Symptom checker
Select audience type

Switch between content for healthcare professionals (PRO) and general audience (GEN).

ADD CONDITION

items per page

Childrens Ibuprofen

Last content change checked dailysee data sync status

Active ingredient
Ibuprofen 100 mg/5 mL
Other brand names
Drug class
Nonsteroidal Anti-inflammatory Drug
Dosage form
Suspension/ Drops
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2023
Label revision date
November 20, 2023
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/ Drops
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 2023
Label revision date
November 20, 2023
Manufacturer
Chain Drug Marketing Association Inc.
Registration number
ANDA210149
NDC root
83324-014
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 a pain reliever and fever reducer specifically designed for children aged 2 to 11 years. This oral suspension contains 100 mg of ibuprofen (a type of medication that helps alleviate pain and reduce fever) per 5 mL. It effectively relieves minor aches and pains associated with common conditions like the cold, flu, sore throat, headache, and toothache, while also helping to lower fever.

This medication is alcohol-free and comes in a pleasant grape flavor, making it easier for children to take. Its effects can last for up to 8 hours, providing relief when your child needs it most.

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. This makes it a safer choice for those who are pregnant, although you should always consult with your healthcare provider before taking any medication.

Dosage and Administration

Before using this product, make sure to shake it well. It's important to follow the dosing instructions carefully. You can find the right dose by checking the dosing chart, which considers both weight and age. If possible, use your child's weight to determine the dose; if not, you can use their age instead. Always use the enclosed dosing cup to measure the medication—other devices may not provide the correct amount.

You should not give more than the recommended dose. If needed, you can repeat the dose every 6 to 8 hours, but remember not to exceed four doses in a single day. For children under 2 years old or weighing less than 24 pounds, it's best to consult a doctor for the appropriate dose. For children aged 2 to 3 years and weighing between 24 and 35 pounds, the dose is 5 mL. As the weight increases, so does the dose, reaching up to 15 mL for children who are 11 years old and weigh between 72 and 95 pounds. Always consult a healthcare professional if you have any questions or concerns.

What to Avoid

You should avoid using this medication if your child has ever had an allergic reaction to ibuprofen or any other pain reliever or fever reducer. Additionally, it is important not to use this medication right before or after your child has heart surgery, as this could pose serious risks. Always consult with a healthcare professional if you have any concerns about your child's health or medication use.

Side Effects

Ibuprofen can cause serious side effects, so it's important to be aware of them. You should watch for signs of a severe allergic reaction, especially if you or your child is allergic to aspirin. Symptoms may include hives, wheezing, skin reddening, facial swelling, and in extreme cases, shock. Additionally, ibuprofen can lead to severe stomach bleeding, particularly 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.

There is also an increased risk of heart attack and stroke associated with NSAIDs, which can be life-threatening. If your child experiences symptoms like chest pain, trouble breathing, or weakness on one side of the body, seek medical help immediately. It's crucial to stop using ibuprofen and consult a doctor if your child shows signs of stomach bleeding, has a sore throat with high fever, or if symptoms worsen or persist beyond a few days. Always consult a healthcare professional before giving ibuprofen if your child has any underlying health conditions or is taking other medications.

Warnings and Precautions

Ibuprofen can cause serious allergic reactions, especially if you are allergic to aspirin. Symptoms may include hives, wheezing, skin redness, facial swelling, shock, rash, or blisters. If you experience any of these symptoms, stop using ibuprofen and seek medical help immediately.

This medication can also lead to severe stomach bleeding, particularly if you have a history of stomach ulcers or bleeding issues, are taking blood thinners or steroids, or are using other NSAIDs (nonsteroidal anti-inflammatory drugs) like aspirin or naproxen. Additionally, using ibuprofen for longer than directed increases the risk of heart attack and stroke, which can be fatal. If you or your child have a severe sore throat, especially with high fever, headache, nausea, or vomiting, consult a doctor right away. Do not use ibuprofen for more than two days in these cases or for children under three years without a doctor's guidance.

If you suspect an overdose, contact a Poison Control Center or seek emergency medical help immediately. You should also stop using ibuprofen and call your doctor if you notice signs of stomach bleeding (like faintness, vomiting blood, or black stools), symptoms of heart problems or stroke (such as chest pain or trouble breathing), or if there is no relief within 24 hours. Additionally, seek medical advice if fever or pain worsens after three days, if there is redness or swelling in the painful area, or if any new symptoms appear.

Overdose

Taking too much ibuprofen can lead to serious health issues. If you or someone you know has taken an overdose, it's important to be aware of the symptoms, which may include nausea (feeling sick), vomiting, stomach pain, dizziness, and drowsiness (feeling unusually tired or sleepy).

