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Childrens Ibuprofen Oral Suspension

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Active ingredient
Ibuprofen 100 mg/5 mL – 200 mg/10 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 2025
Label revision date
August 1, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Ibuprofen 100 mg/5 mL – 200 mg/10 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 2025
Label revision date
August 1, 2025
Manufacturer
PAI Holdings, LLC dba PAI Pharma
Registration number
ANDA214789
NDC roots
0121-0833, 0121-1666
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (4 NDCs)
Packaging & NDC Codes (4)

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Drug Overview

Children's Ibuprofen is an oral suspension that belongs to a class of medications known as nonsteroidal anti-inflammatory drugs (NSAIDs). 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, making it a helpful option for managing discomfort in children.

This medication is formulated to be alcohol-free and dye-free, ensuring a gentle option for young patients. Each dose delivers 100 mg of ibuprofen in a 5 mL serving, providing effective relief for various mild ailments.

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. This makes it a safer choice for those who may be pregnant or planning to become pregnant.

Dosage and Administration

Before using this product, it's important to note that it does not come with complete directions or warnings for adult use. Always make sure to follow the recommended dosage carefully and never exceed the directed amount. To prepare the medication, shake the bottle well before each use.

To find the right dose, refer to the dosing chart based on your child's weight. If possible, use their weight for the most accurate dosing; otherwise, you can use their age. Make sure to use only the enclosed dosing cup, as other devices may not provide the correct measurement. If necessary, you can repeat the dose every 6 to 8 hours, but do not use it more than four times in a single day. For children weighing under 24 pounds (under 2 years), it's best to consult a doctor before administering the medication. For those who weigh between 24 and 95 pounds, the dosing amounts vary, so be sure to check the chart for the specific amount needed.

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 a severe allergic reaction may include hives, facial swelling, wheezing (asthma), shock, skin reddening, rash, or blisters. Additionally, this medication carries a risk of severe stomach bleeding, especially if your child has a history of stomach ulcers, is taking blood thinners or steroids, or uses other NSAIDs (nonsteroidal anti-inflammatory drugs) like aspirin or naproxen.

There is also an increased risk of heart attack and stroke associated with NSAIDs, which can be fatal, particularly if used in higher doses or for extended periods. If your child experiences symptoms such as fainting, vomiting blood, or has bloody or black stools, seek medical attention immediately. It's important to consult a doctor if your child has a severe sore throat with high fever, or if symptoms worsen or persist beyond a few days. Always check with a healthcare professional before using ibuprofen if your child has any underlying health conditions or is taking other medications.

Warnings and Precautions

Ibuprofen can cause serious allergic reactions, especially in those who are allergic to aspirin. If you notice symptoms like hives, facial swelling, wheezing, or skin rash, stop using it immediately and seek medical help. Additionally, ibuprofen may lead to severe stomach bleeding, particularly if your child has a history of stomach ulcers, is taking blood thinners, or uses other NSAIDs (nonsteroidal anti-inflammatory drugs) like aspirin or naproxen. The risk of heart attack and stroke is also increased with NSAID use, especially if taken in higher doses or for longer than recommended.

Before giving ibuprofen to your child, consult a doctor if they have had any allergic reactions to pain relievers, have stomach issues, or are taking other medications. It's important to avoid using ibuprofen right before or after heart surgery. If your child experiences symptoms like faintness, vomiting blood, or severe stomach pain, stop the medication and call your doctor. Seek emergency help if you suspect an overdose or if your child shows signs of heart problems or stroke, such as chest pain or weakness on one side of the body. If your child does not feel better within 24 hours or if symptoms worsen, contact your healthcare provider.

Overdose

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

Always err on the side of caution—if you notice any concerning symptoms or if you’re unsure, don’t hesitate to get help right away. Your health and safety are the top priority.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to be cautious with medications like ibuprofen. The safety of ibuprofen during pregnancy has not been established, and it is particularly contraindicated (not recommended) during the third trimester due to potential risks to your baby. Using nonsteroidal anti-inflammatory drugs (NSAIDs) like ibuprofen during pregnancy may increase the risk of miscarriage, kidney problems in the fetus, and other negative effects.

