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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 2024
Label revision date
March 12, 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 2024
Label revision date
March 12, 2025
Manufacturer
TARO PHARMACEUTICALS U. S. A. , INC.
Registration number
ANDA211666
NDC root
51672-5321
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (2 NDCs)
Packaging & NDC Codes (2)

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

If you are a consumer or patient please visit this version.

Drug Overview

Children's Ibuprofen Oral Suspension is a medication designed for children aged 2 to 11 years. It serves as a pain reliever and fever reducer, helping to alleviate discomfort and lower fevers. Each 5 mL dose contains 100 mg of ibuprofen, and its effects can last for up to 8 hours. This formulation is dye-free, alcohol-free, and comes in a pleasant berry flavor, making it easier for children to take.

This product is available in a 4 fl oz (120 mL) bottle, providing a convenient option for parents looking to manage their child's pain or fever effectively.

Uses

If your child is between the ages of 2 and 11 years and is experiencing pain or fever, this medication can help relieve those symptoms. It is specifically designed to provide comfort during times of discomfort, making it easier for your child to feel better.

Rest assured, there are no known teratogenic effects (which means it does not cause birth defects) associated with this medication, and it also does not have any nonteratogenic effects. This makes it a safe option for managing your child's pain and fever.

Dosage and Administration

Before using this product, it's important to note that it does not come with specific directions or warnings for adults. Always make sure to follow the recommended dosage and never give more than directed. To prepare the medication, shake the bottle well before use. You’ll find a dosing chart that helps you determine the right amount based on your child's weight or age.

To measure the dose, remove the bottle cap and squeeze the correct amount into the enclosed dosing cup—make sure to use only this cup and not any other measuring device. If your child needs another dose, you can repeat it every 6 to 8 hours, but do not exceed four doses in a single day. After use, remember to securely replace the original bottle cap to keep it child-resistant.

What to Avoid

There are no specific contraindications, controlled substance classifications, or risks of abuse, misuse, or dependence associated with this medication. This means that, based on the available information, you can use it without concerns about these particular issues. However, always consult with your healthcare provider for personalized advice and to ensure that this medication is appropriate for your individual health needs.

Side Effects

You should be aware that ibuprofen can cause serious allergic reactions, particularly if you are allergic to aspirin. Symptoms of such reactions may include hives, facial swelling, wheezing (asthma), shock, skin reddening, rash, or blisters. Additionally, ibuprofen, which is a type of nonsteroidal anti-inflammatory drug (NSAID), can lead to severe stomach bleeding, especially if you have a history of stomach ulcers or bleeding issues, are taking blood thinners or steroids, or are using other NSAIDs.

There are also risks associated with heart attacks and strokes when using NSAIDs like ibuprofen, particularly if taken in higher doses or for extended periods. If you or your child experience severe or persistent sore throat, especially with high fever, headache, nausea, or vomiting, it's important to consult a doctor. You should stop using ibuprofen and seek medical advice if you notice signs of stomach bleeding (such as faintness, vomiting blood, or black stools), symptoms of heart problems or stroke (like chest pain or weakness), or if there is no relief within 24 hours.

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 blisters, stop using it immediately and seek medical help. Additionally, ibuprofen may lead to severe stomach bleeding, particularly if your child has a history of stomach ulcers, is taking blood thinners, or uses other NSAIDs (nonsteroidal anti-inflammatory drugs) like aspirin or naproxen. The risk of heart attack and stroke is also increased with NSAIDs, so it’s important to follow dosing instructions carefully.

Before giving ibuprofen to your child, consult a doctor if they have any history of stomach issues, dehydration, high blood pressure, or asthma, or if they are taking other medications. If your child experiences symptoms like faintness, vomiting blood, or severe chest pain, stop the medication and call your doctor right away. Also, seek emergency help if you suspect an overdose by contacting a Poison Control Center at 1-800-222-1222. If your child does not feel better within 24 hours, or if their symptoms worsen or new symptoms appear, it’s important to reach out to a healthcare professional.

Overdose

If you suspect an overdose, it's important to stay calm and take immediate action. While the specific signs of an overdose are not detailed, common symptoms can include extreme drowsiness, confusion, or difficulty breathing. If you notice any of these signs, or if you are unsure, seek medical help right away.

In case of an overdose, contact your local emergency services or go to the nearest hospital. It's crucial to provide them with as much information as possible about the substance taken and the amount, if known. Remember, acting quickly can make a significant difference in your health and safety.

Pregnancy Use

The safety of ibuprofen during pregnancy has not been established, and it is particularly contraindicated (not recommended) during the third trimester. Using ibuprofen while pregnant may pose risks to your fetus, including potential cardiovascular effects.

If you are pregnant or planning to become pregnant, it is essential to consult your healthcare provider before using ibuprofen or any medication. They can help you understand the risks and explore safer alternatives for managing pain or inflammation during this important time.