If you suspect an overdose, seek immediate medical attention or contact a Poison Control Center right away. Acting quickly can help prevent more severe complications. Always prioritize safety and don’t hesitate to reach out for help if you need it.

Pregnancy Use

When considering the use of ibuprofen during pregnancy, it's important to note that the available information does not specify any particular guidelines or risks associated with its use. There are no contraindications (conditions that would prevent its use) mentioned, and no dosage adjustments are recommended for pregnant individuals. Additionally, the text does not highlight any special precautions you should take if you are pregnant.

While this information suggests that ibuprofen may not pose specific risks during pregnancy, it's always best to consult with your healthcare provider before taking any medication. They can provide personalized advice based on your health and pregnancy status.

Lactation Use

If you are breastfeeding, you can feel reassured that there are no specific warnings or recommendations regarding the use of ibuprofen while nursing. The information available does not indicate any concerns about ibuprofen being passed into breast milk or any associated risks for your infant.

As always, if you have any questions or concerns about medications while breastfeeding, it's a good idea to consult with your healthcare provider for personalized advice.

Pediatric Use

When considering this medication for your child, it's important to follow specific guidelines based on their weight and age. For children under 24 pounds (younger than 2 years), you should consult a doctor before use. For those aged 2 to 3 years and weighing between 24-35 pounds, the recommended dose is 5 mL. As your child grows, the dosage increases: 7.5 mL for 36-47 pounds (ages 4-5), 10 mL for 48-59 pounds (ages 6-8), 12.5 mL for 60-71 pounds (ages 9-10), and 15 mL for children weighing 72-95 pounds (around 11 years). Always base the dosage on weight when possible, and if not, use their age.

Safety is a priority, so do not give this medication to children under 3 years unless directed by a doctor. It's also wise to consult a doctor if your child has any history of stomach issues, is on other medications, or has serious health conditions like high blood pressure or asthma. If your child shows signs of stomach bleeding, heart problems, or if their fever or pain worsens or lasts more than three days, stop use and seek medical advice. Always use the provided dosing cup and do not exceed the recommended dose, which can be repeated every 6-8 hours, but not more than four times a day.

Geriatric Use

While there is no specific information available about the use of this medication in older adults, it’s important to approach any new treatment with caution. As you age, your body may process medications differently, and factors like kidney function (renal impairment) and changes in cognition can affect how well a drug works or how it may impact you.

If you are an older adult or a caregiver, it’s wise to discuss any concerns with your healthcare provider. They can help determine the best approach for your individual health needs, ensuring that any medication you take is safe and effective for you. Always keep your doctor informed about all medications you are taking, as this can help prevent potential interactions or side effects.

Renal Impairment

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

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

Hepatic Impairment

If you have liver problems, it's important to know that the drug insert does not provide specific information about dosage adjustments, special monitoring, or precautions for your condition. This means that there are no tailored guidelines for how this medication should be used if you have hepatic impairment (liver issues).

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your liver health. They can help you understand any potential risks and monitor your condition effectively.

Drug Interactions

It's important to be aware that certain medications can interact with each other, potentially leading to serious side effects. For instance, if you or your child are taking ibuprofen, combining it with blood thinners (medications that help prevent blood clots) or steroids can increase the risk of stomach bleeding. This risk is even greater if other nonsteroidal anti-inflammatory drugs (NSAIDs), like aspirin or naproxen, are also being used.

Always discuss any medications you or your child are taking with your healthcare provider. They can help you understand the risks and ensure that your treatment plan is safe and effective.

Storage and Handling

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

Before using the product, check that the carton is unopened and that the inner seal, which should say "SEALED for YOUR PROTECTION," is intact. If the carton is opened or the seal is broken or missing, do not use the product, as this may compromise its safety. Always handle the product with care to ensure it remains in good condition.

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 single day. If you experience stomach upset, it's advisable to take the medication with food or milk.

In the event of an overdose, seek medical assistance immediately or contact a Poison Control Center at 1-800-222-1222 for help.

FAQ

What is Children's Ibuprofen used for?

Children's Ibuprofen is a pain reliever and fever reducer that helps relieve minor aches and pains due to the common cold, flu, sore throat, headache, and toothache.

What age group can use Children's Ibuprofen?

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

How long does the effect of Children's Ibuprofen last?

The effects of Children's Ibuprofen can last up to 8 hours.

How should I dose Children's Ibuprofen?

Dosing is based on weight; if possible, use weight to dose; otherwise, use age. Refer to the dosing chart for specific amounts.

What should I do if my child has a history of 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.

What are the warnings associated with Children's Ibuprofen?

