Childrens Acetaminophen

Description

WinCo® CHILDREN'S Acetaminophen Chewable Tablets contain acetaminophen as the active ingredient, providing effective pain relief and fever reduction. Each chewable tablet is formulated with a dosage strength of 160 mg and is grape flavored to enhance palatability. The product is packaged in a container of 24 tablets and is indicated for use in children aged 2 to 11 years.

The tablets are designed to be chewed or crushed completely before swallowing; they should not be swallowed whole. This formulation is both ibuprofen and aspirin free, making it a suitable option for children who may require an alternative to these medications.

The packaging features tamper-evident technology, and users are advised not to use the product if the package is opened or if the blister unit is torn, broken, or shows any signs of tampering. WinCo® CHILDREN'S Acetaminophen Chewable Tablets are distributed by WINCO FOODS, LLC, located in Boise, ID 83704. This product can be compared to the active ingredient in Children's Tylenol® Chewables.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with headache, sore throat, flu, toothache, 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 healthcare professionals should refer to the dosage chart to determine the appropriate dose based on the patient's weight or age. It is essential to adhere to the following guidelines:

For patients weighing under 24 lb or under 2 years of age, it is advised to consult a physician for appropriate dosing recommendations. For those weighing between 24-35 lb (ages 2-3 years), the recommended dose is 1 chewable tablet. Patients weighing 36-47 lb (ages 4-5 years) should receive 1 ½ chewable tablets. For patients weighing 48-59 lb (ages 6-8 years), the dose is 2 chewable tablets. Patients weighing 60-71 lb (ages 9-10 years) should be administered 2 ½ chewable tablets, and for those weighing 72-95 lb (age 11 years), the recommended dose is 3 chewable tablets.

Patients should chew or crush the tablets completely before swallowing; whole tablets should not be swallowed. Dosing may be repeated every 4 hours as needed while symptoms persist, but it is critical not to exceed 5 doses within a 24-hour period.

Healthcare professionals should ensure that patients do not receive more than the directed amount and should provide guidance on the importance of following these dosing instructions.

Contraindications

Use of this product is contraindicated in patients who are concurrently taking any other medication that contains acetaminophen, whether prescription or nonprescription. This is due to the risk of acetaminophen overdose, which can lead to severe liver damage. If there is uncertainty regarding the presence of acetaminophen in other medications, consultation with a healthcare professional is advised.

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 when this product is used in conjunction with other medications containing acetaminophen, as this may further increase the risk of liver injury.

Acetaminophen has been associated with severe skin reactions. Symptoms indicative of such reactions may include skin reddening, blisters, and rash. In the event of any skin reaction, it is imperative to discontinue use immediately and seek medical assistance without delay.

Healthcare professionals 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, it is essential to consult a physician promptly.

General precautions should be observed prior to administration. It is advisable to consult a healthcare provider if the child has a history of liver disease. Furthermore, if the child is concurrently taking the anticoagulant warfarin, consultation with a doctor or pharmacist is recommended before use.

In cases of overdose, immediate medical attention is critical. Healthcare professionals should instruct caregivers to seek emergency medical help or contact a Poison Control Center right away, regardless of whether any signs or symptoms are present.

Patients should be advised to discontinue use and consult a physician if any of the following occur: pain worsens or persists beyond five days, fever worsens or lasts more than three days, new symptoms develop, or if there is any redness or swelling.

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 acetaminophen, which is five doses within a 24-hour period, or who take this product concurrently with other medications containing acetaminophen.

Additionally, there is 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. In the event of a skin reaction, patients are advised to 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 healthcare professional promptly.

Patients should also stop using the product and consult a doctor if pain worsens or lasts longer than five days, if fever worsens or lasts more than three days, if any new symptoms appear, or if there is any redness or swelling.

Before using this product, it is recommended that patients with liver disease consult a doctor. Furthermore, patients taking the blood-thinning medication warfarin should seek advice from a doctor or pharmacist prior to use.