Before taking ibuprofen, especially in the later stages of your pregnancy, you should consult your healthcare provider. They can help you understand the risks and determine the best options for managing any discomfort you may experience.

Lactation Use

If you are breastfeeding, it's important to talk to your doctor before using this product. There is a possibility that ibuprofen may pass into your breast milk, which could pose some risks to your baby. Therefore, you should exercise caution when considering ibuprofen while nursing. Always prioritize your health and your infant's safety by seeking professional advice.

Pediatric Use

When giving this medication to your child, it's important to follow the dosing guidelines carefully. For children under 2 years old or weighing less than 24 pounds, you should consult a doctor before use. For those aged 2 to 3 years and weighing between 24 to 35 pounds, the recommended dose is 5 mL. As your child grows, the dosage increases based on their weight, reaching up to 15 mL for children aged 11 years and weighing between 72 to 95 pounds.

Be cautious if your child has certain health issues, such as a history of stomach problems, dehydration, or conditions like asthma or heart disease. It's also essential not to use this medication for more than two days for a sore throat, especially in children under 3 years, unless directed by a doctor. If your child does not feel better within 24 hours, or if their symptoms worsen or new symptoms appear, stop using the medication and consult a doctor. Always administer the medication with food or milk if your child experiences stomach upset.

Geriatric Use

While there is no specific information available about the use of this medication in older adults, it’s important to approach any new treatment with caution. If you or a loved one is an older adult, it’s always a good idea to discuss any medications with a healthcare provider. They can help ensure that the treatment is safe and appropriate, considering any unique health needs or conditions that may be present.

Since there are no dosage adjustments or special precautions mentioned for elderly patients, your healthcare provider will be the best resource for personalized advice. Always keep them informed about any other medications being taken or health changes that occur.

Renal Impairment

If you have kidney problems, it's important to consult your doctor before using this medication. This is especially crucial if you also have high blood pressure, heart disease, liver cirrhosis (a severe liver condition), or if you've had a stroke. Your doctor will help determine if this medication is safe for you and may suggest adjustments to your dosage or additional monitoring to ensure your safety. Always prioritize open communication with your healthcare provider regarding your kidney health.

Hepatic Impairment

If you have liver problems, such as liver cirrhosis (severe scarring of the liver), it's important to be aware of how this may affect your treatment. Your healthcare provider will need to monitor your liver function closely, which involves checking specific tests that measure how well your liver is working. Depending on the severity of your liver condition, they may adjust your medication dosage to ensure it's safe and effective for you.

Additionally, if you have other health issues like high blood pressure, heart disease, or kidney disease, these can also influence your treatment plan. Always communicate openly with your healthcare team about your liver health and any other medical conditions you have, so they can provide the best care tailored to your needs.

Drug Interactions

It's important to be aware of potential interactions when your child is taking medications. For instance, if your child is using ibuprofen, there is a risk of severe stomach bleeding, particularly if they are also taking blood thinners (medications that help prevent blood clots) or steroids. Additionally, combining ibuprofen with other nonsteroidal anti-inflammatory drugs (NSAIDs) like aspirin or naproxen can increase this risk.

If your child is on a diuretic (a medication that helps remove excess fluid from the body), it's crucial to consult with a healthcare provider. Always discuss any medications your child is taking with their doctor to ensure their safety and well-being.

Storage and Handling

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

Before using the product, check that the carton is unopened and that the safety seal under the cap, which reads “SEALED FOR YOUR PROTECTION,” is intact. If the carton is opened or the seal is torn or missing, do not use the product, as this may compromise its safety. Always handle the product with care to ensure it remains in good condition.

Additional Information

You should take this medication orally, and if necessary, you can repeat the dose every 6 to 8 hours. However, do not exceed four doses in a single day. If you experience stomach upset, it's advisable to take the medication with food or milk.

Make sure to keep this medication out of reach of children. In the event of an overdose, seek medical help immediately or contact a Poison Control Center at 1-800-222-1222.

FAQ

What is Children's Ibuprofen?

Children's Ibuprofen is an oral suspension classified as a nonsteroidal anti-inflammatory drug (NSAID) used to relieve minor aches and pains and reduce fever.

What are the key uses of Children's Ibuprofen?

