Childrens Acetaminophen Oral Suspension

Description

Childrens Acetaminophen Oral Suspension is a liquid formulation designed for the reduction of fever and relief of pain in pediatric patients. This product is alcohol-free, aspirin-free, and ibuprofen-free, making it suitable for children. It is available in a grape flavor to enhance palatability. The suspension is packaged in a 2 FL OZ (60 mL) bottle. This formulation contains the same active ingredient as found in Childrens Tylenol, providing comparable efficacy in managing fever and pain.

Uses and Indications

This drug is indicated for the reduction of fever and the relief of 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 requires thorough shaking before use. The appropriate dosage should be determined using the chart provided below, prioritizing weight for dosing; if weight is unavailable, age may be used as a secondary reference.

Dosing intervals are every 4 hours as needed while symptoms persist, with a maximum of 5 doses within a 24-hour period. Continuous administration should not exceed 5 days unless specifically directed by a healthcare professional.

Dosage Chart:

• For patients weighing under 24 lb and under 2 years of age, consultation with a doctor is advised.

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

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

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

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

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

It is imperative to consult with a healthcare provider before administering this medication to infants or children.

Contraindications

Use of this product is contraindicated in the following situations:

The product should not be administered concurrently with any other medication containing acetaminophen, whether prescription or non-prescription. 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 in the formulation.

It is also essential to adhere to the recommended dosage, as exceeding this may lead to overdose, which poses significant health risks.

Warnings and Precautions

Severe liver damage may occur in pediatric patients taking this product, which contains acetaminophen. Healthcare professionals should advise caregivers that the maximum daily dosage is five doses within a 24-hour period. Caution is warranted if the child is concurrently using other medications that contain acetaminophen, as this may increase the risk of liver injury.

In cases of severe sore throat, it is imperative to consult a physician if the sore throat persists for more than two days or is accompanied by additional symptoms such as fever, headache, rash, nausea, or vomiting. These symptoms may indicate a more serious underlying condition that requires medical evaluation.

Healthcare providers should recommend that caregivers seek medical advice prior to administering this product if the child has a history of liver disease. Additionally, it is advisable to consult a doctor or pharmacist if the child is currently taking warfarin or any other anticoagulant medication, as potential interactions may necessitate closer monitoring.

Patients should be instructed to discontinue use and contact a healthcare professional if new symptoms arise, if there is any redness or swelling, if pain worsens or persists beyond five days, or if fever intensifies or lasts longer than three days. These signs may indicate a serious condition that requires further investigation and management.

Side Effects

Patients using this product should be aware of potential adverse reactions, particularly concerning liver health and the management of sore throat symptoms.

Severe liver damage may occur if patients exceed the maximum recommended dosage of five doses within a 24-hour period or if they concurrently use other medications containing acetaminophen. In cases of overdose, which may lead to liver damage, it is imperative to seek medical assistance or contact a Poison Control Center immediately, as prompt medical attention is crucial for both adults and children, even in the absence of noticeable symptoms.

Patients should also be vigilant for severe 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 advised to consult a healthcare professional promptly.

Additionally, 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 lasts longer than five days, or if fever intensifies or persists beyond three days, as these may indicate a serious condition.

Before using this product, it is recommended that patients consult a healthcare provider if they have a history of liver disease. Furthermore, patients taking the anticoagulant warfarin should also seek guidance from a doctor or pharmacist prior to use.

Drug Interactions

Co-administration of this medication with any other drug containing acetaminophen, whether prescription or non-prescription, is contraindicated due to the risk of acetaminophen overdose, which can lead to severe liver damage.

In pediatric patients, it is advised to consult a healthcare professional, such as a doctor or pharmacist, prior to use if the child is concurrently taking warfarin, a blood-thinning agent. This is essential to ensure appropriate monitoring and to mitigate the risk of potential interactions that may affect coagulation parameters.

