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Ibuprofen

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Active ingredient
Ibuprofen 100 mg/5 mL
Other brand names
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
March 10, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Ibuprofen 100 mg/5 mL
Other brand names
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
March 10, 2025
Manufacturer
Strides Pharma Inc
Registration number
ANDA211666
NDC roots
59556-234, 59556-235, 59556-876
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (6 NDCs)
Packaging & NDC Codes (6)

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Drug Overview

Children's Ibuprofen Oral Suspension is a 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 available in a pleasant berry flavor. This medication is primarily used to relieve minor aches and pains associated with common conditions like the cold, flu, sore throat, headache, and toothache, as well as to reduce fever.

The effects of Children's Ibuprofen can last up to 8 hours, providing effective relief when your child needs it most. This alcohol-free suspension is a convenient option for parents looking to manage their child's discomfort safely.

Uses

You can use this medication to help relieve minor aches and pains caused by common conditions like the cold, flu, sore throat, headache, and toothache. It’s also effective in reducing fever, making it a helpful option when you're feeling unwell.

Rest assured, this medication does not have any teratogenic effects, meaning it does not cause developmental issues in a fetus. This makes it a safer choice for those who may be pregnant or planning to become pregnant.

Dosage and Administration

Before you use this medication, make sure to shake the bottle well. To find the right dose for you or your child, refer to the dosing chart provided. If possible, use weight to determine the dose; if not, you can use age. It's important to use only the enclosed dosing cup to measure the medication—other devices may not provide the correct amount.

You can repeat the dose every 6 to 8 hours if needed, but remember not to exceed 4 doses in a single day. For children under 2 years old who weigh less than 24 pounds, it's best to consult a doctor before giving any medication. For those who weigh between 24 and 35 pounds (ages 2-3), the dose is 5 mL, and it increases with weight and age up to 15 mL for children who weigh between 72 and 95 pounds (around 11 years old). Always follow the dosing chart or your doctor's instructions for the safest use.

What to Avoid

There are no specific contraindications, controlled substance classifications, or concerns regarding abuse, misuse, or dependence associated with this medication. This means that, based on the available information, there are no known reasons to avoid using it, and it does not fall under any controlled substance regulations.

However, it's always important to consult with your healthcare provider before starting any new medication to ensure it is appropriate for your individual health needs.

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 (a sign of asthma), 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.

There is also an increased risk of heart attack and stroke associated with NSAIDs, which can be life-threatening, particularly if used in higher doses or for extended periods. If your child experiences severe sore throat symptoms, stomach bleeding signs (such as faintness, vomiting blood, or black stools), or symptoms indicating heart problems or stroke (like chest pain or weakness on one side of the body), seek medical attention immediately. It's important to consult a doctor if symptoms do not improve within 24 hours or if fever or pain worsens or lasts more than three days.

Warnings and Precautions

Ibuprofen can cause serious allergic reactions, especially in those who are allergic to aspirin. If you notice symptoms like hives, facial swelling, wheezing, or skin rash, stop using it immediately and seek medical help. Additionally, ibuprofen is a type of nonsteroidal anti-inflammatory drug (NSAID) that may lead to severe stomach bleeding, particularly if your child has a history of stomach ulcers, is taking blood thinners, or uses other NSAIDs. The risk of heart attack, heart failure, and stroke also increases with higher doses or prolonged use.

Before giving ibuprofen to your child, consult a doctor if they have any history of stomach issues, dehydration, high blood pressure, or asthma. It's also important to check with a healthcare professional if your child is taking other medications or is under treatment for a serious condition. If your child experiences symptoms like faintness, vomiting blood, or severe stomach pain, stop the medication and contact your doctor right away. For any overdose situation, seek emergency medical help or contact a Poison Control Center immediately.

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 during pregnancy has not been established. In fact, ibuprofen is not recommended, especially during the third trimester, as it may pose risks to your developing baby, including potential cardiovascular effects.

Before taking ibuprofen, you should consult your healthcare provider, as they may suggest dosage modifications or alternative treatments. It's best to avoid using ibuprofen unless specifically directed by a healthcare professional to ensure the safety of both you and your baby.

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

Pediatric Use

When giving medication to your child, it's important to follow the dosing instructions carefully. Always use the enclosed dosing cup and avoid other measuring devices. If your child is under 2 years old or weighs less than 24 pounds, consult a doctor before administering the medication. For children aged 2 to 10 years, the dose varies based on their weight and age, so refer to the dosing chart provided. You can repeat the dose every 6 to 8 hours, but do not exceed four doses in a day.

