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Leader Childrens Pain and Fever

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Active ingredient
Acetaminophen 160 mg/5 mL
Other brand names
Dosage form
Suspension
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2019
Label revision date
June 26, 2024
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Acetaminophen 160 mg/5 mL
Other brand names
Dosage form
Suspension
Route
Oral
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2019
Label revision date
June 26, 2024
Manufacturer
Cardinal Health 110, LLC. dba Leader
Registration number
M013
NDC root
70000-0496
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info
Packaging & NDC Codes

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

If you are a consumer or patient please visit this version.

Drug Overview

LEADER Children’s Pain & Fever is an oral suspension that contains acetaminophen (a medication commonly used to relieve pain and reduce fever) at a concentration of 160 mg per 5 mL. This product is designed for children aged 2 to 11 years and is effective in alleviating minor aches and pains associated with conditions such as the common cold, flu, headache, sore throat, and toothache.

This formulation is alcohol-free, aspirin-free, and ibuprofen-free, making it a suitable option for young children. It comes in a pleasant grape flavor and is available in a 4 FL OZ (118 mL) bottle.

Uses

You can use this medication to help reduce fever and relieve minor aches and pains. It is effective for discomfort caused by common conditions such as the common cold, flu, headaches, sore throats, and toothaches.

This means that if you're feeling under the weather or experiencing mild pain, this medication can provide some relief to help you feel better.

Dosage and Administration

Before using this product, make sure to shake it well. You’ll need to measure the correct dose based on your child's weight or age, using the provided dosing chart. For example, if your child weighs between 24 and 35 pounds, the dose is 5 milliliters (mL). If they weigh between 36 and 47 pounds, the dose increases to 7.5 mL, and so on. If your child weighs less than 24 pounds or is under 2 years old, consult a doctor for the appropriate dose.

To give the medication, remove the child protective cap and squeeze the correct amount into the dosing cup that comes with the product. You can repeat this dose every 4 hours as long as your child has symptoms, but remember not to exceed 5 doses in a 24-hour period. Always use the dosing cup provided, as other devices may not measure accurately.

What to Avoid

It's important to be cautious when using this medication. You should not use it alongside any other drugs that contain acetaminophen, whether they are prescription or over-the-counter. If you're unsure whether a medication contains acetaminophen, please consult your doctor or pharmacist. Additionally, if your child has ever had an allergic reaction to this product or any of its ingredients, do not use it.

Always follow the recommended dosage and avoid exceeding it, as doing so can lead to serious health risks. Remember, taking this medication responsibly is key to ensuring your safety and well-being.

Side Effects

You should be aware of some important warnings and potential side effects when using this product. It contains acetaminophen, which can lead to severe liver damage if your child takes more than 5 doses in 24 hours or uses it alongside other medications containing acetaminophen. Additionally, acetaminophen may cause serious skin reactions, such as skin reddening, blisters, or rash. If any of these symptoms occur, stop using the product and seek medical help immediately.

If your child experiences a sore throat that is severe, lasts more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting, consult a doctor right away. You should also stop use and contact a healthcare professional if pain worsens or lasts more than 5 days, fever worsens or lasts more than 3 days, new symptoms appear, or if there is redness or swelling, as these could indicate a serious condition.

Warnings and Precautions

This product contains acetaminophen, which can lead to severe liver damage if your child takes more than 5 doses in 24 hours or uses it alongside other medications containing acetaminophen. It's important to be aware of potential severe skin reactions, such as skin reddening, blisters, or rash. If you notice any of these symptoms, stop using the product and seek medical help immediately.

If your child has a sore throat that is severe, lasts more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting, consult a doctor right away. You should also stop using the product and call your doctor if pain worsens or lasts more than 5 days, fever worsens or lasts more than 3 days, new symptoms appear, or if there is redness or swelling, as these could indicate a serious condition. In case of an overdose, seek medical help or contact a Poison Control Center immediately at 1-800-222-1222, even if no symptoms are present, as quick medical attention is crucial.

Overdose

If you suspect an overdose, it’s important to seek medical help immediately or contact a Poison Control Center at 1-800-222-1222. Quick action is crucial, even if you don’t see any signs or symptoms of an overdose.

Signs of an overdose can vary, but they may include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these symptoms, don’t hesitate to get help right away. Remember, acting quickly can make a significant difference in your safety and health.

Pregnancy Use

When it comes to using acetaminophen during pregnancy, there is currently no specific information available regarding its safety, recommended dosage, or any special precautions you should take. This means that if you are pregnant or planning to become pregnant, it’s important to consult with your healthcare provider before taking acetaminophen or any medication. They can help you weigh the potential benefits and risks based on your individual health needs. Always prioritize open communication with your doctor to ensure the best care for you and your baby.

