Childrens Acetaminophen

Description

Acetaminophen Oral Suspension is formulated at a concentration of 16 mg per 5 mL. The product is packaged in a carton containing 118 mL. The National Drug Code (NDC) for this formulation is 72888-459-01.

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 is intended for pediatric use only, and healthcare professionals should refer to the dosage chart for appropriate dosing based on the child's weight and age. It is essential to shake the product well before each use.

To administer the dose, remove the child protective cap and squeeze the appropriate amount into the enclosed dosing cup. The recommended dosing intervals are every 4 hours as needed while symptoms persist, with a maximum of 5 doses within a 24-hour period.

The following dosage chart provides specific dosing recommendations:

• For children weighing under 24 lb (under 2 years): Consult a doctor for the appropriate dose.

• For children weighing 24-35 lb (2-3 years): Administer 5 mL.

• For children weighing 36-47 lb (4-5 years): Administer 7.5 mL.

• For children weighing 48-59 lb (6-8 years): Administer 10 mL.

• For children weighing 60-71 lb (9-10 years): Administer 12.5 mL.

• For children weighing 72-95 lb (11 years): Administer 15 mL.

It is critical not to exceed the recommended doses, and healthcare professionals should be aware of the overdose warning associated with this product. Only the enclosed dosing cup should be used for measurement; other dosing devices are not recommended.

Contraindications

Use of this product is contraindicated in the following situations:

• Co-administration with any other drug containing acetaminophen, whether prescription or nonprescription, due to the risk of acetaminophen overdose. If there is uncertainty regarding the presence of acetaminophen in a medication, consultation with a healthcare professional is advised.

• In patients with a history of allergic reactions to this product or any of its ingredients, as this may lead to severe allergic responses.

• Exceeding the recommended dose is contraindicated, as it poses a risk of overdose.

Warnings and Precautions

This product contains acetaminophen, which poses a significant risk of severe liver damage if the maximum daily dosage is exceeded. Specifically, healthcare professionals should advise 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.

Acetaminophen is also associated with the potential for severe skin reactions. Symptoms indicative of such reactions may include skin reddening, blisters, and rash. In the event that a skin reaction occurs, it is imperative to discontinue use immediately and seek medical assistance without delay.

Healthcare providers should be vigilant regarding patients presenting with a sore throat. If the sore throat is severe, persists for more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting, a prompt consultation with a physician is recommended.

Patients should be instructed to stop use and consult a healthcare professional if any of the following occur: pain worsens or lasts longer than 5 days, fever worsens or persists beyond 3 days, new symptoms develop, or if redness or swelling is observed. These symptoms may indicate the presence of a serious underlying condition.

In the event of an overdose, immediate medical attention is crucial. Patients or caregivers should contact a Poison Control Center at 1-800-222-1222 without delay, even if no signs or symptoms are apparent, as rapid intervention is essential for optimal outcomes.

Side Effects

Severe adverse reactions associated with this product include the potential for severe liver damage, particularly in patients who exceed the maximum daily dosage of five doses within a 24-hour period or who concurrently use other medications containing acetaminophen. Patients should be aware that acetaminophen may also lead to severe skin reactions, which can manifest as skin reddening, blisters, or rash. In the event of a skin reaction, it is imperative to discontinue use and seek immediate 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. Additionally, the product should not be used in conjunction with any other medications containing acetaminophen, whether prescription or nonprescription, without prior consultation with a healthcare provider.

Patients with a history of allergic reactions to this product or any of its ingredients should refrain from use. It is advisable for patients with liver disease to seek medical advice before using this product. Furthermore, patients taking the anticoagulant warfarin should consult a doctor or pharmacist prior to use.

While using this product, patients must adhere to the recommended dosage to avoid overdose. They should discontinue use and consult a healthcare provider if pain worsens or persists beyond five days, if fever worsens or lasts more than three days, if new symptoms arise, or if there is any redness or swelling, as these may indicate a serious condition.

In the event of an overdose, immediate medical attention is crucial, and patients should contact a Poison Control Center without delay, even if no signs or symptoms are present. It is essential to keep this product out of reach of children to prevent accidental ingestion.