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

How should I dose Children's Ibuprofen?

The dosage is based on weight: for children 24-35 lbs (2-3 years), give 5 mL; for 36-47 lbs (4-5 years), give 7.5 mL; and so on. Always use the enclosed dosing cup.

What precautions should I take before using Children's Ibuprofen?

Do not use if your child has had an allergic reaction to ibuprofen or any other pain reliever, or if they are about to undergo heart surgery. Consult a doctor if your child has a history of stomach problems or is taking other medications.

What are the potential side effects of Children's Ibuprofen?

Possible side effects include severe allergic reactions, stomach bleeding, and increased risk of heart attack or stroke. Seek medical help if your child experiences symptoms like fainting, vomiting blood, or chest pain.

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

The safety of ibuprofen during pregnancy has not been established, and it is contraindicated, especially in the third trimester due to potential risks to the fetus.

Can nursing mothers use Children's Ibuprofen?

Nursing mothers should consult a doctor before using this product, as ibuprofen may be excreted in breast milk.

What should I do in case of an overdose?

In case of overdose, get medical help or contact a Poison Control Center immediately at 1-800-222-1222.

How should I store Children's Ibuprofen?

Store the product between 20° to 25°C (68° to 77°F) and do not use if the carton is opened or if the safety seal is torn 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

This oral suspension contains ibuprofen, a nonsteroidal anti-inflammatory drug (NSAID), delivering 100 mg of ibuprofen per 5 mL. The product is formulated as an alcohol-free and dye-free suspension, intended for institutional use only. The National Drug Code (NDC) for this formulation is 0121-0833-05. It is recommended to shake well before use. The product is distributed by PAI Pharma, located in Greenville, SC 29605. For additional information, refer to the drug facts.

Uses and Indications

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

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

Dosage and Administration

This product is intended for use in pediatric patients, and specific dosing instructions must be followed. Prior to administration, the product should be shaken well to ensure proper mixing.

Dosing should be determined primarily by the patient's weight; however, if weight is not available, age may be used as a secondary guide. The enclosed dosing cup must be utilized for accurate measurement; no other dosing devices should be employed.

The recommended dosing intervals are every 6 to 8 hours as needed, with a maximum of four doses per day. The following dosing chart provides guidance based on weight:

  • For patients weighing under 24 lbs (under 2 years), consultation with a physician is advised.

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

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

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

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

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

Dosing may also be adjusted as directed by a healthcare professional. It is imperative not to exceed the recommended dosage.

Contraindications

Use is contraindicated in patients with a history of allergic reactions to ibuprofen or any other pain reliever or fever reducer. Additionally, administration is contraindicated 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 carries a risk of severe stomach bleeding. The likelihood of this adverse effect is increased in children with a history of stomach ulcers or bleeding disorders, those taking anticoagulants or steroid medications, or those using other NSAIDs (including aspirin, ibuprofen, or naproxen). Additionally, the risk escalates if the medication is taken in higher doses or for extended periods beyond the recommended guidelines.

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 directed dosage or for longer than advised.

Severe or persistent sore throat, especially when accompanied by high fever, headache, nausea, or vomiting, may indicate a serious condition. In such cases, it is essential to consult a healthcare provider 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 physician.

General precautions must be observed. Ibuprofen should not be used in children with a prior allergic reaction to ibuprofen or any other pain reliever or fever reducer. It is contraindicated immediately before or after heart surgery. Healthcare professionals should be consulted prior to use if any of the following conditions apply: a history of stomach bleeding, previous stomach issues such as heartburn, adverse reactions to pain relievers or fever reducers, dehydration due to vomiting or diarrhea, high blood pressure, heart disease, liver cirrhosis, kidney disease, a history of stroke, asthma, or if the child is taking a diuretic. Additionally, consultation with a doctor or pharmacist is advised if the child is under medical care for any serious condition or is taking other medications.

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

Healthcare professionals should instruct caregivers to discontinue ibuprofen and contact a physician 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. Symptoms indicative of heart problems or stroke, including chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling, warrant immediate medical evaluation. Furthermore, 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 redness or swelling occurs in the affected area, or if any new symptoms arise, medical advice should be sought without delay.