Lactation Use

If you are breastfeeding, it's important to consult your doctor before using this product. There is a possibility that acetaminophen, an active ingredient in the product, can pass into your breast milk. Because of this, you should exercise caution when considering its use, as there may be risks to your nursing infant. Always prioritize your health and your baby's safety by discussing any medications with your healthcare provider.

Pediatric Use

When considering this medication for your child aged 2 to 11 years, it's important to follow the appropriate dosage based on their weight. For children weighing under 24 pounds, consult a doctor before use. For those weighing between 24 to 95 pounds, the recommended doses range from 5 mL for 2-3 year-olds to 15 mL for 11-year-olds. Remember, the maximum daily limit is 5 doses within a 24-hour period.

Always consult a doctor if your child has liver disease, is taking the blood-thinning medication warfarin, or has had an allergic reaction to this product. If your child's pain worsens or lasts more than 5 days, or if their fever persists for more than 3 days, seek medical advice. Additionally, watch for any new symptoms or signs of redness and swelling, and consult a doctor if these occur.

Geriatric Use

When considering this medication, it's important to note that it does not provide specific directions or complete warnings for adult use, including older adults. This means that if you or a loved one is an older adult, you should consult with a healthcare professional for personalized guidance.

Always ensure that any medication is appropriate for your health needs, especially if there are concerns about age-related changes in health or medication tolerance. Your healthcare provider can help determine the right dosage and monitor for any potential side effects.

Renal Impairment

If you have kidney issues, it's important to consult your doctor before using this medication, especially if your child has liver disease. Your healthcare provider can help determine the right dosage and monitor your condition to ensure safety and effectiveness. Always keep them informed about your kidney health to receive the best care possible.

Hepatic Impairment

If your child has liver disease, it's important to consult a doctor before using this medication. Liver disease can affect how the body processes medications, so your healthcare provider can help determine if this treatment is safe and appropriate for your child. Always prioritize their health by seeking professional advice in these situations.

Drug Interactions

It's important to talk to your doctor or pharmacist before using this medication, especially if your child is taking warfarin, a blood-thinning drug. Mixing these medications can lead to serious complications, so always check first.

Additionally, avoid using this medication alongside any other products that contain acetaminophen, whether they are prescription or over-the-counter. If you're unsure whether a medication has acetaminophen, don't hesitate to ask a healthcare professional for guidance. Keeping open communication with your healthcare provider helps ensure safe and effective treatment.

Storage and Handling

To ensure the best performance and safety of your product, store it at a temperature between 20-25°C (68-77°F). This helps maintain its effectiveness. Before using the product, check the printed neckband; do not use it if the neckband is broken or missing, as this could indicate that the product is compromised.

Always handle the product with care to avoid any damage. Following these guidelines will help you use the product safely and effectively.

Additional Information

You should take this medication orally. If your child has liver disease, it's important to consult a doctor before using it. Additionally, if your child is taking the blood thinner warfarin, check with a doctor or pharmacist first.

If your child's pain worsens or lasts more than 5 days, or if a fever gets worse or lasts more than 3 days, stop using the medication and contact a doctor. Be alert for any new symptoms or signs of redness or swelling, and seek medical advice if these occur.

FAQ

What is LEADER Children’s Pain & Fever?

LEADER Children’s Pain & Fever is an acetaminophen oral suspension that contains 160 mg of acetaminophen per 5 mL.

What does LEADER Children’s Pain & Fever do?

It reduces fever and relieves minor aches and pains due to the common cold, flu, headache, sore throat, and toothache.

What age group is this product suitable for?

This product is suitable for children aged 2 to 11 years.

What are the dosing instructions for LEADER Children’s Pain & Fever?

You should find the right dose based on your child's weight or age, and do not exceed 5 doses in 24 hours.

What should I do if my child has a severe sore throat?

If your child's sore throat is severe, persists for more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Are there any warnings associated with this product?

Yes, it contains acetaminophen, which can cause severe liver damage if more than 5 doses are taken in 24 hours or if used with other acetaminophen-containing drugs.

Can I use this product if my child has liver disease?

You should ask a doctor before using this product if your child has liver disease.

Is it safe to use LEADER Children’s Pain & Fever during pregnancy?

The insert does not provide specific information regarding the use of acetaminophen during pregnancy.

What should nursing mothers know before using this product?

Nursing mothers should consult a doctor before using this product due to the potential for acetaminophen to be excreted in breast milk.

What flavor does LEADER Children’s Pain & Fever come in?

It comes in a grape flavor.

