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Childrens Ibuprofen Oral Suspension

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This product has been discontinued

Active ingredient
Ibuprofen 100 mg/5 mL
Other brand names
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 2024
Label revision date
December 10, 2024
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Ibuprofen 100 mg/5 mL
Other brand names
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 2024
Label revision date
December 10, 2024
Manufacturer
McKesson Corporation dba SKY Packaging
Registration number
ANDA210602
NDC root
63739-798
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (2 NDCs)
Packaging & NDC Codes (2)

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Drug Overview

Children's Ibuprofen Oral Suspension, USP is a medication designed for children that delivers 100 mg of ibuprofen in every 5 mL dose. It is classified as a non-steroidal anti-inflammatory drug (NSAID), which means it helps reduce pain, inflammation, and fever. This medication is commonly used to relieve mild to moderate pain, such as headaches, toothaches, or pain from minor injuries, as well as to lower fever.

As an NSAID, ibuprofen works by blocking certain substances in the body that cause inflammation and pain. It's important to use this medication as directed to ensure safety and effectiveness. If you have any questions about its use or effects, be sure to consult with a healthcare professional.

Uses

When using nonsteroidal anti-inflammatory drugs (NSAIDs), it's important to be aware that they can increase your risk of serious heart-related issues, such as heart attack, heart failure, and stroke. These conditions can be life-threatening, and the risk is greater if you take more than the recommended dose or use them for an extended period.

Fortunately, there are no teratogenic effects (which means they do not cause birth defects) or nonteratogenic effects (which refer to other types of harm) associated with these medications. Always follow your healthcare provider's guidance to minimize risks while managing your pain or inflammation effectively.

Dosage and Administration

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

To find the right dose for children, refer to the dosing chart based on their weight. If possible, use their weight for a more accurate dosage; otherwise, you can use their age. For example, children weighing under 24 pounds (under 2 years) should have their dosage determined by a doctor. For those weighing between 24 and 35 pounds (ages 2-3), the dose is 5 mL (milliliters), while children weighing 36-47 pounds (ages 4-5) should take 7.5 mL. The dosage continues to increase with weight, reaching 15 mL for children weighing 72-95 pounds (11 years). If necessary, you can repeat the dose every 6 to 8 hours, but remember not to use it more than four times a day. Always consult with a healthcare professional if you have any questions or concerns.

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, 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 life-threatening, 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. Other concerning signs include chest pain, difficulty breathing, weakness on one side of the body, or slurred speech. Always consult a doctor if your child has a severe sore throat with high fever or if symptoms worsen or persist beyond a few days.

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, be aware that ibuprofen can lead to severe stomach bleeding, particularly if your child has a history of stomach ulcers, is taking blood thinners or steroids, or is using other NSAIDs (nonsteroidal anti-inflammatory drugs) like aspirin or naproxen.

There is also an increased risk of heart attack and stroke associated with NSAIDs, especially if used in higher doses or for longer than recommended. If your child has a severe or persistent sore throat, especially with high fever, headache, nausea, or vomiting, consult a doctor right away. You should not use ibuprofen for more than two days in children under three years old unless directed by a doctor.

If you suspect an overdose, contact a Poison Control Center (1-800-222-1222) or seek emergency medical help immediately. Stop using ibuprofen and call your doctor if your child experiences signs of stomach bleeding (like faintness, vomiting blood, or black stools), symptoms of heart problems or stroke (such as chest pain or slurred speech), or if their condition does not improve within 24 hours. Also, seek medical advice if fever or pain worsens or lasts more than three days, or if any new symptoms arise.

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

The safety of ibuprofen during pregnancy has not been established, and it is particularly contraindicated (not recommended) during the third trimester. Using ibuprofen while pregnant may pose risks to your fetus, including potential cardiovascular effects.

If you are pregnant or planning to become pregnant, it is essential to consult your healthcare provider before using ibuprofen or any medication. They can help you understand the risks and explore safer alternatives for managing pain or inflammation during this important time.

