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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 2017
Label revision date
March 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 2017
Label revision date
March 3, 2025
Manufacturer
Cardinal Health 110, LLC. dba Leader
Registration number
ANDA074937
NDC root
70000-0263
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (3 NDCs)
Packaging & NDC Codes (3)

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Drug Overview

Children’s Ibuprofen is an oral suspension designed for children aged 2 to 11 years, providing a berry-flavored option that makes it easier for kids to take. 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 reliable choice for parents looking to comfort their children during illness.

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 birth defects. This makes it a safer choice for those who may be concerned about such risks.

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. If possible, use your child's weight to determine the dose; if not, you can use their age instead.

When measuring the dose, always use the enclosed dosing cup, as other devices may not provide accurate measurements. Depending on your child's needs, you can repeat the dose every 6 to 8 hours, but remember not to give more than four doses in a single day. After each use, wash the dosing cup to keep it clean, and be sure to replace the original bottle cap to maintain its child-resistant feature. If your child weighs under 24 pounds (under 2 years), consult a doctor before administering any dose. For children weighing between 24 and 95 pounds, refer to the chart for the appropriate amount to give.

What to Avoid

You should avoid using this medication if your child has ever had an allergic reaction to 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, as this could pose serious health risks. Always consult with a healthcare professional if you have any concerns about your child's health or medication use.

Side Effects

Ibuprofen can cause serious side effects, including severe allergic reactions, especially in those allergic to aspirin. Symptoms of an allergic reaction may include hives, facial swelling, wheezing, shock, skin reddening, rash, and blisters. Additionally, this medication can lead to severe stomach bleeding, particularly in children with a history of stomach ulcers or those taking blood thinners or other NSAIDs. The risk of heart attack and stroke is also increased with NSAIDs, especially if used in higher doses or for longer than recommended.

If your child experiences symptoms such as faintness, vomiting blood, black or bloody stools, or persistent stomach pain, you should stop use and consult a doctor immediately. Other concerning signs include chest pain, difficulty breathing, weakness on one side of the body, slurred speech, or swelling in the legs. It's important to seek medical advice if your child does not find relief within 24 hours, if symptoms worsen, or if new symptoms arise. Always consult a doctor before use if your child has a history of stomach issues, is dehydrated, or has other serious health conditions.

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 symptoms of heart problems like chest pain or trouble breathing, 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 have a severe sore throat with high fever, headache, nausea, or vomiting. 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. In fact, ibuprofen is not recommended during pregnancy, especially in the third trimester, as it may pose risks to your developing baby, including potential cardiovascular effects.

Before taking ibuprofen, you should consult your healthcare provider to discuss any concerns and explore safer alternatives for pain relief or inflammation management during pregnancy. Your health and the health of your baby are the top priority, so always seek professional guidance.

Lactation Use

If you are breastfeeding, it's important to consult your doctor before using this product. There is a possibility that the medication can be passed into your breast milk, which may pose risks to your nursing infant. Therefore, exercise caution when considering this medication while nursing, and discuss any concerns with your healthcare provider to ensure the safety of both you and your baby.

Pediatric Use

It's important to be cautious when giving medication to children. You should not use this medication in children under 3 years of age unless a doctor specifically advises you to do so. For children aged 2 to 11 years, the dosage varies based on their weight, so it's essential to follow the dosing chart provided by your healthcare professional. For example, a child weighing 24-35 lbs (about 2-3 years old) would typically receive 5 mL, while a child weighing 72-95 lbs (11 years old) would receive 15 mL.

Before administering this medication, consult a doctor if your child has any history of stomach issues, has experienced serious side effects from pain relievers or fever reducers, or has not been drinking enough fluids due to vomiting or diarrhea. Additionally, if your child has conditions like high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or is taking a diuretic, it's crucial to seek medical advice. If you notice any signs of stomach bleeding or if your child does not find relief within 24 hours, or if their fever or pain worsens or lasts more than 3 days, stop using the medication and contact a doctor immediately.

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.

Keep in mind that the product does not provide specific instructions 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 you may have.

Renal Impairment

If you have kidney problems, it's important to be aware of how they can affect your health. Conditions like high blood pressure, heart disease, liver cirrhosis (scarring of the liver), and a history of stroke can complicate your kidney health.

