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Childrens Ibuprofen Oral Suspension

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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)
Marketed in the U.S.
Since 2019
Label revision date
December 19, 2025
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
Marketed in the U.S.
Since 2019
Label revision date
December 19, 2025
Manufacturer
Discount Drug Mart
Registration number
ANDA210602
NDC root
53943-119

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Drug Overview

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

This alcohol-free medication comes in a pleasant original berry flavor, making it easier for children to take. If you're considering using Children's Ibuprofen, it's important to read all product information to ensure it's the right choice for your child's needs.

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 harm to a developing fetus. This makes it a safer choice for those who are pregnant, although you should always consult with your healthcare provider before taking any medication.

Dosage and Administration

When using this medication, it’s important to follow the directions carefully. Always shake the bottle well before using it, and make sure to use the enclosed dosing cup for measuring your dose—other devices may not provide the correct amount. You should not take more than the recommended dose, and if you need to, you can repeat the dose every 6 to 8 hours, but do not exceed four doses in a single day.

The amount you should take depends on your weight and age. For children under 2 years old who weigh less than 24 pounds, it’s best to consult a doctor for the appropriate dose. If your child weighs between 24 and 35 pounds and is 2 to 3 years old, the dose is 5 mL. For those weighing 36 to 47 pounds and aged 4 to 5 years, the dose increases to 7.5 mL. Children who weigh between 48 and 59 pounds and are 6 to 8 years old should take 10 mL, while those weighing 60 to 71 pounds and aged 9 to 10 years should take 12.5 mL. Finally, for an 11-year-old who weighs between 72 and 95 pounds, the dose is 15 mL. Always remember to follow your doctor’s advice if they provide specific instructions.

What to Avoid

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

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

Side Effects

Ibuprofen can cause serious allergic reactions, particularly in individuals who are allergic to aspirin. Signs of an allergic reaction may include hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, and blisters. If you notice any of these symptoms, stop using the medication and seek medical help immediately.

Additionally, ibuprofen carries risks of stomach bleeding, heart attack, and stroke. The risk of stomach bleeding is higher if your child has a history of stomach ulcers, is taking blood thinners or steroids, or uses other NSAIDs (nonsteroidal anti-inflammatory drugs). Heart attack and stroke risks increase with higher doses or prolonged use. If your child experiences symptoms like faintness, vomiting blood, chest pain, or weakness, contact a doctor right away. Always consult a healthcare professional if your child has a history of stomach issues, is dehydrated, or is taking other medications.

Warnings and Precautions

You should be aware of some important warnings and precautions when using ibuprofen. First, if you or your child has a known allergy to aspirin, be cautious, as ibuprofen can cause severe allergic reactions. Symptoms may include hives, facial swelling, wheezing, or skin rashes. If any of these occur, stop using the medication and seek medical help immediately. Additionally, ibuprofen can lead to serious stomach bleeding, especially if there is a history of stomach ulcers, if blood-thinning medications are being taken, or if it is used for longer than recommended.

It's also important to note that using ibuprofen can increase the risk of heart attack and stroke, particularly if taken in higher doses or for extended periods. If you notice any signs of stomach bleeding, such as faintness, vomiting blood, or black stools, stop taking ibuprofen and call your doctor right away. Similarly, if you observe symptoms of heart problems or stroke, like chest pain or difficulty breathing, seek immediate medical attention. Always consult a doctor if symptoms persist beyond 24 hours or worsen, and remember to get emergency help in case of an overdose by contacting a Poison Control Center at 1-800-222-1222.

Overdose

It appears that there is no specific information available regarding overdosage for this medication. However, it's always important to be aware of the potential risks associated with taking more than the recommended dose. If you suspect an overdose, look for signs such as unusual drowsiness, confusion, or difficulty breathing.

In the event of an overdose, it is crucial to seek immediate medical help. You can contact your local emergency services or go to the nearest hospital. Always keep your medications in a safe place and follow the prescribed dosage to minimize the risk of an overdose.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that the information regarding the use of Children's Ibuprofen Oral Suspension during pregnancy is limited. The available data does not specify any risks or contraindications associated with using ibuprofen while pregnant, nor does it suggest any dosage modifications for pregnant individuals.

However, since there are no specific guidelines or precautions mentioned, it's always best to consult with your healthcare provider before taking any medication during pregnancy. They can provide personalized advice based on your health and circumstances.

