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Childrens 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 2022
Label revision date
May 31, 2023
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 2022
Label revision date
May 31, 2023
Manufacturer
BluePoint Laboratories
Registration number
ANDA209179
NDC root
68001-521
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (2 NDCs)
Packaging & NDC Codes (2)

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

Ibuprofen is a medication available in an oral suspension form, specifically designed for children aged 2 to 11 years. It acts 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. Additionally, ibuprofen is effective in reducing fever and is alcohol-free, making it a suitable option for young patients.

This medication comes in a berry flavor and is dosed at 100 mg per 5 mL, providing relief that can last up to 8 hours.

Uses

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

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

Dosage and Administration

Before using this product, make sure to shake the bottle well. It's important to measure the correct dose using the enclosed dosing cup, as other devices may not provide accurate measurements. To find the right amount for you or your child, refer to the dosing chart based on weight or age. For example, if your child weighs between 24 and 35 pounds, the recommended dose is 5 milliliters (mL). If they weigh between 36 and 47 pounds, the dose increases to 7.5 mL, and so on, up to 15 mL for those weighing 72 to 95 pounds.

You should only take or give this medication as directed. If needed, you can repeat the dose every 6 to 8 hours, but do not exceed four doses in a single day. After each use, remember to wash the dosing cup to keep it clean, and always replace the original bottle cap to ensure it remains child-resistant. If your child is under 24 pounds or under 2 years old, consult a doctor for guidance on the appropriate dose.

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 this could pose serious risks. Always consult with a healthcare professional if you have any concerns about your child's health or medication use.

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, shock, skin reddening, rash, or blisters. Additionally, this medication can lead to severe stomach bleeding, especially in children with a history of stomach ulcers or those taking blood thinners or other NSAIDs. The risk of heart attack and stroke is also increased with NSAID use, particularly if taken in higher doses or for extended periods.

If your child experiences symptoms such as faintness, vomiting blood, black or bloody stools, or persistent stomach pain, you should seek medical attention immediately. Other concerning signs include chest pain, difficulty breathing, weakness on one side of the body, slurred speech, or swelling in the legs. It's important to consult a doctor if your child has a history of stomach issues, is dehydrated, or has other serious health conditions before using ibuprofen.

Warnings and Precautions

Ibuprofen can cause serious allergic reactions, especially in individuals who are allergic to aspirin. If you notice symptoms like hives, facial swelling, wheezing, or any skin rash, stop using the medication immediately and seek medical help. Additionally, be aware that ibuprofen can lead to severe stomach bleeding, particularly if your child has a history of stomach ulcers, is taking blood thinners or steroids, or is using other NSAIDs (nonsteroidal anti-inflammatory drugs) like aspirin or naproxen.

There is also an increased risk of heart attack and stroke associated with NSAIDs, especially if used in higher doses or for longer than recommended. If your child experiences severe or persistent sore throat symptoms, especially with a high fever, headache, nausea, or vomiting, consult a doctor right away.

You should stop using ibuprofen and contact your doctor if your child shows signs of stomach bleeding (like fainting, vomiting blood, or having black stools), symptoms of heart problems or stroke (such as chest pain or trouble breathing), or if they do not feel better within 24 hours. Additionally, if fever or pain worsens or lasts more than three days, or if new symptoms appear, seek medical advice.

Overdose

Taking too much ibuprofen can be dangerous and may lead to serious health issues. If you or someone you know has taken an overdose, you might notice symptoms such as nausea, vomiting, stomach pain, drowsiness, or headache. In more severe cases, an overdose can result in kidney failure, liver damage, or gastrointestinal bleeding (bleeding in the digestive tract).

If you suspect an overdose, it’s crucial to seek immediate medical attention. Don’t wait for symptoms to worsen; getting help quickly can make a significant difference in treatment and recovery. Always keep medications out of reach and follow the recommended dosages to avoid these risks.

Pregnancy Use

When considering the use of ibuprofen during pregnancy, it's important to note that the available information does not specify any particular guidelines or risks associated with its use. There are no contraindications (conditions that would prevent its use) mentioned, and no dosage adjustments are recommended for pregnant individuals. Additionally, the text does not highlight any special precautions you should take if you are pregnant.

As always, it's best to consult with your healthcare provider before taking any medication during pregnancy to ensure it is safe for you and your baby.

Lactation Use

If you are breastfeeding, you can feel reassured that there are no specific warnings or recommendations regarding the use of ibuprofen while nursing. The information available does not indicate any concerns about ibuprofen being passed into breast milk or any associated risks for your infant.

As always, it's a good idea to consult with your healthcare provider if you have any questions or concerns about medications while breastfeeding.