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. This means that, based on the information available, it is generally considered safe for you to use ibuprofen without special precautions related to breastfeeding.

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

Pediatric Use

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

It's important to be cautious and consult a doctor if your child has a history of stomach issues, is dehydrated, or has certain health conditions like high blood pressure or asthma. You should also stop using the medication and seek medical advice if your child shows signs of stomach bleeding (like vomiting blood or having black stools), experiences heart problems, or if their symptoms do not improve within 24 hours. Always monitor your child closely for any new or worsening symptoms.

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 the drug insert does not provide guidelines tailored for elderly patients.

If you or a loved one is an older adult considering this medication, it’s important to consult with a healthcare provider. They can help assess individual health needs and determine the best approach to treatment, ensuring safety and effectiveness.

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 health. Always prioritize open communication with your doctor regarding your medical history and current 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 may need to adjust your medication dosage or closely monitor your liver function tests (tests that check how well your liver is working) to ensure your safety and the effectiveness of your treatment.

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

Drug Interactions

It's important to be aware that taking ibuprofen can increase the risk of severe stomach bleeding, particularly if you are also using blood thinners (medications that help prevent blood clots) or steroid drugs. This risk is even greater for children who may be taking other nonsteroidal anti-inflammatory drugs (NSAIDs), such as aspirin or naproxen.

If your child is on a diuretic (a medication that helps remove excess fluid from the body), it's crucial to consult with a healthcare provider before giving ibuprofen. Always discuss any medications or tests with your doctor to ensure safety and avoid potential interactions.

Storage and Handling

To ensure the safety and effectiveness of your product, store it in a cool, dry place at a temperature between 20-25°C (68-77°F). It's important to check the packaging before use; do not use the product if the carton is opened or if the tape or bottle wrap marked "SEALED FOR YOUR PROTECTION" is broken or missing. This helps to guarantee that the product remains uncontaminated and safe for your use.

Always handle the product with care, following these guidelines to maintain its integrity and your safety.

Additional Information

You should take this medication orally, and if needed, you can repeat the dose every 6 to 8 hours, but do not exceed 4 doses in a day. If your child experiences stomach upset, it's best to take the medication with food or milk.

Be sure to monitor your child for any concerning signs. Contact a doctor if you notice symptoms like stomach bleeding, heart problems, or stroke, if there is no relief within the first 24 hours, if fever or pain worsens or lasts more than 3 days, if there is redness or swelling in the painful area, or if any new symptoms appear.

FAQ

What is Children's Ibuprofen Oral Suspension used for?

Children's Ibuprofen Oral Suspension is a pain reliever and fever reducer for children aged 2 to 11 years.

What is the dosage for Children's Ibuprofen Oral Suspension?

The dosage varies by weight and age. For example, children aged 2-3 years weighing 24-35 lbs should take 5 mL.

How often can I give Children's Ibuprofen Oral Suspension?

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

Are there any warnings associated with Children's Ibuprofen?

Yes, it may cause severe stomach bleeding, especially if the child has had stomach ulcers or is taking other NSAIDs or blood thinners.

What should I do if my child experiences signs of stomach bleeding?

Stop use and ask a doctor if your child feels faint, vomits blood, has bloody or black stools, or has stomach pain that does not improve.

Can I use Children's Ibuprofen if my child has asthma?

Consult a doctor before use if your child has asthma or any other serious health conditions.

Is it safe to use Children's Ibuprofen during pregnancy?

The safety of ibuprofen during pregnancy has not been established, and it is contraindicated during the third trimester.

What flavor does Children's Ibuprofen Oral Suspension come in?

It comes in a berry flavor and is dye-free and alcohol-free.

How should I store Children's Ibuprofen Oral Suspension?

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

What should I do if my child does not get relief from pain or fever?

If your child does not get any relief within the first 24 hours, or if symptoms worsen or last more than 3 days, consult a doctor.

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 Oral Suspension, USP is a nonsteroidal anti-inflammatory drug (NSAID) formulated to provide relief from pain and reduce fever. Each 5 mL dose contains 100 mg of ibuprofen. The product is designed for pediatric use and is available in a 4 fl oz (120 mL) bottle. It is dye-free and alcohol-free, with a berry flavor to enhance palatability. The effects of the medication can last up to 8 hours. The National Drug Code (NDC) for this formulation is 51672-5321-8.

Uses and Indications

This drug is indicated for the relief of pain and reduction of fever in pediatric patients aged 2 to 11 years.

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

Dosage and Administration

This product is intended for pediatric use only, and healthcare professionals should refer to the dosing chart to determine the appropriate dosage based on the child's weight or age. It is essential to shake the bottle well before each use to ensure proper mixing of the contents.

