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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 2018
Label revision date
August 10, 2022
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 2018
Label revision date
August 10, 2022
Manufacturer
Strategic Sourcing Services
Registration number
ANDA210602
NDC roots
70677-0150, 70677-0151, 70677-0152, 70677-0153
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (5 NDCs)
Packaging & NDC Codes (5)

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Drug Overview

Ibuprofen is a medication available in an oral suspension form, which comes in various flavors such as berry, grape, and bubble gum, with both dye and dye-free options. It is commonly used to relieve minor aches and pains associated with conditions like the common cold, flu, sore throat, headache, and toothache. Additionally, ibuprofen helps reduce fever, making it a versatile choice for managing discomfort and illness.

Uses

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

Rest assured, this medication does not have any teratogenic effects, meaning it does not cause developmental issues in a fetus if taken during pregnancy.

Dosage and Administration

Before using this product, it's important to know that it doesn't come with specific directions or warnings for adults. To ensure safety, always follow the recommended dosage and never exceed the amount directed. Start by shaking the bottle well before each use. You can find the right dose by referring to the dosing chart, which considers either your child's weight or age. If possible, using weight is preferred for more accurate dosing.

Make sure to use only the enclosed dosing cup to measure the liquid; other devices may not provide the correct amount. If necessary, you can repeat the dose every 6 to 8 hours, but remember not to use it more than four times in a single day. After each use, securely replace the original bottle cap to keep it child-resistant and safe. If your child is under 2 years old or weighs less than 24 pounds, consult a doctor for guidance.

What to Avoid

You should avoid using this medication if your child has ever had an allergic reaction to 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 side effects, so it's important to be aware of them. You should watch for signs of a severe allergic reaction, especially if you or your child is allergic to aspirin. Symptoms may include hives, facial swelling, wheezing, shock, skin reddening, rash, or blisters. Additionally, ibuprofen can lead to severe stomach bleeding, particularly 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 fatal, especially if used in higher doses or for longer than recommended. If your child experiences symptoms like chest pain, trouble breathing, weakness on one side of the body, or slurred speech, seek medical help immediately. It's crucial to consult a doctor if your child has a severe sore throat with high fever, if symptoms worsen, or if new symptoms appear. Always talk to a healthcare professional before using ibuprofen if your child has any underlying health conditions or is taking other medications.

Warnings and Precautions

Ibuprofen can cause serious allergic reactions, especially in individuals who are allergic to aspirin. If you notice symptoms like hives, facial swelling, wheezing, or any skin rash, stop using the medication immediately and seek medical help. Additionally, be aware that ibuprofen can lead to severe stomach bleeding, particularly if your child has a history of stomach ulcers, is taking blood thinners or steroids, or is using other NSAIDs (nonsteroidal anti-inflammatory drugs) like aspirin or naproxen. Always follow the recommended dosage to minimize risks.

There are also significant risks associated with heart attacks and strokes when using NSAIDs, including ibuprofen. This risk increases if the medication is taken in higher doses or for longer than recommended. If your child has a severe sore throat, especially with high fever, headache, nausea, or vomiting, consult a doctor right away. Do not use ibuprofen for more than two days in these cases or for children under three years old unless directed by a healthcare professional.

If you suspect an overdose, seek emergency medical help or contact a Poison Control Center immediately at 1-800-222-1222. You should also stop using ibuprofen and consult a doctor if your child experiences signs of stomach bleeding (like faintness, vomiting blood, or black stools), symptoms of heart problems or stroke (such as chest pain or trouble breathing), or if their condition does not improve within 24 hours. If fever or pain worsens or lasts more than three days, or if new symptoms appear, contact your doctor for further guidance.

Overdose

If you suspect an overdose, it's important to stay calm and take immediate action. While there is no specific information available about the effects of an overdose for this medication, you should be aware of general signs that may indicate a problem. These can include unusual drowsiness, confusion, or difficulty breathing.