Make sure to discuss your kidney condition with your healthcare provider, as they may need to adjust your medication dosages or monitor your kidney function more closely. Keeping an open line of communication with your doctor will help ensure that you receive the best care tailored to your needs.

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 taking medications like ibuprofen. If you or your child are allergic to aspirin, using ibuprofen could lead to severe allergic reactions. Additionally, if your child is on blood thinners (medications that prevent blood clots) or steroids, the risk of stomach bleeding increases. This risk is also heightened if they are taking other nonsteroidal anti-inflammatory drugs (NSAIDs), such as aspirin or naproxen.

Using NSAIDs, except for aspirin, can raise the chances of serious heart issues, including heart attack and stroke, especially if taken in higher doses or for longer than recommended. If your child is taking a diuretic (a medication that helps remove excess fluid), it's crucial to consult with a healthcare provider to ensure safety. Always discuss any medications or tests with your doctor to avoid complications and ensure the best care.

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). It's important to keep it away from freezing temperatures, as freezing can damage the product. Before use, check the printed neckband; do not use the product if it is broken or missing, as this could compromise safety.

By following these simple storage and handling guidelines, you can help maintain the integrity of the product and ensure its effectiveness.

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. To help prevent stomach upset, consider taking it with food or milk. Always keep this medication out of reach of children. In case of an overdose, seek medical help immediately or contact a Poison Control Center at 1-800-222-1222. Remember to wash the dosage cup after each use to maintain hygiene.

FAQ

What is Children's Ibuprofen?

Children's Ibuprofen is an oral suspension that provides pain relief and reduces fever for children aged 2 to 11 years. It comes in a berry flavor with a concentration of 100 mg per 5 mL.

What does Children's Ibuprofen treat?

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

How long does the effect of Children's Ibuprofen last?

The effects of Children's Ibuprofen can last up to 8 hours.

What is the dosing chart for Children's Ibuprofen?

Dosing is based on weight: under 24 lbs (ask a doctor), 24-35 lbs (5 mL), 36-47 lbs (7.5 mL), 48-59 lbs (10 mL), 60-71 lbs (12.5 mL), and 72-95 lbs (15 mL).

Are there any contraindications for using Children's Ibuprofen?

Do not use if the child has had an allergic reaction to any pain reliever/fever reducer or if they are about to undergo heart surgery.

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

If your child feels faint, vomits blood, has bloody or black stools, or has persistent stomach pain, stop use and consult a doctor immediately.

Can I give Children's Ibuprofen to my child if they are pregnant or nursing?

Consult a healthcare provider before using Children's Ibuprofen if pregnant or nursing, as it may pose risks to the fetus or infant.

What precautions should I take when using Children's Ibuprofen?

Always use the enclosed dosing cup, do not exceed the recommended dose, and consult a doctor if your child has a history of stomach problems or is taking other medications.

What should I do in case of an overdose?

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

How should I store Children's Ibuprofen?

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

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 as a nonsteroidal anti-inflammatory drug (NSAID) for the relief of pain and reduction of fever. Each 5 mL of the suspension contains 100 mg of ibuprofen. The product is designed for pediatric use in children aged 2 to 11 years and is presented in a berry flavor. It is alcohol-free and is packaged in a 4 fluid ounce (120 mL) bottle.

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 dosage based on the patient's weight or age. It is essential to shake the product well before each use to ensure proper mixing.

For patients weighing under 24 lbs (under 2 years), it is advised to consult a physician for dosing recommendations. For those weighing between 24-35 lbs (2-3 years), the recommended dose is 5 mL. Patients weighing 36-47 lbs (4-5 years) should receive 7.5 mL, while those weighing 48-59 lbs (6-8 years) should be administered 10 mL. For patients weighing 60-71 lbs (9-10 years), the dose is 12.5 mL, and for those weighing 72-95 lbs (11 years), the recommended dose is 15 mL.

Dosing should be performed using only the enclosed dosing cup to ensure accuracy; other dosing devices are not recommended. If necessary, doses may be repeated every 6 to 8 hours, but the total daily administration should not exceed four doses. After each use, the dosing cup should be washed thoroughly to maintain hygiene.

