Symptom checker
Select audience type

Switch between content for healthcare professionals (PRO) and general audience (GEN).

ADD CONDITION

items per page

Childrens Ibuprofen Oral Suspension

Last content change checked dailysee data sync status

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 2019
Label revision date
December 29, 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 2019
Label revision date
December 29, 2023
Manufacturer
DEMOULAS SUPERMARKETS INC.
Registration number
ANDA210602
NDC root
53942-119
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 is an oral suspension that contains 100 mg of ibuprofen (a type of medication that helps reduce pain and inflammation) per 5 mL. It is commonly used to relieve minor aches and pains associated with conditions like the common cold, flu, sore throat, headache, and toothache. Additionally, it helps reduce fever and provides relief that can last up to 8 hours. This medication is alcohol-free and is specifically intended for use in children.

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 medication, make sure to shake the bottle well. It's important to use the dosing cup that comes with the medication, as other devices may not provide the correct amount. You should not exceed the recommended dose, and if you need to take it again, you can do so every 6 to 8 hours, but remember not to use it more than four times 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. If your child is 9 to 10 years old and weighs between 60 and 71 pounds, the dose is 12.5 mL, and for an 11-year-old weighing 72 to 95 pounds, the dose is 15 mL. Always follow these guidelines or consult your doctor if you have any questions.

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 undergone heart surgery. Following these guidelines will help ensure your child's safety and well-being.

Side Effects

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

Additionally, ibuprofen carries risks of severe stomach bleeding, particularly if your child has a history of stomach ulcers, is taking blood thinners or steroids, or uses other NSAIDs (nonsteroidal anti-inflammatory drugs). There is also an increased risk of heart attack and stroke with NSAID use, especially if taken in higher doses or for extended periods. 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 any underlying health conditions 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 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.

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 longer than recommended. If your child experiences severe sore throat symptoms, such as a high fever or persistent pain, consult a doctor right away. You should stop using ibuprofen and call your doctor if your child shows signs of stomach bleeding (like faintness, vomiting blood, or black stools), has symptoms of heart problems or stroke (such as chest pain or trouble breathing), or if their condition does not improve within 24 hours. For any overdose situation, seek emergency medical help or contact a Poison Control Center immediately at 1-800-222-1222.

Overdose

Taking too much ibuprofen can lead to serious health issues. If you or someone you know has taken an overdose, it's important to be aware of the symptoms, which may include nausea (feeling sick), vomiting, stomach pain, drowsiness (extreme tiredness), and headache.

If you suspect an overdose, seek immediate medical attention or contact a poison control center right away. Acting quickly can help prevent more severe complications. Always prioritize safety and don’t hesitate to reach out for help if you need it.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that the safety of ibuprofen during pregnancy has not been established. In fact, ibuprofen is not recommended, especially during the third trimester, as it may pose risks to your developing baby. These risks can include potential cardiovascular issues and kidney problems for the fetus.

Before taking any medication, including ibuprofen, you should consult your healthcare provider. They can help you understand the potential risks and guide you toward safer alternatives if needed. Your health and the health of your baby are the top priority, so always seek professional advice when it comes to medication during pregnancy.

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

It's important to be cautious when using this medication in children. You should not give it to children under 3 years of age unless a doctor specifically advises you to do so. For children aged 2 to 11 years, the dosage depends on their weight. For example, if your child weighs under 24 lbs and is under 2 years old, you should consult a doctor. For children weighing 24-35 lbs (ages 2-3), the recommended dose is 5 mL, and it increases with weight and age up to 15 mL for an 11-year-old weighing 72-95 lbs.

Before giving this medication, consult a doctor if your child has not been drinking fluids, has lost a lot of fluid from vomiting or diarrhea, or has a history of stomach issues like heartburn. It's also important to check with a doctor if your child has high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or is taking a diuretic (a medication that helps remove excess fluid). If you notice any signs of stomach bleeding or symptoms related to heart problems or stroke, stop using the medication and seek medical advice immediately.

Geriatric Use

When it comes to using this medication in older adults, there is no specific information available about dosage adjustments, safety concerns, or special precautions. 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 determine the best approach based on individual health needs and any other medications being taken. Always prioritize open communication with your healthcare team to ensure safe and effective treatment.

