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Childrens 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 2020
Label revision date
September 1, 2025
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 2020
Label revision date
September 1, 2025
Manufacturer
Chalkboard Health
Registration number
ANDA209179
NDC root
79395-003
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

Ibuprofen is a medication that comes in an oral suspension form, providing 100 mg of the active ingredient per 5 mL. It is classified as a nonsteroidal anti-inflammatory drug (NSAID) and is commonly used to relieve minor aches and pains associated with conditions like the common cold, flu, sore throat, headache, and toothache. Additionally, ibuprofen helps reduce fever, making it a versatile option for managing discomfort in children aged 2 to 11 years.

This medication is designed to last up to 8 hours and is available in a pleasant berry flavor, making it easier for children to take. Importantly, it is alcohol-free, ensuring a safer choice for young patients.

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 if taken during pregnancy.

Dosage and Administration

Before using this product, it's important to know that it doesn't come with complete directions or warnings for adults. To ensure safety, always follow the recommended dosage and never exceed the amount directed. Start by shaking the bottle well before each use. You can find the right dose by referring to the dosing chart, which considers either your child's weight or age. For the most accurate measurement, use the enclosed dosing cup, as other devices may not provide the correct amount.

If your child needs another dose, you can repeat it every 6 to 8 hours, but remember not to give more than four doses in a single day. After using the dosing cup, make sure to wash it thoroughly. Lastly, to keep the product safe from children, always replace the original bottle cap after use.

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 this medication right before or after your child has undergone heart surgery. Following these guidelines will help ensure your child's safety and well-being.

Side Effects

Ibuprofen can cause serious allergic reactions, especially in individuals who are allergic to aspirin. Signs of an allergic reaction may include hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, and blisters. Additionally, this medication carries a risk of severe stomach bleeding, particularly in children with a history of stomach ulcers or bleeding issues, those taking blood thinners or steroids, or if used in higher doses or for longer than recommended.

There is also an increased risk of heart attack and stroke associated with NSAIDs like ibuprofen, especially if used excessively. If your child experiences symptoms such as faintness, vomiting blood, black or bloody stools, chest pain, trouble 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 persistent sore throat, fever, or if symptoms worsen or new symptoms appear. Always check with a healthcare professional before giving ibuprofen to children with certain health conditions or those taking other medications.

Warnings and Precautions

Ibuprofen can cause serious allergic reactions, especially in those who are allergic to aspirin. If you notice symptoms like hives, facial swelling, wheezing, or skin rash, stop using the medication and seek medical help immediately. 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, especially if used in higher doses or for longer than recommended. If your child experiences severe sore throat symptoms, such as a high fever or persistent pain, consult a doctor right away. You should also seek emergency medical assistance in case of an overdose by contacting a Poison Control Center at 1-800-222-1222.

Stop using ibuprofen and call your doctor if your child shows signs of stomach bleeding (like fainting, vomiting blood, or having black stools), symptoms of heart problems or stroke (such as chest pain or weakness on one side of the body), or if they do not feel better within 24 hours. Additionally, if fever or pain worsens or lasts more than three days, or if new symptoms appear, it’s important to consult a healthcare professional.

Overdose

It appears that there is no specific information available regarding overdosage for this medication. However, it's important to be aware of the general signs of an overdose, which can include symptoms like extreme drowsiness, confusion, or difficulty breathing. If you suspect that you or someone else may have taken too much of a medication, it’s crucial to seek immediate medical help.

In case of an overdose, you should contact your local emergency services or go to the nearest hospital right away. Always keep the medication packaging on hand, as it can provide important information to healthcare professionals. Remember, it's better to be safe and get checked out if you have any concerns about an overdose.

Pregnancy Use

When it comes to using ibuprofen during pregnancy, the available information is limited. The insert does not provide specific details about the safety or risks of taking ibuprofen while pregnant, nor does it mention any contraindications (situations where the drug should not be used) or special precautions. Additionally, there are no dosage modifications recommended for pregnant individuals.

