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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 2011
Label revision date
March 3, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Ibuprofen 100 mg/5 mL
Other brand names
Drug class
Nonsteroidal Anti-inflammatory Drug
Dosage form
Suspension
Route
Oral
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2011
Label revision date
March 3, 2025
Manufacturer
Padagis Israel Pharmaceuticals Ltd
Registration number
ANDA074937
NDC root
45802-897
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (2 NDCs)
Packaging & NDC Codes (2)

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Drug Overview

Children’s Ibuprofen is an oral suspension designed for children aged 2 to 11 years, providing effective relief from minor aches and pains associated with common conditions like the cold, flu, sore throat, headache, and toothache. As a nonsteroidal anti-inflammatory drug (NSAID), it also helps reduce fever, making it a useful option for managing discomfort during illness.

This medication comes in a berry-flavored liquid form, with a concentration of 100 mg per 5 mL, and can provide relief for up to 8 hours. It is alcohol-free and gluten-free, ensuring it is suitable for a variety of dietary needs.

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 specific directions or warnings for adults. Always make sure to follow the recommended dosage and never exceed the amount directed. To prepare the medication, shake the bottle well before each use. You can find the right dose by referring to the dosing chart, which suggests using your child's weight for the most accurate measurement. If weight isn't available, you can use their age instead.

When measuring the dose, be sure to use only the enclosed dosing cup, as 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, wash the dosing cup to keep it clean, and always replace the original bottle cap to ensure it remains child-resistant.

What to Avoid

It's important to be cautious when considering this medication for your child. You should not use it if your child has ever had an allergic reaction to ibuprofen or any other pain reliever or fever reducer. Additionally, avoid using this medication right before or after heart surgery, as it can pose serious risks in these situations.

Always prioritize your child's safety by following these guidelines closely. If you have any concerns or questions about using this medication, consult with a healthcare professional for personalized advice.

Side Effects

Ibuprofen can cause serious allergic reactions, particularly 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 carries a risk of severe stomach bleeding, especially if your child has a history of stomach ulcers, is taking blood thinners or steroids, or uses other NSAIDs (nonsteroidal anti-inflammatory drugs) like aspirin or naproxen.

There are also warnings regarding heart attack and stroke risks associated with NSAIDs, which can be life-threatening. Symptoms that require immediate medical attention include severe sore throat with high fever, chest pain, difficulty breathing, weakness on one side of the body, slurred speech, or swelling in the legs. If your child experiences any signs of stomach bleeding, does not find relief within 24 hours, or if symptoms worsen or new symptoms appear, consult a doctor promptly. Always check with a healthcare provider 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 if you are allergic to aspirin. Symptoms may include hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, or blisters. If you experience any of these symptoms, stop using the medication 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 symptoms of heart problems like chest pain or trouble breathing, stop using ibuprofen and contact your doctor right away.

For children, do not use ibuprofen for more than 2 days without consulting a doctor, especially if they have a severe sore throat with high fever, headache, nausea, or vomiting. If your child does not feel better within 24 hours, or if their fever or pain worsens or lasts more than 3 days, seek medical advice. In case of an overdose, get emergency medical help or contact a Poison Control Center immediately at 1-800-222-1222.

Overdose

If you suspect an overdose, it’s crucial to seek medical help immediately. You can contact a Poison Control Center at 1-800-222-1222 for guidance. Signs of an overdose can vary, but they may include unusual drowsiness, confusion, or difficulty breathing.

Always take overdosing seriously. If you notice any of these symptoms or have concerns about your health, don’t hesitate to reach out for help right away. Your safety is the top priority.

Pregnancy Use

Using ibuprofen during pregnancy is generally not recommended, especially in the later stages. In particular, it is contraindicated (not allowed) during the third trimester because it can lead to serious complications, such as the premature closure of a vital blood vessel in the fetus called the ductus arteriosus. There is also a potential risk of harm to fetal development when ibuprofen is taken at any point during pregnancy.

If you are pregnant or planning to become pregnant, it’s important to consult your healthcare provider for safer alternatives and to discuss any necessary dosage modifications. Your provider can help you find the best options for managing pain or inflammation while keeping you and your baby safe.

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

It's important to be cautious when using this medication for children. You should not give it to children under 3 years old unless a doctor specifically advises you to do so. For children aged 2 to 11 years, the dosage depends on their weight and age. For example, if your child weighs between 24-35 lbs and is 2-3 years old, the recommended dose is 5 mL. Always consult your doctor if your child has a history of stomach issues, has experienced serious side effects from pain relievers or fever reducers, or has conditions like high blood pressure, heart disease, or asthma.

