Infants Pain and Fever

Description

KinderMed® is an oral suspension formulated for children aged 2 to 3 years, containing the same active ingredient as Infants' Tylenol® for Children. Each 5 mL dose delivers 160 mg of acetaminophen, serving as both a pain reliever and fever reducer. The product is presented in a 2 FL OZ (59 mL) bottle and features an organic cherry flavor. KinderMed® is verified by the Non-GMO Project, ensuring it contains no genetically modified organisms. The formulation is free from dyes, artificial flavors, and artificial sweeteners. A syringe is included for accurate dosing.

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 pediatric use only, and healthcare professionals should ensure that dosing is based on the child's weight or age as outlined in the dosage chart. Prior to administration, the product must be shaken well.

The enclosed syringe is the only appropriate dosing device; other syringes, droppers, spoons, or dosing devices should not be used. To administer the medication, remove the cap and insert the syringe into the hole at the top of the bottle until it snaps into place. The bottle should then be turned upside down.

The syringe should be pulled back until filled to the prescribed level. If the prescribed level is exceeded, the assembly should be inverted to the right side up on a flat surface, and the syringe should be pushed back until the correct dose is achieved. The liquid should be dispensed slowly into the child's mouth, directed towards the inner cheek.

Dosing may be repeated every 4 hours as needed while symptoms persist, but should not exceed 5 doses in a 24-hour period. Continuous use beyond 5 days is not recommended unless directed by a physician. After use, the cap should be replaced tightly to maintain child resistance.

The following dosage chart provides guidance for dosing:

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

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

Healthcare professionals should ensure that caregivers are aware of the importance of adhering to these guidelines to prevent overdose and ensure safe administration.

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 with the use of this product, which contains acetaminophen, if the child exceeds five doses within a 24-hour period or if it is taken concurrently with other medications containing acetaminophen. Healthcare professionals should advise caregivers to adhere strictly to the recommended dosage 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 if it is accompanied by fever, headache, rash, nausea, or vomiting, prompt consultation with a healthcare provider is recommended to rule out serious underlying conditions.

General precautions should be observed, particularly in children with pre-existing liver disease. It is advisable to consult a healthcare professional before administering this product to children who are taking warfarin or other anticoagulants, as interactions may occur.

Caregivers should be instructed to discontinue use and contact a healthcare provider if any new symptoms arise, if redness or swelling is observed, if pain worsens or persists beyond five days, or if fever intensifies or lasts more than three days. These symptoms may indicate a serious condition requiring medical evaluation.

Side Effects

Severe liver damage may occur in patients who exceed the maximum daily amount of five doses within a 24-hour period or who take the medication concurrently with other drugs 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 two days, or is accompanied by fever, headache, rash, nausea, or vomiting, should consult a healthcare professional promptly. The medication should not be used in conjunction with any other drug containing acetaminophen, whether prescription or nonprescription. If there is uncertainty regarding the presence of acetaminophen in another medication, patients are advised to consult a doctor or pharmacist. Additionally, this product should not be used by individuals who are allergic to acetaminophen or any of the inactive ingredients.

Before using this product, patients with liver disease should seek medical advice. Furthermore, it is recommended that patients taking the blood-thinning medication warfarin consult a healthcare provider or pharmacist prior to use.

While using this product, patients must adhere to the recommended dosage and should 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.

An overdose warning is in place, as taking more than the recommended dose can lead to liver damage. In the event of an overdose, it is crucial to seek medical help or contact a Poison Control Center (1-800-222-1222) immediately, as prompt medical attention is essential even if no signs or symptoms are present.

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 Infants Pain and Fever (acetaminophen). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients should be administered this medication with caution, adhering strictly to the recommended dosing guidelines. The enclosed syringe must be used for dosing; other devices such as droppers or spoons are not appropriate.

For dosing, the following guidelines apply based on weight and age:

• For children under 24 pounds or under 2 years of age, consultation with a doctor is advised before administration.

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

Doses may be repeated every 4 hours as needed while symptoms persist, but should not exceed 5 doses in a 24-hour period. Continuous use beyond 5 days should only occur under a physician's direction.

Healthcare professionals should inquire about any pre-existing liver conditions in pediatric patients prior to use. Additionally, it is important to consult a doctor or pharmacist if the child is concurrently taking the anticoagulant warfarin.

As with all medications, this product should be kept out of reach of children. In the event of an overdose, immediate medical assistance should be sought, or contact a Poison Control Center (1-800-222-1222) without delay, as prompt intervention is crucial even if no symptoms are apparent.

Geriatric Use

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

Healthcare providers are advised to carefully evaluate the potential risks and benefits of administering this product to elderly patients, taking into account the lack of established safety and efficacy data in this population. Monitoring for adverse effects and therapeutic response is recommended, as elderly patients may have altered pharmacokinetics and pharmacodynamics.

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 acetaminophen to pregnant patients, as the absence of safety data necessitates careful consideration of potential risks versus benefits.

Given the lack of detailed information on dosage modifications or special precautions, it is advisable for women of childbearing potential to consult with their healthcare provider before using acetaminophen during pregnancy. Further research may be required to fully understand the implications of acetaminophen use in this population and its potential effects on fetal outcomes.

Lactation

There are no specific warnings or recommendations regarding the use of acetaminophen in lactating mothers. Additionally, there are no specific considerations or precautions related to lactation mentioned in the provided text. Therefore, acetaminophen may be used by nursing mothers without special precautions.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the drug insert text 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 there is no available data to guide treatment decisions in this population. Regular monitoring of renal function may be prudent in these patients, although specific recommendations are not provided.

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. Careful assessment and ongoing monitoring may be necessary to ensure the safe and effective use of the medication in this population.

Overdosage

In the event of an overdose, defined as the ingestion of more than the recommended dose, 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.

Immediate medical assistance is crucial. In cases of suspected overdose, it is imperative to seek medical help or contact a Poison Control Center at 1-800-222-1222 without delay. Prompt intervention is necessary, even in the absence of noticeable signs or symptoms, to mitigate potential harm and ensure appropriate management.

Healthcare providers should remain vigilant and prepared to assess and manage any complications arising from an overdose, emphasizing the importance of early recognition and treatment.

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

Postmarketing experience has identified rare cases of severe skin reactions associated with acetaminophen use. Reported symptoms include skin reddening, blisters, and rash. These events were documented through voluntary reports and surveillance programs.

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.

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

While using this product, patients must be reminded not to exceed the recommended dosage, and they should be made aware of the overdose warning. It is also advisable for patients to consult a doctor before use if their child has liver disease. Furthermore, patients should be encouraged to speak with a doctor or pharmacist 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 can be referenced for identification. It is essential to store the product at a temperature range of 20-25˚C (68-77˚F). Refrigeration is not permitted, as it may compromise the integrity of the product.

For traceability, the lot number and expiration date can be found on the bottom panel of the packaging. Proper adherence to these storage conditions is crucial for maintaining product efficacy and safety.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)