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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 2022
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 2022
Label revision date
September 1, 2025
Manufacturer
7-Eleven
Registration number
ANDA209179
NDC root
10202-150
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 medication that comes in an oral suspension form, providing 100 mg of the active ingredient per 5 mL. It is classified as a nonsteroidal anti-inflammatory drug (NSAID), which means it helps relieve pain and reduce fever. You can use ibuprofen to alleviate minor aches and pains associated with common conditions like the cold, flu, sore throat, headache, and toothache.

This medication is designed for children aged 2 to 11 years and is alcohol-free, making it a safer option for young patients. With a pleasant berry flavor, ibuprofen can provide relief for up to 8 hours, helping to make your child more comfortable during times of 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 developmental issues in a fetus if taken during pregnancy.

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 necessary, 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. Finally, always replace the original bottle cap to ensure it remains child-resistant and safe. 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 undergone heart surgery. Following these guidelines will help ensure your child's safety and well-being.

Side Effects

Ibuprofen can cause serious allergic reactions, particularly in individuals who are allergic to aspirin. Symptoms of such reactions may include hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, and blisters. Additionally, this medication carries a risk of severe stomach bleeding, especially if your child has a history of stomach ulcers, is taking blood thinners or steroids, or uses other NSAIDs (nonsteroidal anti-inflammatory drugs) like aspirin or naproxen. The risk of heart attack and stroke is also increased with NSAID use, particularly if taken in higher doses or for extended periods.

You should stop using ibuprofen and consult a doctor if your child experiences signs of stomach bleeding, such as feeling faint, vomiting blood, or having black stools. Seek medical attention if they show symptoms of heart problems or stroke, like chest pain or weakness on one side of the body. If your child does not find relief within 24 hours, or if their fever or pain worsens or lasts more than three days, it's important to reach out to a healthcare professional. 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

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

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

It's important to consult a doctor if symptoms do not improve within 24 hours, if fever or pain worsens or lasts more than three days, or if new symptoms appear. For any suspected 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, if you suspect that you or someone else may have taken too much of a medication, it’s important to be aware of potential signs of an overdose, which can include unusual drowsiness, confusion, or difficulty breathing.

If you notice any of these symptoms, or if you are unsure whether an overdose has occurred, seek immediate medical help. You can contact your local emergency services or a poison control center for guidance on what to do next. Always keep medications out of reach of children and follow the prescribed dosage to prevent any risks.

Pregnancy Use

When it comes to using ibuprofen during pregnancy, there is no specific information available about its safety, dosage adjustments, or any special precautions you should take. This means that if you are pregnant or planning to become pregnant, it’s important to consult with your healthcare provider before taking ibuprofen. They can help you understand any potential risks and suggest safer alternatives if necessary. Always prioritize your health and the health of your baby by seeking professional advice.

Lactation Use

If you are breastfeeding, it's important to talk to your doctor before using this product. There is a possibility that it can pass into your breast milk, which means it could affect your nursing infant. Since the effects of ibuprofen on babies who are breastfed haven't been thoroughly studied, it's best to be cautious and seek professional advice. Your health and your baby's well-being are the top priorities.

Pediatric Use

When considering this medication for your child, it's important to note that it should not be used in children under 3 years of age unless a doctor specifically advises it for severe or persistent sore throat, especially if accompanied by high fever, headache, nausea, or vomiting. For children aged 2 to 11 years, the dosage varies based on weight, so it's essential to follow the dosing chart: for those under 24 lbs, consult a doctor; for 24-35 lbs, give 5 mL; for 36-47 lbs, 7.5 mL; for 48-59 lbs, 10 mL; for 60-71 lbs, 12.5 mL; and for 72-95 lbs, 15 mL.

Always consult a doctor before use if your child has a history of stomach issues, is under treatment for a serious condition, or is taking other medications. If your child does not feel better within 24 hours, if their fever or pain worsens or lasts more than 3 days, or if new symptoms develop, stop using the medication and seek medical advice. Remember to keep this medication out of reach of children, and in case of an overdose, contact a medical professional or Poison Control Center immediately.

Geriatric Use

While the drug insert for Children's Ibuprofen does not provide specific information about its use in older adults, it primarily focuses on children. This means there are no recommended age considerations, dosage adjustments, or safety concerns specifically outlined for elderly patients.