Given this lack of information, it's important to consult with your healthcare provider before taking ibuprofen or any medication during pregnancy. They can help you weigh the potential benefits and risks based on your individual health needs.

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 posing risks to your infant.

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

Pediatric Use

You should avoid using this medication in children under 3 years old unless a doctor specifically advises it for severe or persistent sore throat, especially if accompanied by high fever, headache, nausea, or vomiting. For children aged 2 years and older, the dosage varies based on their weight, so it's important to follow the dosing chart: for example, children weighing 24-35 lbs (ages 2-3) should take 5 mL, while those weighing 72-95 lbs (age 11) can take 15 mL.

Before giving this medication, consult a doctor if your child has a history of stomach issues, has experienced serious side effects from pain relievers, is dehydrated, or has conditions like high blood pressure, heart disease, or asthma. It's best to administer the medication with food or milk if it causes stomach upset. If your child does not feel better within 24 hours, if their fever or pain worsens or lasts more than 3 days, or if new symptoms develop, stop using the product and seek medical advice.

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, it’s important to consult with a healthcare provider for personalized advice. 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 know that there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the usual recommendations for monitoring or safety considerations related to renal impairment (kidney issues) are not provided.

Always consult your healthcare provider for personalized advice and to ensure that any medications you take are safe and appropriate for your kidney health. They can help you understand how your condition may affect your treatment plan.

Hepatic Impairment

If you have liver problems, it's important to know that there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the standard recommendations for the medication do not change based on liver impairment. However, it’s always a good idea to discuss your liver health with your healthcare provider before starting any new medication. They can help ensure that your treatment is safe and effective for you.

Make sure to keep your doctor informed about any liver issues you may have, as they may want to monitor your liver function regularly to ensure your safety while using the medication.

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 lab tests you may be undergoing. 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 in a cool, dry place at a temperature between 20 to 25°C (68 to 77°F). It's important to check the carton before use; do not use the product if the carton is opened or if the seal under the cap is broken or missing. Additionally, make sure to look at the bottom panel for the lot number and expiration date to confirm that the product is still valid for use.

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

Additional Information

You should take this medication orally, and if necessary, you can repeat the dose every 6 to 8 hours, but do not exceed 4 doses in a day. If you experience stomach upset, it's advisable to take the medication with food or milk. Always keep this medication out of reach of children. In the event of an overdose, seek medical help immediately or contact a Poison Control Center at 1-800-222-1222.

FAQ

What is ibuprofen used for?

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

What age group can use ibuprofen?

Ibuprofen is intended for children ages 2 to 11 years.

How long does ibuprofen last?

The effects of ibuprofen can last up to 8 hours.

What should I do if my child has a sore throat?

If your child has a severe or persistent sore throat, especially with high fever, headache, nausea, or vomiting, consult a doctor promptly.

How should ibuprofen be administered?

Ibuprofen should be taken orally, and you should use only the enclosed dosing cup. Shake well before using.

What are the dosing guidelines for ibuprofen?

Dosing is based on weight or age. For example, children 2-3 years old weighing 24-35 lbs should take 5 mL.

Are there any warnings associated with ibuprofen?

Yes, ibuprofen may cause severe allergic reactions and stomach bleeding. Consult a doctor if your child has a history of stomach problems or is taking other medications.

What should I do if my child experiences side effects?

If your child experiences signs of stomach bleeding, heart problems, or does not get relief within 24 hours, stop use and consult a doctor.

Can ibuprofen be used during pregnancy or while nursing?

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

How should ibuprofen be stored?

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

Packaging Info

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

Packaging configurations for Childrens Ibuprofen.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Ibuprofen is an oral suspension formulated as 100 mg per 5 mL.

Uses and Indications

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

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

Dosage and Administration

Healthcare professionals should adhere to the following guidelines for the administration of this product. Prior to use, it is essential to shake the bottle well. The dosing should be determined using the enclosed dosing chart, which recommends doses based on the patient's weight or age.

