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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 2021
Label revision date
November 8, 2024
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 2021
Label revision date
November 8, 2024
Manufacturer
Rite Aid Corporation
Registration number
ANDA074916
NDC root
11822-6159
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 berry flavor. It effectively relieves minor aches and pains associated with common conditions like the cold, flu, sore throat, headache, and toothache, while also helping to lower fever.

This medication is alcohol-free, paraben-free, and dye-free, making it a gentle option for your child. It provides relief that can last up to 8 hours, ensuring your little one feels more comfortable during their recovery. Always remember to read the product information carefully before use.

Uses

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

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

Dosage and Administration

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

You should not take more than the recommended dose. If needed, you can repeat the dose every 6 to 8 hours, but do not exceed four doses in a single day. After using the medication, remember to securely replace the original bottle cap to keep it safe from children. If you have any questions or concerns about the dosage, it's best to consult a doctor.

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, 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. If your child does not feel better within 24 hours, or if fever or pain worsens or lasts more than three days, contact a healthcare professional. Always consult a doctor before use if your child has a history of stomach issues, is dehydrated, or has other serious health conditions.

Warnings and Precautions

Ibuprofen can cause serious allergic reactions, especially if you are allergic to aspirin. Symptoms may include hives, facial swelling, wheezing, shock, skin reddening, rash, or blisters. If you experience any of these symptoms, stop using the medication 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 chest pain, trouble breathing, or weakness, 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 have a severe sore throat with high fever, headache, nausea, or vomiting. If your child does not feel better within 24 hours, or if their fever or pain worsens or lasts more than three days, seek medical advice. In case of an overdose, get medical help or contact a Poison Control Center immediately at 1-800-222-1222.

Overdose

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

If you suspect an overdose, seek immediate medical help or contact a Poison Control Center right away. Acting quickly can make a significant difference in ensuring safety and health.

Pregnancy Use

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

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

Lactation Use

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

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

Pediatric Use

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 depends on their weight. For example, if your child weighs under 24 pounds and is under 2 years old, consult a doctor before administering the medication.

Here’s a quick guide for dosing based on weight and age: for children weighing 24-35 pounds (ages 2-3 years), the dose is 5 mL; for those weighing 36-47 pounds (ages 4-5 years), it's 7.5 mL; for 48-59 pounds (ages 6-8 years), the dose is 10 mL; for 60-71 pounds (ages 9-10 years), it's 12.5 mL; and for children weighing 72-95 pounds (age 11 years), the dose is 15 mL. Always follow these guidelines to ensure your child's safety.

Geriatric Use

When it comes to using this medication in older adults, the insert does not provide specific guidelines or recommendations. This means there are no particular dosage adjustments, safety concerns, or special precautions outlined for elderly patients.

If you are caring for an older adult, it's always a good idea to consult with a healthcare professional about their individual needs and any potential risks associated with medications, even if no specific geriatric considerations are mentioned.

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.

It's always best to discuss your individual situation with your healthcare provider, who can offer personalized advice and ensure that any medications you take are safe and appropriate for your kidney health.

Hepatic Impairment

If you have liver 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 standard recommendations apply, but you should always consult your healthcare provider for personalized advice. They can help determine the best approach for your treatment and monitor your liver function as needed.

Make sure to keep your doctor informed about your liver health, as they may want to conduct regular tests to ensure your safety while using any medication. Your well-being is a priority, so don't hesitate to ask questions or express any concerns you may have.

Drug Interactions

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

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

Storage and Handling

To ensure the product remains effective and safe for use, store it in a cool, dry place at a temperature between 20° to 25°C (68° to 77°F). Before using, make sure to shake the bottle well. It's important to use only the enclosed dosing cup for measuring your dose; avoid using any other devices to ensure accurate dosing. After opening, please discard the product if applicable to maintain safety.

Additionally, always remember to replace the original bottle cap after use to keep it child-resistant, helping to prevent accidental ingestion by children. Following these guidelines will help you use the product safely and effectively.

