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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
April 29, 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 2022
Label revision date
April 29, 2022
Manufacturer
FSA Store Inc. (Caring Mills)
Registration number
ANDA074916
NDC root
81522-938
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info
Packaging & NDC Codes

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

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

Drug Overview

Ibuprofen is a children's oral suspension that contains 100 mg of the medication per 5 mL. It is classified as a nonsteroidal anti-inflammatory drug (NSAID) and is commonly used to relieve minor aches and pains associated with conditions like the common cold, flu, sore throat, headache, and toothache. Additionally, it helps reduce fever, making it a helpful option for managing discomfort in children aged 2 to 11 years.

This grape-flavored liquid is designed to be easy for children to take and provides relief that can last up to 8 hours. Always ensure to read the product information carefully before use to understand its intended purpose and proper administration.

Uses

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

Rest assured, this medication does not have any teratogenic effects, meaning it does not cause developmental issues in a fetus. This makes it a safer choice for those who may be pregnant or planning to become pregnant.

Dosage and Administration

Before using this product, it's important to note that it does not come with complete directions or warnings for adult use. To ensure safety, always follow the recommended dosage and never exceed the directed amount. 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.

Use the enclosed dosing cup to measure the dose accurately; do not use any other device. If necessary, you can repeat the dose every 6 to 8 hours, but remember not to use it more than four times a day. After each use, make sure to replace the original bottle cap to keep it child-resistant and safe. If your child is under 2 years old and 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 ibuprofen or any other pain reliever or fever reducer. Additionally, do not use it right before or after heart surgery, as this could pose serious risks.

If your child experiences any signs of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or persistent stomach pain, stop use immediately and consult a doctor. Also, seek medical attention if your child shows symptoms of heart problems or stroke, including chest pain, difficulty breathing, weakness on one side of the body, slurred speech, or swelling in the legs. If there is no relief within the first 24 hours, or if fever or pain worsens or lasts more than three days, or if new symptoms arise, it’s important to contact a healthcare professional.

Side Effects

Ibuprofen can cause serious side effects, including severe allergic reactions, especially in those allergic to aspirin. Symptoms of an allergic reaction may include hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, and 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, which can be fatal if used improperly.

You should stop using ibuprofen and consult a doctor if your child experiences signs of stomach bleeding, such as feeling faint, vomiting blood, or having black stools. Seek medical attention if your child shows symptoms of heart problems or stroke, like chest pain or trouble breathing. It's important to ask a doctor before use if your child has a history of stomach issues, is dehydrated, or has other serious health conditions. Always monitor for any new symptoms or if the condition worsens.

Warnings and Precautions

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

This medication can also lead to severe stomach bleeding, particularly if you have a history of stomach ulcers or bleeding, 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 symptoms of heart problems like chest pain or trouble breathing, stop using ibuprofen and contact your doctor right away.

It's important to consult a doctor if your sore throat is severe or lasts more than two days, especially if accompanied by high fever, headache, nausea, or vomiting. You should also stop using ibuprofen and call your doctor if your child does not find relief within 24 hours, if fever or pain worsens or lasts more than three days, or if any new symptoms appear.

Overdose

Taking too much ibuprofen can lead to several uncomfortable symptoms. You might experience nausea (feeling sick), vomiting, stomach pain, dizziness, or drowsiness (feeling unusually tired or sleepy).

If you suspect an overdose, it’s important to act quickly. Seek immediate medical attention or contact a Poison Control Center for guidance. Your health and safety are the top priority, so don’t hesitate to get help if you notice any of these symptoms.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that the safety of ibuprofen has not been established. In fact, using ibuprofen during pregnancy, especially in the third trimester, is not recommended because it can pose risks to your baby, including potential kidney problems, low amniotic fluid (oligohydramnios), and heart issues.

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

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 passed into breast milk or any associated risks for your infant.

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

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 aged 2 to 11 years, the dosage depends on their weight. For example, if your child weighs under 24 pounds (less than 2 years), you should consult a doctor first. For those weighing between 24 to 35 pounds (ages 2-3), the recommended dose is 5 mL, while children weighing 36 to 47 pounds (ages 4-5) should receive 7.5 mL. The dosage continues to increase with weight, reaching 15 mL for children who weigh between 72 to 95 pounds (11 years).

Always consult a doctor if your child has a history of stomach issues, is taking other medications, or is not drinking enough fluids. Additionally, do not use this medication for more than 2 days for a sore throat unless directed by a doctor. If your child shows any signs of stomach bleeding or symptoms related to heart problems or stroke, stop using the medication and seek medical advice immediately.

