Childrens Pain and Fever

Description

No description information is available for the specified drug.

Uses and Indications

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

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 administered does not exceed the recommended limits.

Prior to administration, the product must be shaken well. The provided dose cup should be utilized to measure the appropriate dosage accurately. The correct dose can be determined using the dosage chart below, which recommends dosing based on the patient's weight; if weight is not available, age may be used as a secondary guide.

The recommended dosing intervals are every 4 hours while symptoms persist, with a maximum of 5 doses within a 24-hour period.

Dosage Chart:

• For patients weighing under 24 lb or under 2 years of age, consult a physician for guidance.

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

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

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

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

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

Dosing should always be in accordance with the recommendations provided or as directed by a healthcare professional.

Contraindications

Use of this product is contraindicated in patients who are concurrently taking any other medication that contains acetaminophen, whether prescribed or over-the-counter. The combination may lead to an increased risk of acetaminophen-related hepatotoxicity. If there is uncertainty regarding the acetaminophen content of a medication, consultation with a healthcare professional is advised.

Warnings and Precautions

Severe liver damage may occur in children who take this product, which contains acetaminophen, if they exceed the maximum daily dosage of 5 doses within a 24-hour period or if they are concurrently using other medications that contain acetaminophen.

Acetaminophen has been associated with the potential for severe skin reactions. Symptoms indicative of such reactions may include skin reddening, blisters, and rash. In the event of a skin reaction, it is imperative to discontinue use immediately and seek medical assistance.

Healthcare professionals should be vigilant regarding sore throat symptoms. If a child presents with a severe sore throat that persists for more than 2 days, or if it is accompanied or followed by fever, headache, rash, nausea, or vomiting, prompt consultation with a physician is advised.

Prior to administration, it is essential to inquire about the child’s medical history. Specifically, consultation with a healthcare provider is recommended if the child has a history of liver disease. Additionally, if the child is currently taking the anticoagulant warfarin, it is crucial to seek advice from a doctor or pharmacist before use.

In cases of suspected overdose, immediate medical attention is necessary. Parents and caregivers should contact a Poison Control Center or seek emergency medical help without delay, as timely intervention is critical for both adults and children, even in the absence of overt symptoms.

Healthcare professionals should instruct caregivers to discontinue use and consult a physician if any of the following occur: pain worsens or persists beyond 5 days, fever intensifies or lasts more than 3 days, redness or swelling is observed, or any new symptoms develop.

Side Effects

Severe adverse reactions associated with this product include significant liver damage, which may occur if a child exceeds five doses within a 24-hour period or if the product is taken concurrently with other medications containing acetaminophen. Patients should be aware of the potential for 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 immediate medical assistance.

Participants should also be cautioned regarding the risk of severe sore throat. If a sore throat is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, it is essential to consult a healthcare provider promptly.

Patients are advised to stop 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 redness or swelling occurs, or if any new symptoms arise.

It is recommended that a healthcare professional be consulted prior to use if the child has liver disease or is taking the anticoagulant warfarin. In the event of an overdose, immediate medical attention should be sought, or contact with a Poison Control Center is advised. Prompt medical intervention is critical for both adults and children, even in the absence of noticeable signs or symptoms.

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 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 aged 2 to 11 years may receive this medication with specific dosing guidelines based on weight. The recommended doses are as follows: for children under 24 lb and under 2 years of age, consultation with a doctor is advised prior to administration. For those weighing 24-35 lb (ages 2-3 years), the dose is 5 mL; for 36-47 lb (ages 4-5 years), the dose is 7.5 mL; for 48-59 lb (ages 6-8 years), the dose is 10 mL; for 60-71 lb (ages 9-10 years), the dose is 12.5 mL; and for those weighing 72-95 lb (age 11 years), the dose is 15 mL.

Healthcare professionals should advise caregivers to consult a doctor before use if the child has liver disease or is taking the blood-thinning medication warfarin. It is crucial to keep this medication out of reach of children. In the event of an overdose, immediate medical assistance should be sought, or a Poison Control Center should be contacted, as prompt medical attention is essential for both children and adults, even if no signs or symptoms are present.

Geriatric Use

Elderly patients may be treated with this product; however, no specific information regarding geriatric use is provided in the prescribing information. The product is primarily indicated for children ages 2–11 years, and there are no dosage adjustments or safety concerns mentioned for elderly patients.

Healthcare providers should exercise caution when prescribing this product to geriatric patients, as individual responses may vary. It is advisable to monitor these patients closely for any potential adverse effects, given the lack of specific data on 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 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 thoroughly evaluated.

Lactation

There are no specific warnings or recommendations regarding the use of acetaminophen in lactating mothers. Additionally, there is no information available about the potential for excretion of acetaminophen in breast milk or any associated risks to breastfed infants.

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 be closely monitored when using this product, which contains acetaminophen. It is important to note that severe liver damage may occur if the maximum daily amount of more than 5 doses in 24 hours is exceeded, or if the patient is concurrently taking other medications that contain acetaminophen.

Prior to administration, it is recommended that a healthcare professional be consulted if the patient has a history of liver disease. This precaution is essential to ensure the safe use of the product and to mitigate the risk of potential adverse effects related to compromised liver function.

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, regardless of whether any signs or symptoms are apparent.

Healthcare professionals should be aware that the absence of symptoms does not preclude the possibility of serious complications arising from an overdose. 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 understanding of the potential toxicological profile in nonclinical settings.

Postmarketing Experience

Acetaminophen has been associated with severe skin reactions, as reported in postmarketing surveillance. Symptoms of these reactions may include skin reddening, blisters, and rash. In the event of a skin reaction, it is advised to discontinue use immediately and seek medical assistance.

Additionally, cases of overdose have been reported. It is crucial to obtain medical help or contact a Poison Control Center without delay, as prompt medical attention is essential for both adults and children, even in the absence of noticeable signs or symptoms.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center in the event of an overdose, emphasizing that prompt medical attention is crucial for both adults and children, even if no signs or symptoms are apparent.

Patients should be informed not to use this medication in conjunction with any other drug that contains acetaminophen, whether prescription or nonprescription. If patients are uncertain about the presence of acetaminophen in their medications, they should be encouraged to consult with a doctor or pharmacist for clarification.

Healthcare providers should instruct patients to discontinue use and consult a doctor if their pain worsens or persists for more than five days. Similarly, patients should be advised to stop use and seek medical advice if their fever intensifies or lasts longer than three days. Additionally, patients should be informed to stop use and consult a doctor if they notice any redness or swelling, or if any new symptoms arise.

It is important for healthcare providers to remind patients to consult a doctor before using this medication if their child has liver disease. 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.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for reference. It should be stored at a controlled room temperature of 25°C (77°F), with permissible excursions between 15°C and 30°C (59°F to 86°F).

Healthcare professionals are advised to check the end flap of the packaging for the expiration date and lot number to ensure proper tracking and usage.

Additional Clinical Information

The medication is administered orally, with a recommended repeat dose every 4 hours as needed for symptom relief, not to exceed 5 doses within a 24-hour period. Clinicians should counsel patients to keep the medication out of reach of children and to seek immediate medical assistance or contact a Poison Control Center in the event of an overdose, as prompt attention is crucial for both adults and children, regardless of the presence of symptoms.

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)