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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
August 21, 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 1999
Label revision date
August 21, 2025
Manufacturer
ATLANTIC BIOLOGICALS CORP.
Registration number
ANDA074937
NDC root
17856-5310
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 berry-flavored oral suspension designed for children aged 2 to 11 years. It contains 100 mg of ibuprofen (a type of medication that helps reduce pain and fever) per 5 mL and is alcohol-free. This medication is commonly used to relieve minor aches and pains associated with conditions like the common cold, flu, sore throat, headache, and toothache, as well as to reduce fever. Its effects can last for up to 8 hours, making it a helpful option for managing discomfort in children.

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 product, make sure to shake the bottle well. It's important to follow the dosing chart to find the right amount for you or your child. If possible, use weight to determine the dose; if not, you can use age. Always use the enclosed dosing cup to measure the liquid, as other devices may not provide accurate measurements.

For children under 2 years old who weigh less than 24 pounds, it's best to consult a doctor for the appropriate dose. For children aged 2 to 3 years and weighing between 24 and 35 pounds, the dose is 5 mL. If your child is 4 to 5 years old and weighs between 36 and 47 pounds, the dose increases to 7.5 mL. For those aged 6 to 8 years and weighing 48 to 59 pounds, the dose is 10 mL. Children aged 9 to 10 years who weigh between 60 and 71 pounds should take 12.5 mL, and for an 11-year-old weighing between 72 and 95 pounds, the dose is 15 mL.

You can repeat the dose every 6 to 8 hours if needed, but do not exceed 4 doses in a single day. After each use, wash the dosing cup to keep it clean, and remember to replace the original bottle cap to keep it safe from children.

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, particularly in individuals who are allergic to aspirin. Signs of an allergic reaction may include hives, facial swelling, wheezing, shock, skin reddening, rash, or blisters. Additionally, this medication carries a risk of severe stomach bleeding, especially if your child has a history of stomach ulcers, is taking blood thinners or steroids, or uses other NSAIDs (nonsteroidal anti-inflammatory drugs) like aspirin or naproxen.

There is also an increased risk of heart attack and stroke associated with NSAIDs, which can be life-threatening. This risk is heightened if the medication is used in higher doses or for longer than recommended. If your child experiences symptoms such as faintness, vomiting blood, or severe stomach pain, or if they show signs of heart problems like chest pain or difficulty breathing, seek medical attention immediately. Always consult a doctor if your child has a history of stomach issues, is dehydrated, or is taking other medications.

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 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 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 a doctor's guidance, especially if they are under three years old. If your child does not feel better within 24 hours, or if their fever or pain worsens or lasts more than three days, consult a 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 health and safety are the top priority.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that ibuprofen is not recommended, especially during the third trimester. Using nonsteroidal anti-inflammatory drugs (NSAIDs) like ibuprofen during pregnancy may pose risks to your baby, including potential heart problems and other complications.

Always consult your healthcare provider for safe alternatives or dosage adjustments if you need pain relief while pregnant. It's best to avoid ibuprofen unless your doctor specifically advises you to use it. Your health and the health of your baby are the top priority, so make sure to discuss any medications with your healthcare team.

Lactation Use

When it comes to breastfeeding, it's important to be aware that there are no specific guidelines or statements regarding nursing mothers or lactation (the process of producing milk). This means that if you are breastfeeding, you may not find detailed information about how certain medications or treatments could affect you or your baby.

If you have concerns about breastfeeding while taking any medication, it's always a good idea to consult with your healthcare provider. They can help you understand any potential risks and provide personalized advice based on your situation.

Pediatric Use

When giving medication to children aged 2 to 11 years, it's important to follow specific dosing guidelines based on their weight. For example, if your child weighs between 24-35 pounds, the recommended dose is 5 mL, while a child weighing 72-95 pounds can take 15 mL. Always ensure you do not exceed the recommended dosage and avoid using the medication for sore throat in children under 3 years unless directed by a doctor.

Before administering this medication, consult a doctor if your child has a history of stomach issues, dehydration, or any serious health conditions like high blood pressure or asthma. If your child shows signs of stomach bleeding, heart problems, or does not improve within 24 hours, stop the medication and seek medical advice. Always be cautious and prioritize your child's safety when using any medication.

Geriatric Use

When it comes to using this medication in older adults, there are no specific recommendations or considerations outlined. This means that the standard guidelines apply, and you should always consult with a healthcare provider to ensure the medication is appropriate for your individual health needs.

It's important to keep in mind that older adults may have different responses to medications due to factors like age-related changes in the body. Always discuss any concerns or questions with your doctor or pharmacist to ensure safe and effective use.