Additional Information

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

It's important to keep this medication out of reach of children. If your child shows any signs of stomach bleeding or symptoms related to heart problems or stroke, stop using the medication and consult a doctor immediately. In case of an overdose, seek medical help or contact a Poison Control Center at 1-800-222-1222 right away.

FAQ

What is Children's Ibuprofen used for?

Children's Ibuprofen is a fever reducer and pain reliever that helps relieve 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.

How often can I give Children's Ibuprofen?

You can repeat the dose every 6-8 hours, but do not use more than 4 times a day.

Are there any warnings associated with Children's Ibuprofen?

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

Can I use Children's Ibuprofen for children under 2 years?

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

Is Children's Ibuprofen safe during pregnancy or breastfeeding?

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

What should I do in case of an overdose?

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) immediately.

How should I store Children's Ibuprofen?

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

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 non-steroidal anti-inflammatory drug (NSAID) formulated as an oral suspension. Each 5 mL dose contains 100 mg of ibuprofen. The product is designed for children aged 2 to 11 years and is presented in a berry flavor. It is free from dyes, alcohol, and parabens, ensuring a non-staining formulation. A dosage cup is included for accurate measurement, and the effects of the medication can last up to 8 hours.

Uses and Indications

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

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

Dosage and Administration

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

For patients weighing under 24 pounds or under 2 years of age, it is advised to consult a physician for the appropriate dose. For patients weighing 24 to 35 pounds (2-3 years), the recommended dose is 5 mL. For those weighing 36 to 47 pounds (4-5 years), the dose is 7.5 mL. Patients weighing 48 to 59 pounds (6-8 years) should receive 10 mL, while those weighing 60 to 71 pounds (9-10 years) should be administered 12.5 mL. For patients weighing 72 to 95 pounds (11 years), the dose is 15 mL.

If necessary, doses may be repeated every 6 to 8 hours, but it is crucial not to exceed four doses in a 24-hour period. After use, the original bottle cap should be replaced to ensure child resistance. Healthcare professionals should not exceed the recommended dosage and should always follow the guidance of a physician when determining the appropriate dose.

Contraindications

Use is contraindicated in children 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 cause severe allergic reactions, particularly in individuals with a known allergy to aspirin. Symptoms indicative of an allergic reaction 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.

The use of ibuprofen, an NSAID, carries a risk of severe stomach bleeding. This risk is heightened in pediatric patients with a history of stomach ulcers or bleeding disorders, those concurrently taking anticoagulants or steroid medications, or those using other NSAIDs (including aspirin, ibuprofen, or naproxen). Additionally, exceeding the recommended dosage or duration of treatment increases the likelihood of gastrointestinal complications.

Healthcare professionals should be aware that NSAIDs, excluding aspirin, are 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 used for more than two days in such instances, 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 ibuprofen 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. Any new symptoms that arise should also prompt a discussion with a healthcare provider.

In the event of an overdose, it is crucial to seek medical help or contact a Poison Control Center (1-800-222-1222) without delay.

Side Effects

Patients using ibuprofen may experience a range of adverse reactions, some of which can be serious.

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 is associated with an increased risk of severe stomach bleeding, particularly in patients with a history of stomach ulcers or bleeding problems, those taking anticoagulants or steroid medications, and individuals using other NSAIDs, including aspirin and naproxen. The risk of stomach bleeding is heightened if the medication is taken in higher doses or for extended periods beyond the recommended guidelines.

Additionally, ibuprofen carries warnings regarding the potential for heart attack, heart failure, and stroke, which can be fatal. The likelihood of these cardiovascular events increases with prolonged use or higher-than-recommended dosages.

Patients should be advised to discontinue use and consult a healthcare provider 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 medical attention. Furthermore, if a patient does not achieve relief within the first 24 hours of treatment, or if fever or pain worsens or persists beyond three days, they should seek medical advice. Redness or swelling in the painful area or the emergence of new symptoms should also prompt consultation with a healthcare professional.

Before initiating treatment with ibuprofen, it is advisable for patients to consult a healthcare provider if they have a history of stomach issues, have experienced serious side effects from pain relievers or fever reducers, are dehydrated, or have 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.