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 Childrens Acetaminophen (acetaminophen). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 2 years of age should consult a doctor before use. For children aged 2 to 3 years weighing 24-35 lb, the recommended dose is 5 mL. For those aged 4 to 5 years 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 may take 12.5 mL. For children aged 11 years weighing 72-95 lb, the dose is 15 mL, or as directed by a physician.

Healthcare professionals should be aware of several warnings associated with this medication. Severe liver damage may occur if a child takes more than 5 doses in a 24-hour period, which is the maximum daily amount. Acetaminophen may also cause severe skin reactions, including skin reddening, blisters, or 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.

Before administering this product, it is advisable to consult a doctor if the child has liver disease or is taking the blood-thinning medication warfarin. When using this product, it is crucial not to exceed the recommended dose. Parents and caregivers should stop use and seek medical advice if pain worsens or lasts more than 5 days, fever worsens or lasts more than 3 days, new symptoms develop, or if redness or swelling occurs, as these may indicate a serious condition.

In the event of an overdose, immediate medical help should be sought, or the Poison Control Center contacted at 1-800-222-1222. Quick medical attention is essential, even if no signs or symptoms are apparent.

Geriatric Use

Elderly patients may not have specific information regarding the use of Children's Acetaminophen as the drug insert does not provide data pertinent to this population. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients.

Due to the lack of clinical findings or dosage adjustments specified for elderly patients, it is advisable to monitor this population closely for any adverse effects or changes in efficacy. Additionally, healthcare providers should consider the overall health status and potential comorbidities of geriatric patients when determining the appropriateness of Children's Acetaminophen for pain or fever management.

Pregnancy

The available prescribing information does not provide specific data regarding the use of acetaminophen during pregnancy. Consequently, healthcare professionals should exercise caution when recommending acetaminophen to pregnant patients. Due to the absence of safety concerns, dosage modifications, or special precautions outlined in the insert, the potential risks and benefits should be carefully considered on a case-by-case basis. It is advisable for women of childbearing potential to consult with their healthcare provider before using acetaminophen during pregnancy to ensure appropriate management and monitoring.

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 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 use, particularly if they have a history of liver disease. It is essential to assess liver function and consider potential adjustments in dosage or monitoring requirements based on the severity of the impairment. Careful evaluation and ongoing monitoring may be necessary to ensure the safe and effective use of the medication in this population.

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 medical intervention is crucial, even in the absence of noticeable signs or symptoms.

Healthcare professionals should be aware that the severity of symptoms may vary depending on the specific substance involved in the overdose. Therefore, a thorough assessment and monitoring of the patient are essential.

Management of an overdose may include supportive care and symptomatic treatment, tailored to the individual patient's needs. Continuous evaluation and appropriate interventions should be implemented to mitigate potential complications associated with the 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 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 that contain 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 history of allergic reactions to it or any of its ingredients. Additionally, patients should be advised to discontinue use and consult a doctor if pain worsens or persists for more than five days, if fever intensifies or lasts longer than three days, if new symptoms arise, or if there is any redness or swelling, as these may indicate a serious condition.

Patients must be cautioned against exceeding the recommended dose, as this could lead to overdose. Furthermore, healthcare providers should recommend that patients consult a doctor before use if their child has liver disease or is currently taking the blood-thinning medication warfarin.

Storage and Handling

The product is supplied in configurations that include specific NDC numbers. It should be stored at a temperature range of 20-25°C (68-77°F) to maintain its integrity and efficacy.

Healthcare professionals are advised to inspect the product prior to use; it should not be utilized if the tamper-evident ring is broken or missing, as this may indicate potential compromise of the product's safety. Proper handling and storage conditions are essential to ensure the product remains effective and safe for patient use.

Additional Clinical Information

The medication is administered orally, with a recommended repeat dose every 4 hours as needed for symptom relief, not to exceed 5 doses within a 24-hour period. Clinicians should advise patients to keep the medication out of reach of children. In the event of an overdose, it is crucial for patients to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222, as prompt medical attention is essential even if no symptoms are apparent.

No further information is available regarding laboratory tests, abuse potential, 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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