Packaging & NDC

Below are the non-prescription pack sizes of Childrens Acetaminophen Oral Suspension (acetaminophen). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 2 years of age should not use this medication without consulting a doctor. For children aged 2-3 years, the recommended dose is 5 mL (1 teaspoon). For those aged 4-5 years, the recommended dose increases to 7.5 mL (1.5 teaspoons). Children aged 6-8 years should receive 10 mL (2 teaspoons), while those aged 9-10 years are recommended to take 12.5 mL (2.5 teaspoons). For children aged 11 years, the appropriate dose is 15 mL (3 teaspoons).

It is crucial to consult a doctor before administering this medication to any infant or child. The maximum daily dosage for pediatric patients is 5 doses within a 24-hour period, and treatment should not exceed 5 days unless directed by a healthcare professional. Additionally, consultation with a doctor is advised if the child has liver disease or is concurrently taking the anticoagulant warfarin.

Geriatric Use

There is no specific information 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

The safety of acetaminophen use during pregnancy has not been established, as the prescribing information does not provide specific data regarding its use in this population. Consequently, healthcare professionals should exercise caution when recommending acetaminophen to pregnant patients. There are no documented safety concerns, dosage modifications, or special precautions outlined for its use during pregnancy. Given the lack of information, it is advisable for women of childbearing potential to consult with their healthcare provider before using acetaminophen to weigh the potential benefits against any unknown risks to fetal outcomes.

Lactation

There are no specific warnings or recommendations regarding the use of this medication in nursing mothers. Additionally, there are no specific warnings or recommendations related to lactation. Healthcare professionals should consider the absence of data when advising lactating mothers on the use of this medication.

Renal Impairment

There is no information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution and consider the lack of specific guidance when prescribing to patients with reduced kidney function.

Hepatic Impairment

Patients with hepatic impairment should be closely monitored when using this product, which contains acetaminophen. It is critical to adhere to the recommended dosage guidelines to prevent severe liver damage. Specifically, patients must not exceed 5 doses within a 24-hour period, as this represents the maximum daily amount. 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. Regular assessment of liver function may be warranted in patients with compromised liver health to ensure safety and efficacy.

Overdosage

Taking more than the recommended dose may lead to significant liver damage. It is imperative that in the event of an overdose, immediate medical assistance is sought. Healthcare professionals should advise patients or caregivers to contact a Poison Control Center without delay.

Quick medical attention is crucial for both adults and children, even in the absence of noticeable signs or symptoms. Prompt intervention can mitigate potential complications associated with overdose and improve outcomes.

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

No postmarketing experience details are available in the provided data.

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 non-prescription. If patients are uncertain about the presence of acetaminophen in other medications, they should be encouraged to consult with a doctor or pharmacist.

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. They should be instructed to stop use and seek medical advice if new symptoms arise, if there is any redness or swelling, or if pain worsens or persists beyond five days. Additionally, if a fever worsens or lasts more than three days, patients should be advised to stop use and consult a doctor, as these may indicate a serious condition.

When using this product, it is crucial to adhere to the recommended dosage and to be aware of the overdose warning. Healthcare providers should also recommend that patients consult a doctor before use if their child has liver disease. Furthermore, patients taking the blood-thinning medication warfarin should be advised to seek guidance from a doctor or pharmacist prior to using this product.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available upon request. It should be stored at a temperature range of 15-30˚C (59-86˚F) to maintain its efficacy. Care must be taken to protect the product from freezing, as exposure to low temperatures may compromise its integrity. Additionally, the product should be shielded from light to prevent degradation. Proper handling and storage conditions are essential to ensure the quality and safety of the product throughout its shelf life.

Additional Clinical Information

The medication is administered orally. Clinicians should advise patients to always consult with their doctor prior to giving this medicine to an infant or child. No additional information is available regarding laboratory tests, abuse potential, or postmarketing experience.

Drug Information (PDF)

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

View product document (PDF)