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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 2017
Label revision date
July 11, 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 2017
Label revision date
July 11, 2025
Manufacturer
Kroger Company
Registration number
ANDA209207
NDC root
30142-965
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

Kroger® is a medication designed to help relieve minor aches and pains associated with common conditions such as the cold, flu, sore throat, headache, and toothache. It also works to reduce fever, making it a useful option when you're feeling unwell. This product is available in a 120 mL bottle and has been effective since February 1, 2023.

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 is also effective in reducing fever, making it a helpful option when you're feeling unwell.

Rest assured, this medication does not have any teratogenic effects, meaning it does not cause developmental issues in a fetus if taken during pregnancy.

Dosage and Administration

Before you use this medication, make sure to shake the bottle well. It's important to use only the enclosed dosing cup to measure your dose; avoid using any other devices to ensure accuracy. To find the right dose, refer to the dosing chart provided. If possible, base the dose on your child's weight; if you don't have that information, you can use their age instead.

For children weighing under 24 pounds (under 2 years), it's best to consult a doctor before administering any dose. If your child weighs between 24 and 35 pounds (ages 2-3), the dose is 5 mL. For those weighing 36 to 47 pounds (ages 4-5), the dose increases to 7.5 mL, and for children weighing 48 to 59 pounds (ages 6-8), the dose is 10 mL. If your child weighs between 60 and 71 pounds (ages 9-10), the dose is 12.5 mL, and for those weighing 72 to 95 pounds (11 years), the dose is 15 mL. If needed, you can repeat the dose every 6 to 8 hours, but remember not to exceed 4 doses in a single day.

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. Symptoms of a severe allergic reaction may include hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, and 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 severe or persistent sore throat, high fever, or symptoms of stomach bleeding (such as faintness, vomiting blood, or black stools), or shows signs of heart problems or stroke (like chest pain or weakness on one side of the body), seek medical attention immediately. Always consult a doctor if your child has a history of stomach issues, is dehydrated, or has other serious health conditions before using ibuprofen.

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 a doctor's guidance, especially if they are under three years old. If symptoms do not improve within 24 hours, or if fever or pain worsens or lasts more than three days, consult a doctor. In case of an overdose, seek 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 health and safety are the top priority.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that the safety of ibuprofen during pregnancy has not been established. In fact, ibuprofen is not recommended, especially during the third trimester, as it may pose risks to your developing baby. Using nonsteroidal anti-inflammatory drugs (NSAIDs) like ibuprofen during pregnancy could potentially lead to cardiovascular issues and kidney problems for the fetus.

Before taking any medication, including ibuprofen, you should consult your healthcare provider to discuss your options and ensure the safety of both you and your baby.

Lactation Use

If you are breastfeeding, you can feel reassured that there are no specific warnings or recommendations regarding the use of ibuprofen while nursing. The information available does not indicate any concerns about ibuprofen being passed into breast milk or any associated risks for your infant.

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

Pediatric Use

When considering this medication for your child, it's important to note that it should not be used in children under 2 years of age unless specifically directed by a doctor. For children aged 2 to 11 years, the dosage varies based on their weight. For example, if your child weighs between 24-35 pounds (ages 2-3), the recommended dose is 5 mL, while a child weighing 72-95 pounds (11 years) should take 15 mL. Always consult your doctor if your child has a history of stomach issues, is on other medications, or has conditions like high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma.

It's crucial to follow the dosing guidelines carefully and not exceed 4 doses in a day. If your child's symptoms do not improve within 24 hours, or if they experience a fever or pain that worsens or lasts more than 3 days, seek medical advice. Additionally, if your child has a severe or persistent sore throat, especially if accompanied by high fever, headache, nausea, or vomiting, contact a doctor immediately.

Geriatric Use

While the drug insert for Children's Ibuprofen does not provide specific information about its use in older adults, it primarily focuses on children. This means there are no recommended age considerations, dosage adjustments, or safety concerns specifically outlined for elderly patients.

If you are caring for an older adult, it's important to consult with a healthcare professional before administering any medication, including Children's Ibuprofen, to ensure it is appropriate and safe for their individual health needs.

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 whether any adjustments are needed based on your kidney health. Always prioritize open communication with your doctor regarding your medical history and current health conditions.

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 closely monitor your liver function tests (tests that check how well your liver is working) to ensure your safety and the effectiveness of your treatment.

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

Drug Interactions

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

Before giving ibuprofen to your child, make sure to consult with a healthcare provider, especially if they are on a diuretic (a medication that helps remove excess fluid from the body) or any other medications. Always check with a doctor or pharmacist to ensure that it’s safe to use ibuprofen alongside any other drugs your child may be taking. This helps protect their health and avoid potential complications.

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 range is considered a controlled room temperature, which helps maintain the product's quality. Always check the carton before use; do not use the product if the carton is opened or if the bottle wrap marked "SEALED FOR SAFETY" is broken or missing.

Additionally, make sure to look at the bottom panel of the carton for the lot number and expiration date, as this information is crucial for tracking the product's safety and effectiveness. Proper handling and storage are key to ensuring you get the best results from your product.

