Childrens Pain and Fever

Description

No description information is available for the drug.

Uses and Indications

This drug is indicated for the temporary reduction of fever. It also provides relief from 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

Shake the product well before use. Dosing should be determined based on the patient's weight; if weight is not available, age may be used as a secondary guide. The following dosing chart provides the recommended doses:

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

• For patients weighing 24-35 lb or aged 2-3 years, administer 5 mL (1 tsp).

• For patients weighing 36-47 lb or aged 4-5 years, administer 7.5 mL (1 1/2 tsp).

• For patients weighing 48-59 lb or aged 6-8 years, administer 10 mL (2 tsp).

• For patients weighing 60-71 lb or aged 9-10 years, administer 12.5 mL (2 1/2 tsp).

• For patients weighing 72-95 lb or aged 11 years, administer 15 mL (3 tsp).

Doses may be repeated every 4 hours as needed while symptoms persist, but do not exceed 5 doses in a 24-hour period. Treatment should not continue for more than 5 days unless directed by a healthcare professional.

Use only the enclosed dosing cup specifically designed for this product; do not utilize any other dosing device.

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.

Additionally, this product should not be used in patients with a known allergy to acetaminophen or any of the inactive ingredients contained in this formulation, as this may lead to severe allergic reactions.

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.

Acetaminophen may also trigger severe skin reactions, which can 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.

Healthcare providers should be vigilant regarding the potential for severe sore throat symptoms. If a child experiences a sore throat that is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, prompt consultation with a physician is recommended.

Before administering this product, it is advisable to consult a healthcare professional if the child has a history of liver disease. Furthermore, caregivers should seek guidance from a doctor or pharmacist if the child is currently taking warfarin, a blood-thinning medication, to avoid potential interactions.

Caregivers should be instructed to discontinue use and contact a healthcare provider 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, as these may indicate a serious underlying condition.

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. In cases of overdose, which involves taking more than the recommended dose, patients are advised to seek immediate medical assistance or contact a Poison Control Center, as prompt medical attention is crucial for both adults and children, even in the absence of noticeable signs or symptoms.

Patients should be aware of the potential for severe skin reactions associated with acetaminophen use. Symptoms may include skin reddening, blisters, and rash. If any of these skin reactions occur, it is imperative to discontinue use and seek medical help immediately.

Additionally, a warning is issued regarding sore throat symptoms. If a sore throat is severe, persists for more than two days, or is accompanied or followed by fever, headache, rash, nausea, or vomiting, patients should consult a healthcare professional promptly.

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 avoid potential adverse effects related to increased bleeding risk. Adjustments to the dosage of either medication may be required based on clinical judgment and patient response.

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 should not use this product if they are allergic to acetaminophen or any of the inactive ingredients. Prior to administration, it is advisable to consult a healthcare professional if the child has liver disease or is taking the anticoagulant warfarin.

Dosing should be determined using the weight of the child whenever possible; otherwise, age may be used. The following dosing guidelines apply:

• For children under 24 lb (under 2 years), consultation with a doctor is recommended.

• For children weighing 24-35 lb (2-3 years), the dose is 5 mL (1 tsp).

• For children weighing 36-47 lb (4-5 years), the dose is 7.5 mL (1 1/2 tsp).

• For children weighing 48-59 lb (6-8 years), the dose is 10 mL (2 tsp).

• For children weighing 60-71 lb (9-10 years), the dose is 12.5 mL (2 1/2 tsp).

• For children weighing 72-95 lb (11 years), the dose is 15 mL (3 tsp).

Doses may be repeated every 4 hours as needed, but should not exceed 5 doses in a 24-hour period. Use should not extend beyond 5 days unless directed by a healthcare professional.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any adverse effects or changes in therapeutic response, given the lack of targeted data for this population.

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. The absence of safety concerns, dosage modifications, or special precautions in the labeling indicates a lack of comprehensive clinical or animal study data to inform risk assessment. Therefore, healthcare providers are encouraged to weigh the potential benefits against any unknown risks when considering acetaminophen for women of childbearing potential. It is advisable to discuss the use of this medication with patients who are pregnant or planning to become pregnant to ensure informed decision-making.

Lactation

Lactating mothers should consult a doctor before using this product. There is a potential for excretion in breast milk. The effects of acetaminophen on nursing infants are not well studied; therefore, caution is advised.

Renal Impairment

There is no information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution and consider the lack of data when prescribing to patients with reduced kidney function.

Hepatic Impairment

Patients with hepatic impairment should be closely monitored when using this product, which contains acetaminophen. It is important to note that severe liver damage may occur if patients exceed the maximum daily amount of 5 doses within a 24-hour period. Additionally, caution is advised when administering this product in conjunction with other medications that also contain acetaminophen, as this may further increase the risk of liver damage.

Healthcare providers should assess liver function prior to initiating treatment and consider dosage adjustments based on the severity of hepatic impairment. Regular monitoring of liver function tests may be warranted to ensure patient safety and to mitigate the risk of adverse effects associated with acetaminophen use in this population.

Overdosage

In cases of overdose, the potential for liver damage is a significant concern. It is imperative that individuals who suspect an overdose 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 noticeable signs or symptoms.

Healthcare professionals should be aware that the severity of liver damage can vary based on the amount ingested and the time elapsed since the overdose occurred. Therefore, it is essential to monitor the patient closely and initiate appropriate management procedures as soon as possible. This may include supportive care and specific treatments aimed at mitigating liver injury.

In summary, any instance of overdose necessitates urgent medical evaluation and intervention to prevent serious health consequences.

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 compound in these areas.

Postmarketing Experience

Acetaminophen has been associated with severe skin reactions reported in postmarketing experience. Symptoms of these reactions may include skin reddening, blisters, and rash. In cases where a skin reaction occurs, 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 whether a drug contains acetaminophen, they should be encouraged to consult with 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 present in the formulation. Providers should emphasize the importance of adhering to the recommended dosage and inform patients about the risks associated with exceeding this dosage, including the potential for overdose.

Patients should be instructed to discontinue use and seek medical advice if their child's pain worsens or persists for more than five days. Similarly, if a fever worsens or lasts longer than three days, or if new symptoms arise, patients should be advised to stop use and consult a healthcare professional. Additionally, the presence of redness or swelling should prompt patients to seek medical attention, as these may indicate a serious condition.

Healthcare providers should also recommend that patients consult a doctor before using this product if their child has liver disease. Furthermore, it is advisable for patients 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 various package configurations, with specific NDC numbers available upon request. 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. Proper handling and storage conditions must be adhered to in order to maintain product efficacy and safety.

Additional Clinical Information

No further data are available.

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.

View product document (PDF)