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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 2004
Label revision date
August 8, 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 2004
Label revision date
August 8, 2025
Manufacturer
Precision Dose Inc.
Registration number
ANDA074937
NDC root
68094-494
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (3 NDCs)
Packaging & NDC Codes (3)

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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.

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.

Dosage and Administration

When using this medication, it's important to follow the instructions provided by your healthcare professional. This product does not come with complete directions or warnings for adult use, so make sure to consult your doctor if you have any questions. Always shake the bottle well before using it, and be careful not to exceed the recommended dose.

To find the right amount for your child, refer to the dosing chart based on their weight. If possible, use their weight to determine the dose; if not, you can use their age. For children weighing under 24 pounds (under 2 years), it's best to ask a doctor for guidance. For those weighing between 24 and 35 pounds (ages 2-3), the dose is 5 mL (milliliters). 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 needed, 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 it right before or after heart surgery, as this could pose serious risks. Always consult with a healthcare professional if you have any concerns about your child's health or medication use.

Side Effects

Ibuprofen can cause serious allergic reactions, particularly in individuals who are allergic to aspirin. Signs of a severe allergic reaction may include hives, facial swelling, wheezing (asthma), shock, skin reddening, rash, 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. This risk is heightened if the medication is used in higher doses or for longer than recommended. If your child experiences symptoms such as fainting, vomiting blood, or has bloody or black stools, seek medical attention immediately. Other concerning signs include chest pain, difficulty breathing, weakness on one side of the body, slurred speech, or swelling in the legs. Always consult a doctor if your child has a severe sore throat with high fever or if symptoms worsen or persist beyond a few days.

Warnings and Precautions

Ibuprofen can cause serious allergic reactions, especially 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 ibuprofen 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 your child does not feel better within 24 hours, if their fever or pain worsens or lasts more than three days, or if any new symptoms appear, 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 reach out for help. Your safety is the top priority.

Pregnancy Use

When considering the use of ibuprofen during pregnancy, it's important to note that the available information does not specify any particular guidelines or risks associated with its use. There are no stated contraindications (conditions that would make the use of a drug inadvisable) or special precautions for pregnant individuals. Additionally, the text does not provide any recommendations for dosage modifications for those who are pregnant.

As always, it's best to consult with your healthcare provider before taking any medication during pregnancy to ensure it is safe for you and your baby.

Lactation Use

If you are breastfeeding and considering using ibuprofen, it's important to talk to your healthcare professional first. While ibuprofen may be present in breast milk, the effects on your nursing infant have not been thoroughly studied, so caution is advised.

If you do take ibuprofen, keep an eye on your baby for any unusual reactions or side effects. Your healthcare provider can help you weigh the benefits and risks to ensure both you and your infant stay healthy.

Pediatric Use

It's important to be cautious when using this medication for children. You should avoid giving it to children under 3 years old unless a doctor specifically advises you to do so. For children aged 2 to 11 years, the dosage varies based on their weight. For example, if your child weighs under 24 pounds, consult a doctor before use. For those weighing 24-35 pounds, the recommended dose is 5 mL, while children weighing 36-47 pounds should receive 7.5 mL. As the weight increases, so does the dosage, reaching 15 mL for children who weigh between 72-95 pounds.

Always consult a doctor if your child has a history of stomach issues, is taking other medications, or has experienced significant fluid loss from vomiting or diarrhea. If your child does not feel better within 24 hours, or if their fever or pain worsens or lasts more than 3 days, stop using the medication and seek medical advice. Remember to keep this medication out of reach of children, and in case of an overdose, contact a medical professional or Poison Control Center immediately.

Geriatric Use

When it comes to using this medication in older adults, there is no specific information available about dosage adjustments, safety concerns, or special precautions. This means that if you or a loved one is an older adult considering this medication, it’s important to consult with a healthcare provider. They can help determine the best approach based on individual health needs and any other medications being taken. Always prioritize open communication with your healthcare team to ensure safe and effective treatment.

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 factors can 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 cautious when using ibuprofen, especially if you or your child are taking other medications. Ibuprofen can increase the risk of severe stomach bleeding, particularly when combined with blood thinners (medications that prevent blood clots) or steroids. Additionally, if your child is taking other nonsteroidal anti-inflammatory drugs (NSAIDs) like aspirin or naproxen, the risk of stomach bleeding is even higher.

