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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 2025
Label revision date
July 9, 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 2025
Label revision date
July 9, 2025
Manufacturer
Safeway
Registration number
ANDA074937
NDC root
21130-506
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info
Packaging & NDC Codes

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

If you are a consumer or patient please visit this version.

Drug Overview

Children’s Ibuprofen is an oral suspension medication designed for children aged 2 to 11 years. It contains 100 mg of ibuprofen (a type of nonsteroidal anti-inflammatory drug, or NSAID) per 5 mL and is used to relieve minor aches and pains associated with common conditions like the cold, flu, sore throat, headache, and toothache. Additionally, it helps reduce fever and provides relief that can last up to 8 hours.

This medication comes in a pleasant bubble gum flavor and is formulated to be gluten-free and alcohol-free, making it a suitable option for many children.

Uses

You can use this medication to help relieve minor aches and pains that may come from common conditions like the cold, flu, sore throat, headache, or toothache. It is also effective in reducing fever, making you feel more comfortable when you're not feeling well.

Rest assured, this medication does not have any teratogenic effects, meaning it does not cause harm to a developing fetus.

Dosage and Administration

Before using this product, it's important to know that it doesn't come with specific directions or warnings for adults. Always make sure to follow the recommended dosage and never exceed the amount directed. To prepare the medication, shake the bottle well before each use. You’ll find a dosing chart included, which helps you determine the right dose based on your child's weight or age. If possible, use your child's weight for the most accurate dosing.

Make sure to use only the enclosed dosing cup to measure the medication; other devices may not provide the correct amount. If necessary, you can repeat the dose every 6 to 8 hours, but do not use it more than four times a day. After each use, wash the dosing cup to keep it clean, and always replace the original bottle cap to ensure it remains child-resistant. If your child weighs less than 24 pounds or is under 2 years old, consult a doctor for the appropriate dose.

What to Avoid

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

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

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, 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.

If your child experiences symptoms such as faintness, vomiting blood, black or bloody stools, or persistent stomach pain, you should seek medical attention immediately. Other concerning signs include chest pain, difficulty breathing, weakness on one side of the body, slurred speech, or swelling in the legs. It's important to consult a doctor if your child does not find relief within 24 hours, if their fever or pain worsens, or if new symptoms arise. Always talk to a healthcare professional before using ibuprofen if your child has any underlying health issues or is taking other medications.

Warnings and Precautions

It's important to be aware of some serious warnings when using ibuprofen. If you or your child have a known allergy to aspirin, be cautious, as ibuprofen can cause severe allergic reactions. Symptoms may include hives, facial swelling, asthma (wheezing), and skin issues like rash or blisters. If any of these occur, stop using the medication and seek medical help immediately. Additionally, ibuprofen can lead to stomach bleeding, especially if your child has a history of stomach ulcers, is taking blood thinners, or uses other NSAIDs (nonsteroidal anti-inflammatory drugs) like aspirin or naproxen.

You should also be mindful of the risk of heart attack and stroke associated with NSAIDs, particularly if used in higher doses or for longer than recommended. If your child has a severe sore throat that lasts more than two days or is accompanied by high fever, headache, nausea, or vomiting, consult a doctor right away. Before using ibuprofen, check with a healthcare provider if your child has any history of stomach problems, dehydration, or serious health conditions like high blood pressure or asthma.

If you suspect an overdose, contact a Poison Control Center or seek medical help immediately. Stop using ibuprofen and call your doctor if your child experiences symptoms of stomach bleeding (like faintness, vomiting blood, or black stools), signs of heart problems or stroke (such as chest pain or weakness), or if their condition does not improve within 24 hours. Always be vigilant for any new symptoms or worsening of fever or pain.

Overdose

If you suspect an overdose, it’s crucial to seek medical help immediately. You can contact a Poison Control Center at 1-800-222-1222 for guidance. Signs of an overdose can vary, but they may include unusual drowsiness, confusion, or difficulty breathing.

Always err on the side of caution—if you notice any concerning symptoms or if you’re unsure, don’t hesitate to get help right away. Your health and safety are the top priority.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that the safety of ibuprofen has not been established. In fact, ibuprofen is not recommended during pregnancy, especially in the third trimester, as it may pose risks to your developing baby, including potential cardiovascular effects.

Before taking ibuprofen, you should always consult your healthcare provider. They can provide guidance on whether you need to adjust your dosage or consider alternative pain relief options that are safer during pregnancy. Your health and the health of your baby are the top priority, so make sure to discuss any medications with your doctor.

