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Childrens Ibuprofen

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Active ingredient
Ibuprofen 100 mg/5 mL
Other brand names
Drug class
Nonsteroidal Anti-inflammatory Drug
Dosage form
Suspension
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2014
Label revision date
January 29, 2025
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 2014
Label revision date
January 29, 2025
Manufacturer
Padagis Israel Pharmaceuticals Ltd
Registration number
ANDA074937
NDC root
45802-133
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 Oral Suspension is a medication that contains ibuprofen, which is a type of pain reliever and fever reducer known as a nonsteroidal anti-inflammatory drug (NSAID). It is specifically formulated for children aged 2 to 11 years and is designed to help relieve minor aches and pains associated with common conditions like the cold, flu, sore throat, headache, and toothache. Additionally, it effectively reduces fever and provides relief that can last up to 8 hours.

This oral suspension comes in a grape flavor and is alcohol-free and gluten-free, making it a suitable option for many children. Each 5 mL dose contains 100 mg of ibuprofen, allowing for easy measurement and administration.

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, make sure to shake the bottle well. It's important to follow the dosing chart to find the right amount for you or your child. If possible, use weight to determine the dose; if not, you can use age. Always use the enclosed dosing cup to measure the liquid, as other devices may not provide accurate measurements.

For most cases, you can repeat the dose every 6 to 8 hours, but do not exceed four doses in a single day. After each use, wash the dosing cup to keep it clean. Finally, remember to replace the original bottle cap to keep it child-resistant and safe. If your child weighs less than 24 pounds or is under 2 years old, please consult a doctor for the appropriate dose.

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

Side Effects

Ibuprofen can cause serious allergic reactions, particularly in individuals who are allergic to aspirin. Signs of an allergic reaction may include hives, facial swelling, 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 faintness, vomiting blood, black or bloody stools, chest pain, difficulty breathing, or weakness on one side of the body, seek medical attention immediately. It's important to consult a doctor before using ibuprofen if your child has any history of stomach issues, dehydration, or other serious health conditions.

Warnings and Precautions

Ibuprofen can cause serious allergic reactions, especially if you are allergic to aspirin. Symptoms may include hives, facial swelling, wheezing, shock, skin reddening, rash, or blisters. If you experience any of these symptoms, stop using the medication and seek medical help immediately.

This medication can also lead to severe stomach bleeding, particularly if you have a history of stomach ulcers or bleeding problems, are taking blood thinners or steroids, or are using other NSAIDs (nonsteroidal anti-inflammatory drugs) like aspirin or naproxen. Additionally, using ibuprofen for longer than directed increases the risk of heart attack and stroke, which can be fatal. If you notice signs of stomach bleeding, such as feeling faint, vomiting blood, or having black stools, or if you experience chest pain, trouble breathing, or weakness, stop using ibuprofen and contact your doctor right away.

For children, do not use ibuprofen for more than two days without consulting a doctor, especially if they have a severe sore throat with high fever, headache, nausea, or vomiting. If your child does not feel better within 24 hours, or if their fever or pain worsens or lasts more than three days, seek medical advice. In case of an overdose, get emergency medical help or contact a Poison Control Center immediately at 1-800-222-1222.

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 safety is the top priority.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that the safety of ibuprofen has not been established. In fact, ibuprofen is not recommended during pregnancy, especially in the third trimester, as it may pose risks to your developing baby, including potential cardiovascular effects.

Before considering the use of ibuprofen, you should always consult your healthcare provider. They can help determine if it's appropriate for you and may suggest dosage adjustments based on your stage of pregnancy and individual health needs. Your health and the health of your baby are the top priority, so make sure to seek professional guidance.

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 avoid giving 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 and age. Here’s a quick guide:

  • For children under 24 lbs (under 2 years), consult a doctor.

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

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

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

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

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

Always follow your doctor’s instructions regarding dosage, as they may adjust it based on your child's specific needs.