Using NSAIDs, except for aspirin, can also raise the chances of serious heart issues, such as heart attack or stroke, especially if taken in higher doses or for longer than recommended. Always consult your healthcare provider before starting ibuprofen or any new medication, particularly if other drugs are being used. This ensures safe and effective treatment tailored to your needs.

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 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 directed by your healthcare professional. If necessary, you can repeat the dose every 6 to 8 hours, but do not exceed four doses in a single day.

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

FAQ

What is Children's Ibuprofen 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 dose Children's Ibuprofen?

You should find the right dose on the dosing chart based on your child's weight or age. If needed, you can repeat the dose every 6-8 hours, but do not exceed 4 doses in a day.

What should I do if my child has a severe allergic reaction?

If your child experiences symptoms like hives, facial swelling, or difficulty breathing, stop using Children's Ibuprofen and seek medical help immediately.

Are there any warnings associated with Children's Ibuprofen?

Yes, it may cause severe stomach bleeding, especially if your child has a history of stomach ulcers or is taking other NSAIDs. It also increases the risk of heart attack and stroke.

Can I give Children's Ibuprofen to my child if they are under 2 years old?

If your child weighs under 24 lbs (under 2 years), you should ask a doctor before giving them Children's Ibuprofen.

What should I do if my child does not get relief from pain or fever?

If your child does not experience relief within the first 24 hours of treatment, or if their fever or pain worsens or lasts more than 3 days, consult a doctor.

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

The provided information does not specify any risks or contraindications for using ibuprofen during pregnancy, but you should consult a healthcare professional.

What precautions should I take if my child has other health conditions?

Consult a doctor before use if your child has high blood pressure, heart disease, liver cirrhosis, kidney disease, or has had a stroke.

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 in case of an overdose?

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

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 at a concentration of 100 mg of ibuprofen per 5 mL. It is manufactured by Precision Dose, Inc., located in South Beloit, Illinois, with the National Drug Code (NDC) 68094-494-59. The product is designed for precise dosing, utilizing the PrecisionDose™ technology to ensure accurate administration for pediatric patients.

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. The appropriate dose can be determined using the dosing chart provided below. When possible, dosing should be based on the patient's weight; if weight is not available, age may be used as a guide.

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 dose is 12.5 mL, and for those weighing 72-95 lbs (11 years), the recommended dose is 15 mL.

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

Contraindications

Use of this product is contraindicated in the following situations:

Patients with a history of allergic reactions to ibuprofen or any other pain reliever or fever reducer should not use this product, as it may trigger severe allergic responses. Additionally, the product should not be administered immediately before or after heart surgery due to potential complications associated with its use in this context.

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 extended periods.

In cases of severe or persistent sore throat, especially when accompanied by high fever, headache, nausea, or vomiting, prompt medical consultation is advised. 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 physician.

Healthcare providers should instruct caregivers to discontinue use and consult a physician if the child exhibits any signs of stomach bleeding, such as feeling faint, vomiting blood, passing bloody or black stools, or experiencing persistent stomach pain. Additionally, symptoms suggestive 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 crucial 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 in children under three years of age without a doctor's guidance.

Parents should discontinue use and consult a healthcare professional if their child exhibits signs of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain. Symptoms indicative of heart problems or stroke, including chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling, also warrant immediate medical evaluation. Furthermore, if the child does not achieve relief within the first 24 hours of treatment, or if fever or pain worsens or persists beyond three days, medical advice should be sought. Redness or swelling in the painful area or the emergence of any new symptoms should also prompt consultation.

It is crucial to avoid the use of ibuprofen in children with a history of allergic reactions to the drug or other pain relievers/fever reducers. The medication should not be administered immediately before or after heart surgery. Prior to use, consultation with a healthcare provider is recommended if the child has a history of stomach issues, has experienced serious side effects from pain relievers, is dehydrated, or has conditions such as high blood pressure, heart disease, liver cirrhosis, kidney disease, or a history of stroke. Additionally, children with asthma or those taking diuretics should seek medical advice before using ibuprofen. Parents should also consult a doctor or pharmacist if their child is under treatment for any serious condition or is taking other medications.

Drug Interactions

Ibuprofen has been associated with several significant drug interactions that warrant careful consideration, particularly regarding the risk of gastrointestinal and cardiovascular events.