To administer the medication, the healthcare provider should instruct the caregiver to remove the bottle cap and squeeze the prescribed dose into the enclosed dosing cup. It is critical to use only the provided dosing cup and not any other dosing device to ensure accurate measurement.

The recommended dosing intervals are every 6 to 8 hours as needed, with a maximum of four doses per day. The following dosing chart provides specific dosage recommendations:

  • For children weighing under 24 lbs or under 2 years of age, consult a doctor for guidance.

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

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

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

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

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

Caregivers should be advised not to exceed the recommended dosage and to replace the original bottle cap after use to maintain child resistance.

Contraindications

There are no contraindications associated with the use of this product. It is deemed safe for use in the absence of specific conditions or situations that would warrant avoidance.

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 with a history of stomach ulcers or bleeding disorders, those taking anticoagulants or steroid medications, individuals using other NSAIDs (including aspirin, ibuprofen, or naproxen), or those exceeding the recommended dosage or duration of treatment.

NSAIDs, excluding aspirin, are also 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 healthcare provider promptly. The use of ibuprofen should not exceed two days, nor should it be administered to children under three years of age unless directed by a physician.

General precautions must be observed. Ibuprofen should not be used in children with a prior allergic reaction to ibuprofen or any other pain reliever or fever reducer. It is contraindicated immediately before or after heart surgery. Prior to use, consultation with a healthcare provider is advised if any of the following conditions apply: a history of stomach bleeding, previous stomach issues such as heartburn, adverse reactions to pain relievers or fever reducers, inadequate fluid intake, significant fluid loss due to vomiting or diarrhea, high blood pressure, heart disease, liver cirrhosis, kidney disease, a history of stroke, asthma, or if the child is taking a diuretic. Additionally, consultation with a doctor or pharmacist is recommended if the child is under medical care for any serious condition or is taking other medications.

In the event of an overdose, immediate medical attention should be sought, or the Poison Control Center should be contacted at 1-800-222-1222.

Healthcare professionals should advise caregivers to discontinue use and consult a physician if the child exhibits any signs of stomach bleeding, such as feeling faint, vomiting blood, passing bloody or black stools, or experiencing persistent stomach pain. 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, if fever or pain worsens or persists beyond three days, if redness or swelling occurs in the affected area, or if any new symptoms arise, medical consultation is necessary.

Side Effects

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

The use of this product, which contains a nonsteroidal anti-inflammatory drug (NSAID), carries a warning for severe stomach bleeding. The risk of this serious adverse reaction is heightened in patients with a history of stomach ulcers or bleeding problems, those taking anticoagulants or steroid medications, and individuals using other NSAIDs, including aspirin and naproxen. Additionally, prolonged use or exceeding the recommended dosage increases the likelihood of stomach bleeding.

Patients should also be aware of the increased risk of heart attack, heart failure, and stroke associated with NSAID use, excluding aspirin. These cardiovascular events can be fatal, and the risk escalates with higher doses or extended duration of use.

Common adverse reactions may include severe or persistent sore throat, especially when accompanied by high fever, headache, nausea, or vomiting. Such symptoms warrant prompt medical consultation. It is advised not to use this product for more than two days or to administer it to children under three years of age without a doctor's guidance.

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

Drug Interactions

Ibuprofen has been associated with significant drug interactions that may increase the risk of adverse effects, particularly gastrointestinal bleeding.

Anticoagulants and Steroids The concomitant use of ibuprofen with anticoagulants or steroid medications may lead to an increased risk of severe stomach bleeding. It is advisable to monitor patients closely for signs of gastrointestinal distress and consider alternative pain management strategies if necessary.

Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) The risk of stomach bleeding is further heightened when ibuprofen is taken alongside other NSAIDs, including both prescription and nonprescription medications such as aspirin and naproxen. Healthcare providers should evaluate the necessity of ibuprofen in patients who are already using other NSAIDs and consider dosage adjustments or alternative therapies to mitigate this risk.

Diuretics In pediatric patients, it is recommended to consult a healthcare professional if the child is concurrently taking a diuretic. Monitoring may be warranted to ensure safety and efficacy, as the interaction between ibuprofen and diuretics could necessitate dosage adjustments or alternative treatment options.

Packaging & NDC

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

Packaging configurations for Ibuprofen.
Details

Pediatric Use

Pediatric patients under 3 years of age should not use this medication unless directed by a doctor. For children aged 2 to 11 years, dosing is based on weight and age, as follows:

  • Under 24 lb / Under 2 years: Ask a doctor

  • 24-35 lbs / 2-3 years: 5 mL

  • 36-47 lbs / 4-5 years: 7.5 mL

  • 48-59 lbs / 6-8 years: 10 mL

  • 60-71 lbs / 9-10 years: 12.5 mL

  • 72-95 lbs / 11 years: 15 mL

Caution is advised due to an increased risk of stomach bleeding, particularly in children with a history of stomach ulcers or bleeding problems, those taking anticoagulants or steroids, or those using other NSAIDs (e.g., aspirin, ibuprofen, naproxen).

