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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
January 18, 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
January 18, 2022
Manufacturer
Camber Consumer Care Inc
Registration number
ANDA210602
NDC roots
69230-308, 69230-309, 69230-310, 69230-311
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (7 NDCs)
Packaging & NDC Codes (7)

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

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

Drug Overview

Ibuprofen is a medication available in an oral suspension form, offered in various flavors such as berry, grape, and bubble gum. 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 option for managing discomfort and elevated body temperature.

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 is 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.

Dosage and Administration

Before you use this medication, make sure to shake the bottle well. To find the right dose for you or your child, refer to the dosing chart provided. If possible, use weight to determine the dose; if not, you can use age. It's important to measure the dose using only the enclosed dosing cup, as other devices may not provide accurate measurements.

You can repeat the dose every 6 to 8 hours if needed, but remember not to exceed four doses in a single day. For children under 24 pounds or under 2 years old, it's best to consult a doctor before administering any medication. For those who weigh between 24 and 95 pounds or are between 2 and 11 years old, the chart will guide you on the appropriate amount to give. Always follow the instructions carefully to ensure safe and effective use.

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 allergic reactions, especially in individuals who are allergic to aspirin. Signs of an allergic reaction may include hives, facial swelling, wheezing (asthma), shock, skin reddening, rash, or blisters. Additionally, this medication can lead to severe stomach bleeding, particularly in children with a history of stomach ulcers or those taking blood thinners or other NSAIDs. There is also an increased risk of heart attack and stroke associated with NSAIDs, especially if used in higher doses or for extended periods.

If your child experiences symptoms such as faintness, vomiting blood, black or bloody stools, or persistent stomach pain, you should stop use and consult a doctor immediately. Other concerning signs include chest pain, difficulty breathing, weakness on one side of the body, slurred speech, or swelling in the legs. It's important to seek medical advice if your child does not find relief within 24 hours, if symptoms worsen, or if new symptoms arise. Always consult a doctor before use if your child has a history of stomach issues, is dehydrated, or has other serious health conditions.

Warnings and Precautions

Ibuprofen can cause serious allergic reactions, especially if you are allergic to aspirin. Symptoms may include hives, facial swelling, wheezing, shock, skin reddening, rash, or blisters. If you experience any of these symptoms, stop using ibuprofen and seek medical help immediately.

This medication can also lead to severe stomach bleeding, particularly if you have a history of stomach ulcers or bleeding problems, are taking blood thinners or steroids, or are using other NSAIDs (nonsteroidal anti-inflammatory drugs) like aspirin or naproxen. Additionally, using ibuprofen for longer than directed increases the risk of heart attack and stroke, which can be fatal. If you notice signs of stomach bleeding, such as feeling faint, vomiting blood, or having black stools, or if you experience chest pain, trouble breathing, or weakness, stop using ibuprofen and contact your doctor right away.

For children, do not use ibuprofen for more than two days without consulting a doctor, especially if they are under three years old. If your child does not feel better within 24 hours, or if their fever or pain worsens or lasts more than three days, seek medical advice. In case of an overdose, get medical help or contact a Poison Control Center immediately at 1-800-222-1222.

Overdose

If you suspect an overdose, it's important to be aware that there may not be specific information available about the effects or treatment for this situation. However, you should always take any signs of overdose seriously. Common signs can include unusual drowsiness, confusion, or difficulty breathing (respiratory depression).

If you notice any of these symptoms or have concerns about a possible overdose, seek immediate medical help. It's better to be cautious and get professional assistance to ensure your safety. Always remember to keep medications out of reach and follow prescribed dosages to prevent any risk of overdose.

Pregnancy Use

If you are considering using this medication for your child, it's important to be aware of a few key precautions. First, do not use it if your child has ever had an allergic reaction to any other pain reliever or fever reducer. Before giving this medication, consult with a doctor if your child has a history of stomach issues, like heartburn. To help prevent stomach upset, it’s advisable to take the medication with food or milk.

While using this product, watch for any signs of stomach bleeding or symptoms that could indicate heart problems or a stroke, and stop use immediately if these occur. Always keep the medication out of reach of children, and in case of an overdose, seek medical help or contact a Poison Control Center right away.

Lactation Use

If you are breastfeeding and considering using ibuprofen, it's important to consult your doctor first. While ibuprofen may be present in breast milk, the effects on your nursing infant have not been thoroughly studied. Because of this uncertainty, it's best to exercise caution and discuss any potential risks with your healthcare provider before taking this medication. Your health and the well-being of your baby are the top priorities.