To ensure child safety, the original bottle cap should be replaced securely after each use. It is crucial to adhere strictly to the recommended dosages and not exceed the directed amounts.

Contraindications

Use is contraindicated in children with a history of allergic reactions to any other pain reliever or fever reducer, due to the potential for severe allergic responses. Additionally, the product should not be administered immediately before or after heart surgery, as it may pose risks to the patient's recovery and overall cardiovascular stability.

Warnings and Precautions

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

This product contains a nonsteroidal anti-inflammatory drug (NSAID), which carries a risk of severe stomach bleeding. The likelihood of this adverse effect is heightened in pediatric patients with a history of stomach ulcers or bleeding disorders, those concurrently using anticoagulants or steroid medications, or those taking other NSAIDs, whether prescription or over-the-counter (such as aspirin, ibuprofen, or naproxen). Additionally, exceeding the recommended dosage or duration of use increases the risk of stomach bleeding.

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 an extended period.

Healthcare professionals should be vigilant for signs of severe or persistent sore throat, especially when accompanied by high fever, headache, nausea, or vomiting, as these symptoms may indicate a serious condition. Patients should be advised to consult a physician promptly and to avoid using the medication for more than two days or administering it to children under three years of age without medical guidance.

Patients should be instructed to discontinue use and seek medical advice if any of the following symptoms occur: signs of stomach bleeding such as feeling faint, vomiting blood, having 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; redness or swelling in the affected area; or the emergence of any new symptoms.

In the event of an overdose, immediate medical attention should be sought, or contact should be made with 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 the potential risk of severe stomach bleeding. This risk 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, the risk increases if the medication is taken in higher doses or for extended periods beyond the recommended guidelines.

There is also a significant warning regarding the increased risk of heart attack, heart failure, and stroke associated with NSAID use, excluding aspirin. These cardiovascular events can be fatal, particularly when the medication is used in excess or for longer durations than prescribed.

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 in cases of sore throat or to administer it to children under three years of age without a doctor's direction.

In the event of symptoms indicative of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain, patients should discontinue use and consult a healthcare provider. Additionally, symptoms suggesting heart problems or stroke, including chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling, warrant immediate medical evaluation.

Patients are advised to seek medical advice before using ibuprofen if they have a history of stomach issues, have experienced serious side effects from pain relievers or fever reducers, are dehydrated, or have underlying health conditions such as high blood pressure, heart disease, liver cirrhosis, kidney disease, or a history of stroke. Furthermore, individuals with asthma or those taking diuretics should also consult a healthcare professional prior to use.

It is important for patients to monitor their response to treatment; if relief is not achieved within the first 24 hours, or if fever or pain worsens or persists beyond three days, medical consultation is recommended. Redness or swelling in the affected area or the emergence of new symptoms should also prompt a discussion with a healthcare provider.

Drug Interactions

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

Allergic Reactions Ibuprofen may induce severe allergic reactions, particularly in individuals with a known allergy to aspirin. It is essential to assess the patient's allergy history before prescribing ibuprofen.

Gastrointestinal Risks The concomitant use of ibuprofen with anticoagulants or steroid medications increases the risk of gastrointestinal bleeding. This risk is further 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. Clinicians should monitor patients closely for signs of gastrointestinal distress and consider alternative pain management strategies if necessary.

Cardiovascular Risks The use of NSAIDs, excluding aspirin, is associated with an increased risk of cardiovascular events, including heart attack, heart failure, and stroke. This risk is particularly pronounced when these medications are used in higher doses or for extended periods. It is advisable to limit the duration and dosage of NSAID therapy and to evaluate the patient's cardiovascular risk factors prior to initiation.

Diuretics Patients taking diuretics should be advised to consult their healthcare provider before using ibuprofen. The interaction between ibuprofen and diuretics may necessitate dosage adjustments or increased monitoring to prevent potential adverse effects.

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 doctor. For dosing, the following guidelines apply:

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

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

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

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

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

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

Healthcare professionals should advise parents or guardians to consult a doctor if the child has a history of stomach problems, such as heartburn, or if the child has experienced serious side effects from pain relievers or fever reducers. Additionally, consultation is necessary if the child has not been drinking fluids or has lost significant fluid due to vomiting or diarrhea, or if there are concerns regarding high blood pressure, heart disease, liver cirrhosis, kidney disease, a history of stroke, or asthma.