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 healthcare provider can help determine if this medication is safe for you and whether any adjustments are needed based on your kidney function. Always prioritize open communication with your doctor regarding your health conditions.

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 will need to monitor your liver function closely, which involves checking specific tests that measure how well your liver is working. Depending on the severity of your liver condition, they may adjust your medication dosage to ensure it's safe and effective for you.

Additionally, if you have other health issues like high blood pressure, heart disease, or kidney disease, these can also influence your treatment plan. Always communicate openly with your healthcare team about your liver health and any other medical conditions you have, so they can provide the best care tailored to your needs.

Drug Interactions

It's important to be aware of potential interactions when using medications like ibuprofen. If you or your child are allergic to aspirin, using ibuprofen could lead to a severe allergic reaction. Additionally, ibuprofen is a type of nonsteroidal anti-inflammatory drug (NSAID), which can increase the risk of serious stomach bleeding, especially if combined with blood thinners or other NSAIDs like aspirin or naproxen.

Using NSAIDs, except for aspirin, may also raise the risk of heart attack, heart failure, and stroke, particularly if taken in higher doses or for longer than recommended. Always discuss any medications your child is taking with a healthcare provider to ensure safety and avoid harmful interactions.

Storage and Handling

To ensure the best performance of your product, store it at a temperature between 20-25°C (68-77°F). It's important to avoid freezing, as this can damage the product.

When handling the product, make sure to do so in a clean environment to maintain its integrity. Always follow any additional safety instructions provided to ensure safe and effective use.

Additional Information

You should not use this medication more than four times a day, and if necessary, you can repeat the dose every 6 to 8 hours. If you suspect an overdose, it’s important to seek medical help immediately or contact a Poison Control Center at 1-800-222-1222 for assistance.

FAQ

What is Children's Ibuprofen?

Children's Ibuprofen is an oral suspension that comes in a berry-flavored liquid form, containing 100 mg of ibuprofen per 5 mL and is alcohol-free.

What does Children's Ibuprofen do?

It acts as a pain reliever and fever reducer, helping to relieve minor aches and pains from conditions like the common cold, flu, sore throat, headache, and toothache.

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 or age, and use only the enclosed dosing cup.

How often can I give Children's Ibuprofen?

You can repeat the dose every 6-8 hours, but do not exceed 4 doses in a day.

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.

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 if my child is pregnant or breastfeeding?

Children's Ibuprofen is not recommended for use during pregnancy, especially in the third trimester, and there are no specific statements regarding breastfeeding.

What should I do in case of an overdose?

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

How should I store Children's Ibuprofen?

Store it at 20-25°C (68-77°F) and do not freeze.

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)

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 does not contain directions or complete warnings for adult use. Healthcare professionals should ensure that the dosage does not exceed the recommended limits.

Prior to administration, the product must be shaken well. The appropriate dose should be determined using the provided dosing chart, which is based on the patient's weight. If weight is not available, age may be used as a secondary guide. Only the enclosed dosing cup should be utilized for measuring the dose; other dosing devices are not recommended.

The following dosing chart provides guidance based on weight and age:

  • For patients weighing under 24 lbs (under 2 years of age), the dose should be determined by consulting a doctor.

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

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

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

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

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

If necessary, doses may be repeated every 6-8 hours, but the total daily administration should not exceed 4 doses. After each use, the dosing cup should be washed thoroughly. To maintain child resistance, the original bottle cap must be replaced securely after each use.

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/fever reducer should not use this product due to the risk of severe allergic reactions. Additionally, the product should not be administered immediately before or after heart surgery, as it may interfere with postoperative recovery and increase the risk of complications.

Warnings and Precautions

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

This product contains a nonsteroidal anti-inflammatory drug (NSAID), which is associated with an increased risk of severe stomach bleeding. The likelihood of this adverse effect is heightened in children who have a history of stomach ulcers or bleeding disorders, are concurrently taking anticoagulants or steroid medications, are using other NSAIDs (including aspirin, ibuprofen, or naproxen), or exceed the recommended dosage or duration of treatment.

Healthcare professionals should be aware that the use of NSAIDs, excluding aspirin, is linked to 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.

Severe or persistent sore throat, especially when accompanied by high fever, headache, nausea, or vomiting, may indicate a serious condition. In such cases, it is essential to consult a physician promptly. The use of ibuprofen should not exceed two days, nor should it be administered to children under three years of age unless specifically directed by a healthcare provider.

Healthcare providers should advise caregivers to discontinue use and seek medical attention 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 help or contact a Poison Control Center immediately at 1-800-222-1222.