Pediatric Use

It's important to be cautious when using this medication for children. You should not give it to children under 3 years of age unless a doctor specifically advises you to do so. For children who are older, the dosage depends on their weight. For example, if your child weighs under 24 pounds, you should consult a doctor before administering any dose. For those weighing between 24 to 35 pounds, the recommended dose is 5 mL, while children weighing 36 to 47 pounds should receive 7.5 mL. The dosage increases with weight, reaching 15 mL for children who weigh between 72 to 95 pounds.

Always consult a doctor if your child has a history of stomach issues, is taking other medications, or has experienced significant fluid loss from vomiting or diarrhea. If your child does not feel better within 24 hours, if their fever or pain worsens or lasts more than three days, or if any new symptoms develop, stop using the medication and seek medical advice. Remember to keep the medication out of reach of children, and in case of an overdose, contact a medical professional or Poison Control Center immediately.

Geriatric Use

When considering this product for older adults, it's important to consult with a doctor first, especially if you or your loved one has any existing health conditions. This includes high blood pressure, heart disease, liver cirrhosis (a serious liver condition), kidney disease, or a history of stroke. These conditions can affect how the product works and may require special attention or adjustments in dosage.

Please note that the product does not provide specific directions or warnings for adult use, which means it’s crucial to seek professional medical advice to ensure safety and effectiveness. Taking these precautions can help you or your loved one use the product safely.

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 standard recommendations for the medication do not include special monitoring or safety considerations tailored for patients with renal impairment (kidney issues).

Always consult your healthcare provider for personalized advice and to ensure that your treatment plan is safe and effective for your specific health needs. They can provide guidance based on your kidney function and overall health.

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 aware that taking ibuprofen can lead to serious side effects, especially when combined with certain medications. For instance, using ibuprofen alongside blood thinners (medications that prevent blood clots) or steroids can significantly increase the risk of severe stomach bleeding. Additionally, using nonsteroidal anti-inflammatory drugs (NSAIDs) like ibuprofen for extended periods or at higher doses may raise your chances of having a heart attack or stroke.

If you or your child are taking other medications, it's crucial to discuss this with your healthcare provider. They can help you understand potential interactions and ensure that your treatment is safe and effective. Always prioritize open communication about any medications you are using.

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. It's also important to check the packaging before use; do not use the product if the carton is opened or if the printed neckband on the bottle is broken or missing, as this could indicate that the product is compromised.

By following these simple storage and handling guidelines, you can help ensure that the product remains safe and effective for your use. Always keep it in a secure place to avoid any damage or contamination.

Additional Information

If your child is taking this medication, it's important to follow the dosing instructions carefully. You should give the medication with food or milk if it causes stomach upset, and repeat the dose every 6 to 8 hours, but do not exceed four doses in a day.

Be alert for any serious side effects. If your child shows 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. Additionally, seek medical attention if your child experiences symptoms of heart problems or stroke, such as chest pain, difficulty breathing, weakness on one side of the body, slurred speech, or leg swelling. If there is no relief within 24 hours, if fever or pain worsens or lasts more than three days, if redness or swelling occurs in the painful area, or if any new symptoms develop, contact a healthcare professional.

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.

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 4 doses in a day.

What should I do if my child has an allergic reaction to Ibuprofen?

If your child experiences symptoms of a severe allergic reaction, such as hives or difficulty breathing, stop use immediately and seek medical help.

Are there any warnings associated with Ibuprofen?

Yes, Ibuprofen may cause severe stomach bleeding, especially if taken with blood thinners or if the child has a history of stomach problems. It also increases the risk of heart attack and stroke.

Can I use Ibuprofen if my child has had an allergic reaction to other pain relievers?

No, do not use Ibuprofen if your child has ever had an allergic reaction to any other pain reliever or fever reducer.

What should I do if my child does not get relief from Ibuprofen?

If your child does not get any relief within the first 24 hours of treatment, or if fever or pain worsens or lasts more than 3 days, consult a doctor.

Is it safe to use Ibuprofen during breastfeeding?

Nursing mothers should consult a doctor before using Ibuprofen, as it may be excreted in breast milk and its effects on a nursing infant are not well studied.

What should I do in case of an overdose of Ibuprofen?

In case of overdose, get medical help or contact a Poison Control Center immediately.