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

This product is safe for children, but there are important guidelines to follow. It should not be used in children under 3 years old unless a doctor specifically advises it. For children aged 2 to 11 years, the dosage depends on their weight and age. For example, a child weighing 24-35 pounds (2-3 years old) should receive 5 mL, while a child weighing 72-95 pounds (11 years old) can take 15 mL. Always consult a doctor for the correct dosage, especially if your child has any health issues like stomach problems, dehydration, or a history of heart or kidney disease.

If your child does not feel better within 24 hours, if their fever or pain worsens or lasts more than 3 days, or if they develop new symptoms, stop using the product and consult a doctor. It's essential to keep a close eye on your child's condition while using this medication.

Geriatric Use

While there is no specific information about the use of this product in older adults, it is primarily intended for children. This means that there are no special dosage adjustments, safety concerns, or precautions outlined for elderly patients.

If you are caring for an older adult, it's always a good idea to consult with a healthcare professional before starting any new medication, even if there are no specific warnings or guidelines for their age group. This ensures that their unique health needs are taken into account.

Renal Impairment

If you have kidney problems, it's important to consult your doctor before using this medication. Your healthcare provider needs to know about any existing conditions, such as high blood pressure, heart disease, liver cirrhosis, or a history of stroke, as these can affect how the medication works for you. Always prioritize open communication with your doctor to ensure your safety and the effectiveness of your treatment.

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 allergic to aspirin, using ibuprofen could lead to a severe allergic reaction. Additionally, if your child is on blood thinners (medications that prevent blood clots) or steroids, the risk of stomach bleeding increases significantly. This risk is also heightened if they are taking other nonsteroidal anti-inflammatory drugs (NSAIDs), such as aspirin or naproxen.

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

Storage and Handling

To ensure the best performance of your product, store it in a cool, dry place at a temperature between 20º to 25ºC (68º to 77ºF). This temperature range helps maintain the product's effectiveness and safety.

When handling the product, be sure to do so with clean hands and in a clean environment to avoid contamination. Always follow any specific disposal instructions provided to ensure safe and responsible disposal.

Additional Information

You should take this medication orally. It's important to keep it out of the reach of children to prevent accidental ingestion. If you suspect an overdose, seek medical help immediately or contact a Poison Control Center at 1-800-222-1222 for assistance.

FAQ

What is Children's Ibuprofen Oral Suspension?

Children's Ibuprofen Oral Suspension is an NSAID (Non-Steroidal Anti-Inflammatory Drug) that delivers 100 mg of ibuprofen per 5 mL.

What should I do if my child has a history of allergic reactions to pain relievers?

Do not use this product if your child has ever had an allergic reaction to ibuprofen or any other pain reliever/fever reducer.

How should I dose Children's Ibuprofen?

Use the dosing chart based on your child's weight. For example, a child weighing 24-35 lbs (2-3 years) should receive 5 mL.

What are the risks associated with using ibuprofen?

Using ibuprofen can increase the risk of heart attack, heart failure, and stroke, especially if used more than directed or for longer than directed.

What should I do if my child experiences stomach bleeding?

Stop use and seek medical help immediately if your child experiences symptoms like faintness, vomiting blood, or bloody stools.

Can I give ibuprofen to my child if they are under 3 years old?

Do not use this product in children under 3 years of age unless directed by a doctor.

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 symptoms worsen or last more than 3 days, consult a doctor.

Is it safe to use ibuprofen during pregnancy?

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

What should I do in case of an overdose?

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

How should I store Children's Ibuprofen Oral Suspension?

Store the product between 20º to 25ºC (68º to 77ºF) and keep it out of the reach of children.

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

Children's Ibuprofen Oral Suspension, USP is a nonsteroidal anti-inflammatory drug (NSAID) formulated for pediatric use. Each 5 mL of the suspension contains 100 mg of ibuprofen. The product is identified by the National Drug Code (NDC) 63739-798-01.

Uses and Indications

This drug is indicated for the management of pain and inflammation. It is important to note that the use of nonsteroidal anti-inflammatory drugs (NSAIDs), with the exception of aspirin, is associated with an increased risk of serious cardiovascular events, including heart attack, heart failure, and stroke, which can be fatal. The risk of these adverse effects is heightened when the drug is used in higher doses or for extended periods beyond the recommended duration.