Pediatric Use

When considering this medication for your child, it's important to note that it 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 weight and age. For example, if your child weighs under 24 lbs and is under 2 years old, you should consult a doctor before use. For children aged 2-3 years who weigh between 24-35 lbs, the recommended dose is 5 mL, while those aged 4-5 years and weighing 36-47 lbs should receive 7.5 mL. The dosage continues to increase with age and weight, reaching 15 mL for an 11-year-old weighing 72-95 lbs.

Before giving this medication, consult your doctor if your child has any history of stomach issues, dehydration, high blood pressure, heart disease, liver or kidney problems, or asthma. It's also crucial to limit use to no more than 2 days and to seek medical advice if your child does not feel better within 24 hours, if their fever or pain worsens or lasts more than 3 days, or if any new symptoms develop.

Geriatric Use

When it comes to using Children's Ibuprofen for older adults, there is no specific information available about dosage adjustments, safety concerns, or special precautions. This means that the drug insert does not provide guidelines tailored for elderly patients.

If you are caring for an older adult, it's important to consult with a healthcare professional before administering any medication, including Children's Ibuprofen, to ensure it is safe and appropriate for their individual health needs.

Renal Impairment

If you have kidney problems, it's important to know that there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the usual recommendations for monitoring or safety considerations related to renal impairment (kidney issues) are not provided.

It's always best to consult with your healthcare provider about your specific situation, as they can offer personalized advice and ensure that any medications you take are safe and effective for you.

Hepatic Impairment

If you have liver problems, it's important to know that there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the standard recommendations for the medication do not change based on liver function. However, it’s always a good idea to discuss your liver health with your healthcare provider before starting any new medication. They can help ensure that your treatment is safe and effective for you.

Drug Interactions

It's important to be aware of potential interactions when your child is taking ibuprofen. This medication can cause severe allergic reactions, particularly in those who are allergic to aspirin. Additionally, if your child is on blood thinners (medications that prevent blood clots) or steroids, or if they are taking other nonsteroidal anti-inflammatory drugs (NSAIDs) like aspirin or naproxen, the risk of stomach bleeding increases significantly.

Before giving ibuprofen to your child, make sure to consult with a healthcare provider, especially if they are taking a diuretic (a medication that helps remove excess fluid from the body) or any other medications. It's always best to discuss any medications or tests with your doctor or pharmacist to ensure your child's safety and well-being.

Storage and Handling

To ensure the best performance and safety of your product, store it in a cool, dry place at a temperature between 20 to 25°C (68 to 77°F). It's important to check the packaging before use; do not use the product if the carton is opened or if the seal under the cap is broken or missing. Additionally, make sure to look at the bottom panel for the lot number and expiration date to confirm that the product is still valid for use.

By following these simple storage and handling guidelines, you can help maintain the product's effectiveness and safety.

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

It's important to monitor for any serious side effects, especially in children. If you notice signs of stomach bleeding or symptoms related to heart problems or stroke, stop using the medication and consult a doctor immediately. Always keep this medication out of reach of children, and in the event of an overdose, seek medical help or contact a Poison Control Center right away.

FAQ

What is Ibuprofen?

Ibuprofen is an oral suspension pain reliever and fever reducer for children aged 2 to 11 years, available in a berry flavor.

What does Ibuprofen treat?

Ibuprofen 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 Ibuprofen for my child?

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 are the warnings associated with Ibuprofen?

Ibuprofen 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 Ibuprofen if my child is under 2 years old?

You should ask a doctor before using Ibuprofen for children under 2 years old, especially if they weigh less than 24 lbs.

What should I do if my child experiences side effects?

Stop using Ibuprofen and consult a doctor if your child shows signs of stomach bleeding, heart problems, or does not get relief within 24 hours.

Is it safe to use Ibuprofen during pregnancy or while nursing?

The provided information does not specify any risks or recommendations for using Ibuprofen during pregnancy or lactation.

How should I store Ibuprofen?

Store Ibuprofen between 20 to 25°C (68 to 77°F) and do not use it if the carton is opened or the seal is broken.

Packaging Info

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

Packaging configurations for Childrens Ibuprofen.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

NDC 68001-521-92 designates this product as a Children's Ibuprofen Oral Suspension USP, specifically 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) that serves as a pain reliever and fever reducer. The suspension is alcohol-free and features a berry flavor to enhance palatability. The formulation is designed to provide relief that lasts up to 8 hours, and the product is packaged in a 4 FL OZ (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 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 used for accurate measurement; no other dosing devices should be utilized.

