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Leader 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 2017
Label revision date
April 18, 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 2017
Label revision date
April 18, 2025
Manufacturer
Cardinal Health 110, LLC. dba Leader
Registration number
ANDA074937
NDC root
70000-0262
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

Children’s Dye-Free Ibuprofen is an oral suspension designed for children aged 2 to 11 years, providing a berry-flavored option that is non-staining and alcohol-free. This medication acts as a pain reliever and fever reducer, helping to alleviate minor aches and pains associated with common conditions like the cold, flu, sore throat, headache, and toothache. It can also effectively reduce fever and lasts for up to 8 hours, making it a convenient choice for parents looking to manage their child's discomfort.

Uses

You can use this medication to help relieve minor aches and pains that may come from common conditions like the cold, flu, sore throat, headache, or 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 if taken during pregnancy.

Dosage and Administration

Before using this product, it's important to know that it doesn't 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 provided, which is based on weight. If you can't use weight, you can use age as a guide.

When measuring your dose, use only the enclosed dosing cup, as other devices may not provide accurate measurements. Depending on your needs, you can repeat the dose every 6 to 8 hours, but remember not to take it more than four times a 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. If your child weighs under 24 pounds (or is under 2 years old), consult a doctor for guidance.

What to Avoid

It's important to be cautious when considering this medication for your child. You should not use it if your child has ever had an allergic reaction to ibuprofen or any other pain reliever or fever reducer. Additionally, avoid using this medication right before or after heart surgery, as it can pose serious risks in these situations.

Always prioritize safety by following these guidelines closely. If you have any concerns or questions about your child's health or medication, consult with a healthcare professional for personalized advice.

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 has bloody or black stools, you should seek medical attention immediately. It's important to consult a doctor if your child has a severe sore throat with high fever, or if symptoms worsen or persist beyond a few days. Always discuss with a healthcare provider before using ibuprofen if your child has any underlying health conditions 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 immediately and seek medical help.

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 consulting a doctor, especially if they are under three years old. If your child does not feel better within 24 hours, or if their fever or pain worsens or lasts more than three days, seek medical advice. In case of an overdose, get 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. Specifically, using ibuprofen during the later stages of pregnancy (the third trimester) is not recommended, as it can lead to serious risks for your baby, such as premature closure of a vital blood vessel called the ductus arteriosus. Additionally, there may be potential cardiovascular effects on the fetus.

Before taking ibuprofen at any stage of your pregnancy, you should consult your healthcare provider. They can provide guidance tailored to your specific situation and help you understand any necessary dosage modifications. In general, it's best to avoid using ibuprofen unless a healthcare professional has advised you to do so.

Lactation Use

If you are breastfeeding and considering using ibuprofen, it's important to consult your doctor first. This is because ibuprofen can potentially pass into your breast milk, which may pose risks to your nursing infant. Therefore, exercising caution is advised when taking this medication while breastfeeding. Always prioritize your health and your baby's safety by discussing any medications with your healthcare provider.

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 10 years, the dosage depends on their weight. For example, if your child weighs under 24 lbs and is under 2 years old, you should consult a doctor. If they weigh between 24-35 lbs and are 2-3 years old, the recommended dose is 5 mL. Always use the enclosed dosing cup to measure the medication accurately, and if possible, base the dose on your child's weight rather than their age.

Additionally, it's crucial to limit use to no more than 2 days and to seek medical advice if your child has any history of stomach issues, dehydration from vomiting or diarrhea, or conditions like high blood pressure, heart disease, or asthma. Always keep the medication out of reach of children, and in case of an overdose, contact a medical professional or Poison Control Center immediately.

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 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 necessary adjustments to your treatment plan. Always prioritize open communication with your doctor regarding your health conditions.

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 how ibuprofen can interact with other medications you may be taking. For instance, if you are using blood thinners (medications that help prevent blood clots) or steroids, taking ibuprofen could increase your risk of stomach bleeding. Additionally, using ibuprofen, especially in higher doses or for longer than recommended, can raise your chances of serious heart issues like heart attack or stroke. You should also avoid taking ibuprofen alongside other nonsteroidal anti-inflammatory drugs (NSAIDs), such as aspirin or naproxen, as this can lead to further complications.

Always discuss your current medications and any lab tests with your healthcare provider. They can help you understand the risks and ensure that your treatment plan is safe and effective.

