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Ibuprofen

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Active ingredient
Ibuprofen 100 mg/5 mL
Other brand names
Drug class
Nonsteroidal Anti-inflammatory Drug
Dosage form
Suspension
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2002
Label revision date
February 13, 2026
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Ibuprofen 100 mg/5 mL
Other brand names
Drug class
Nonsteroidal Anti-inflammatory Drug
Dosage form
Suspension
Route
Oral
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2002
Label revision date
February 13, 2026
Manufacturer
Major Pharmaceuticals
Registration number
ANDA074937
NDC root
0904-5577
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

MAJOR® is a children's ibuprofen oral suspension designed to relieve minor aches and pains, such as those caused by the common cold, flu, sore throat, headache, and toothache. It contains ibuprofen (a type of medication that reduces inflammation and pain) at a concentration of 100 mg per 5 ml and is suitable for children aged 2 to 11 years. This medication also helps to reduce fever and provides relief that can last up to 8 hours.

MAJOR® is alcohol-free, paraben-free, and gluten-free, making it a gentle option for young ones. It comes in a pleasant grape flavor and includes a dosage cup for easy measurement.

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 is 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. You should find the right dose by referring to the dosing chart provided, which is based on weight. If you can't use weight, you can use age as a guide.

When measuring your dose, use only the enclosed dosing cup, as other devices may not provide accurate measurements. For children, if the dose is needed again, you can repeat it every 6 to 8 hours, but do not use it more than four times a day. After each use, remember to wash the dosing cup to keep it clean. Finally, always replace the original bottle cap to ensure it remains child-resistant and safe.

What to Avoid

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

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

Side Effects

Ibuprofen can cause serious allergic reactions, particularly in individuals who are allergic to aspirin. Signs of an allergic reaction may include hives, facial swelling, wheezing (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 symptoms such as faintness, vomiting blood, black or bloody stools, chest pain, difficulty breathing, or weakness on one side of the body, seek medical attention immediately. It's important to consult a doctor if your child has a severe sore throat with high fever or if symptoms worsen or persist beyond a few days. Always discuss any pre-existing health conditions or medications with a healthcare provider before use.

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 any skin rash, stop using the medication immediately and seek medical help. Additionally, be aware that ibuprofen can lead to severe stomach bleeding, particularly if your child has a history of stomach ulcers, is taking blood thinners or steroids, or is using other NSAIDs (nonsteroidal anti-inflammatory drugs) like aspirin or naproxen.

There is also an increased risk of heart attack and stroke associated with NSAIDs, so it’s important to use this medication only as directed. 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 not use ibuprofen for more than two days in children under three years old unless directed by a healthcare professional.

If you suspect an overdose, contact a Poison Control Center or seek emergency medical help immediately. You should also stop using ibuprofen and consult a doctor if your child experiences symptoms of stomach bleeding (like faintness, vomiting blood, or black stools), signs of heart problems or stroke (such as chest pain or weakness on one side of the body), or if their condition does not improve within 24 hours. Additionally, if fever or pain worsens or lasts more than three days, or if any new symptoms arise, it’s important to seek medical advice.

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

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 stated contraindications (conditions that would make the use of a drug inadvisable) or special precautions for pregnant individuals. Additionally, the insert does not provide any recommendations for dosage modifications for those who are pregnant.

While the absence of warnings may seem reassuring, it's always best to consult with your healthcare provider before taking any medication during pregnancy. They can provide personalized advice based on your specific situation and health needs.

Lactation Use

If you are breastfeeding and considering using ibuprofen, it's important to consult your doctor first. Currently, it is unclear whether ibuprofen passes into breast milk, which raises concerns about its potential effects on your nursing infant.

Due to the lack of thorough studies on how ibuprofen may affect breastfeeding babies, you should carefully weigh the benefits of taking this medication against any possible risks. Always prioritize your health and your baby's well-being by discussing any medications with your healthcare provider.