Additionally, if your child has been vomiting or has diarrhea and is not drinking enough fluids, or if they are taking a diuretic or are under care for a serious health issue, it's best to check with a doctor before administering this medication. Remember, do not use this medication for more than 2 days without medical advice, especially for children under 3 years old.

Geriatric Use

When it comes to using this product, it's important to be aware that it doesn't provide specific directions or warnings for adult use. If you are an older adult or caring for one, special precautions are necessary, especially if there are existing health concerns like high blood pressure, heart disease, liver cirrhosis, kidney disease, or a history of stroke.

Older adults may experience side effects more intensely, so monitoring for any unusual reactions is crucial. Additionally, if kidney function is reduced, dosage adjustments might be needed to ensure safety and effectiveness. Always consult with a healthcare provider to determine the best approach for your specific situation.

Renal Impairment

If you have kidney problems, it's important to be aware of how they can affect your health. Conditions like high blood pressure, heart disease, liver cirrhosis (scarring of the liver), and a history of stroke can complicate your kidney health.

Make sure to discuss your kidney condition with your healthcare provider, as they may need to adjust your medication dosages or monitor your kidney function more closely. Keeping an open line of communication with your doctor will help ensure that you receive the best care tailored to your needs.

Hepatic Impairment

If you have liver problems, such as liver cirrhosis (a severe scarring of the liver), it's important to be aware of how this may affect your treatment. Your healthcare provider may need to adjust your medication dosage or closely monitor your liver function tests (tests that check how well your liver is working) to ensure your safety and the effectiveness of your treatment.

Additionally, if you have other health issues like high blood pressure, heart disease, or kidney disease, these conditions can also influence your treatment plan. Always communicate openly with your healthcare team about your liver health and any other medical conditions you have, so they can provide the best care tailored to your needs.

Drug Interactions

It's important to be aware of potential interactions when taking ibuprofen. If you or your child are allergic to aspirin, using ibuprofen could lead to severe allergic reactions. Additionally, if your child is on blood thinners (medications that help prevent blood clots) or steroids, the risk of stomach bleeding increases. This risk is also heightened if your child is taking other nonsteroidal anti-inflammatory drugs (NSAIDs), such as aspirin or naproxen.

Always consult with a healthcare provider if your child is taking a diuretic (a medication that helps remove excess fluid from the body). Discussing all medications and any lab tests with your doctor is crucial to ensure safety and avoid serious side effects.

Storage and Handling

To ensure the best performance of your product, store it at a temperature between 20-25°C (68-77°F). It's important to keep it away from freezing temperatures, as freezing can damage the product.

When handling the product, make sure to do so with clean hands and in a clean environment to maintain its integrity. Always follow any specific disposal instructions provided to ensure safety and compliance.

Additional Information

You should take this medication orally, and if needed, you can repeat the dose every 6 to 8 hours, but do not exceed 4 doses in a day. To help prevent stomach upset, consider taking it with food or milk. Always use the enclosed dosing cup for accurate measurement, and make sure to shake the bottle well before each use.

It's important to keep this medication out of reach of children. In case of an overdose, seek medical help immediately or contact a Poison Control Center at 1-800-222-1222. Additionally, store the medication at room temperature (20-25°C or 68-77°F) and do not freeze it. Do not use the medication if the printed neckband is broken or missing.

FAQ

What is Children's Ibuprofen?

Children's Ibuprofen is an oral suspension that acts as a pain reliever and fever reducer, containing 100 mg of ibuprofen per 5 mL.

What age group can use Children's Ibuprofen?

Children's Ibuprofen is intended for children aged 2 to 11 years.

How long does the effect of Children's Ibuprofen last?

The effects of Children's Ibuprofen can last up to 8 hours.

What should I do if my child has a stomach upset?

If your child experiences a stomach upset, you can give Children's Ibuprofen with food or milk.

How should I measure the dose of Children's Ibuprofen?

Use only the enclosed dosing cup to measure the dose, and refer to the dosing chart based on your child's weight or age.

What are the potential side effects of Children's Ibuprofen?

Potential side effects include severe allergic reactions, stomach bleeding, and increased risk of heart attack or stroke.

When should I consult a doctor before using Children's Ibuprofen?

Consult a doctor if your child has a history of stomach problems, is taking other medications, or has certain health conditions like high blood pressure or asthma.

Is Children's Ibuprofen safe during pregnancy?

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

Can nursing mothers use Children's Ibuprofen?

Nursing mothers should consult a doctor before using Children's Ibuprofen due to the potential for excretion in breast milk.

What should I do in case of an overdose?

In case of overdose, seek medical help or contact a Poison Control Center immediately at 1-800-222-1222.