Packaging Info

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

Packaging configurations for Leader Childrens Pain and Fever.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Acetaminophen is formulated as an oral suspension containing 160 mg of acetaminophen per 5 mL. This preparation serves as both a pain reliever and a fever reducer, specifically designed for pediatric use in children aged 2 to 11 years. The product is presented in a grape flavor and is packaged in a 4 FL OZ (118 mL) bottle. It is alcohol-free, aspirin-free, and ibuprofen-free, and does not contain parabens.

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 does not contain complete directions or warnings for adult administration. Healthcare professionals should ensure that the dosage does not exceed the recommended limits to avoid overdose.

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

To administer the dose, remove the child protective cap and squeeze the prescribed amount into the enclosed dosing cup. The dose may be repeated every 4 hours as needed while symptoms persist, but should not exceed 5 doses within a 24-hour period.

Dosage Chart:

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

  • For children weighing 24-35 lb (2-3 years), the recommended dose is 5 mL.

  • For children weighing 36-47 lb (4-5 years), the recommended dose is 7.5 mL.

  • For children weighing 48-59 lb (6-8 years), the recommended dose is 10 mL.

  • For children weighing 60-71 lb (9-10 years), the recommended dose is 12.5 mL.

  • For children weighing 72-95 lb (11 years), the recommended dose is 15 mL.

*Dosing should be as directed by a healthcare professional.

It is imperative to use only the enclosed dosing cup specifically designed for this product; other dosing devices should not be utilized.

Contraindications

Use of this product is contraindicated in the following situations:

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

  • The product should not be administered to children who have a history of allergic reactions to this product or any of its components.

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

Warnings and Precautions

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

Acetaminophen is associated with the potential for severe skin reactions. Symptoms indicative of such reactions may include skin reddening, blisters, and rash. In the event of a skin reaction, it is imperative to discontinue use immediately and seek medical assistance.

In cases of severe sore throat, particularly if it persists for more than two days or is accompanied by fever, headache, rash, nausea, or vomiting, patients should be instructed to consult a healthcare provider without delay.

Healthcare professionals should also advise patients to stop using the product and seek medical advice if any of the following occur: worsening pain that lasts longer than five days, fever that worsens or persists beyond three days, the emergence of new symptoms, or the presence of redness or swelling, as these may indicate a serious underlying condition.

In the event of an overdose, immediate medical attention is crucial. Patients or caregivers should be directed to contact a Poison Control Center at 1-800-222-1222, even if no signs or symptoms are apparent, as prompt intervention is essential.

Side Effects

Patients using this product should be aware of several potential adverse reactions, which may vary in seriousness and frequency.

Severe liver damage is a significant concern associated with the use of this product, particularly due to its acetaminophen content. Patients are at increased risk if they exceed five doses within a 24-hour period, which is the maximum recommended daily amount, or if they concurrently use other medications containing acetaminophen.

Additionally, there is an allergy alert regarding the potential for severe skin reactions. Symptoms of such reactions may include skin reddening, blisters, and rash. In the event of a skin reaction, patients are advised to discontinue use immediately and seek medical assistance.

Patients should also be vigilant for symptoms related to sore throat. If a sore throat is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, it is essential to consult a healthcare professional promptly.

Furthermore, patients are advised to stop using the product and consult a doctor if pain worsens or lasts longer than five days, if fever intensifies or persists beyond three days, if new symptoms arise, or if there is any redness or swelling present. These symptoms could indicate a serious underlying condition that requires medical evaluation.

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. If there is uncertainty regarding the presence of acetaminophen in other medications, it is advisable to seek guidance from a healthcare provider. This precaution is essential to avoid the risk of acetaminophen overdose, which can lead to serious liver damage.

Packaging & NDC

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

Packaging configurations for Leader Childrens Pain and Fever.
Details

Pediatric Use

Pediatric patients aged 2 to 11 years may use this medication with specific dosing guidelines based on weight. For children weighing under 24 lb, consultation with a doctor is advised for those under 2 years of age. The recommended dosages for children aged 2 to 11 years are as follows:

  • 24-35 lb (2-3 years): 5 mL

  • 36-47 lb (4-5 years): 7.5 mL

  • 48-59 lb (6-8 years): 10 mL

  • 60-71 lb (9-10 years): 12.5 mL

  • 72-95 lb (11 years): 15 mL

The maximum daily dose should not exceed 5 doses within a 24-hour period.

Healthcare professionals should advise parents or guardians to consult a doctor if the child has liver disease, is taking the blood-thinning medication warfarin, or has a history of allergic reactions to this product or any of its ingredients.

Additionally, parents or guardians should be instructed to stop use and seek medical advice if the child's pain worsens or persists beyond 5 days, if fever worsens or lasts more than 3 days, if new symptoms develop, or if there is any redness or swelling.

