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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 2016
Label revision date
April 28, 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 2016
Label revision date
April 28, 2025
Manufacturer
H E B
Registration number
ANDA074937
NDC root
37808-023
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info
Packaging & NDC Codes

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

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

Drug Overview

Children’s Ibuprofen Oral Suspension is a pain reliever and fever reducer designed for children aged 2 to 11 years. It contains ibuprofen, which is a type of medication known as a nonsteroidal anti-inflammatory drug (NSAID). This medication helps relieve minor aches and pains associated with common conditions like the cold, flu, sore throat, headache, and toothache, while also effectively reducing fever.

The suspension is alcohol-free and comes in a pleasant berry flavor, making it easier for children to take. It provides relief that can last up to 8 hours, ensuring your child feels more comfortable during their recovery.

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 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.

Use the enclosed dosing cup to measure the dose accurately; do not use any other device. If necessary, you can repeat the dose every 6 to 8 hours, but remember not to give it more than four times a day. After each use, wash the dosing cup to keep it clean, and always replace the original bottle cap to ensure it remains child-resistant. If your child weighs under 24 pounds or is under 2 years old, consult a doctor for the appropriate dose. For children weighing between 24 to 95 pounds, the dosing chart provides specific amounts to use based on their weight or age.

What to Avoid

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

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

Side Effects

Ibuprofen can cause serious allergic reactions, particularly in individuals who are allergic to aspirin. Signs of a severe allergic reaction may include hives, facial swelling, wheezing (asthma), shock, skin reddening, rash, and 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 has bloody or black stools, 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 issues, 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 consulting a doctor, especially if they have a severe sore throat with high fever, headache, nausea, or vomiting. If your child does not feel better within 24 hours, or if their fever or pain worsens or lasts more than three days, seek medical advice. In case of an overdose, get emergency medical help or contact a Poison Control Center immediately at 1-800-222-1222.

Overdose

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

Don’t wait for symptoms to worsen; getting prompt assistance can be vital. Always prioritize your safety and the safety of others by acting quickly in these situations.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to be cautious with medications like ibuprofen. The safety of ibuprofen during pregnancy has not been established, and it is particularly not recommended during the third trimester (the final three months of pregnancy). Using ibuprofen may pose risks to your developing baby, including potential cardiovascular effects.

Before taking ibuprofen, you should consult your healthcare provider to discuss your specific situation. It's best to avoid using ibuprofen unless a healthcare professional has directed you to do so. Always prioritize your health and the health of your baby by seeking guidance from a medical expert.

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

When considering medication for your child, it's important to note that this product should not be used in children under 3 years of age unless specifically directed by a doctor. For children aged 2 to 11 years, the dosage varies based 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 your doctor for the appropriate dosage tailored to your child's needs.

Be aware of potential risks, especially if your child has a history of stomach issues, such as ulcers or heartburn, as this could increase the chance of stomach bleeding. If your child shows any signs of stomach bleeding—like feeling faint, vomiting blood, or having black stools—seek medical attention immediately. Additionally, if your child experiences symptoms like chest pain, trouble breathing, or weakness, contact a doctor right away. If your child does not find relief within 24 hours, or if their fever or pain worsens or lasts more than three days, consult a healthcare professional. Always keep an eye out for any new symptoms or changes in your child's condition.

Geriatric Use

When it comes to using this medication in older adults, there are no specific guidelines or recommendations provided. This means that the insert does not mention any age-related dosage adjustments, safety concerns, or special precautions that you should be aware of.

If you are an older adult or a caregiver, it's always a good idea to consult with a healthcare professional before starting any new medication. They can help ensure that the treatment is safe and appropriate for your individual health needs.

Renal Impairment

If you have kidney problems, it's important to 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 are needed based on your kidney health. Always prioritize open communication with your healthcare provider to ensure your safety and well-being.

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 (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 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, so they can provide the best care tailored to your needs.

Drug Interactions

It's important to be aware that ibuprofen can interact with certain medications. For instance, if you are taking blood thinners (medications that help prevent blood clots) or steroid drugs, ibuprofen may affect how these medications work. Additionally, using ibuprofen alongside other nonsteroidal anti-inflammatory drugs (NSAIDs), such as aspirin or naproxen, can also lead to interactions.

To ensure your safety and the effectiveness of your treatment, always discuss any medications you are taking with your healthcare provider. This includes both prescription and over-the-counter drugs. They can help you understand potential interactions and make informed decisions about your health.

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 in a cool, dry place and avoid freezing, as this can damage the product.