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 be heightened, leading to serious hepatic complications. 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 Acetaminophen (acetaminophen). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients should not exceed the recommended dosage. The appropriate dose can be determined using the following weight-based chart; if weight is not available, age may be used as a guide:

• For patients under 24 lb (under 2 years), consult a doctor.

• For patients weighing 24-35 lb (2-3 years), the recommended dose is 1 chewable tablet.

• For patients weighing 36-47 lb (4-5 years), the recommended dose is 1.5 chewable tablets.

• For patients weighing 48-59 lb (6-8 years), the recommended dose is 2 chewable tablets.

• For patients weighing 60-71 lb (9-10 years), the recommended dose is 2.5 chewable tablets.

• For patients weighing 72-95 lb (11 years), the recommended dose is 3 chewable tablets.

Treatment should not exceed 5 days unless directed by a healthcare professional. In the event of an overdose, immediate medical assistance should be sought, or contact a Poison Control Center. Prompt medical attention is essential for both children and adults, even if no signs or symptoms are present.

Geriatric Use

There is no specific information available regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population.

Pregnancy

Pregnant patients should be advised against the use of this product if they have a known allergy to acetaminophen or any of the inactive ingredients contained within. It is essential for healthcare providers to assess the overall health of pregnant patients, particularly those with liver disease, as this condition may necessitate a consultation prior to use. Additionally, pregnant patients who are taking anticoagulants such as warfarin should seek guidance from a healthcare professional or pharmacist before using this product, due to potential interactions.

Healthcare providers should emphasize the importance of keeping this product out of reach of children. In the event of an overdose, immediate medical assistance should be sought, and contacting a Poison Control Center is recommended. Prompt medical attention is critical for both adults and children, even in the absence of noticeable signs or symptoms.

Lactation

Lactating mothers should consult a doctor before using this product. There is a potential for excretion of acetaminophen in breast milk. Caution is advised when administering this product to nursing mothers due to the potential risk to the infant.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the drug insert regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the absence of detailed guidance 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, as it contains acetaminophen, which is associated with the risk of severe liver damage. It is critical to adhere to the maximum daily dosage of 5 doses within a 24-hour period to mitigate the risk of hepatotoxicity.

Before administration, it is advised 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 evaluate the potential need for dosage adjustments or additional monitoring based on the severity of the hepatic impairment.

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 noticeable signs or symptoms.

Healthcare professionals should be aware that the lack of immediate symptoms does not preclude the potential for serious health consequences. Therefore, it is essential to monitor the patient closely and provide appropriate care as needed.

Nonclinical Toxicology

No information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or toxicology.

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 seek immediate medical assistance or contact a Poison Control Center in the event of an overdose. It is essential to emphasize that prompt medical attention is critical for both adults and children, even if no signs or symptoms are initially 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 any other medications they are taking, 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, if a patient's fever worsens or lasts longer than three days, they should stop using the medication and seek medical advice. Patients should also be advised to stop use and consult a doctor if they experience any new symptoms, or if they notice redness or swelling.

For pediatric patients, it is important to recommend that parents or guardians consult a doctor before using this medication if their child has liver disease. Additionally, they should be advised to speak with a doctor or pharmacist if their child is currently taking the blood-thinning medication warfarin.

Storage and Handling

The product is supplied in tamper-evident packaging. It should not be used if the outer package is opened or if the blister is torn or broken.

Storage conditions require the product to be maintained at a temperature of 25ºC (77ºF), with permissible excursions between 15°-30°C (59°-86°F). It is important to avoid high humidity during storage.

For reference, the expiration date and lot number can be found on the end flap of the packaging.

Additional Clinical Information

The medication is administered orally, with specific instructions for patients to chew or crush the tablets completely before swallowing, as whole tablets should not be swallowed. Dosing should be repeated every 4 hours as needed, with a maximum of 5 doses within a 24-hour period. Patients should not use the medication for more than 5 consecutive days unless directed by a healthcare professional.

No additional information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experiences.

Drug Information (PDF)

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

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