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Leader Childrens Ibuprofen

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Active ingredient
Ibuprofen 100 mg/5 mL
Other brand names
Drug class
Nonsteroidal Anti-inflammatory Drug
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 2016
Label revision date
June 3, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Ibuprofen 100 mg/5 mL
Other brand names
Drug class
Nonsteroidal Anti-inflammatory Drug
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 2016
Label revision date
June 3, 2025
Manufacturer
Cardinal Health 110, LLC. dba Leader
Registration number
ANDA074937
NDC root
70000-0181
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (2 NDCs)
Packaging & NDC Codes (2)

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Drug Overview

LEADER™ Children’s Ibuprofen is an oral suspension designed for children aged 2 to 11 years, providing effective relief from minor aches and pains associated with common conditions like the cold, flu, sore throat, headache, and toothache. As a nonsteroidal anti-inflammatory drug (NSAID), it also helps reduce fever, making it a useful option for parents looking to ease their child's discomfort.

This medication comes in a grape-flavored liquid form, with a concentration of 100 mg of ibuprofen per 5 mL. Its effects can last up to 8 hours, offering extended relief for your child when they need it most.

Uses

You can use this medication to help relieve minor aches and pains caused by common conditions like the cold, flu, sore throat, headache, and toothache. It’s also effective in reducing fever, making it a helpful option when you're feeling unwell.

Rest assured, this medication does not have any teratogenic effects, meaning it does not cause developmental issues in a fetus. This makes it a safer choice for those who may be pregnant or planning to become pregnant.

Dosage and Administration

Before using this product, it's important to note that it does not come with specific directions or warnings for adults. Always make sure to follow the recommended dosage and never exceed the amount directed. To prepare the medication, shake the bottle well before each use. You should find the right dose by referring to the dosing chart, which is based on weight or age. If possible, using weight is preferred for determining the correct amount.

When measuring the dose, use only the enclosed dosing cup, as other devices may not provide accurate measurements. If you need to take another dose, you can do so every 6 to 8 hours, but remember not to exceed four doses in a single day. After using the dosing cup, wash it thoroughly to keep it clean. Finally, always replace the original bottle cap to ensure it remains child-resistant and safe.

What to Avoid

You should avoid using this medication if your child has ever had an allergic reaction to ibuprofen or any other pain reliever or fever reducer. Additionally, it is important not to use this medication right before or after your child has undergone heart surgery. Following these guidelines will help ensure your child's safety and well-being.

Side Effects

Ibuprofen can cause serious allergic reactions, particularly in individuals who are allergic to aspirin. Signs of an allergic reaction may include hives, facial swelling, wheezing (asthma), shock, skin reddening, rash, or blisters. Additionally, this medication carries a risk of severe stomach bleeding, especially if your child has a history of stomach ulcers, is taking blood thinners or steroids, or uses other NSAIDs (nonsteroidal anti-inflammatory drugs) like aspirin or naproxen.

There is also an increased risk of heart attack and stroke associated with NSAIDs, which can be life-threatening, particularly if used in higher doses or for extended periods. If your child experiences symptoms such as faintness, vomiting blood, or black stools, or shows signs of heart problems like chest pain or difficulty breathing, seek medical attention immediately. It's important to consult a doctor if your child has a history of stomach issues, is dehydrated, or is taking other medications.

Warnings and Precautions

Ibuprofen can cause serious allergic reactions, especially if you are allergic to aspirin. Symptoms may include hives, facial swelling, wheezing, shock, skin reddening, rash, or blisters. If you experience any of these symptoms, stop using ibuprofen and seek medical help immediately.

This medication can also lead to severe stomach bleeding, particularly if you have a history of stomach ulcers or bleeding problems, are taking blood thinners or steroids, or are using other NSAIDs (nonsteroidal anti-inflammatory drugs) like aspirin or naproxen. Additionally, using ibuprofen for longer than directed increases the risk of heart attack and stroke, which can be fatal. If you notice signs of stomach bleeding, such as feeling faint, vomiting blood, or having black stools, or if you experience chest pain, trouble breathing, or weakness, stop using ibuprofen and contact your doctor right away.

