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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 2024
Label revision date
September 1, 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 2024
Label revision date
September 1, 2025
Manufacturer
KROGER COMPANY
Registration number
ANDA209179
NDC root
30142-281
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 nonsteroidal anti-inflammatory drug (NSAID) that helps relieve minor aches and pains, such as those caused by the common cold, flu, sore throat, headache, and toothache. It also works to reduce fever, making it a useful option for managing discomfort in children aged 2 to 11 years. This particular formulation is a children's oral suspension with a pleasant berry flavor, providing effective relief that can last up to 8 hours.

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, make sure to shake the bottle well. It's important to measure the correct dose using the enclosed dosing cup, as other devices may not provide accurate measurements. To find the right amount for you or your child, refer to the dosing chart based on weight or age. For example, if your child weighs between 24 and 35 pounds, the dose is 5 milliliters (mL). If they weigh between 36 and 47 pounds, the dose increases to 7.5 mL, and so on, up to 15 mL for those weighing 72 to 95 pounds.

You should only take or give this medication as directed. If needed, you can repeat the dose every 6 to 8 hours, but do not exceed four doses in a single day. After each use, remember to wash the dosing cup to keep it clean, and always replace the original bottle cap to ensure it remains child-resistant. If your child is under 24 pounds or under 2 years old, consult a doctor for guidance on the appropriate dose.

What to Avoid

You should avoid using this medication if your child has ever had an allergic reaction to ibuprofen or any other pain reliever or fever reducer. Additionally, it is important not to use this medication right before or after your child has 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 allergic reactions, particularly in individuals who are allergic to aspirin. If you notice symptoms such as hives, facial swelling, wheezing, shock, skin reddening, rash, or blisters, seek medical attention immediately. 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. Be vigilant for signs of stomach bleeding, such as faintness, vomiting blood, black or bloody stools, or persistent stomach pain. Similarly, watch for symptoms of heart problems or stroke, including chest pain, difficulty breathing, weakness on one side of the body, slurred speech, or leg swelling. If your child does not find relief within 24 hours, if fever or pain worsens after three days, or if new symptoms arise, consult a doctor.

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 issues, 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, stop using ibuprofen and contact your doctor right away.

For children, do not use ibuprofen for more than two days without a doctor's guidance, especially if they 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, consult a doctor. In case of an overdose, seek emergency medical help or contact a Poison Control Center immediately at 1-800-222-1222.

Overdose

It appears that there is no specific information available regarding overdosage for this medication. However, it's always important to be aware of the signs of an overdose, which can include unusual drowsiness, confusion, or difficulty breathing. If you suspect that you or someone else may have taken too much of a medication, it’s crucial to seek immediate medical help.

In case of an overdose, contact your local emergency services or go to the nearest hospital. Having the medication packaging or information on hand can help medical professionals provide the best care. Always remember that when it comes to medications, it's better to be safe and get help if you have any concerns.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to be cautious with medications. The information provided does not specify any safety concerns, dosage changes, or special precautions for using ibuprofen during pregnancy. This means that there is no clear guidance on its use in this situation.

Before taking ibuprofen or any medication, you should consult with your healthcare provider to discuss potential risks and benefits tailored to your individual circumstances. Your health and the health of your baby are the top priority, so always seek professional advice when it comes to medication during pregnancy.

Lactation Use

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

If you do take ibuprofen while nursing, keep an eye on your baby for any unusual reactions or side effects. Your healthcare provider can help you weigh the benefits and risks to ensure the safety of both you and your child.

Pediatric Use

It's important to be cautious when using this medication for children. You should not give it to children under 3 years of age unless a doctor specifically advises you to do so. For children aged 2 to 11 years, the dosage varies based on their weight. For example, if your child weighs between 24-35 pounds, the recommended dose is 5 mL, while a child weighing 72-95 pounds should receive 15 mL.

Always consult your child's doctor if they have a history of stomach issues, are taking other medications, or are not drinking enough fluids. If you notice any signs of stomach bleeding or symptoms related to heart problems or stroke, stop using the medication and seek medical advice immediately.

Geriatric Use

When it comes to using this medication in older adults, there is no specific information available about dosage adjustments, safety concerns, or special precautions. This means that if you or a loved one is an older adult, it’s important to consult with a healthcare provider before starting the medication. They can help determine the best approach based on individual health needs and any other medications being taken. Always prioritize open communication with your healthcare team to ensure safe and effective treatment.

Renal Impairment

If you have kidney problems, it's important to know that there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the usual recommendations for monitoring or safety considerations related to renal impairment (kidney issues) are not provided.

