Childrens Pain and Fever

Description

Acetaminophen is formulated as a liquid solution containing 160 mg of acetaminophen per 5 mL. It serves as a pain reliever and fever reducer, indicated for use in children aged 2 to 11 years. The formulation is free of alcohol, aspirin, ibuprofen, and gluten, and is flavored with cherry. A dosage cup is included for accurate administration. The product is tamper evident; it should not be used if the carton is opened or if the printed safety seal around the bottle or under the cap is broken or missing. This product is distributed by CVS Pharmacy, Inc., located at One CVS Drive, Woonsocket, RI 02895.

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 specific populations, and healthcare professionals should refer to the dosage chart for appropriate dosing. It is essential to shake the product well before use. The enclosed dosing cup, specifically designed for this product, must be utilized; no other dosing devices should be employed.

Dosing should be determined primarily by weight; however, age may be used as an alternative if weight is not available. The following dosing recommendations apply:

• For patients weighing less than 24 lb or under 2 years of age, the dose should be determined by consulting a doctor.

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

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

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

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

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

If necessary, doses may be repeated every 4 hours while symptoms persist. However, it is critical not to exceed 5 doses within a 24-hour period and not to administer the product for more than 5 consecutive days unless directed by a healthcare professional. Adherence to these guidelines is essential to ensure safe and effective use of the product.

Contraindications

Use of this product is contraindicated in the following situations:

The product should not be used in conjunction with any other medication containing acetaminophen, whether prescription or nonprescription. If there is uncertainty regarding the presence of acetaminophen in a medication, consultation with a healthcare professional is advised.

Additionally, this product is contraindicated in patients with a known allergy to acetaminophen or any of the inactive ingredients contained within the formulation.

Exceeding the recommended dosage is also contraindicated, as it may lead to overdose.

Warnings and Precautions

Severe liver damage may occur with the use of this product, which contains acetaminophen, if the maximum daily dosage is exceeded. Specifically, healthcare professionals should advise that no more than five doses should be administered within a 24-hour period. Additionally, caution is warranted if the product is used concurrently with other medications containing acetaminophen.

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.

Healthcare providers should be vigilant regarding sore throat symptoms. If a sore throat 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 physician if the child has a history of liver disease. Furthermore, healthcare professionals should inquire about the use of anticoagulants, such as warfarin, as interactions may occur.

In cases of overdose, immediate medical attention is crucial. Patients or caregivers should contact a Poison Control Center at 1-800-222-1222 without delay, even if no symptoms are apparent.

Patients should be instructed to discontinue use and consult a healthcare provider if 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. These symptoms may indicate a serious underlying condition that requires further evaluation.

Side Effects

Patients using this product should be aware of several important warnings and potential adverse reactions.

Severe liver damage may occur if the maximum daily amount of acetaminophen, which is more than 5 doses in 24 hours, is exceeded or if the product is taken concurrently with other medications containing acetaminophen. Patients are advised to avoid using this product in conjunction with any other drug containing acetaminophen, whether prescription or nonprescription, and to consult a healthcare professional if there is uncertainty regarding the presence of acetaminophen in other medications.

There is also an allergy alert associated with acetaminophen, as it may lead to severe skin reactions. Symptoms of such reactions can include skin reddening, blisters, and rash. Should any skin reaction occur, patients must stop using the product and seek medical assistance immediately.

In cases where a sore throat is severe, persists for more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting, patients should consult a doctor promptly.

Patients with a history of liver disease should seek medical advice before using this product. Additionally, those taking the blood-thinning medication warfarin should consult a doctor or pharmacist prior to use.

While using this product, it is crucial not to exceed the recommended dosage. Patients should discontinue use and consult a healthcare professional if new symptoms arise, if redness or swelling occurs, if pain worsens or lasts more than 5 days, or if fever intensifies or lasts more than 3 days, as these may indicate a serious condition.

An overdose warning is also pertinent; taking more than the recommended dose may result in liver damage. In the event of an overdose, it is imperative to seek medical help or contact a Poison Control Center (1-800-222-1222) immediately, as prompt medical attention is critical even if no signs or symptoms are initially apparent.

