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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
May 12, 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
May 12, 2025
Manufacturer
CVS Pharmacy
Registration number
ANDA074937
NDC root
59779-166
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (3 NDCs)
Packaging & NDC Codes (3)

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

Drug Overview

Children’s Ibuprofen is an oral suspension designed for children aged 2 to 11 years, providing a convenient way to relieve minor aches and pains. This medication works as a pain reliever and fever reducer, helping to alleviate discomfort caused by common conditions such as the cold, flu, sore throat, headache, and toothache.

In addition to its effectiveness, Children’s Ibuprofen is gluten-free and alcohol-free, making it a suitable option for many families. With a pleasant bubble gum flavor, it can be an easier choice for children to take, and its effects can last up to 8 hours.

Uses

You can use this medication to help relieve minor aches and pains that may come from common conditions like the cold, flu, sore throat, headache, or 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, make sure to shake the bottle well. It's important to find the right dose based on the dosing chart provided. If possible, use your child's weight to determine the dose; if not, you can use their age. Always use the enclosed dosing cup to measure the medication, as other devices may not provide accurate measurements.

For children weighing under 24 pounds or younger than 2 years, it's best to consult a doctor for the appropriate dose. For children weighing between 24 and 35 pounds (ages 2-3 years), the dose is 5 mL. If your child weighs 36 to 47 pounds (ages 4-5 years), the dose increases to 7.5 mL. For those weighing 48 to 59 pounds (ages 6-8 years), the dose is 10 mL, and for children weighing 60 to 71 pounds (ages 9-10 years), the dose is 12.5 mL. Finally, for children who weigh between 72 and 95 pounds (age 11 years), the dose is 15 mL.

You can repeat the dose every 6 to 8 hours if needed, but do not exceed 4 doses in a single day. After each use, wash the dosing cup to keep it clean, and remember to replace the original bottle cap to maintain child resistance. Always follow the directions carefully and do not give more than directed.

What to Avoid

You should avoid using this medication if your child has ever had an allergic reaction to any other pain reliever or fever reducer. Additionally, it is important not to use this medication right before or after your child has undergone heart surgery. Following these guidelines will help ensure your child's safety and well-being.

Side Effects

Ibuprofen can cause serious allergic reactions, 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 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, bloody or black stools, chest pain, or difficulty breathing, you should seek medical attention immediately. It's important to consult a doctor if your child has a history of stomach issues, is dehydrated, 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 ibuprofen and seek medical help immediately.

This medication can also lead to severe stomach bleeding, particularly if you have a history of stomach ulcers or bleeding problems, are taking blood thinners or steroids, or are using other NSAIDs (nonsteroidal anti-inflammatory drugs) like aspirin or naproxen. Additionally, using ibuprofen for longer than directed increases the risk of heart attack and stroke, which can be fatal. If you notice signs of stomach bleeding, such as feeling faint, vomiting blood, or having black stools, or if you experience 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, if their fever or pain worsens or lasts more than three days, or if any new symptoms appear, 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

The safety of ibuprofen during pregnancy has not been established, and it is generally not recommended, especially in the third trimester (the final three months of pregnancy). Using ibuprofen while pregnant may pose risks to your developing baby, including potential cardiovascular issues.

If you are pregnant or planning to become pregnant, it’s important to consult your healthcare provider before using ibuprofen or any medication. They can help you understand the risks and explore safer alternatives for managing pain or inflammation during this time.

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. Your healthcare provider can help you weigh the benefits and risks to ensure both you and your infant stay healthy.

Pediatric Use

It's important to be cautious when giving this medication to children. You should not use it in children under 3 years of age unless a doctor specifically advises you to do so. For children aged 2 to 11 years, the dosage varies based on their weight, so it's essential to follow the dosing chart carefully. For example, a child weighing 24-35 lbs (about 2-3 years old) should receive 5 mL, while a child weighing 72-95 lbs (11 years old) should receive 15 mL.

If your child experiences stomach upset, it's best to give the medication with food or milk. Always consult a doctor if your child has a history of stomach issues, has not been drinking enough fluids, or has any serious health conditions like high blood pressure or asthma. Additionally, if your child shows any signs of stomach bleeding, heart problems, or if their symptoms worsen or do not improve within 24 hours, seek medical advice immediately.

Geriatric Use

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

Keep in mind that the product does not provide specific instructions or warnings for adult use, so professional guidance is essential to ensure safety and effectiveness. Always prioritize open communication with healthcare providers to address any concerns or questions you may have.

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 can help determine if this medication is safe for you and whether any adjustments to the dosage or monitoring are necessary to ensure your health and safety. Always prioritize open communication with your healthcare provider regarding your kidney health and any other medical conditions you may have.

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 how ibuprofen can interact with other medications you may be taking. For instance, if you are using blood thinners (medications that help prevent blood clots) or steroids, taking ibuprofen could increase your risk of stomach bleeding. Additionally, using ibuprofen or other nonsteroidal anti-inflammatory drugs (NSAIDs) for longer than recommended can raise your chances of serious heart issues, such as heart attack or stroke.