For children, do not use ibuprofen for more than two days without a doctor's guidance, especially if they are under three years old. If your child does not feel better within 24 hours, if their fever or pain worsens or lasts more than three days, or if new symptoms appear, consult a doctor. In case of an overdose, seek medical help or contact a Poison Control Center immediately at 1-800-222-1222.

Overdose

If you suspect an overdose, it’s crucial to seek medical help immediately. You can contact a Poison Control Center at 1-800-222-1222 for guidance. Signs of an overdose can vary, but they may include unusual drowsiness, confusion, or difficulty breathing.

Always err on the side of caution—if you notice any concerning symptoms or if you’re unsure, don’t hesitate to get help right away. Your health and safety are the top priority.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that the safety of ibuprofen has not been established. In fact, using ibuprofen during pregnancy, particularly in the third trimester, is not recommended due to potential risks to your baby, such as cardiovascular problems and kidney issues.

Before taking ibuprofen, you should always consult your healthcare provider. They can help determine if it's appropriate for you and may suggest dosage adjustments based on your stage of pregnancy and overall health. Your safety and the health of your baby are the top priorities, so make sure to seek professional advice.

Lactation Use

If you are breastfeeding, it's important to talk to your doctor before using this product. There is a possibility that the medication can pass into your breast milk, and the effects on your nursing infant have not been thoroughly studied. Because of this uncertainty, it's wise to be cautious.

If you do decide to take this medication while nursing, keep an eye on your baby for any unusual reactions or side effects. Your health and your baby's well-being are the top priorities, so staying informed and vigilant is key.

Pediatric Use

It's important to be cautious when using this medication for children. You should not give it to children under 3 years of age unless a doctor specifically advises you to do so. For children aged 2 to 11 years, the dosage depends on their weight. Here’s a quick guide:

  • If your child weighs under 24 lbs and is under 2 years old, consult a doctor.

  • For children weighing 24-35 lbs (ages 2-3), the dose is 5 mL.

  • For those weighing 36-47 lbs (ages 4-5), the dose is 7.5 mL.

  • If your child weighs 48-59 lbs (ages 6-8), the dose is 10 mL.

  • For children weighing 60-71 lbs (ages 9-10), the dose is 12.5 mL.

  • If your child weighs 72-95 lbs (age 11), the dose is 15 mL.

Always follow your doctor’s instructions regarding dosage.

Geriatric Use

When considering this product for older adults, it's important to consult with a doctor first, especially if you or your loved one has any existing health conditions. This includes high blood pressure, heart disease, liver cirrhosis (a serious liver condition), kidney disease, or a history of stroke. These conditions can affect how the product works and may require special attention or adjustments in dosage.

Please note that the product does not provide specific directions or warnings for adult use, so professional guidance is essential to ensure safety and effectiveness. Always prioritize open communication with healthcare providers to address any concerns or questions.

Renal Impairment

If you have kidney problems, it's important to consult your doctor before using this medication. This is especially crucial if you also have high blood pressure, heart disease, liver cirrhosis (a severe liver condition), or if you've had a stroke. Your healthcare provider can help determine if this medication is safe for you and may suggest adjustments to your dosage or additional monitoring based on your specific health needs. Always prioritize open communication with your doctor regarding your kidney health and any other medical conditions you may have.

Hepatic Impairment

If you have liver problems, such as liver cirrhosis (severe scarring of the liver), it's important to be aware of how this may affect your treatment. Your healthcare provider may need to adjust your medication dosage or closely monitor your liver function tests (blood tests that check how well your liver is working). This is crucial to ensure that the medication is safe and effective for you.

Additionally, if you have other health conditions like high blood pressure, heart disease, or kidney disease, these factors can also influence your treatment plan. Always communicate openly with your healthcare team about your liver health and any other medical issues you may have to receive the best care possible.

Drug Interactions

It's important to be aware of potential interactions when using ibuprofen. If you or your child are allergic to aspirin, taking ibuprofen could lead to a severe allergic reaction. Additionally, if your child is on blood thinners (medications that prevent blood clots) or steroids, the risk of stomach bleeding increases. The same applies if they are taking other nonsteroidal anti-inflammatory drugs (NSAIDs) like aspirin or naproxen.

