Childrens Pain and Fever

Description

Acetaminophen is presented as an oral suspension containing 160 mg of acetaminophen per 5 mL. This formulation serves as a pain reliever and fever reducer. The product is dye-free and features a cherry flavor. It is packaged in an 8 FL OZ (236 mL) bottle and is free of dyes, alcohol, aspirin, ibuprofen, parabens, and high fructose corn syrup.

Uses and Indications

This drug is indicated for the reduction of fever and the relief of minor aches and pains associated with various conditions, including the common cold, influenza, headache, sore throat, and toothache.

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

Dosage and Administration

This product is intended for pediatric use only and does not contain directions or complete warnings for adult use. Healthcare professionals should ensure that the dosage is not exceeded, adhering to the overdose warning.

Prior to administration, the product must be shaken well. The appropriate dose should be determined using the provided dosage chart, which recommends dosing based on the child's weight. If weight is not available, age may be used as a secondary guide.

To administer the dose, the child protective cap should be removed, and the prescribed amount should be squeezed into the enclosed dosing cup, which is specifically designed for this product.

The recommended dosing intervals are every 4 hours while symptoms persist, with a maximum of 5 doses within a 24-hour period.

Dosage Chart:

• For children weighing less than 24 lb or under 2 years of age, consult a doctor for the appropriate dose.

• For children weighing 24-35 lb (2-3 years), the dose is 5 mL.

• For children weighing 36-47 lb (4-5 years), the dose is 7.5 mL.

• For children weighing 48-59 lb (6-8 years), the dose is 10 mL.

• For children weighing 60-71 lb (9-10 years), the dose is 12.5 mL.

• For children weighing 72-95 lb (11 years), the dose is 15 mL.

Dosing should only be performed using the enclosed dosing cup; other dosing devices are not recommended.

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 due to the risk of acetaminophen overdose. If there is uncertainty regarding the presence of acetaminophen in other medications, consultation with a healthcare professional is advised.

• This product should not be used in patients who have a history of allergic reactions to this product or any of its components, as this may lead to severe allergic responses.

Care should be taken to adhere to the recommended dosage to avoid the risk of overdose.

Warnings and Precautions

Severe liver damage may occur with the use of this product, which contains acetaminophen. It is critical to adhere to the recommended dosage guidelines, as taking more than five doses within a 24-hour period, or using it concurrently with other medications containing acetaminophen, significantly increases the risk of liver injury.

Acetaminophen has been associated with severe skin reactions. Healthcare professionals should be vigilant for symptoms such as skin reddening, blisters, or rash. If any of these reactions occur, it is imperative to discontinue use immediately and seek medical assistance.

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

Before administering this product, it is essential to consult a physician if the child has a history of liver disease. Additionally, healthcare professionals should inquire about the use of warfarin or other blood-thinning medications, as interactions may occur.

In the event of an overdose, immediate medical attention is necessary. Contact a Poison Control Center at 1-800-222-1222 without delay, even if no symptoms are present, as rapid intervention is crucial.

Patients should be instructed to discontinue use and consult a healthcare provider if pain worsens or persists beyond five days, if fever intensifies or lasts more than three days, if new symptoms arise, or if there is any redness or swelling. These may indicate a serious underlying condition that requires further evaluation.

Side Effects

Severe adverse reactions associated with this product include significant liver damage, which may occur if a child exceeds five doses within a 24-hour period or if it is taken concurrently with other medications containing acetaminophen. Patients should be aware of the potential for 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 assistance.

Participants should also be cautioned regarding the risk of severe sore throat. If a sore throat is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, it is essential to consult a healthcare provider promptly.

Patients are advised to stop use and consult a doctor if pain worsens or lasts longer than five days, if fever intensifies or persists beyond three days, if new symptoms arise, or if redness or swelling is observed, as these may indicate a serious underlying condition.

It is recommended that a healthcare professional be consulted prior to use if the child has liver disease or is taking the anticoagulant warfarin. In the event of an overdose, immediate medical attention should be sought, or contact should be made with a Poison Control Center at 1-800-222-1222, as prompt medical intervention is crucial even in the absence of noticeable signs or symptoms.

Drug Interactions

The concomitant use of this medication with warfarin, a blood-thinning agent, should be approached with caution. It is advisable for patients to consult a healthcare professional, such as a doctor or pharmacist, prior to initiating treatment if they are currently taking warfarin. This is to ensure appropriate monitoring and management of potential interactions that may affect coagulation parameters.

Additionally, this medication should not be used in conjunction with other products containing acetaminophen, whether they are prescription or nonprescription. Patients are encouraged to verify the presence of acetaminophen in any other medications they may be taking. If there is uncertainty regarding the contents of a medication, it is recommended to seek guidance from a healthcare professional to avoid the risk of acetaminophen overdose.