Additional Information

You should take this medication orally, and if necessary, you can repeat the dose every 6 to 8 hours, but do not exceed four doses in a day. If you experience stomach upset, taking it with food or milk may help. It's important to monitor for any signs of stomach bleeding or symptoms related to heart problems or stroke in children. If these occur, stop using the medication and consult a doctor immediately.

Always keep this medication out of reach of children. In the event of an overdose, seek medical assistance or contact a Poison Control Center right away.

FAQ

What is Kroger® used for?

Kroger® 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 Kroger®?

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

What should I do if my child has a severe sore throat?

Consult a doctor if your child has a severe or persistent sore throat, especially if accompanied by high fever, headache, nausea, or vomiting.

Are there any contraindications for using Kroger®?

Do not use Kroger® if your child has had an allergic reaction to ibuprofen or any other pain reliever/fever reducer, or if they are recovering from heart surgery.

What are the potential side effects of Kroger®?

Possible side effects include severe allergic reactions, stomach bleeding, and increased risk of heart attack or stroke. Seek medical help if your child experiences any severe symptoms.

Is Kroger® safe to use during pregnancy?

Safety during pregnancy has not been established, and ibuprofen is contraindicated during the third trimester due to potential risks to the fetus.

How should Kroger® be stored?

Store Kroger® at 20° to 25°C (68° to 77°F) and do not use if the carton is opened or if the safety seal is broken.

What should I do in case of an overdose?

In case of overdose, get medical help or contact a Poison Control Center immediately.

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

Kroger® is identified by the National Drug Code (NDC) 30142-965-08. This product is formulated for professional use and adheres to the specifications outlined in its labeling. Further details regarding its composition, dosage form, and other characteristics are available in the complete product documentation.

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

Healthcare professionals should instruct patients to shake the medication well before use. The enclosed dosing cup must be utilized for accurate measurement; no other dosing devices should be employed.

To determine the appropriate dose, practitioners should refer to the dosing chart. Whenever possible, dosing should be based on the patient's weight; if weight is not available, age may be used as a secondary reference. The following dosing recommendations apply:

  • 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.

If necessary, doses may be repeated every 6 to 8 hours, but it is imperative not to exceed four doses in a 24-hour period.

Contraindications

Use is contraindicated in patients with a history of allergic reactions to ibuprofen or any other pain reliever or fever reducer. Additionally, administration is contraindicated immediately before or after heart surgery due to potential complications associated with surgical recovery.

Warnings and Precautions

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

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

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

Healthcare professionals should be vigilant for signs of severe or persistent sore throat, especially when accompanied by high fever, headache, nausea, or vomiting, as these symptoms may indicate a serious condition. Consultation with a physician is advised if symptoms persist beyond two days or if the patient is under three years of age unless otherwise directed by a healthcare provider.

It is crucial to advise caregivers to discontinue use and consult a physician if the child exhibits any of the following signs of stomach bleeding: feeling faint, vomiting blood, passing bloody or black stools, or experiencing persistent stomach pain. Additionally, symptoms suggestive of heart problems or stroke, such as 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, medical advice should be sought. Redness or swelling in the affected area or the emergence of new symptoms also necessitates consultation with a healthcare professional.

In cases of overdose, immediate medical attention is required. Caregivers should contact a Poison Control Center or seek emergency medical help without delay (1-800-222-1222).

Side Effects

Patients using ibuprofen should be aware of the potential for serious adverse reactions, particularly those related to allergic responses, gastrointestinal complications, and cardiovascular events.

Severe allergic reactions may occur, especially 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.

The use of ibuprofen, as a nonsteroidal anti-inflammatory drug (NSAID), carries a significant 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. Patients are advised to adhere strictly to dosing instructions, as exceeding the recommended dosage or duration of use increases the likelihood of gastrointestinal complications.

Additionally, 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 in patients who use the medication beyond the recommended duration or dosage.

Patients should seek immediate medical attention if they experience severe or persistent sore throat, especially when accompanied by high fever, headache, nausea, or vomiting. It is recommended that ibuprofen not be used for more than two days in such cases or in children under three years of age unless directed by a healthcare provider.

Parents and caregivers should discontinue use and consult a physician 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.

It is crucial to consult a healthcare professional before administering ibuprofen if the child has a history of stomach issues, is dehydrated, has high blood pressure, heart disease, liver cirrhosis, kidney disease, or has experienced a stroke. Additionally, caution is advised for children with asthma or those taking diuretics. Parents should also inform their healthcare provider if the child is under medical care for any serious condition or is taking other medications.

Drug Interactions

Ibuprofen is associated with several significant drug interactions that warrant careful consideration.

Allergic Reactions Ibuprofen may induce severe allergic reactions, particularly in individuals with a known allergy to aspirin. It is essential to assess the patient's allergy history before administration.

Gastrointestinal Risks The concomitant use of ibuprofen with anticoagulants or steroid medications increases the risk of gastrointestinal bleeding. This risk is also heightened when ibuprofen is taken alongside other nonsteroidal anti-inflammatory drugs (NSAIDs), including aspirin and naproxen. Clinicians should monitor patients closely for signs of gastrointestinal distress and consider alternative pain management strategies if necessary.

