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Childrens Ibuprofen

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Active ingredient
Ibuprofen 100 mg
Other brand names
Drug class
Nonsteroidal Anti-inflammatory Drug
Dosage form
Tablet, Chewable
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2025
Label revision date
August 4, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Ibuprofen 100 mg
Other brand names
Drug class
Nonsteroidal Anti-inflammatory Drug
Dosage form
Tablet, Chewable
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 2025
Label revision date
August 4, 2025
Manufacturer
Meijer, Inc.
Registration number
ANDA076359
NDC root
79481-0419
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

Ibuprofen is a chewable pain reliever and fever reducer designed for children ages 2 to 11. It comes in orange-flavored, dye-free tablets, each containing 100 mg of the active ingredient. As a nonsteroidal anti-inflammatory drug (NSAID), ibuprofen works by reducing fever and alleviating minor aches and pains associated with common conditions like colds, flu, sore throats, headaches, and toothaches.

This medication is a convenient option for parents looking to manage their child's discomfort, as it can provide relief for up to 8 hours. It's important to ensure that children chew or crush the tablets completely before swallowing for effective use.

Uses

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

This means that if you're feeling under the weather or dealing with everyday aches, this medication can provide some relief to help you feel better.

Dosage and Administration

Before taking this medication, make sure to chew or crush the tablets completely before swallowing them. It's important to follow the dosing instructions carefully, so do not exceed the recommended amount. To find the right dose, refer to the dosing chart based on weight or age. If you need to take another dose, you can do so every 6 to 8 hours, but remember not to use it more than four times in a single day.

For children under 2 years old who weigh less than 24 pounds, it's best to consult a doctor before giving any tablets. For children aged 2 to 3 years who weigh between 24 and 35 pounds, the recommended dose is 1 tablet. If your child is 4 to 5 years old and weighs between 36 and 47 pounds, they should take 1 and a half tablets. For those aged 6 to 8 years weighing 48 to 59 pounds, the dose is 2 tablets. If your child is 9 to 10 years old and weighs between 60 and 71 pounds, they should take 2 and a half tablets. Finally, for an 11-year-old weighing between 72 and 95 pounds, the dose is 3 tablets. Always ensure you are giving the correct amount based on the chart.

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, do not use it right before or after heart surgery.

If your child experiences any signs of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or persistent stomach pain, stop use immediately and consult a doctor. Also, seek medical attention if your child shows symptoms of heart problems or stroke, including chest pain, trouble breathing, weakness on one side of the body, slurred speech, or leg swelling. If there is no relief within the first 24 hours, or if fever or pain worsens or lasts more than three days, or if redness or swelling appears in the painful area, contact a healthcare professional. Always be alert for any new symptoms that may arise.

Side Effects

Ibuprofen can cause serious allergic reactions, particularly in individuals who are allergic to aspirin. Symptoms to watch for include hives, facial swelling, wheezing, shock, skin reddening, rash, and blisters. Additionally, this medication may lead to 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. If your child experiences symptoms such as chest pain, trouble breathing, weakness on one side of the body, or slurred speech, 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 talk to a healthcare professional 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 in individuals who are allergic to aspirin. If you notice symptoms like hives, facial swelling, wheezing, or any skin rash, stop using the medication immediately and seek medical help. Additionally, be aware that ibuprofen can lead to severe stomach bleeding, particularly if your child has a history of stomach ulcers, is taking blood thinners or steroids, or is using other NSAIDs (nonsteroidal anti-inflammatory drugs) like aspirin or naproxen.

There is also an increased risk of heart attack and stroke associated with NSAIDs, especially if used in higher doses or for longer than recommended. If your child experiences severe sore throat symptoms, such as a high fever or persistent pain, consult a doctor right away. You should stop using ibuprofen and contact a healthcare provider if your child shows signs of stomach bleeding (like fainting, vomiting blood, or having black stools), symptoms of heart problems or stroke (such as chest pain or weakness on one side of the body), or if their condition does not improve within 24 hours. Always seek medical advice if new symptoms arise or if fever or pain worsens or lasts more than three days.

Overdose

If you suspect an overdose, it’s crucial to seek medical help immediately or contact a Poison Control Center. Signs of an overdose can vary, but they may include unusual drowsiness, confusion, or difficulty breathing.

Don’t wait for symptoms to worsen; getting prompt assistance can be vital. Always prioritize your safety and the safety of others by acting quickly in these situations.