Always consult your healthcare provider for personalized advice and to ensure that any medications you take are safe and appropriate for your kidney health. They can help you understand how your condition may affect your treatment plan.

Hepatic Impairment

If you have liver problems, it's important to know that there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the standard recommendations apply, but you should always consult your healthcare provider for personalized advice. They can help determine the best approach for your treatment and monitor your liver function as needed.

Make sure to keep your doctor informed about your liver health, as they may want to conduct regular tests to ensure your safety while using any medication. Your well-being is a priority, so don't hesitate to ask questions or express any concerns you may have.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications or tests you may be taking. While there are no specific drug interactions or laboratory test interactions noted for this medication, your healthcare provider can help ensure that everything you are taking works well together and is safe for you.

Always feel free to ask questions and share your complete list of medications and any lab tests you may be undergoing. This way, you can receive the best possible care tailored to your needs.

Storage and Handling

To ensure the safety and effectiveness of your product, store it in a cool, dry place at a temperature between 20 to 25°C (68 to 77°F). It's important to check the carton before use; do not use the product if the carton is opened or if the seal under the cap is broken or missing. Additionally, make sure to look at the bottom panel for the lot number and expiration date to confirm that the product is still valid for use.

By following these simple storage and handling guidelines, you can help maintain the quality and safety 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 day. If you experience stomach upset, it's advisable to take the medication with food or milk.

Make sure to keep this medication out of reach of children. In the event of an overdose, seek medical help immediately or contact a Poison Control Center at 1-800-222-1222.

FAQ

What is Ibuprofen used for?

Ibuprofen is used to relieve minor aches and pains due to the common cold, flu, sore throat, headache, and toothache, as well as to reduce fever.

What is the recommended age for using Ibuprofen?

Ibuprofen is intended for children ages 2 to 11 years.

How should I dose Ibuprofen for my child?

You should find the right dose on the dosing chart based on your child's weight or age. Use only the enclosed dosing cup.

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 get better.

Can Ibuprofen cause allergic reactions?

Yes, Ibuprofen may cause severe allergic reactions, especially in those allergic to aspirin. Symptoms can include hives, facial swelling, and difficulty breathing.

Is it safe to use Ibuprofen during pregnancy?

The provided information does not specify safety concerns or dosage modifications for using Ibuprofen during pregnancy.

What should I do if my child does not get relief from Ibuprofen?

If your child does not get any relief within the first 24 hours of treatment, or if fever or pain worsens or lasts more than 3 days, consult a doctor.

How should Ibuprofen be stored?

Store Ibuprofen between 20 to 25°C (68 to 77°F) and do not use if the carton is opened or the seal under the cap is broken or missing.

What are the potential side effects of Ibuprofen?

Potential side effects include stomach bleeding, allergic reactions, and increased risk of heart attack or stroke, especially if used more than directed.

Can I give Ibuprofen to my child if they have had an allergic reaction to pain relievers before?

No, do not use Ibuprofen if your child has ever had an allergic reaction to it or any other pain reliever/fever reducer.

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

Ibuprofen is an oral suspension formulated as a 100 mg per 5 mL dosage. It features a berry flavor and is alcohol-free.

Uses and Indications

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

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

Dosage and Administration

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

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

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

Contraindications

Use of this product is contraindicated in the following situations:

Patients with a history of allergic reactions to ibuprofen or any other pain reliever/fever reducer should not use this product due to the risk of severe allergic reactions. Additionally, the product should not be administered immediately before or after heart surgery, as it may pose risks related to surgical recovery and cardiovascular stability.

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 medical assistance.

The use of ibuprofen, an NSAID, carries a significant risk of severe stomach bleeding. This risk is notably elevated in pediatric patients with a history of stomach ulcers or bleeding disorders, those concurrently using anticoagulants or steroid medications, and individuals taking other NSAIDs, whether prescription or over-the-counter (e.g., aspirin, ibuprofen, naproxen). Additionally, exceeding the recommended dosage or duration of treatment increases the likelihood of gastrointestinal complications.

Healthcare professionals should be aware that the use of NSAIDs, excluding aspirin, is 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 in excess of the recommended dosage or for prolonged periods.

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

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

Healthcare providers should instruct caregivers to discontinue ibuprofen and seek medical advice if the child exhibits any signs of stomach bleeding, such as feeling faint, vomiting blood, passing bloody or black stools, or experiencing persistent stomach pain. Additionally, symptoms indicative of heart problems or stroke, including chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling, warrant immediate medical evaluation.

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 necessary. Caregivers should also be vigilant for the emergence of any new symptoms and seek guidance accordingly.