Be cautious if your child has a severe or persistent sore throat, especially if it comes with a high fever, headache, nausea, or vomiting—contact a doctor in such cases. Remember to keep the medication out of reach of children, and if an overdose occurs, seek medical help immediately or call a Poison Control Center at 1-800-222-1222.

Geriatric Use

While the drug insert does not provide specific information regarding the use of this medication in older adults, it is always important to approach any new treatment with caution. If you or a loved one is an older adult, it’s wise to consult with a healthcare provider about any potential risks or benefits before starting a new medication.

Since there are no specific dosage adjustments or safety concerns mentioned for elderly patients, your healthcare provider can help determine the best approach based on individual health needs and conditions. Always keep open communication with your doctor about any changes in health or concerns you may have.

Renal Impairment

If you have kidney problems, it's important to consult your doctor before using this medication. This is especially crucial if you also have high blood pressure, heart disease, liver cirrhosis (a severe liver condition), or if you've had a stroke. Your healthcare provider can help determine if this medication is safe for you and whether any adjustments are needed based on your kidney health. Always prioritize open communication with your doctor regarding your medical history and current health conditions.

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). This is crucial to ensure that the medication is safe and effective for you.

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

Drug Interactions

It's important to be aware of potential interactions when taking medications. For instance, if you or your child is allergic to aspirin, using ibuprofen could lead to a severe allergic reaction. Additionally, if your child is on blood thinners (medications that prevent blood clots) or steroids, the risk of serious stomach bleeding increases. This risk is also heightened if they are taking other nonsteroidal anti-inflammatory drugs (NSAIDs), such as aspirin or naproxen.

Before starting any new medication, including ibuprofen, it's crucial to consult with a healthcare provider, especially if your child is taking a diuretic (a medication that helps remove excess fluid from the body). Discussing all medications and health conditions with your doctor can help ensure safety and effectiveness in treatment.

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). It's important to keep the product in its original carton until you're ready to use it. If the carton is opened or if the tape or bottle wrap marked "SEALED FOR YOUR PROTECTION" is broken or missing, do not use the product, as this may compromise its safety.

Always handle the product with care, and make sure to follow these storage guidelines to maintain its quality. If you have any concerns about the packaging or the product itself, it's best to consult with a healthcare professional before use.

Additional Information

You should take this medication orally, and if needed, you can repeat the dose every 6 to 8 hours. However, do not exceed four doses in a single day. If you or your child experience stomach upset, it's best to take the medication with food or milk.

Be sure to stop using the medication and consult a doctor if your child shows any signs of stomach bleeding, heart problems, or stroke. Additionally, seek medical advice if there is no relief within the first 24 hours, if fever or pain worsens or lasts more than three days, if there is redness or swelling in the painful area, or if any new symptoms develop.

FAQ

What is Children's Ibuprofen Oral Suspension used for?

Children's Ibuprofen Oral Suspension 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's Ibuprofen?

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

How often can I give Children's Ibuprofen?

You can repeat the dose every 6-8 hours, but do not exceed 4 doses in a day.

Are there any warnings associated with Children's Ibuprofen?

Yes, it may cause severe allergic reactions, stomach bleeding, and increase the risk of heart attack and stroke. Consult a doctor if your child has a history of stomach problems or is taking other medications.

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 experiences signs of stomach bleeding?

Stop use and seek medical help immediately if your child feels faint, vomits blood, has bloody or black stools, or has persistent stomach pain.

Can I use Children's Ibuprofen if my child has asthma?

You should ask a doctor before use if your child has asthma or any other serious health conditions.

How should I store Children's Ibuprofen?

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

What flavor does Children's Ibuprofen come in?

Children's Ibuprofen Oral Suspension is available in a berry flavor.

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 Ibuprofen. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Ibuprofen.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Children's Ibuprofen Oral Suspension, USP is a nonsteroidal anti-inflammatory drug (NSAID) formulated to provide relief from pain and reduce fever. Each 5 mL dose contains 100 mg of ibuprofen. The suspension is alcohol-free and is presented in a berry flavor to enhance palatability. The product is packaged in a 4 fl oz (120 mL) bottle, with effects lasting up to 8 hours. The National Drug Code (NDC) for this formulation is 59556-876-72.

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 effective in reducing fever.