Pregnancy Use

The safety of ibuprofen during pregnancy has not been established, and it is generally not recommended, especially in the third trimester (the final three months of pregnancy). Using ibuprofen while pregnant may pose risks to your developing baby, including potential cardiovascular issues.

If you are pregnant or planning to become pregnant, it’s important to consult your healthcare provider before using ibuprofen or any medication. They can help you understand the risks and explore safer alternatives for managing pain or inflammation during this time.

Lactation Use

If you are breastfeeding and considering using this product, it's important to consult your doctor first. 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 take ibuprofen while breastfeeding, keep an eye on your baby for any unusual reactions or side effects. Monitoring your infant can help ensure their safety while you manage your own health needs.

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 3 years who weigh between 24 and 35 pounds, the recommended dose is 1 tablet. As children grow, the dosage increases based on their weight and age, so be sure to follow the dosing chart carefully.

Before giving this medication, consult a doctor if your child has a history of allergies to pain relievers, stomach issues, or has experienced serious side effects from similar medications. Additionally, if your child has not been drinking fluids, has certain health conditions like high blood pressure or asthma, or is taking other medications, it's best to seek medical advice first. Remember, if your child does not feel better within 24 hours or if their fever or pain worsens or lasts more than 3 days, contact a doctor. Always prioritize your child's health and safety.

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 tailored advice and guidance on how to use this product safely and effectively.

Always prioritize open communication with your doctor or pharmacist about any concerns or questions you may have regarding medications, especially if you are managing multiple health conditions or taking other treatments. Your safety and well-being are paramount, so ensure you have all the necessary information before starting any new medication.

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 whether any adjustments are needed based on your kidney health. Always prioritize open communication with your doctor regarding your medical history and current 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 may 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 talk to your healthcare provider about any medications you are taking, especially if you are using blood thinners (anticoagulants) or steroid drugs. These medications can interact with other drugs, including common over-the-counter pain relievers like aspirin, ibuprofen, and naproxen, which may increase the risk of side effects or complications.

While there are no specific laboratory test interactions noted, discussing all your medications and any upcoming tests with your healthcare provider ensures that you receive safe and effective care tailored to your needs. Always keep your provider informed about everything you are taking to help avoid any potential issues.

Storage and Handling

To ensure the best performance of your product, store it in a cool, dry place at a temperature between 20-25°C (68-77°F). This temperature range helps maintain the product's effectiveness.

When handling the product, be sure to check that the printed seal under the cap is intact. If the seal is broken or missing, do not use the product, as this may compromise its safety and effectiveness. Always prioritize these guidelines to ensure safe and proper use.

Additional Information

No further information is available.

FAQ

What is ibuprofen used for?

Ibuprofen is used to reduce fever and relieve minor aches and pains due to the common cold, flu, sore throat, headaches, and toothaches.

What age group can use Meijer Children’s ibuprofen?

Meijer Children’s ibuprofen is intended for children ages 2 to 11.

How should I administer the chewable tablets?

You should chew or crush the tablets completely before swallowing.

What is the maximum dosage for ibuprofen?

Do not use more than 4 times a day and do not exceed the recommended dose based on your child's weight or age.

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

Stop use and ask a doctor if your child feels faint, vomits blood, has bloody or black stools, or has stomach pain that does not improve.

Can ibuprofen be used during pregnancy?

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

What should I do if my child has a history of allergies?

Consult a doctor before use if your child has ever had an allergic reaction to ibuprofen or any other pain reliever/fever reducer.

What are the storage conditions for ibuprofen?

Store ibuprofen between 20-25°C (68-77°F) and do not use if the printed seal under the cap is broken or missing.

What should I do if my child does not get relief within 24 hours?

If your child does not get any relief within the first day of treatment, consult a doctor.

Is there a risk of ibuprofen affecting nursing infants?

Yes, nursing mothers should consult a doctor before using ibuprofen, as there is potential for excretion in breast milk.

Packaging Info

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

Packaging configurations for Childrens Ibuprofen.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Meijer® Children's Ibuprofen is a nonsteroidal anti-inflammatory drug (NSAID) indicated for children ages 2 to 11. Each chewable tablet contains 100 mg of ibuprofen, serving as a pain reliever and fever reducer. The tablets are designed to be chewed or crushed completely before swallowing and provide relief that lasts up to 8 hours. These dye-free, orange-flavored chewables are formulated without parabens or preservatives. The product is available in a package containing 24 tablets.