Side Effects

Patients may experience a range of adverse reactions associated with the use of ibuprofen, which can be categorized by seriousness and frequency.

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 significant 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, whether prescription or over-the-counter. Patients should be vigilant for signs of stomach bleeding, which may manifest as feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain.

Additionally, NSAIDs, excluding aspirin, are associated with an increased risk of heart attack, heart failure, and stroke, which can be fatal. This risk escalates with the use of higher doses or prolonged treatment durations. Patients should seek medical attention if they exhibit symptoms indicative of heart problems or stroke, such as chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling.

Other important considerations include the lack of relief from fever or pain within the first 24 hours of treatment, worsening symptoms after three days, the presence of redness or swelling in the affected area, and the emergence of any new symptoms. In such cases, it is advisable for patients to consult a healthcare professional.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there is no information available regarding interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

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 product unless directed by a healthcare professional. For children aged 2 to 11 years, dosing varies by weight as follows:

  • For those under 24 lbs (under 2 years), consultation with a doctor is required.

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

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

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

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

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

Healthcare professionals should advise parents to consult a doctor if the child has a history of stomach problems, is taking other medications, or has not been adequately hydrated. Parents should also be instructed to discontinue use and seek medical advice if the child exhibits signs of stomach bleeding or symptoms indicative of heart problems or stroke.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any potential adverse effects or changes in efficacy, given the lack of targeted data for this population.

Pregnancy

There is no specific mention of pregnancy use, safety concerns, dosage modifications, or special precautions regarding the use of ibuprofen during pregnancy in the provided text. Healthcare professionals should consider the lack of data when prescribing ibuprofen to pregnant patients and weigh the potential risks and benefits. It is advisable to exercise caution and to discuss alternative treatment options with women of childbearing potential.

Lactation

Nursing mothers should consult a doctor before using this product. There is a potential for excretion in breast milk, and 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 have not been specifically addressed in the available data regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the lack of information necessitates careful clinical judgment and monitoring.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there are no established dosage adjustments, special monitoring requirements, or precautions outlined for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population. Regular monitoring of liver function may be prudent in these cases, although specific parameters are not defined in the available information.

Overdosage

There is currently no specific information available regarding overdosage for this medication. Healthcare professionals are advised to monitor patients closely for any signs of adverse effects or symptoms that may arise from excessive dosing.

In the event of suspected overdosage, it is recommended that healthcare providers initiate supportive care and symptomatic treatment as necessary. Patients should be evaluated for potential complications, and appropriate interventions should be implemented based on the clinical presentation.

For further guidance, healthcare professionals should refer to established protocols and consult relevant toxicology resources.

Nonclinical Toxicology

No information is available regarding teratogenic effects. Similarly, there is no information provided concerning non-teratogenic effects. The insert does not contain any details related to nonclinical toxicology. Additionally, there is no information available regarding animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions associated with the use of the medication. Reports have included gastrointestinal bleeding, renal impairment, and elevations in liver enzymes. Serious skin reactions, such as Stevens-Johnson syndrome and toxic epidermal necrolysis, have also been documented.

Additionally, cases of anaphylactic reactions, including angioedema and bronchospasm, have been reported. Cardiovascular events, including myocardial infarction and stroke, have been noted in patients using nonsteroidal anti-inflammatory drugs (NSAIDs). Furthermore, elevated blood pressure has been observed in patients taking ibuprofen. Hypersensitivity reactions, such as rash and urticaria, have been experienced by some patients.

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 that the medication be taken with food or milk if the patient 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 stop 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 child has a history of stomach problems, such as heartburn, or if the stomach bleeding warning applies. Patients should also be advised to seek medical guidance 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.

Furthermore, healthcare providers should recommend that patients consult a doctor before use if the child has high blood pressure, heart disease, liver cirrhosis, kidney disease, or a history of stroke. Patients with asthma or those taking a diuretic should also be encouraged to seek medical advice prior to use. Lastly, it is prudent for patients to consult a doctor or pharmacist if the child is under care for any serious condition or is taking any other medications.

Storage and Handling

The product is supplied in a secure carton, and it is essential to store it at a temperature range of 20 to 25°C (68 to 77°F). Healthcare professionals should ensure that the carton remains unopened and that the seal under the cap is intact; the product should not be used if either of these conditions is not met. For reference, the lot number and expiration date can be found on the bottom panel of the carton.

Additional Clinical Information

The medication is administered orally, with a recommended dosing frequency of every 6 to 8 hours as needed, not to exceed four doses per day. Patients are advised to take the medication with food or milk if they experience stomach upset.

Clinicians should counsel 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 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.