If you are caring for an older adult, it's important to consult with a healthcare professional before administering any medication, including Children's Ibuprofen, to ensure it is safe and appropriate for their individual health needs.

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.

It's always best to discuss your individual situation with your healthcare provider, who can offer personalized advice and ensure that any medications you take are safe and effective for you.

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, and your healthcare team is there to support you.

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 tests you are 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, but do not exceed 4 doses in a day. If you experience stomach upset, it's advisable to take the medication with food or milk. Always 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?

Ibuprofen is an oral suspension that acts as a pain reliever and fever reducer, available in a concentration of 100 mg per 5 mL.

What conditions does Ibuprofen help relieve?

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

Who can use 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, and use only the enclosed dosing cup.

What should I do if my child has a severe allergic reaction to Ibuprofen?

If your child experiences symptoms like hives, facial swelling, or difficulty breathing, stop use and seek medical help immediately.

What are the warnings associated with Ibuprofen?

Ibuprofen may cause stomach bleeding, increase the risk of heart attack and stroke, and should not be used if your child has had an allergic reaction to it or other pain relievers.

What should I do if my child experiences stomach bleeding?

If your child feels faint, vomits blood, or has bloody or black stools, stop use and call your doctor right away.

Can I give Ibuprofen to my child if they are under 3 years old?

Do not use Ibuprofen in children under 3 years of age unless directed by a doctor for severe or persistent sore throat.

Is it safe to use Ibuprofen during pregnancy?

The drug insert does not provide specific information regarding the use of Ibuprofen during pregnancy, so consult your doctor.

What should nursing mothers know about using Ibuprofen?

Nursing mothers should consult a doctor before using Ibuprofen, as it may be excreted in breast milk.

How should I store Ibuprofen?

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

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

No description information is available for the drug.

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.

Prior to administration, the product must be shaken well. The enclosed dosing cup should be utilized exclusively for measuring the dose; no other dosing devices should be employed.

The recommended dosing intervals are every 6 to 8 hours as needed, with a maximum of four doses per day. The following dosing chart provides specific dosage recommendations:

  • For patients weighing under 24 lbs or under 2 years of age, consult a doctor for the appropriate dose.

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

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

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

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

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

It is imperative not to exceed the recommended dosage. 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.

Contraindications

Use of this product is contraindicated in the following situations:

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

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

Warnings and Precautions

Ibuprofen may cause severe allergic reactions, particularly in individuals with a known allergy to aspirin. Symptoms indicative of an allergic reaction 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 is associated with an increased risk of severe stomach bleeding. The likelihood of this adverse effect is heightened in children who have a history of stomach ulcers or bleeding disorders, are concurrently taking anticoagulants or steroid medications, are using other NSAIDs (including aspirin, ibuprofen, or naproxen), or exceed the recommended dosage or duration of treatment.

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

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

Healthcare providers should instruct caregivers to discontinue ibuprofen and seek medical attention 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, if symptoms indicative of heart problems or stroke arise—such as chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling—immediate medical evaluation is warranted.

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 advice should be sought. Any new symptoms that develop should also prompt a consultation with a healthcare professional.

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

Side Effects

Patients using ibuprofen should be aware of potential adverse reactions, which can range from serious to common.

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

The use of ibuprofen is associated with an increased risk of severe stomach bleeding, particularly in patients with a history of stomach ulcers or bleeding problems, those taking anticoagulants or steroid medications, or those using other NSAIDs (including aspirin, ibuprofen, or naproxen). The risk of stomach bleeding is heightened if the medication is taken in higher doses or for extended periods beyond the recommended duration.

Additionally, ibuprofen carries warnings regarding the potential for 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 longer than directed.

Patients should seek medical attention if they experience 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, weakness on one side of the body, 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 contact a healthcare provider. Redness or swelling in the painful area or the emergence of any new symptoms should also prompt a consultation.

Before using ibuprofen, it is advisable for patients to consult a healthcare professional if they have a history of stomach issues, such as heartburn, or if they have experienced serious side effects from pain relievers or fever reducers. Patients who have not been adequately hydrated, have lost significant fluids due to vomiting or diarrhea, or have conditions such as high blood pressure, heart disease, liver cirrhosis, kidney disease, or a history of stroke should also seek medical advice prior to use. Additionally, patients with asthma or those taking diuretics should consult a healthcare provider before using this medication.