Uses and Indications

This drug is indicated for the reduction of fever and the relief of minor aches and pains associated with conditions such as the common cold, influenza, sore throat, headaches, and toothaches.

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

Dosage and Administration

Patients should chew or crush the tablets completely before swallowing to ensure proper administration. This product does not include specific directions or complete warnings for adult use. It is imperative that the dosage does not exceed the recommended amount.

Healthcare professionals are advised to refer to the dosing chart below to determine the appropriate dose. Whenever possible, dosing should be based on the patient's weight; if weight is not available, age may be used as a guide. If necessary, the dose may be repeated every 6 to 8 hours, but it is important not to exceed a total of 4 doses in a 24-hour period.

Dosing Chart:

  • For patients weighing less than 24 lb or under 2 years of age: Tablets - consult a doctor.

  • For patients weighing 24-35 lb or aged 2-3 years: Tablets - 1.

  • For patients weighing 36-47 lb or aged 4-5 years: Tablets - 1 ½.

  • For patients weighing 48-59 lb or aged 6-8 years: Tablets - 2.

  • For patients weighing 60-71 lb or aged 9-10 years: Tablets - 2 ½.

  • For patients weighing 72-95 lb or aged 11 years: Tablets - 3.

Contraindications

Use of this product is contraindicated in children with a history of allergic reactions to ibuprofen or any other pain reliever/fever reducer. Additionally, administration is contraindicated immediately before or after heart surgery due to potential complications.

Healthcare professionals should advise discontinuation and seek medical consultation if the child exhibits signs of stomach bleeding, including faintness, vomiting blood, bloody or black stools, or persistent stomach pain. Symptoms indicative of heart problems or stroke, such as chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling, also warrant immediate medical attention.

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, medical advice should be sought. Presence of redness or swelling in the affected area, as well as any new symptoms, should also prompt consultation with a healthcare provider.

Warnings and Precautions

Ibuprofen may induce 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 emergency 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 (including aspirin, ibuprofen, or naproxen). Additionally, exceeding the recommended dosage or duration of treatment increases this risk.

NSAIDs, with the exception of 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 prolonged periods.

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. Consultation with a physician is advised if such symptoms occur. The use of ibuprofen should not exceed two days, nor should it be administered to children under three years of age without a physician's directive.

In cases of suspected allergic reactions, immediate cessation of the medication and prompt medical evaluation are essential.

Healthcare providers should instruct caregivers to discontinue use 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, if the child shows symptoms suggestive of heart problems or stroke, such as chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling, immediate medical attention is warranted.

Further, 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, or if redness or swelling occurs in the affected area, medical consultation is recommended. Caregivers should also be alert for the emergence of any new symptoms and seek medical advice accordingly.

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, the risk increases if the medication is taken in higher doses or for extended periods beyond the recommended guidelines.

Patients should also be aware of 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 directed.

In clinical settings, patients presenting with severe or persistent sore throat, especially when accompanied by high fever, headache, nausea, or vomiting, should seek medical attention promptly. It is advised not to use ibuprofen for more than two days or to administer it to 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 signs of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or persistent stomach pain. Symptoms indicative of heart problems or stroke, including chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling, also warrant immediate medical consultation. Furthermore, if a patient does not achieve relief within the first 24 hours of treatment, or if fever or pain worsens or persists beyond three days, they should seek medical advice. The presence of redness or swelling in the painful area or the emergence of any new symptoms should also prompt a consultation.

Before initiating treatment with ibuprofen, it is crucial for patients to consult a healthcare provider 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. Additionally, patients with asthma or those taking diuretics should seek medical advice prior to use. It is also recommended that patients under a doctor's care for any serious condition or those taking other medications consult with a healthcare professional or pharmacist before using ibuprofen.

Drug Interactions

Patients taking anticoagulants or steroid medications may experience significant drug interactions. The concurrent use of these agents can increase the risk of bleeding complications. It is advisable for healthcare providers to closely monitor patients for signs of bleeding and consider dosage adjustments as necessary.

Additionally, the use of nonsteroidal anti-inflammatory drugs (NSAIDs), including both prescription and over-the-counter options such as aspirin, ibuprofen, and naproxen, can further exacerbate the risk of gastrointestinal bleeding when taken alongside anticoagulants or steroids. Patients should be advised to use caution and consult their healthcare provider before combining these medications.

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

Packaging & NDC

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

Packaging configurations for 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 weighing under 24 lb and under 2 years of age, consult a doctor.

