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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 2020
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 2020
Label revision date
September 1, 2025
Manufacturer
Aurohealth LLC
Registration number
ANDA209179
NDC root
58602-008
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 commonly used to relieve minor aches and pains, such as those caused by the common cold, flu, sore throat, headache, and toothache. It also helps reduce fever. This specific formulation, Children's Ibuprofen Oral Suspension, is designed for children aged 2 to 11 years and comes in a pleasant berry flavor, making it easier for kids to take.

As a nonsteroidal anti-inflammatory drug (NSAID), ibuprofen works by reducing inflammation and pain in the body. Each dose contains 100 mg of ibuprofen per 5 mL, and its effects can last for up to 8 hours, providing effective relief when your child needs it.

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’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 who weigh between 72 and 95 pounds.

You should only give the medication as directed and not exceed four doses in a single day. If needed, you can repeat the dose every 6 to 8 hours. 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. 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. If your child experiences symptoms such as chest pain, difficulty breathing, weakness on one side of the body, slurred speech, or leg swelling, stop use and consult a doctor right away. Be alert for signs of stomach bleeding, including faintness, vomiting blood, or black stools, and seek medical advice if your child does not find relief within 24 hours, if symptoms worsen, or if new symptoms arise.

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 the medication and seek medical help immediately.

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

If you or 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 promptly. For any overdose, seek emergency medical help or contact a Poison Control Center immediately at 1-800-222-1222. Always stop use and call your doctor if symptoms worsen or new symptoms appear.

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 potential 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 in doubt, it’s better to err on the side of caution and seek assistance.

Pregnancy Use

When considering the use of ibuprofen during pregnancy, it's important to note that the available information does not provide specific guidelines or warnings. There are no stated risks or contraindications associated with taking ibuprofen while pregnant, and no dosage adjustments are recommended for pregnant individuals. Additionally, the insert does not mention any special precautions you should take if you are pregnant.

However, since the absence of information does not imply complete safety, it's always best to consult with your healthcare provider before using any medication during pregnancy. They can offer personalized advice based on your health and circumstances.

Lactation Use

If you are breastfeeding and considering using this product, it's important to consult your doctor first. There is a possibility that the medication can pass into your breast milk, and the effects on your nursing infant have not been thoroughly studied. Because of this uncertainty, it's wise to be cautious.

If you do take ibuprofen while 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 both you and your infant stay healthy.

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 between 2 and 11 years, the dosage varies based on their weight. For example, if your child weighs under 24 pounds (under 2 years), you should consult a doctor first. For those weighing 24-35 pounds (2-3 years), the recommended dose is 5 mL, while children weighing 36-47 pounds (4-5 years) should receive 7.5 mL. The dosage continues to increase with weight, reaching 15 mL for an 11-year-old weighing 72-95 pounds.

Always consult a doctor if your child has a history of stomach issues, is taking other medications, or isn't drinking enough fluids. Make sure not to exceed the recommended dose, which should not be more than four times a day. If your child's symptoms do not improve within 24 hours, seek medical advice. Lastly, 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

When it comes to using this medication in older adults, there are no specific guidelines or recommendations provided. This means that the insert does not mention any age-related dosage adjustments, safety concerns, or special precautions that you should be aware of.

If you are an older adult or a caregiver, it's always a good idea to consult with a healthcare professional about any medications being considered. They can provide personalized advice and ensure that the treatment is safe and effective for your specific 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.

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 and what steps to take for your safety.

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 share your complete list of medications and any health conditions you have to receive the best care possible.

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 dosage for children?

The dosage varies by weight and age. For example, children weighing 24-35 lbs (2-3 years) should take 5 mL, while those weighing 72-95 lbs (11 years) should take 15 mL.

Are there any warnings associated with Ibuprofen?

Yes, Ibuprofen may cause severe allergic reactions, stomach bleeding, and increase the risk of heart attack and stroke. Consult a doctor if symptoms occur.

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

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

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

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

Is it safe to use Ibuprofen during pregnancy?

The provided information does not mention specific risks or contraindications for using Ibuprofen during pregnancy, but consult a doctor for personalized advice.

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 and its effects on nursing infants are not well studied.

How should Ibuprofen be stored?

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

What should I do in case of an overdose?

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

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 specified 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 specific dosing instructions must be followed to ensure safety and efficacy. Prior to administration, the product should be shaken well. The appropriate dose can be determined using the dosing chart provided, which considers both weight and age. If possible, weight should be used to determine the dose; otherwise, age may be utilized.

The dosing cup enclosed with the product must be used exclusively for measuring doses. Other dosing devices are not recommended. The following dosing guidelines should be adhered to:

  • 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 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.

If necessary, doses may be repeated every 6 to 8 hours, but the total daily administration should not exceed 4 doses. After each use, the dosing cup should be washed to maintain hygiene. It is essential to replace the original bottle cap after use to ensure child resistance and prevent accidental ingestion. Care should be taken not to exceed the recommended dosage.

