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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 1999
Label revision date
April 29, 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 1999
Label revision date
April 29, 2025
Manufacturer
CVS Pharmacy
Registration number
ANDA074937
NDC root
59779-897
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. It serves as a pain reliever and fever reducer, helping to alleviate minor aches and pains associated with common conditions like the cold, flu, sore throat, headache, and toothache. This medication is a type of nonsteroidal anti-inflammatory drug (NSAID), which means it works by reducing inflammation and pain in the body.

The formulation comes in a pleasant berry flavor and is gluten-free and alcohol-free. Each dose lasts up to 8 hours, providing effective relief when your child needs it most.

Uses

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

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

Dosage and Administration

Before using this product, it's important to know that it doesn't 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, which is based on your child's weight or age. If possible, using weight is preferred for accuracy.

When measuring the dose, 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 do not use it more than four times a day. After each use, wash the dosing cup to keep it clean. Finally, remember to securely replace the original bottle cap to maintain its child-resistant feature.

What to Avoid

You should avoid using this medication if your child has ever had an allergic reaction to ibuprofen or any other pain reliever or fever reducer. Additionally, it is important not to use this medication right before or after your child has heart surgery, as it could pose serious risks. Always consult with a healthcare professional if you have any concerns or questions about using this medication for your child.

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. This risk is heightened if the medication is used in higher doses or for longer than recommended. If your child experiences symptoms such as faintness, vomiting blood, or severe stomach pain, or if they show signs of heart problems like chest pain or difficulty breathing, seek medical attention immediately. Always 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, wheezing, shock, skin reddening, rash, or blisters. If you experience any of these symptoms, stop using the medication and seek medical help immediately. Additionally, ibuprofen can lead to severe stomach bleeding, particularly if you have a history of stomach ulcers, are taking blood thinners or steroids, or are using other NSAIDs (nonsteroidal anti-inflammatory drugs) like aspirin or naproxen.

There are also risks of heart attack and stroke associated with ibuprofen, especially if taken in higher doses or for longer than recommended. If you or your child experience severe sore throat symptoms, such as high fever, headache, nausea, or vomiting, consult a doctor right away. You should stop using ibuprofen and contact a doctor if you notice signs of stomach bleeding (like faintness, vomiting blood, or black stools), symptoms of heart problems (such as chest pain or trouble breathing), or if there is no relief within 24 hours.

In case of an overdose, it’s crucial to 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 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 safety is the top priority.

Pregnancy Use

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

Before taking ibuprofen, you should always consult your healthcare provider to discuss any potential risks and to explore safer alternatives for pain relief or inflammation during your pregnancy. Your health and the health of your baby are the top priority.

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, 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 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 varies based on their weight, so it's essential to follow the dosing chart provided by your healthcare professional. For example, a child weighing 24-35 pounds (about 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 if your child has a history of stomach issues, has experienced serious side effects from pain relievers, or has not been drinking enough fluids due to vomiting or diarrhea. Additionally, if your child has conditions like high blood pressure, heart disease, or asthma, or is taking other medications, it's crucial to seek medical advice before use. If your child shows any signs of stomach bleeding or does not find relief within 24 hours, contact a doctor immediately. Remember, this medication should not be used for more than 2 days without a doctor's guidance.

Geriatric Use

When it comes to using Children's Ibuprofen Oral Suspension for older adults, there are no specific guidelines or dosage adjustments needed. This means that, based on the information available, elderly patients can use this medication without special considerations or safety concerns.

However, as with any medication, it's always a good idea to consult with a healthcare provider to ensure it's appropriate for your individual health needs, especially if you have other medical conditions or are taking other medications.

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 (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 especially crucial if you also have other health issues like high blood pressure, heart disease, or kidney disease.

Always communicate openly with your doctor about your liver condition and any other medical history, as this will help ensure you receive the safest and most effective 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 a severe allergic reaction. Additionally, if your child is on blood thinners (medications that prevent blood clots) or steroids, the risk of stomach bleeding increases. This risk is also heightened if they are taking other nonsteroidal anti-inflammatory drugs (NSAIDs), such as aspirin or naproxen.

Using ibuprofen can also raise the chances of serious heart issues, like heart attack or stroke, especially if taken in higher doses or for longer than recommended. If your child is taking a diuretic (a medication that helps remove excess fluid), it's crucial to consult with a healthcare provider before using ibuprofen. Always discuss any medications or tests with your doctor to ensure safety and effectiveness.

Storage and Handling

To ensure the best performance and safety 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 using, check the printed neckband; do not use the product if it is broken or missing, as this could compromise its safety and effectiveness.