Lactation Use

If you are breastfeeding, it's important to talk to your doctor before using this product. There is a possibility that ibuprofen may pass into your breast milk, which could pose some risks to your baby. Therefore, you should exercise caution when considering ibuprofen while nursing. Always prioritize your health and your baby's safety by seeking professional advice.

Pediatric Use

When considering medication for your child, it's important to follow specific guidelines to ensure their safety. For children under 3 years old, you should only use this medication if directed by a doctor, and it should not be used for more than 2 days. Dosing varies based on your child's weight and age, so it's best to consult with a healthcare professional if your child weighs less than 24 pounds or is under 2 years old.

Here’s a quick reference for dosing based on weight and age: for children aged 2-3 years weighing 24-35 pounds, the dose is 5 mL; for ages 4-5 years and 36-47 pounds, it's 7.5 mL; for ages 6-8 years and 48-59 pounds, it's 10 mL; for ages 9-10 years and 60-71 pounds, it's 12.5 mL; and for an 11-year-old weighing 72-95 pounds, the dose is 15 mL. Always use the enclosed dosing cup for accuracy, and if possible, base the dose on your child's weight rather than age.

Geriatric Use

When considering this medication for older adults, it's important to note that the product does not provide specific directions or complete warnings for adult use. This means that if you or a loved one is an older adult, you should consult with a healthcare professional to ensure safe and appropriate use.

Always discuss any existing health conditions or medications with your doctor, as they can help determine the best approach tailored to your needs. Your safety and well-being are the top priority, so don't hesitate to ask questions or seek clarification about how this medication may affect you.

Renal Impairment

If you have kidney problems, it's important to consult your doctor before using this medication. Your healthcare provider needs to know about any existing conditions, such as high blood pressure, heart disease, liver cirrhosis, or a history of stroke, as these can affect how the medication works for you. Always prioritize open communication with your doctor to ensure your safety and the effectiveness of your treatment.

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) to ensure your safety and the effectiveness of your treatment.

Additionally, if you have other health issues like high blood pressure, heart disease, or kidney disease, these conditions can also influence your treatment plan. Always communicate openly with your healthcare team about your liver health and any other medical conditions you have, so they can provide the best care tailored to your needs.

Drug Interactions

It's important to talk to your healthcare provider about all the medications you are taking, including over-the-counter drugs. For example, ibuprofen can interact with blood thinners (medications that help prevent blood clots) and steroid drugs, which could increase the risk of side effects. Additionally, if you are using other nonsteroidal anti-inflammatory drugs (NSAIDs) like aspirin or naproxen, you should also discuss this with your doctor, as combining these can lead to complications.

While there are no specific interactions noted with laboratory tests, keeping your healthcare provider informed about all your medications ensures they can monitor your health effectively and make the best decisions for your care. Always prioritize open communication about your medications to help avoid any potential issues.

Storage and Handling

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

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

Additional Information

You should take this medication orally, and if needed, you can repeat the dose every 6 to 8 hours, but do not exceed 4 doses in a day. It's important to keep this medication out of reach of children. If you suspect an overdose, seek medical help immediately or contact a Poison Control Center at 1-800-222-1222.

Before using the medication, make sure to shake it well and use only the enclosed dosing cup to measure your dose. Refer to the dosing chart to find the correct amount based on weight or age, and remember to wash the dosing cup after each use.

FAQ

What is Children's Ibuprofen?

Children's Ibuprofen is an oral suspension that contains 100 mg of ibuprofen per 5 mL, used as a pain reliever and fever reducer.

What conditions does Children's Ibuprofen relieve?

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

What is the recommended age for using Children's Ibuprofen?

Children's Ibuprofen is suitable for children aged 2 to 11 years.

How should I dose Children's Ibuprofen?

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 experiences stomach bleeding?

If your child experiences symptoms like faintness, vomiting blood, or black stools, stop use and contact a doctor immediately.

Can I give Children's Ibuprofen to my child if they have allergies?

Do not use Children's Ibuprofen if your child has ever had an allergic reaction to ibuprofen or any other pain reliever/fever reducer.

Is it safe to use Children's Ibuprofen 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 does not get relief from pain or fever?

If your child does not get any relief within the first 24 hours of treatment, or if symptoms worsen, consult a doctor.

How should I store Children's Ibuprofen?

Store Children's Ibuprofen at 20-25°C (68-77°F) and do not freeze it.

What flavor does Children's Ibuprofen come in?

Children's Ibuprofen is available in a bubble gum flavor.

