Kids Pain and Fever

Description

KinderMed® is an oral suspension formulated for pediatric use, containing acetaminophen as the active ingredient, identical to that found in Children's Tylenol®. This product is indicated for children aged 2 to 11 years and provides effective relief for pain and fever. Each 5 mL dose delivers 160 mg of acetaminophen. The formulation is presented in a 4 FL OZ (118 mL) bottle and features an organic cherry flavor. KinderMed® is verified by the Non-GMO Project, ensuring it contains no genetically modified organisms. The product is free from dyes, artificial flavors, and artificial sweeteners. A dosing cup is included for accurate measurement.

Uses and Indications

This drug is indicated for the temporary reduction of fever and the temporary relief of minor aches and pains associated with conditions such as 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 use in pediatric patients and does not contain directions or complete warnings for adult use. Healthcare professionals should ensure that the dosage is not exceeded, as outlined in the Overdose warning.

Prior to administration, the product must be shaken well. It is imperative to use only the enclosed dosing cup specifically designed for this product; no other dosing devices should be utilized.

The recommended dosing is based on the patient's weight or age, as detailed in the dosage chart below. If necessary, doses may be repeated every 4 hours while symptoms persist, but it is crucial not to exceed 5 doses within a 24-hour period. Additionally, treatment should not extend beyond 5 days unless directed by a physician.

Dosage Chart:

• Under 24 lb / Under 2 years: Ask a doctor

• 24-35 lb / 2-3 years: 5 mL

• 36-47 lb / 4-5 years: 7.5 mL

• 48-59 lb / 6-8 years: 10 mL

• 60-71 lb / 9-10 years: 12.5 mL

• 72-95 lb / 11 years: 15 mL

Dosing should be adjusted according to the chart or as directed by a healthcare professional.

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 this formulation.

Additionally, it is imperative to adhere to the recommended dosage guidelines, as exceeding the recommended dose may lead to serious adverse effects.

Warnings and Precautions

Severe liver damage may occur in children taking this product, which contains acetaminophen, if they exceed five doses within a 24-hour period or if it is used concurrently with other medications containing acetaminophen. Healthcare professionals should advise caregivers to strictly adhere to the recommended dosing guidelines to mitigate the risk of liver injury.

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.

In cases of severe sore throat that persists for more than two days or is accompanied by additional symptoms such as fever, headache, rash, nausea, or vomiting, prompt consultation with a healthcare provider is recommended to rule out serious underlying conditions.

This product should not be used in conjunction with any other medications containing acetaminophen, whether prescription or nonprescription. If there is uncertainty regarding the presence of acetaminophen in other medications, it is advisable to consult a healthcare professional. Additionally, this product is contraindicated in children with known allergies to acetaminophen or any of its inactive ingredients.

Before administering this product, healthcare professionals should inquire about any history of liver disease in the child. Furthermore, caution is warranted if the child is concurrently taking warfarin, a blood-thinning medication; consultation with a doctor or pharmacist is recommended in such cases.

Caregivers must be instructed not to exceed the recommended dosage when using this product.

If any new symptoms arise, or if there is evidence of redness or swelling, or if pain persists or worsens beyond five days, or if fever intensifies or lasts more than three days, it is crucial to discontinue use and seek medical advice. These symptoms may indicate a serious condition requiring 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 overdose, which may lead to liver damage, and they should seek immediate medical assistance or contact a Poison Control Center (1-800-222-1222) if an overdose is suspected, even in the absence of symptoms.

Allergic reactions may manifest as severe skin reactions, including symptoms such as skin reddening, blisters, and rash. Should any of these symptoms occur, patients must discontinue use and seek medical help promptly. Additionally, if a sore throat is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, patients should consult a healthcare professional without delay.

Patients with a history of liver disease or those taking blood-thinning medications such as warfarin should consult a doctor before using this product. It is also crucial to avoid using this product in conjunction with any other medications containing acetaminophen, whether prescription or nonprescription, to prevent the risk of overdose.

Patients are advised to stop use and consult a doctor if any new symptoms arise, if redness or swelling occurs, if pain worsens or persists beyond five days, or if fever intensifies or lasts more than three days, 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 interaction between this medication and warfarin may necessitate careful monitoring of coagulation parameters to ensure patient safety and efficacy of treatment. Adjustments to the dosage of either medication may be required based on clinical judgment and laboratory results.