Geriatric Use

While the drug insert does not provide specific information about its use in older adults, it is important to approach medication with caution as you age. Since the insert mainly discusses pediatric use, there are no recommended dosage adjustments or safety guidelines specifically for elderly patients.

If you or a loved one is an older adult, it’s always wise to consult with a healthcare provider before starting any new medication. They can help ensure that the treatment is safe and appropriate for your individual health needs.

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 the drug insert does not provide specific information about dosage adjustments, special monitoring, or precautions for your condition. This means that there are no tailored guidelines for how this medication may affect you if you have hepatic impairment (liver issues).

Always consult your healthcare provider for personalized advice and to discuss any concerns regarding your liver health and how it may relate to your treatment. They can help ensure that you receive the safest and most effective care.

Drug Interactions

It's important to be aware that certain medications can interact with each other, potentially leading to serious side effects. For instance, if you or your child are taking ibuprofen, be cautious about using it alongside blood thinners (medications that help prevent blood clots) or steroids, as this combination can significantly increase the risk of severe stomach bleeding. Additionally, if your child is already taking other nonsteroidal anti-inflammatory drugs (NSAIDs) like aspirin or naproxen, the risk of stomach bleeding is even higher.

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 treatments with your doctor ensures that you can safely manage your health and avoid any harmful interactions.

Storage and Handling

To ensure the best use of your product, store it in a cool, dry place at a temperature between 20° to 25°C (68° to 77°F). Before using, make sure to shake the bottle well to mix the contents properly. After each use, remember to replace the original bottle cap to keep it child-resistant, ensuring safety in your home. It's important to discard the product after opening to maintain its effectiveness and safety.

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 four doses in a single day. If you experience an upset stomach, taking the medication with food or milk may help.

It's important to monitor for any serious side effects, especially in children. If you notice signs of stomach bleeding or symptoms related to heart problems or stroke, stop using the medication and consult a doctor immediately. Always keep this medication out of reach of children, and in the event of an overdose, seek medical assistance or contact a Poison Control Center at 1-800-222-1222 right away.

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 age group is Ibuprofen intended for?

Ibuprofen is intended for use in children aged 2 to 11 years.

How should I administer Ibuprofen to my child?

Shake well before using and use only the enclosed dosing cup. Follow the dosing chart based on your child's weight or age.

What should I do if my child experiences stomach bleeding?

Stop use and ask a doctor if your child experiences signs of stomach bleeding, such as feeling faint, vomiting blood, or having bloody or black stools.

Can I give Ibuprofen to my child if they have allergies?

Do not give Ibuprofen if your child has ever had an allergic reaction to it or any other pain reliever/fever reducer.

Is it safe to use Ibuprofen during pregnancy?

The safety of Ibuprofen during pregnancy has not been established, and it is contraindicated, especially during the third trimester due to potential risks to the fetus.

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.

How should I store Ibuprofen?

Store Ibuprofen between 20° to 25°C (68° to 77°F) and replace the original bottle cap to maintain child resistance.

What are the dosing instructions for Ibuprofen?

Dosing varies by weight: for example, children weighing 24-35 lbs should receive 5 mL, while those weighing 72-95 lbs should receive 15 mL. Always consult the dosing chart.

What should I do in case of an overdose?

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

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

Ibuprofen is an oral suspension formulated as a nonsteroidal anti-inflammatory drug (NSAID) with a concentration of 100 mg per 5 mL. This preparation serves as a pain reliever and fever reducer. The suspension is presented in a grape flavor and is alcohol-free, making it suitable for a wide range of patients.

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 ensure that the product is administered according to the following guidelines. Prior to use, the product must be shaken well. The appropriate dose should be determined using the dosing chart provided, which considers both weight and age. If possible, weight should be used to ascertain the correct dosage; if weight is not available, age may be utilized instead.

The dosing cup enclosed with the product must be used exclusively for measuring doses; no other dosing devices should be employed. The recommended dosing intervals are every 6 to 8 hours as needed, with a maximum of four doses per day.

The dosing chart is as follows:

  • For patients under 24 lbs or under 2 years of age, consult a doctor for the appropriate dose.

  • 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.

It is imperative not to exceed the recommended dosage. After use, the original bottle cap should be replaced to maintain child resistance.

Contraindications

Use of this product is contraindicated in children with a history of allergic reactions to ibuprofen or any other pain reliever/fever reducer. Additionally, administration is contraindicated immediately before or after heart surgery due to potential complications.

