Children Pain and Fever Reliever

Description

NDC 11673-241-24. This product contains children's acetaminophen, a pain reliever and fever reducer, available in chewable tablet form with a dosage of 160 mg per tablet. The product is aspirin-free and ibuprofen-free, suitable for children aged 2 to 11 years. Each package contains 24 chewable tablets, flavored with grape, and includes both natural and artificial flavoring. The product is manufactured under the brand name up & up. It is tamper evident; do not use if the package is opened or if the blister unit is torn, broken, or shows any signs of tampering. This product is not manufactured or distributed by McNeil Consumer Healthcare, the owner of the registered trademark Children's Tylenol® Chewable.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with the common cold, flu, headache, sore throat, and toothache. Additionally, it is indicated for the temporary reduction of fever.

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

Dosage and Administration

The appropriate dosage of this product is determined by the patient's weight or age, as outlined in the dosage chart below. It is imperative that healthcare professionals do not exceed the recommended dosage, and patients should be advised not to take more than directed, in accordance with the overdose warning.

For optimal dosing, the following guidelines should be adhered to:

• Weight-Based Dosing:

  • Patients weighing under 24 lbs: Consult a doctor.

  • Patients weighing 24-35 lbs: Administer 1 tablet.

  • Patients weighing 36-47 lbs: Administer 1 ½ tablets.

  • Patients weighing 48-59 lbs: Administer 2 tablets.

  • Patients weighing 60-71 lbs: Administer 2 ½ tablets.

  • Patients weighing 72-95 lbs: Administer 3 tablets.

• Age-Based Dosing:

  • Patients under 2 years: Consult a doctor.

  • Patients aged 2-3 years: Administer 1 tablet.

  • Patients aged 4-5 years: Administer 1 ½ tablets.

  • Patients aged 6-8 years: Administer 2 tablets.

  • Patients aged 9-10 years: Administer 2 ½ tablets.

  • Patients aged 11 years and older: Administer 3 tablets.

The product should be chewed completely before swallowing; it must not be swallowed whole. Dosing may be repeated every 4 hours as needed while symptoms persist, but should not exceed 5 doses within a 24-hour period unless directed by a physician.

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

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

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 5 doses should be administered within a 24-hour period. Additionally, caution is warranted when this product is used concurrently with other medications containing acetaminophen, as this may further increase the risk of liver injury.

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

Sore Throat Warning In cases where a sore throat is severe, persists beyond 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting, prompt consultation with a healthcare provider is recommended.

Pre-existing Conditions Healthcare professionals should advise caregivers to consult a doctor prior to administering this product if the child has a history of liver disease. Furthermore, it is essential to inquire about the use of anticoagulants, such as warfarin, as this may necessitate additional monitoring or alternative treatment options.

Dosage and Administration When utilizing this product, it is critical to adhere strictly to the recommended dosage guidelines. Exceeding the recommended dose can lead to serious health consequences.

Monitoring and Discontinuation Caregivers should be instructed to stop use and seek medical advice if any of the following occur: worsening pain that lasts more than 5 days, fever that worsens or persists beyond 3 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.

Overdose Warning In the event of an overdose, immediate medical attention is essential. Caregivers should be advised to contact a Poison Control Center at 1-800-222-1222 without delay, even if no symptoms are apparent, as prompt intervention is crucial.

Side Effects

Severe liver damage may occur in patients taking this product containing acetaminophen if they exceed five doses within a 24-hour period, which is the maximum daily amount, or if they use it concurrently with other medications containing acetaminophen.

Patients should be aware of the potential for severe skin reactions associated with acetaminophen, which may manifest as skin reddening, blistering, or rash. In the event of any skin reaction, it is imperative to discontinue use and seek medical assistance immediately.

In cases where a sore throat is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, patients are advised to consult a healthcare professional promptly.

Patients should discontinue use and consult a doctor if pain worsens or lasts longer than five days, if fever worsens or persists for more than three days, if new symptoms arise, or if redness or swelling is observed, as these may indicate a serious condition.

It is recommended that patients consult a doctor prior to use if they have a history of liver disease. Additionally, patients taking the blood-thinning medication warfarin should seek advice from a healthcare provider or pharmacist before using this product.

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. Co-administration may lead to an increased risk of acetaminophen-related hepatotoxicity. Monitoring for signs of liver damage is advised if there is a possibility of overlapping acetaminophen use.

Packaging & NDC

Below are the non-prescription pack sizes of Children Pain and Fever Reliever (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 lbs, consultation with a doctor is advised. For those weighing 24-35 lbs (ages 2-3 years), the dosage is 1 tablet; for 36-47 lbs (ages 4-5 years), 1 ½ tablets; for 48-59 lbs (ages 6-8 years), 2 tablets; for 60-71 lbs (ages 9-10 years), 2 ½ tablets; and for 72-95 lbs (age 11 years), 3 tablets.

Dosing instructions specify that the dose may be repeated every 4 hours while symptoms persist, with a maximum of 5 doses in a 24-hour period unless directed otherwise by a doctor.

Safety considerations include the necessity to consult a doctor before use if the child has liver disease. Additionally, it is important to seek advice from a doctor or pharmacist if the child is concurrently taking the blood-thinning medication warfarin.

In the event of an overdose, immediate medical assistance should be sought, or contact with a Poison Control Center is recommended, as prompt medical attention is crucial even if no symptoms are apparent.

Geriatric Use

Elderly patients may not receive specific directions or complete warnings for adult use with this product. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is essential to consider the unique physiological changes and potential comorbidities that may affect drug metabolism and response in this population.

Monitoring for adverse effects and therapeutic efficacy is recommended, as elderly patients may have an altered pharmacokinetic and pharmacodynamic profile. Dose adjustments may be necessary based on individual patient assessments.

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

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 medication 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.

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 at 1-800-222-1222. Prompt medical intervention is crucial, 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.

It is recommended that healthcare providers remain vigilant and prepared to manage any complications that may arise from an overdose. Continuous monitoring and supportive care may be necessary, depending on the severity of the situation and the specific substance involved.

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 specific postmarketing experience details have been reported. As such, there are no additional adverse events or rare case reports to summarize at this time.

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. It is crucial to emphasize that prompt medical attention is necessary, even if the patient does not exhibit any signs or symptoms of overdose.

Patients should be instructed not to exceed the recommended dose, as doing so may lead to serious health risks. It is important for healthcare providers to remind patients of the overdose warning associated with the medication.

Additionally, healthcare providers should encourage patients to consult with a doctor before using this medication if their child has liver disease. This precaution is essential to ensure the safety and appropriateness of the treatment.

Furthermore, 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. This interaction could have significant implications for the child's health and treatment plan.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for reference. It should be stored at room temperature, ensuring that it is kept away from high humidity and protected from light exposure. For optimal preservation, it is essential to check the end flap for the expiration date and lot number.

Additional Clinical Information

Patients should be advised that the medication is administered orally, with a recommended repeat dose every 4 hours as needed for symptom relief. It is important not to exceed 5 doses within a 24-hour period unless directed by a healthcare professional.

Clinicians should counsel patients to consult a doctor before use if the child has liver disease or is taking warfarin, a blood-thinning medication. Additionally, patients should verify whether any other medications contain acetaminophen to avoid unintentional overdose. If a child has a known allergy to acetaminophen or any inactive ingredients, or if symptoms worsen or persist beyond specified durations, medical advice should be sought.

Drug Information (PDF)

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

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