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 carries a warning for potential severe stomach bleeding, especially in patients with a history of stomach ulcers or bleeding problems. The risk is heightened in those taking anticoagulants, steroid medications, or other NSAIDs, including aspirin and naproxen. Patients should be monitored for signs of stomach bleeding, which may manifest as feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain.

Additionally, ibuprofen is associated with an increased risk of heart attack, heart failure, and stroke, particularly when used in higher doses or for extended periods. Patients should be vigilant for symptoms indicative of heart problems or stroke, such as chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling.

In clinical trials, it is advised that patients do not use ibuprofen for more than two days for sore throat unless directed by a healthcare provider, particularly if accompanied by high fever, headache, nausea, or vomiting. If symptoms persist or worsen after 24 hours of treatment, or if new symptoms arise, patients should seek medical advice.

Patients with certain pre-existing conditions should consult a healthcare professional before using ibuprofen. This includes those with a history of stomach issues, dehydration, high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma. It is also recommended that patients under a doctor's care for serious conditions or those taking other medications discuss their use of ibuprofen with a healthcare provider or pharmacist.

Drug Interactions

Ibuprofen is associated with several significant drug interactions that warrant careful consideration.

Allergic Reactions Ibuprofen may induce severe allergic reactions, particularly in individuals with a known allergy to aspirin. It is essential to assess the patient's allergy history before administration.

Gastrointestinal Risks As a nonsteroidal anti-inflammatory drug (NSAID), ibuprofen carries a risk of severe gastrointestinal bleeding. This risk is notably increased in pediatric patients who are concurrently taking anticoagulants or steroid medications. Additionally, the risk is heightened if the patient is using other NSAIDs, whether prescription or over-the-counter, such as aspirin, ibuprofen, or naproxen. Close monitoring for signs of gastrointestinal distress is advised in these cases.

Cardiovascular Risks The use of NSAIDs, excluding aspirin, is associated with an elevated risk of cardiovascular events, including heart attack, heart failure, and stroke. This risk is particularly pronounced when the medication is used in higher doses or for extended periods. It is recommended that healthcare providers evaluate the necessity of ibuprofen therapy and consider alternative treatments if prolonged use is anticipated.

General Recommendations Healthcare providers should inquire about any concurrent medications before prescribing ibuprofen to ensure safe use. Monitoring for adverse effects is advised, especially in patients with pre-existing conditions or those taking multiple medications.

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 aged 2 to 11 years may receive this medication with specific dosing guidelines based on weight. For children under 24 lbs, consultation with a doctor is advised. The recommended dosages for children aged 2 to 11 years are as follows: 5 mL for those weighing 24-35 lbs (ages 2-3 years), 7.5 mL for those weighing 36-47 lbs (ages 4-5 years), 10 mL for those weighing 48-59 lbs (ages 6-8 years), 12.5 mL for those weighing 60-71 lbs (ages 9-10 years), and 15 mL for those weighing 72-95 lbs (age 11 years). It is crucial not to exceed the directed dosage.

Caution is advised when administering this medication to children under 3 years of age for sore throat unless directed by a doctor. The medication should not be given to children with a known allergy to ibuprofen or any other pain reliever or fever reducer.

Before use, healthcare professionals should be consulted if any of the following conditions apply: the child has a history of stomach problems (e.g., heartburn), has experienced serious side effects from pain relievers or fever reducers, has not been drinking fluids, has lost significant fluid due to vomiting or diarrhea, has high blood pressure, heart disease, liver cirrhosis, kidney disease, a history of stroke, asthma, or is taking a diuretic.

Parents or caregivers should discontinue use and seek medical advice if the child exhibits signs of stomach bleeding (e.g., feeling faint, vomiting blood, having bloody or black stools, or persistent stomach pain), symptoms of heart problems or stroke (e.g., chest pain, difficulty breathing, weakness on one side of the body, slurred speech, leg swelling), does not achieve relief within the first 24 hours of treatment, experiences worsening fever or pain lasting more than 3 days, shows redness or swelling in the painful area, or develops any new symptoms.

Geriatric Use

Elderly patients may not have specific recommendations or considerations outlined in the provided text. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients, particularly those aged 65 and older.

It is advisable to monitor these patients closely for any potential adverse effects or changes in efficacy, as age-related physiological changes may influence drug metabolism and response. Additionally, healthcare providers should consider individual patient factors, including comorbidities and concurrent medications, when determining the appropriate dosage and treatment regimen for elderly patients.

Pregnancy

The use of ibuprofen during pregnancy is contraindicated, particularly in the third trimester. Nonsteroidal anti-inflammatory drugs (NSAIDs), including ibuprofen, may pose risks to the fetus, which can include potential cardiovascular issues and other complications.