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 require careful dosing based on weight and age. For those under 24 lb and under 2 years, consultation with a doctor is advised prior to use. Dosing for children aged 2-3 years (24-35 lb) is 5 mL, for ages 4-5 years (36-47 lb) is 7.5 mL, for ages 6-8 years (48-59 lb) is 10 mL, for ages 9-10 years (60-71 lb) is 12.5 mL, and for 11 years (72-95 lb) is 15 mL.

Dosing should primarily be based on weight; if weight is not available, age may be used. Doses may be repeated every 4 hours as needed while symptoms persist, but should not exceed 5 doses in a 24-hour period.

Warnings include the necessity of consulting a doctor before use if the child has liver disease or is taking the blood-thinning medication warfarin. It is crucial not to exceed the recommended dose due to the risk of overdose. The product should be kept out of reach of children, and in the event of an overdose, immediate medical assistance should be sought or contact with a Poison Control Center (1-800-222-1222) is recommended, as prompt medical attention is essential even if no symptoms are observed.

Geriatric Use

Elderly patients may require special consideration when using this product, as it does not contain directions or complete warnings for adult use. Healthcare providers should exercise caution and closely monitor geriatric patients for any adverse effects or complications that may arise due to the lack of specific guidance. It is advisable to assess the individual needs and health status of elderly patients before prescribing this product, as the absence of comprehensive information may necessitate dose adjustments or alternative therapeutic options.

Pregnancy

The available prescribing information does not provide specific data regarding the use of acetaminophen during pregnancy. Consequently, there are no established safety concerns, dosage modifications, or special precautions outlined for pregnant patients. Healthcare professionals should consider the lack of information when advising women of childbearing potential and weigh the potential benefits against any unknown risks associated with the use of acetaminophen during pregnancy. It is advisable to monitor emerging data and guidelines to inform clinical decision-making in this population.

Lactation

There is no specific information available regarding the use of this medication in nursing mothers or its effects on lactation. Consequently, healthcare professionals should exercise caution when prescribing this medication to lactating mothers, as the potential risks to breastfed infants are not well characterized. It is advisable to consider the benefits of breastfeeding alongside the potential risks associated with the medication.

Renal Impairment

Patients with renal impairment should consult a healthcare professional prior to use, particularly if there is a concurrent liver disease. It is essential to assess renal function and consider potential dosing adjustments or monitoring requirements based on the patient's overall health status.

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 dosage adjustments or monitoring requirements based on the severity of the impairment. Close monitoring of liver function tests may be warranted to ensure safety and efficacy in this patient population.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222. Prompt intervention is essential, as the absence of noticeable signs or symptoms does not preclude the possibility of serious health consequences.

Healthcare professionals should be aware that quick medical attention can significantly impact the outcome of an overdose situation. Therefore, it is crucial to act swiftly, regardless of the presence of overt symptoms.

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 fully evaluate the nonclinical toxicology profile.

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 at 1-800-222-1222 in the event of an overdose, emphasizing that prompt medical attention is crucial even if no signs or symptoms are apparent.

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

It is important to instruct patients not to use this product if their child has a history of allergic reactions to it or any of its ingredients. Additionally, patients should be advised to discontinue use and consult a doctor if pain worsens or persists beyond five days, if fever intensifies 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.

Patients must be cautioned against exceeding the recommended dose, as this could lead to overdose. Furthermore, healthcare providers should recommend that patients consult a doctor before using this product if their child has liver disease. Lastly, 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 configurations that include specific NDC numbers, which should be referenced for accurate identification. It is essential to store the product at a controlled temperature range of 20-25°C (68-77°F) to maintain its integrity and efficacy.

Healthcare professionals are advised to inspect the product prior to use; it should not be utilized if the printed neckband is broken or missing, as this may indicate tampering or compromise of the product's safety. Proper handling and storage conditions are crucial to ensure the product remains effective and safe for patient use.

Additional Clinical Information

Patients should be advised that the medication is administered orally, with a recommended repeat dose every 4 hours while symptoms persist, not to exceed 5 doses within a 24-hour period.

Clinicians should counsel patients to consult a doctor before use if the child has liver disease or is taking the anticoagulant warfarin. Patients must be instructed to discontinue use and seek medical advice if pain worsens or persists beyond 5 days, if fever intensifies or lasts more than 3 days, if new symptoms arise, or if there is any redness or swelling. In the event of an overdose, immediate medical assistance should be sought, and patients are encouraged to contact a Poison Control Center at 1-800-222-1222, as prompt attention is crucial even in the absence of symptoms.

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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