Geriatric Use

When it comes to using Children's Ibuprofen for older adults, there is no specific information available regarding dosage adjustments or safety concerns. This means that the drug insert does not provide special precautions for elderly patients. If you or a caregiver are considering this medication, it's important to consult with a healthcare professional to ensure it is appropriate for your individual health needs. Always prioritize safety and seek guidance tailored to older adults' unique considerations.

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 healthcare provider can help determine if this medication is safe for you and may suggest necessary adjustments to your dosage or monitoring based on your kidney function. Always prioritize your health and communicate openly with your doctor about your medical history.

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 may need to adjust your medication dosage or monitor your liver function closely. This is to ensure that the medication is safe and effective for you, considering your liver's ability to process it.

Additionally, if you have other health issues like high blood pressure, heart disease, or kidney disease, these conditions 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 how ibuprofen can interact with other medications you may be taking. For instance, if you use ibuprofen alongside blood thinners (medications that help prevent blood clots) or steroids, you could face a higher risk of stomach bleeding. Additionally, using ibuprofen, especially in higher doses or for extended periods, may increase your chances of serious heart issues, such as heart attack or stroke. You should also be cautious if you're taking other nonsteroidal anti-inflammatory drugs (NSAIDs), like aspirin or naproxen, as combining these can elevate risks.

Always discuss your current medications and any potential interactions with your healthcare provider. They can help ensure that your treatment plan is safe and effective, taking into account all the medications you are using.

Storage and Handling

To ensure the safety and effectiveness of your product, store it at a temperature between 20-25°C (68-77°F). It's important to keep it away from freezing temperatures, as freezing can damage the product. Before use, check the printed neckband; do not use the product if it is broken or missing, as this could compromise its safety.

By following these simple storage and handling guidelines, you can help maintain the quality and reliability of your product.

Additional Information

You should take this medication orally and follow some important safety guidelines. Always keep it out of reach of children. If you suspect an overdose, seek medical help immediately or contact a Poison Control Center at 1-800-222-1222. To avoid stomach upset, consider taking it with food or milk. Remember to shake the bottle well before use and only use the enclosed dosing cup for measuring your dose—other devices may not be safe. You can repeat the dose every 6-8 hours if needed, but do not exceed four doses in a day. After each use, wash the dosing cup and make sure to replace the original bottle cap to keep it child-resistant.

FAQ

What is the active ingredient in Children's Ibuprofen Oral Suspension?

The active ingredient is ibuprofen.

What age group is Children's Ibuprofen Oral Suspension indicated for?

It is indicated for children ages 2 to 11 years.

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

The effects can last up to 8 hours.

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

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 enclosed dosing cup and find the right dose based on your child's weight or age. Do not exceed 4 doses in a day.

What are the potential side effects of ibuprofen?

Possible side effects include severe allergic reactions, stomach bleeding, and increased risk of heart attack or stroke.

Can I give Children's Ibuprofen with food?

Yes, it is recommended to give it with food or milk if stomach upset occurs.

Is Children's Ibuprofen safe to use during pregnancy?

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

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

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

How should I store Children's Ibuprofen?

Store it at 20-25°C (68-77°F) and do not freeze.

Packaging Info

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

Packaging configurations for Childrens Ibuprofen.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Children’s Ibuprofen Oral Suspension contains 100 mg of ibuprofen per 5 mL and is formulated as a nonsteroidal anti-inflammatory drug (NSAID) for the relief of pain and reduction of fever. This product is indicated for use in children aged 2 to 11 years. The suspension provides effects that last up to 8 hours and is presented in a grape flavor. It is alcohol-free and gluten-free, ensuring suitability for a wider range of dietary needs. The product is packaged in a 4 FL OZ (118 mL) bottle and is marketed under the brand Padagis®.

Uses and Indications

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

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

Dosage and Administration

This product is intended for use in pediatric patients, and healthcare professionals should refer to the dosing chart to determine the appropriate dose based on the patient's weight or age. It is essential to shake the product well before each use. The enclosed dosing cup must be used for accurate measurement; no other dosing devices should be utilized.

