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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 1999
Label revision date
February 21, 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 1999
Label revision date
February 21, 2026
Manufacturer
HyVee Inc
Registration number
ANDA074937
NDC root
42507-897
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (2 NDCs)
Packaging & NDC Codes (2)

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 an oral suspension medication designed for children aged 2 to 11 years. It contains 100 mg of ibuprofen per 5 mL and is commonly used to relieve minor aches and pains associated with conditions like the common cold, flu, sore throat, headache, and toothache. Additionally, it helps reduce fever, providing comfort when your child is feeling unwell.

As a nonsteroidal anti-inflammatory drug (NSAID), Children's Ibuprofen works by blocking certain substances in the body that cause pain and inflammation. This berry-flavored, alcohol-free suspension lasts up to 8 hours, making it a convenient option for managing your child's discomfort.

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 know that it doesn't come with complete instructions 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. If possible, use your child's weight to determine the dose; if not, you can use their age instead.

Make sure to use only the enclosed dosing cup to measure the medication, as other devices may not provide accurate measurements. Depending on your child's needs, you can repeat the dose every 6 to 8 hours, but remember not to give more than four doses in a single day. After each use, wash the dosing cup to keep it clean, and always replace the original bottle cap to ensure it remains child-resistant. If your child weighs under 24 pounds (or is under 2 years old), consult a doctor for guidance on the appropriate dosage.

What to Avoid

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

Always consult with a healthcare professional if you have any concerns or questions about your child's health and medication use. Your child's well-being is the top priority, and understanding these guidelines helps keep them safe.

Side Effects

You should be aware of some potential side effects when using this medication. A severe allergic reaction is possible, especially if you or your child is allergic to aspirin. Symptoms may include hives, facial swelling, wheezing, shock, skin reddening, rash, or blisters. Additionally, this medication can increase the risk of severe stomach bleeding, particularly if there is a history of stomach ulcers, bleeding problems, or if other blood-thinning medications are being taken.

There is also a risk of heart attack, heart failure, and stroke associated with nonsteroidal anti-inflammatory drugs (NSAIDs), especially if used in higher doses or for longer than recommended. If you notice signs of stomach bleeding, such as faintness, vomiting blood, or black stools, or symptoms of heart problems like chest pain or difficulty breathing, seek medical attention immediately. It's important to consult a doctor if your child has a history of stomach issues, is dehydrated, or has other serious health conditions before using this medication.

Warnings and Precautions

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

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

For children, do not use ibuprofen for more than two days without consulting a doctor, especially if they are under three years old. If your child does not feel better within 24 hours, if their fever or pain worsens or lasts more than three days, or if any new symptoms appear, stop use and call your doctor. In case of an overdose, seek medical help or contact a Poison Control Center immediately at 1-800-222-1222.

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 safety is the top priority.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that the safety of ibuprofen has not been established. In fact, using ibuprofen during pregnancy, especially in the third trimester, is not recommended because it can pose risks to your baby. These risks may include potential cardiovascular issues and kidney problems for the fetus.

Before taking ibuprofen, you should always consult your healthcare provider, particularly if you are in the later stages of your pregnancy. They can help you understand the safest options for managing any discomfort you may experience.

Lactation Use

If you are breastfeeding and considering using ibuprofen, it's important to consult your doctor first. While ibuprofen can be helpful for pain relief, there is a possibility that it can pass into your breast milk. The effects of ibuprofen on nursing infants haven't been thoroughly studied, so it's wise to be cautious.

If you do take ibuprofen while breastfeeding, keep an eye on your baby for any unusual reactions or side effects. Monitoring your infant can help ensure their safety while you manage your own discomfort.

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 10 years, the dosage depends on their weight. For example, if your child weighs under 24 lbs and is under 2 years old, you should consult a doctor for the appropriate dose. For children weighing 24-35 lbs (ages 2-3), the dose is 5 mL; for those weighing 36-47 lbs (ages 4-5), it's 7.5 mL; for 48-59 lbs (ages 6-8), it's 10 mL; for 60-71 lbs (ages 9-10), it's 12.5 mL; and for 72-95 lbs (age 11), it's 15 mL.

Always follow the dosing instructions carefully and do not exceed the recommended amount. You can repeat the dose every 6-8 hours if necessary, but do not give more than four doses in a day. Keep the medication out of reach of children, and in case of an overdose, seek medical help or contact a Poison Control Center immediately.

Geriatric Use

When it comes to using this medication in older adults, there is no specific information available about dosage adjustments, safety concerns, or special precautions. This means that if you or a loved one is an older adult considering this medication, it’s important to consult with a healthcare provider. They can help determine the best approach based on individual health needs and any other medications being taken. Always prioritize open communication with your healthcare team to ensure safe and effective treatment.