Warnings include the risk of severe allergic reactions, stomach bleeding, and increased risk of heart attack and stroke. Consult a doctor if your child has a history of stomach problems or is taking other medications.

Can I give Children's Ibuprofen to my child if they are under 2 years old?

For children under 24 lbs (under 2 years), you should ask a doctor before administering Children's Ibuprofen.

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

Stop use and call your doctor if your child experiences symptoms such as vomiting blood, having bloody or black stools, or stomach pain that does not improve.

Is it safe to use Children's Ibuprofen during pregnancy?

The insert does not provide specific information regarding the use of ibuprofen during pregnancy.

What should I do in case of an overdose?

In case of overdose, get medical help or contact a Poison Control Center right away 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

NDC 83324-014-04. QUALITY CHOICE Children's Ibuprofen is an oral suspension formulation classified as a nonsteroidal anti-inflammatory drug (NSAID) intended for the relief of pain and reduction of fever in children aged 2 to 11 years. Each 5 mL dose contains 100 mg of ibuprofen. The product is alcohol-free and features a grape flavor for palatability. The suspension is packaged in a 4 FL OZ (120 mL) bottle and provides relief that lasts up to 8 hours. This formulation is comparable to the active ingredient in Children's Motrin®.

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 dosage based on the patient's weight or age. It is essential to shake the product well before each use. The enclosed dosing cup must be utilized for accurate measurement; no other dosing devices should be employed.

The recommended dosing intervals are every 6 to 8 hours as needed, with a maximum frequency of 4 doses per day. The following dosing chart provides specific dosage recommendations:

  • For patients weighing under 24 lbs or under 2 years of age, the dose should be determined by consulting a doctor.

  • 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 ensure that patients do not exceed the recommended dosage and should advise caregivers to seek medical guidance if there are any uncertainties regarding dosing.

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, asthma (wheezing), skin reddening, facial swelling, shock, 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 NSAIDs, excluding aspirin, elevate the 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.

In cases of severe or persistent sore throat, especially when accompanied by high fever, headache, nausea, or vomiting, immediate medical consultation is advised. The use of ibuprofen should not exceed two days, and it should not be administered to children under three years of age unless specifically directed by a physician.

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

Healthcare providers 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. Additionally, symptoms indicative of heart problems or stroke, including chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling, warrant immediate medical attention. If the child does not experience relief within the first 24 hours of treatment, or if fever or pain worsens or persists beyond three days, or if redness or swelling occurs in the affected area, or if any new symptoms arise, medical advice should be sought promptly.

Side Effects

Patients using ibuprofen may experience a range of adverse reactions, which can be categorized by seriousness and frequency.

Severe allergic reactions have been reported, particularly in individuals with a known allergy to aspirin. Symptoms of such reactions may include hives, asthma (wheezing), skin reddening, facial swelling, shock, 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, and individuals using other NSAIDs, including aspirin and 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 cardiovascular risks. The use of NSAIDs, excluding aspirin, has been 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 longer than directed.

Patients should be advised to 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, unilateral weakness, slurred speech, or leg swelling, also warrant immediate medical consultation. Furthermore, if a patient does not achieve relief within the first 24 hours of treatment, or if fever or pain worsens or persists beyond three days, medical advice should be sought. 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 to consult a healthcare professional if the patient has a history of stomach issues, has experienced serious side effects from pain relievers or fever reducers, is dehydrated, or has underlying conditions such as high blood pressure, heart disease, liver cirrhosis, kidney disease, or a history of stroke. Patients with asthma or those taking diuretics should also seek medical advice prior to use.

Finally, it is recommended that patients under a doctor's care for any serious condition or those taking other medications consult with a healthcare provider or pharmacist before using ibuprofen.

Drug Interactions

Ibuprofen has been associated with an increased risk of gastrointestinal bleeding when co-administered with anticoagulants or corticosteroids. This risk is particularly pronounced in pediatric patients who may also be taking other nonsteroidal anti-inflammatory drugs (NSAIDs), including aspirin and naproxen.

Healthcare professionals should exercise caution when prescribing ibuprofen in conjunction with these medications. It is advisable to monitor patients closely for signs of gastrointestinal bleeding and consider dosage adjustments or alternative therapies as necessary to mitigate this risk.

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

Packaging & NDC

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

Packaging configurations for Childrens Ibuprofen.
Details

Pediatric Use

Pediatric patients under 24 lbs (under 2 years) should not use this medication unless directed by a doctor. For children aged 2-3 years weighing 24-35 lbs, the recommended dose is 5 mL. Children weighing 36-47 lbs (4-5 years) should receive 7.5 mL, while those weighing 48-59 lbs (6-8 years) should be given 10 mL. For children aged 9-10 years weighing 60-71 lbs, the dose is 12.5 mL, and for those weighing 72-95 lbs (11 years), the recommended dose is 15 mL. Dosing should primarily be based on weight; if weight is not available, age may be used as a guide.