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 plan.

Hepatic Impairment

If you have liver problems, it's important to know that the drug insert does not provide specific information about dosage adjustments, special monitoring, or precautions for your condition. This means that there are no tailored guidelines for how this medication should be used if you have hepatic impairment (liver issues).

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your liver health. They can help you understand how to manage your treatment effectively.

Drug Interactions

It's important to be aware that ibuprofen can cause serious allergic reactions, particularly in individuals who are allergic to aspirin. Additionally, if your child is taking blood thinners (medications that help prevent blood clots) or steroids, the risk of stomach bleeding increases. This risk is also heightened if your child is using other nonsteroidal anti-inflammatory drugs (NSAIDs), such as aspirin or naproxen.

Before giving ibuprofen to your child, it's crucial to consult with a healthcare provider, especially if they are on a diuretic (a medication that helps remove excess fluid from the body) or any other medications. Always discuss any potential interactions with your doctor or pharmacist to ensure your child's safety.

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 neckband on the bottle is intact. If either of these is broken or missing, do not use the product, as this may indicate that it has been compromised. Always handle the product with care to ensure your safety and the best results.

Additional Information

No further information is available.

FAQ

What is Children's Ibuprofen?

Children's Ibuprofen is an oral suspension (NSAID) that contains 100mg of ibuprofen per 5mL.

What does Children's Ibuprofen treat?

It relieves minor aches and pains due to the common cold, flu, sore throat, headache, and toothache, and it also reduces fever.

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

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

What are the dosing instructions for Children's Ibuprofen?

You should not give more than directed, and doses can be repeated every 6-8 hours, not exceeding 4 times a day.

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 heartburn.

Are there any contraindications for using Children's Ibuprofen?

Do not use if your child has ever had an allergic reaction to ibuprofen or any other pain reliever/fever reducer, or right before or after heart surgery.

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

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

Is it safe to use Children's Ibuprofen during pregnancy?

Safety during pregnancy has not been established, and ibuprofen is contraindicated in pregnancy, 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 get any 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 Children's Ibuprofen be stored?

Store Children's Ibuprofen between 20-25° C (68-77° F) and do not use if the carton is opened or the printed bottle neckband is broken or missing.

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

MARKET BASKET® Children's Ibuprofen is an oral suspension formulation designed to relieve pain and reduce fever. Each 5 mL dose contains 100 mg of ibuprofen, a nonsteroidal anti-inflammatory drug (NSAID). The product is alcohol-free and features an original berry flavor. It is packaged in a 4 FL OZ (118 mL) bottle and provides relief that lasts up to 8 hours. This medication is specifically intended for use in children, and it is important to read all product information prior to use.

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

The medication should be administered according to the following guidelines. It is imperative to adhere strictly to the prescribed dosage and not exceed the recommended limits. Prior to use, the bottle must be shaken well. Only the enclosed dosing cup should be utilized for measurement; the use of any other dosing device is 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 dosing recommendations based on weight and age are as follows:

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

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

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

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

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

Healthcare providers should instruct 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, symptoms indicative of heart problems or stroke, including chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling, warrant immediate medical evaluation.

If the child does not experience relief within the first 24 hours of treatment, or if fever or pain worsens or persists beyond three days, or if redness or swelling occurs in the affected area, medical advice should be sought. Any new symptoms that arise during treatment should also prompt a consultation with a healthcare professional.

In the event of an overdose, immediate medical assistance should be obtained, or the Poison Control Center should be contacted at 1-800-222-1222.

Side Effects

Patients using ibuprofen should be aware of the potential for serious adverse reactions, including severe allergic reactions, gastrointestinal bleeding, and cardiovascular events.

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, patients should discontinue use immediately and seek medical assistance.

The use of ibuprofen, as a nonsteroidal anti-inflammatory drug (NSAID), carries a risk of severe stomach bleeding. This risk is heightened in patients with a history of stomach ulcers or bleeding disorders, those taking anticoagulants or steroid medications, and individuals using other NSAIDs, including aspirin and naproxen. Patients are advised to adhere strictly to dosing instructions to minimize this risk.

