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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 2002
Label revision date
June 25, 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 2002
Label revision date
June 25, 2025
Manufacturer
Kroger Company
Registration number
ANDA074937
NDC root
30142-660
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (2 NDCs)
Packaging & NDC Codes (2)

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

Drug Overview

Children's Ibuprofen is an oral suspension medication designed for children aged 2 to 11 years. It contains 100 mg of ibuprofen (a type of nonsteroidal anti-inflammatory drug, or NSAID) per 5 mL and is used to relieve minor aches and pains associated with common conditions like the cold, flu, sore throat, headache, and toothache. Additionally, it helps reduce fever and provides relief that can last up to 8 hours. This grape-flavored medication is alcohol-free, making it a suitable option for young children.

Uses

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

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

Dosage and Administration

Before using this product, it's important to 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 should find the right dose by referring to the dosing chart provided, which is based on weight. If you can't use weight, you can use age as a guide.

When measuring the dose, use only the enclosed dosing cup, as other devices may not provide accurate measurements. For children, if the dose is needed again, you can repeat it every 6 to 8 hours, but do not use it more than four times in a single day. After each use, wash the dosing cup to keep it clean, and remember to replace the original bottle cap to ensure it remains child-resistant. If your child weighs under 24 pounds (under 2 years), consult a doctor for guidance. For children weighing between 24 and 95 pounds, refer to the chart for the correct dosage.

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 safety by following these guidelines closely. If you have any concerns or questions about your child's health or 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 a severe 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 is also an increased risk of heart attack and stroke associated with NSAIDs, which can be life-threatening, particularly if used in higher doses or for extended periods. If your child experiences symptoms such as faintness, vomiting blood, or black stools, or shows signs of heart problems like chest pain or difficulty breathing, seek medical attention immediately. It's important to consult a doctor if your child has a severe sore throat with high fever or if symptoms worsen or persist beyond a few days. Always discuss any pre-existing health conditions or medications with a healthcare provider before use.

Warnings and Precautions

Ibuprofen can cause serious allergic reactions, especially if you are allergic to aspirin. Symptoms may include hives, facial swelling, wheezing, shock, skin reddening, rash, or blisters. If you experience any of these symptoms, stop using 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 two days without a doctor's guidance, 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, consult a doctor. In case of an overdose, seek 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 err on the side of caution—if you notice any concerning symptoms or if you’re unsure, don’t hesitate to get help right away. Your health and safety are the top priority.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that the safety of ibuprofen has not been established. Specifically, using ibuprofen during the third trimester (the last three months of pregnancy) is not recommended, as it can lead to serious complications for your baby, such as the premature closure of a vital blood vessel called the ductus arteriosus. Additionally, there may be other risks to your baby's heart and overall health.

Before taking ibuprofen, you should always consult your healthcare provider. They can help you understand the potential risks and suggest safer alternatives for managing pain or inflammation during your pregnancy. Your health and your baby's health are the top priority, so it's best to seek professional advice.

Lactation Use

If you are breastfeeding and considering using ibuprofen, it's important to consult your doctor first. While ibuprofen can be helpful for pain relief, there is a possibility that it can pass into your breast milk. The effects of ibuprofen on nursing infants haven't been thoroughly studied, so it's wise to be cautious.

If you do take ibuprofen while breastfeeding, keep an eye on your baby for any unusual reactions or side effects. Monitoring your infant can help ensure their safety while you manage your own discomfort.

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 10 years, the dosage depends on their weight and age. For example, a child weighing between 24-35 pounds (2-3 years old) should receive 5 mL, while a child weighing 72-95 pounds (11 years old) can take 15 mL. Always consult a doctor for the correct dosage and before use if your child has had any allergic reactions to pain relievers or fever reducers.

Make sure to monitor your child closely while using this medication. It should not be used for more than 2 days, and if your child does not feel better within 24 hours, or if their fever or pain worsens or lasts more than 3 days, you should stop using it and consult a doctor. If your child experiences stomach upset, giving the medication with food or milk may help.