Healthcare professionals should advise parents to consult a doctor before use if the following conditions apply:

  • The child has a history of stomach problems, such as heartburn.

  • The child has experienced serious side effects from pain relievers or fever reducers.

  • The child has not been adequately hydrated or has lost significant fluids due to vomiting or diarrhea.

  • The child has high blood pressure, heart disease, liver cirrhosis, kidney disease, or a history of stroke.

  • The child has asthma or is taking a diuretic.

Parents should be instructed to stop use and seek medical advice if the child exhibits any 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 24 hours, 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

There is no specific information regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population.

Pregnancy

The safety of ibuprofen during pregnancy has not been established. Ibuprofen is contraindicated in pregnancy, particularly during the third trimester, due to potential risks to the fetus. The use of ibuprofen during this period may pose risks, including potential cardiovascular effects on the developing fetus.

Pregnant women are advised to consult a healthcare provider before using ibuprofen to discuss potential risks and alternative treatment options.

Lactation

There are no specific warnings or recommendations regarding the use of ibuprofen in nursing mothers. Additionally, there are no specific considerations or precautions related to lactation mentioned in the provided text. Therefore, healthcare professionals may consider the use of ibuprofen in lactating mothers without specific concerns related to breastfeeding.

Renal Impairment

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

Hepatic Impairment

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

In patients with liver cirrhosis, dosage adjustments may be necessary to avoid potential toxicity. Close monitoring of liver function tests, including alanine aminotransferase (ALT), aspartate aminotransferase (AST), and bilirubin levels, is recommended throughout the treatment course.

Additionally, patients with a history of significant liver disease, such as cirrhosis, should be evaluated for any contraindications related to their hepatic condition. It is crucial to consider the overall health status of these patients, including any coexisting conditions such as high blood pressure, heart disease, or kidney disease, which may further complicate their treatment regimen.

Healthcare providers should exercise caution and tailor the therapeutic approach based on the individual patient's liver function and overall clinical picture.

Overdosage

In the absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdose.

It is essential to monitor the patient closely for any potential symptoms that may arise, as the clinical presentation can vary depending on the substance involved. Common symptoms of overdose may include, but are not limited to, respiratory depression, altered mental status, cardiovascular instability, and gastrointestinal disturbances.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should initiate supportive care, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs. The use of activated charcoal may be considered if the patient presents within a suitable timeframe and if the ingestion was recent.

Furthermore, specific antidotes or treatments may be indicated based on the clinical scenario and the substance involved. Consultation with a poison control center or a medical toxicologist is recommended for guidance on the appropriate management strategies tailored to the individual case.

Overall, vigilance and prompt intervention are critical in managing potential overdosage situations effectively.

Nonclinical Toxicology

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

Postmarketing Experience

Postmarketing experience has identified several adverse reactions reported voluntarily or through surveillance programs. These include allergic reactions such as hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, and blisters. Additionally, there have been reports of severe stomach bleeding, particularly in children with a history of stomach ulcers or bleeding problems, as well as in those taking blood thinners, steroids, or other nonsteroidal anti-inflammatory drugs (NSAIDs).

Furthermore, an increased risk of heart attack, heart failure, and stroke has been associated with the use of NSAIDs. Symptoms indicative of heart problems or stroke reported include chest pain, difficulty breathing, weakness in one part or side of the body, slurred speech, and leg swelling.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222 in the event of an overdose. It is essential for patients to understand the importance of prompt action in such situations to ensure their safety and well-being.

Storage and Handling

The product is supplied in a carton that must remain unopened until use. It is essential to inspect the carton for any signs of tampering; do not use the product if the carton is opened or if the carton tape or bottle wrap imprinted with "SEALED FOR YOUR PROTECTION" is broken or missing.

For optimal storage, the product should be maintained at a temperature range of 20-25°C (68-77°F). Proper adherence to these storage conditions is crucial to ensure the integrity and efficacy of the product.

Additional Clinical Information

Patients should be informed that the medication is administered orally, with the option to repeat doses every 6-8 hours as needed, not exceeding four doses in a 24-hour period. It is recommended to take the medication with food or milk if stomach upset occurs.

Clinicians should counsel patients to discontinue use and seek medical advice if the child exhibits any signs of stomach bleeding, symptoms indicative of heart problems or stroke, does not experience relief within the first 24 hours, or if fever or pain worsens or persists beyond three days. Additionally, any redness or swelling in the painful area or the emergence of new symptoms warrants immediate consultation with a healthcare provider.

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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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.