For patients weighing under 24 pounds or under 2 years of age, it is advised to consult a doctor for the appropriate dose. For those weighing between 24 to 35 pounds (ages 2 to 3 years), the recommended dose is 5 mL. For patients weighing 36 to 47 pounds (ages 4 to 5 years), the dose is 7.5 mL. For those weighing 48 to 59 pounds (ages 6 to 8 years), the dose is 10 mL. For patients weighing 60 to 71 pounds (ages 9 to 10 years), the dose is 12.5 mL, and for those weighing 72 to 95 pounds (age 11 years), the dose is 15 mL.

Doses may be repeated every 6 to 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 to adhere to the recommended dosing guidelines and not exceed the directed amount.

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

The use of ibuprofen, an NSAID, carries a significant risk of severe stomach bleeding. This risk is notably elevated in pediatric patients with a history of stomach ulcers or bleeding disorders, those concurrently using anticoagulants or steroid medications, and individuals taking other NSAIDs, whether prescription or over-the-counter (such as aspirin, ibuprofen, or naproxen). Additionally, exceeding the recommended dosage or duration of treatment increases the likelihood of gastrointestinal complications.

Healthcare professionals should be aware that the use of NSAIDs, excluding aspirin, is associated with an increased risk of heart attack, heart failure, and stroke, which can be fatal. This risk is amplified when the medication is used in excess of the recommended dosage or for prolonged periods.

In cases of severe or persistent sore throat, particularly when accompanied by high fever, headache, nausea, or vomiting, immediate medical consultation is advised. Ibuprofen should not be administered for more than two days, nor should it be given to children under three years of age unless specifically directed by a healthcare provider.

Healthcare providers should instruct caregivers to discontinue ibuprofen and seek medical advice if the child exhibits any signs of stomach bleeding, including feeling faint, vomiting blood, passing bloody or black stools, or experiencing persistent stomach pain. Additionally, symptoms suggestive of heart problems or stroke, such as 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. Caregivers should also be vigilant for the emergence of any new symptoms and seek guidance accordingly.

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. Signs of stomach bleeding may include feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain.

Additionally, there is an increased risk of heart attack, heart failure, and stroke associated with NSAID use, excluding aspirin. This risk is particularly pronounced when the medication is used in higher doses or for extended periods. Symptoms indicative of heart problems or stroke may include chest pain, difficulty breathing, weakness on one side of the body, slurred speech, and leg swelling.

Patients should be advised to consult a healthcare professional if they experience 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 recommended that ibuprofen not be used for more than two days in such cases or in children under three years of age unless directed by a physician.

In clinical trials and postmarketing experiences, it is essential for patients to seek medical advice before using ibuprofen if they have a history of stomach issues, are dehydrated, or have underlying health conditions such as high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma. Furthermore, patients should inform their healthcare provider if they are taking diuretics or any other medications.

Patients should discontinue use and consult a doctor 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 painful area, or if any new symptoms arise.

Drug Interactions

Ibuprofen has the potential to induce severe allergic reactions, particularly in individuals with a known allergy to aspirin. This risk necessitates careful consideration when prescribing ibuprofen to patients with such allergies.

In pediatric patients, the concomitant use of ibuprofen with anticoagulants or steroid medications significantly increases the risk of gastrointestinal bleeding. Additionally, caution is advised when ibuprofen is administered alongside other nonsteroidal anti-inflammatory drugs (NSAIDs), including both prescription and over-the-counter options such as aspirin and naproxen.

For children who are prescribed diuretics, it is essential to consult a healthcare professional prior to initiating ibuprofen therapy to ensure safety and efficacy. Furthermore, it is recommended that caregivers seek guidance from a doctor or pharmacist before administering ibuprofen if the child is taking any other medications, to avoid potential drug interactions and ensure appropriate management.

Packaging & NDC

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

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

Healthcare professionals should advise parents to consult a doctor before use if the child has a history of stomach problems, is not adequately hydrated, has experienced significant fluid loss due to vomiting or diarrhea, has high blood pressure, heart disease, liver cirrhosis, kidney disease, a history of stroke, or asthma.

The medication should not be used for more than 2 days, and if the child does not experience relief within the first 24 hours, or if fever or pain worsens or persists beyond 3 days, or if any new symptoms arise, parents should stop use and seek medical advice.

Geriatric Use

Elderly patients may not have specific information regarding the use of Children's Ibuprofen, as the drug insert does not provide details on dosage adjustments, safety concerns, or special precautions for this population. Healthcare providers should exercise caution when considering the use of this medication in geriatric patients, given the potential for altered pharmacokinetics and increased sensitivity to nonsteroidal anti-inflammatory drugs (NSAIDs) in older adults.