Packaging Info

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

Packaging configurations for Ibuprofen.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Children’s Ibuprofen is an oral suspension formulated as a nonsteroidal anti-inflammatory drug (NSAID) for the relief of pain and reduction of fever. Each 5 mL dose contains 100 mg of ibuprofen, and the product is intended for use in children aged 2 to 11 years. The suspension is alcohol-free and gluten-free, presented in a berry flavor to enhance palatability. The product is packaged in a 4 FL OZ (118 mL) bottle and provides relief that lasts up to 8 hours. This formulation is comparable to the active ingredient found in Children’s Motrin®. Manufactured by Padagis®.

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 dose based on the patient's weight or age. It is essential to shake the product well before each use. The enclosed dosing cup must be utilized for accurate measurement; no other dosing devices should be employed.

For patients weighing under 24 lbs or under 2 years of age, it is advised to consult a physician for the appropriate dosage. For those weighing between 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 recommended dose is 12.5 mL, and for those weighing 72-95 lbs (age 11 years), the dose is 15 mL.

Dosing may be repeated every 6-8 hours as needed, but should not exceed four doses in a 24-hour period. After each use, the dosing cup should be washed thoroughly. To maintain child resistance, the original bottle cap should be replaced securely after each use. It is critical to adhere to the recommended dosing guidelines and not exceed the directed amount.

Contraindications

Use of this product is contraindicated in the following situations:

Patients with a history of allergic reactions to ibuprofen or any other pain reliever or fever reducer should not use this product, as it may trigger a severe allergic response. Additionally, the product should not be administered immediately before or after heart surgery due to potential complications associated with its use in this context.

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.

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, whether prescription or over-the-counter (e.g., aspirin, ibuprofen, naproxen). Additionally, exceeding the recommended dosage or duration of treatment increases this risk.

Healthcare professionals should be aware that the use of NSAIDs, excluding aspirin, is 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.

In cases of severe or persistent sore throat, especially when accompanied by high fever, headache, nausea, or vomiting, immediate medical consultation is advised. Ibuprofen should not be used for more than two days in such instances or administered to children under three years of age unless directed by a physician.

Healthcare providers should instruct caregivers to discontinue use and seek medical advice if the child exhibits any signs of stomach bleeding, such as feeling faint, vomiting blood, passing bloody or black stools, or experiencing persistent stomach pain. Additionally, 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, medical consultation is necessary. Any new symptoms that arise should also prompt a discussion with a healthcare professional.

In the event of an overdose, it is crucial to obtain emergency medical assistance or contact a Poison Control Center immediately at 1-800-222-1222.

Side Effects

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

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

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

Common adverse reactions may include severe or persistent sore throat, especially when accompanied by high fever, headache, nausea, and vomiting. Such symptoms warrant prompt medical consultation.

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

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 consult a healthcare provider. The presence of redness or swelling in the painful area or the emergence of any new symptoms should also prompt medical advice.

Before using this product, patients should consult a healthcare professional if they have a history of stomach problems, such as heartburn, or if they have experienced serious side effects from pain relievers or fever reducers. Additional caution is advised for patients with dehydration, high blood pressure, heart disease, liver cirrhosis, kidney disease, or a history of stroke, as well as those with asthma or those taking diuretics. It is also recommended that patients under a doctor's care for any serious condition or those taking other medications consult a doctor or pharmacist prior to use.

Drug Interactions

Ibuprofen has the potential to induce severe allergic reactions, particularly in individuals with a known allergy to aspirin.

When considering the concomitant use of ibuprofen with anticoagulants or steroid medications, it is important to note that the risk of gastrointestinal bleeding is significantly increased. This risk is also elevated when ibuprofen is taken alongside other nonsteroidal anti-inflammatory drugs (NSAIDs), including both prescription and over-the-counter options such as aspirin and naproxen.

In pediatric patients, caution is advised when ibuprofen is administered in conjunction with diuretics. It is recommended that healthcare providers be consulted to evaluate the appropriateness of ibuprofen use in these cases, ensuring proper monitoring and dosage adjustments as necessary.

Packaging & NDC

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

Packaging configurations for Ibuprofen.
Details

Pediatric Use

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

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

  • For patients 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 recommended dose is 7.5 mL.

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

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

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

Healthcare professionals should advise parents or guardians to consult a doctor 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 due to vomiting or diarrhea, or if there are concerns regarding high blood pressure, heart disease, liver cirrhosis, kidney disease, a history of stroke, or asthma. It is also important to consult a doctor if the child is taking a diuretic or is under care for any serious condition. The medication should not be used for more than 2 days in pediatric patients or administered to children under 3 years of age without medical guidance.