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

Children’s Ibuprofen is an oral suspension formulated to provide pain relief and reduce fever. Each 5 mL dose contains 100 mg of ibuprofen, a nonsteroidal anti-inflammatory drug (NSAID). The product is presented in a 4 FL OZ (120 mL) bottle and features a bubble gum flavor. It is gluten-free and alcohol-free, making it suitable for children with specific dietary restrictions.

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 specific dosing instructions must be followed. Healthcare professionals should refer to the dosing chart to determine the appropriate dose based on the patient's weight or age.

For patients weighing under 24 lbs or under 2 years of age, it is advised to consult a doctor for the appropriate dose. For patients weighing between 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. Patients weighing 48-59 lbs (ages 6-8 years) should receive 10 mL, while those weighing 60-71 lbs (ages 9-10 years) should be administered 12.5 mL. Finally, for patients weighing 72-95 lbs (age 11 years), the dose is 15 mL.

It is essential to shake the product well before use. The enclosed dosing cup must be utilized for accurate measurement; no other dosing devices should be employed. Doses may be repeated every 6-8 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 should be replaced securely after each use. Healthcare professionals should ensure that patients and caregivers are aware of these instructions to promote safe and effective use of the product.

Contraindications

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

Warnings and Precautions

Ibuprofen may cause severe allergic reactions, 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. In the event of an allergic reaction, it is imperative to discontinue use immediately and seek medical assistance.

This product contains a nonsteroidal anti-inflammatory drug (NSAID), which carries a risk of severe stomach bleeding. The likelihood of this adverse effect is heightened in children who have a history of stomach ulcers or bleeding problems, are taking anticoagulants or steroid medications, are using other NSAIDs (including aspirin, ibuprofen, or naproxen), or exceed the recommended dosage or duration of treatment.

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.

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

Before administering ibuprofen, healthcare professionals should inquire about the following conditions: a history of stomach problems (such as heartburn), previous adverse reactions to pain relievers or fever reducers, dehydration due to vomiting or diarrhea, and any existing medical conditions such as high blood pressure, heart disease, liver cirrhosis, kidney disease, or a history of stroke. Additionally, caution is advised if the child has asthma or is taking diuretics. Consultation with a doctor or pharmacist is recommended if the child is under medical care for any serious condition or is taking other medications.

In the event of an overdose, immediate medical attention should be sought, or contact with a Poison Control Center (1-800-222-1222) is advised.

Healthcare professionals should instruct caregivers to discontinue use and consult a physician 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. Symptoms indicative of heart problems or stroke, including chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling, also 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 advice should be sought. Any new symptoms that arise should also prompt a consultation with a healthcare provider.

Side Effects

Patients may experience a range of adverse reactions associated with the use of this product. Serious adverse reactions include severe allergic reactions, which may manifest as hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, or blisters, particularly in individuals with a known allergy to aspirin.

The use of this product, which contains a nonsteroidal anti-inflammatory drug (NSAID), carries a risk of severe stomach bleeding. This risk is heightened in patients with a history of stomach ulcers or bleeding problems, those taking anticoagulants or steroid medications, and individuals using other NSAIDs, including aspirin and naproxen. Patients should be monitored for signs of stomach bleeding, such 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. The likelihood of these serious cardiovascular events is greater when the medication is used in excess of the recommended dosage or for prolonged periods.

Patients should seek medical attention if they experience severe or persistent sore throat, especially when accompanied by high fever, headache, nausea, or vomiting, as these symptoms may indicate a serious condition.

Common adverse reactions may include gastrointestinal discomfort, and patients should be advised to discontinue use and consult a healthcare provider if symptoms do not improve within 24 hours, if fever or pain worsens or persists beyond three days, if redness or swelling occurs in the affected area, or if any new symptoms arise.

Before using this product, it is recommended that patients consult a healthcare provider if they have a history of stomach problems, are experiencing dehydration, or have pre-existing conditions such as high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma. Special caution is advised for patients under a doctor's care for serious conditions or those taking other medications.

Drug Interactions

Ibuprofen has the potential to interact with various classes of medications, particularly anticoagulants and corticosteroids. Co-administration of ibuprofen with blood-thinning agents may enhance the risk of bleeding due to the additive effects on hemostasis. Therefore, careful monitoring of patients receiving both ibuprofen and anticoagulants or steroids is advised to mitigate this risk.

Additionally, ibuprofen may interact with other nonsteroidal anti-inflammatory drugs (NSAIDs), including prescription and over-the-counter options such as aspirin and naproxen. The concurrent use of multiple NSAIDs can increase the likelihood of adverse effects, particularly gastrointestinal complications. It is recommended that patients avoid the simultaneous use of ibuprofen with other NSAIDs unless specifically directed by a healthcare professional.