Pediatric Use

You should avoid using this medication in children under 3 years of age unless a doctor specifically advises it. For children aged 2 to 11 years, the dosage depends on their weight and age. For example, children weighing under 24 pounds should consult a doctor, while those weighing 24-35 pounds (ages 2-3) can take 5 mL, and the dosage increases with weight and age up to 15 mL for an 11-year-old weighing 72-95 pounds.

Before giving this medication, it's important to consult a doctor if your child has a history of stomach issues, has not been drinking fluids, or has lost a lot of fluid due to vomiting or diarrhea. Additionally, if your child has high blood pressure, heart disease, liver or kidney problems, asthma, or is taking certain other medications, you should seek medical advice first. When administering the medication, consider giving it with food or milk to help prevent stomach upset. If your child shows any signs of serious side effects, such as stomach bleeding or symptoms of heart problems, or if their condition does not improve within 24 hours, contact a doctor immediately.

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. If you or a loved one is an older adult, it’s always a good idea to discuss any medications with a healthcare provider. They can help ensure that the treatment is safe and appropriate, considering any unique health needs or conditions that may be present.

Since there are no dosage adjustments or special precautions mentioned for elderly patients, your healthcare provider will be the best resource for personalized advice. Always keep them informed about any other medications or health issues to ensure safe and effective care.

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 doctor 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 healthcare provider to ensure your safety and well-being.

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 (tests that check how well your liver is working) to ensure your safety and the effectiveness of your treatment.

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

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications or tests you may be taking. While there are no specific drug interactions or laboratory test interactions noted for this medication, your healthcare provider can help ensure that everything you are taking works well together and is safe for you.

Always feel free to ask questions and share your complete list of medications and any tests you might be undergoing. This way, you can avoid any potential issues and receive the best care possible.

Storage and Handling

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

By following these simple storage and handling guidelines, you can help maintain the integrity and effectiveness of your device.

Additional Information

You should take this medication orally. It's important to keep it out of reach of children to prevent accidental ingestion. If you suspect an overdose, seek medical help immediately or contact a Poison Control Center at 1-800-222-1222 for assistance.

FAQ

What is MAJOR®?

MAJOR® is a children's ibuprofen oral suspension that acts as a pain reliever and fever reducer. It contains 100 mg of ibuprofen per 5 mL and is suitable for children aged 2 to 11 years.

How should I dose MAJOR®?

Use the enclosed dosing cup to measure the dose based on your child's weight. For children weighing 24-35 lbs (2-3 years), the dose is 5 mL; for 36-47 lbs (4-5 years), it's 7.5 mL, and so on.

What should I do if my child has a stomach upset while taking MAJOR®?

If your child experiences a stomach upset, give MAJOR® with food or milk to help alleviate the discomfort.

What are the potential side effects of MAJOR®?

MAJOR® may cause severe allergic reactions, stomach bleeding, and increase the risk of heart attack or stroke. If your child experiences symptoms like faintness, vomiting blood, or chest pain, seek medical help immediately.

Can I use MAJOR® if my child has had an allergic reaction to ibuprofen before?

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

Is MAJOR® safe for use during pregnancy?

The provided information does not specify any risks or contraindications for using ibuprofen during pregnancy. Consult a doctor for personalized advice.

What should I do if my child does not get relief from MAJOR®?

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.

How should I store MAJOR®?

Store MAJOR® at 20-25°C (68-77°F) and do not freeze. Ensure the printed neckband is intact before use.

What should I do in case of an overdose?

In case of overdose, seek medical help or contact a Poison Control Center immediately 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

No description information is available for the specified drug.

Uses and Indications

This drug is indicated for the relief of minor aches and pains associated with the common cold, influenza, sore throat, headache, and toothache. Additionally, it is utilized to reduce fever.

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

Dosage and Administration

This product is intended for use in pediatric patients, and 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 consult a physician for patients weighing under 24 lbs (under 2 years of age).