Using ibuprofen for longer than recommended can also raise the risk of serious heart issues, such as heart attack or stroke. To ensure safety, always discuss any medications your child is taking with a healthcare provider or pharmacist before using ibuprofen. This helps prevent harmful interactions and ensures the best care for your child.

Storage and Handling

To ensure the best performance of your product, store it at a temperature between 20-25°C (68-77°F). It's important to keep it away from freezing temperatures, as freezing can damage the product.

When handling the product, make sure to do so with clean hands and in a clean environment to maintain its integrity. Always follow any specific disposal instructions provided to ensure safety and compliance.

Additional Information

You should take this medication orally, and if needed, you can repeat the dose every 6 to 8 hours, but do not exceed four doses in a day. It's important to keep this medication out of reach of children. If you suspect an overdose, seek medical help immediately or contact a Poison Control Center at 1-800-222-1222.

To avoid stomach upset, consider taking the medication with food or milk. Always use the enclosed dosing cup for accurate measurement—do not use any other device. Remember to shake the bottle well before use, and after each use, wash the dosing cup. Store the medication at room temperature (20-25°C or 68-77°F) and do not freeze it. Ensure the original bottle cap is replaced to maintain child resistance, and do not use the medication if the printed neckband is broken or missing.

FAQ

What is LEADER™ Children’s Ibuprofen?

LEADER™ Children’s Ibuprofen is an oral suspension that contains 100 mg of ibuprofen per 5 mL, used as a pain reliever and fever reducer.

What age group is this medication suitable for?

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

How long does the effect of this medication last?

The effects of LEADER™ Children’s Ibuprofen can last up to 8 hours.

What should I do if my child has a stomach upset?

If your child experiences a stomach upset, you can give the medication with food or milk.

How should I measure the dose?

Use only the enclosed dosing cup to measure the dose, and refer to the dosing chart based on your child's weight or age.

What are the dosing guidelines for this medication?

Dosing varies by weight: for example, children weighing 24-35 lbs should receive 5 mL, while those weighing 72-95 lbs should receive 15 mL.

What are the warnings associated with this medication?

Warnings include the risk of severe allergic reactions, stomach bleeding, and increased risk of heart attack or stroke, especially if used more than directed.

What should I do if my child experiences signs of stomach bleeding?

If your child shows signs of stomach bleeding, such as vomiting blood or having black stools, stop use and seek medical help immediately.

Is it safe to use this medication during pregnancy?

The safety of ibuprofen during pregnancy has not been established, and it is contraindicated, especially in the third trimester.

Can nursing mothers use this medication?

Nursing mothers should consult a doctor before using this product, as ibuprofen may be excreted in breast milk.

What should I do in case of an overdose?

In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222.

Packaging Info

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

Packaging configurations for Leader Childrens Ibuprofen.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Children’s Ibuprofen is an oral suspension formulated to provide pain relief and reduce fever, containing 100 mg of ibuprofen per 5 mL. This nonsteroidal anti-inflammatory drug (NSAID) is designed for pediatric use in children aged 2 to 11 years. The product features a grape flavor and is alcohol-free, ensuring a palatable experience for young patients. Each bottle contains 4 fluid ounces (120 mL) of the suspension, which is comparable to the active ingredient found in Children’s Motrin. The effects of the medication can last up to 8 hours.

Uses and Indications

This drug is indicated for the relief of minor aches and pains associated with the common cold, influenza, sore throat, headache, and toothache. Additionally, it is utilized to reduce fever.

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

Dosage and Administration

This product is intended for use in pediatric patients, and healthcare professionals should refer to the dosing chart to determine the appropriate dose based on the patient's weight or age. It is essential to shake the product well before each use. The enclosed dosing cup must be used for accurate measurement; no other dosing devices should be utilized.

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 (2-3 years), the recommended dose is 5 mL. For those weighing 36-47 lbs (4-5 years), the dose is 7.5 mL. Patients weighing 48-59 lbs (6-8 years) should receive 10 mL, while those weighing 60-71 lbs (9-10 years) should be administered 12.5 mL. For patients weighing 72-95 lbs (11 years), the dose is 15 mL.