Monitoring for adverse effects and therapeutic efficacy is recommended when prescribing this medication to elderly patients, particularly those with comorbidities or concurrent medications that may interact with NSAIDs.

Pregnancy

There are no specific statements regarding the use of ibuprofen during pregnancy in the provided information. The prescribing information does not mention any contraindications or risks associated with ibuprofen use during this period. Additionally, no dosage modifications for pregnant individuals are provided, nor are there any special precautions outlined regarding the use of ibuprofen during pregnancy. Healthcare professionals should consider the absence of specific data when advising pregnant patients and weigh the potential benefits against any unknown risks.

Lactation

There are no specific warnings or recommendations regarding the use of ibuprofen in nursing mothers. Additionally, there is no information available concerning the potential for excretion of ibuprofen in breast milk or any associated risks to breastfed infants during lactation.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available data regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution and consider individual patient factors when prescribing to patients with reduced kidney function, as the absence of specific guidance necessitates careful clinical judgment.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there are no established dosage adjustments, special monitoring requirements, or precautions outlined for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population. Regular monitoring of liver function may be prudent in these cases, although specific parameters are not defined in the available information.

Overdosage

Overdosage of ibuprofen can result in significant health risks and requires prompt medical intervention.

Symptoms of Overdose Healthcare professionals should be aware that symptoms of ibuprofen overdose may manifest as nausea, vomiting, stomach pain, drowsiness, and headache. In more severe instances, the overdose can escalate to critical conditions such as kidney failure, liver damage, or gastrointestinal bleeding.

Recommended Actions In the event of a suspected overdose, it is imperative to seek immediate medical attention. Timely intervention is crucial to mitigate potential complications and ensure appropriate management of the patient's condition.

Nonclinical Toxicology

No teratogenic or non-teratogenic effects have been reported in the available nonclinical studies. Additionally, there is no information regarding animal pharmacology and toxicology. The absence of data limits the assessment of potential risks associated with the use of the compound in question.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions reported voluntarily or through surveillance programs. These include allergic reactions such as hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, and blisters. Additionally, cases of stomach bleeding have been noted, particularly in patients with a history of stomach ulcers or bleeding problems, or those concurrently using anticoagulants or other nonsteroidal anti-inflammatory drugs (NSAIDs).

There is an increased risk of serious cardiovascular events, including heart attack, heart failure, and stroke, associated with the use of NSAIDs. Reports have also indicated that severe or persistent sore throat, especially when accompanied by high fever, headache, nausea, and vomiting, may suggest serious underlying conditions.

Symptoms indicative of stomach bleeding include feeling faint, vomiting blood, having bloody or black stools, and experiencing stomach pain that does not improve. Furthermore, symptoms associated with heart problems or stroke may manifest as chest pain, difficulty breathing, weakness in one part or side of the body, slurred speech, and leg swelling.

Patients are advised that the emergence of new symptoms during treatment should lead to discontinuation of the medication and prompt consultation with a healthcare provider.

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 that the medication be taken with food or milk if the patient 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 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.

Patients should also be counseled to stop use and consult a doctor if the child does not experience 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 painful area, or if any new symptoms arise.

It is important for healthcare providers to remind patients to consult a doctor before use if the stomach bleeding warning is applicable to their child, or if the child has a history of stomach issues, such as heartburn. Patients should also be advised to seek medical advice if the child has experienced serious side effects from pain relievers or fever reducers, has not been adequately hydrated, or has lost significant fluids due to vomiting or diarrhea.

Furthermore, healthcare providers should recommend that patients consult a doctor before use if the child has high blood pressure, heart disease, liver cirrhosis, kidney disease, or a history of stroke. Patients with asthma or those taking diuretics should also be advised to seek medical guidance prior to use. Lastly, it is prudent for patients to consult a doctor or pharmacist 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 secure carton, and it is essential to store it at a temperature range of 20 to 25°C (68 to 77°F). Healthcare professionals should ensure that the carton remains unopened and that the seal under the cap is intact; the product should not be used if either of these conditions is not met. For traceability, the lot number and expiration date can be found on the bottom panel of the carton.

Additional Clinical Information

The medication is administered orally, with a recommended dosing frequency of every 6 to 8 hours as needed, not to exceed four doses per day. Patients should be advised to take the medication with food or milk if they experience stomach upset.

Clinicians should counsel patients to discontinue use and seek medical attention if a child exhibits any signs of stomach bleeding or symptoms indicative of heart problems or stroke. It is crucial to keep the medication out of reach of children, and in the event of an overdose, immediate medical assistance or contact with a Poison Control Center is necessary.

Drug Information (PDF)

This file contains official product information for Childrens 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 Childrens 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.

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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.