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 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 oral suspension is available in various flavors, including berry, grape, and bubble gum. The formulations include both options with dye and dye-free variants. The berry flavor is offered in both original and dye-free versions, while the grape and bubble gum flavors are provided in standard formulations. Each flavor is packaged in a container carton designed for oral administration.

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

The medication should be shaken well before use. Healthcare professionals are advised to determine the appropriate dose using the provided dosing chart, prioritizing weight for dosing whenever possible; if weight is not available, age may be used as a secondary measure.

Dosing should be administered using only the enclosed dosing cup, as other dosing devices may lead to inaccuracies. The recommended dosing intervals allow for the administration of a repeat dose every 6 to 8 hours, with a maximum of four doses per day.

The dosing chart is as follows:

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

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

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

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

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

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

Dosing may also be adjusted as directed by a healthcare professional.

Contraindications

Use is contraindicated in children with a history of allergic reactions to any pain reliever or fever reducer. Additionally, administration is contraindicated immediately before or after heart surgery due to potential complications associated with surgical recovery.

Warnings and Precautions

Ibuprofen may cause severe allergic reactions, particularly in individuals with a known allergy to aspirin. Symptoms indicative of an allergic reaction 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 carries a risk of severe stomach bleeding. The likelihood of this adverse effect is heightened in pediatric patients with a history of stomach ulcers or bleeding disorders, those concurrently using anticoagulants or steroid medications, or those taking other NSAIDs (including aspirin, ibuprofen, naproxen, or similar agents). Additionally, exceeding the recommended dosage or duration of treatment increases the risk of stomach bleeding.

Healthcare professionals should be aware that NSAIDs, excluding aspirin, are associated with an elevated risk of heart attack, heart failure, and stroke, which can be fatal. This risk is particularly pronounced when the medication is used in excess of the recommended dosage or for prolonged periods.

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

Healthcare providers should advise caregivers to discontinue use and seek medical attention if the child exhibits any signs of stomach bleeding, such as feeling faint, vomiting blood, passing bloody or black stools, or experiencing persistent stomach pain. Additionally, symptoms suggestive of heart problems or stroke, including chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling, warrant immediate medical evaluation. If the child does not experience relief within the first 24 hours of treatment, or if fever or pain worsens or persists beyond three days, or if redness or swelling occurs in the affected area, further medical consultation is necessary. Any new symptoms that arise should also prompt a discussion with a healthcare professional.

In the event of an overdose, immediate medical assistance should be sought, or contact with a Poison Control Center (1-800-222-1222) is recommended.

Side Effects

Patients using ibuprofen may experience a range of adverse reactions, some of which can be serious.

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

The use of ibuprofen 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, including 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 advised to discontinue use and consult a healthcare provider if they experience 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.

It is recommended that patients seek medical advice if they do not achieve 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, patients should consult a healthcare provider if they have a history of stomach issues, such as heartburn, or if they have experienced serious side effects from pain relievers or fever reducers. Additional caution is advised for patients with conditions such as high blood pressure, heart disease, liver cirrhosis, kidney disease, or a history of stroke, as well as those with asthma or those taking diuretics.

Finally, it is important for patients under a doctor's care for any serious condition or those taking other medications to seek guidance from a healthcare professional prior to using ibuprofen.

Drug Interactions

Ibuprofen has notable interactions with various drug classes, particularly concerning its pharmacodynamic effects and potential for increased adverse events.

Anticoagulants and Steroids The concomitant use of ibuprofen with anticoagulants or steroid medications may significantly elevate the risk of severe gastrointestinal bleeding. It is advisable for healthcare providers to monitor patients closely for signs of bleeding and to consider alternative pain management strategies when these medications are used together.

Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) The use of ibuprofen, as with other NSAIDs, is associated with an increased risk of cardiovascular events, including heart attack and stroke. This risk is particularly pronounced when ibuprofen is administered at higher doses or for extended periods. Clinicians should evaluate the necessity of ibuprofen therapy in patients with existing cardiovascular risk factors and consider dosage adjustments or alternative therapies as appropriate.

Pediatric Considerations In pediatric patients, it is essential to consult a healthcare professional if the child is receiving any other medications, as potential drug interactions may arise. Monitoring for adverse effects and adjusting dosages may be necessary based on the child's overall medication regimen.

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 under 3 years of age should not use this medication unless directed by a healthcare professional. For dosing, the following guidelines apply based on weight:

  • For patients weighing under 24 lbs, consultation with a doctor is required.