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 or 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 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 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.

NSAIDs, excluding aspirin, are also 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.

Healthcare professionals should be vigilant for signs of severe or persistent sore throat, especially when accompanied by high fever, headache, nausea, or vomiting, as these symptoms may indicate a serious condition. It is advised to consult a physician promptly in such cases. Additionally, ibuprofen should not be used for more than two days or administered to children under three years of age unless specifically directed by a healthcare provider.

In cases of overdose, immediate medical attention is required. Contact a Poison Control Center or seek emergency medical help without delay (1-800-222-1222).

Healthcare providers should instruct caregivers to discontinue use and consult a physician if the child exhibits any of the following signs indicative of stomach bleeding: feeling faint, vomiting blood, passing bloody or black stools, or experiencing persistent stomach pain. Symptoms suggestive of heart problems or stroke, such as chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling, also warrant immediate medical evaluation. Furthermore, 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 redness or swelling occurs in the affected area, or if any new symptoms arise, medical advice should be sought.

Side Effects

Patients using ibuprofen should be aware of the potential for serious adverse reactions, particularly those related to allergic responses and gastrointestinal complications. Severe allergic reactions may occur, especially 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, 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, including aspirin and naproxen. 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. If any of these symptoms occur, it is imperative to discontinue use and consult a healthcare professional.

Additionally, the use of NSAIDs, excluding aspirin, has been associated with an increased risk of heart attack, heart failure, and stroke, which can be fatal. This risk is particularly pronounced when the medication is used in higher doses or for extended periods. Patients should seek medical attention if they experience 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 fever or pain lasting more than three days, the presence of redness or swelling in the affected area, and the emergence of any new symptoms. In such cases, patients should consult their healthcare provider for further evaluation and guidance.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there are no known interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are necessary 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 dosing, the following guidelines apply:

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

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

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

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

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

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

Healthcare professionals should advise parents or guardians to consult a doctor if the child has a history of stomach problems, is taking other medications, or has not been adequately hydrated. It is important to adhere to the dosing recommendations and not exceed 4 doses in a day. If symptoms do not improve within 24 hours, a consultation with a healthcare professional is advised. Additionally, this medication should be kept out of reach of children, and in the event of an overdose, immediate medical assistance or contact with a Poison Control Center is necessary.

Geriatric Use

Geriatric use information is not specifically provided in the prescribing information. There are no recommended age considerations, dosage adjustments, safety concerns, or special precautions for elderly patients mentioned. Healthcare providers should exercise clinical judgment when prescribing this medication to geriatric patients, considering the individual health status and potential for altered pharmacokinetics in this population. Regular monitoring may be warranted to ensure safety and efficacy in elderly patients.

Pregnancy

There are no specific statements regarding the use of ibuprofen during pregnancy in the provided text. The insert does not mention any contraindications or risks associated with ibuprofen use during this period. Additionally, no dosage modifications for pregnant individuals are provided. Furthermore, the insert does not include any special precautions regarding the use of ibuprofen during pregnancy. Healthcare professionals should consider the absence of specific data when advising pregnant patients and weigh the potential benefits against any unknown risks.

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

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 significantly 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, and specific interventions may be required based on the symptoms presented.

Management of an overdose may involve the administration of activated charcoal if the patient presents within a suitable timeframe and is not at risk for aspiration. In cases of severe toxicity, advanced interventions such as airway management, intravenous fluids, or antidotes may be indicated, depending on the specific agent involved.

It is crucial for healthcare professionals to consult local poison control centers or toxicology experts for guidance on the management of overdose cases, as they can provide tailored recommendations based on the latest evidence and clinical protocols.

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

Cardiovascular events, including heart attack and stroke, have been observed in patients using nonsteroidal anti-inflammatory drugs (NSAIDs), particularly among those with pre-existing cardiovascular conditions. Furthermore, elevated blood pressure and fluid retention have been reported in patients taking ibuprofen. Instances of asthma exacerbation have also been noted in individuals with a history of asthma when using ibuprofen.

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 crucial to inform patients that this medication should not be used if the child has a history of allergic reactions to ibuprofen or any other pain reliever or fever reducer. Additionally, patients should be cautioned against using this medication right before or after heart surgery.

Patients should be instructed to discontinue use and consult a doctor if the child exhibits any signs of stomach bleeding, which may include feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain. Furthermore, healthcare providers should emphasize the importance of stopping the medication and seeking medical advice if the child shows symptoms indicative of heart problems or stroke, such as chest pain, difficulty breathing, weakness on one side of the body, slurred speech, or swelling in the legs.

Patients should also be informed to 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 affected area, or if any new symptoms arise.

When administering this product, patients should be advised to take it with food or milk if stomach upset occurs. Healthcare providers should encourage 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. It is also 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 significant fluid due to vomiting or diarrhea.

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

Storage and Handling

The product is supplied in a 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.

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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.