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

Dosage and Administration

The medication should be shaken well before use. Healthcare professionals are advised to determine the appropriate dose using the provided dosing chart, prioritizing weight for dosing whenever possible; if weight is not available, age may be used as a secondary measure.

Only the enclosed dosing cup should be utilized for measuring the dose; the use of any other dosing device is not recommended. Dosing may be repeated every 6 to 8 hours as necessary, but it is important to ensure that the medication is not administered more than four times within a 24-hour period.

The following dosing chart provides specific dosage recommendations based on weight and age:

  • For patients weighing under 24 lb or under 2 years of age, consultation with a doctor is required.

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

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

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

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

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

Dosing may also be adjusted as directed by a healthcare professional.

Contraindications

There are no contraindications associated with the use of this product. It is not classified as a controlled substance, and there are no known risks of abuse, misuse, or dependence.

Warnings and Precautions

Ibuprofen may induce severe allergic reactions, particularly in individuals with a known allergy to aspirin. Symptoms indicative of such reactions may include hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, and blisters. In the event of an allergic reaction, it is imperative to discontinue use immediately and seek medical assistance.

This product contains a nonsteroidal anti-inflammatory drug (NSAID), which is associated with a risk of severe stomach bleeding. The likelihood of this adverse effect is heightened in pediatric patients with a history of stomach ulcers or bleeding disorders, those concurrently using anticoagulants or steroid medications, individuals taking other NSAIDs (including aspirin, ibuprofen, or naproxen), or those exceeding the recommended dosage or duration of treatment. Additionally, NSAIDs, excluding aspirin, are linked to an increased risk of heart attack, heart failure, and stroke, which can be fatal. This risk escalates with prolonged use or higher-than-recommended dosages.

Healthcare professionals should be vigilant for severe or persistent sore throat, particularly when accompanied by high fever, headache, nausea, and vomiting, as these symptoms may indicate a serious condition. Consultation with a physician is advised in such cases. The use of this medication should not exceed two days, nor should it be administered to children under three years of age without a physician's directive.

General precautions should be observed prior to administration. Consultation with a healthcare provider is recommended if the following conditions apply: the child has a history of stomach bleeding, has experienced stomach issues such as heartburn, has had adverse reactions to pain relievers or fever reducers, is dehydrated due to vomiting or diarrhea, has high blood pressure, heart disease, liver cirrhosis, kidney disease, or a history of stroke, has asthma, or is taking diuretics. Additionally, it is prudent to seek advice from a doctor or pharmacist 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 the Poison Control Center should be contacted at 1-800-222-1222.

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, warrant immediate medical evaluation. Furthermore, if the child does not achieve 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 consultation is necessary.

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 warning for severe stomach bleeding. The risk of this serious adverse reaction 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, ibuprofen, or naproxen. Additionally, the risk increases if the medication is taken in higher doses or for extended periods beyond the recommended guidelines.

Patients should also be aware of the increased risk of heart attack, heart failure, and stroke associated with NSAID use, excluding aspirin. These cardiovascular events can be fatal, and the risk is amplified when the medication is used in excess of the directed dosage or duration.

Common adverse reactions may include severe or persistent sore throat, especially when accompanied by high fever, headache, nausea, and vomiting. Such symptoms warrant prompt medical consultation. It is advised not to use the product for more than two days or to administer it to children under three years of age unless directed by a healthcare professional.

Patients should discontinue use and seek medical advice if they experience any 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 necessitate immediate medical attention. 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, or if redness or swelling occurs in the affected area, they should consult a healthcare provider. Any new symptoms that arise should also prompt a discussion with a medical professional.

Drug Interactions

Ibuprofen has the potential to induce severe allergic reactions, particularly in individuals with a known allergy to aspirin.

When considering the concomitant use of ibuprofen with anticoagulants or steroid medications, it is important to note that the risk of severe gastrointestinal bleeding is significantly increased. This risk is also elevated when ibuprofen is taken alongside other nonsteroidal anti-inflammatory drugs (NSAIDs), including both prescription and over-the-counter options such as aspirin and naproxen.

In pediatric patients, it is advisable to consult a healthcare professional prior to administering ibuprofen if the child is currently prescribed a diuretic, as this may necessitate careful monitoring or dosage adjustments.

