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Ibuprofen

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This product has been discontinued

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 2022
Label revision date
November 8, 2024
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 2022
Label revision date
November 8, 2024
Manufacturer
Rite Aid Corporation
Registration number
ANDA074916
NDC root
11822-9380
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 fever reducer and pain reliever 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 and is available in a pleasant grape flavor. It works by relieving minor aches and pains associated with common conditions like the cold, flu, sore throat, headache, and toothache, while also effectively lowering fever for up to 8 hours.

This medication is alcohol-free, gluten-free, and paraben-free, making it a suitable option for many children. It is important to follow the product information and dosage guidelines to ensure safe and effective use.

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, it's important to note that it does not come with specific directions or warnings for adults. Always make sure to follow the recommended dosage and never exceed the amount directed. To prepare the medication, shake the bottle well before each use.

To find the right dose, refer to the dosing chart provided. If possible, use your child's weight to determine the correct amount; if not, you can use their age. Make sure to use only the enclosed dosing cup for measuring, as other devices may not provide accurate doses. If necessary, you can repeat the dose every 6 to 8 hours, but do not use it more than four times in a single day. After each use, remember to securely replace the original bottle cap to keep it child-resistant.

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 it right before or after heart surgery, as this could pose serious health 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, including severe allergic reactions, particularly in those allergic to aspirin. Symptoms of an allergic reaction may include hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, and blisters. Additionally, this medication can lead to severe stomach bleeding, especially in children with a history of stomach ulcers or those taking blood thinners or other NSAIDs. There is also an increased risk of heart attack and stroke associated with NSAIDs, which can be fatal if used improperly.

You should stop using ibuprofen and consult a doctor if your child experiences signs of stomach bleeding, such as feeling faint, vomiting blood, or having black stools. Seek medical attention if your child shows symptoms of heart problems or stroke, like chest pain or trouble breathing. It's important to ask a doctor before use if your child has a history of stomach issues, is dehydrated, or has other serious health conditions. Always monitor for any new symptoms or if the condition worsens.

Warnings and Precautions

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

This medication can also lead to severe stomach bleeding, particularly if you have a history of stomach ulcers or bleeding, 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 your child has a severe or persistent sore throat, especially with high fever, headache, nausea, or vomiting, consult a doctor right away. You should stop using ibuprofen and call your doctor if your child shows signs of stomach bleeding (like feeling faint, vomiting blood, or having black stools), symptoms of heart problems or stroke (such as chest pain or trouble breathing), does not feel better within 24 hours, or if fever or pain worsens or lasts more than three days. Always be cautious and monitor for any new symptoms.

Overdose

Taking too much ibuprofen can lead to serious side effects. If you or someone you know has taken an overdose, you might notice symptoms such as nausea (feeling sick), vomiting, stomach pain, drowsiness (feeling unusually sleepy), and dizziness (feeling lightheaded).

It's important to act quickly in these situations. If an overdose occurs, seek immediate medical attention or contact a Poison Control Center for guidance. Your health and safety are the top priority, so don’t hesitate to get help.

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. These risks can include potential cardiovascular issues and kidney problems for the fetus.

Before taking any medication, including ibuprofen, you should consult your healthcare provider. They can help you understand the potential risks and guide you toward safer alternatives if needed. Your health and the health of your baby are the top priority, so always seek professional advice when it comes to medication during pregnancy.

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

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 aged 2 to 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.

Before giving this medication, it's wise to consult a doctor if your child has a history of stomach issues, is on other medications, or has certain health conditions like high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma. If your child shows any signs of stomach bleeding or symptoms related to heart problems or stroke, stop using the medication and seek medical advice immediately.

Geriatric Use

While there is no specific information about the use of this product in older adults, it is primarily intended for children aged 2 to 11 years. This means that if you are caring for an older adult, there are no established recommendations or precautions for their use of this medication.

It's always important to consult with a healthcare professional before starting any new medication, especially for older adults, as their health needs can be different from those of younger individuals.

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 may affect you differently due to your liver health.

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your liver condition. They can help monitor your health and make any necessary adjustments to your treatment plan.

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 stomach bleeding increases significantly. This risk is also heightened if they are taking other nonsteroidal anti-inflammatory drugs (NSAIDs), such as aspirin or naproxen.

If your child is prescribed a diuretic (a medication that helps remove excess fluid from the body), it's crucial to consult with a healthcare provider before starting ibuprofen. Always discuss any medications or tests with your healthcare provider to ensure safety and avoid serious complications.

Storage and Handling

To ensure the product remains effective and safe for use, store it at a temperature between 20° to 25°C (68° to 77°F). Before using, make sure to shake the bottle well to mix the contents properly. After each use, remember to replace the original bottle cap to keep it child-resistant, preventing accidental access by children.