Anticoagulants and Steroids The concomitant use of ibuprofen with anticoagulants or steroid medications may lead to an increased risk of severe gastrointestinal bleeding. It is advisable to monitor patients closely for signs of bleeding and to consider dosage adjustments or alternative therapies if necessary.

Other Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) The risk of stomach bleeding is notably heightened when ibuprofen is taken alongside other NSAIDs, whether prescription or nonprescription, such as aspirin or naproxen. Healthcare providers should evaluate the necessity of using multiple NSAIDs concurrently and advise against their combined use.

Cardiovascular Risks Ibuprofen, along with other NSAIDs (excluding aspirin), has been linked to an elevated risk of serious cardiovascular events, including heart attack, heart failure, and stroke. This risk is particularly pronounced when these medications are used in excess of recommended dosages or for prolonged periods. Patients should be counseled on the importance of adhering to prescribed dosages and the potential risks associated with extended use.

Consultation Recommendation It is imperative for caregivers to consult a healthcare professional if the child is taking any other medications prior to initiating ibuprofen therapy. This ensures a comprehensive assessment of potential interactions and the implementation of appropriate monitoring strategies.

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 dosing, the following guidelines apply:

  • For children under 24 lbs (under 2 years), consultation with a doctor is advised.

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

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

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

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

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

Healthcare professionals should advise parents to consult a doctor if the child has a history of stomach problems, is taking other medications, or has experienced significant fluid loss due to vomiting or diarrhea.

Parents should be instructed to stop use and seek medical advice if the child does not experience relief within the first 24 hours of treatment, or if fever or pain worsens or persists beyond 3 days. It is essential to keep this 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.

Geriatric Use

There is no specific information regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy.

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. The text also 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. The effects of ibuprofen on a nursing infant are not well studied; therefore, caution is advised. It is recommended to monitor the nursing infant for any adverse effects if the mother is taking ibuprofen.

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 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 course. 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.

Healthcare providers should ensure that appropriate laboratory evaluations are conducted to monitor liver function and adjust the treatment regimen accordingly.

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 attention 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 ensure that they are familiar with the appropriate protocols for the substance in question to facilitate effective treatment.

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 compound in these areas.

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, or those concurrently using anticoagulants or other nonsteroidal anti-inflammatory drugs (NSAIDs).

There is an increased risk of cardiovascular events, including heart attack, heart failure, and stroke, especially associated with prolonged use or doses exceeding the recommended guidelines. Furthermore, reports of severe or persistent sore throat, particularly when accompanied by high fever, headache, nausea, and vomiting, have been noted as serious conditions that necessitate 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 be instructed to seek medical help or contact a Poison Control Center immediately at 1-800-222-1222.

It is essential 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 stop use and consult a doctor if the child exhibits any signs of stomach bleeding, which may include feeling faint, vomiting blood, having bloody or black stools, or experiencing stomach pain that does not improve. Furthermore, patients should be advised to discontinue use and seek medical attention 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.

Healthcare providers should also inform patients to stop use and consult a doctor if the child does not experience relief within the first 24 hours of treatment, if fever or pain worsens or persists beyond three days, if there is redness or swelling in the painful area, or if any new symptoms arise.

When administering this product, patients should be advised to give it with food or milk if stomach upset occurs. It is important for patients to consult a doctor before use if the stomach bleeding warning applies to their child or if the child has a history of stomach problems, such as heartburn.

Patients should also be encouraged to seek medical advice before use if the child has experienced serious side effects from pain relievers or fever reducers, has not been drinking fluids, or has lost a significant amount of fluid due to vomiting or diarrhea. Additionally, patients should consult a doctor before use if the child has high blood pressure, heart disease, liver cirrhosis, kidney disease, or a history of stroke, as well as if the child has asthma or is taking a diuretic.

Finally, patients should be advised to consult a doctor or pharmacist before use if the child is under a doctor's 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. If necessary, doses may be repeated every 6-8 hours, but it is important not to exceed four doses in a 24-hour period. Clinicians should advise patients to keep the medication out of reach of children and to seek immediate medical assistance or contact a Poison Control Center (1-800-222-1222) in the event of an overdose.

No additional information is available regarding laboratory tests, abuse potential, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Childrens Ibuprofen, 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.