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 needed, you can repeat the dose every 6 to 8 hours, but do not exceed 4 doses in a day. It's important to keep this medication out of reach of children. If you suspect an overdose, seek medical help immediately or contact a Poison Control Center at 1-800-222-1222. To avoid stomach upset, consider taking it with food or milk. Always use the enclosed dosing cup for measuring your dose, and make sure to shake the bottle well before use. Do not use the medication if the printed neckband is broken or missing, and store it at room temperature between 20-25°C (68-77°F); do not freeze it.

FAQ

What is Children's Ibuprofen?

Children's Ibuprofen is an oral suspension that contains 100 mg of ibuprofen per 5 mL, used to relieve minor aches and pains and reduce fever in children.

What age group can use Children's Ibuprofen?

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

How does Children's Ibuprofen work?

It acts as a pain reliever and fever reducer, classified as a nonsteroidal anti-inflammatory drug (NSAID).

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 also reduces fever.

How should I dose Children's Ibuprofen?

Use the enclosed dosing cup and refer to the dosing chart based on your child's weight and age. Do not exceed the recommended dose.

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

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

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 certain health conditions.

Can I use Children's Ibuprofen if my child is allergic to aspirin?

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

Is Children's Ibuprofen safe 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 in case of an overdose?

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

Packaging Info

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

Packaging configurations for Ibuprofen.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

CVS Health® Children’s Ibuprofen is an oral suspension 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 a berry flavor. The suspension is packaged in an 8 FL OZ (240 mL) bottle, which includes a dosage cup for accurate measurement. The effects of the medication may last up to 8 hours.

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 does not contain directions or complete warnings for adult use. Healthcare professionals should ensure that the dosage does not exceed the recommended limits.

Prior to administration, the product must be shaken well. The appropriate dose should be determined using the provided dosing chart, which is based on the patient's weight. If weight is not available, age may be used as a secondary reference. It is imperative to use only the enclosed dosing cup for measurement; other dosing devices are not recommended.

The following dosing chart should be utilized:

  • For patients weighing under 24 lbs or under 2 years of age, the dose should be determined by consulting a physician.

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

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

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

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

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

If necessary, doses may be repeated every 6-8 hours, but should not exceed 4 doses in a 24-hour period. After each use, the dosing cup should be washed thoroughly to maintain hygiene. Additionally, it is important to replace the original bottle cap after use to ensure child resistance.

Contraindications

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

Warnings and Precautions

Ibuprofen is associated with several significant warnings and precautions that healthcare professionals must consider to ensure safe use in pediatric patients.

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

Stomach Bleeding Warning As a nonsteroidal anti-inflammatory drug (NSAID), ibuprofen carries a risk of severe stomach bleeding. This risk is heightened in children with a history of stomach ulcers or bleeding disorders, those taking anticoagulants or steroid medications, and those concurrently using other NSAIDs (including aspirin, ibuprofen, or naproxen). Additionally, exceeding the recommended dosage or duration of treatment increases the likelihood of gastrointestinal complications.

Heart Attack and Stroke Warning 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 extended periods.

Sore Throat Warning Healthcare professionals should be vigilant for severe or persistent sore throat symptoms, especially when accompanied by high fever, headache, nausea, or vomiting, as these may indicate a serious condition. It is advised not to use ibuprofen for more than two days or to administer it to children under three years of age without explicit medical direction.

Monitoring and Consultation Healthcare providers should instruct caregivers to discontinue ibuprofen 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, further medical consultation is necessary. Caregivers should also be advised to monitor for any redness or swelling in the affected area or the emergence of new symptoms.

Emergency Medical Help In cases of suspected 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, which can be categorized by seriousness and frequency.

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

The use of ibuprofen carries a warning for potential severe stomach bleeding, especially 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.

Additionally, ibuprofen is associated with an increased 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 guidelines.

Patients should be vigilant for signs of serious conditions. If a child experiences symptoms indicative of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or persistent stomach pain, medical attention should be sought immediately. Symptoms suggestive of heart problems or stroke, including chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling, also warrant prompt consultation with a healthcare provider.

Common adverse reactions may include a severe or persistent sore throat, especially when accompanied by high fever, headache, nausea, or vomiting. In such cases, it is advised to consult a doctor promptly and to limit use to no more than two days without medical guidance, particularly in children under three years of age.

Patients are advised to discontinue use and seek medical advice if they do not achieve relief within the first 24 hours of treatment, if fever or pain worsens or persists beyond three days, if redness or swelling occurs in the affected area, or if any new symptoms arise.