Additionally, NSAIDs, excluding aspirin, have been associated with an increased risk of heart attack, heart failure, and stroke, which can be fatal. The likelihood of these serious cardiovascular events increases with prolonged use or exceeding the recommended dosage.

Patients should also 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 requiring prompt medical evaluation.

In clinical practice, it is recommended that patients discontinue ibuprofen and consult a healthcare provider if they experience any 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 warrant immediate medical attention.

Patients should seek medical advice before using ibuprofen if they have a history of stomach issues, are experiencing dehydration, or have pre-existing conditions such as high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma. Furthermore, it is advisable to consult a healthcare professional if the patient is under treatment for any serious condition or is taking other medications.

In summary, while ibuprofen can be effective for pain relief and fever reduction, careful consideration of the associated risks and monitoring for adverse reactions is essential for patient safety.

Drug Interactions

Ibuprofen has the potential to induce severe allergic reactions, particularly in individuals with a known allergy to aspirin.

When considering the concomitant use of ibuprofen with anticoagulants or steroid medications, there is an increased risk of gastrointestinal bleeding. This risk is also elevated when ibuprofen is taken alongside other nonsteroidal anti-inflammatory drugs (NSAIDs), including both prescription and over-the-counter options such as aspirin and naproxen.

It is advisable to consult a healthcare professional prior to administering ibuprofen if the child is currently prescribed a diuretic. Additionally, it is recommended that a doctor or pharmacist be consulted before the use of ibuprofen in conjunction with any other medications.

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 under 3 years of age should not use this product unless directed by a healthcare professional. For dosing, the following guidelines apply based on weight and age:

  • For children weighing under 24 lbs and under 2 years of age, consultation with a doctor is advised.

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

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

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

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

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

Healthcare professionals should advise parents to consult a doctor if the child has not been drinking fluids or has experienced significant fluid loss due to vomiting or diarrhea. Additionally, consultation is recommended for children with a history of stomach problems, such as heartburn, or those 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's advice should also be sought.

Parents should be instructed to stop use and consult a doctor if the child exhibits signs of stomach bleeding or symptoms indicative of heart problems or stroke. This product is specifically intended for use in children.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any potential adverse effects or changes in therapeutic response, given the lack of targeted data for this population.

Pregnancy

The safety of ibuprofen during pregnancy has not been established. Ibuprofen is contraindicated in pregnancy, particularly during the third trimester, due to potential risks to the fetus. The use of nonsteroidal anti-inflammatory drugs (NSAIDs), including ibuprofen, during pregnancy may be associated with adverse fetal outcomes, such as cardiovascular effects and renal impairment.

Women of childbearing potential should consult a healthcare provider before using ibuprofen if they are pregnant or planning to become pregnant. It is essential to weigh the potential risks against the benefits in these populations.

Lactation

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

Renal Impairment

There is no specific information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in this patient population.

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 lead to significant adverse effects that require prompt medical intervention. Healthcare professionals should be aware of the potential symptoms associated with an overdose, which may include nausea, vomiting, stomach pain, drowsiness, and headache.

In the event of an overdose, it is crucial to seek immediate medical attention. Healthcare providers should advise patients or caregivers to contact a poison control center for further guidance and management. Timely intervention is essential to mitigate the risks associated with ibuprofen overdosage and to ensure appropriate treatment measures are implemented.

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 reported voluntarily or through surveillance programs. These include allergic reactions such as hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, and blisters. Additionally, instances of stomach bleeding have been observed, 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 heart attack, heart failure, and stroke associated with NSAID use, especially when used in doses higher than directed or for durations exceeding recommendations. Reports have also indicated severe or persistent sore throat, particularly when accompanied by high fever, headache, nausea, and vomiting, which may be considered potentially serious.

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 advise against use right before or after heart surgery.

Healthcare providers should counsel patients to stop 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. Furthermore, patients should be alerted to 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 advised 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 beyond three days, if there is redness or swelling in the painful area, or if any new symptoms arise.

When using this product, it is recommended that it be taken with food or milk to mitigate potential stomach upset. Healthcare providers should encourage 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.

Patients should be advised to seek medical advice 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, it is important 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, healthcare providers should recommend that patients 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.

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.