Kroger Children Pain Plus Fever Chewables

Description

Children’s Pain + Fever Chewables contain 160 mg of acetaminophen per tablet, serving as a pain reliever and fever reducer. The product is formulated without aspirin or ibuprofen, making it suitable for children aged 2 to 11. Each chewable tablet is grape-flavored, with both natural and artificial flavoring agents included. The product is packaged in a tamper-evident container, consisting of 24 chewable tablets, each containing 160 mg of the active ingredient. Users are instructed to chew or crush the tablets completely before swallowing. The product is distributed by an unspecified distributor and 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

This product is intended for use in accordance with the following dosage guidelines. It is essential to adhere strictly to the recommended dosages and not exceed the maximum limits to avoid potential overdose.

For optimal dosing, healthcare professionals should refer to the dosage chart below, utilizing the patient's weight for dosing whenever possible. If weight is not available, age may be used as a secondary reference.

Dosage Chart:

• For patients weighing under 24 lb: Consult a physician before administration.

• For patients weighing 24-35 lb: Administer 1 tablet.

• For patients weighing 36-47 lb: Administer 1 ½ tablets.

• For patients weighing 48-59 lb: Administer 2 tablets.

• For patients weighing 60-71 lb: Administer 2 ½ tablets.

• For patients weighing 72-95 lb: Administer 3 tablets.

Tablets must be chewed or crushed completely before swallowing to ensure proper absorption. The recommended dosing interval is every 4 hours as needed while symptoms persist. It is critical not to exceed 5 doses within a 24-hour period.

For any specific dosing adjustments or concerns, healthcare professionals should consult with 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 dosage 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 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.

Allergy Alert Acetaminophen may lead to 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 of severe sore throat that persists for more than two days, or if accompanied by fever, headache, rash, nausea, or vomiting, it is essential to consult a physician without delay.

Pre-existing Conditions Healthcare professionals should inquire about the patient's medical history, particularly regarding liver disease, before recommending this product. Furthermore, it is advisable to consult a doctor or pharmacist if the patient is concurrently taking warfarin, a blood-thinning medication.

Usage Guidelines When administering this product, it is critical to adhere strictly to the recommended dosage to avoid overdose.

Monitoring and Discontinuation Patients should be advised to stop using the product and consult a healthcare provider if any of the following occur: worsening pain that lasts more than five days, fever that worsens or persists for more than three days, the emergence of new symptoms, or the presence of redness or swelling. These signs may indicate a serious underlying condition.

Overdose Warning In the event of an overdose, immediate medical attention is necessary. Patients or caregivers should 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

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

Severe liver damage may occur in patients who exceed the maximum daily dosage of five doses within a 24-hour period or who take this product concurrently with other medications containing acetaminophen. Additionally, acetaminophen may cause severe skin reactions, which can manifest as skin reddening, blistering, or rash. If any of these symptoms occur, patients are advised to discontinue use immediately and seek medical assistance.

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 should consult a healthcare professional promptly.

Patients should also be instructed to stop use and contact a doctor if pain worsens or lasts longer than five days, if fever worsens or persists for more than three days, if new symptoms develop, or if redness or swelling is observed, as these may indicate a serious condition.

In the event of an overdose, it is critical to seek medical help or contact a Poison Control Center immediately at 1-800-222-1222, as prompt medical attention is essential 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 may arise from unintentional duplication of therapy. 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 Kroger Children Pain Plus Fever Chewables (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. Dosing varies by age: children under 2 years should consult a doctor; those aged 2-3 years may take 1 tablet; 4-5 years may take 1 ½ tablets; 6-8 years may take 2 tablets; 9-10 years may take 2 ½ tablets; and children aged 11 years may take 3 tablets. The maximum allowable dose is 5 doses within a 24-hour period. Tablets should be chewed or crushed completely before swallowing.