Healthcare professionals should advise discontinuation and seek medical consultation if the child exhibits signs of stomach bleeding, including faintness, vomiting blood, bloody or black stools, or persistent stomach pain. Symptoms indicative of heart problems or stroke, such as chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling, also warrant immediate medical attention.

If the child does not experience relief within the first 24 hours of treatment, or if fever or pain worsens or persists beyond three days, or if redness or swelling occurs in the affected area, medical advice should be sought. Any new symptoms that arise during treatment should also prompt consultation with a healthcare provider.

Warnings and Precautions

Ibuprofen may induce severe allergic reactions, particularly in individuals with a known allergy to aspirin. Symptoms indicative of an allergic response 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.

The use of ibuprofen, an NSAID, carries a significant risk of severe stomach bleeding. This risk is notably elevated in pediatric patients with a history of stomach ulcers or bleeding disorders, those concurrently using anticoagulants or steroid medications, and individuals taking other NSAIDs, whether prescription or over-the-counter (such as aspirin, ibuprofen, or naproxen). Additionally, exceeding the recommended dosage or duration of treatment increases the likelihood of gastrointestinal complications.

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

In cases of severe or persistent sore throat, particularly when accompanied by high fever, headache, nausea, or vomiting, immediate medical consultation is advised. Ibuprofen should not be administered for more than two days, nor should it be given to children under three years of age unless specifically directed by a healthcare provider.

Healthcare providers should instruct caregivers to discontinue ibuprofen and seek medical advice if the child exhibits any of the following signs of potential stomach bleeding: feeling faint, vomiting blood, passing bloody or black stools, or experiencing persistent stomach pain. Additionally, symptoms suggestive of heart problems or stroke, such as 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 there is noticeable redness or swelling in the affected area, medical consultation is necessary. Caregivers should also be vigilant for the emergence of any new symptoms and seek guidance accordingly.

Side Effects

Patients using ibuprofen may experience a range of adverse reactions, which can be categorized by seriousness and frequency.

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 guidelines.

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 duration.

Patients should be vigilant for signs of serious conditions, such as severe or persistent sore throat, especially when accompanied by high fever, headache, nausea, or vomiting, and should seek medical attention promptly.

Patients are advised to discontinue use and consult a healthcare professional if they experience any signs of stomach bleeding, including feeling faint, vomiting blood, having bloody or black stools, or persistent stomach pain. Symptoms indicative of heart problems or stroke, such as chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling, also warrant immediate medical consultation.

If a patient does not achieve relief within the first 24 hours of treatment, or if fever or pain worsens or persists beyond three days, they should seek medical advice. The presence of redness or swelling in the painful area or the emergence of new symptoms should also prompt consultation with a healthcare provider.

Before using ibuprofen, it is essential for patients to consult a doctor if they have a history of stomach problems, are experiencing dehydration, or have 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. Furthermore, individuals under a doctor's care for any serious condition or those taking other medications should consult a healthcare professional before using ibuprofen.

Drug Interactions

Ibuprofen has been associated with an increased risk of severe gastrointestinal bleeding, particularly when co-administered with anticoagulants or corticosteroids. This interaction is primarily pharmacodynamic in nature, as both classes of drugs can exacerbate the gastrointestinal side effects of ibuprofen.

In pediatric patients, the risk of stomach bleeding is further heightened if the child is concurrently taking other nonsteroidal anti-inflammatory drugs (NSAIDs), including but not limited to aspirin and naproxen. Clinicians should exercise caution and consider alternative pain management strategies in these cases.

Additionally, it is advisable to consult a healthcare professional if the child is receiving diuretic therapy. Monitoring for potential adverse effects and adjusting dosages may be necessary to ensure patient safety.

Packaging & NDC

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

Packaging configurations for Ibuprofen.
Details

Pediatric Use

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

  • For those weighing under 24 lbs (under 2 years), consultation with a doctor is required.

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

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

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

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

  • For children weighing 72-95 lbs (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 not been drinking fluids. The product should not be used for more than 2 days for sore throat unless directed by a doctor. Parents should be instructed to stop use and seek medical advice if the child exhibits signs of stomach bleeding or symptoms indicative of heart problems or stroke.

Geriatric Use

There is no specific information regarding the use of this medication in geriatric patients. The prescribing information primarily emphasizes pediatric use and does not provide any recommendations concerning age considerations, dosage adjustments, safety concerns, or special precautions for elderly patients.