Packaging & NDC

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

Pediatric Use

Pediatric patients aged 2 to 11 years may receive this medication with specific dosing guidelines based on weight and age. For children weighing under 24 lb and under 2 years of age, consultation with a doctor is advised. For those aged 2-3 years and weighing 24-35 lb, the recommended dose is 5 mL. Children aged 4-5 years and weighing 36-47 lb should receive 7.5 mL, while those aged 6-8 years and weighing 48-59 lb may take 10 mL. For patients aged 9-10 years weighing 60-71 lb, the dose is 12.5 mL, and for an 11-year-old weighing 72-95 lb, the dose is 15 mL.

It is critical not to exceed 5 doses within a 24-hour period and to limit use to no more than 5 days unless directed by a healthcare professional.

Healthcare providers should be aware of several warnings associated with this medication. Severe liver damage may occur if the maximum daily dosage is exceeded or if the medication is taken concurrently with other products containing acetaminophen. Additionally, there is an allergy alert for potential severe skin reactions, which may manifest as skin reddening, blisters, or rash. If a pediatric patient experiences a severe sore throat that persists for more than 2 days or is accompanied by fever, headache, rash, nausea, or vomiting, prompt medical consultation is recommended.

Consultation with a healthcare provider is also advised if the child has liver disease or is taking the anticoagulant warfarin.

Geriatric Use

Elderly patients may not have specific information regarding the use of this product, as the drug insert does not provide guidance tailored to geriatric populations. Additionally, the absence of directions or complete warnings for adult use suggests that caution should be exercised when considering this product for elderly patients.

Healthcare providers are advised to carefully evaluate the potential risks and benefits of administering this product to geriatric patients, taking into account the lack of established safety and efficacy data in this demographic. Monitoring for adverse effects and adjusting dosages as necessary may be prudent in this population, given the general considerations for age-related physiological changes and increased sensitivity to medications.

Pregnancy

There is no specific information available regarding the use of KIDS PAIN AND FEVER - acetaminophen suspension during pregnancy. As such, the safety of this medication in pregnant patients has not been established, and there are no known dosage modifications or special precautions recommended for use during pregnancy. Healthcare professionals should consider the potential risks and benefits when prescribing this medication to women of childbearing potential. It is advisable to consult available guidelines and weigh the necessity of treatment against any potential fetal impacts.

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, as the effects on the nursing infant are not well studied.

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 evaluate 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, defined as the ingestion of a dose exceeding the recommended amount, there is a significant risk of liver damage. Healthcare professionals should be aware that the severity of symptoms may not be immediately apparent, making it essential to act swiftly.

It is imperative that individuals who suspect an overdose seek medical assistance immediately. Contacting a Poison Control Center at 1-800-222-1222 is strongly advised. Prompt medical attention is critical, even in the absence of noticeable signs or symptoms, as early intervention can be crucial in mitigating potential harm.

Healthcare providers should ensure that patients are informed about the risks associated with overdose and the importance of adhering to prescribed dosages.

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 these contexts.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

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 whether a drug contains acetaminophen, 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 present in the formulation. They should be instructed to stop using the medication and seek medical advice if any new symptoms arise, if there is redness or swelling, or if pain worsens or persists beyond five days. Additionally, if a fever worsens or lasts more than three days, patients should be advised to discontinue use and consult a doctor, as these may indicate a serious condition.

While using this product, it is crucial for patients to adhere to the recommended dosage and to be aware of the overdose warning. Healthcare providers should also recommend that patients consult a doctor before use if their child has liver disease. Furthermore, patients taking the blood-thinning medication warfarin should be advised to seek guidance from a doctor or pharmacist prior to using this product.

Storage and Handling

The product is supplied in configurations that include specific NDC numbers, which can be found on the packaging. It is essential to store the product at a temperature range of 20-25˚C (68-77˚F). Refrigeration is not recommended, as it may compromise the integrity of the product. For traceability, the lot number and expiration date are located on the bottom panel of the packaging. Proper handling and storage conditions are crucial to maintain the product's efficacy and safety.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)