Storage and Handling

To ensure the safety and effectiveness of your product, store it at a temperature between 20-25°C (68-77°F). It's important to avoid freezing the product, as this can damage it. Before use, check the printed neckband; do not use the product if it is broken or missing, as this could indicate a safety issue.

By following these simple storage and handling guidelines, you can help maintain the quality and reliability of your product.

Additional Information

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

FAQ

What is Children's Dye-Free Ibuprofen?

Children's Dye-Free Ibuprofen is an oral suspension that contains 100 mg of ibuprofen per 5 mL, designed to relieve pain and reduce fever in children.

What conditions does it treat?

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

What is the recommended dosage for children?

Dosage varies by weight: for children weighing 24-35 lbs (2-3 years), give 5 mL; for 36-47 lbs (4-5 years), give 7.5 mL; and so on. Always consult the dosing chart or a doctor.

Are there any warnings associated with this medication?

Yes, ibuprofen may cause severe allergic reactions, stomach bleeding, and increase the risk of heart attack and stroke. Consult a doctor if your child has a history of stomach problems or is taking other medications.

Can I use this medication if my child is pregnant or breastfeeding?

The safety of ibuprofen during pregnancy has not been established, and it is contraindicated in late pregnancy. Nursing mothers should consult a doctor before use due to potential risks to the infant.

What should I do if my child experiences side effects?

If your child shows signs of stomach bleeding, heart problems, or does not get relief within 24 hours, stop use and consult a doctor immediately.

How should I store Children's Dye-Free Ibuprofen?

Store it at 20-25°C (68-77°F) and do not freeze. Ensure the printed neckband is intact before use.

Is there a money-back guarantee?

Yes, there is a 100% money-back guarantee for this product.

Packaging Info

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

Packaging configurations for Leader Ibuprofen.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Children’s Dye-Free Ibuprofen is an oral suspension formulated to provide pain relief and reduce fever. Each 5 mL dose contains 100 mg of ibuprofen, a nonsteroidal anti-inflammatory drug (NSAID). The product is designed for children aged 2 to 11 years and features a berry flavor that enhances palatability. It is non-staining and alcohol-free, ensuring a safer option for pediatric use. The suspension is packaged in a 4 FL OZ (120 mL) bottle and 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 children and does not contain directions or complete warnings for adult use. Healthcare professionals should ensure that the dosage administered does not exceed the recommended limits.

Prior to administration, the product must be shaken well. The appropriate dose should be determined using the provided dosing chart, with weight being the preferred method for dosing. If weight is not available, age may be used as a secondary reference. It is imperative to utilize only the enclosed dosing cup for measurement; other dosing devices are not recommended.

The following dosing chart should be referenced:

  • For children weighing under 24 lbs (under 2 years), consultation with a doctor is advised.

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

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

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

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

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

If necessary, doses may be repeated every 6 to 8 hours, but should not exceed four doses in a 24-hour period. After each use, the dosing cup should be washed thoroughly to maintain hygiene. To ensure child safety, the original bottle cap should be replaced after each use to maintain child resistance.

Dosing may also be directed by a healthcare professional based on individual patient needs.

Contraindications

Use is contraindicated in patients with a history of allergic reactions to ibuprofen or any other pain reliever or fever reducer. Additionally, administration is contraindicated in the perioperative period surrounding heart surgery due to potential complications.

Warnings and Precautions

Ibuprofen may elicit severe allergic reactions, particularly in individuals with a known allergy to aspirin. Symptoms indicative of an allergic response may 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.

The use of ibuprofen carries a risk of severe stomach bleeding, a potential consequence of its classification as a nonsteroidal anti-inflammatory drug (NSAID). The likelihood of experiencing stomach bleeding is heightened in pediatric patients with a history of stomach ulcers or bleeding disorders, those concurrently taking anticoagulants or steroid medications, or those using other NSAIDs (including aspirin, ibuprofen, naproxen, or similar agents). Additionally, exceeding the recommended dosage or duration of treatment increases this risk.

Healthcare professionals should be aware that NSAIDs, excluding aspirin, are associated with 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.

In cases of severe or persistent sore throat, especially when accompanied by high fever, headache, nausea, or vomiting, immediate medical consultation is advised. Ibuprofen should not be administered for more than two days, nor should it be given to children under three years of age unless specifically directed by a physician.