To stay safe, always discuss your current medications with your healthcare provider, especially if you are considering taking ibuprofen or any other NSAIDs. This conversation is crucial to ensure that your treatment plan is effective and minimizes any potential risks.

Storage and Handling

To ensure the safety and effectiveness of your product, store it at a temperature between 20-25°C (68-77°F). It's important to avoid freezing the product, as this can damage it. Before use, check the printed neckband; do not use the product if it is broken or missing, as this could indicate a safety issue.

By following these simple storage and handling guidelines, you can help maintain the quality and reliability of your product.

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 stomach upset, it's advisable to take the medication with food or milk.

Make sure to keep this medication out of reach of children. In the event of an overdose, seek medical assistance immediately or contact a Poison Control Center at 1-800-222-1222.

FAQ

What is Children's Ibuprofen used for?

Children's 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 is the recommended dosage for Children's Ibuprofen?

The dosage varies by weight and age. For example, children aged 2-3 years weighing 24-35 lbs should take 5 mL, while those aged 11 years weighing 72-95 lbs should take 15 mL.

How often can I give Children's Ibuprofen?

You can repeat the dose every 6-8 hours, but do not use more than 4 times a day.

Are there any warnings associated with Children's Ibuprofen?

Yes, it may cause severe allergic reactions, stomach bleeding, and increase the risk of heart attack and stroke. Consult a doctor if your child has a history of stomach problems or is taking other medications.

Can I use Children's Ibuprofen if my child is pregnant or breastfeeding?

Consult a healthcare provider before using ibuprofen if pregnant or planning to become pregnant. Nursing mothers should also consult a doctor, as ibuprofen may be excreted in breast milk.

What should I do if my child experiences signs of stomach bleeding?

Stop use and ask a doctor if your child feels faint, vomits blood, has bloody or black stools, or has stomach pain that does not improve.

Is Children's Ibuprofen gluten-free?

Yes, Children's Ibuprofen is gluten-free and alcohol-free.

What flavor does Children's Ibuprofen come in?

Children's Ibuprofen is available in a bubble gum flavor.

How should I store Children's Ibuprofen?

Store it at 20-25°C (68-77°F) and do not freeze. Ensure the printed neckband is intact.

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

CVS Health® Children’s Ibuprofen is an oral suspension liquid formulated for pediatric use in children aged 2 to 11 years. Each 5 mL dose contains 100 mg of ibuprofen, a nonsteroidal anti-inflammatory drug (NSAID) indicated for the relief of pain and reduction of fever. The product is gluten-free and alcohol-free, and it is available in an 8 FL OZ (240 mL) bottle. The suspension features a bubble gum flavor and is designed to provide relief that lasts up to 8 hours. The actual bottle size is indicated on the side panel. This formulation is comparable to the active ingredient found in Children’s Motrin®.

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 doctor for the appropriate dose. For patients 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. Patients weighing 48-59 lbs (6-8 years) should receive 10 mL, while those weighing 60-71 lbs (9-10 years) should be administered 12.5 mL. For patients weighing 72-95 lbs (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 must be replaced securely after each use. It is critical to adhere to the recommended dosing guidelines and not exceed the directed amount.

Contraindications

Use is contraindicated in the following situations:

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

Warnings and Precautions

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

This product contains a nonsteroidal anti-inflammatory drug (NSAID), which is associated with an increased risk of severe stomach bleeding. The likelihood of this adverse effect is heightened in children who have a history of stomach ulcers or bleeding disorders, are concurrently taking anticoagulants or steroid medications, are using other NSAIDs (including aspirin, ibuprofen, or naproxen), or exceed the recommended dosage or duration of treatment.

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

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

Healthcare providers should advise caregivers to discontinue use and seek medical 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 indicative 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 cases of overdose, it is critical to obtain emergency medical assistance or contact a Poison Control Center immediately at 1-800-222-1222.

Side Effects

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

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

The use of ibuprofen, as a nonsteroidal anti-inflammatory drug (NSAID), carries a warning for potential severe stomach bleeding. The risk of this 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, the risk increases if the medication is taken in higher doses or for extended periods beyond the recommended guidelines.

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, particularly when the medication is used in excess or for longer durations than directed.

In clinical settings, severe or persistent sore throat, especially when accompanied by high fever, headache, nausea, and vomiting, may indicate a serious condition requiring prompt medical consultation. It is advised not to use ibuprofen for more than two days or to administer it to children under three years of age without a doctor's guidance.

Patients are instructed to discontinue use and seek medical advice if they experience signs of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain. Symptoms indicative of heart problems or stroke, including chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling, also warrant immediate medical attention. Furthermore, 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 professional. Redness or swelling in the painful area or the emergence of any new symptoms should also prompt a medical evaluation.