Geriatric Use

You can feel reassured that there are no specific concerns regarding the use of Ibuprofen Children's suspension for older adults. The information available does not indicate any need for dosage adjustments or special safety precautions for elderly patients. This means that, in general, you can use this medication without worrying about unique risks associated with age. However, as always, it's a good idea to consult with a healthcare provider before starting any new medication, especially if you have other health conditions or are taking other medications.

Renal Impairment

If you have kidney problems, it's important to consult your doctor before using this medication. This is especially crucial if you also have high blood pressure, heart disease, liver cirrhosis (a severe liver condition), or if you've had a stroke. Your doctor will help determine if this medication is safe for you and may suggest adjustments to your dosage or additional monitoring to ensure your health and safety. Always prioritize open communication with your healthcare provider regarding your kidney health and any medications you are considering.

Hepatic Impairment

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

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

Drug Interactions

It's important to talk to your healthcare provider about any medications you are taking, especially if you are considering using ibuprofen. This is because ibuprofen can increase the risk of stomach bleeding when combined with blood thinners (medications that prevent blood clots) or steroids. Additionally, using ibuprofen, particularly in higher doses or for extended periods, may raise the risk of serious heart issues, such as heart attack or stroke.

You should also avoid taking ibuprofen alongside other nonsteroidal anti-inflammatory drugs (NSAIDs), like aspirin or naproxen, as this can lead to further complications. Always consult with your healthcare provider to ensure your safety and the effectiveness of your treatment plan.

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 safe environment to maintain its integrity. Always follow any additional safety instructions provided with the product to ensure proper use and disposal.

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 are considering this medication for a child, it's important to consult a doctor first, especially if the child has any serious health conditions. Always keep the medication out of reach of children, and in the event of an overdose, seek medical help immediately or contact a Poison Control Center at 1-800-222-1222.

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 is Children's Ibuprofen suitable for?

It is suitable for children aged 2 to 11 years.

How should I administer Children's Ibuprofen?

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

What are the common uses of Children's Ibuprofen?

It relieves minor aches and pains due to the common cold, flu, sore throat, headache, and toothache, and it reduces fever.

What should I do if my child has a severe allergic reaction?

If your child experiences symptoms like hives, facial swelling, or difficulty breathing, stop use immediately and seek medical help.

Are there any warnings associated with Children's Ibuprofen?

Yes, it may cause severe stomach bleeding, especially if your child has a history of stomach ulcers or is taking blood thinners.

Can I give Children's Ibuprofen to my child if they have high blood pressure?

You should ask a doctor before use if your child has high blood pressure, heart disease, liver cirrhosis, kidney disease, or has had a stroke.

Is it safe to use Children's Ibuprofen during pregnancy?

The safety of ibuprofen during pregnancy has not been established, and it is contraindicated in late pregnancy due to potential risks to the fetus.

What should I do if my child does not get relief from pain or fever?

If your child does not get any relief within the first 24 hours, or if symptoms worsen or last more than 3 days, consult a doctor.

How should I store Children's Ibuprofen?

Store it at 20-25°C (68-77°F) and do not freeze.

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

Kroger® health Children's Ibuprofen Oral Suspension is a nonsteroidal anti-inflammatory drug (NSAID) indicated for pain relief and fever reduction in children aged 2 to 11 years. Each 5 mL dose contains 100 mg of ibuprofen. The formulation is alcohol-free and is presented in a grape flavor. The product is packaged in a 4 FL OZ (118 mL) bottle and provides relief that lasts up to 8 hours. This product is comparable to the active ingredient in Children's Motrin® Ibuprofen Oral Suspension.

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 children, and healthcare professionals should refer to the dosing chart to determine the appropriate dosage based on the child's weight or age. It is essential to shake the product well before each use. The enclosed dosing cup must be used for accurate measurement; no other dosing devices should be utilized.

