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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 2022
Label revision date
July 7, 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 2022
Label revision date
July 7, 2025
Manufacturer
Sun Pharmaceutical Industries, Inc.
Registration number
ANDA209207
NDC root
51672-2144
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, providing effective relief from minor aches and pains associated with common conditions like the cold, flu, sore throat, headache, and toothache. It also helps reduce fever. This formulation contains 100 mg of ibuprofen (a type of nonsteroidal anti-inflammatory drug, or NSAID) per 5 mL and is available in a pleasant berry flavor, making it easier for children to take.

This dye-free and alcohol-free suspension lasts up to 8 hours, offering extended relief for your child's discomfort. It is comparable to the active ingredient found in Children's Motrin® Dye-Free Berry Flavor, ensuring you have a reliable option for managing your child's pain and fever.

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 birth defects. This makes it a safer choice for those who may be concerned about such risks.

Dosage and Administration

Before using the medication, make sure to shake the bottle well. It's important to use only the enclosed dosing cup to measure your dose; avoid using any other measuring devices to ensure accuracy. To find the right dose, refer to the dosing chart based on your child's weight. If you can, use their weight for a more precise dosage; if not, you can use their age instead.

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

If needed, you can repeat the dose every 6 to 8 hours, but remember not to exceed 4 doses in a single day.

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. Symptoms of a severe allergic reaction may include hives, facial swelling, wheezing (asthma), shock, skin reddening, rash, and 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 fainting, vomiting blood, or has bloody or black stools, seek medical attention immediately. It's important to consult a doctor if your child has a severe sore throat with high fever, or if symptoms worsen or persist beyond a few days. Always discuss any pre-existing health conditions or medications with a healthcare provider before use.

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 issues, 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, stop use and contact your doctor right away.

If you or your child have a severe sore throat that lasts more than two days or is accompanied by high fever, headache, nausea, or vomiting, consult a doctor. For any overdose, seek emergency medical help or contact a Poison Control Center immediately at 1-800-222-1222. Always stop use and consult your doctor if symptoms worsen or new symptoms appear.

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

It is generally not recommended to use ibuprofen during pregnancy, especially in the later stages. In particular, using ibuprofen in the third trimester can lead to serious complications, such as the premature closure of a vital blood vessel in the fetus called the ductus arteriosus. There is also a potential risk of harm to fetal development when taking ibuprofen at any stage of pregnancy.

If you are pregnant or planning to become pregnant, it is crucial to consult your healthcare provider before using ibuprofen. They may suggest dosage modifications or alternative pain relief options to ensure the safety of both you and your baby. Always prioritize open communication with your healthcare team regarding any medications you consider 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. The information available does not indicate any concerns about ibuprofen being excreted in breast milk or any precautions you need to take while using it.

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

Pediatric Use

It's important to be cautious when giving this medication to children. You should not give it to children under 2 years old unless a doctor specifically advises you to do so. For children aged 2 to 3 years who weigh between 24 and 35 pounds, the recommended dose is 5 mL. As your child grows, the dosage increases: for ages 4 to 5 years (36-47 lbs), it's 7.5 mL; for ages 6 to 8 years (48-59 lbs), it's 10 mL; for ages 9 to 10 years (60-71 lbs), it's 12.5 mL; and for an 11-year-old (72-95 lbs), the dose is 15 mL.

Be sure to consult a doctor if your child has a history of stomach issues, is taking other medications, or has any serious health conditions. Additionally, do not use this medication for more than 2 days in children under 3 years old unless directed by a doctor. If your child does not feel better within the first 24 hours of treatment, it's important to reach out to a healthcare professional.

Geriatric Use

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

Renal Impairment

If you have kidney problems, it's important to consult your doctor before using this medication. This is especially crucial if you also have high blood pressure, heart disease, liver cirrhosis (a severe liver condition), or if you've had a stroke. Your 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 taking medications like ibuprofen. If you or your child are allergic to aspirin, using ibuprofen could lead to severe allergic reactions. Additionally, if your child is taking blood thinners (medications that help prevent blood clots) or steroids, the risk of stomach bleeding increases. This risk is also heightened if your child is using other nonsteroidal anti-inflammatory drugs (NSAIDs), such as aspirin or naproxen.

Always consult with a healthcare provider if your child is on a diuretic (a medication that helps remove excess fluid from the body) or any other medications. Discussing all medications and health conditions with your doctor ensures safe and effective treatment.

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). This range is considered a controlled room temperature, which helps maintain the product's quality. Always check the carton before use; do not use the product if the carton is opened or if the bottle wrap marked "SEALED FOR SAFETY" is broken or missing.

Additionally, make sure to look at the bottom panel of the carton for the lot number and expiration date, as this information is crucial for tracking the product's safety and effectiveness. Proper handling and storage are key to ensuring you get the best results from your product.

Additional Information

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

Be sure to stop using the medication and consult a doctor if your child shows any signs of stomach bleeding, heart problems, or stroke. Additionally, seek medical advice 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 develop.

FAQ

What is Children's Ibuprofen Oral Suspension used for?