Before using ibuprofen, it is essential for patients to consult a healthcare provider if they have a history of stomach issues, such as heartburn, or if they have experienced serious side effects from pain relievers or fever reducers. Additional caution is advised for patients with 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 to seek advice from 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 as necessary.

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 lead to an increased risk of adverse effects, including gastrointestinal complications.

Cardiovascular Risks The use of ibuprofen, particularly at doses exceeding recommended levels or for prolonged durations, is associated with an increased 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 product unless directed by a doctor. For dosing, the following guidelines apply:

  • For children under 24 lbs (under 2 years): consult a doctor.

  • For children weighing 24-35 lbs (2-3 years): administer 5 mL.

  • For children weighing 36-47 lbs (4-5 years): administer 7.5 mL.

  • For children weighing 48-59 lbs (6-8 years): administer 10 mL.

  • For children weighing 60-71 lbs (9-10 years): administer 12.5 mL.

  • For children weighing 72-95 lbs (11 years): administer 15 mL.

The product should be given with food or milk if stomach upset occurs. Healthcare professionals should advise parents to consult a doctor if the child has a history of stomach problems, such as heartburn, or if they have experienced serious side effects from pain relievers or fever reducers. Additionally, consultation is recommended if the child has not been drinking fluids or has lost significant fluid due to vomiting or diarrhea, or if they have high blood pressure, heart disease, liver cirrhosis, kidney disease, or a history of stroke.

Children with asthma or those taking diuretics should also be evaluated by a doctor before use. It is important to seek medical advice if the child is under care for any serious condition or is taking other medications. Parents should discontinue use and consult a doctor if the child shows signs of stomach bleeding, symptoms of heart problems or stroke, does not achieve relief within the first 24 hours of treatment, or if fever or pain worsens or persists beyond 3 days.

Geriatric Use

Elderly patients should exercise caution when considering the use of this product, particularly in the presence of underlying health conditions. It is advisable for geriatric patients to consult a healthcare provider prior to use if they have a history of high blood pressure, heart disease, liver cirrhosis, kidney disease, or stroke.

Due to the lack of specific directions or complete warnings for adult use, healthcare providers should carefully evaluate the potential risks and benefits of administering this product to elderly patients. Monitoring for adverse effects and adjusting dosages as necessary may be warranted to ensure safety and efficacy in this population.

Pregnancy

The safety of ibuprofen during pregnancy has not been established. Ibuprofen is contraindicated in pregnancy, particularly during the third trimester, due to potential risks to the fetus. The use of ibuprofen during pregnancy may pose risks, including potential cardiovascular effects on the developing fetus.

Women who are pregnant or planning to become pregnant should consult a healthcare provider before using ibuprofen to discuss the potential risks and benefits.

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 nursing mother takes ibuprofen.

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. 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 due to impaired drug metabolism. 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.

Patients with significant hepatic impairment should be approached with caution, and the potential benefits of treatment must be weighed against the risks associated with compromised liver function.

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 effectively. Symptoms of overdose may vary depending on the substance involved, and healthcare providers should be prepared to assess and address any potential complications that may arise.

Management procedures may include supportive care and symptomatic treatment, tailored to the specific clinical presentation of the patient. Continuous monitoring and evaluation are essential to ensure patient safety and to mitigate any adverse effects associated with the overdose.

Nonclinical Toxicology

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

Postmarketing Experience

Allergic reactions have been reported in the postmarketing experience, including manifestations such as hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, and blisters. Additionally, cases of stomach bleeding have been documented in patients using nonsteroidal anti-inflammatory drugs (NSAIDs), including ibuprofen. Furthermore, occurrences of heart attack and stroke have also been reported among patients taking NSAIDs, including ibuprofen. 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.

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.

It is important to advise patients to 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 administering this product, healthcare providers should recommend giving it with food or milk to mitigate potential stomach upset.

Patients should be encouraged to consult a doctor before use if any of the following apply: the child has a history of stomach bleeding, has experienced stomach problems such as heartburn, has had adverse reactions to 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.

Finally, healthcare providers should remind patients to consult a doctor or pharmacist before use if the child is under medical care for any serious condition or is taking any other medications.

Storage and Handling

The product is supplied in a configuration that includes specific NDC numbers, which should be referenced for accurate identification. It is essential to store the product at a temperature range of 20-25°C (68-77°F) to maintain its integrity and efficacy.

Freezing the product is strictly prohibited, as it may compromise its quality. Additionally, healthcare professionals should ensure that the product is not used if the printed neckband is broken or missing, as this may indicate tampering or compromise of the product's safety. Proper handling and adherence to these storage conditions are crucial for optimal product performance.

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 they experience stomach upset.

It is crucial to keep the medication out of reach of children. In the event of an overdose, patients should seek medical assistance immediately or contact a Poison Control Center at 1-800-222-1222. No additional information is available regarding laboratory tests, abuse potential, or postmarketing experiences.

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.