Childrens Acetaminophen

Description

Children's Acetaminophen Oral Suspension is formulated to provide effective pain relief and fever reduction. Each 5 mL dose contains 160 mg of acetaminophen. This product is specifically designed for institutional use only and is free from ibuprofen, alcohol, and aspirin, making it suitable for a wide range of pediatric patients.

Uses and Indications

This drug is indicated for the relief of pain and the reduction of fever.

There are no teratogenic effects associated with this drug, and no nonteratogenic effects have been reported.

Dosage and Administration

This product is intended for use in pediatric patients and does not contain directions or complete warnings for adult use. Healthcare professionals should advise caregivers to adhere strictly to the dosing recommendations provided, ensuring that no more than the directed amount is administered, in accordance with the overdose warning.

Prior to administration, the product must be shaken well. The appropriate dose should be determined using the dosage chart below, with weight being the preferred method for dosing. If weight is not available, age may be used as an alternative.

Dosing should be repeated every 4 hours as needed while symptoms persist, but it is imperative that no more than 5 doses are given within a 24-hour period.

Dosage Chart:

• For patients weighing under 24 lb or under 2 years of age, consult a doctor for appropriate dosing.

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

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

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

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

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

Dosing may also be adjusted as directed by a healthcare professional.

Contraindications

There are no specified contraindications for the use of this product. No conditions or situations have been identified that would warrant avoidance of use.

Warnings and Precautions

Severe liver damage may occur with the use of this product, which contains acetaminophen. Healthcare professionals should advise caregivers that exceeding five doses within a 24-hour period, which is the maximum daily amount, or administering this product concurrently with other medications containing acetaminophen significantly increases the risk of liver injury.

Acetaminophen may also provoke severe skin reactions. Symptoms indicative of such reactions include skin reddening, blisters, and rash. In the event of any skin reaction, it is imperative to discontinue use immediately and seek medical assistance.

In cases of severe sore throat that persists for more than two days, or if it is accompanied or followed by fever, headache, rash, nausea, or vomiting, prompt consultation with a healthcare provider is essential.

Before administering this product, it is advisable to consult a physician if the child has a history of liver disease. Additionally, caregivers should seek guidance from a doctor or pharmacist if the child is concurrently taking the anticoagulant warfarin, as interactions may occur.

Caregivers must adhere strictly to the recommended dosing guidelines to avoid overdose. In the event of an overdose, immediate medical attention is crucial. Caregivers should contact a Poison Control Center at 1-800-222-1222 without delay, as rapid intervention is vital for both adults and children, even in the absence of noticeable symptoms.

Healthcare professionals should instruct caregivers to discontinue use and consult a physician if the child experiences worsening pain lasting more than five days, fever that worsens or persists beyond three days, the emergence of new symptoms, or any signs of redness or swelling, as these may indicate a serious underlying condition.

Side Effects

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

Severe liver damage may occur if patients exceed the maximum daily dosage of acetaminophen, which is five doses within a 24-hour period, or if they 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.

Furthermore, a sore throat warning is in place; if 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.

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. Co-administration may lead to an increased risk of acetaminophen-related hepatotoxicity. 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 under 2 years of age who weigh less than 24 lb should consult a doctor before use. For children aged 2 to 3 years weighing between 24-35 lb, the recommended dose is 5 mL. For those aged 4 to 5 years and weighing 36-47 lb, the dose increases to 7.5 mL. Children aged 6 to 8 years weighing 48-59 lb should receive 10 mL, while those aged 9 to 10 years weighing 60-71 lb should be given 12.5 mL. For children aged 11 years and weighing 72-95 lb, the appropriate dose is 15 mL.

Severe liver damage may occur if a child takes more than 5 doses in 24 hours, which is the maximum daily amount, or if used concurrently with other medications containing acetaminophen. Acetaminophen may also cause severe skin reactions, including skin reddening, blisters, and rash; if any of these symptoms occur, use should be discontinued immediately, and medical assistance sought. Additionally, if a sore throat is severe, persists for more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting, a doctor should be consulted promptly.