Children's Ibuprofen Oral Suspension is used to relieve minor aches and pains due to the common cold, flu, sore throat, headache, and toothache, as well as to reduce fever.

What is the recommended dosage for children aged 2-3 years?

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

How often can I give Children's Ibuprofen?

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

Are there any warnings associated with Children's Ibuprofen?

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

Is Children's Ibuprofen safe to use during pregnancy?

The use of ibuprofen during pregnancy is generally not recommended, especially in the third trimester due to potential risks to the fetus.

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

If your child feels faint, vomits blood, has bloody or black stools, or has stomach pain that does not improve, stop use and consult a doctor immediately.

How should I store Children's Ibuprofen?

Store at 20° to 25°C (68° to 77°F) and do not use if the carton is opened or if the bottle wrap is broken or missing.

Can I use any dosing device for Children's Ibuprofen?

No, you should only use the enclosed dosing cup to measure the dose.

What flavor does Children's Ibuprofen come in?

Children's Ibuprofen Oral Suspension is available in a berry flavor.

What should I do if my child does not get relief within 24 hours?

If your child does not get any relief within the first day of treatment, 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 pain relief and reduce fever. Each 5 mL dose contains 100 mg of ibuprofen. The suspension is dye-free and alcohol-free, ensuring a formulation suitable for pediatric use. It is available in a berry flavor, enhancing palatability for children. The product is packaged in a 4 FL OZ (120 mL) bottle and is designed to provide relief that lasts up to 8 hours.

Uses and Indications

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

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

Dosage and Administration

Healthcare professionals should instruct patients to shake the medication well before use. The enclosed dosing cup provided with the medication must be utilized; no other dosing devices should be employed to ensure accurate dosing.

To determine the appropriate dose, healthcare providers should refer to the dosing chart, prioritizing weight for dosing whenever possible. If weight is not available, age may be used as an alternative. The recommended dosing intervals are every 6 to 8 hours as needed, with a maximum of 4 doses per day.

The dosing chart is as follows:

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

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

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

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

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

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

It is essential to adhere to these guidelines to ensure safe and effective use of the medication.

Contraindications

Use of this product is contraindicated in the following situations:

  • In patients with a history of allergic reactions to ibuprofen or any other pain reliever or fever reducer, due to the risk of severe allergic reactions.

  • In patients undergoing heart surgery, as use immediately before or after such procedures may pose significant risks.

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, and 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.

In the event of an overdose, immediate medical attention is required. Healthcare professionals should advise caregivers to contact a Poison Control Center (1-800-222-1222) without delay.

Healthcare providers should instruct caregivers to discontinue use and seek medical advice if the child exhibits any signs of stomach bleeding, such as feeling faint, vomiting blood, passing bloody or black stools, or experiencing persistent stomach pain. Additionally, if the child shows symptoms indicative of heart problems or stroke—such as chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling—immediate medical evaluation is warranted.

Furthermore, 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, it is crucial to consult a healthcare professional.

Side Effects

Ibuprofen may cause a range of adverse reactions, some of which can be serious. Patients should be aware of the potential for severe allergic reactions, 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, as a nonsteroidal anti-inflammatory drug (NSAID), carries a warning regarding the risk of severe stomach bleeding. This risk 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, the risk increases if the medication is taken in higher doses or for extended periods beyond the recommended guidelines.

Patients should also be informed 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 is amplified when the medication is used inappropriately, such as exceeding the recommended dosage or duration of treatment.

Severe or persistent sore throat, especially when accompanied by high fever, headache, nausea, and vomiting, may indicate a serious condition requiring prompt medical consultation. It is advised not to use ibuprofen for more than two days or to administer it to children under three years of age without a doctor's direction.

Patients should discontinue use and seek medical advice if they experience any signs of stomach bleeding, such as feeling faint, vomiting blood, having 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, also warrant immediate medical attention. 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 consultation is recommended. Redness or swelling in the painful area or the emergence of any new symptoms should also prompt a discussion with a healthcare provider.

Before using ibuprofen, it is essential to consult a doctor if the stomach bleeding warning applies to the child, if there is a history of stomach issues such as heartburn, or if the child has experienced serious side effects from pain relievers or fever reducers. Additional considerations include ensuring adequate fluid intake, especially in cases of significant fluid loss due to vomiting or diarrhea, and assessing for pre-existing 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. Lastly, it is advisable to consult a doctor or pharmacist if the child is under medical care for any serious condition or is taking other medications.

Drug Interactions

Ibuprofen has the potential to induce severe allergic reactions, particularly in individuals with a known allergy to aspirin. This risk necessitates careful consideration when prescribing ibuprofen to such patients.

In terms of pharmacodynamic interactions, the concomitant use of ibuprofen with anticoagulants or steroid medications significantly increases the risk of gastrointestinal bleeding. This risk is further amplified when ibuprofen is taken alongside other nonsteroidal anti-inflammatory drugs (NSAIDs), including both prescription and over-the-counter options such as aspirin and naproxen. Clinicians should exercise caution and consider alternative therapies or implement close monitoring for signs of gastrointestinal complications in patients requiring these combinations.