If you notice any of these symptoms or have concerns about a possible overdose, seek medical help right away. Contact your healthcare provider or go to the nearest emergency room. It's always better to be safe and get checked out if you think you may have taken too much of a medication.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to be cautious with medications like ibuprofen. This medication is not recommended during pregnancy, especially in the third trimester, as it may pose risks to your baby, including potential heart and kidney complications. Additionally, using nonsteroidal anti-inflammatory drugs (NSAIDs) like ibuprofen in early pregnancy may increase the risk of miscarriage.

Before taking ibuprofen, you should consult your healthcare provider, as they may suggest dosage adjustments or alternative treatments. It's best to avoid using ibuprofen unless your doctor specifically advises it. Your health and the health of your baby are the top priority, so always seek professional guidance when considering medication during pregnancy.

Lactation Use

If you are breastfeeding and considering using ibuprofen, it’s important to consult your doctor first. This is because ibuprofen can potentially pass into your breast milk, which may pose risks to your nursing infant. Therefore, exercising caution is advised when taking this medication while breastfeeding. Always prioritize your health and your baby's safety by discussing any medications with your healthcare provider.

Pediatric Use

When considering medication for your child, it's important to follow specific guidelines to ensure their safety. For children under 3 years old, you should only use this medication if directed by a doctor, and it should not be used for more than 2 days. Dosing varies based on your child's weight and age, so it's crucial to refer to the dosing chart: for example, children weighing under 24 pounds should consult a doctor, while those weighing 24-35 pounds (ages 2-3 years) can take 5 mL, and so on, up to 15 mL for an 11-year-old weighing 72-95 pounds.

Before giving this medication, consult your child's doctor if they have a history of stomach issues, have experienced serious side effects from pain relievers or fever reducers, or if they have not been drinking enough fluids due to vomiting or diarrhea. Additionally, it's important to check with a doctor if your child has high blood pressure, heart disease, liver or kidney problems, asthma, or is taking a diuretic (a type of medication that helps remove excess fluid from the body). Always prioritize your child's health and safety by seeking professional advice when needed.

Geriatric Use

As an older adult or caregiver, it's important to know that there are no specific dosage adjustments or safety concerns noted for elderly patients regarding this medication. This means that the standard dosage can generally be used without special modifications for older individuals. However, always consult with a healthcare provider to ensure that this medication is appropriate for your specific health needs and circumstances.

Renal Impairment

If you have kidney problems, it's important to know that there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the usual recommendations for monitoring or safety considerations related to renal impairment (kidney issues) are not provided.

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

Hepatic Impairment

If you have liver problems, it's important to know that there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the standard recommendations apply, but you should always consult your healthcare provider for personalized advice. They can help determine the best approach for your treatment and monitor your liver function as needed.

Make sure to keep your doctor informed about your liver health, as they may want to conduct regular tests to ensure your safety while using any medication. Your well-being is a priority, and your healthcare team is there to support you.

Drug Interactions

It's important to be cautious when using ibuprofen, as it can lead to serious side effects, especially if combined with certain medications. For instance, taking ibuprofen alongside blood thinners (medications that help prevent blood clots) or steroids can significantly increase the risk of severe stomach bleeding. Additionally, using ibuprofen or other nonsteroidal anti-inflammatory drugs (NSAIDs) for extended periods or in higher doses than recommended can raise your chances of having a heart attack or stroke.

If you or your child are taking any other medications, it's crucial to consult with a healthcare provider before using ibuprofen. They can help ensure that it's safe and appropriate for your situation, helping you avoid potential interactions and side effects. Always prioritize open communication with your doctor about any medications or treatments you are considering.

Storage and Handling

To ensure the safety and effectiveness of your product, store it at a temperature between 20-25°C (68-77°F). This helps maintain its quality. Before using, check that the carton is unopened and that the printed bottle neckband is intact; do not use the product if either of these conditions is not met, as this could compromise safety.

By following these simple storage and handling guidelines, you can help ensure that the product remains safe and effective for your use.

Additional Information

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

Be alert for serious side effects. If your child shows any signs of stomach bleeding—such as feeling faint, vomiting blood, having bloody or black stools, or persistent stomach pain—stop the medication and consult a doctor immediately. Additionally, seek medical help if your child has symptoms of heart problems or stroke, does not find relief within the first 24 hours, or if fever or pain worsens or lasts more than three days. Redness or swelling in the painful area or any new symptoms should also prompt a call to the doctor.

