Childrens Pain Plus Fever Relief

Description

Acetaminophen is presented as an oral suspension with a strength of 160 mg per 5 mL. The formulation is flavored with natural strawberry and is packaged in a 4 FL. OZ. (120 mL) bottle. It contains no added alcohol, is sugar-free, dye-free, aspirin-free, ibuprofen-free, and does not contain parabens.

Uses and Indications

This drug is indicated for the temporary 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 healthcare professionals should refer to the dosage chart to determine the appropriate dose based on the child's weight or age.

Prior to administration, the product must be shaken well. The enclosed dosing cup, specifically designed for this product, should be used to measure the dose accurately. It is imperative not to use any other dosing device to ensure proper dosing.

To administer the dose, remove the child protective cap and squeeze the appropriate amount into the dosing cup. The recommended dosing intervals are every 4 hours as needed while symptoms persist. However, it is crucial not to exceed 5 doses within a 24-hour period.

The following dosage chart provides guidance based on weight and age:

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

• For children weighing 24-35 lb and aged 2-3 years, the recommended dose is 5 mL.

• For children weighing 36-47 lb and aged 4-5 years, the recommended dose is 7.5 mL.

• For children weighing 48-59 lb and aged 6-8 years, the recommended dose is 10 mL.

• For children weighing 60-71 lb and aged 9-10 years, the recommended dose is 12.5 mL.

• For children weighing 72-95 lb and aged 11 years, the recommended dose is 15 mL.

Healthcare professionals should ensure that caregivers are aware of the overdose warning and the importance of adhering to the recommended dosing guidelines.

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 administered to children with a known allergy to acetaminophen or any of the inactive ingredients contained in the formulation.

Additionally, exceeding the recommended dose is contraindicated, as it poses a risk of overdose.

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.

Allergy Alert Acetaminophen may induce severe skin reactions. Symptoms indicative of such reactions include skin reddening, blisters, and rash. Should any of these symptoms manifest, it is imperative to discontinue use immediately and seek medical assistance.

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

General Precautions Prior to administration, it is advisable to consult a physician if the child has a history of liver disease. Additionally, caregivers should seek guidance from a doctor or pharmacist if the child is concurrently taking the anticoagulant warfarin. It is crucial to adhere strictly to the recommended dosage to avoid the risk of overdose.

In the event of an overdose, immediate medical attention is essential. Caregivers should contact a Poison Control Center at 1-800-222-1222 without delay, as rapid intervention is critical for both adults and children, even in the absence of noticeable symptoms.

Monitoring and Follow-Up Healthcare professionals should instruct caregivers to discontinue use and consult a physician if any of the following occur: worsening pain that lasts more than five days, worsening fever that persists for 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 liver damage may occur in patients who exceed the maximum daily amount of acetaminophen, which is more than 5 doses in 24 hours, or who take this product in conjunction with other medications containing acetaminophen. Patients should be aware that acetaminophen can cause severe skin reactions, 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.

Patients experiencing a severe sore throat that persists for more than 2 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 drug containing acetaminophen, whether prescription or nonprescription. Patients uncertain about the presence of acetaminophen in other medications should consult a doctor or pharmacist. 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 provider or pharmacist prior to use. It is crucial for patients to adhere to the recommended dosage and to stop 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 the event of an overdose, patients should seek medical help or contact a Poison Control Center immediately at 1-800-222-1222. Quick medical attention is essential for both adults and children, even if no signs or symptoms are apparent.

Drug Interactions

Acetaminophen may interact with anticoagulants, particularly warfarin. Co-administration of acetaminophen and warfarin can potentially enhance the anticoagulant effects of warfarin, leading to an increased risk of bleeding.

It is advisable for patients to consult with a healthcare professional, such as a doctor or pharmacist, prior to using acetaminophen if they are currently taking warfarin. Monitoring of coagulation parameters may be warranted to ensure safe and effective use of both medications.

Packaging & NDC

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

Pediatric Use

Pediatric patients should not exceed the recommended dosage. For children under 2 years of age and weighing less than 24 pounds, a healthcare professional should be consulted before administration. The following dosing guidelines apply for children aged 2 to 11 years based on weight:

• 24-35 pounds (2-3 years): 5 mL

• 36-47 pounds (4-5 years): 7.5 mL

• 48-59 pounds (6-8 years): 10 mL

• 60-71 pounds (9-10 years): 12.5 mL

• 72-95 pounds (11 years): 15 mL

It is essential to keep the medication out of reach of children. Prior to use, parents or caregivers should consult a healthcare professional if the child has liver disease or is taking the blood-thinning medication warfarin. In the event of an overdose, immediate medical assistance should be sought, or contact a Poison Control Center, as prompt attention is crucial for both children and adults, even if no symptoms are apparent.

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 indicated for use in children aged 2-11 years, and there are no documented dosage adjustments or safety concerns specifically addressing the geriatric population.

Healthcare providers should exercise caution when prescribing this product to elderly patients, considering the absence of data on its safety and efficacy in this demographic. Monitoring for potential adverse effects and therapeutic responses is advisable, given the lack of established guidelines for geriatric use.

Pregnancy

The available prescribing information does not provide specific data regarding the use of acetaminophen during pregnancy. Consequently, healthcare professionals should exercise caution when recommending this medication to pregnant patients. There are no documented safety concerns, dosage modifications, or special precautions outlined for the use of acetaminophen in this population. Given the lack of information, it is advisable for women of childbearing potential to consult with their healthcare provider before using acetaminophen during pregnancy to ensure that potential risks and benefits are adequately assessed.

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 product to nursing mothers due to the potential risk to the infant.

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. Regular monitoring of renal function may be advisable in these patients to ensure safety and efficacy.

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. 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 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 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 keep this medication out of reach of children to prevent accidental ingestion. It is important to inform patients not to use this product in conjunction with any other medications that contain acetaminophen, whether prescription or nonprescription. If patients are uncertain about the presence of acetaminophen in other medications, they should be encouraged to consult a doctor or pharmacist for clarification.

Patients should be cautioned against using this product if their child has a known allergy to acetaminophen or any of the inactive ingredients contained in the formulation. Healthcare providers should instruct patients to discontinue use and seek medical advice if pain worsens or persists for more than five days, if fever intensifies or lasts longer than three days, if new symptoms develop, or if there is any redness or swelling, as these may indicate a serious condition.

It is essential to emphasize the importance of adhering to the recommended dosage and to inform patients about the risks associated with exceeding this dosage, including the potential for overdose. Additionally, healthcare providers should recommend that patients consult a doctor before using this product if their child has liver disease. Furthermore, patients should be advised to speak with a doctor or pharmacist if their child is currently taking the blood-thinning medication warfarin, to ensure safe and effective use of the product.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at room temperature to maintain its integrity and efficacy. No special handling requirements are noted; however, standard precautions should be observed to ensure optimal storage conditions.

Additional Clinical Information

The medication is administered orally, with a recommended repeat dose every 4 hours as needed, 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 should be advised to discontinue use and seek immediate medical attention if a skin reaction occurs, if pain worsens or persists beyond 5 days, if fever intensifies or lasts more than 3 days, or if new symptoms arise, including redness or swelling.

Drug Information (PDF)

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

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