immediate medical attention is crucial. Patients or caregivers should contact a Poison Control Center or seek emergency medical help without delay, regardless of the presence of symptoms.

Patients should be instructed to discontinue use and consult a physician if any of the following occur: worsening pain lasting more than five days, worsening fever lasting more than 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

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 should be advised of the risk of 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 and seek immediate medical attention.

Patients experiencing a severe sore throat that persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, should consult a healthcare professional promptly.

This product should not be used in conjunction with any other medications containing acetaminophen, whether prescription or nonprescription. Patients should verify the presence of acetaminophen in other medications with a healthcare provider or pharmacist if uncertain. Additionally, this product is contraindicated in patients with a known allergy to acetaminophen or any of the inactive ingredients.

Before using this product, patients with liver disease should seek medical advice. Furthermore, patients taking the anticoagulant warfarin should consult a healthcare professional or pharmacist prior to use.

Patients are advised to discontinue use and consult a doctor if pain worsens or persists beyond five days, if fever worsens or lasts more than three days, if new symptoms arise, or if there is any redness or swelling, as these may indicate a serious condition.

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 increase the risk of bleeding due to potential pharmacodynamic interactions.

Additionally, this medication should not be used in conjunction with any other products containing acetaminophen, whether prescription or over-the-counter. The risk of acetaminophen overdose and associated hepatotoxicity may be heightened. If there is uncertainty regarding the presence of acetaminophen in other medications, it is advisable to seek guidance from a healthcare provider.

Packaging & NDC

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

Pediatric Use

Pediatric patients aged 2 to 11 years are indicated for use of this product. Weight-based dosing is recommended as follows: for children under 24 lb, consultation with a doctor is advised; for those weighing 24-35 lb (ages 2-3 years), the dose is 5 mL; for 36-47 lb (ages 4-5 years), the dose is 7.5 mL; for 48-59 lb (ages 6-8 years), the dose is 10 mL; for 60-71 lb (ages 9-10 years), the dose is 12.5 mL; and for 72-95 lb (age 11 years), the dose is 15 mL.

It is critical not to exceed 5 doses in a 24-hour period, as severe liver damage may occur with higher intake. Parents and caregivers should be aware of a sore throat warning; if the 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.

Before administering this product, consultation with a healthcare professional is necessary if the child has liver disease or is taking the anticoagulant warfarin. Additionally, parents should stop use and seek medical advice if the child's pain worsens or lasts more than 5 days, if fever worsens or lasts more than 3 days, if new symptoms arise, or if redness or swelling occurs.

Geriatric Use

Elderly patients may not have specific information regarding the use of this product, as the prescribing information does not provide guidance on geriatric use. The product is primarily indicated for children aged 2 to 11 years, and there are no documented dosage adjustments or safety concerns specifically related to elderly patients.

Healthcare providers should exercise caution when considering this product for geriatric patients, given the absence of data on its safety and efficacy in this population. Monitoring for potential adverse effects is advisable, as the lack of specific geriatric studies may limit the understanding of how elderly patients may respond to treatment.

Pregnancy

The safety of acetaminophen during pregnancy has not been established. Pregnant patients or those planning to become pregnant should consult a healthcare provider before use, as there may be potential risks to the fetus. Further studies are needed to determine the safety profile of acetaminophen in this population.

Dosage adjustments may be necessary, and it is essential for healthcare providers to offer recommendations tailored to individual circumstances. Acetaminophen should only be used if clearly needed and after a thorough discussion with a healthcare professional regarding the potential risks and benefits.

Lactation

There are no specific warnings or recommendations regarding nursing mothers or lactation in the provided text. Therefore, healthcare professionals should consider the absence of data when advising lactating mothers about the use of this medication. It is advisable to monitor breastfed infants for any potential effects, although no specific information is available.

Renal Impairment

Patients with renal impairment have no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the drug insert. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the lack of data necessitates careful clinical judgment.

Hepatic Impairment

Patients with hepatic impairment should consult a healthcare professional prior to use, particularly if they have a history of liver disease. It is essential to assess liver function and consider potential adjustments in dosage or monitoring requirements based on the severity of the impairment. Careful evaluation is necessary to ensure the safe and effective use of the medication in this population.

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 noticeable 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

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. Further studies may be necessary to elucidate these aspects of nonclinical toxicology.

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, as prompt medical attention is critical for both adults and children, even in the absence of noticeable signs or symptoms.

Patients should be informed not to use this medication in conjunction with any other drug that contains acetaminophen, whether prescription or nonprescription. If there is uncertainty regarding the presence of acetaminophen in another medication, patients are encouraged to consult with a doctor or pharmacist.

It is essential to inform patients that this medication should not be used if their child has a known allergy to acetaminophen or any of the inactive ingredients present in the product.

Patients should be instructed to discontinue use and consult a doctor if pain worsens or persists for more than 5 days, or if fever worsens or lasts longer than 3 days. Additionally, they should stop use and seek medical advice if new symptoms arise or if there is any redness or swelling, as these may indicate a serious condition.

Healthcare providers should also recommend that patients consult a doctor before using this medication if their child has liver disease. Furthermore, it is important to advise patients 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 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 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. It is crucial for both adults and children to receive prompt medical attention, even if no signs or symptoms of overdose are apparent.

Drug Information (PDF)

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

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