Healthcare providers should instruct caregivers to discontinue ibuprofen and seek medical advice if the child exhibits any of the following signs of stomach bleeding: feeling faint, vomiting blood, passing bloody or black stools, or experiencing persistent stomach pain. Additionally, symptoms suggestive of heart problems or stroke, such as chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling, warrant immediate medical evaluation. If the child does not achieve relief within the first 24 hours of treatment, or if fever or pain worsens or persists beyond three days, or if redness or swelling occurs in the affected area, medical consultation is necessary. Any emergence of new symptoms should also prompt a discussion with a healthcare provider.

In the event of an overdose, it is crucial to seek medical assistance or contact a Poison Control Center immediately at 1-800-222-1222.

Side Effects

Patients using ibuprofen may experience a range of adverse reactions, which can vary in severity.

Serious adverse reactions include severe allergic reactions, particularly in individuals with a known allergy to aspirin. Symptoms of such reactions may manifest as hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, or blisters. Additionally, the use of ibuprofen, as a nonsteroidal anti-inflammatory drug (NSAID), carries a risk of severe stomach bleeding, especially in patients with a history of stomach ulcers or bleeding problems, those taking anticoagulants or steroid medications, or those using other NSAIDs. The risk of gastrointestinal bleeding is heightened with prolonged use or higher than recommended dosages.

Furthermore, NSAIDs, excluding aspirin, are associated with an increased risk of heart attack, heart failure, and stroke, which can be fatal. This risk is amplified when the medication is used beyond the recommended duration or dosage. Patients should be vigilant for signs of serious conditions, such as chest pain, difficulty breathing, weakness on one side of the body, slurred speech, or leg swelling, and seek immediate medical attention if these symptoms occur.

Common adverse reactions may include gastrointestinal discomfort, and patients should be advised 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, if fever or pain worsens or persists beyond three days, or if new symptoms arise, medical advice should be sought.

Patients are also cautioned to consult a healthcare professional before using ibuprofen if they have a history of stomach issues, are dehydrated, or have underlying health conditions such as high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma. Special consideration should be given to children under a doctor’s care for serious conditions or those taking other medications.

Drug Interactions

Ibuprofen is associated with several significant drug interactions that warrant careful consideration.

Anticoagulants and Steroids The concomitant use of ibuprofen with anticoagulants or steroid medications may elevate the risk of gastrointestinal bleeding. It is advisable to monitor patients closely for signs of bleeding and consider dosage adjustments or alternative therapies where appropriate.

Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) Ibuprofen should not be administered alongside other NSAIDs, whether prescription or nonprescription, such as aspirin or naproxen. The combined use of these agents can increase the risk of adverse effects, including gastrointestinal complications.

Cardiovascular Risks The use of ibuprofen, particularly at doses exceeding recommended levels or for prolonged durations, is associated with an increased risk of serious cardiovascular events, including heart attack, heart failure, and stroke. Clinicians should evaluate the necessity of ibuprofen therapy in patients with existing cardiovascular conditions and consider alternative pain management strategies when appropriate.

No specific laboratory test interactions have been identified in the available data.

Packaging & NDC

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

Packaging configurations for Leader Ibuprofen.
Details

Pediatric Use

Pediatric patients under 3 years of age should not use this medication unless directed by a doctor. For dosing, it is recommended to use weight as the primary guide; if weight is not available, age may be used. The following dosing chart applies:

  • For patients weighing under 24 lbs (under 2 years of age), consult a doctor.

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

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

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

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

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

Only the enclosed dosing cup should be used; other dosing devices are not recommended. The medication should not be used for more than 2 days, and medical consultation is advised if the child has a history of stomach problems, such as heartburn, or if they have not been drinking fluids or have lost significant fluid due to vomiting or diarrhea. Additional consultation is necessary for children with high blood pressure, heart disease, liver cirrhosis, kidney disease, a history of stroke, asthma, or those taking diuretics.

This medication should be kept out of reach of children. In the event of an overdose, immediate medical assistance or contact with a Poison Control Center is essential.

Geriatric Use

Elderly patients may not receive specific directions or complete warnings for adult use with this product. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is essential to consider the unique physiological changes and potential comorbidities that may affect drug metabolism and response in this population.