Healthcare professionals should be aware of specific warnings associated with this product. Severe liver damage may occur if the recommended dose is exceeded. Additionally, acetaminophen may cause severe skin reactions; medical attention should be sought if such symptoms arise. A sore throat warning is in place, advising consultation with a doctor if the sore throat is severe, persists for more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting.

It is essential to consult a doctor if the pediatric patient has liver disease or is taking the blood-thinning medication warfarin.

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 primarily indicated for children aged 2 to 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, given the absence of data on its safety and efficacy in this population. Monitoring for potential adverse effects is advisable, as the pharmacokinetics and pharmacodynamics may differ in elderly patients compared to younger populations.

Pregnancy

The available prescribing information does not provide specific data regarding the use of this product during pregnancy. Consequently, the safety concerns, dosage modifications, or special precautions for pregnant patients remain undefined. Healthcare professionals should exercise caution when considering this product for women of childbearing potential and weigh the potential risks against the benefits. It is advisable to discuss any concerns with patients who are pregnant or planning to become pregnant.

Lactation

There are no specific statements regarding the use of this medication in lactating mothers. Additionally, there are no known data on the excretion of this medication in breast milk or its effects on breastfed infants. Healthcare professionals should consider the absence of information when advising lactating mothers about the use of this medication.

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 be closely monitored when using this product, as it contains acetaminophen, which is associated with the risk of severe liver damage. It is critical that patients do not exceed five doses within a 24-hour period, as this represents the maximum daily amount. Additionally, patients should avoid concomitant use with other medications containing acetaminophen to prevent the risk of overdose and subsequent liver injury.

Before initiating treatment, it is advisable for patients with liver disease to consult a healthcare professional. This precaution is essential to ensure the safe use of the product and to evaluate the potential need for dosage adjustments or alternative therapies based on the severity of hepatic impairment. Regular monitoring of liver function may be warranted in these patients to detect any signs of liver damage early.

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 intervention is essential, as the absence of noticeable signs or symptoms does not preclude the potential for serious health consequences.

Healthcare professionals should be aware that quick medical attention can significantly impact the outcome of an overdose situation. Therefore, it is crucial to act swiftly, regardless of the presence of overt symptoms.

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 question.

Postmarketing Experience

Postmarketing experience has identified that acetaminophen may be associated with severe skin reactions. Reports indicate that symptoms can include skin reddening, blistering, 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 seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222 in the event of an overdose, emphasizing that prompt medical attention is crucial even if no signs or symptoms are apparent.

Patients should be informed not to use this product in conjunction with any other medications containing acetaminophen, whether prescription or nonprescription. If there is uncertainty regarding the presence of acetaminophen in other medications, patients are encouraged to consult with a doctor or pharmacist.

It is important to instruct patients not to use this product if their child has a known allergy to acetaminophen or any of the inactive ingredients contained in the formulation.

Patients should be advised to discontinue use and consult a doctor if pain worsens or persists for more than 5 days, or if fever worsens or lasts longer than 3 days. Additionally, they should be instructed to seek medical advice if new symptoms arise or if there is any redness or swelling, as these may indicate a serious condition.

While using this product, patients must be cautioned against exceeding the recommended dose, in light of the overdose warning.

Healthcare providers should also recommend that patients consult a doctor before use 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 configurations that include specific NDC numbers, which can be found on the packaging. It is essential to store the product at room temperature, ensuring that it is kept away from high humidity and protected from light exposure. For tracking purposes, the expiration date and lot number are located on the end flap of the packaging.

Additional Clinical Information

The medication is administered orally, with patients advised to chew or crush the tablets completely before swallowing. Dosing can be repeated every 4 hours as needed, but should not exceed 5 doses within a 24-hour period.

Clinicians should counsel patients to keep the medication out of reach of children. In the event of an overdose, it is crucial to seek medical assistance immediately or contact a Poison Control Center at 1-800-222-1222, as prompt medical attention is essential even if no symptoms are apparent.

Drug Information (PDF)

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

View product document (PDF)