For patients weighing under 24 lbs or under 2 years of age, it is advised to consult a doctor for the appropriate dose. For patients weighing 24-35 lbs (2-3 years), the recommended dose is 5 mL. For those weighing 36-47 lbs (4-5 years), the dose is 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. For patients weighing 72-95 lbs (11 years), the dose is 15 mL.

If necessary, doses may be repeated every 6-8 hours, but it is crucial not to exceed 4 doses in a 24-hour period. After each use, the dosing cup should be washed thoroughly. To maintain child resistance, the original bottle cap should be replaced securely after each use. It is imperative to adhere strictly to the dosing recommendations and not exceed the directed amounts.

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 induce severe allergic reactions, particularly in individuals with a known allergy to aspirin. Symptoms indicative of an allergic response may include hives, facial swelling, wheezing, shock, skin reddening, rash, and blisters. Should any signs of an allergic reaction manifest, 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 such an event is heightened in pediatric patients with a history of stomach ulcers or bleeding disorders, those concurrently using anticoagulants or steroid medications, or those taking other NSAIDs, whether prescription or over-the-counter (e.g., aspirin, ibuprofen, naproxen). Additionally, exceeding the recommended dosage or duration of treatment increases this risk.

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

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

Healthcare providers should advise 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 symptoms that arise should also prompt consultation with a healthcare professional.

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

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 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 to administer it to children under three years of age without a doctor's guidance.

Patients are instructed to discontinue use and consult a healthcare professional if they experience 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 consultation. Furthermore, if there is no 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 a consultation.

Before using ibuprofen, it is essential for patients to consult a healthcare provider if they have a history of stomach issues, are experiencing dehydration, or have conditions such as high blood pressure, heart disease, liver cirrhosis, kidney disease, or a history of stroke. Additionally, patients with asthma or those taking diuretics should seek medical advice prior to use. It is also recommended that patients under a doctor's care for any serious condition or those taking other medications consult with a healthcare professional or pharmacist before using ibuprofen.

Drug Interactions

Ibuprofen has several notable drug interactions that warrant careful consideration.

Pharmacodynamic Interactions:

Ibuprofen may increase the risk of gastrointestinal bleeding when used concurrently with anticoagulants or steroid medications. Clinicians should monitor patients closely for signs of gastrointestinal distress and consider alternative pain management strategies if necessary.

Additionally, the use of ibuprofen, as with other nonsteroidal anti-inflammatory drugs (NSAIDs), may elevate the risk of cardiovascular events, including heart attack, heart failure, and stroke. This risk is particularly pronounced with higher doses or prolonged use. It is advisable to evaluate the necessity of ibuprofen therapy in patients with existing cardiovascular conditions and to use the lowest effective dose for the shortest duration possible.

Caution is also recommended when ibuprofen is administered alongside other NSAIDs, whether prescription or over-the-counter, such as aspirin or naproxen. The combined use of these agents may exacerbate the risk of adverse effects, and healthcare providers should consider dose adjustments or alternative therapies to mitigate this risk.

Drug & Laboratory Test Interactions:

No specific laboratory test interactions have been identified in the available data. However, ongoing monitoring of patient responses to therapy is recommended to ensure safety and efficacy.

Packaging & NDC

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

Packaging configurations for Childrens Ibuprofen.
Details

Pediatric Use

Pediatric patients under 3 years of age should not use this medication unless directed by a healthcare professional. For children aged 2 to 11 years, dosing is based on weight and age, as outlined in the following chart:

  • 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

Dosing may also be adjusted as directed by a healthcare professional. Care should be taken to adhere to these guidelines to ensure safety and efficacy in pediatric patients.

Geriatric Use

Elderly patients may not have specific information regarding the use of Children's Ibuprofen, including dosage adjustments, safety concerns, or special precautions. As such, 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, 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, including cardiovascular effects. Pregnant women should consult a healthcare provider before using ibuprofen to discuss potential risks and benefits. Additionally, dosage adjustments may be necessary based on the stage of pregnancy and individual health considerations.

Lactation

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

Renal Impairment

Patients with renal impairment 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 may experience altered pharmacokinetics of the medication. It is essential to assess liver function prior to initiating treatment and to monitor liver parameters throughout the course of therapy.