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 should not use this medication for more than 2 days or be administered to children under 3 years of age unless directed by a healthcare professional.

For dosing, the following guidelines apply based on weight and age:

  • For patients under 24 lbs and under 2 years, consultation with a doctor is advised.

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

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

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

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

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

Dosing should ideally be based on weight; if weight is not available, age may be used as a guide. It is important to use only the enclosed dosing cup and not any other dosing device.

Geriatric Use

Elderly patients may not receive adequate guidance regarding the use of this product, as it does not contain directions or complete warnings specifically for adult use. Healthcare providers should exercise caution when considering this product for geriatric patients, as the absence of comprehensive information may impact safety and efficacy. It is essential to monitor these patients closely and consider alternative therapies that provide clearer dosing and safety information tailored to their needs.

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.

Dosage modifications may be necessary, and pregnant women should consult their healthcare provider for guidance before using ibuprofen. It is essential for healthcare professionals to advise pregnant patients to seek medical advice prior to the use of this medication.

Lactation

Lactating mothers should consult a doctor before using this product. There is a potential for excretion of ibuprofen in breast milk. Caution is advised when administering ibuprofen to nursing mothers due to the potential risk to the infant.

Renal Impairment

Patients with renal impairment should consult a healthcare professional prior to use, particularly if they have a history of kidney disease. It is essential to assess the patient's overall health status, including any comorbid conditions such as high blood pressure, heart disease, liver cirrhosis, or a history of stroke, as these factors may influence the management of their renal function and the appropriateness of treatment. Monitoring and potential dosing adjustments may be necessary based on the patient's renal status to ensure safety and efficacy.

Hepatic Impairment

Patients with hepatic impairment may experience altered pharmacokinetics of the medication due to compromised liver function. It is essential to assess the severity of liver impairment before initiating treatment.

In patients with liver cirrhosis, dosage adjustments may be necessary to avoid potential toxicity. Close monitoring of liver function tests is recommended throughout the treatment course to ensure safety and efficacy.

Additionally, patients with a history of significant cardiovascular conditions, such as high blood pressure or heart disease, as well as those with kidney disease or a history of stroke, should be evaluated carefully, as these factors may further complicate the management of their hepatic condition.

Overall, a thorough assessment of each patient's individual health status is crucial in determining the appropriate treatment plan and monitoring requirements for those with hepatic impairment.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. Healthcare professionals should advise patients or caregivers to call the Poison Control Center at 1-800-222-1222 for guidance.

Prompt intervention is crucial in managing overdose situations, as timely medical support can significantly influence outcomes. Symptoms of overdose may vary depending on the substance involved and the individual’s health status. Therefore, a thorough assessment and monitoring of the patient are essential.

Management procedures may include supportive care, symptomatic treatment, and specific antidotes if applicable. Healthcare providers should remain vigilant and prepared to implement appropriate interventions based on the clinical presentation 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 in these areas limits the understanding of the compound's potential effects in nonclinical settings.

Postmarketing Experience

No specific postmarketing experience details are available. As such, there are no additional adverse events or rare case reports to summarize at this time.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222 in the event of an overdose. It is recommended to administer the medication with food or milk if the patient experiences stomach upset.

Providers should encourage patients to consult a doctor before use if the child has a history of stomach problems, such as heartburn, or if there is a concern regarding stomach bleeding. Additionally, it is important to ask a doctor before use if the child has experienced serious side effects from pain relievers or fever reducers, has not been drinking fluids, or has lost a significant amount of fluid due to vomiting or diarrhea.

Patients should also be advised to consult a doctor before use if the child has any of the following conditions: high blood pressure, heart disease, liver cirrhosis, kidney disease, a history of stroke, or asthma. Furthermore, it is essential to ask a doctor before use if the child is taking a diuretic or if they are under a doctor’s care for any serious condition. Lastly, patients should be encouraged to speak with 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 specific NDC numbers, which should be referenced for accurate identification. It is essential to store the product at a temperature range of 20-25°C (68-77°F) to maintain its integrity and efficacy. Freezing the product is strictly prohibited, as it may compromise its quality.

Additionally, healthcare professionals should ensure that the product is not used if the printed neckband is broken or missing, as this may indicate tampering or compromise of the product's safety. Proper handling and storage conditions are crucial for ensuring the product remains safe and effective for patient use.

Additional Clinical Information

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

For proper administration, patients should shake the medication well before use and utilize only the enclosed dosing cup, avoiding any other dosing devices. It is important to determine the correct dose based on the provided chart, using weight when possible; otherwise, age may be used. Patients are also advised to wash the dosing cup after each use.

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.