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

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

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

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

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

Healthcare professionals should advise parents to consult a doctor if the child has a history of stomach problems, is taking other medications, or has experienced significant fluid loss due to vomiting or diarrhea.

If the child does not experience relief within the first 24 hours of treatment, if fever or pain worsens or persists beyond 3 days, or if any new symptoms arise, parents should discontinue use and seek medical advice.

It is essential to keep this medication out of reach of children. In the event of an overdose, immediate medical assistance or contact with a Poison Control Center is necessary.

Geriatric Use

Elderly patients should exercise caution when considering the use of this product, particularly due to the absence of specific directions or complete warnings for adult use. It is advisable for geriatric patients to consult a healthcare provider prior to use, especially if they have underlying health conditions such as high blood pressure, heart disease, liver cirrhosis, kidney disease, or a history of stroke.

Given the potential for increased sensitivity to medications in this population, careful monitoring and consideration of individual health status are essential. Healthcare providers should evaluate the risks and benefits of treatment in elderly patients, ensuring that any necessary dose adjustments or additional precautions are taken to safeguard their health.

Pregnancy

Pregnant patients should be advised against the use of this product if there is a history of allergic reactions to any other pain reliever or fever reducer. It is essential for healthcare providers to inquire about any history of stomach problems, such as heartburn, before recommending this product to pregnant patients.

When using this product, it is recommended to take it with food or milk to mitigate potential stomach upset. Healthcare professionals should instruct patients to discontinue use and seek medical advice if any signs of stomach bleeding or symptoms indicative of heart problems or stroke occur.

Additionally, this product should be kept out of reach of children to prevent accidental ingestion. In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center should be contacted without delay.

Lactation

Lactating mothers should consult a doctor before using ibuprofen. There is a potential for excretion of ibuprofen in breast milk. The effects of ibuprofen on a nursing infant are not well studied; therefore, caution is advised when considering its use during lactation.

Renal Impairment

There is no specific information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in this patient population.

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 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 following excessive administration of the product.

Management Procedures In the absence of detailed guidance, standard protocols for managing drug overdosage should be followed. This may include gastric decontamination, administration of activated charcoal if appropriate, and supportive care 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 overdosage incidents to the relevant authorities to contribute to the ongoing assessment of the product's safety profile.

Nonclinical Toxicology

No teratogenic or non-teratogenic effects have been reported in the available nonclinical studies. Additionally, there is no information regarding animal pharmacology and toxicology. The absence of data limits the assessment of potential risks associated with the compound in these areas.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions reported voluntarily or through surveillance programs. Notable gastrointestinal events include gastrointestinal bleeding and discomfort. Renal impairment has also been documented among the reported adverse reactions.

Serious cardiovascular events, such as myocardial infarction and stroke, have been received in postmarketing reports. Additionally, cases of liver injury have been noted, characterized by elevated liver enzymes and instances of hepatitis.

Severe skin reactions have been reported, including Stevens-Johnson syndrome and toxic epidermal necrolysis. Other adverse reactions include dizziness and headache, which have also been documented in the postmarketing experience. Hypersensitivity reactions, encompassing anaphylaxis and various skin reactions, have been observed as well.

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 attention 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 be made aware that if the child does not experience relief within the first 24 hours of treatment, or if fever or pain worsens or persists for more than three days, they should consult a healthcare professional. Redness or swelling in the painful area or the appearance of any new symptoms should also prompt a discussion with a doctor.

It is important for healthcare providers to remind patients to consult a doctor before use if the warning regarding stomach bleeding applies to the child, particularly 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. Patients should also be advised to seek medical advice 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, a history of stroke, or asthma.

Furthermore, healthcare providers should recommend that patients consult a doctor or pharmacist before use if the child is taking a diuretic or is under medical care for any serious condition, as well as if the child is currently taking any other medications.

Storage and Handling

The product is supplied in packaging that includes specific NDC numbers. It should be stored at a temperature range of 20-25°C (68-77°F) to maintain its integrity 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 ensure the product remains safe and effective for patient use.

Additional Clinical Information

Patients should take the medication with food or milk if they experience stomach upset. The recommended dosing frequency is every 6-8 hours, with a maximum of four doses per day.

Clinicians should counsel patients to discontinue use and seek medical advice if the child exhibits signs of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain. Additionally, they should be alert for symptoms indicative of heart problems or stroke, including chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling. Patients should also contact a healthcare provider if there is no relief within the first 24 hours, 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.

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.