In patients with liver cirrhosis, dosage adjustments may be necessary to mitigate the risk of adverse effects due to impaired drug metabolism. Close monitoring of liver function tests is recommended to ensure safety and efficacy.

Additionally, patients with a history of significant liver disease, such as cirrhosis, should be evaluated for potential contraindications related to their hepatic condition. Careful consideration should be given to the overall health status of these patients, particularly if they also present with comorbidities such as high blood pressure, heart disease, or kidney disease.

It is advised that healthcare providers remain vigilant in monitoring these patients for any signs of hepatic decompensation or other complications that may arise during treatment.

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 timely medical support can significantly influence outcomes. Symptoms of overdose may vary depending on the substance involved and the individual’s health status. Therefore, a thorough assessment and monitoring of the patient are essential.

Management procedures may include supportive care, symptomatic treatment, and specific antidotes if applicable. Healthcare providers should remain vigilant and prepared to implement appropriate interventions based on the clinical presentation of the patient.

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 hives, facial swelling, asthma characterized by wheezing, shock, skin reddening, rash, and blisters.

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 crucial to inform patients 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, patients should be cautioned against using this medication right before or after heart surgery.

Patients should be instructed to discontinue use and consult a doctor if the child exhibits any signs of stomach bleeding, which may include feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain. Furthermore, they should be made aware to stop use and seek medical advice if the child shows symptoms indicative of heart problems or stroke, such as chest pain, difficulty breathing, weakness on one side of the body, slurred speech, or swelling in the legs.

It is important for healthcare providers to inform patients that if the child does not experience relief within the first 24 hours of treatment, they should stop use and consult a doctor. Patients should also be advised to seek medical attention 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 administering this product, healthcare providers should recommend giving it with food or milk to mitigate potential stomach upset. 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.

Additionally, healthcare providers should advise patients to seek medical guidance if the child has experienced serious side effects from pain relievers or fever reducers, has not been adequately hydrated, or has lost significant fluids due to vomiting or diarrhea. It is also essential 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.

Lastly, patients should be reminded to discuss with their healthcare provider or pharmacist if the child is taking a diuretic, is under care for any serious condition, or is currently taking any other medications.

Storage and Handling

The product is supplied in a configuration that includes specific NDC numbers, which should be referenced for accurate identification. It is essential to store the product at a temperature range of 20-25°C (68-77°F) to maintain its integrity and efficacy.

Freezing the product is strictly prohibited, as it may compromise its quality. Additionally, healthcare professionals should ensure that the product is not used if the printed neckband is broken or missing, as this may indicate tampering or compromise of the product's safety. Proper handling and adherence to these storage conditions are crucial for optimal product performance.

Additional Clinical Information

Patients should be informed that the medication is administered orally. It is essential to keep the product out of reach of children. In the event of an overdose, medical assistance should be sought immediately, or the Poison Control Center can be contacted at 1-800-222-1222. To minimize stomach upset, the medication may be taken with food or milk.

Clinicians should advise patients to shake the bottle well before use and to utilize only the enclosed dosing cup, avoiding any other dosing devices. If necessary, doses may be repeated every 6-8 hours, but should not exceed four doses in a 24-hour period. Patients should also be instructed to replace the original bottle cap to ensure child resistance and to wash the dosing cup after each use.

Drug Information (PDF)

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

View product document (PDF)

Data Generation & Sources

This page was automatically generated and is maintained by the AllDrugs AI Data-Science Team. It was built from the FDA Structured Product Label (DailyMed) for Childrens Ibuprofen, retrieved by a validated AI data-extraction workflow.

All FDA-listed dosage forms and strengths are shown in the Packaging & NDC Codes section above. Regulatory status appears in the Summary Information panel above and was verified in the FDA National Drug Code directory and the NSDE NDC Directory daily file.

Note: an automated daemon monitors NSDE checksums; when the record for this NDC changes, the new file is pulled instantly and this page is refreshed.

No human clinician has reviewed this version.

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.