For patients weighing between 24-35 lbs (2-3 years), the recommended dose is 5 mL. For those weighing 36-47 lbs (4-5 years), the dose increases to 7.5 mL. Patients weighing 48-59 lbs (6-8 years) should receive 10 mL, while those weighing 60-71 lbs (9-10 years) should be administered 12.5 mL. Finally, for patients weighing 72-95 lbs (11 years), the appropriate dose is 15 mL.

Dosing should be performed using only the enclosed dosing cup; other dosing devices are not recommended. Prior to administration, the product must be shaken well. If necessary, doses may be repeated every 6-8 hours, but the total daily administration should not exceed four doses. After each use, the dosing cup should be washed thoroughly.

To maintain child resistance, the original bottle cap must be replaced after each use. It is crucial to adhere strictly to the recommended dosages and not exceed the directed amounts.

Contraindications

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

Warnings and Precautions

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

This product contains a nonsteroidal anti-inflammatory drug (NSAID), which 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 prolonged 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, nor should it 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, if symptoms indicative of heart problems or stroke arise—such as chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling—medical attention should be sought without delay.

Furthermore, if the child does not experience relief within the first 24 hours of treatment, if fever or pain worsens or persists beyond three days, if redness or swelling occurs in the affected area, or if any new symptoms develop, it is essential to seek medical advice.

Side Effects

Patients using ibuprofen may experience a range of adverse reactions, which can vary in severity.

Severe allergic reactions have been reported, particularly in individuals with a known allergy to aspirin. Symptoms of such reactions may include hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, and blisters.

The use of ibuprofen, as a nonsteroidal anti-inflammatory drug (NSAID), carries a warning for potential 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 and naproxen. Additionally, exceeding the recommended dosage or duration of use increases the likelihood of stomach bleeding.

There is also a significant risk associated with NSAIDs, excluding aspirin, for heart attack, heart failure, and stroke, which can be fatal. This risk escalates with prolonged use or higher than recommended dosages.

Patients should be vigilant for signs of serious conditions, such as severe or persistent sore throat, especially when accompanied by high fever, headache, nausea, or vomiting, and should seek medical attention promptly. It is advised not to use ibuprofen for more than two days or in children under three years of age without a doctor's guidance.

Patients are instructed to discontinue use and consult a healthcare provider if they experience any signs of stomach bleeding, including feeling faint, vomiting blood, having bloody or black stools, or persistent stomach pain. Symptoms indicative of heart problems or stroke, such as chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling, also warrant immediate medical consultation. Furthermore, if there is no 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 new symptoms should also prompt a consultation.

Before using ibuprofen, it is essential for patients to consult a healthcare provider if any of the following apply: a history of stomach problems, previous serious side effects from pain relievers or fever reducers, dehydration, high blood pressure, heart disease, liver cirrhosis, kidney disease, a history of stroke, asthma, or if the patient is taking a diuretic. Additionally, patients under a doctor's care for any serious condition or those taking other medications should seek advice from a healthcare professional or pharmacist prior to use.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there is no information available regarding interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

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 doctor. For children aged 2 to 11 years, dosing is based on weight and age, as follows:

  • Under 24 lbs / Under 2 years: Ask 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

Before administering this product, healthcare professionals should advise parents to consult a doctor if the child has any of the following conditions: a history of stomach problems (e.g., heartburn), issues with pain relievers or fever reducers, dehydration from vomiting or diarrhea, high blood pressure, heart disease, liver cirrhosis, kidney disease, a history of stroke, asthma, or if the child is taking a diuretic.

When using this product, it is recommended to administer it with food or milk to minimize stomach upset. Parents should be instructed to stop use and seek medical advice if the child exhibits signs of stomach bleeding (e.g., feeling faint, vomiting blood, having bloody or black stools, or persistent stomach pain), symptoms of heart problems or stroke (e.g., chest pain, difficulty breathing, weakness on one side of the body, slurred speech, leg swelling), does not experience relief within 24 hours, has fever or pain that worsens or lasts more than 3 days, shows redness or swelling in the painful area, or develops any new symptoms.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any potential adverse effects or changes in efficacy, given the lack of targeted data for this population.

