Childrens Acetaminophen

Description

No relevant information is available for SPL code 34089-3.

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, immunizations, and toothache.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

This product should be administered according to the following guidelines. Prior to use, the container must be shaken well to ensure proper mixing of the formulation.

Dosing should be determined using the dosage chart provided below. Whenever possible, weight should be used to ascertain the appropriate dose; if weight is not available, age may be used as an alternative.

Dosage Chart:

• For patients weighing under 24 lbs or under 2 years of age, it is advised to consult a doctor for the appropriate dose.

• For patients weighing 24-35 lbs or aged 2-3 years, the recommended dose is 1 teaspoon (5 mL).

• For patients weighing 36-47 lbs or aged 4-5 years, the recommended dose is 1½ teaspoons (7.5 mL).

• For patients weighing 48-59 lbs or aged 6-8 years, the recommended dose is 2 teaspoons (10 mL).

• For patients weighing 60-71 lbs or aged 9-10 years, the recommended dose is 2½ teaspoons (12.5 mL).

• For patients weighing 72-95 lbs or aged 11 years, the recommended dose is 3 teaspoons (15 mL).

If necessary, doses may be repeated every 4 hours. However, it is imperative not to exceed 5 doses within a 24-hour period. Continuous use beyond 5 days should only occur under the guidance of a healthcare professional.

The enclosed measuring cup must be utilized for accurate dosing to ensure safety and efficacy.

Contraindications

Use of this product is contraindicated in the following situations:

• Co-administration with any other drug containing acetaminophen, whether prescription or non-prescription, 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.

• Exceeding the recommended dosage while using this product is contraindicated, as it may lead to serious adverse effects.

Warnings and Precautions

Severe liver damage may occur in children taking this product, which contains acetaminophen, if they exceed the maximum daily amount of 5 doses within a 24-hour period or if they are concurrently using other medications that contain acetaminophen. Healthcare professionals should advise parents and caregivers to monitor the total intake of acetaminophen from all sources to prevent potential toxicity.

In cases of severe sore throat that persists for more than 2 days, or if it is accompanied by fever, headache, rash, nausea, or vomiting, it is imperative to consult a physician promptly. These symptoms may indicate a more serious underlying condition that requires medical evaluation.

Before administering this product, it is essential to consult a healthcare provider if the child has a history of liver disease. Additionally, if the child is currently taking warfarin or any other blood-thinning medication, a discussion with a doctor or pharmacist is recommended to assess potential interactions.

Healthcare professionals should emphasize the importance of adhering to the recommended dosage to avoid overdose. In the event of an overdose, immediate medical assistance should be sought, or contact with a Poison Control Center should be made without delay, as rapid intervention is crucial even in the absence of noticeable symptoms.

Parents and caregivers should be instructed to discontinue use and seek medical advice if new symptoms arise, if there is any redness or swelling, if pain worsens or persists beyond 5 days, or if fever intensifies or lasts more than 3 days. These signs may indicate a serious condition that necessitates further medical assessment.

Side Effects

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

Severe liver damage may occur if the maximum daily amount of acetaminophen is exceeded, specifically if more than five doses are taken within a 24-hour period or if the product is used concurrently with other medications containing acetaminophen. Patients with a history of liver disease should consult a doctor before using this product.

In the event of a severe sore throat that persists for more than two days, or if it is accompanied by fever, headache, rash, nausea, or vomiting, patients are advised to seek medical attention promptly.

It is crucial to avoid using this product in conjunction with any other drug containing acetaminophen, whether prescription or non-prescription. Patients should verify the contents of any other medications with a healthcare provider or pharmacist if there is uncertainty regarding acetaminophen inclusion. Additionally, individuals with known allergies to acetaminophen or any inactive ingredients in this product should refrain from its use.

Patients taking the blood-thinning medication warfarin should consult a doctor or pharmacist prior to using this product.

While using this product, patients must adhere to the recommended dosage to prevent overdose, which can lead to liver damage. In the case of an overdose, immediate medical assistance should be sought, or contact with a Poison Control Center is recommended, as prompt medical attention is critical even if no symptoms are initially apparent.

Patients should discontinue use and consult a doctor if new symptoms arise, if redness or swelling occurs, if pain worsens or persists beyond five days, or if fever intensifies or lasts more than three days, as these may indicate a serious condition.