Dosing may be repeated every 6-8 hours as needed, but should not exceed 4 doses in a 24-hour period. After each use, the dosing cup should be washed to ensure cleanliness. To maintain child resistance, the original bottle cap should be securely replaced after each use. It is critical to adhere to the recommended dosing guidelines and not exceed the directed amount.

Contraindications

Use of this product is contraindicated in the following situations:

  • In patients with a history of allergic reactions to ibuprofen or any other pain reliever/fever reducer, due to the risk of severe allergic reactions.

  • In patients undergoing heart surgery, as use immediately before or after such procedures may pose significant risks.

Warnings and Precautions

Ibuprofen may cause severe allergic reactions, particularly in individuals with a known allergy to aspirin. Symptoms indicative of an allergic reaction can include hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, and blisters. In the event of an allergic reaction, it is imperative to discontinue use immediately and seek medical assistance.

This product contains a nonsteroidal anti-inflammatory drug (NSAID), which is associated with an increased risk of severe stomach bleeding. The likelihood of this adverse effect is heightened in children who have a history of stomach ulcers or bleeding disorders, are concurrently taking anticoagulants or steroid medications, are using other NSAIDs (including aspirin, ibuprofen, or naproxen), or exceed the recommended dosage or duration of treatment.

Healthcare professionals should be aware that the use of NSAIDs, excluding aspirin, is linked to an elevated risk of heart attack, heart failure, and stroke, which can be fatal. This risk is particularly pronounced when the medication is used in excess of the recommended dosage or for extended periods.

Severe or persistent sore throat, especially when accompanied by high fever, headache, nausea, or vomiting, may indicate a serious condition. In such cases, it is essential to consult a physician promptly. The use of ibuprofen should not exceed two days, nor should it be administered to children under three years of age unless specifically directed by a healthcare provider.

Healthcare providers should advise patients to discontinue use and seek medical attention if any of the following occur: signs of stomach bleeding such as feeling faint, vomiting blood, passing bloody or black stools, or experiencing persistent stomach pain; symptoms indicative of heart problems or stroke, including chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling; lack of relief within the first 24 hours of treatment; worsening fever or pain lasting more than three days; presence of redness or swelling in the affected area; or the emergence of any new symptoms.

In the event of an overdose, immediate medical assistance should be sought, or contact a Poison Control Center at 1-800-222-1222.

Side Effects

Patients using ibuprofen may experience a range of adverse reactions, some of which can be serious.

Severe allergic reactions have been reported, particularly in individuals with a known allergy to aspirin. Symptoms of such reactions may include hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, and blisters.

The use of ibuprofen, as a nonsteroidal anti-inflammatory drug (NSAID), carries a warning for potential severe stomach bleeding. The risk of this adverse reaction is heightened in patients with a history of stomach ulcers or bleeding problems, those taking anticoagulants or steroid medications, and individuals using other NSAIDs, including aspirin and naproxen. Additionally, prolonged use or exceeding the recommended dosage increases the likelihood of stomach bleeding.

There is also a significant risk associated with the use of NSAIDs, excluding aspirin, regarding cardiovascular events. Patients may face an increased risk of heart attack, heart failure, and stroke, which can be fatal. This risk is particularly pronounced when the medication is used in higher doses or for extended periods.

Patients should be vigilant for signs of serious conditions, such as severe or persistent sore throat, especially when accompanied by high fever, headache, nausea, or vomiting, and should seek medical attention promptly. It is advised not to use ibuprofen for more than two days or in children under three years of age without a doctor's guidance.

Patients are instructed to discontinue use and consult a healthcare provider if they experience symptoms indicative of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or persistent stomach pain. Additionally, symptoms of heart problems or stroke, including chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling, warrant immediate medical consultation. If relief is not achieved within the first 24 hours of treatment, or if fever or pain worsens or persists beyond three days, medical advice should be sought. The presence of redness or swelling in the painful area or the emergence of new symptoms also necessitates consultation with a healthcare professional.

Before using ibuprofen, it is essential for patients to consult a doctor if they have a history of stomach issues, have experienced serious side effects from pain relievers or fever reducers, are dehydrated, or have conditions such as high blood pressure, heart disease, liver cirrhosis, kidney disease, or a history of stroke. Patients with asthma or those taking diuretics should also seek medical advice prior to use. Furthermore, individuals under a doctor's care for any serious condition or those taking other medications should consult a healthcare provider or pharmacist before using ibuprofen.