For children weighing under 24 lbs (under 2 years), it is advised to consult a doctor for appropriate dosing. For children weighing between 24-35 lbs (2-3 years), the recommended dose is 5 mL. For those weighing 36-47 lbs (4-5 years), the dose increases to 7.5 mL. Children weighing 48-59 lbs (6-8 years) should receive 10 mL, while those weighing 60-71 lbs (9-10 years) should be given 12.5 mL. For children weighing 72-95 lbs (11 years), the recommended dose is 15 mL.

Dosing may be repeated every 6-8 hours as needed, but should not exceed 4 doses in a 24-hour period. After each use, the dosing cup should be washed thoroughly. To maintain child resistance, the original bottle cap must be replaced securely after each use. It is critical to adhere to the prescribed dosage and not exceed the recommended limits.

Contraindications

Use is contraindicated in patients with a history of allergic reactions to ibuprofen or any other pain reliever or fever reducer. Additionally, administration is contraindicated in the perioperative period surrounding heart surgery due to potential complications.

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 use increases the risk of gastrointestinal complications.

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.

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 administered for more than two days without medical guidance, particularly in children under three years of age.

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 or unusual symptoms should also prompt a discussion with a healthcare professional.

In the event of an overdose, it is critical 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, particularly due to its nonsteroidal anti-inflammatory drug (NSAID) properties.

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

The use of this NSAID is also associated with a risk of severe stomach bleeding, particularly in patients with a history of stomach ulcers or bleeding problems. The risk is heightened in those taking anticoagulants, steroid medications, or other NSAIDs, as well as in patients who exceed the recommended dosage or duration of use. Signs of stomach bleeding may include feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain.

Additionally, there is an increased risk of heart attack, heart failure, and stroke associated with NSAID use, excluding aspirin. These cardiovascular events can be fatal, and the risk is amplified when the medication is used in excess or for prolonged periods.

Patients should be vigilant for severe or persistent sore throat symptoms, particularly when accompanied by high fever, headache, nausea, or vomiting, and should seek medical attention promptly. The product should not be used for more than two days or administered to children under three years of age without a doctor's guidance.

It is advised that patients discontinue use and consult a healthcare professional if they experience any signs of stomach bleeding, symptoms indicative of heart problems or stroke, lack of relief within the first 24 hours of treatment, worsening fever or pain lasting more than three days, redness or swelling in the painful area, or the emergence of any new symptoms.

Before using this product, patients should consult a doctor if any of the following apply: a history of stomach problems, previous serious side effects from pain relievers or fever reducers, dehydration due to vomiting or diarrhea, or pre-existing conditions such as high blood pressure, heart disease, liver cirrhosis, kidney disease, or a history of stroke. Additionally, patients with asthma or those taking diuretics should seek medical advice prior to use. It is also recommended to consult a doctor or pharmacist if the patient is under medical care for any serious condition or is taking other medications.

Drug Interactions

Ibuprofen is associated with several significant drug interactions that warrant careful consideration.

Anticoagulants and Steroids The concomitant use of ibuprofen with anticoagulants or steroid medications may elevate the risk of gastrointestinal bleeding. It is advisable to monitor patients closely for signs of bleeding and consider dosage adjustments or alternative therapies where appropriate.

Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) Ibuprofen should not be administered alongside other NSAIDs, including both prescription and nonprescription options such as aspirin and naproxen. The use of multiple NSAIDs can increase the risk of adverse effects, including gastrointestinal complications.

Cardiovascular Risks The use of ibuprofen, particularly at doses exceeding recommended levels or for prolonged durations, may heighten the risk of serious cardiovascular events, including heart attack, heart failure, and stroke. Clinicians should evaluate the necessity of ibuprofen therapy in patients with existing cardiovascular conditions and consider alternative pain management strategies when appropriate.

No specific laboratory test interactions have been identified in the available data.