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 may suggest adjustments to your dosage or additional monitoring to ensure your health and safety. Always prioritize open communication with your healthcare provider regarding your kidney health and any medications you are considering.

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 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 supplements during your appointments. This way, you can receive the best possible care tailored to your needs.

Storage and Handling

To ensure the safety and effectiveness of your product, store it at a temperature between 20-25°C (68-77°F). It's important to keep it away from freezing temperatures, as freezing can damage the product. Before use, check the printed neckband; do not use the product if it is broken or missing, as this could indicate a safety issue.

By following these simple storage and handling guidelines, you can help maintain the quality and reliability of your product.

Additional Information

You should take this medication orally, and if necessary, you can repeat the dose every 6 to 8 hours. However, do not exceed four doses in a single day. It's important 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 for help.

FAQ

What is Children's Ibuprofen?

Children's Ibuprofen is an oral suspension that contains 100 mg of ibuprofen per 5 mL, used as a pain reliever and fever reducer.

What conditions does Children's Ibuprofen relieve?

It relieves minor aches and pains due to the common cold, flu, sore throat, headache, and toothache, and it also reduces fever.

What is the recommended age for using Children's Ibuprofen?

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

How should I dose Children's Ibuprofen?

You should find the right dose on the dosing chart based on your child's weight. Use only the enclosed dosing cup and do not exceed the recommended dose.

What should I do if my child experiences stomach bleeding?

If your child shows signs of stomach bleeding, such as feeling faint, vomiting blood, or having bloody or black stools, stop use and consult a doctor immediately.

Can I give Children's Ibuprofen to my child if they have had an allergic reaction to ibuprofen before?

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

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 due to potential risks to the fetus.

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.

How should I store Children's Ibuprofen?

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

What are the side effects of Children's Ibuprofen?

Possible side effects include severe allergic reactions, stomach bleeding, and increased risk of heart attack or stroke. Consult a doctor if any severe symptoms occur.

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 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 children, and healthcare professionals should refer to the dosing chart to determine the appropriate dosage based on the child's weight or age. It is essential to shake the product well before each use. The enclosed dosing cup must be used for accurate measurement; no other dosing devices should be employed.

For children weighing under 24 lbs (under 2 years), consultation with a doctor is required before administration. For children 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. Children weighing 48-59 lbs (6-8 years) should receive 10 mL, while those weighing 60-71 lbs (9-10 years) should be given 12.5 mL. For children weighing 72-95 lbs (11 years), the appropriate dose is 15 mL.

If necessary, doses may be repeated every 6-8 hours, but it is crucial not to exceed 4 doses in a 24-hour period. After each use, the dosing cup should be washed thoroughly to ensure hygiene. To maintain child resistance, the original bottle cap should be replaced securely after each use. It is important to adhere strictly to the recommended dosages and consult a healthcare professional if there are any uncertainties regarding administration.

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 immediately before or after heart surgery due to potential complications associated with surgical recovery.

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 is associated with an increased risk of severe stomach bleeding. The likelihood of such an event 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, naproxen, or similar agents). Additionally, exceeding the recommended dosage or duration of treatment may further elevate this risk.

Healthcare professionals should be aware that the use of NSAIDs, excluding aspirin, is linked to an increased risk of heart attack, heart failure, and stroke, which can be fatal. This risk is particularly pronounced when the medication is used in excess of the recommended dosage or for extended periods.

In cases of severe or persistent sore throat, especially when accompanied by high fever, headache, nausea, or vomiting, immediate medical consultation is advised. The use of ibuprofen should not exceed two days for sore throat relief, nor should it be administered to children under three years of age unless specifically directed by a physician.

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 indicative 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. Any new symptoms that arise should also prompt a discussion with a healthcare professional.

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

Side Effects

Patients may experience a range of adverse reactions associated with the use of this medication. Serious adverse reactions include severe allergic reactions, which may manifest as hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, or blisters. Such reactions are particularly concerning in individuals with a known allergy to aspirin.

The medication carries a warning for severe stomach bleeding, which is more likely to occur in patients with a history of stomach ulcers or bleeding problems, those taking anticoagulants or steroid drugs, or those using other nonsteroidal anti-inflammatory drugs (NSAIDs) such as aspirin, ibuprofen, or naproxen. The risk of stomach bleeding is also heightened if the medication is taken in higher doses or for extended periods beyond the recommended duration.

Additionally, the use of NSAIDs, excluding aspirin, is associated with 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.

Patients should be vigilant for signs of severe or persistent sore throat, especially when accompanied by high fever, headache, nausea, or vomiting, and should seek medical advice promptly. The medication should not be used for more than two days or in children under three years of age unless directed by a healthcare provider.