Packaging & NDC

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

Packaging configurations for Ibuprofen.
Details

Pediatric Use

Pediatric patients should not exceed the recommended dosage. Dosing should primarily be based on weight; if weight is not available, age may be used as a guide. Only the enclosed dosing cup should be utilized for administration, and other dosing devices are not recommended. Doses may be repeated every 6-8 hours as needed, but should not exceed four doses in a 24-hour period.

The following dosing chart provides guidance based on weight and age:

  • Under 24 lbs / Under 2 years: Consult a doctor

  • 24-35 lbs / 2-3 years: 5 mL

  • 36-47 lbs / 4-5 years: 7.5 mL

  • 48-59 lbs / 6-8 years: 10 mL

  • 60-71 lbs / 9-10 years: 12.5 mL

  • 72-95 lbs / 11 years: 15 mL

This medication is not recommended for children under 3 years of age unless directed by a healthcare professional. Parents and caregivers should seek medical advice promptly if a child experiences a severe or persistent sore throat, especially if accompanied by high fever, headache, nausea, or vomiting.

It is essential to keep this medication out of reach of children. In the event of an overdose, immediate medical assistance should be sought, or contact a Poison Control Center at 1-800-222-1222.

Geriatric Use

Geriatric patients, defined as individuals aged 65 years and older, have not been specifically addressed in the prescribing information regarding the use of this medication. The absence of explicit recommendations for age considerations, dosage adjustments, safety concerns, or special precautions indicates that the available data does not highlight any unique risks or requirements for this population.

Healthcare providers should exercise clinical judgment when prescribing this medication to elderly patients, considering the general principles of pharmacotherapy in geriatric care. It is advisable to monitor these patients closely for any potential adverse effects or changes in therapeutic response, as age-related physiological changes may influence drug metabolism and efficacy.

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 for pregnant individuals, and it is advised that they consult a healthcare provider before use. Pregnant women should avoid using ibuprofen unless specifically directed by a healthcare professional.

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 during lactation.

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 liver function prior to initiating treatment and to monitor liver parameters throughout the course of therapy.

In patients with liver cirrhosis, dosage adjustments may be necessary to mitigate the risk of adverse effects. Close monitoring of liver function tests, including alanine aminotransferase (ALT), aspartate aminotransferase (AST), and bilirubin levels, is recommended to ensure patient safety and therapeutic efficacy.

Additionally, patients with a history of significant liver disease, such as cirrhosis, should be evaluated for potential contraindications or the need for alternative therapeutic options. Regular follow-up assessments are advised to monitor for any changes in liver function that may necessitate further dosage modifications or discontinuation of therapy.

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 symptoms may vary depending on the substance involved. Therefore, a thorough assessment of the patient's condition is essential to determine the appropriate course of action.

Management procedures may include supportive care and symptomatic treatment, tailored to the specific symptoms presented. Continuous monitoring of the patient's vital signs and clinical status is recommended to ensure safety and effectiveness of the treatment provided.

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 use of the compound in these contexts.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions associated with the use of ibuprofen. These include gastrointestinal bleeding, renal impairment, and hypersensitivity reactions, which encompass anaphylaxis and various skin reactions. Additionally, reports of serious cardiovascular events, such as myocardial infarction and stroke, have been noted. Cases of liver enzyme elevations and liver failure have also been documented. Furthermore, some patients have experienced severe skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis. There have been reports of asthma exacerbations in patients with a history of asthma following the use of 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 essential for patients to understand the importance of prompt action in such situations to ensure their safety and well-being.

Storage and Handling

The product is supplied in a carton that must remain unopened until use. It is essential to inspect the carton for any signs of tampering; do not use the product if the carton is opened or if the carton tape or bottle wrap imprinted with "SEALED FOR YOUR PROTECTION" is broken or missing.

For optimal storage, the product should be maintained at a temperature range of 20-25°C (68-77°F). Proper adherence to these storage conditions is crucial to ensure the integrity and efficacy of the product.

Additional Clinical Information

Patients should be informed that the medication is administered orally, with the option to repeat doses every 6-8 hours as needed, not exceeding four doses in a 24-hour period. It is recommended to take the medication with food or milk if stomach upset occurs.

Clinicians should counsel patients to discontinue use and seek medical advice if the child exhibits any signs of stomach bleeding, symptoms indicative of heart problems or stroke, does not experience relief within the first 24 hours, or if fever or pain worsens or persists beyond three days. Additionally, they should be alert for any redness or swelling in the painful area or the emergence of new symptoms.

Drug Information (PDF)

This file contains official product information for 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 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.