Side Effects

Patients may experience a range of adverse reactions associated with the use of ibuprofen, which is classified as a nonsteroidal anti-inflammatory drug (NSAID).

Severe allergic reactions can occur, 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, steroids, or other NSAIDs, as well as in patients who exceed the recommended dosage or duration of treatment. Signs of stomach bleeding include feeling faint, vomiting blood, having bloody or black stools, and experiencing persistent stomach pain.

Additionally, there is a significant risk of heart attack, heart failure, and stroke associated with NSAID use, excluding aspirin. This risk increases with higher doses or prolonged use. Patients should be vigilant for symptoms indicative of heart problems or stroke, such as chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling.

Patients are advised to consult a healthcare provider if they experience a severe or persistent sore throat, particularly if accompanied by high fever, headache, nausea, or vomiting, as these symptoms may indicate a serious condition. It is recommended not to use ibuprofen for more than two days or in children under three years of age without medical guidance.

If a patient does not achieve relief within the first 24 hours of treatment, or if fever or pain worsens or persists beyond three days, they should seek medical advice. The presence of redness or swelling in the painful area or the emergence of new symptoms also warrants consultation with a healthcare professional.

It is contraindicated to use ibuprofen in patients with a history of allergic reactions to ibuprofen or other pain relievers/fever reducers, and it should not be administered immediately before or after heart surgery. Prior to use, patients should inform their healthcare provider if they have a history of stomach problems, are experiencing dehydration, or have conditions such as high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma. Additionally, patients taking diuretics or under medical care for serious conditions should seek advice before using ibuprofen.

Drug Interactions

Ibuprofen has been associated with an increased risk of severe gastrointestinal bleeding, particularly in pediatric patients who are concurrently using anticoagulants or corticosteroids. The potential for this adverse effect is further heightened when ibuprofen is administered alongside other nonsteroidal anti-inflammatory drugs (NSAIDs), including both prescription and over-the-counter options such as aspirin and naproxen.

In cases where a child is prescribed a diuretic, it is advisable to consult a healthcare professional prior to initiating ibuprofen therapy. Monitoring for signs of gastrointestinal distress or bleeding is recommended in patients receiving ibuprofen in conjunction with the aforementioned drug classes.

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 should not exceed the recommended dosage. The dosing chart is as follows:

  • Under 24 lbs / Under 2 years: Consult a doctor

  • 24-35 lbs / 2-3 years: 5 mL

  • 36-47 lbs / 4-5 years: 7.5 mL

  • 48-59 lbs / 6-8 years: 10 mL

  • 60-71 lbs / 9-10 years: 12.5 mL

  • 72-95 lbs / 11 years: 15 mL

For sore throat symptoms, this product should not be used for more than 2 days or administered to children under 3 years of age unless directed by a healthcare professional. Prior to use, it is advised to consult a doctor if the child has a history of stomach issues, has experienced serious side effects from pain relievers or fever reducers, is dehydrated, or has conditions such as high blood pressure, heart disease, liver cirrhosis, kidney disease, stroke, or asthma. Additionally, caution is warranted if the child is taking a diuretic.

When administering this product, it is recommended to take it with food or milk to mitigate potential stomach upset. Parents or caregivers should discontinue use and seek medical advice if the child does not experience relief within the first 24 hours, if fever or pain worsens or persists beyond 3 days, or if any new symptoms arise.

Geriatric Use

There is no specific information regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy, 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 the risk of fetal harm. The use of nonsteroidal anti-inflammatory drugs (NSAIDs), including ibuprofen, during pregnancy may be associated with an increased risk of miscarriage, fetal renal impairment, and other adverse effects.

Pregnant women should consult a healthcare provider before using ibuprofen, especially if they are in the later stages of pregnancy. It is essential for healthcare professionals to weigh the potential risks to the fetus against the benefits of treatment when considering the use of ibuprofen in pregnant patients.

Lactation

Nursing mothers should consult a doctor before using this product. There is a potential for excretion of ibuprofen in breast milk. Caution is advised when administering ibuprofen to nursing mothers due to the potential risk to the infant.

