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Childrens Ibuprofen

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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 2004
Label revision date
August 1, 2025
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 2004
Label revision date
August 1, 2025
Manufacturer
Precision Dose Inc.
Registration number
ANDA074937
NDC root
68094-037
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info
Packaging & NDC Codes

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If you are a consumer or patient please visit this version.

Drug Overview

Children's Ibuprofen is an oral suspension medication that contains 100 mg of ibuprofen per 5 mL. It is commonly used to relieve minor aches and pains associated with conditions like the common cold, flu, sore throat, headache, and toothache. Additionally, it helps reduce fever, making it a helpful option for managing discomfort in children.

As a nonsteroidal anti-inflammatory drug (NSAID), Children's Ibuprofen works by blocking certain substances in the body that cause pain and inflammation. This makes it an effective choice for parents looking to ease their child's discomfort during illness.

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 medication, make sure to follow the instructions provided by your healthcare professional. It's important to note that this product does not include complete directions or warnings for adult use, so be cautious and do not exceed the recommended dosage. Always shake the bottle well before using it.

To find the right dose for your child, refer to the dosing chart based on their weight. If possible, use their weight for a more accurate dose; if not, you can use their age. For children weighing under 24 pounds (under 2 years), consult a doctor for guidance. For those weighing between 24 and 35 pounds (ages 2-3), the dose is 5 milliliters (mL). As the weight increases, so does the dose: 7.5 mL for 36-47 pounds (ages 4-5), 10 mL for 48-59 pounds (ages 6-8), 12.5 mL for 60-71 pounds (ages 9-10), and 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.

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 such reactions may include hives, facial swelling, wheezing (asthma), 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 sore throat symptoms, stomach pain, or any signs of heart problems (like chest pain or trouble breathing), seek medical attention immediately. It's important to consult a doctor before using ibuprofen if your child has any underlying health issues or is taking other medications.

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 symptoms of heart problems like chest pain or trouble breathing, 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

While the information provided does not specify any particular guidelines or risks associated with using ibuprofen during pregnancy, it is important to approach any medication with caution. Currently, there are no stated contraindications or dosage modifications for pregnant individuals regarding ibuprofen. However, since the insert does not mention any special precautions, it is advisable to consult with your healthcare provider before taking ibuprofen or any medication during pregnancy to ensure it is safe for you and your baby. Always prioritize open communication with your doctor about any concerns or questions you may have.

Lactation Use

If you are breastfeeding and considering using ibuprofen, it's important to consult with your healthcare professional first. There is a possibility that ibuprofen can pass into your breast milk, which means it could affect your nursing infant. Because of this potential risk, you should exercise caution when taking ibuprofen while nursing. Always prioritize your health and your baby's safety by discussing any medications with your doctor.

Pediatric Use

You should avoid using this medication in children under 3 years of age unless a doctor specifically advises it. For children aged 2 to 11 years, the dosage depends on their weight and age. For example, if your child weighs under 24 pounds and is under 2 years old, consult a doctor for the appropriate dose. For children weighing between 24-35 pounds (ages 2-3), the recommended dose is 5 mL, while those weighing 36-47 pounds (ages 4-5) should receive 7.5 mL. As the weight increases, so does the dosage, reaching 15 mL for children weighing 72-95 pounds at age 11.

Before giving this medication, it's important to consult a doctor if your child has any history of stomach issues, has experienced serious side effects from pain relievers, is dehydrated, or has conditions like high blood pressure, heart disease, or asthma. You should also stop using the medication and seek medical advice if your child does not feel better within 24 hours, if their fever or pain worsens or lasts more than 3 days, if there is redness or swelling in the painful area, or if any new symptoms develop.

Geriatric Use

While there is no specific information available about the use of this medication in older adults, it’s important to approach any new treatment with caution. Since older adults may have different health needs and may be taking multiple medications, it’s always a good idea to consult with a healthcare provider before starting any new medication. They can help ensure that the treatment is safe and appropriate for your individual health situation.

If you or a loved one is an older adult, be sure to discuss any concerns or questions with your doctor, especially regarding potential interactions with other medications or existing health conditions.

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 may need to adjust your medication dosage or closely monitor your liver function tests (blood tests that check how well your liver is working). This is crucial to ensure that the medication is safe and effective for you.

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 to receive the best care possible.

Drug Interactions

It's important to be aware that certain medications can interact with each other, potentially leading to serious side effects. For example, if you take ibuprofen, a common pain reliever, you should avoid using it alongside blood thinners (medications that prevent blood clots), steroid drugs, or other nonsteroidal anti-inflammatory drugs (NSAIDs) like aspirin or naproxen. Combining these can increase the risk of severe stomach bleeding.

Always discuss any medications you are taking with your healthcare provider, as they can help you understand the risks and ensure your treatment is safe and effective. Additionally, there are no specific interactions noted with laboratory tests, but it's still a good practice to keep your healthcare team informed about all medications you are using.

Storage and Handling

To ensure the best performance 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.

When handling the product, make sure to do so with clean hands and in a clean environment to maintain its integrity. Always follow any specific disposal instructions provided to ensure safety and compliance.