Geriatric Use

Elderly patients may not receive comprehensive directions or warnings regarding the use of this product. Therefore, healthcare providers should exercise caution when prescribing this product to geriatric patients. It is essential to consider the unique physiological changes and potential comorbidities that may affect the safety and efficacy of the treatment in this population.

Healthcare providers are advised to closely monitor elderly patients for any adverse effects and to assess the appropriateness of the dosage, as adjustments may be necessary based on individual patient factors. Given the lack of specific guidance for adult use, careful evaluation and clinical judgment are paramount when managing treatment in geriatric patients.

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 this medication to pregnant patients. There are no documented safety concerns, dosage modifications, or special precautions outlined for the use of acetaminophen in this population. Given the lack of information, it is advisable for women of childbearing potential to consult with their healthcare provider before using acetaminophen during pregnancy to ensure that potential risks and benefits are adequately assessed.

Lactation

Lactating mothers should consult a doctor before using this product. There is a potential for excretion of acetaminophen in breast milk. Caution is advised when administering this product to nursing mothers due to the potential risk to the infant.

Renal Impairment

Patients with renal impairment should consult a healthcare professional prior to use, particularly if there is a concurrent liver disease. It is essential to assess renal function and consider potential dosing adjustments or monitoring requirements based on the patient's overall health status.

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 evaluate liver function and consider potential adjustments in dosage 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 patient 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 intervention is essential, as quick medical attention can significantly impact the outcome, even in the absence of noticeable signs or symptoms.

Healthcare professionals should be aware that the lack of immediate symptoms does not preclude the potential for serious complications. Therefore, monitoring and evaluation should be conducted as soon as possible to assess the patient's condition and determine the appropriate course of action.

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 about the importance of seeking immediate medical attention in the event of an overdose. Patients should be informed to contact a Poison Control Center at 1-800-222-1222, as prompt medical intervention is crucial, even if no signs or symptoms are apparent.

It is essential to instruct patients not to use this product in conjunction with any other medications that contain acetaminophen, whether prescription or nonprescription. If patients are uncertain about the contents of a medication, they should be encouraged to consult with a doctor or pharmacist for clarification.

Patients should be made aware that this product should not be used if their child has a history of allergic reactions to it or any of its ingredients. Additionally, healthcare providers should counsel patients to discontinue use and seek medical advice if the child's pain worsens or persists beyond five days, if fever intensifies 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.

When using this product, patients must be reminded not to exceed the recommended dosage, in line with the overdose warning. Furthermore, it is advisable for patients to consult a doctor before use if their child has liver disease. Lastly, patients should be encouraged to speak with a doctor or pharmacist if their child is currently taking the blood-thinning medication warfarin, to ensure safe and effective use of the product.

Storage and Handling

The product is supplied in configurations that include specific NDC numbers, which should be referenced for accurate identification. It is essential to store the product at a controlled temperature range of 20-25°C (68-77°F) to maintain its integrity and efficacy.

Care should be taken to ensure that the product is not used if the printed neckband is broken or missing, as this may indicate tampering or compromise of the product's safety. Proper handling and storage conditions are crucial to ensure the product remains effective and safe for use.

Additional Clinical Information

The medication is administered orally. Clinicians should advise patients or caregivers to consult a doctor before use if the child has liver disease or is 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 worsens or lasts more than 3 days, if new symptoms arise, or if there is any redness or swelling. No additional information is available regarding laboratory tests, abuse potential, or postmarketing experience.

Drug Information (PDF)

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

View product document (PDF)

Data Generation & Sources

This page was automatically generated and is maintained by the AllDrugs AI Data-Science Team. It was built from the FDA Structured Product Label (DailyMed) for Leader Childrens Pain and Fever, retrieved by a validated AI data-extraction workflow.

All FDA-listed dosage forms and strengths are shown in the Packaging & NDC Codes section above. Regulatory status appears in the Summary Information panel above and was verified in the FDA National Drug Code directory and the NSDE NDC Directory daily file.

Note: an automated daemon monitors NSDE checksums; when the record for this NDC changes, the new file is pulled instantly and this page is refreshed.

No human clinician has reviewed this version.

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Primary FDA sources:

Orange Book data shown on this page are limited to Regulatory Status (Rx), Established Pharmacologic Class (EPC), and Mechanism of Action (MoA).

Regulatory data notice: Information on this page is reproduced verbatim from FDA public databases (NSDE, Orange Book, Purple Book, DailyMed SPL). NDA/ANDA drugs are FDA-approved, BLA biologics are FDA-licensed. Inclusion alone does not guarantee current market availability or imply FDA endorsement.

Medical disclaimer: This AI-generated content is provided for educational purposes only and does not constitute medical advice. Always consult a licensed healthcare professional for diagnosis or treatment decisions.