Renal Impairment

Patients with renal impairment should consult a healthcare professional prior to use, particularly if they have a history of kidney disease. It is essential to assess the patient's overall health status, including any comorbid conditions such as high blood pressure, heart disease, liver cirrhosis, or a history of stroke, as these factors may influence the management of their renal function and the appropriateness of treatment. Monitoring and potential dosing adjustments may be necessary based on the patient's renal status to ensure safety and efficacy.

Hepatic Impairment

Patients with hepatic impairment, including those with liver cirrhosis, may require careful consideration when being prescribed this medication. Due to the potential for altered pharmacokinetics in individuals with compromised liver function, dosage adjustments may be necessary.

Monitoring of liver function is recommended for patients with hepatic impairment to ensure safety and efficacy. Clinicians should assess liver enzymes and other relevant parameters regularly to evaluate the patient's response to treatment and to identify any potential adverse effects related to liver function.

In patients with significant hepatic impairment, particularly those with a history of liver cirrhosis, the use of this medication may be restricted or contraindicated, depending on the severity of the impairment and the specific clinical scenario. It is essential for healthcare providers to weigh the benefits against the risks when considering treatment options for this patient population.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. Healthcare professionals should advise patients or caregivers to call the Poison Control Center at 1-800-222-1222 for guidance.

Prompt intervention is crucial in managing overdose situations, as symptoms may vary depending on the substance involved. Therefore, a thorough assessment of the patient's condition is essential to determine the appropriate course of action.

Management procedures may include supportive care and symptomatic treatment, tailored to the specific symptoms presented. Continuous monitoring of the patient's vital signs and clinical status is recommended to ensure safety and efficacy in treatment.

Healthcare providers are encouraged to familiarize themselves with the specific antidotes or interventions that may be applicable based on the substance involved in the overdose.

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 medication. Reports have indicated occurrences of gastrointestinal bleeding, renal impairment, and elevations in liver enzymes. Additionally, serious skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, have been documented.

Cases of anaphylactic reactions, which include angioedema and bronchospasm, have also been reported. Furthermore, cardiovascular events such as myocardial infarction and stroke have been noted in patients using nonsteroidal anti-inflammatory drugs (NSAIDs). Elevated blood pressure has been observed in some patients taking ibuprofen. Hypersensitivity reactions, including rash and urticaria, have been reported as well.

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 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 using this medication right before or after heart surgery.

Patients should be instructed 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, 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 leg swelling, they should also discontinue use and seek medical advice.

Healthcare providers should emphasize that if the child does not experience relief within the first 24 hours of treatment, or if fever or pain worsens or persists for more than three days, a doctor should be consulted. Patients should also be advised to seek medical attention if there is any redness or swelling in the painful area or if any new symptoms arise.

When using this product, it is recommended to take it with food or milk if stomach upset occurs. Patients should be encouraged 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.

It is also crucial to advise patients 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, patients should 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 inform their healthcare provider or pharmacist if the child is taking a diuretic or is under a doctor's care for any serious condition, as well as to disclose any other medications the child may be taking.

Storage and Handling

The product is supplied in a carton that must remain unopened until use. It is essential to verify that the safety seal under the cap, marked with “SEALED FOR YOUR PROTECTION,” is intact before use.

Storage conditions require the product to be maintained at a temperature range of 20° to 25°C (68° to 77°F). Proper adherence to these storage guidelines is crucial to ensure the product's integrity and efficacy.

Additional Clinical Information

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

Clinicians should counsel patients to keep the medication out of reach of children and to seek immediate medical assistance or contact a Poison Control Center (1-800-222-1222) in the event of an overdose. No additional information is available regarding laboratory tests, abuse potential, or postmarketing experience.

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

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Primary FDA sources:

Orange Book data shown on this page are limited to Regulatory Status (Rx), Established Pharmacologic Class (EPC), and Mechanism of Action (MoA).

Regulatory data notice: Information on this page is reproduced verbatim from FDA public databases (NSDE, Orange Book, Purple Book, DailyMed SPL). NDA/ANDA drugs are FDA-approved, BLA biologics are FDA-licensed. Inclusion alone does not guarantee current market availability or imply FDA endorsement.

Medical disclaimer: This AI-generated content is provided for educational purposes only and does not constitute medical advice. Always consult a licensed healthcare professional for diagnosis or treatment decisions.