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

Pediatric Use

When considering this medication for your child aged 2 to 11 years, it's important to follow specific dosing guidelines based on their weight and age. For children under 2 years old, you should consult a doctor before use. For those aged 2 to 3 years and weighing between 24-35 pounds, the recommended dose is 5 mL. As your child grows, the dosage increases: 7.5 mL for ages 4-5 years (36-47 lbs), 10 mL for ages 6-8 years (48-59 lbs), 12.5 mL for ages 9-10 years (60-71 lbs), and 15 mL for 11-year-olds (72-95 lbs).

It's crucial to consult a doctor if your child has any history of stomach issues, dehydration from vomiting or diarrhea, high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or if they are taking a diuretic (a medication that helps remove excess fluid). Additionally, if your child shows any signs of stomach bleeding or symptoms related to heart problems or stroke, stop use immediately and seek medical advice. Always prioritize your child's health and safety by discussing any concerns with a healthcare professional.

Geriatric Use

When it comes to using this medication in older adults, there is no specific information available about its effects or safety for this age group. This means that if you or a loved one is an older adult, it’s important to consult with a healthcare provider before starting the medication. They can help assess any potential risks and determine the best approach based on individual health needs.

Always keep in mind that older adults may have different responses to medications due to factors like age-related changes in the body and existing health conditions. Your healthcare provider can guide you on the appropriate dosage and monitor for any side effects.

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.

Always consult your healthcare provider for personalized advice and to ensure that any medications you take are safe and appropriate for your kidney health. They can help you understand how your condition may affect your treatment and what steps to take for your safety.

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 impairment. 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 have open conversations with your healthcare provider about any medications or tests you may be taking. While there are no specific drug interactions or laboratory test interactions noted for this medication, your healthcare provider can help ensure that everything you are taking works well together and is safe for you. Always share your complete list of medications and any recent lab tests to avoid any potential issues. Your health and safety should always come first.

Storage and Handling

To ensure the safety and effectiveness of your product, store it in a cool, dry place at a temperature between 20-25°C (68-77°F). This helps maintain its quality and performance.

Before using the product, check that the carton is unopened and that the printed bottle neckband is intact. If either of these is broken or missing, do not use the product, as this could compromise its safety. Always handle the product with care to avoid any damage.

Additional Information

No further information is available.

FAQ

What is Children's Ibuprofen?

Children's Ibuprofen is an oral suspension (NSAID) that provides relief from minor aches and pains and reduces fever in children.

What age group is Children's Ibuprofen intended for?

It is intended for use in children ages 2 to 11 years.

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

The effects can last up to 8 hours.

What should I do before using Children's Ibuprofen?

You should read all product information before using it.

How should I administer Children's Ibuprofen?

Shake well before using and use only the enclosed dosing cup. Do not exceed the recommended dose.

What are the dosing recommendations for Children's Ibuprofen?

Dosing varies by weight and age; for example, a child weighing 24-35 lbs (2-3 years) should receive 5 mL.

Are there any contraindications for using Children's Ibuprofen?

Do not use if the child has had an allergic reaction to Ibuprofen or any other pain reliever, or right before or after heart surgery.

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

Stop use and call a doctor if your child feels faint, vomits blood, or has bloody or black stools.

Can Children's Ibuprofen be used during pregnancy?

There are no specific statements regarding the use of Children's Ibuprofen during pregnancy.

Is it safe to use Children's Ibuprofen while nursing?

The insert does not provide specific warnings or recommendations for nursing mothers.

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

Consult a doctor if your child does not get any relief within the first 24 hours of treatment.

How should I store Children's Ibuprofen?

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

Packaging Info

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

Packaging configurations for Childrens Ibuprofen Oral Suspension.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Ibuprofen is an oral suspension classified as a nonsteroidal anti-inflammatory drug (NSAID). It is formulated to deliver 100 mg of ibuprofen per 5 mL. This medication serves as a pain reliever and fever reducer, with effects that last up to 8 hours. The product is alcohol-free and features an original berry flavor. Each bottle contains 4 fluid ounces (118 mL) of the suspension.

Uses and Indications

This drug is indicated for the relief of minor aches and pains associated with the common cold, influenza, sore throat, headache, and toothache. Additionally, it is utilized to reduce fever.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

Patients should adhere strictly to the prescribed dosage and administration guidelines. Prior to use, the product must be shaken well. It is imperative to utilize only the enclosed dosing cup for measurement; other dosing devices are not recommended.