Limitations of Use: There are no teratogenic or nonteratogenic effects associated with this drug. However, healthcare professionals should remain vigilant regarding the cardiovascular risks associated with NSAID use and counsel patients accordingly.

Dosage and Administration

This product is intended for use in pediatric patients, and healthcare professionals should refer to the dosing chart to determine the appropriate dosage based on the patient's weight or age. Prior to administration, the product must be shaken well to ensure proper mixing.

For patients weighing under 24 lbs (under 2 years), it is recommended to consult a physician for appropriate dosing guidance. For patients weighing between 24-35 lbs (2-3 years), the recommended dose is 5 mL. For those weighing 36-47 lbs (4-5 years), the dose increases to 7.5 mL. Patients weighing 48-59 lbs (6-8 years) should receive 10 mL, while those weighing 60-71 lbs (9-10 years) should be administered 12.5 mL. Finally, for patients weighing 72-95 lbs (11 years), the recommended dose is 15 mL.

Dosing may be repeated every 6 to 8 hours as needed, but it is imperative not to exceed four doses in a 24-hour period. Healthcare professionals should ensure that patients do not receive more than the directed amount. If there are any uncertainties regarding dosing, consultation with a physician is advised.

Contraindications

Use is contraindicated in patients with a history of allergic reactions to ibuprofen or any other pain reliever or fever reducer. Additionally, administration is contraindicated in the perioperative period surrounding heart surgery due to potential complications.

Warnings and Precautions

Ibuprofen may cause severe allergic reactions, particularly in individuals with a known allergy to aspirin. Symptoms 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.

In cases of severe or persistent sore throat, especially when accompanied by high fever, headache, nausea, or vomiting, immediate medical consultation is advised. Ibuprofen should not be used for more than two days or administered to children under three years of age unless directed by a physician.

In the event of an overdose, it is crucial to seek emergency medical help or contact a Poison Control Center at 1-800-222-1222 without delay.

Healthcare providers should instruct caregivers to discontinue use and consult 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. 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 or unusual symptoms that arise during treatment should also prompt consultation with a healthcare professional.

Side Effects

Patients using ibuprofen may experience a range of adverse reactions, which can vary in severity.

Severe allergic reactions have been reported, particularly in individuals with a known allergy to aspirin. Symptoms of such reactions may include hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, and blisters.

The use of ibuprofen, as a nonsteroidal anti-inflammatory drug (NSAID), carries a warning for the potential risk of severe stomach bleeding. This risk is heightened in patients with a history of stomach ulcers or bleeding problems, those taking anticoagulants or steroid medications, and individuals using other NSAIDs, including aspirin and naproxen. Additionally, the risk increases if the medication is taken in higher doses or for extended periods beyond the recommended duration.

There is also a significant warning regarding the increased risk of heart attack, heart failure, and stroke associated with NSAID use, excluding aspirin. These cardiovascular events can be fatal, particularly when the medication is used in excess of the recommended dosage or for longer than directed.

Patients should 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 attention. It is advised not to use ibuprofen for more than two days or in children under three years of age without a doctor's guidance.

Parents should discontinue use and consult a healthcare professional if their child exhibits 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 evaluation. Furthermore, if the child does not achieve relief within the first 24 hours of treatment, or if fever or pain worsens or persists beyond three days, medical advice should be sought. Redness or swelling in the painful area or the emergence of any new symptoms should also prompt consultation with a healthcare provider.

It is crucial to avoid the use of ibuprofen in children 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, consultation with a healthcare professional is recommended if the child has a history of stomach issues, has experienced serious side effects from pain relievers, is dehydrated, or has underlying conditions such as high blood pressure, heart disease, liver cirrhosis, kidney disease, or a history of stroke. Additionally, children with asthma or those taking diuretics should seek medical advice before using ibuprofen. Parents should also consult a doctor or pharmacist if their child is under medical care for any serious condition or is taking other medications.