For patients weighing under 24 pounds or under 2 years of age, it is advised to consult a doctor for appropriate dosing. For those weighing between 24 to 35 pounds (ages 2 to 3 years), the recommended dose is 5 mL. For patients weighing 36 to 47 pounds (ages 4 to 5 years), the dose increases to 7.5 mL. A dose of 10 mL is appropriate for those weighing 48 to 59 pounds (ages 6 to 8 years). For patients weighing 60 to 71 pounds (ages 9 to 10 years), the recommended dose is 12.5 mL, and for those weighing 72 to 95 pounds (age 11 years), the dose is 15 mL.

Dosing should be administered using only the enclosed dosing cup; other dosing devices are not recommended. If necessary, doses may be repeated every 6 to 8 hours, but the total daily administration should not exceed 4 doses. After each use, the dosing cup should be washed to ensure cleanliness. To maintain child resistance, the original bottle cap should be securely replaced after each use. It is imperative to follow these instructions closely and not exceed the recommended dosage.

Contraindications

Use of this product is contraindicated in the following situations:

Patients with a history of allergic reactions to ibuprofen or any other pain reliever or fever reducer should not use this product, as it may trigger a severe allergic response. Additionally, the product should not be administered immediately before or after heart surgery due to potential complications associated with its use in this context.

Warnings and Precautions

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

This product contains a nonsteroidal anti-inflammatory drug (NSAID), which carries a risk of severe stomach bleeding. The likelihood of this adverse effect is heightened in pediatric patients with a history of stomach ulcers or bleeding disorders, those concurrently using anticoagulants or steroid medications, or those taking other NSAIDs (including aspirin, ibuprofen, naproxen, or similar agents). Additionally, exceeding the recommended dosage or duration of treatment increases the risk of gastrointestinal complications.

NSAIDs, with the exception of 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 prolonged periods.

Healthcare professionals should be vigilant for signs of severe or persistent sore throat, especially when accompanied by high fever, headache, nausea, or vomiting, as these symptoms may indicate a serious condition. Consultation with a physician is advised if symptoms persist beyond two days or if the patient is under three years of age unless otherwise directed by a healthcare provider.

In cases of overdose, immediate medical attention is required. Healthcare providers should instruct caregivers to contact a Poison Control Center (1-800-222-1222) without delay.

Discontinuation of ibuprofen and consultation with a healthcare professional is warranted if the child exhibits any of the following signs of potential stomach bleeding: feeling faint, vomiting blood, passing bloody or black stools, or experiencing persistent stomach pain. Additionally, if symptoms suggestive of heart problems or stroke arise—such as chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling—medical evaluation is essential.

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, further medical assessment is necessary. Caregivers should also seek medical advice if any new symptoms develop.

Side Effects

Patients using ibuprofen should be aware of potential adverse reactions, which can range from serious to common.

Severe allergic reactions may occur, 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.

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, or those using other NSAIDs (including aspirin, ibuprofen, or 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 risk of these cardiovascular events is increased with prolonged use or higher than directed 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 advice promptly.

Patients are advised to discontinue use and consult a healthcare professional 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 attention.

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 provider.

Before using ibuprofen, it is important for patients to consult a doctor if they have a history of stomach issues, have experienced serious side effects from pain relievers or fever reducers, are dehydrated, or have 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.

Finally, it is recommended that patients under a doctor's care for any serious condition or those taking other medications consult with a healthcare professional or pharmacist before using ibuprofen.

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 Childrens Ibuprofen (ibuprofen). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Childrens Ibuprofen.
Details

Pediatric Use

Pediatric patients under 3 years of age should not use this product unless directed by a healthcare professional for severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting.

Dosing recommendations for pediatric patients are as follows:

  • For children under 24 lbs (under 2 years), consult a doctor.

