Walgreen Childrens Pain Plus Fever

Description

No description information is available for the specified 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

This product is intended for pediatric use only, and healthcare professionals should refer to the dosage chart to determine the appropriate dose based on the child's weight or age. Prior to administration, the product must be shaken well to ensure proper mixing.

For dosing, the following guidelines should be adhered to:

• For children weighing under 24 lbs (under 2 years), consultation with a physician is required before administration.

• For children weighing between 24-35 lbs (2-3 years), the recommended dose is 5 mL.

• For children weighing between 36-47 lbs (4-5 years), the recommended dose is 7.5 mL.

• For children weighing between 48-59 lbs (6-8 years), the recommended dose is 10 mL.

• For children weighing between 60-71 lbs (9-10 years), the recommended dose is 12.5 mL.

• For children weighing 72-95 lbs (11 years), the recommended dose is 15 mL.

The dosing cup provided with the product must be used exclusively for measuring doses; no other dosing devices should be utilized. To administer the dose, remove the child protective cap and squeeze the appropriate amount into the dosing cup.

Doses may be repeated every 4 hours as needed while symptoms persist, but it is imperative not to exceed 5 doses within a 24-hour period. Healthcare professionals should ensure that caregivers are aware of the overdose warning and the importance of adhering to the recommended dosing guidelines.

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 the formulation.

Additionally, exceeding the recommended dose is contraindicated, as it poses a risk of overdose.

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, blisters, 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 essential.

General Precautions Prior to administration, it is advisable to consult a physician if the child has a history of liver disease. Furthermore, caregivers should seek guidance from a doctor or pharmacist if the child is concurrently taking the anticoagulant warfarin. It is critical to adhere to the recommended dosage to avoid the risk of overdose.

Emergency Medical Help In the event of an overdose, immediate medical attention is required. Caregivers should contact a Poison Control Center at 1-800-222-1222 without delay, as rapid intervention is crucial for both adults and children, even in the absence of overt symptoms.

Discontinuation and Consultation Healthcare professionals should instruct caregivers to stop the use of this product and consult a physician if any of the following occur: worsening pain lasting more than 5 days, worsening fever lasting more than 3 days, the emergence of new symptoms, or the presence of redness or swelling. These signs may indicate a serious underlying condition that necessitates further evaluation.

Side Effects

Patients using this product should be aware of several potential adverse reactions, including serious warnings and common 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 this product in conjunction with other medications containing acetaminophen. Patients should be advised to avoid using this product 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.

Acetaminophen may also cause severe skin reactions, which can manifest as skin reddening, blisters, or rash. In the event of a skin reaction, patients should discontinue use immediately and seek medical assistance.

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 doctor promptly. Additionally, patients with a history of liver disease should seek medical advice before using this product.

It is important for patients taking the blood-thinning medication warfarin to consult a doctor or pharmacist prior to use. During the use of this product, patients should not exceed the recommended dose, as doing so may lead to overdose.

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

In the event of an overdose, patients should seek medical help or contact a Poison Control Center immediately, as prompt medical attention is critical for both adults and children, 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 necessitate careful monitoring of coagulation parameters due to the potential for altered anticoagulant effects. Adjustments to the dosage of warfarin may be required based on clinical judgment and laboratory results.

Packaging & NDC

Below are the non-prescription pack sizes of Walgreen Childrens Pain Plus 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 and age. For patients under 24 lbs, consultation with a healthcare provider is advised. The recommended dosages for children are as follows:

• For those weighing 24-35 lbs (2-3 years), the dose is 5 mL.

• For those weighing 36-47 lbs (4-5 years), the dose is 7.5 mL.

• For those weighing 48-59 lbs (6-8 years), the dose is 10 mL.

• For those weighing 60-71 lbs (9-10 years), the dose is 12.5 mL.

• For those weighing 72-95 lbs (11 years), the dose is 15 mL.

It is crucial not to exceed 5 doses within a 24-hour period. Dosing should primarily be based on weight; if weight is not available, age may be used as a secondary reference. Additionally, it is important to utilize only the enclosed dosing cup specifically designed for this product and to refrain from using any other dosing devices.

Geriatric Use

Elderly patients may not have specific information regarding the use of this product, as the prescribing information does not provide guidance on geriatric use. The product is indicated for use in children aged 2-11 years, and there are no documented dosage adjustments or safety concerns specifically related to elderly patients.

Healthcare providers should exercise caution when prescribing this product to geriatric patients, considering the lack of data on its safety and efficacy in this population. Monitoring for potential adverse effects is advisable, given the absence of established guidelines for use in individuals aged 65 and older.

Pregnancy

The available prescribing information does not provide specific data regarding the use of this product during pregnancy, including safety concerns, dosage modifications, or special precautions. Therefore, healthcare professionals are advised to exercise caution when prescribing this product to pregnant patients. The potential risks and benefits should be carefully weighed, and alternative treatments should be considered when appropriate. Women of childbearing potential should be informed of the lack of data and encouraged to discuss any concerns with their healthcare provider.

Lactation

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

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 using this product, particularly if they have a history of liver disease. The formulation contains acetaminophen, which poses a risk of severe liver damage if the maximum daily dosage of 5 doses within a 24-hour period is exceeded. 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 injury. Monitoring of liver function may be warranted in patients with compromised liver function to ensure safety and efficacy.

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, even in the absence of observable signs or symptoms.

Healthcare professionals should be aware that the lack of immediate symptoms does not preclude the potential for serious health consequences. Therefore, vigilance and proactive management are essential in cases of suspected overdose.

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

Postmarketing experience has identified that acetaminophen may be associated with severe skin reactions. Reports indicate that symptoms can include skin reddening, blisters, and rash. In the event of a skin reaction, 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 about the presence of acetaminophen in other medications, they should be encouraged to consult a doctor or pharmacist for clarification.

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. Healthcare providers should instruct patients to discontinue use and seek medical advice if the child's pain worsens or persists for more than five days, or if a fever worsens or lasts longer than three days. Additionally, patients should be advised to stop use and consult a doctor if new symptoms arise or if there is any redness or swelling, as these may indicate a serious condition.

It is essential to emphasize the importance of adhering to the recommended dosage and to inform patients about the risks associated with exceeding this dosage, including the potential for overdose. Healthcare providers should also recommend that patients consult a doctor before using this product if their child has liver disease. Furthermore, patients should be advised to seek guidance from a doctor or pharmacist if their child is currently taking the blood-thinning medication warfarin, to ensure safe and effective use of the product.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at room temperature to maintain its integrity and efficacy. No special handling requirements are noted; however, standard precautions should be observed to ensure optimal storage conditions.

Additional Clinical Information

Patients should be informed that the medication is administered orally, with a recommended repeat dose every 4 hours as needed, not to exceed 5 doses within a 24-hour period.

Clinicians should counsel patients on potential severe skin reactions associated with acetaminophen, which may manifest as skin reddening, blisters, or rash. In such cases, patients should discontinue use and seek immediate medical attention. Additionally, if a sore throat is severe, persists beyond 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting, patients should consult a healthcare provider. It is advisable to seek medical advice before use if the patient has liver disease or is taking warfarin. Patients should also be instructed to stop use and consult a doctor if pain worsens or lasts more than 5 days, if fever worsens or lasts more than 3 days, or if new symptoms arise, including redness or swelling.

Drug Information (PDF)

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

View product document (PDF)