When handling the product, make sure to maintain a clean environment to prevent contamination. Always follow any specific instructions provided for safe use and disposal to ensure your safety and the effectiveness of the product.

Additional Information

You should take this medication orally, and if necessary, you can repeat the dose every 6 to 8 hours, but do not exceed four 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 help prevent stomach upset, consider taking the medication with food or milk. Always use the enclosed dosing cup for measuring your dose, and remember to wash it after each use.

FAQ

What is Children's Ibuprofen Oral Suspension used for?

Children's Ibuprofen Oral Suspension is used to relieve minor aches and pains due to the common cold, flu, sore throat, headache, and toothache, as well as to reduce fever.

What age group can use Children's Ibuprofen Oral Suspension?

This medication is intended for children aged 2 to 11 years.

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

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

What should I do if my child has a history of stomach problems?

Consult a doctor before using Children's Ibuprofen if your child has a history of stomach problems, such as ulcers or bleeding.

What are the dosing instructions for Children's Ibuprofen?

You should find the right dose on the dosing chart based on your child's weight or age, and do not exceed 4 doses in a day.

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

If your child feels faint, vomits blood, has bloody or black stools, or has stomach pain that does not improve, stop use and consult a doctor immediately.

Can I give Children's Ibuprofen to my child if they are 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 it safe to use Children's Ibuprofen during pregnancy?

The safety of ibuprofen during pregnancy has not been established, and it is contraindicated, especially during the third trimester.

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

If your child does not experience relief within the first 24 hours of treatment, or if fever or pain worsens or lasts more than 3 days, consult a doctor.

How should I store Children's Ibuprofen?

Store Children's Ibuprofen 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

This product is an oral suspension formulation of ibuprofen, specifically designed for pediatric use. Each 5 mL dose contains 100 mg of ibuprofen, a nonsteroidal anti-inflammatory drug (NSAID) recognized for its efficacy as a pain reliever and fever reducer. It is suitable for children aged 2 to 11 years and provides relief that lasts up to 8 hours. The suspension is alcohol-free and is flavored with berry to enhance palatability. The product is packaged in a 4 fluid ounce (120 mL) bottle.

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 effective in reducing 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 used for accurate measurement; no other dosing devices should be utilized.

For patients weighing under 24 lbs or under 2 years of age, it is advised to consult a doctor for the appropriate dose. For those weighing 24-35 lbs (2-3 years), the recommended dose is 5 mL. For patients weighing 36-47 lbs (4-5 years), the dose is 7.5 mL. For those weighing 48-59 lbs (6-8 years), the dose is 10 mL. For patients weighing 60-71 lbs (9-10 years), the dose is 12.5 mL, and for those 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 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 should be replaced securely after each use. It is critical not to exceed the recommended dosage.

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 cause severe allergic reactions, particularly in individuals with a known allergy to aspirin. Symptoms indicative of an allergic reaction 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 is associated with an increased 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 (including aspirin, ibuprofen, naproxen, or others). Additionally, exceeding the recommended dosage or duration of use may further elevate this risk.

NSAIDs, with the exception of aspirin, are known to increase the risk of serious cardiovascular events, including 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.

Healthcare professionals should be vigilant for signs of severe or persistent sore throat, especially when accompanied by high fever, headache, nausea, or vomiting, as these symptoms may indicate a serious condition. It is advised to consult a physician promptly in such cases. Furthermore, ibuprofen should not be administered for more than two days or to children under three years of age unless specifically directed by a healthcare provider.

Patients should be instructed to discontinue use and consult a physician if any of the following occur: signs of stomach bleeding such as feeling faint, vomiting blood, passing bloody or black stools, or experiencing persistent stomach pain; symptoms suggestive of heart problems or stroke, including chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling; lack of relief within the first 24 hours of treatment; worsening fever or pain lasting more than three days; presence of redness or swelling in the affected area; or the emergence of any new symptoms.

In the event of an overdose, immediate medical attention is required. Patients should contact a Poison Control Center or seek emergency medical help without delay (1-800-222-1222).

Side Effects

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

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

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

Common adverse reactions may include severe or persistent sore throat, especially when accompanied by high fever, headache, nausea, or vomiting. Such symptoms warrant prompt medical consultation. It is advised not to use the product for more than two days or in children under three years of age without a doctor's guidance.

Patients should discontinue use and seek medical attention if they experience signs of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or persistent stomach pain. Symptoms indicative of heart problems or stroke, including chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling, also necessitate immediate medical evaluation. Furthermore, if symptoms do not improve within the first 24 hours of treatment, or if fever or pain worsens or persists beyond three days, medical advice should be sought.