Drug Interactions

Ibuprofen is associated with several significant drug interactions that warrant careful consideration, particularly in pediatric populations.

Allergic Reactions Ibuprofen may induce severe allergic reactions in individuals with a known allergy to aspirin. It is crucial to assess the patient's allergy history prior to administration.

Gastrointestinal Risks The concomitant use of ibuprofen with anticoagulants or steroid medications increases the risk of gastrointestinal bleeding. Additionally, the risk of stomach bleeding is elevated when ibuprofen is taken alongside other nonsteroidal anti-inflammatory drugs (NSAIDs), including both prescription and over-the-counter options such as aspirin and naproxen. Monitoring for signs of gastrointestinal distress is advised in patients receiving these combinations.

Cardiovascular Risks There is an increased risk of cardiovascular events, including heart attack, heart failure, and stroke, associated with ibuprofen, particularly when used in higher doses or for extended periods. It is recommended that healthcare providers evaluate the necessity of ibuprofen therapy and consider alternative treatments when appropriate.

General Recommendations Healthcare professionals should advise caregivers to consult with a doctor or pharmacist before administering ibuprofen if the child is taking any other medications. This precaution helps to ensure safe and effective use while minimizing the potential for adverse interactions.

Packaging & NDC

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

Packaging configurations for Leader Childrens Ibuprofen.
Details

Pediatric Use

Pediatric patients under 3 years of age should not use this medication unless directed by a healthcare professional. For children aged 2 to 11 years, dosing is based on weight and age, as outlined in the following chart:

  • Under 24 lbs / Under 2 years: Consult a doctor

  • 24-35 lbs / 2-3 years: 5 mL

  • 36-47 lbs / 4-5 years: 7.5 mL

  • 48-59 lbs / 6-8 years: 10 mL

  • 60-71 lbs / 9-10 years: 12.5 mL

  • 72-95 lbs / 11 years: 15 mL

Dosing may also be adjusted as directed by a healthcare professional. Caution is advised when administering this medication to pediatric patients, particularly those under 3 years of age.

Geriatric Use

Elderly patients should exercise caution when considering the use of this product, as it does not contain specific directions or complete warnings for adult use. It is imperative for healthcare providers to assess the individual health status of geriatric patients prior to administration.

Particular attention should be given to patients aged 65 and older who have underlying health conditions. Healthcare providers are advised to inquire about the presence of high blood pressure, heart disease, liver cirrhosis, kidney disease, or a history of stroke before recommending this product. Monitoring for potential adverse effects and interactions is essential in this population to ensure safety and efficacy.

Pregnancy

The safety of ibuprofen during pregnancy has not been established. Ibuprofen is contraindicated in pregnancy, particularly during the third trimester, due to the risk of fetal harm. The use of ibuprofen during pregnancy may pose risks to the fetus, including potential cardiovascular issues and renal impairment.

Pregnant women are advised to consult a healthcare provider before using ibuprofen. Additionally, dosage adjustments may be necessary based on the stage of pregnancy and individual health conditions. It is essential for healthcare professionals to consider these factors when prescribing ibuprofen to pregnant patients.

Lactation

Nursing mothers should consult a doctor before using this product. There is a potential for excretion in breast milk, and the effects on nursing infants are not well studied; therefore, caution is advised. It is recommended to monitor the infant for any adverse effects if the nursing mother takes this medication.

Renal Impairment

Patients with renal impairment should consult a healthcare professional prior to use, particularly if they have a history of kidney disease. It is essential to assess the patient's overall health status, including any comorbid conditions such as high blood pressure, heart disease, liver cirrhosis, or a history of stroke, as these factors may influence the management of their renal function and the appropriateness of treatment. Monitoring and potential dosing adjustments may be necessary based on the patient's renal status to ensure safety and efficacy.

Hepatic Impairment

Patients with hepatic impairment may experience altered pharmacokinetics of the medication due to compromised liver function. It is essential to assess the severity of liver impairment before initiating treatment.