  • For patients weighing 24-35 lb and aged 2-3 years, the recommended dose is 1 tablet.

  • For patients weighing 36-47 lb and aged 4-5 years, the recommended dose is 1 ½ tablets.

  • For patients weighing 48-59 lb and aged 6-8 years, the recommended dose is 2 tablets.

  • For patients weighing 60-71 lb and aged 9-10 years, the recommended dose is 2 ½ tablets.

  • For patients weighing 72-95 lb and aged 11 years, the recommended dose is 3 tablets.

This medication should not be used for more than 2 days in pediatric patients without medical advice. Prior to use, consultation with a doctor is advised if the child has a history of allergic reactions to ibuprofen or other pain relievers/fever reducers, stomach problems (such as heartburn), or has experienced serious side effects from pain relievers or fever reducers.

Additionally, if the child has not been adequately hydrated due to vomiting or diarrhea, has high blood pressure, heart disease, liver cirrhosis, kidney disease, a history of stroke, or asthma, a doctor should be consulted before administration. If the child is taking a diuretic, medical advice is also recommended.

If there is no 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 may not receive comprehensive guidance or warnings regarding the use of this product, as the labeling does not include specific directions for adult use. Healthcare providers should exercise caution when considering this product for geriatric patients, as the absence of detailed information may impact the safety and efficacy of treatment in this population. It is advisable to closely monitor elderly patients for any adverse effects and to consider potential dose adjustments based on individual patient needs and responses.

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 who are pregnant or planning to become pregnant should consult a healthcare provider before using ibuprofen 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. The effects of ibuprofen on a nursing infant are not well studied; therefore, caution is advised. It is recommended to monitor the infant for any adverse effects if the nursing mother takes ibuprofen.

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 liver disease, such as cirrhosis, should be evaluated for any contraindications related to their hepatic condition. Regular assessment of clinical parameters and laboratory values is advised to manage any adverse effects that may arise from the medication's use in this population.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. Prompt intervention is crucial to mitigate potential adverse effects associated with the overdose.

Healthcare professionals should be aware that the symptoms of overdose may vary depending on the specific substance involved. Therefore, a thorough assessment of the patient's condition is essential to determine the appropriate course of action.

Management of an overdose typically involves supportive care and symptomatic treatment. This may include monitoring vital signs, providing respiratory support, and administering activated charcoal if indicated and within the appropriate time frame. In cases where specific antidotes are available, their use should be considered based on the clinical scenario.

It is essential for healthcare providers to remain vigilant and prepared to implement emergency protocols in the event of an overdose, ensuring the safety and well-being of the patient.

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 use of the compound in these contexts.

Postmarketing Experience

No specific postmarketing experience details are available in the extracted data. As such, there are no reported adverse events or case reports to summarize.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. It is important to inform patients that this product should not be used if the child has a history of allergic reactions to ibuprofen or any other pain reliever or fever reducer. Additionally, patients should be cautioned against using this medication right before or after heart surgery.

Patients should be instructed to stop 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. Furthermore, healthcare providers should emphasize the importance of seeking 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 informed 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.

When using this product, patients may experience mouth or throat burning; therefore, it is advisable to administer the medication with food or water. If stomach upset occurs, taking the medication with food or milk may help alleviate discomfort.

Healthcare providers should encourage patients to consult a doctor before use if the stomach bleeding warning is applicable to their child, or if the child has a history of stomach issues such as heartburn. It is also essential to seek medical advice if the child has experienced serious side effects from pain relievers or fever reducers, has not been drinking fluids, or has lost significant fluid due to vomiting or diarrhea.

Patients should be advised to consult a doctor before use if the child has high blood pressure, heart disease, liver cirrhosis, kidney disease, or a history of stroke. Additionally, it is important to ask a doctor before use if the child has asthma, is taking a diuretic, or is under a doctor's care for any serious condition. Lastly, patients should be encouraged to consult a doctor or pharmacist before use if the child is taking any other medications.

Storage and Handling

The product is supplied in a configuration that includes an NDC number for identification. It should be stored at a temperature range of 20-25°C (68-77°F) to maintain its integrity and efficacy.

Healthcare professionals are advised to inspect the product prior to use; it should not be utilized if the printed seal under the cap is broken or missing, as this may indicate potential tampering or compromise of the product. Proper handling and storage conditions are essential to ensure the product remains safe and effective for patient use.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for 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 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.