In summary, while ibuprofen can be effective for pain and fever relief, it is essential for patients to be vigilant about potential adverse reactions and to seek medical advice when necessary.

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 medication unless directed by a healthcare professional for severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting.

For dosing, the following guidelines apply:

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

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

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

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

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

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

Healthcare professionals should advise parents to consult a doctor before use if the child has a history of stomach problems, is under a doctor's care for any serious condition, or is taking any other medication.

If the child does not experience relief within the first 24 hours of treatment, or if fever or pain worsens or lasts more than 3 days, or if any new symptoms appear, parents should stop use and seek medical advice.

It is essential to keep this medication out of reach of children. In the event of an overdose, immediate medical assistance or contact with a Poison Control Center is necessary.

Geriatric Use

The prescribing information for Children's Ibuprofen does not provide specific guidance regarding the use of this medication in geriatric patients. There is a notable absence of recommendations concerning age considerations, dosage adjustments, safety concerns, or special precautions for elderly patients.

Healthcare providers should exercise caution when considering the use of this medication in geriatric populations, given the lack of data. It is advisable to monitor elderly patients closely for any potential adverse effects or interactions, as they may have different pharmacokinetic and pharmacodynamic responses compared to younger populations.

Pregnancy

The available prescribing information does not provide specific data regarding the use of ibuprofen during pregnancy, including safety concerns, dosage modifications, or special precautions. As such, healthcare professionals should exercise caution when considering ibuprofen for pregnant patients. The lack of detailed information necessitates a careful assessment of the potential risks versus benefits for women of childbearing potential. It is advisable to consider alternative therapies that have established safety profiles during pregnancy, particularly during the third trimester, when nonsteroidal anti-inflammatory drugs (NSAIDs) may be associated with adverse fetal outcomes.

Lactation

Lactating 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.

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

In the absence of specific overdosage information, it is essential for healthcare professionals to remain vigilant and prepared for potential scenarios involving overdose.

Healthcare providers should be aware that the clinical presentation of an overdose may vary depending on the substance involved and the individual patient’s characteristics. Symptoms of overdose can range from mild to severe and may include altered mental status, cardiovascular instability, respiratory distress, and gastrointestinal disturbances.

In the event of suspected overdosage, immediate medical evaluation is recommended. Healthcare professionals should assess the patient's vital signs and conduct a thorough clinical examination. Supportive care should be initiated as necessary, which may include airway management, intravenous fluids, and monitoring of vital parameters.

If specific antidotes or treatments are available for the substance involved, they should be administered according to established protocols. Consultation with a poison control center or toxicology expert may also be beneficial in managing the case effectively.

It is crucial to document all findings and interventions in the patient's medical record to ensure continuity of care and facilitate any necessary follow-up.

Nonclinical Toxicology

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

Postmarketing Experience

Postmarketing experience has indicated that several adverse reactions have been reported voluntarily or through surveillance programs. These include gastrointestinal bleeding, renal impairment, and elevations in liver enzymes.

Additionally, allergic reactions, such as anaphylaxis, and skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, have been documented. Reports of cardiovascular events, including heart attack and stroke, have also been associated with the use of NSAIDs, including ibuprofen.

Furthermore, cases of aseptic meningitis have been noted in patients receiving ibuprofen, particularly among those with systemic lupus erythematosus (SLE). Rare instances of serious skin reactions, such as exfoliative dermatitis and erythema multiforme, have been reported as well.

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.

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

Patients should be instructed to consult a doctor before use if the child has not been adequately hydrated or has lost significant fluids due to vomiting or diarrhea. It is also crucial to inquire about any existing conditions, such as high blood pressure, heart disease, liver cirrhosis, kidney disease, or a history of stroke, as well as asthma. If the child is taking a diuretic or is under a doctor's care for any serious condition, a consultation with a doctor or pharmacist is advised.

Healthcare providers should inform patients to stop using the medication and seek medical advice if the child exhibits any signs of stomach bleeding, including feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain. They should also 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 swelling in the legs.

Patients should be advised to discontinue use and consult a doctor if there is no 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 affected area, or if any new symptoms arise.

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 traceability, 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 experiences.

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.