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 children aged 2 to 11 years, dosing is based on weight and age, as outlined in the following chart:

  • Under 24 lbs / Under 2 years: Ask a doctor

  • 24-35 lbs / 2-3 years: 5 mL

  • 36-47 lbs / 4-5 years: 7.5 mL

  • 48-59 lbs / 6-8 years: 10 mL

  • 60-71 lbs / 9-10 years: 12.5 mL

  • 72-95 lbs / 11 years: 15 mL

Dosing may also be adjusted as directed by a doctor. It is important to limit use to no more than 2 days and to consult a doctor if the child has a history of allergic reactions to ibuprofen or other pain relievers/fever reducers.

To minimize the risk of stomach upset, the medication should be administered with food or milk. Parents and caregivers should monitor the child’s response to treatment; if there is no relief within the first 24 hours, if fever or pain worsens or persists beyond 3 days, or if redness or swelling occurs in the painful area, they should stop use and consult a doctor.

Geriatric Use

Elderly patients do not have specific geriatric use considerations, dosage adjustments, or safety concerns noted in the prescribing information for Ibuprofen Children's suspension. Therefore, healthcare providers may not need to implement any additional precautions or modifications when prescribing this medication to geriatric patients. However, as with any medication, it is advisable to monitor elderly patients for any potential adverse effects, given their unique physiological characteristics and potential for polypharmacy.

Pregnancy

The safety of ibuprofen during pregnancy has not been established. Ibuprofen is contraindicated in late pregnancy (third trimester) due to the risk of premature closure of the ductus arteriosus in the fetus. The use of ibuprofen during pregnancy may pose risks to the fetus, including potential cardiovascular effects. Therefore, pregnant women should consult a healthcare provider before using ibuprofen.

Lactation

Nursing 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. It is recommended to monitor the infant for any adverse effects if the mother is taking ibuprofen while breastfeeding.

Renal Impairment

Patients with renal impairment should consult a healthcare professional prior to use, particularly if they have a history of kidney disease. It is essential to assess the patient's overall health status, including any comorbid conditions such as high blood pressure, heart disease, liver cirrhosis, or a history of stroke, as these factors may influence the management of their renal function and the appropriateness of treatment. Monitoring and potential dosing adjustments may be necessary based on the patient's renal status to ensure safety and efficacy.

Hepatic Impairment

Patients with hepatic impairment may experience altered pharmacokinetics of the medication 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 options. Regular follow-up assessments are advised to monitor any changes in liver function that may impact 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 the individual’s health status. Therefore, a thorough assessment and monitoring of the patient are essential.

Management procedures should include supportive care and symptomatic treatment as necessary. Healthcare providers are encouraged to follow established protocols for overdose management, which may involve decontamination, administration of antidotes if applicable, and continuous monitoring of vital signs and clinical status.

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 reported the following adverse reactions: hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, and blisters. These events were reported voluntarily or identified through surveillance programs.

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 counseled to monitor the child’s response to treatment. If the child does not experience relief within the first 24 hours, or if fever or pain worsens or persists beyond three days, they should contact a healthcare professional. The presence of redness or swelling in the painful area or the emergence of any new symptoms should also prompt a consultation with a doctor.

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

Finally, healthcare providers should encourage patients 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 upon request. It should be stored at a temperature range of 20-25°C (68-77°F). Freezing is not permitted, as it may compromise the integrity of the product. Proper container requirements must be adhered to, ensuring that the product is kept in a suitable environment to maintain its efficacy. Special handling needs should be observed to prevent any damage or degradation during storage.

Additional Clinical Information

The medication is administered orally, with a recommended repeat dose every 6-8 hours, not to exceed four doses in a 24-hour period. Clinicians should advise patients to consult a doctor prior to use if the child is under medical care for any serious condition. It is crucial to keep the medication out of reach of children. In the event of an overdose, patients should seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222.

No additional 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.