Parents or caregivers should consult a doctor before use if the child has liver disease or is taking the blood-thinning medication warfarin. In the event of an overdose, immediate medical help should be sought, or contact a Poison Control Center, as prompt medical attention is critical for both adults and children, even if no signs or symptoms are present.

Geriatric Use

There is no specific information regarding the use of this medication in geriatric patients. The prescribing information primarily emphasizes pediatric use and does not provide any recommendations concerning age considerations, dosage adjustments, safety concerns, or special precautions for elderly patients.

Healthcare providers should exercise caution when prescribing this medication to geriatric patients, given the absence of data on its safety and efficacy in this population. Monitoring for potential adverse effects and therapeutic responses is advisable, as elderly patients may have different pharmacokinetic and pharmacodynamic profiles compared to younger populations.

Pregnancy

The safety of acetaminophen during pregnancy has not been established. Acetaminophen is contraindicated in pregnant patients who have a known hypersensitivity to acetaminophen or any of the inactive ingredients. There may be potential risks to the fetus; therefore, it is essential for pregnant women to consult a healthcare provider before using this medication.

Dosage adjustments may be necessary for pregnant individuals, and healthcare providers should be consulted for recommendations specific to this population. Pregnant women should use acetaminophen only if clearly needed and after thorough consultation with a healthcare professional to ensure the benefits outweigh any potential risks.

Lactation

There are no specific warnings or recommendations regarding the use of this product in nursing mothers. Additionally, there is no information available about the potential for excretion in breast milk or any associated risks to breastfed infants.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available data regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the lack of information necessitates careful clinical judgment and monitoring of these patients.

Hepatic Impairment

Patients with hepatic impairment should consult a healthcare professional prior to use, particularly if they have a history of liver disease. It is essential to assess liver function and consider potential dosage adjustments or monitoring requirements based on the severity of the impairment. Close monitoring of liver function tests may be warranted to ensure safety and efficacy in this population.

Overdosage

Severe liver damage may occur in pediatric patients who exceed the recommended dosage of this product, which contains acetaminophen. Specifically, healthcare professionals should be aware that administering more than five doses within a 24-hour period, which constitutes the maximum daily amount, significantly increases the risk of hepatotoxicity.

Additionally, caution is advised when this product is used concurrently with other medications containing acetaminophen, as this can further elevate the risk of overdose and subsequent liver damage.

In the event of suspected overdosage, it is imperative to adhere to the overdose warning and to take immediate action. Healthcare providers should assess the patient's condition and consider appropriate management procedures, which may include monitoring liver function and providing supportive care as necessary.

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 rare cases of severe skin reactions associated with acetaminophen use. Reported symptoms include skin reddening, blisters, and rash. These events were documented through voluntary reports and surveillance programs.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of the reach of children to prevent accidental ingestion. It is essential to emphasize the importance of seeking immediate medical assistance in the event of an overdose. Patients should be informed to contact a Poison Control Center at 1-800-222-1222 or seek medical help right away, regardless of whether they observe any signs or symptoms. Quick medical attention is critical for both adults and children in such situations.

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 a controlled temperature range of 20° to 25°C (68° to 77°F) to maintain its integrity and efficacy. Proper storage conditions must be adhered to, ensuring that the product is kept in a suitable container that protects it from environmental factors. Special handling requirements should be followed to prevent any compromise to the product's quality.

Additional Clinical Information

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 advise patients to consult a doctor prior to use if the child has liver disease or is concurrently taking the anticoagulant warfarin.

Patients should be instructed to discontinue use and seek medical advice if pain worsens or persists beyond 5 days, if fever intensifies or lasts more than 3 days, if new symptoms arise, or if there is any redness or swelling.

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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