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 to a child who is currently prescribed a diuretic, as this may necessitate careful monitoring or dosage adjustments.

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

This product is intended for use in pediatric patients. It is contraindicated in children under 3 years of age unless directed by a healthcare professional.

Dosing recommendations are 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

Doses may be adjusted as directed by a healthcare professional.

Healthcare providers should consult a doctor if the pediatric patient has a history of gastrointestinal issues, is not adequately hydrated, has experienced significant fluid loss due to vomiting or diarrhea, or has pre-existing conditions such as high blood pressure, heart disease, liver cirrhosis, kidney disease, or a history of stroke.

If the child does not experience relief within the first 24 hours of treatment, if fever or pain worsens or persists beyond 3 days, or if any new symptoms arise, the healthcare provider should be contacted immediately.

Geriatric Use

Elderly patients may not have specific considerations outlined for the use of this product, as the prescribing information does not provide data regarding geriatric use. The product is primarily intended for use in children, and there are no age-related dosage adjustments, safety concerns, or special precautions indicated for geriatric patients.

Healthcare providers should exercise clinical judgment when prescribing this product to elderly patients, considering the absence of specific data and the unique health profiles often present in this population. Monitoring for any potential adverse effects or interactions is advisable, given the lack of targeted information for elderly individuals.

Pregnancy

The safety of ibuprofen during pregnancy has not been established. Ibuprofen is contraindicated in pregnancy, particularly during the third trimester, due to potential risks to the fetus. The use of ibuprofen during this period may pose risks, including potential cardiovascular effects on the developing fetus.

Pregnant women are advised to consult a healthcare provider before using ibuprofen to discuss potential risks and alternative treatment options.

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

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, such as 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 these patients.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance. Healthcare professionals are advised to contact a Poison Control Center at 1-800-222-1222 for guidance on managing the situation effectively.

Prompt intervention is crucial, as the symptoms of an overdose can vary significantly depending on the substance involved. Therefore, a thorough assessment and appropriate management strategies should be implemented as soon as possible to mitigate potential risks to the patient’s health.

Nonclinical Toxicology

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

Postmarketing Experience

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

The data also indicate an increased risk of heart attack, heart failure, and stroke associated with NSAID use. Serious side effects have been reported, including symptoms indicative of heart problems or stroke, such as chest pain, difficulty breathing, unilateral weakness, slurred speech, and leg swelling. Furthermore, cases of overdose have been documented, which require immediate medical attention or contact with a Poison Control Center.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222 in the event of an overdose. It is recommended that the medication be taken with food or milk if the patient experiences stomach upset.

Providers should encourage patients to consult a doctor before use if any of the following conditions apply to the child: a warning for stomach bleeding, a history of stomach problems such as heartburn, previous serious side effects from pain relievers or fever reducers, insufficient fluid intake, significant fluid loss due to vomiting or diarrhea, high blood pressure, heart disease, liver cirrhosis, kidney disease, a history of stroke, or asthma. Additionally, patients should be advised to inform their healthcare provider if the child is taking a diuretic.

Patients should also be instructed to consult a doctor or pharmacist before use if the child is under medical care for any serious condition or is taking any other medications.

Healthcare providers should inform patients to discontinue use and seek medical advice if the child exhibits any signs of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain. Symptoms indicating potential heart problems or stroke, including chest pain, difficulty breathing, weakness on one side of the body, slurred speech, or leg swelling, should also prompt immediate medical consultation.

Patients should be advised to seek medical attention 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.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at a controlled temperature range of 20º to 25ºC (68º to 77ºF) to maintain its efficacy and stability. Proper storage conditions must be adhered to, ensuring that the product is kept within the specified temperature limits to prevent degradation.

Additional Clinical Information

The medication is administered orally. Clinicians should advise patients to keep the medication out of the reach of children. In the event of an overdose, patients are instructed to seek medical assistance or contact a Poison Control Center immediately at 1-800-222-1222. No further information is available regarding laboratory tests, abuse potential, or postmarketing experiences.

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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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.