Healthcare providers are advised to closely monitor elderly patients for any adverse effects and to adjust dosages as necessary based on individual patient needs and responses. Given the lack of comprehensive guidance for adult use, careful evaluation and clinical judgment are paramount when treating geriatric patients with this product.

Pregnancy

The safety of ibuprofen during pregnancy has not been established. Ibuprofen is contraindicated in late pregnancy (third trimester) due to the risk of premature closure of the ductus arteriosus in the fetus, which may lead to significant cardiovascular effects. The use of ibuprofen during pregnancy may pose risks to the fetus, and therefore, pregnant women should avoid using ibuprofen unless directed by a healthcare professional. It is essential for healthcare providers to be consulted before using ibuprofen during pregnancy, particularly in the later stages, to assess the potential risks and determine appropriate dosage modifications.

Lactation

Nursing mothers are advised to consult a doctor prior to using ibuprofen. There is a potential for excretion of ibuprofen in breast milk. Caution is recommended when administering ibuprofen to lactating mothers due to the potential risk to the breastfed infant.

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 course. Additionally, patients with a history of significant liver disease, such as cirrhosis, should be evaluated for any contraindications related to their hepatic condition.

Healthcare providers should consider the overall health status of patients, including any coexisting conditions such as high blood pressure, heart disease, kidney disease, or a history of stroke, as these may further complicate the management of therapy in individuals with hepatic impairment. Regular follow-up and reassessment of liver function are advised to ensure safe and effective use of the medication 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 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 support can significantly influence outcomes. Symptoms of overdose may vary depending on the substance involved, and healthcare providers should be prepared to assess and manage these symptoms accordingly.

Management procedures may include supportive care, monitoring of vital signs, and symptomatic treatment as necessary. It is essential for healthcare professionals to remain vigilant and act swiftly to mitigate potential complications associated with overdose.

Nonclinical Toxicology

No teratogenic or non-teratogenic effects have been reported in the available data. Additionally, there is no information regarding nonclinical toxicology or animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has identified the following adverse reactions reported voluntarily or through surveillance programs: hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, and blisters. These events have been documented in the context of postmarketing surveillance and should be considered when evaluating the safety profile of the product.

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 child experiences stomach upset.

Patients should be instructed to discontinue use and consult a doctor if the child exhibits any signs of stomach bleeding, which may include feeling faint, vomiting blood, having bloody or black stools, or experiencing stomach pain that does not improve. Additionally, healthcare providers should inform patients to stop use and seek medical advice if the child shows symptoms indicative of heart problems or stroke, such as chest pain, difficulty breathing, weakness on one side of the body, slurred speech, or swelling in the legs.

Patients should also be counseled to discontinue use and consult a doctor if the child does not experience relief within the first 24 hours of treatment, if fever or pain worsens or persists beyond three days, if there is redness or swelling in the painful area, or if any new symptoms arise.

It is important for healthcare providers to remind patients to consult a doctor before use if the stomach bleeding warning is applicable to their child. Patients should also be advised to seek medical guidance if the child has a history of stomach issues, such as heartburn, or if they have experienced serious side effects from pain relievers or fever reducers. Furthermore, patients should be encouraged to consult a doctor before use if the child has not been adequately hydrated, has lost significant fluids due to vomiting or diarrhea, or has pre-existing conditions such as high blood pressure, heart disease, liver cirrhosis, kidney disease, or a history of stroke.

Patients should also be advised to consult a doctor before use if the child has asthma, is taking a diuretic, or is under a physician's care for any serious condition. Lastly, it is prudent for patients to discuss with a doctor or pharmacist if the child is currently taking any other medications.

Storage and Handling

The product is supplied in a configuration that includes 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). Freezing the product is strictly prohibited, as it may compromise its integrity and efficacy.

Healthcare professionals are advised to inspect the product prior to use. The product should not be utilized if the printed neckband is broken or missing, as this may indicate tampering or compromise of the product's safety. Proper handling and adherence to these storage conditions are crucial to ensure the product's quality and effectiveness.

Additional Clinical Information

The medication is administered orally, with a recommended dosing frequency of every 6-8 hours as needed, not to exceed four doses in a 24-hour period. Clinicians should advise patients to keep the medication out of reach of children and to seek immediate medical assistance or contact a Poison Control Center (1-800-222-1222) in the event of an overdose.

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

Drug Information (PDF)

This file contains official product information for Leader 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 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

Last AI update:

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.