Healthcare providers should exercise caution when prescribing this medication to geriatric patients, given the absence of data on its safety and efficacy in this population. Monitoring for potential adverse effects and therapeutic responses is advised, as elderly patients may respond differently to treatment compared to younger populations.

Pregnancy

The safety of ibuprofen during pregnancy has not been established. Ibuprofen is contraindicated in pregnancy, particularly during the third trimester, due to the risk of fetal harm. The use of ibuprofen during pregnancy may be associated with risks such as fetal renal impairment, oligohydramnios, and potential cardiovascular effects.

Dosage modifications may be necessary, and it is advised that pregnant patients consult a healthcare provider before using ibuprofen. Pregnant women should avoid using ibuprofen unless specifically directed by a healthcare professional.

Lactation

There are no specific warnings or recommendations regarding the use of ibuprofen in nursing mothers. Additionally, there is no information available about the potential for excretion of ibuprofen in breast milk or any associated risks to breastfed infants.

Renal Impairment

Patients with renal impairment have no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the text. Therefore, healthcare professionals should exercise caution and consider individual patient factors when prescribing to patients with reduced kidney function. Regular monitoring of renal function may be warranted in these patients, although specific guidelines are not outlined.

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

Overdosage of ibuprofen can lead to a range of symptoms that may vary in severity. Common manifestations include nausea, vomiting, stomach pain, dizziness, and drowsiness.

In the event of an overdose, it is imperative to seek immediate medical attention. Healthcare professionals should advise patients or caregivers to contact a Poison Control Center for further guidance and management. Prompt intervention is crucial to mitigate potential complications associated with ibuprofen overdosage.

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 in these areas limits the understanding of the compound's potential effects in nonclinical settings.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions associated with the use of the product. Reports indicate occurrences of allergic reactions, which may include hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, and blisters. Additionally, there have been instances of stomach bleeding, particularly in patients with a history of stomach ulcers or bleeding disorders, as well as those concurrently using anticoagulants or other nonsteroidal anti-inflammatory drugs (NSAIDs).

There is an increased risk of serious cardiovascular events, including heart attack, heart failure, and stroke, associated with NSAID use. Reports have also highlighted severe or persistent sore throat, especially when accompanied by high fever, headache, nausea, and vomiting, as potential indicators of serious underlying conditions.

Symptoms indicative of stomach bleeding may include feeling faint, vomiting blood, passing bloody or black stools, and experiencing stomach pain that does not improve. Furthermore, symptoms suggestive of heart problems or stroke can manifest as chest pain, difficulty breathing, unilateral weakness, slurred speech, and leg swelling.

Patients experiencing new symptoms during treatment are advised to discontinue use and seek medical consultation.

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.

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 any relief within the first 24 hours of treatment, if fever or pain worsens or persists beyond three days, if there is redness or swelling in the affected area, or if any new symptoms arise.

When using this product, it is recommended that patients take it with food or milk to mitigate potential stomach upset. 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.

Patients should be advised to seek medical guidance before use if the child has experienced serious side effects from pain relievers or fever reducers, has not been adequately hydrated, or has lost significant fluids due to vomiting or diarrhea.

Furthermore, healthcare providers should recommend consulting a doctor before use if the child has high blood pressure, heart disease, liver cirrhosis, kidney disease, or a history of stroke, as well as if the child has asthma or is taking a diuretic.

Lastly, patients should be encouraged to speak with a doctor or pharmacist before use if the child is under medical care for any serious condition or is currently taking any other medications.

Storage and Handling

The product is supplied in a container that requires careful handling to ensure safety and efficacy. It should be stored at a temperature range of 20° to 25°C (68° to 77°F). Prior to use, the container must be shaken well to ensure proper mixing of the contents.

To maintain child resistance, it is essential to replace the original bottle cap after each use. Additionally, the product should be discarded after opening to ensure safety and prevent any potential contamination.

Additional Clinical Information

The medication is administered orally, with a recommended repeat dose every 6-8 hours as needed, not to exceed four doses in a 24-hour period. Patients should be advised to take the medication with food or milk if they experience stomach upset.

Clinicians should counsel patients to discontinue use and seek medical attention if a child exhibits signs of stomach bleeding or symptoms indicative of heart problems or stroke. It is crucial to keep the medication out of reach of children, and in the event of an overdose, patients should obtain medical help or contact a Poison Control Center immediately at 1-800-222-1222.

Drug Information (PDF)

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

View product document (PDF)

Data Generation & Sources

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

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

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

No human clinician has reviewed this version.

Learn more in our Editorial Policy

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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.