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

Pediatric Use

Pediatric patients aged 2 to 11 years may use this product according to the following dosing guidelines based on weight and age. For children under 24 lb (under 2 years), consultation with a doctor is advised. For those weighing 24-35 lb (ages 2-3 years), the recommended dose is 5 mL; for 36-47 lb (ages 4-5 years), 7.5 mL; for 48-59 lb (ages 6-8 years), 10 mL; for 60-71 lb (ages 9-10 years), 12.5 mL; and for 72-95 lb (age 11 years), 15 mL.

It is critical to adhere to the maximum dosage guidelines, which stipulate that no more than 5 doses should be administered within a 24-hour period and that treatment should not exceed 5 days unless directed by a healthcare professional.

Healthcare providers should be aware of the liver warning associated with this product, as severe liver damage may occur if a child exceeds the maximum dosage or concurrently takes other medications containing acetaminophen. Additionally, consultation with a doctor is recommended if the child has liver disease or is taking the anticoagulant warfarin.

Parents and caregivers should also be vigilant for signs of severe sore throat, which, if persistent for more than 2 days or accompanied by fever, headache, rash, nausea, or vomiting, necessitates prompt medical consultation. In the event of an overdose, immediate medical assistance or contact with a Poison Control Center is essential, as exceeding the recommended dose may lead to liver damage.

Geriatric Use

There is no specific information regarding the use of this medication in geriatric patients. Therefore, healthcare providers should exercise caution when prescribing this medication to elderly patients. It is advisable to closely monitor this population for any potential adverse effects or changes in drug efficacy, given the physiological changes associated with aging that may affect drug metabolism and response. Additionally, consideration should be given to the presence of comorbidities and polypharmacy, which are common in geriatric patients and may necessitate dosage adjustments or increased vigilance in monitoring.

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 exercise caution when recommending acetaminophen to women of childbearing potential, considering the lack of comprehensive data on its effects during pregnancy. It is advisable to weigh the potential benefits against any unknown risks to 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, healthcare professionals may consider the use of acetaminophen in nursing mothers without specific concerns for breastfed infants.

Renal Impairment

Patients with renal impairment have not been specifically studied in relation to dosage adjustments, special monitoring, or safety considerations for this medication. As such, there is no available information regarding the use of this drug in individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing this medication to patients with renal impairment.

Hepatic Impairment

Patients with hepatic impairment should be closely monitored when using this product, which contains acetaminophen. It is essential 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 product is taken concurrently with other medications containing acetaminophen.

Prior to use, it is recommended that patients with liver disease consult a healthcare professional. In the event of an overdose, which may result from taking more than the recommended dose, immediate medical assistance should be sought, or the Poison Control Center (1-800-222-1222) should be contacted. Prompt medical attention is critical, even if no signs or symptoms of overdose are apparent.

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 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. Quick intervention is vital, even in the absence of noticeable signs or symptoms, to mitigate potential harm and ensure appropriate management.

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

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients about the potential risks associated with overdose, emphasizing that taking more than the recommended dose may lead to liver damage. In the event of an overdose, patients should be instructed to seek medical help immediately or contact a Poison Control Center at 1-800-222-1222, as prompt medical attention is crucial even if no signs or symptoms are apparent.

Patients should be cautioned against using 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.

It is important to inform patients that this product should not be used if their child has a known allergy to acetaminophen or any of the inactive ingredients present in the formulation. Patients should be instructed to discontinue use and consult a doctor if 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.

While using this product, patients must be reminded not to exceed the recommended dosage. Additionally, healthcare providers should recommend that patients consult a doctor before use if their child has liver disease or 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 found on the packaging. It is essential to store the product at a temperature range of 20-25ºC (68-77ºF). Refrigeration is not recommended, as it may compromise the integrity of the product.

For proper identification, the lot number and expiration date are located on the bottom panel of the packaging. Care should be taken to ensure that these details are accessible for reference.

Additional Clinical Information

The medication is administered orally, with a recommended dosing frequency of every 4 hours as needed, not to exceed 5 doses within a 24-hour period. Continuous use should not extend beyond 5 days unless directed by a healthcare professional.

Clinicians should counsel patients to consult a doctor prior to use if the child has liver disease or is concurrently taking the anticoagulant warfarin. Patients are advised to discontinue use and seek medical advice if new symptoms arise, if there is any redness or swelling, if pain worsens or persists beyond 5 days, or if fever intensifies or lasts more than 3 days.

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.

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