Childrens Acetaminophen Liquid

Description

Children's Acetaminophen Elixir is formulated as a cherry-flavored liquid dosage form intended for pediatric use in children aged 2 to 11 years. The product is packaged in a 2 fluid ounce (60 mL) container. It is comparable to the active ingredient found in Children's Tylenol®. This elixir is not manufactured or distributed by McNeil Consumer & Specialty Pharmaceuticals, the distributor of Tylenol®.

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

Shake the formulation well before use. The appropriate dose should be determined using the dosing chart provided below, prioritizing weight for dosing whenever possible; if weight is not available, age may be used as a secondary reference.

Dosing should be repeated every 4 hours as needed while symptoms persist. However, administration should not exceed 5 doses within a 24-hour period. Continuous use beyond 5 days is not recommended unless directed by a healthcare professional.

Dosing Chart:

• For patients weighing under 24 lb. or under 2 years of age, consult a physician for the appropriate dose.

• 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.

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

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 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.

In cases of severe sore throat that persists for more than 2 days, or if it is accompanied or followed by fever, headache, rash, nausea, or vomiting, it is imperative to consult a healthcare professional promptly.

Healthcare providers should inquire about the child’s medical history, particularly regarding liver disease, before recommending this product. Additionally, it is advisable to consult a doctor or pharmacist if the child is currently taking anticoagulants, such as warfarin, to avoid potential interactions.

In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center should be contacted without delay. Rapid medical intervention is crucial for both adults and children, even in the absence of noticeable symptoms.

Patients should discontinue use and contact a healthcare provider 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 longer than 3 days. These symptoms may indicate a serious underlying condition that requires further evaluation.

Side Effects

Severe liver damage may occur in patients if more than 5 doses are taken within a 24-hour period, which is the maximum daily amount, or if the product is used concurrently with other drugs containing acetaminophen. Patients should be advised not to use this product in conjunction with any other medication containing acetaminophen, whether prescription or non-prescription. If there is uncertainty regarding the presence of acetaminophen in another medication, consultation with a doctor or pharmacist is recommended.

Patients with a known allergy to acetaminophen or any of the inactive ingredients in this product should not use it. Additionally, it is important to consult a doctor before use if the patient has liver disease or is taking blood-thinning medications such as warfarin.

While using this product, patients must adhere to the recommended dosage to avoid the risk of overdose. Signs that warrant discontinuation of use and consultation with a doctor include the emergence of new symptoms, the presence of redness or swelling, worsening pain lasting more than 5 days, or a fever that worsens or persists for more than 3 days. These symptoms may indicate a serious condition.

In the event of an overdose, which may result in liver damage, immediate medical assistance should be sought, or the Poison Control Center should be contacted. Prompt medical attention is critical for both adults and children, even if no signs or symptoms are initially apparent.

Drug Interactions

Patients should consult a healthcare professional prior to using this medication if they are concurrently taking anticoagulants, such as warfarin. The combination may increase the risk of bleeding, necessitating careful monitoring of coagulation parameters.

Co-administration with any other product containing acetaminophen, whether prescription or over-the-counter, is contraindicated. The risk of acetaminophen-related hepatotoxicity may be elevated in such cases. If there is uncertainty regarding the presence of acetaminophen in other medications, patients are advised to seek guidance from a healthcare provider.

Packaging & NDC

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

Pediatric Use

Pediatric patients under 2 years of age and weighing less than 24 pounds should consult a doctor before administration. For children aged 2 to 3 years and weighing between 24 to 35 pounds, the recommended dose is 5 mL. For those aged 4 to 5 years and weighing 36 to 47 pounds, the dose increases to 7.5 mL. Children aged 6 to 8 years, weighing 48 to 59 pounds, should receive 10 mL, while those aged 9 to 10 years and weighing 60 to 71 pounds should be given 12.5 mL. Finally, for an 11-year-old weighing between 72 to 95 pounds, the dose is 15 mL.

Healthcare professionals should be aware of the following warnings: severe liver damage may occur if a child takes more than 5 doses in a 24-hour period, which is the maximum daily amount. Consultation with a doctor is advised if a sore throat is severe, persists for more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting. It is crucial not to exceed the recommended dose. Parents should stop use and seek medical advice if new symptoms arise, if redness or swelling occurs, if pain worsens or lasts more than 5 days, or if fever worsens or lasts more than 3 days.

In cases of overdose, prompt medical attention is essential for both children and adults.

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

This product is not indicated for use in pregnancy. Pregnant patients or those planning to become pregnant should consult a healthcare professional prior to use. There are no specific dosage modifications or safety concerns noted for the use of this product during pregnancy; however, the absence of indication suggests that the potential risks may outweigh any benefits. It is essential for healthcare providers to evaluate the individual circumstances of pregnant patients when considering treatment options.

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 during lactation.

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 exercise caution when using this product, which contains acetaminophen. It is important to note that severe liver damage may occur if the maximum daily amount of more than 5 doses is exceeded within a 24-hour period. Additionally, the risk of liver damage increases if this product is taken concurrently with other medications containing acetaminophen.

Before administering this product, it is advisable for caregivers to consult a healthcare professional if the patient has a history of liver disease. In the event of an overdose, which is defined as taking more than the recommended dose, immediate medical attention is essential. Caregivers should contact a Poison Control Center or seek medical help right away, as prompt intervention is critical for both adults and children, even in the absence of noticeable signs or symptoms of overdose.

Overdosage

Taking more than the recommended dose of this medication 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 and caregivers to contact a Poison Control Center or seek emergency medical help without delay.

Prompt medical attention is crucial for both adults and children, even in the absence of noticeable symptoms. The potential for serious health consequences necessitates a proactive approach to managing overdose situations.

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 understanding of potential risks associated with the compound in nonclinical settings. Further studies may be necessary to elucidate these aspects.

Postmarketing Experience

Postmarketing experience has identified rare cases of severe skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, associated with the use of acetaminophen. Additionally, reports of acute liver failure have been noted, particularly in patients with underlying liver disease or those exceeding the recommended dosage. Instances of allergic reactions, including anaphylaxis, have also been documented. Furthermore, there have been reports of renal impairment linked to the use of acetaminophen, especially in patients with pre-existing kidney conditions.

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 a doctor or pharmacist for clarification.

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 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, if a fever intensifies or lasts longer than three days, patients should be advised to stop use and consult a doctor, as these may indicate a serious underlying condition.

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

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 temperature range of 15° to 30°C (59° to 86°F). Care should be taken to protect the product from freezing, as exposure to low temperatures may compromise its integrity. Additionally, the product must be shielded from light to maintain its efficacy and stability. Proper handling and storage conditions are crucial to ensure the product's quality and effectiveness.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)