FAQ

What is Ibuprofen used for?

Ibuprofen 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 flavors does Ibuprofen oral suspension come in?

Ibuprofen oral suspension is available in various flavors including berry, grape, and bubble gum, with options for dye and dye-free formulations.

How should I dose Ibuprofen for my child?

You should find the right dose on the dosing chart based on your child's weight or age. Use only the enclosed dosing cup and do not exceed the recommended dose.

What should I do if my child experiences stomach bleeding?

If your child experiences signs of stomach bleeding, such as feeling faint, vomiting blood, or having bloody or black stools, stop use and seek medical help immediately.

Is Ibuprofen safe to use during pregnancy?

Ibuprofen is contraindicated in pregnancy, especially during the third trimester, due to potential risks to the fetus, including cardiovascular and renal complications.

Can nursing mothers use Ibuprofen?

Nursing mothers should consult a doctor before using ibuprofen, as there is a potential for excretion in breast milk.

What are the warnings associated with Ibuprofen?

Ibuprofen 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.

How should I store Ibuprofen?

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

Packaging Info

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

Packaging configurations for Ibuprofen Oral.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Ibuprofen is available in oral suspension form, offered in various flavors including berry, grape, and bubble gum. The product is packaged in cartons, with specific formulations that may include dye or be dye-free. Each formulation is designed to provide effective relief while catering to different taste preferences.

Uses and Indications

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

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

Dosage and Administration

This product is intended for use in pediatric patients, and healthcare professionals should refer to the dosing chart to determine the appropriate dosage based on the patient's weight or age.

Prior to administration, the product must be shaken well. The recommended dosing is as follows:

  • For patients weighing under 24 pounds or under 2 years of age, consultation with a doctor is advised.

  • For patients weighing 24-35 pounds or aged 2-3 years, the recommended dose is 5 mL.

  • For patients weighing 36-47 pounds or aged 4-5 years, the recommended dose is 7.5 mL.

  • For patients weighing 48-59 pounds or aged 6-8 years, the recommended dose is 10 mL.

  • For patients weighing 60-71 pounds or aged 9-10 years, the recommended dose is 12.5 mL.

  • For patients weighing 72-95 pounds or aged 11 years, the recommended dose is 15 mL.

Doses may be repeated every 6-8 hours as needed, but should not exceed four doses in a 24-hour period. It is imperative to use only the enclosed dosing cup for measurement; other dosing devices should not be utilized to ensure accurate dosing. After use, the original bottle cap should be replaced to maintain child resistance.

Healthcare professionals should ensure that patients do not exceed the recommended dosage and should provide guidance on the importance of adhering to these instructions.

Contraindications

Use is contraindicated in the following situations:

Patients with a history of allergic reactions to any pain reliever or fever reducer should not use this product, as it may precipitate a severe allergic response. Additionally, the product is contraindicated for use immediately before or after heart surgery due to potential complications associated with surgical recovery and medication interactions.

Warnings and Precautions

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

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 NSAIDs, excluding aspirin, elevate the 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 cases of overdose, immediate medical attention is required. Healthcare professionals should advise caregivers to contact a Poison Control Center (1-800-222-1222) without delay.

Discontinuation of ibuprofen and consultation with a physician is warranted 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 symptoms indicative of heart problems or stroke arise—such as chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling—medical evaluation is necessary.

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, or if any new symptoms develop, it is crucial to seek medical advice.

Side Effects

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

Severe allergic reactions may occur, particularly in individuals with a known allergy to aspirin. Symptoms of such reactions can include hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, and blisters.

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

Additionally, ibuprofen carries warnings regarding cardiovascular risks. The use of NSAIDs, excluding aspirin, has been 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 longer than directed.

Patients should be vigilant for signs of serious conditions. If a child experiences symptoms indicative of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or persistent stomach pain, medical attention should be sought immediately. Symptoms suggestive of heart problems or stroke, including chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling, also warrant prompt consultation with a healthcare provider.