Patients are advised to discontinue use and consult a doctor if they experience symptoms indicative of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or persistent stomach pain. Signs of heart problems or stroke, including chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling, also warrant immediate medical attention. Furthermore, if relief is not achieved within the first 24 hours of treatment, or if fever or pain worsens or persists beyond three days, medical consultation is recommended.

Before using this medication, it is essential to consult a healthcare provider if the patient has a history of stomach problems, has experienced serious side effects from pain relievers or fever reducers, is dehydrated, or has underlying conditions such as high blood pressure, heart disease, liver cirrhosis, kidney disease, or a history of stroke. Patients with asthma or those taking diuretics should also seek medical advice prior to use.

It is contraindicated to use this medication in patients with a known allergy to ibuprofen or any other pain reliever or fever reducer. Additionally, it should not be administered immediately before or after heart surgery.

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 medication unless directed by a healthcare professional. For dosing, the following guidelines apply:

  • For patients weighing under 24 lbs and under 2 years of age, a doctor should be consulted for the appropriate dose.

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

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

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

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

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

Dosing should not exceed the recommended amounts, with a maximum of 4 doses per day. If needed, doses may be repeated every 6-8 hours. It is essential to keep this medication out of reach of children. In the event of an overdose, immediate medical assistance or contact with a Poison Control Center is advised.

Geriatric Use

There is no specific information regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy, given the lack of targeted clinical data in this population.

Pregnancy

The safety of ibuprofen during pregnancy has not been established. Ibuprofen is contraindicated in pregnancy, particularly during the third trimester, due to the risk of fetal harm. The use of ibuprofen during pregnancy may be associated with risks such as fetal cardiovascular effects and the potential for renal impairment in the fetus.

Pregnant women should consult a healthcare provider before using ibuprofen, especially if they are in the later stages of pregnancy. It is essential for healthcare professionals to advise women of childbearing potential about these risks and the importance of discussing any medication use during pregnancy with their healthcare provider.

Lactation

Nursing mothers should consult a doctor before using ibuprofen. There is a potential for excretion of ibuprofen in breast milk. The effects of ibuprofen on a nursing infant are not well studied; therefore, caution is advised. It is recommended to monitor the infant for any adverse effects if the mother is taking ibuprofen while breastfeeding.

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.

Healthcare providers should consider the overall health status of patients, including any coexisting conditions such as high blood pressure, heart disease, or kidney disease, which may further complicate treatment in this population. Regular follow-up and assessment of liver function are crucial 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 effectively. Symptoms of overdose may vary depending on the substance involved, and healthcare providers should be prepared to assess and address any potential complications that may arise.

Management procedures may include supportive care, monitoring of vital signs, and symptomatic treatment as necessary. It is essential for healthcare professionals to remain vigilant and act swiftly to mitigate the effects 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, as well as 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 also indicated that severe or persistent sore throat, especially when accompanied by high fever, headache, nausea, and vomiting, may suggest serious underlying conditions. Other adverse reactions may present as symptoms indicative of heart problems or stroke, including chest pain, difficulty breathing, unilateral weakness, slurred speech, and leg swelling.

Patient Counseling

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

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

Patients should also be counseled to stop use and consult a doctor if the child does not experience relief within the first 24 hours of treatment, if fever or pain worsens or persists beyond three days, if there is redness or swelling in the affected area, or if any new symptoms arise.

Before initiating treatment, healthcare providers should recommend that patients consult a doctor if the stomach bleeding warning is applicable to their child, if the child has a history of stomach issues like heartburn, or if there have been previous adverse reactions to pain relievers or fever reducers. It is also important to advise patients to seek medical advice if the child has not been adequately hydrated, has lost significant fluids due to vomiting or diarrhea, or has pre-existing conditions such as high blood pressure, heart disease, liver cirrhosis, kidney disease, or a history of stroke.

Furthermore, patients should be encouraged to consult a doctor before use if the child has asthma, is taking a diuretic, or is under medical care for any serious condition. Lastly, it is prudent for patients to discuss with a doctor or pharmacist any other medications the child may be taking prior to starting treatment.

Storage and Handling

The product is supplied in a configuration that includes specific NDC numbers, which should be referenced for accurate identification. It is essential to store the product at a temperature range of 20-25°C (68-77°F) to maintain its integrity and efficacy. Freezing the product is strictly prohibited, as it may compromise its quality.

Healthcare professionals should ensure that the product is not used if the printed neckband is broken or missing, as this may indicate tampering or compromise of the product's safety. Proper handling and adherence to these storage conditions are crucial for optimal product performance.

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 in a 24-hour period. Clinicians should advise 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.

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.