When measuring your dose, always use the enclosed dosing cup provided with the product. Avoid using any other dosing devices, as they may not provide the correct amount needed for safe and effective use. Following these guidelines will help you handle the product safely and effectively.

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.

Make sure to keep this medication out of reach of children. In the event of an overdose, seek medical assistance immediately or contact a Poison Control Center at 1-800-222-1222.

FAQ

What is Children's Ibuprofen used for?

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

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.

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.

Can Children's Ibuprofen be used during pregnancy?

Safety during pregnancy has not been established, and it is contraindicated, especially during the third trimester due to potential risks to the fetus.

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

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

How should Children's Ibuprofen be stored?

Store Children's Ibuprofen between 20° to 25°C (68° to 77°F) and keep it out of reach of children.

Is Children's Ibuprofen safe for children under 2 years?

You should ask a doctor before giving Children's Ibuprofen to children under 2 years of age.

What should I do if my child does not get relief from pain or fever?

If your child does not experience relief within the first 24 hours of treatment, or if fever or pain worsens or lasts more than 3 days, consult a doctor.

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 is a nonsteroidal anti-inflammatory drug (NSAID) formulated as an oral suspension. Each 5 mL dose contains 100 mg of ibuprofen and is presented in a grape flavor. The product is alcohol-free, gluten-free, and paraben-free. It is designed for use in children aged 2 to 11 years and provides relief that lasts up to 8 hours. A dosage cup is included for accurate measurement. Users are advised to shake well before use and to read all product information prior to administration. The packaging features a tamper-evident neckband; do not use if the neckband is broken or missing.

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

Healthcare professionals should ensure that the product is administered according to the following guidelines. Prior to use, the product must be shaken well. The appropriate dose should 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 administration. No other dosing devices should be employed to ensure accurate dosing. The recommended dosing intervals are every 6 to 8 hours as needed, with a maximum of four doses per day.

The dosing chart is as follows:

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

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

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

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

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

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

It is imperative not to exceed the recommended dosage. After use, the original bottle cap should be replaced to maintain child resistance.

Contraindications

Use is contraindicated in the following situations:

Patients with a history of allergic reactions to ibuprofen or any other pain reliever or fever reducer should not use this product, as it may trigger severe allergic responses. Additionally, the product is contraindicated for use immediately before or after heart surgery due to potential complications associated with its effects on cardiovascular function.

Warnings and Precautions

Ibuprofen may induce severe allergic reactions, particularly in individuals with a known allergy to aspirin. Symptoms indicative of an allergic response 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 carries 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, or those taking other NSAIDs (including aspirin, ibuprofen, or naproxen). Additionally, exceeding the recommended dosage or duration of treatment increases the risk of gastrointestinal complications.

Healthcare professionals should be aware that the use of NSAIDs, excluding aspirin, is associated with 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.

In cases of severe or persistent sore throat, especially when accompanied by high fever, headache, nausea, or vomiting, immediate medical consultation is advised. Ibuprofen should not be administered for more than two days, nor should it be given to children under three years of age unless specifically directed by a healthcare provider.

Healthcare providers should instruct caregivers to discontinue use and seek medical advice 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 suggestive of heart problems or stroke, including chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling, warrant immediate medical evaluation.

If the child does not experience relief within the first 24 hours of treatment, or if fever or pain worsens or persists beyond three days, or if redness or swelling occurs in the affected area, medical consultation is necessary. Caregivers should also be vigilant for the emergence of any new symptoms and seek guidance accordingly.

Side Effects

Patients using ibuprofen should be aware of the potential for serious adverse reactions, including severe allergic reactions, which may manifest as hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, or blisters. Individuals with a known allergy to aspirin are particularly at risk.

The use of ibuprofen, as a nonsteroidal anti-inflammatory drug (NSAID), carries a warning for the possibility 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. It is crucial for patients to adhere to the recommended dosage and duration of treatment to minimize this risk.

Additionally, ibuprofen is associated with an increased risk of heart attack, heart failure, and stroke, particularly when used in higher doses or for extended periods. These cardiovascular events can be fatal, underscoring the importance of following dosing guidelines.

Patients should seek medical attention if they experience signs of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or 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 consultation with a healthcare provider.

It is advised that patients discontinue use and consult a doctor if they do 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.

Before initiating treatment with ibuprofen, patients should consult a healthcare professional if they have a history of stomach issues, have experienced serious side effects from pain relievers or fever reducers, are dehydrated, or have pre-existing conditions such as high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma. Special caution is advised for patients under a doctor's care for serious conditions or those taking other medications.

Drug Interactions

Ibuprofen has the potential to induce severe allergic reactions, particularly in individuals with a known allergy to aspirin. This risk necessitates careful consideration when prescribing ibuprofen to such patients.