Common adverse reactions may include a sore throat, especially if it is severe or persistent, or accompanied by high fever, headache, nausea, and vomiting. In such cases, it is advised to consult a doctor promptly and to limit use to no more than two days, particularly in children under three years of age unless directed by a physician.

Patients are advised to discontinue use and seek medical advice if there is no 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 painful area, or if any new symptoms arise.

Before using ibuprofen, it is important to consult a healthcare provider if the child has a history of stomach problems, has experienced serious side effects from pain relievers or fever reducers, is dehydrated, or has underlying health conditions such as high blood pressure, heart disease, liver cirrhosis, kidney disease, or a history of stroke. Additionally, children with asthma or those taking diuretics should seek medical advice prior to use.

Drug Interactions

Ibuprofen has several notable drug interactions that warrant careful consideration, particularly regarding the potential for increased adverse effects.

Anticoagulants and Steroids The concomitant use of ibuprofen with anticoagulants (blood thinners) or steroid medications may significantly elevate the risk of severe gastrointestinal bleeding. It is advisable to monitor patients closely for signs of gastrointestinal distress and consider dosage adjustments or alternative therapies when these medications are used together.

Other Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) Co-administration of ibuprofen with other NSAIDs, such as aspirin or naproxen, can also heighten the risk of gastrointestinal bleeding. Clinicians should evaluate the necessity of using multiple NSAIDs concurrently and consider alternative pain management strategies to mitigate this risk.

Cardiovascular Risks The use of NSAIDs, excluding aspirin, is associated with an increased risk of cardiovascular events, including heart attack and stroke, particularly when used in higher doses or for extended periods. It is recommended that healthcare providers assess the cardiovascular risk profile of patients prior to initiating ibuprofen therapy, especially in those with pre-existing cardiovascular conditions.

Pediatric Considerations In pediatric patients, it is crucial to consult a healthcare professional before administering ibuprofen if the child is taking any other medications. This ensures that potential drug interactions are evaluated and managed appropriately to safeguard the child's health.

Packaging & NDC

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

Packaging configurations for Ibuprofen Oral.
Details

Pediatric Use

Pediatric patients should not use this medication for more than 2 days or in children under 3 years of age unless directed by a healthcare professional.

Dosing recommendations are as follows:

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

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

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

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

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

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

Healthcare professionals should advise parents or guardians to consult a doctor before use if the child has a history of stomach problems, such as heartburn, or has experienced serious side effects from pain relievers or fever reducers. Additionally, consultation is necessary if the child has not been adequately hydrated, has high blood pressure, heart disease, liver cirrhosis, kidney disease, a history of stroke, or asthma. It is also important to seek medical advice if the child is taking a diuretic.

Geriatric Use

Elderly patients may not require specific dosage adjustments when receiving this medication, as there are no safety concerns noted in the provided information. However, healthcare providers should remain vigilant in monitoring this population for any potential adverse effects, given the general considerations associated with pharmacotherapy in geriatric patients. It is advisable to assess the overall health status and comorbidities of elderly patients to ensure optimal therapeutic outcomes.

Pregnancy

The use of ibuprofen during pregnancy is contraindicated, particularly in the third trimester. The administration of nonsteroidal anti-inflammatory drugs (NSAIDs), including ibuprofen, may pose risks to the fetus, which can include potential cardiovascular and renal complications. Additionally, there is a potential risk of miscarriage associated with the use of NSAIDs during early pregnancy.

Due to these safety concerns, dosage adjustments may be necessary, and it is essential for pregnant patients to consult a healthcare provider before using ibuprofen. Special precautions should be taken, and pregnant women are advised to avoid the use of ibuprofen unless specifically directed by a healthcare professional.

Lactation

Nursing mothers are advised to consult a doctor prior to using ibuprofen. There is a potential for excretion of ibuprofen in breast milk, and caution is recommended when administering this medication to lactating mothers due to the potential risk to the breastfed infant.