Additionally, it is advisable to consult a healthcare professional if the patient is concurrently using a diuretic. This consultation is essential to evaluate potential interactions and to determine the need for dosage adjustments or enhanced monitoring.

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 2 years of age should not be given this medication unless directed by a doctor. For children aged 2-3 years (24-35 lbs), the recommended dose is 5 mL. For those aged 4-5 years (36-47 lbs), the recommended dose increases to 7.5 mL. Children aged 6-8 years (48-59 lbs) should receive 10 mL, while those aged 9-10 years (60-71 lbs) are recommended a dose of 12.5 mL. For children aged 11 years (72-95 lbs), the appropriate dose is 15 mL.

It is important to consult a doctor if the child has a history of stomach problems, is taking other medications, or has any serious health conditions. Additionally, this medication should not be used for more than 2 days in children under 3 years of age unless directed by a doctor. If the child does not experience relief within the first 24 hours of treatment, a doctor should be consulted.

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 use of ibuprofen during pregnancy is generally not recommended. It is contraindicated in the third trimester due to the risk of premature closure of the ductus arteriosus in the fetus. There is a potential risk of fetal harm associated with ibuprofen use, particularly in the later stages of pregnancy. Safety concerns have been raised regarding adverse effects on fetal development when ibuprofen is administered during this period.

Healthcare providers should consider that dosage modifications may be necessary, and it is advised that pregnant patients consult with their healthcare provider before using ibuprofen.

Lactation

There are no specific warnings or recommendations regarding the use of ibuprofen in lactating mothers. Additionally, no specific considerations or precautions are mentioned concerning lactation or the potential for excretion of ibuprofen in breast milk. Therefore, healthcare professionals may consider the use of ibuprofen in nursing 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, including those with liver cirrhosis, may require careful consideration when being prescribed this medication. Due to the potential impact of compromised liver function on drug metabolism and clearance, dosage adjustments may be necessary.

Monitoring of liver function is recommended for patients with hepatic impairment to ensure safety and efficacy. Regular assessment of liver enzymes and other relevant laboratory values should be conducted to evaluate the patient's liver status and adjust treatment as needed.

Additionally, patients with a history of significant comorbidities such as high blood pressure, heart disease, kidney disease, or a history of stroke should be closely monitored throughout the treatment process. It is essential to weigh the benefits against the risks in this population to optimize therapeutic outcomes.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. Healthcare professionals should advise patients or caregivers to call the Poison Control Center at 1-800-222-1222 for guidance.

Prompt intervention is crucial in managing overdose situations, as timely medical attention can significantly influence outcomes. 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 may include supportive care, symptomatic treatment, and specific antidotes if applicable. Healthcare providers should remain vigilant and prepared to implement appropriate interventions based on the clinical presentation of the patient.

Nonclinical Toxicology

No teratogenic effects have been reported in the available data. Similarly, there is no information regarding non-teratogenic effects. The nonclinical toxicology section does not provide any additional insights. Furthermore, there is no information available concerning animal pharmacology and toxicology.

Postmarketing Experience

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

There is an increased risk of heart attack, heart failure, and stroke associated with prolonged use or higher than directed doses. Furthermore, reports of severe or persistent sore throat, or sore throat accompanied by high fever, headache, nausea, and vomiting have been noted as serious conditions that require prompt medical consultation.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. In the event of an overdose, patients should seek medical help or contact a Poison Control Center immediately at 1-800-222-1222.

Patients should be instructed to take the medication with food or milk if they experience stomach upset. It is important to inform patients 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 stomach pain that does not improve.

Additionally, patients should be made aware to discontinue 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 advised 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.

Healthcare providers should encourage 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. It is also essential to advise patients to seek medical advice if the child has experienced serious side effects from pain relievers or fever reducers, has not been drinking fluids, or has lost a significant amount of fluid due to vomiting or diarrhea.

Furthermore, patients should be instructed to consult a doctor before use if the child has high blood pressure, heart disease, liver cirrhosis, kidney disease, or a history of stroke. Patients with children who have asthma or are taking diuretics should also seek medical advice prior to use. Lastly, it is recommended that patients consult a doctor or pharmacist 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 a carton that contains a bottle, with specific handling instructions to ensure safety and efficacy. It is essential to store the product at a temperature range of 20° to 25°C (68° to 77°F), in accordance with USP Controlled Room Temperature guidelines.

Healthcare professionals should inspect the packaging prior to use. The product must not be used if the carton is opened or if the bottle wrap, which is imprinted with "SEALED FOR SAFETY," is broken or missing. For traceability, 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 repeat dose every 6 to 8 hours as needed, not to exceed four doses in a 24-hour period. Clinicians should advise patients to take the medication with food or milk if gastrointestinal upset occurs.

Patients and caregivers should be counseled to seek medical attention if the child exhibits any signs of stomach bleeding, symptoms indicative of heart problems or stroke, or if there is no relief within the first 24 hours of treatment. Additionally, they should monitor for worsening fever or pain lasting more than three days, the presence of redness or swelling in the affected area, or the emergence of any new symptoms.

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.