Before using ibuprofen, it is recommended that patients consult a healthcare provider if they have a history of stomach problems, are experiencing dehydration, or have conditions such as high blood pressure, heart disease, liver cirrhosis, kidney disease, or a history of stroke. Additionally, patients under a doctor's care for serious conditions or those taking other medications should seek professional advice prior to use.

Drug Interactions

Ibuprofen is associated with several significant drug interactions that may impact patient safety and treatment efficacy.

Allergic Reactions Ibuprofen may induce severe allergic reactions, particularly in individuals with a known allergy to aspirin. It is crucial for healthcare providers to assess the patient's allergy history before prescribing ibuprofen.

Gastrointestinal Risks The concomitant use of ibuprofen with anticoagulants or steroid medications increases the risk of gastrointestinal bleeding. This risk is further elevated when ibuprofen is taken alongside other nonsteroidal anti-inflammatory drugs (NSAIDs), including prescription and nonprescription options such as aspirin and naproxen. Monitoring for signs of gastrointestinal distress is recommended in patients receiving these combinations.

Cardiovascular Risks The use of ibuprofen has been linked to an increased risk of cardiovascular events, including heart attack, heart failure, and stroke. This risk is particularly pronounced when ibuprofen is used in higher doses or for extended periods. Healthcare providers should counsel patients on the importance of adhering to prescribed dosages and durations of therapy.

Diuretic Interaction Patients taking diuretics should consult their healthcare provider prior to initiating ibuprofen therapy. The interaction between ibuprofen and diuretics may necessitate dosage adjustments or increased monitoring to ensure patient safety and therapeutic effectiveness.

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: children under 24 lbs (under 2 years) should consult a doctor; those weighing 24-35 lbs (2-3 years) may receive 5 mL; 36-47 lbs (4-5 years) may receive 7.5 mL; 48-59 lbs (6-8 years) may receive 10 mL; 60-71 lbs (9-10 years) may receive 12.5 mL; and 72-95 lbs (11 years) may receive 15 mL.

Healthcare professionals should advise parents 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 recommended if the child has not been drinking fluids or has lost significant fluid due to vomiting or diarrhea, or if there are pre-existing conditions such as 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 limit use to no more than 2 days and to seek medical advice if the child does not experience relief within the first 24 hours, or if fever or pain worsens or persists beyond 3 days. Signs of stomach bleeding, such as feeling faint, vomiting blood, or having bloody or black stools, necessitate immediate cessation of use and consultation with a doctor.

Geriatric Use

Elderly patients do not have specific geriatric use considerations, dosage adjustments, or safety concerns noted in the prescribing information for Children's Ibuprofen Oral Suspension. Therefore, standard dosing guidelines may be applicable to this population. However, healthcare providers should remain vigilant and monitor for any potential adverse effects, as individual responses to medication can vary among geriatric patients.

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, women who are pregnant or planning to become pregnant 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 nursing mother takes ibuprofen.

Renal Impairment

Patients with renal impairment may require careful consideration regarding dosing adjustments and monitoring. In particular, those with reduced kidney function should be assessed for potential changes in drug clearance. It is essential to evaluate 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 further complicate the management of therapy in this population. Regular monitoring of renal function is recommended to ensure safe and effective use of the medication in patients with compromised renal status.

Hepatic Impairment

Patients with hepatic impairment may experience altered pharmacokinetics of the medication. It is essential to assess liver function prior to initiating treatment. In patients with liver cirrhosis, dosage adjustments may be necessary, and close monitoring of liver function is recommended throughout the treatment course.

Patients with significant hepatic impairment should be evaluated for potential contraindications, particularly if they have comorbid conditions such as high blood pressure, heart disease, kidney disease, or a history of stroke. Regular monitoring of liver enzymes and other relevant laboratory values is advised to ensure patient safety and therapeutic efficacy.

Healthcare providers should exercise caution when prescribing this medication to patients with compromised liver function and consider alternative therapies if necessary.

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. 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 to determine the appropriate course of action.

Management procedures may include supportive care, symptomatic treatment, and, if applicable, the administration of specific antidotes. Continuous evaluation of the patient's condition is necessary to address any complications that may arise during the management of an overdose.

Nonclinical Toxicology

No relevant information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no pertinent data concerning nonclinical toxicology or 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 emergence 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 like heartburn, has had adverse reactions to pain relievers or fever reducers, is dehydrated, 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 prior to 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 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.

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 gastrointestinal upset occurs. It is essential to use only the enclosed dosing cup for administration and to shake the product well before use.

Patients should be counseled 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 product 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.

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.