For dosing frequency, if necessary, the dose may be repeated every 6 to 8 hours, with a maximum of four doses per day.

The following dosing chart provides guidance based on weight and age:

  • For patients weighing under 24 lbs and under 2 years of age, the dose should be determined by a healthcare professional.

  • For patients weighing between 24-35 lbs and aged 2-3 years, the recommended dose is 5 mL.

  • For patients weighing between 36-47 lbs and aged 4-5 years, the recommended dose is 7.5 mL.

  • For patients weighing between 48-59 lbs and aged 6-8 years, the recommended dose is 10 mL.

  • For patients weighing between 60-71 lbs and aged 9-10 years, the recommended dose is 12.5 mL.

  • For patients weighing between 72-95 lbs and aged 11 years, the recommended dose is 15 mL.

Dosing may also be adjusted as directed by a healthcare professional.

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 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.

This product contains a nonsteroidal anti-inflammatory drug (NSAID), which carries a risk of severe stomach bleeding. The likelihood of this adverse effect is heightened in children with a history of stomach ulcers or bleeding disorders, those taking anticoagulants or steroid medications, or those concurrently using other NSAIDs (including aspirin, ibuprofen, or naproxen). Additionally, exceeding the recommended dosage or duration of use increases this risk.

NSAIDs, excluding aspirin, are associated with an elevated risk of heart attack, heart failure, and stroke, which can be fatal. This risk is particularly pronounced when the medication is used in excess of the recommended dosage or for prolonged periods.

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

Healthcare providers should advise caregivers to discontinue ibuprofen and seek medical attention 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, if symptoms indicative of heart problems or stroke arise—such as chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling—immediate medical consultation is warranted.

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, medical advice should be sought. Caregivers should also be vigilant for any new symptoms or signs of redness or swelling in the affected area.

In the event of an overdose, it is crucial to obtain emergency medical assistance or contact a Poison Control Center immediately at 1-800-222-1222.

Side Effects

Patients using ibuprofen should be aware of potential adverse reactions, which can range from serious to common.

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

The use of ibuprofen is associated with a risk of severe stomach bleeding, particularly in patients with a history of stomach ulcers or bleeding problems, those taking anticoagulants or steroid medications, or those using other NSAIDs (including aspirin, ibuprofen, or naproxen). The risk of stomach bleeding increases with prolonged use or higher than recommended dosages.

Additionally, ibuprofen carries warnings regarding cardiovascular risks. The use of NSAIDs, excluding aspirin, has been linked to an increased risk of heart attack, heart failure, and stroke, which can be fatal. This risk is heightened when the medication is used in excess of the recommended duration or dosage.

Patients should also 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 requiring prompt medical consultation. It is advised not to use ibuprofen for more than two days for sore throat relief or to administer it to children under three years of age without a doctor's guidance.

Patients should stop using ibuprofen and consult a healthcare provider if they experience signs of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain. Symptoms indicative of heart problems or stroke, including chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling, also warrant immediate medical attention. If relief is not achieved within the first 24 hours of treatment, or if fever or pain worsens or persists beyond three days, patients should seek medical advice. Redness or swelling in the painful area or the emergence of new symptoms should also prompt consultation with a healthcare professional.

Before using ibuprofen, patients should consult a doctor if they have a history of stomach problems, such as heartburn, or if they have experienced serious side effects from pain relievers or fever reducers. Additional caution is advised for patients who have not been adequately hydrated, have lost significant fluids due to vomiting or diarrhea, or have pre-existing 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.

Finally, it is recommended that patients under a doctor's care for any serious condition or those taking other medications consult with a healthcare provider or pharmacist before using ibuprofen.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there is no information available regarding interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

Packaging & NDC

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

Packaging configurations for Childrens Ibuprofen Oral Suspension.
Details

Pediatric Use

Pediatric patients aged 2 to 11 years may use this product, with specific dosing based on weight and age. For children weighing under 24 lbs and under 2 years of age, a doctor should be consulted before use. The recommended doses for children aged 2 to 11 years are as follows:

  • 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

Caution is advised for pediatric patients with a history of stomach problems, such as heartburn, or those who have not been adequately hydrated due to vomiting or diarrhea. Additionally, consultation with a doctor is recommended for children with high blood pressure, heart disease, liver cirrhosis, kidney disease, a history of stroke, or asthma. If the child is taking a diuretic, a doctor should also be consulted.