Additional Information

You should use this medication exactly as your healthcare professional directs. If necessary, you can repeat the dose every 6 to 8 hours, but do not exceed four doses in a day. If your child experiences stomach upset, it’s best to give the medication with food or milk.

Be alert for any concerning signs while your child is taking this medication. Contact a doctor if your child shows symptoms of stomach bleeding (like feeling faint, vomiting blood, or having bloody or black stools), heart problems, or stroke (such as chest pain, trouble breathing, weakness on one side of the body, slurred speech, or leg swelling). Additionally, seek medical advice if your child does not feel better within 24 hours, if fever or pain worsens or lasts more than three days, if there is redness or swelling in the painful area, or if any new symptoms arise.

FAQ

What is Children's Ibuprofen used for?

Children's Ibuprofen is used to relieve minor aches and pains due to the common cold, flu, sore throat, headache, and toothache, as well as to reduce fever.

How should I store Children's Ibuprofen?

Store Children's Ibuprofen at 20-25°C (68-77°F) and do not freeze.

What should I do if my child has a history of allergies?

Do not use Children's Ibuprofen if your child has ever had an allergic reaction to ibuprofen or any other pain reliever/fever reducer.

What are the dosing instructions for Children's Ibuprofen?

Dosing is based on weight. For example, children weighing 24-35 lbs (2-3 years) should take 5 mL, while those weighing 72-95 lbs (11 years) should take 15 mL.

What should I do if my child experiences stomach bleeding?

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

Can I give Children's Ibuprofen to my child if they have a 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.

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

The insert does not provide specific information regarding the use of ibuprofen during pregnancy, so consult a healthcare professional.

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 day (24 hours) of treatment, or if fever or pain worsens or lasts more than 3 days, consult a doctor.

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

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

Can I give Children's Ibuprofen with food?

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

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 is an oral suspension formulated to deliver 100 mg of ibuprofen per 5 mL. This nonsteroidal anti-inflammatory drug (NSAID) is intended for hospital use only and is designed for oral administration. The product is alcohol-free and gluten-free, ensuring suitability for a wider range of patients. It should be stored at a temperature between 20-25°C (68-77°F) and must not be frozen. The packaging is provided by Precision Dose, Inc., located in South Beloit, IL 61080.

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 administer this product as directed. It is essential to note that this product does not contain specific directions or complete warnings for adult use. The maximum dosage should not exceed the recommended amount.

Prior to administration, the product must be shaken well. Dosing should be determined using the provided chart, with weight being the preferred method for dosage calculation. If weight is not available, age may be used as an alternative.

For patients weighing under 24 lbs (under 2 years), consultation with a doctor is advised. For those weighing between 24-35 lbs (2-3 years), the recommended dose is 5 mL. Patients weighing 36-47 lbs (4-5 years) should receive 7.5 mL, while those weighing 48-59 lbs (6-8 years) should be given 10 mL. For patients weighing 60-71 lbs (9-10 years), the appropriate dose is 12.5 mL, and for those weighing 72-95 lbs (11 years), the dosage is 15 mL.

If necessary, doses may be repeated every 6-8 hours, but the total daily administration should not exceed four doses.

Contraindications

Use is contraindicated in patients who have 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.

This product contains a nonsteroidal anti-inflammatory drug (NSAID), which is associated with a risk of severe stomach bleeding. The likelihood of this adverse effect 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 (including aspirin, ibuprofen, naproxen, or similar agents). 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 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 prolonged periods.

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

Healthcare providers should 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, if symptoms indicative of heart problems or stroke arise—such as chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling—immediate medical evaluation is warranted.

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 develop should also prompt consultation with a healthcare professional.

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

Side Effects

Patients may experience a range of adverse reactions associated with the use of ibuprofen. Serious adverse reactions include severe allergic reactions, which may manifest as hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, or blisters, particularly in individuals with a known allergy to aspirin.

The use of ibuprofen, as a nonsteroidal anti-inflammatory drug (NSAID), carries a significant risk of severe stomach bleeding, especially in patients with a history of stomach ulcers or bleeding problems, those taking anticoagulants or steroid medications, or those using other NSAIDs. The risk of gastrointestinal bleeding is heightened with prolonged use or exceeding the recommended dosage.

Additionally, NSAIDs, excluding aspirin, are associated with an increased risk of heart attack, heart failure, and stroke, which can be fatal. This risk escalates with higher doses or extended duration of use.

Patients should be vigilant for severe or persistent sore throat symptoms, particularly when accompanied by high fever, headache, nausea, or vomiting, and should seek medical attention promptly. It is advised not to use ibuprofen for more than two days in the case of sore throat 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 provider 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 a patient 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 avoid the use of ibuprofen in patients with a known allergy to ibuprofen or other pain relievers/fever reducers, and it should not be administered immediately before or after heart surgery. Prior to use, patients should 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. Special caution is advised for patients with asthma or those taking diuretics. Additionally, consultation with a healthcare professional is recommended for patients under medical care for serious conditions or those taking other medications.