In patients with liver cirrhosis, dosage adjustments may be necessary to avoid potential toxicity. Close monitoring of liver function tests is recommended throughout the treatment period to ensure safety and efficacy.

Additionally, patients with a history of significant cardiovascular conditions, such as high blood pressure or heart disease, as well as those with kidney disease or a history of stroke, should be evaluated carefully, as these factors may further complicate the management of their hepatic condition.

Overall, a thorough assessment of each patient's individual health status is crucial in determining the appropriate therapeutic approach for those with hepatic impairment.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. Healthcare professionals should advise patients or caregivers to call the Poison Control Center at 1-800-222-1222 for guidance.

Prompt intervention is crucial in managing overdose situations, as timely medical attention can significantly influence outcomes. Symptoms of overdose may vary depending on the substance involved and the individual’s health status. Therefore, a thorough assessment and monitoring of the patient are essential.

Management procedures may include supportive care, symptomatic treatment, and specific antidotes if applicable. Healthcare providers should remain vigilant and prepared to implement appropriate interventions based on the clinical presentation of the patient.

Nonclinical Toxicology

No teratogenic effects have been identified in the available data. Additionally, there is no information regarding non-teratogenic effects. The nonclinical toxicology section does not provide any specific details. Furthermore, there is no information available concerning animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has identified a range of adverse events reported voluntarily or through surveillance programs. Allergic reactions, such as hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, and blisters, have been documented. Additionally, instances of stomach bleeding have been reported in patients using nonsteroidal anti-inflammatory drugs (NSAIDs), including ibuprofen. Serious cardiovascular events, including heart attack and stroke, have also been noted in patients taking NSAIDs. Other adverse reactions include gastrointestinal complications, renal complications, and elevations in liver enzymes.

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. It is recommended to administer the medication with food or milk if the patient experiences stomach upset.

Providers should encourage patients to consult a doctor before use if there is a history of stomach bleeding in the child. Additionally, it is important to ask about any previous stomach problems, such as heartburn, and to discuss any serious side effects experienced from pain relievers or fever reducers.

Patients should be instructed to consult a doctor before use if the child has not been adequately hydrated or has lost significant fluids due to vomiting or diarrhea. It is also crucial to inquire about any existing conditions, including high blood pressure, heart disease, liver cirrhosis, kidney disease, or a history of stroke. If the child has asthma or is taking a diuretic, a doctor's advice should be sought prior to use.

Healthcare providers should recommend that patients consult a doctor or pharmacist if the child is under care for any serious condition or is taking other medications.

Patients should be informed to discontinue use and seek medical advice if the child exhibits any signs of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain.

Furthermore, patients should be advised to stop use and consult a doctor if the child shows symptoms indicative of heart problems or stroke, including chest pain, difficulty breathing, weakness on one side of the body, slurred speech, or leg swelling.

If the child does not experience relief within the first 24 hours of treatment, or if fever or pain worsens or persists beyond three days, patients should be instructed to seek medical advice. Additionally, any redness or swelling in the painful area or the appearance of new symptoms should prompt a consultation with a healthcare provider.

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 20-25°C (68-77°F). Freezing the product is strictly prohibited, as it may compromise its integrity and effectiveness. Proper storage conditions must be maintained to ensure the product's quality and safety.

Additional Clinical Information

The medication is administered orally, with a recommended repeat dose every 6-8 hours as needed, not to exceed four doses per day. Clinicians should advise patients to take the medication with food or milk if gastrointestinal upset occurs.

Patient counseling should emphasize the importance of keeping the medication out of reach of children and instructing patients to seek immediate medical assistance or contact a Poison Control Center (1-800-222-1222) in the event of an overdose. Patients should use only the enclosed dosing cup, ensuring it is washed after each use, and should shake the bottle well before use. It is crucial to replace the original bottle cap to maintain child resistance and to avoid using the medication if the printed neckband is broken or missing. Proper storage conditions include maintaining a temperature of 20-25°C (68-77°F) and avoiding freezing.

Drug Information (PDF)

This file contains official product information for Leader Childrens Ibuprofen, 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 Ibuprofen, 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.

Learn more in our Editorial Policy

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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.