Parents and caregivers should discontinue use and seek medical advice if the child exhibits any signs of stomach bleeding or symptoms indicative of heart problems or stroke. This product is specifically intended for use in children.

Geriatric Use

There is no specific information regarding the use of this medication in geriatric patients. Therefore, healthcare providers should exercise caution when prescribing this medication to elderly patients. It is advisable to monitor this population closely for any potential adverse effects or changes in efficacy, as age-related physiological changes may influence drug metabolism and response. Additionally, consideration should be given to the presence of comorbidities and concurrent medications that are common in geriatric patients, which may necessitate dosage adjustments or increased monitoring.

Pregnancy

There are no specific statements regarding the use of Children's Ibuprofen Oral Suspension during pregnancy. The available information does not indicate any contraindications or risks associated with the use of ibuprofen during this period. Additionally, no dosage modifications for pregnant individuals are provided. The insert does not include any special precautions regarding the use of this medication during pregnancy. Healthcare professionals should consider the absence of 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 lactating mothers. Additionally, there is no information available concerning the potential for excretion of ibuprofen in breast milk or any associated risks to breastfed infants.

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 when prescribing this medication to patients with reduced kidney function, as the lack of information necessitates careful clinical judgment and monitoring of these patients.

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 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

In the absence of specific overdosage information, it is essential for healthcare professionals to remain vigilant regarding the potential for overdose with this medication. In cases where an overdose is suspected, immediate medical attention should be sought.

Healthcare providers are advised to monitor patients closely for any signs or symptoms that may indicate an overdose. These may include, but are not limited to, altered mental status, cardiovascular instability, or gastrointestinal disturbances.

Management of an overdose should be tailored to the individual patient and may involve supportive care, symptomatic treatment, and, if applicable, the use of specific antidotes. It is crucial to consult local poison control guidelines and the product's prescribing information for detailed management protocols.

In summary, while specific overdosage data is not available, healthcare professionals should exercise caution and be prepared to act swiftly in the event of an overdose scenario.

Nonclinical Toxicology

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

Postmarketing Experience

Postmarketing experience has identified several adverse reactions associated with the use of the product. These include allergic reactions such as hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, and blisters. Additionally, instances of stomach bleeding have been reported, particularly in patients with a history of stomach ulcers or bleeding problems, as well as 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 NSAID use. Reports have also indicated that severe or persistent sore throat, especially when accompanied by high fever, headache, nausea, and vomiting, may suggest the presence of serious underlying conditions.

Furthermore, cases of overdose have been documented, highlighting the importance of seeking immediate medical assistance or contacting a Poison Control Center in such situations.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. In the event of an overdose, patients should be instructed to seek medical help or contact a Poison Control Center immediately at 1-800-222-1222.

Patients should be informed that this medication should not be used if the child has a history of allergic reactions to Ibuprofen or any other pain reliever or fever reducer. Additionally, it is important to avoid use right before or after heart surgery.

Healthcare providers should counsel patients to stop the medication 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. Furthermore, patients should be advised to 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 also be informed to discontinue 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 for more than three days, if there is redness or swelling in the painful area, or if any new symptoms arise.

When using this product, patients should be advised to take it with food or milk if stomach upset occurs. It is essential for patients to consult a doctor before use if the child has a history of stomach problems, such as heartburn, or if the stomach bleeding warning applies.

Healthcare providers should encourage patients to seek medical advice before use if the child has experienced serious side effects from pain relievers or fever reducers, has not been drinking fluids, or has lost a significant amount of fluid due to vomiting or diarrhea. Additionally, patients should be advised to consult a doctor before use if the child has high blood pressure, heart disease, liver cirrhosis, kidney disease, a history of stroke, or asthma.

Finally, patients should be reminded to consult a doctor or pharmacist before use if the child is taking a diuretic or is under a doctor's care for any serious condition, as well as before using this medication if the child is taking any other drugs.

Storage and Handling

The product is supplied in a configuration that includes specific packaging requirements. It must be stored at a temperature range of 20-25° C (68-77° F) to ensure its stability and efficacy.

Healthcare professionals are advised to inspect the packaging prior to use. The product should not be utilized if the carton has been opened or if the printed bottle neckband is broken or missing, as this may compromise the integrity of the product.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Childrens Ibuprofen Oral Suspension, 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 Oral Suspension, 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.