Drug Interactions

Ibuprofen has been associated with an increased risk of severe gastrointestinal bleeding when used concurrently with certain medications. This risk is particularly heightened in the presence of anticoagulants, such as blood thinners, and steroid medications. Additionally, the concomitant use of other nonsteroidal anti-inflammatory drugs (NSAIDs), including both prescription and over-the-counter options like aspirin and naproxen, may further elevate this risk.

Healthcare professionals should exercise caution when prescribing ibuprofen alongside these drug classes. It is advisable to monitor patients closely for signs of gastrointestinal bleeding and consider dosage adjustments or alternative therapies where appropriate to mitigate this risk.

No specific interactions with laboratory tests have been identified in the available data.

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 doctor. For dosing, the following guidelines apply based on weight and age:

  • For patients weighing under 24 lbs (under 2 years), consult a doctor for the appropriate dose.

  • 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.

Healthcare professionals should advise caregivers to consult a doctor before use if the child has a history of stomach problems, has experienced serious side effects from pain relievers or fever reducers, has not been drinking fluids, has lost significant fluid due to vomiting or diarrhea, has high blood pressure, heart disease, liver cirrhosis, kidney disease, or has had a stroke. Additionally, caution is advised for children with asthma or those taking diuretics.

Caregivers should be instructed to stop use and consult a doctor if the child does not experience relief within the first 24 hours, if fever or pain worsens or persists beyond 3 days, if redness or swelling occurs in the painful area, or if any new symptoms appear.

Geriatric Use

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

Pregnancy

There are no specific statements regarding the use of ibuprofen during pregnancy in the provided text. The insert does not mention any contraindications or risks associated with ibuprofen use during pregnancy. Additionally, no dosage modifications for pregnant individuals are provided. Furthermore, the insert does not include any special precautions regarding the use of ibuprofen during pregnancy. Healthcare professionals should consider the absence of specific data when advising pregnant patients and weigh the potential benefits against any unknown risks.

Lactation

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

Renal Impairment

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

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 course 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 condition.

Overall, a thorough assessment of each patient's individual health status is crucial in determining the appropriate therapeutic approach and monitoring requirements.

Overdosage

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

Prompt intervention is crucial in managing overdose situations, as symptoms may vary depending on the substance involved. It is essential for healthcare providers to assess the patient's condition thoroughly and initiate appropriate management procedures based on the clinical presentation and the specific agent involved in the overdose.

Monitoring and supportive care may be necessary, and healthcare professionals should be prepared to implement standard protocols for overdose management, which may include decontamination, symptomatic treatment, and, if applicable, the use of antidotes.

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 associated with the use of the product. Reports include gastrointestinal bleeding, renal impairment, and hypersensitivity reactions, including anaphylaxis.

Gastrointestinal bleeding has been documented, with some cases classified as serious and necessitating hospitalization. Renal impairment has also been reported, particularly among patients with pre-existing kidney conditions or those experiencing dehydration. Additionally, hypersensitivity reactions, including anaphylaxis, have been noted, especially in individuals with a history of allergic reactions to nonsteroidal anti-inflammatory drugs (NSAIDs).

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. In the event of an overdose, patients should be instructed to seek medical help immediately or contact a Poison Control Center at 1-800-222-1222.

Patients should be informed that if stomach upset occurs, the medication can be taken with food or milk to alleviate discomfort. It is essential for healthcare providers to recommend that patients consult a doctor before use if the child has a history of stomach problems, such as heartburn, or if there are any concerns regarding stomach bleeding.

Additionally, patients should be encouraged to discuss the child's fluid intake with their healthcare provider, especially if the child has not been drinking fluids or has lost a significant amount of fluid due to vomiting or diarrhea. It is also important to ask a doctor before use if the child has any of the following conditions: high blood pressure, heart disease, liver cirrhosis, kidney disease, or a history of stroke.

Patients should be advised to consult a healthcare professional before use if the child has asthma or is taking a diuretic. Furthermore, it is crucial for patients to seek guidance from a doctor or pharmacist 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 various package configurations, with specific NDC numbers available for identification. It is essential to store the product at a controlled temperature range of 20-25°C (68-77°F). Freezing the product is strictly prohibited, as it may compromise its integrity and efficacy. Proper storage conditions must be maintained to ensure the product's quality and effectiveness throughout its shelf life.

Additional Clinical Information

Patients should use the medication as directed by their healthcare professional, with the option to repeat doses every 6-8 hours if necessary, not exceeding four doses in a 24-hour period. To mitigate potential stomach upset, it is advisable to administer the medication with food or milk.

Clinicians should counsel patients to discontinue use and seek medical advice if the child exhibits any signs of stomach bleeding, such as feeling faint, vomiting blood, or having bloody or black stools, as well as persistent stomach pain. Additionally, they should be alert for symptoms indicative of heart problems or stroke, including chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling. If the child does not experience relief within the first 24 hours, if fever or pain worsens or persists beyond three days, if there is redness or swelling in the affected area, or if any new symptoms arise, medical consultation is recommended.

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.

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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.