Pregnancy

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

Lactation

Nursing mothers should consult a doctor before using ibuprofen, as it is not known whether ibuprofen is excreted in human milk. Caution is advised when administering ibuprofen to nursing mothers due to the potential for excretion in breast milk and the risk to the infant. The effects of ibuprofen on a nursing infant are not well studied; therefore, nursing mothers should weigh the benefits against the potential risks.

Renal Impairment

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

Hepatic Impairment

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

In patients with liver cirrhosis, dosage adjustments may be necessary to avoid potential toxicity. Close monitoring of liver function tests is recommended throughout the treatment course. Additionally, patients with a history of significant liver disease, such as cirrhosis, should be evaluated for any contraindications related to their hepatic condition.

Regular assessment of liver enzymes and other relevant laboratory parameters is advised to ensure patient safety and therapeutic efficacy.

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. Symptoms of overdose may vary depending on the substance involved and the individual’s health status. Therefore, a thorough assessment and monitoring of the patient are essential to determine the appropriate course of action.

Management procedures may include supportive care, symptomatic treatment, and, if applicable, the administration of specific antidotes. Continuous evaluation of the patient's condition is necessary to address any complications that may arise during the management of an overdose.

Nonclinical Toxicology

No information is available regarding teratogenic effects. Additionally, there is no information provided concerning non-teratogenic effects. The insert does not contain any details related to nonclinical toxicology. Furthermore, there is no information available regarding animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions reported voluntarily or through surveillance programs. These include allergic reactions such as hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, and blisters. Additionally, cases of stomach bleeding have been noted, particularly in patients with a history of stomach ulcers or bleeding problems, or those concurrently using anticoagulants or other nonsteroidal anti-inflammatory drugs (NSAIDs).

There is an increased risk of heart attack, heart failure, and stroke associated with the use of NSAIDs. Reports have indicated that severe or persistent sore throat, especially when accompanied by high fever, headache, nausea, and vomiting, may suggest serious underlying conditions. Symptoms indicative of stomach bleeding include feeling faint, vomiting blood, having bloody or black stools, and experiencing stomach pain that does not improve. Furthermore, symptoms associated with heart problems or stroke may manifest as chest pain, difficulty breathing, weakness on one side of the body, slurred speech, and leg swelling.

Patients are advised that the emergence of new symptoms during treatment should lead to discontinuation of the medication and prompt consultation with a healthcare professional.

Patient Counseling

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

Providers should encourage patients to consult a doctor before use if any of the following conditions apply to the child: a warning for stomach bleeding, a history of stomach problems such as heartburn, previous serious side effects from pain relievers or fever reducers, insufficient fluid intake, significant fluid loss due to vomiting or diarrhea, high blood pressure, heart disease, liver cirrhosis, kidney disease, a history of stroke, asthma, or if the child is taking a diuretic.

Additionally, patients should be instructed to ask a doctor or pharmacist before use if the child is under medical care for any serious condition or is taking any other medications.

Patients should be advised to discontinue use and consult a doctor if the child exhibits any signs of stomach bleeding, including feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain. They should also seek medical attention if the child shows symptoms of heart problems or stroke, such as chest pain, difficulty breathing, weakness on one side of the body, slurred speech, or leg swelling. Furthermore, if the child does not experience relief within the first 24 hours of treatment, if fever or pain worsens or persists for more than three days, if redness or swelling occurs in the painful area, or if any new symptoms arise, patients should be instructed to contact their healthcare provider.

Storage and Handling

The product is supplied in configurations that include specific NDC numbers. It should be stored at a temperature range of 20-25°C (68-77°F) to maintain its integrity. Freezing is not permitted, as it may compromise the product's quality. Additionally, the product must not be used if the printed neckband is broken or missing, ensuring that only intact and properly labeled items are utilized.

Additional Clinical Information

The medication is administered orally. Clinicians should advise patients to keep the medication out of reach of children. In the event of an overdose, patients are instructed to seek medical assistance or contact a Poison Control Center immediately at 1-800-222-1222. No further 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.

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.