In pediatric patients, the concomitant use of ibuprofen with anticoagulants or steroid medications significantly increases the risk of gastrointestinal bleeding. Therefore, it is imperative to monitor these patients closely and consider alternative pain management strategies if necessary.

Additionally, the risk of stomach bleeding is further elevated when ibuprofen is used in conjunction with other nonsteroidal anti-inflammatory drugs (NSAIDs), including both prescription and over-the-counter options such as aspirin and naproxen. Clinicians should exercise caution and evaluate the necessity of combining these medications.

For children who are prescribed diuretics, it is advisable to consult a healthcare professional prior to initiating ibuprofen therapy to ensure safe and effective use.

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 under 3 years of age should not use this product unless directed by a healthcare professional. For dosing, the following guidelines apply:

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

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

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

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

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

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

Healthcare professionals should advise parents to consult a doctor before use if the child has a history of stomach problems, is taking other medications, or has specific medical conditions such as high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma. Parents should also be instructed to discontinue use and seek medical advice if the child exhibits signs of stomach bleeding or symptoms indicative of heart problems or stroke. This product is intended for use in children aged 2-11 years.

Geriatric Use

Elderly patients have not been specifically studied in relation to the use of this product, and no recommendations or precautions are provided for this population. The product is primarily intended for use in children aged 2 to 11 years.

Healthcare providers should exercise caution when considering the use of this product in geriatric patients, as the absence of data may limit the understanding of its safety and efficacy in this age group. Monitoring for potential adverse effects is advised if the product is administered to elderly patients, given the lack of established guidelines or dosage adjustments for this demographic.

Pregnancy

The safety of ibuprofen during pregnancy has not been established. It is contraindicated in pregnancy, particularly during the third trimester, due to potential risks to the fetus. The use of nonsteroidal anti-inflammatory drugs (NSAIDs), including ibuprofen, during pregnancy may be associated with adverse fetal outcomes, such as cardiovascular effects and renal impairment.

Healthcare providers should be consulted before the use of ibuprofen in pregnant patients or those planning to become pregnant. It is essential to weigh the potential risks against the benefits when considering treatment options in this population.

Lactation

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

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

Overdosage of ibuprofen may lead to significant adverse effects that require prompt medical intervention.

Symptoms of Overdose Individuals experiencing an overdose may present with a range of symptoms, including nausea, vomiting, stomach pain, drowsiness, and dizziness. These manifestations can vary in severity and may necessitate immediate evaluation by healthcare professionals.

Recommended Actions In the event of an ibuprofen overdose, it is crucial to seek immediate medical attention. Healthcare providers should be contacted without delay, or alternatively, the local Poison Control Center should be reached for guidance on appropriate management strategies. Timely intervention is essential to mitigate potential complications associated with ibuprofen overdosage.

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 the medication. Reports include allergic reactions such as hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, and blisters. Additionally, instances of stomach bleeding have been noted, particularly in patients with a history of stomach ulcers or bleeding disorders, as well as those concurrently using anticoagulants or other nonsteroidal anti-inflammatory drugs (NSAIDs).

There is an increased risk of serious cardiovascular events, including heart attack, heart failure, and stroke, linked to NSAID use. Reports have also highlighted severe or persistent sore throat, especially when accompanied by high fever, headache, nausea, and vomiting.

Patients are advised to be vigilant for signs of stomach bleeding, which may manifest as feeling faint, vomiting blood, having bloody or black stools, or experiencing stomach pain that does not improve. Symptoms indicative of heart problems or stroke, such as chest pain, difficulty breathing, unilateral weakness, slurred speech, and leg swelling, should also be monitored closely.

Any new symptoms that arise during treatment should lead to immediate discontinuation of the medication and consultation with a healthcare provider.

Patient Counseling

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

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

Patients should be instructed to inform their healthcare provider if the child has not been drinking fluids or has lost a significant amount of fluid due to vomiting or diarrhea. It is also crucial to discuss any existing health conditions, including high blood pressure, heart disease, liver cirrhosis, kidney disease, or a history of stroke, as these may affect the safety of the medication.

Furthermore, patients should be advised to consult a doctor before use if the child has asthma or is taking a diuretic. It is essential to recommend that patients speak with a doctor or pharmacist if the child is under care for any serious condition or is taking any other medications.

Storage and Handling

The product is supplied in a configuration that ensures optimal use and safety. It should be stored at a temperature range of 20° to 25°C (68° to 77°F) to maintain its efficacy. Prior to each use, it is essential to shake the bottle well to ensure proper mixing of the contents.

To preserve child resistance, the original bottle cap must be replaced after each use. It is important to utilize only the enclosed dosing cup for administration; the use of any other dosing device is not recommended to ensure accurate dosing and safety.

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.

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 experience.

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.

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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.