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 under 2 years of age should not be given this medication without consulting a doctor. For children aged 2 to 3 years weighing between 24-35 lbs, the recommended dose is 1 teaspoon (5 mL). For those aged 4 to 5 years and weighing 36-47 lbs, the dose increases to 1½ teaspoons (7.5 mL). Children aged 6 to 8 years, weighing 48-59 lbs, may receive 2 teaspoons (10 mL), while those aged 9 to 10 years and weighing 60-71 lbs can take 2½ teaspoons (12.5 mL). Finally, for children aged 11 years weighing 72-95 lbs, the dose is 3 teaspoons (15 mL).

It is important to note that no more than 5 doses should be administered within a 24-hour period, and the medication should not be given for more than 5 consecutive days unless directed by a healthcare professional. Caution is advised, and a doctor should be consulted prior to use if the child has liver disease, as severe liver damage may occur if more than 5 doses are taken in 24 hours, particularly when combined with other medications containing acetaminophen.

Geriatric Use

Elderly patients may not have specific information regarding the use of Children's Acetaminophen, as the drug insert does not provide data on geriatric use. 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 this population, it is advisable to monitor elderly patients 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 this medication.

Pregnancy

There are no specific statements regarding the use of Children's Acetaminophen during pregnancy, including safety concerns, dosage modifications, or special precautions. As such, healthcare professionals should consider the lack of data when advising pregnant patients. It is recommended that women of childbearing potential discuss the use of this medication with their healthcare provider to weigh potential benefits against any unknown risks to fetal outcomes.

Lactation

There are no specific warnings or recommendations regarding the use of this product by lactating mothers. Additionally, there are no statements concerning the potential for excretion in breast milk, risks to breastfed infants, or any other lactation-related considerations.

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 prudent in these patients to ensure safety and efficacy.

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 critical to adhere to the recommended dosage, as exceeding this may lead to liver damage. Specifically, severe liver damage can occur if a patient takes more than five doses within a 24-hour period, which is the maximum daily allowance, or if they concurrently use other medications containing acetaminophen.

To mitigate the risk of hepatic injury, patients must avoid the use of any other drugs that contain acetaminophen, whether prescription or non-prescription. If there is uncertainty regarding the presence of acetaminophen in a medication, patients are advised to seek guidance from a healthcare provider or pharmacist. Regular monitoring of liver function may be warranted in patients with compromised liver function to ensure safety and efficacy.

Overdosage

In the event of an overdose, defined as the ingestion of more than the recommended dose, there is a significant risk of liver damage. Healthcare professionals should be aware that the severity of the effects may not be immediately apparent, as symptoms can be delayed or absent initially.

It is imperative that individuals who suspect an overdose seek medical assistance immediately. Contacting a Poison Control Center or obtaining medical help without delay is crucial for effective management. Quick medical attention is essential, even in the absence of noticeable signs or symptoms, to mitigate potential complications and ensure appropriate treatment is administered.

Healthcare providers should remain vigilant and prepared to assess and manage any cases of overdose, prioritizing patient safety and timely intervention.

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 these contexts.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

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 whether a drug contains acetaminophen, 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 present in the formulation. Healthcare providers should instruct patients to discontinue 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, patients should be advised to stop use and consult a doctor if fever intensifies or lasts more than three days, as these may indicate a serious underlying condition.

It is essential to emphasize the importance of adhering to the recommended dosage and to inform patients about the risks associated with overdose. Healthcare providers should also recommend that patients consult a doctor before using this product 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

This product is supplied in a configuration that ensures its integrity and safety. It should be stored at room temperature, specifically within the range of 15º to 30ºC (59º to 86ºF). It is essential to protect the product from freezing and to shield it from light exposure to maintain its efficacy.

Additionally, the product features a tamper-evident design. Healthcare professionals are advised not to use this product if the printed inner cap seal is broken or missing, as this may indicate potential compromise of the product's safety.

Additional Clinical Information

The medication is administered orally, with the option to repeat the dose every 4 hours as needed. Clinicians should advise patients not to exceed 5 doses within a 24-hour period and to limit use to a maximum of 5 days unless otherwise directed by a healthcare professional.

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

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.

View product document (PDF)