Renal Impairment

Patients with renal impairment may not have specific information regarding dosage adjustments, special monitoring, or safety considerations outlined in the prescribing information. Therefore, healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment and individualized patient assessment. Regular monitoring of renal function is advisable to ensure patient safety and therapeutic efficacy.

Hepatic Impairment

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

Overdosage

In the absence of specific information regarding overdosage in the provided sections of the Summary of Product Characteristics (SPL), healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdosage.

Recommended Actions In the event of an overdosage, it is essential for healthcare providers to assess the patient's clinical status and initiate appropriate supportive measures. Monitoring of vital signs and symptomatic treatment should be implemented as necessary.

Potential Symptoms While specific symptoms of overdosage are not detailed, healthcare professionals should remain vigilant for any unusual or severe reactions that may arise, given the variability in individual responses to medication.

Management Procedures In the absence of detailed guidance, standard protocols for managing overdosage should be followed. This may include gastric decontamination, supportive care, and symptomatic treatment tailored to the patient's needs. Consultation with a poison control center or a medical toxicologist is recommended for further guidance in managing suspected overdosage cases.

Healthcare professionals are encouraged to report any cases of overdosage to the appropriate regulatory authorities to contribute to the ongoing assessment of the safety profile of the medication.

Nonclinical Toxicology

No teratogenic effects were identified in the studies conducted. Additionally, there were no reported non-teratogenic effects. The available data does not provide any specific details regarding nonclinical toxicology. Furthermore, there are no findings related to 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).

There is also an increased risk of heart attack, heart failure, and stroke associated with the use of NSAIDs. Furthermore, reports of severe or persistent sore throat, or sore throat accompanied by high fever, headache, nausea, and vomiting, may indicate serious underlying conditions.

Patient Counseling

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

Patients should be instructed to discontinue use and consult a doctor if the child exhibits any signs of stomach bleeding, which may include feeling faint, vomiting blood, having bloody or black stools, or experiencing stomach pain that does not improve. Additionally, healthcare providers should inform patients to stop use and seek medical advice if the child shows symptoms indicative of heart problems or stroke, such as chest pain, difficulty breathing, weakness on one side of the body, slurred speech, or swelling in the legs.

Patients should also be counseled to stop use and consult a doctor if the child does not experience relief within the first 24 hours of treatment, if fever or pain worsens or persists beyond three days, if there is redness or swelling in the affected area, or if any new symptoms arise.

Before initiating treatment, healthcare providers should encourage patients to consult a doctor if the stomach bleeding warning is applicable to their 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. It is also important to ask a doctor before use if the child has not been adequately hydrated, has lost significant fluids due to vomiting or diarrhea, or has pre-existing conditions such as high blood pressure, heart disease, liver cirrhosis, kidney disease, or a history of stroke.

Furthermore, patients should be advised to consult a doctor before use if the child has asthma, is taking a diuretic, or is under medical care for any serious condition. Lastly, it is prudent to recommend that patients speak with a doctor or pharmacist before use if the child is currently taking any other medications.

Storage and Handling

The product is supplied in a configuration that includes specific packaging requirements. It must be stored at a temperature range of 20-25°C (68-77°F) to ensure its stability and efficacy.

Healthcare professionals are advised to inspect the packaging prior to use; the product should not be utilized if the carton is opened or if the printed bottle neckband is broken or missing. Proper handling and storage conditions are essential to maintain the integrity of the product.

Additional Clinical Information

Patients should be advised that the medication is administered orally, with a recommended repeat dose every 6-8 hours, not to exceed four doses in a 24-hour period. To mitigate potential stomach upset, it is recommended to take the medication with food or milk.

Clinicians should counsel patients to seek medical attention if the child exhibits any signs of serious adverse effects, including symptoms indicative of stomach bleeding (such as faintness, vomiting blood, or black stools), heart problems, or stroke (including chest pain, difficulty breathing, weakness, slurred speech, or leg swelling). Additionally, if the child does not experience relief within the first 24 hours, 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, medical advice should be sought.

Drug Information (PDF)

This file contains official product information for Ibuprofen Oral, 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 Oral, 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.