Safety precautions are critical for pediatric use. This medication should not be administered to children under 3 years of age unless specifically directed by a healthcare professional. Consultation with a doctor is advised if the child has a history of stomach problems, is taking other medications, or has serious health conditions such as high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma. Parents and caregivers should discontinue use and seek medical advice if the child exhibits signs of stomach bleeding, symptoms indicative of heart problems or stroke, or if fever or pain persists or worsens beyond 3 days.

General precautions include adhering strictly to the recommended dosing guidelines. The enclosed dosing cup should be used exclusively for measuring doses; other dosing devices are not recommended. If necessary, doses may be repeated every 6-8 hours, but the total daily dosage should not exceed four doses.

Geriatric Use

There is no specific information regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as they may have altered pharmacokinetics and pharmacodynamics. Close monitoring is recommended to ensure safety and efficacy in this population.

Pregnancy

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

Lactation

There are no specific warnings or recommendations regarding the use of ibuprofen in nursing mothers. Additionally, there is no information available concerning the potential for excretion of ibuprofen in breast milk or any associated risks to breastfed infants.

Renal Impairment

There is no specific information regarding renal impairment, dosage adjustments, special monitoring, or safety considerations for patients with reduced kidney function provided in the text. Healthcare professionals should exercise caution and consider individual patient factors when prescribing to patients with renal impairment, as the absence of detailed guidance necessitates careful clinical judgment.

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

Overdosage of ibuprofen can lead to significant health risks and serious harm. Healthcare professionals should be aware of the potential symptoms associated with an overdose, which may include nausea, vomiting, stomach pain, dizziness, and drowsiness.

In the event of an overdose, it is imperative to seek immediate medical attention. Healthcare providers should advise patients or caregivers to contact a Poison Control Center for further guidance and management. Prompt intervention is crucial to mitigate the effects of ibuprofen overdosage and to ensure appropriate treatment is administered.

Nonclinical Toxicology

No teratogenic or non-teratogenic effects have been reported in the available nonclinical studies. Additionally, there is no information regarding animal pharmacology and toxicology. The absence of data limits the assessment of potential risks associated with the compound in these areas.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions reported voluntarily or through surveillance programs. These include allergic reactions such as hives, asthma (wheezing), skin reddening, facial swelling, shock, rash, and blisters. Additionally, there have been reports of severe stomach bleeding, particularly in children with a history of stomach ulcers or bleeding problems, as well as in those taking blood thinners, steroids, or other nonsteroidal anti-inflammatory drugs (NSAIDs).

Furthermore, an increased risk of heart attack, heart failure, and stroke has been associated with NSAID use. Symptoms indicative of heart problems or stroke reported include chest pain, difficulty breathing, weakness in one part or side of the body, slurred speech, and leg swelling.

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 for patients to understand the importance of prompt action in such situations.

Additionally, healthcare providers should recommend that patients take the medication with food or milk if they experience any stomach upset. This guidance can help mitigate gastrointestinal discomfort and enhance the overall tolerability of the treatment.

Storage and Handling

The product is supplied in packaging that includes specific NDC numbers. It should be stored at a temperature range of 20-25°C (68-77°F) to ensure optimal stability and efficacy.

Healthcare professionals are advised to inspect the carton prior to use; the product should not be utilized if the carton is opened or if the printed inner seal marked "SEALED for YOUR PROTECTION" is broken or missing. Proper handling and storage conditions are essential to maintain the integrity of the product.

Additional Clinical Information

The medication is administered orally, with a recommended dosing frequency of every 6-8 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. In the event of an overdose, it is crucial for patients to seek medical assistance or contact a Poison Control Center immediately at 1-800-222-1222.

No additional information is available regarding laboratory tests, abuse potential, or postmarketing experience.

Drug Information (PDF)

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

View product document (PDF)

Data Generation & Sources

This page was automatically generated and is maintained by the AllDrugs AI Data-Science Team. It was built from the FDA Structured Product Label (DailyMed) for Childrens Ibuprofen, retrieved by a validated AI data-extraction workflow.

All FDA-listed dosage forms and strengths are shown in the Packaging & NDC Codes section above. Regulatory status appears in the Summary Information panel above and was verified in the FDA National Drug Code directory and the NSDE NDC Directory daily file.

Note: an automated daemon monitors NSDE checksums; when the record for this NDC changes, the new file is pulled instantly and this page is refreshed.

No human clinician has reviewed this version.

Learn more in our Editorial Policy

Last AI update:

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.