If the child is taking a diuretic or is under a doctor's care for any serious condition, a doctor should be consulted prior to use. Parents or guardians should be instructed to discontinue use and seek medical advice if the child exhibits signs of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain. If the child does not achieve relief within the first 24 hours of treatment, or if fever or pain worsens or persists beyond 3 days, a doctor should be consulted.

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 may have underlying health conditions. It is advisable for these patients to consult with a healthcare professional before use, especially if they have a history of high blood pressure, heart disease, liver cirrhosis, kidney disease, or stroke. Monitoring for potential adverse effects and interactions is recommended to ensure patient safety and efficacy of treatment.

Pregnancy

The safety of ibuprofen during pregnancy has not been established. Ibuprofen is contraindicated in pregnancy, particularly during the third trimester, due to potential risks to the fetus. The use of ibuprofen during pregnancy may pose risks, including potential cardiovascular effects on the developing fetus.

Women of childbearing potential should consult a healthcare provider before using ibuprofen if they are pregnant or planning to become pregnant to discuss the potential risks and benefits.

Lactation

Nursing mothers should consult a doctor before using this product. There is a potential for excretion in breast milk, and caution is advised when administering this medication to nursing mothers due to the potential risk to the infant.

Renal Impairment

Patients with renal impairment may require careful consideration regarding dosing adjustments and monitoring. In particular, those with reduced kidney function should be assessed for potential changes in drug clearance. It is essential to evaluate 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 further complicate the management of therapy in this population. Regular monitoring of renal function is recommended to ensure safe and effective use of the medication in patients with compromised renal status.

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, including alanine aminotransferase (ALT), aspartate aminotransferase (AST), and bilirubin levels, is recommended throughout the treatment course.

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 impairment.

Overall, a thorough assessment and ongoing monitoring are critical to ensure the safe and effective use of the medication in patients 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 effectively. 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 to determine the appropriate course of action.

Management procedures may include supportive care, symptomatic treatment, and, if applicable, the administration of specific antidotes. Continuous evaluation of the patient's condition is necessary to address any complications that may arise during the management of an overdose.

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 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.

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 persistent stomach pain. Additionally, healthcare providers should inform patients to be vigilant for symptoms indicative of heart problems or stroke, such as chest pain, difficulty breathing, weakness on one side of the body, slurred speech, or leg swelling. It is also important to advise that 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, they should seek medical advice. Redness or swelling in the painful area or the appearance of any new symptoms should also prompt a consultation with a healthcare professional.

When administering this product, patients should be advised to give it with food or milk if stomach upset occurs.

Healthcare providers should recommend that patients consult a doctor before use if any of the following apply: the stomach bleeding warning is relevant to the child, the child has a history of stomach issues such as heartburn, has experienced serious side effects from pain relievers or fever reducers, has not been adequately hydrated, has lost significant fluids due to vomiting or diarrhea, or has conditions such as high blood pressure, heart disease, liver cirrhosis, kidney disease, or a history of stroke. Additionally, patients should be cautioned to seek medical advice if the child has asthma or is taking a diuretic.

Finally, healthcare providers should encourage patients to consult a doctor or pharmacist before use if the child is under medical care for any serious condition or is taking any other medications.

Storage and Handling

The product is supplied in configurations that include specific NDC numbers. It should be stored at a temperature range of 20-25°C (68-77°F) to maintain its integrity. Freezing is not permitted, as it may compromise the product's quality. Additionally, the product must not be used if the printed neckband is broken or missing, as this indicates potential tampering or compromise of the product. Proper handling and storage conditions are essential to ensure the safety and efficacy of the product.

Additional Clinical Information

The medication is administered orally, with a recommended repeat dose every 6-8 hours as needed, not to exceed four doses in a 24-hour period. 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 instruct patients to seek immediate medical assistance or contact a Poison Control Center (1-800-222-1222) in the event of an overdose. Additionally, it is recommended that patients wash the dosage cup after each use to ensure proper hygiene.

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.