In summary, while ibuprofen can be effective for pain and fever relief, careful consideration of potential adverse reactions and appropriate medical consultation is essential for safe use.

Drug Interactions

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

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

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

Packaging & NDC

Below are the non-prescription pack sizes of 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 children aged 2 to 11 years, dosing is based on weight as follows:

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

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

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

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

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

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

This product is specifically intended for use in children, and careful adherence to the dosing guidelines is essential for safety and efficacy.

Geriatric Use

Geriatric patients may not have specific use information provided in the prescribing information. There are no recommended age considerations, dosage adjustments, safety concerns, or special precautions outlined for elderly patients. Healthcare providers should exercise clinical judgment when prescribing this medication to geriatric patients, considering individual patient factors and potential age-related physiological changes that may affect drug metabolism and response. Regular monitoring and assessment of therapeutic outcomes are advised to ensure safety and efficacy in this population.

Pregnancy

There are no specific statements regarding the use of ibuprofen during pregnancy in the provided information. The prescribing information does not mention any contraindications or risks associated with ibuprofen use during this period. Additionally, no dosage modifications for pregnant individuals are provided, nor are there any special precautions outlined 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

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 no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the text. Therefore, healthcare professionals should exercise caution and consider individual patient factors when prescribing to patients with reduced kidney function. Regular monitoring of renal function may be warranted in these patients, although specific guidelines are not outlined.

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 for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population. Regular monitoring of liver function may be prudent in these cases, although specific parameters are not defined in the available information.

Overdosage

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

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

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 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 disorders, or those concurrently using anticoagulants or other nonsteroidal anti-inflammatory drugs (NSAIDs).

There is an increased risk of cardiovascular events, including heart attack, heart failure, and stroke, especially with prolonged use or doses exceeding the recommended levels. Reports have also indicated that severe or persistent sore throat, or sore throat accompanied by high fever, headache, nausea, and vomiting, may suggest serious underlying conditions.

Symptoms indicative of stomach bleeding include feeling faint, vomiting blood, passing 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, unilateral weakness, slurred speech, and leg swelling. It is advised that any new symptoms arising during treatment should lead to discontinuation of the medication and prompt 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 crucial to inform patients that this medication should not be used if the child has a history of allergic reactions to ibuprofen or any other pain reliever or fever reducer. Additionally, patients should be cautioned against using this product right before or after heart surgery.

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. Furthermore, healthcare providers should emphasize the importance of stopping use and seeking 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 informed 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.

When administering this product, patients should be advised to take it with food or milk if stomach upset occurs. Healthcare providers should encourage patients to consult a doctor before use if the child has a history of stomach problems, such as heartburn, or if the stomach bleeding warning applies. It is also important to ask a doctor before use if the child has experienced serious side effects from pain relievers or fever reducers, has not been drinking fluids, or has lost significant fluid due to vomiting or diarrhea.

Patients should be advised to seek medical guidance before use if the child has high blood pressure, heart disease, liver cirrhosis, kidney disease, or a history of stroke. Additionally, it is essential to consult a doctor before use if the child has asthma, is taking a diuretic, or is under a doctor's care for any serious condition. Lastly, patients should be encouraged to speak with a doctor or pharmacist before use if the child is taking any other medications.

Storage and Handling

The product is supplied in a configuration that includes an enclosed dosing cup, which is the only approved device for measuring doses. It is essential to shake the product well before use to ensure proper mixing.

For optimal storage, the product should be kept at a temperature range of 20° to 25°C (68° to 77°F). To maintain child resistance, the original bottle cap must be replaced after each use. It is advised to discard the product after opening if applicable, to ensure safety and efficacy.

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 discontinue use and seek medical attention if a child shows signs of stomach bleeding or symptoms indicative of heart problems or stroke. It is crucial to keep the medication out of reach of children, and in the event of an overdose, patients should obtain medical help or contact a Poison Control Center immediately at 1-800-222-1222.

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.