Geriatric Use

Special precautions should be taken when administering this product to elderly patients, particularly those aged 65 and older, as they may exhibit increased sensitivity to side effects. This heightened sensitivity necessitates careful monitoring and consideration of individual health status.

Elderly patients with comorbid conditions such as high blood pressure, heart disease, liver cirrhosis, kidney disease, or a history of stroke require particular attention. These conditions may exacerbate potential adverse effects and complicate the management of therapy.

Dosage adjustments may be necessary for elderly patients, especially for those with reduced kidney function. It is essential for healthcare providers to evaluate renal function and adjust dosages accordingly to ensure safety and efficacy in this population.

Pregnancy

The use of ibuprofen during pregnancy is generally not recommended. It is contraindicated in the third trimester due to the risk of premature closure of the ductus arteriosus in the fetus. There is a potential risk of fetal harm associated with ibuprofen use, particularly in the later stages of pregnancy. Safety concerns include possible adverse effects on fetal development. Healthcare providers should be consulted for appropriate alternatives and dosage modifications if ibuprofen is deemed necessary during pregnancy.

Lactation

Lactating mothers should consult a doctor before using ibuprofen. There is a potential for excretion of ibuprofen in breast milk. Caution is advised when administering ibuprofen to nursing mothers due to the potential risk to the breastfed infant.

Renal Impairment

Patients with renal impairment may require careful consideration regarding dosing adjustments and monitoring. In particular, those with reduced kidney function, such as children with high blood pressure, heart disease, liver cirrhosis, or a history of stroke, should be evaluated for potential impacts on drug clearance and overall treatment efficacy. It is essential to assess renal function regularly to ensure safe and effective use of medications in this population.

Hepatic Impairment

Patients with hepatic impairment may experience altered pharmacokinetics of the drug due to compromised liver function. It is essential to assess liver function prior to initiating treatment and to monitor liver parameters throughout the course of therapy.

In patients with liver cirrhosis, dosage adjustments may be necessary to mitigate the risk of adverse effects. Close monitoring of liver function tests, including alanine aminotransferase (ALT), aspartate aminotransferase (AST), and bilirubin levels, is recommended to ensure patient safety and therapeutic efficacy.

Additionally, patients with a history of significant liver disease, such as cirrhosis, should be evaluated for potential contraindications or the need for alternative therapeutic strategies. It is crucial to consider the overall health status of patients, including any coexisting conditions such as high blood pressure, heart disease, or kidney disease, which may further complicate treatment decisions.

Overdosage

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

Prompt intervention is crucial in managing overdose situations, as timely medical support can significantly influence outcomes. Symptoms of overdose may vary depending on the substance involved, and healthcare providers should be prepared to assess and manage these symptoms accordingly.

Management procedures may include supportive care, monitoring of vital signs, and symptomatic treatment as necessary. It is essential for healthcare professionals to remain vigilant and act swiftly to mitigate potential complications associated with overdose.

Nonclinical Toxicology

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

Postmarketing Experience

Postmarketing experience has identified the following adverse reactions reported voluntarily or through surveillance programs: hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, and blisters. These events have been documented in the context of ongoing safety monitoring.

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 to administer the medication with food or milk if the child 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 persistent stomach pain. 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 beyond 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.

Before initiating treatment, healthcare providers should encourage patients to consult a doctor if any of the following conditions apply: the child has a history of stomach bleeding, has experienced stomach problems such as heartburn, has had serious side effects from pain relievers or fever reducers, has not been adequately hydrated, has lost significant fluids due to vomiting or diarrhea, has high blood pressure, heart disease, liver cirrhosis, kidney disease, or a history of stroke, has asthma, or is taking a diuretic.

Furthermore, patients should be advised to consult a doctor or pharmacist before use if the child is currently under medical care for any serious condition or is taking any other medications.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at a temperature range of 20-25°C (68-77°F) to maintain its efficacy. Freezing the product is strictly prohibited, as it may compromise its integrity. Proper storage conditions must be adhered to in order to ensure optimal performance and safety.

Additional Clinical Information

The medication is administered orally, with a recommended dosing frequency of every 6-8 hours as needed, not to exceed four doses per day. Clinicians should advise patients to take the medication with food or milk if gastrointestinal upset occurs. It is essential to use only the enclosed dosing cup for administration and to shake the bottle well before use. Patients should be instructed to keep the medication out of reach of children and to seek immediate medical assistance or contact a Poison Control Center (1-800-222-1222) in the event of an overdose. Additionally, the medication should not be used if the printed neckband is broken or missing, and it should be stored at a temperature of 20-25°C (68-77°F), avoiding freezing.

No further information is available regarding laboratory tests, abuse potential, or postmarketing experience.

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.