Pregnant patients are advised to avoid the use of ibuprofen unless specifically directed by a healthcare professional. In cases where ibuprofen is deemed necessary, it is essential for healthcare providers to consult with the patient regarding appropriate alternatives or dosage modifications to ensure maternal and fetal safety.

Lactation

There are no specific statements regarding the use of this medication in nursing mothers or its effects during lactation. Additionally, there is no available data on the excretion of this medication in breast milk or its potential effects on breastfed infants. Healthcare professionals should consider the absence of information when advising lactating mothers about the use of this medication.

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, including those with liver cirrhosis, may require careful consideration when being prescribed this medication. Due to the potential for altered pharmacokinetics in individuals with compromised liver function, dosage adjustments may be necessary.

Monitoring of liver function is recommended for patients with hepatic impairment to ensure safety and efficacy. Clinicians should assess liver enzymes and other relevant parameters regularly to evaluate the patient's response to treatment and to identify any potential adverse effects related to liver function.

It is essential to consider the overall health status of patients, particularly those with comorbid conditions such as high blood pressure, heart disease, kidney disease, or a history of stroke, as these factors may further complicate the management of therapy in this population.

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 are advised to call 1-800-222-1222 for expert guidance.

Prompt intervention is crucial in managing overdose situations effectively. Symptoms of overdose may vary depending on the substance involved and the individual’s health status. Therefore, a thorough assessment and monitoring of the patient are essential.

Management procedures should be initiated as soon as possible, which may include supportive care and symptomatic treatment. Healthcare providers should remain vigilant for any signs of adverse reactions and be prepared to implement appropriate therapeutic measures based on the clinical presentation of the patient.

Nonclinical Toxicology

No teratogenic effects were noted in animal studies. Additionally, there was no increase in fetal malformations observed in these studies.

Postmarketing Experience

No specific postmarketing experience details are provided in the available data.

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 stop 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 discontinuing 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, healthcare providers should recommend giving it with food or milk to mitigate potential stomach upset. It is advisable for patients to consult a doctor before use if the stomach bleeding warning is applicable to their child or if the child has a history of stomach issues, such as heartburn. Additionally, patients should be encouraged to seek medical advice if the child has experienced serious side effects from pain relievers or fever reducers, has not been adequately hydrated, or has lost significant fluids due to vomiting or diarrhea.

Healthcare providers should also recommend consulting a doctor before use if the child has high blood pressure, heart disease, liver cirrhosis, kidney disease, or a history of stroke, as well as if the child has asthma or is taking a diuretic. Lastly, patients should be advised to consult a doctor or pharmacist before use if the child is under medical care for any serious condition or is taking any other medications.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It should be stored at a controlled room temperature of 20-25°C (68-77°F). Freezing is not permitted, as it may compromise the integrity of the product. Proper handling and storage conditions are essential to maintain the quality and efficacy of the product.

Additional Clinical Information

Patients should not exceed a maximum of four doses per day, with the option to repeat doses every 6 to 8 hours as needed. In the event of an overdose, it is crucial for patients to seek medical assistance immediately or contact a Poison Control Center at 1-800-222-1222 for guidance.

No additional information is available regarding laboratory tests, abuse potential, or postmarketing experiences.

Drug Information (PDF)

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

View product document (PDF)

Data Generation & Sources

This page was automatically generated and is maintained by the AllDrugs AI Data-Science Team. It was built from the FDA Structured Product Label (DailyMed) for Ibuprofen, retrieved by a validated AI data-extraction workflow.

All FDA-listed dosage forms and strengths are shown in the Packaging & NDC Codes section above. Regulatory status appears in the Summary Information panel above and was verified in the FDA National Drug Code directory and the NSDE NDC Directory daily file.

Note: an automated daemon monitors NSDE checksums; when the record for this NDC changes, the new file is pulled instantly and this page is refreshed.

No human clinician has reviewed this version.

Learn more in our Editorial Policy

Last AI update:

Primary FDA sources:

Orange Book data shown on this page are limited to Regulatory Status (Rx), Established Pharmacologic Class (EPC), and Mechanism of Action (MoA).

Regulatory data notice: Information on this page is reproduced verbatim from FDA public databases (NSDE, Orange Book, Purple Book, DailyMed SPL). NDA/ANDA drugs are FDA-approved, BLA biologics are FDA-licensed. Inclusion alone does not guarantee current market availability or imply FDA endorsement.

Medical disclaimer: This AI-generated content is provided for educational purposes only and does not constitute medical advice. Always consult a licensed healthcare professional for diagnosis or treatment decisions.