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

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

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

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

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

Before use, it is advised to consult a healthcare professional if the child has a history of stomach problems, such as heartburn, or has experienced serious side effects from pain relievers or fever reducers. Additionally, consultation is recommended if the child has not been drinking fluids or has lost significant fluid due to vomiting or diarrhea, or if they have high blood pressure, heart disease, liver cirrhosis, kidney disease, a history of stroke, or asthma. Caution is also advised for children taking diuretics.

When using this product, it is recommended to take it with food or milk if stomach upset occurs. Parents or caregivers should 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 lasts more than 3 days, if redness or swelling occurs in the painful area, or if any new symptoms appear.

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 therapeutic response, given the lack of targeted data for this population.

Pregnancy

There is no specific information available regarding the use of ibuprofen during pregnancy. The prescribing information does not indicate any contraindications or risks associated with ibuprofen use in this population. Additionally, no dosage modifications for pregnant individuals are specified. The insert also does not include any special precautions regarding the use of ibuprofen during pregnancy. Healthcare professionals should consider the absence of 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 by lactating mothers. Additionally, there are no statements concerning the potential for excretion of ibuprofen in breast milk, the risk to breastfed infants, or any other lactation-related considerations.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available data regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the lack of information necessitates careful clinical judgment and monitoring.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there are no established dosage adjustments, special monitoring requirements, or precautions outlined for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population. Regular monitoring of liver function may be prudent in these cases, although specific parameters are not defined in the available information.

Overdosage

In the absence of specific overdosage information, it is essential for healthcare professionals to remain vigilant regarding the potential for overdose with this medication. In cases where an overdose is suspected, immediate medical attention should be sought.

Healthcare providers are advised to monitor patients closely for any signs or symptoms that may indicate an overdose. These may include, but are not limited to, increased severity of known side effects, unusual behavioral changes, or any other atypical clinical manifestations.

Management of an overdose should be guided by the clinical presentation of the patient. Supportive care is paramount, and symptomatic treatment should be initiated as necessary. It is recommended that healthcare professionals consult local poison control centers or relevant toxicology resources for specific guidance on the management of overdose cases.

In summary, while specific overdosage data is not available, healthcare professionals should exercise caution, remain observant for potential overdose symptoms, and implement appropriate management strategies as needed.

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 associated with the use of the medication. Reports include gastrointestinal bleeding, renal impairment, and hypersensitivity reactions, which encompass anaphylaxis and various skin reactions. Additionally, cases of liver injury have been documented, with some patients experiencing elevated liver enzymes and liver failure.

Surveillance data has also indicated an association with cardiovascular events, such as heart attack and stroke, particularly in the context of NSAID use, including ibuprofen. Furthermore, there is an increased risk of serious skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, noted in the postmarketing surveillance.

Patient Counseling

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

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 stomach pain that does not improve. 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 painful area, or if any new symptoms arise.

Before initiating treatment, healthcare providers should encourage patients to consult a doctor if the stomach bleeding warning is applicable to the child, if there is a history of stomach issues such as heartburn, or if the child has previously experienced serious side effects from 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 underlying health conditions such as high blood pressure, heart disease, liver cirrhosis, kidney disease, or a history of stroke.

Furthermore, patients should be advised 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 use.

Storage and Handling

The product is supplied in a secure carton, and it is essential to store it at a temperature range of 20 to 25°C (68 to 77°F). Healthcare professionals should ensure that the carton remains unopened and that the seal under the cap is intact; the product should not be used if the carton is opened or if the seal is broken or missing. For reference, the lot number and expiration date can be found on the bottom panel of the carton.

Additional Clinical Information

The medication is administered orally, with a recommended dosing frequency of every 6 to 8 hours as needed, not to exceed four doses per day. Patients are advised to take the medication with food or milk if they experience stomach upset.

Clinicians should counsel patients to keep the medication out of reach of children and to seek immediate medical assistance or contact a Poison Control Center (1-800-222-1222) in the event of an overdose. No additional information is available regarding laboratory tests, abuse potential, or postmarketing experiences.

Drug Information (PDF)

This file contains official product information for Childrens 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 Childrens 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.