Before using this product, it is essential to consult a healthcare professional if the patient has a history of stomach issues, has experienced serious side effects from pain relievers or fever reducers, is dehydrated, or has underlying conditions such as high blood pressure, heart disease, liver cirrhosis, kidney disease, or a history of stroke. Patients with asthma or those taking diuretics should also seek medical advice prior to use. Additionally, consultation is recommended for patients under a doctor's care for any serious condition or those taking other medications.

Drug Interactions

Ibuprofen has several notable interactions with other drug classes that may affect its clinical use.

Anticoagulants Ibuprofen may enhance the effects of anticoagulant medications, potentially increasing the risk of bleeding. It is advisable to monitor patients closely for signs of bleeding and consider dosage adjustments of the anticoagulant as necessary.

Corticosteroids The concomitant use of ibuprofen with steroid drugs may increase the risk of gastrointestinal adverse effects, such as ulceration or bleeding. Clinicians should evaluate the necessity of both medications and monitor for gastrointestinal symptoms.

Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) Ibuprofen may interact with other NSAIDs, including prescription and nonprescription agents such as aspirin and naproxen. The combined use of these medications can elevate the risk of adverse effects, particularly gastrointestinal complications. It is recommended to avoid the concurrent use of multiple NSAIDs unless specifically directed by a healthcare professional.

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 directed by a doctor.

Caution is advised for pediatric patients with a history of stomach ulcers or bleeding problems, as well as those with a history of stomach issues such as heartburn, due to the risk of stomach bleeding. Parents or caregivers should consult a doctor if the child experiences any serious side effects from pain relievers or fever reducers.

Signs of potential stomach bleeding include feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain. Additionally, parents should seek medical attention if the child exhibits symptoms of heart problems or stroke, such as chest pain, difficulty breathing, weakness on one side of the body, slurred speech, or leg swelling.

If the child does not experience relief within the first 24 hours of treatment, if fever or pain worsens or lasts more than 3 days, if redness or swelling is present in the painful area, or if any new symptoms appear, a doctor should be consulted.

Geriatric Use

Geriatric use information is not specifically provided in the prescribing information. There are no recommended age considerations, dosage adjustments, safety concerns, or special precautions for elderly patients mentioned. Healthcare providers should exercise clinical judgment when prescribing this medication to geriatric patients, considering the individual health status and potential for altered pharmacokinetics in this population. Regular monitoring may be warranted to ensure safety and efficacy in elderly patients.

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 this period may pose risks, including potential cardiovascular effects on the developing fetus.

Pregnant patients or those planning to become pregnant should consult a healthcare provider before using ibuprofen. It is recommended that pregnant women avoid using ibuprofen unless directed by a healthcare professional to ensure the safety of both the mother and the fetus.

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 strategies. 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 are advised to call the Poison Control Center at 1-800-222-1222 for guidance on managing the situation.

Prompt intervention is crucial in mitigating potential adverse effects associated with an overdose. Symptoms may vary depending on the substance involved, and healthcare providers should be prepared to assess and manage these symptoms accordingly.

Management procedures may include supportive care and symptomatic treatment, tailored to the specific clinical presentation of the patient. Continuous monitoring and evaluation are essential to ensure patient safety and effective recovery.

Nonclinical Toxicology

No teratogenic effects have been reported in the available data. Additionally, there is no information regarding non-teratogenic effects. The nonclinical toxicology section does not provide any specific details. Furthermore, there is no information available concerning 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 postmarketing surveillance and are included for informational purposes.

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 stomach pain that does not improve. 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 for more than three days, they should consult a doctor. Redness or swelling in the painful area or the appearance of any new symptoms should also prompt a discussion with a healthcare professional.

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 serious side effects from pain relievers or fever reducers, has not been adequately hydrating, 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 discuss the use of this medication if the child has asthma or is taking a diuretic.

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

Storage and Handling

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

Additional Clinical Information

The medication is administered orally, with a recommended dosing frequency of every 6-8 hours as needed, not to exceed four doses per day. Clinicians should advise patients to take the medication with food or milk if gastrointestinal upset occurs.

Patient counseling should emphasize the importance of keeping the medication out of reach of children and the necessity of seeking immediate medical assistance or contacting a Poison Control Center (1-800-222-1222) in the event of an overdose. Patients are instructed to use only the enclosed dosing cup for administration and to wash it after each use to ensure proper hygiene.

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

Last AI update:

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.