Diuretics Patients taking diuretics should consult a healthcare provider prior to using ibuprofen. The interaction may necessitate dosage adjustments or increased monitoring of renal function and electrolyte levels.

General Recommendations It is advisable for patients to seek guidance from a healthcare professional or pharmacist before using ibuprofen in conjunction with any other medications. This precaution helps to mitigate potential interactions and ensures safe therapeutic outcomes.

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 2 years of age should not use this medication unless directed by a healthcare professional. For dosing, the following guidelines apply:

  • For children weighing under 24 lbs, consultation with a doctor is required.

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

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

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

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

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

It is important to consult a doctor if the child has a history of stomach problems, is taking other medications, or has medical conditions such as high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma.

Patients should not exceed the recommended dosage and should not take more than 4 doses in a day. If symptoms do not improve within 24 hours, or if fever or pain worsens or persists for more than 3 days, a healthcare professional should be consulted. Additionally, severe or persistent sore throat, especially when accompanied by high fever, headache, nausea, or vomiting, may indicate a serious condition, and prompt medical attention is advised.

Geriatric Use

The prescribing information for Children's Ibuprofen does not provide specific guidance regarding its use in geriatric patients. There are no recommended age considerations, dosage adjustments, or safety concerns outlined for elderly patients. Consequently, healthcare providers should exercise caution when considering the use of this medication in the geriatric population, as the absence of data may limit the understanding of its safety and efficacy in this age group. Monitoring for potential adverse effects and individual patient response is advised when prescribing this medication to elderly patients.

Pregnancy

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

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

Lactation

There are no specific warnings or recommendations regarding the use of ibuprofen in nursing mothers. Additionally, there is no information available concerning 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 may experience altered pharmacokinetics of the medication due to compromised liver function. It is essential to assess the severity of liver impairment before initiating treatment.

In patients with liver cirrhosis, dosage adjustments may be necessary to avoid potential toxicity. Close monitoring of liver function tests is recommended throughout the treatment period to ensure safety and efficacy.

Additionally, patients with a history of significant cardiovascular conditions, such as high blood pressure or heart disease, as well as those with kidney disease or a history of stroke, should be evaluated carefully, as these factors may further complicate the management of their hepatic impairment.

Healthcare providers should consider these factors when determining the appropriate therapeutic approach for patients with hepatic impairment.

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 healthcare providers should be prepared to assess and manage these symptoms accordingly.

Management procedures may include supportive care, monitoring of vital signs, and symptomatic treatment as necessary. It is essential for healthcare professionals to remain vigilant and act swiftly to mitigate potential complications associated with overdose.

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 these contexts.

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, cases of stomach bleeding have been reported, particularly in patients with a history of stomach ulcers or bleeding problems, as well as those concurrently using anticoagulants or other nonsteroidal anti-inflammatory drugs (NSAIDs). There is also an increased risk of heart attack, heart failure, and stroke associated with the use of NSAIDs. Furthermore, reports of severe or persistent sore throat, or sore throat accompanied by high fever, headache, nausea, and vomiting have been noted as serious conditions that require prompt medical consultation.

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 assistance immediately or contact a Poison Control Center at 1-800-222-1222.

Patients should be instructed to stop using the medication and consult a doctor if the child experiences 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. Additionally, if the child exhibits 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, medical advice should be sought promptly.

It is important to inform patients that if the child does not achieve relief within the first 24 hours of treatment, or if fever or pain worsens or persists for more than three days, they should contact a healthcare professional. Patients should also be aware that the presence of redness or swelling in the painful area, or the emergence of any new symptoms, warrants a discussion with a doctor.

When using this product, patients should be advised to take it with food or milk if stomach upset occurs. Furthermore, healthcare providers should recommend that patients consult a doctor before use if any of the following apply: the child has a history of stomach problems, such as heartburn; has experienced serious side effects from pain relievers or fever reducers; has not been adequately hydrated; has lost significant fluids due to vomiting or diarrhea; has high blood pressure, heart disease, liver cirrhosis, kidney disease, or a history of stroke; has asthma; or is taking a diuretic.

Lastly, patients should be encouraged 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.

Storage and Handling

The product is supplied in a carton that contains a bottle, with specific handling instructions to ensure safety and efficacy. It is essential to store the product at a temperature range of 20° to 25°C (68° to 77°F), in accordance with USP Controlled Room Temperature guidelines.

Healthcare professionals should not use the product if the carton has been opened or if the bottle wrap, which is imprinted with "SEALED FOR SAFETY," is broken or missing. For traceability, the lot number and expiration date can be found on the bottom panel of the carton.

Additional Clinical Information

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

Clinicians should counsel patients to discontinue use and seek medical attention if any signs of stomach bleeding or symptoms indicative of heart problems or stroke occur. It is crucial to keep the medication out of reach of children, and in the event of an overdose, immediate medical assistance or contact with a Poison Control Center is necessary.

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.