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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/ Drops
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2023
Label revision date
November 10, 2023
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/ Drops
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 2023
Label revision date
November 10, 2023
Manufacturer
Chain Drug Marketing Association Inc.
Registration number
ANDA210149
NDC root
83324-013
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info
Packaging & NDC Codes

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

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

Drug Overview

Children's Ibuprofen is a pain reliever and fever reducer specifically designed for children aged 2 to 11 years. This oral suspension contains 100 mg of ibuprofen (a type of nonsteroidal anti-inflammatory drug, or NSAID) per 5 mL and is available in a pleasant bubble gum flavor. It effectively relieves minor aches and pains associated with common conditions like the cold, flu, sore throat, headache, and toothache, while also helping to reduce fever.

The effects of Children's Ibuprofen can last for up to 8 hours, making it a convenient option for managing discomfort in young children. It is important to note that this medication is alcohol-free and comes in a 4 FL OZ (120 mL) package size.

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 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 dosing cup that comes with the medication, as other devices may not provide the correct amount. To find the right dose for you or your child, refer to the dosing chart based on weight or age. If you’re unsure, especially for children under 24 pounds or under 2 years old, consult a doctor.

Once you have the correct dose, you can take it every 6 to 8 hours if needed, but remember not to exceed 4 doses in a single day. Following these guidelines will help ensure you use the medication safely and effectively.

What to Avoid

It's important to be cautious when considering this medication for your child. You should not use it if your child has ever had an allergic reaction to ibuprofen or any other pain reliever or fever reducer. Additionally, avoid using this medication right before or after heart surgery, as it can pose serious risks in these situations.

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

Side Effects

Ibuprofen can cause serious side effects, so it's important to be aware of them. You should watch for signs of a severe allergic reaction, especially if you or your child is allergic to aspirin. Symptoms may include hives, wheezing, skin reddening, facial swelling, and in extreme cases, shock. Additionally, ibuprofen can lead to severe stomach bleeding, particularly if your child has a history of stomach ulcers, is taking blood thinners or other NSAIDs, or uses the medication for longer than recommended.

There is also an increased risk of heart attack and stroke associated with NSAIDs like ibuprofen, especially if used in higher doses or for extended periods. If your child experiences symptoms such as chest pain, trouble breathing, or weakness on one side of the body, seek medical attention immediately. It's crucial to consult a doctor if your child has a severe sore throat with high fever or if symptoms worsen or persist beyond a few days. Always talk to a healthcare professional before using ibuprofen if your child has any underlying health conditions 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, wheezing, skin redness, facial swelling, shock, 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 issues, 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 or your child have a severe sore throat with high fever, headache, nausea, or vomiting, consult a doctor right away. Do not use ibuprofen for more than two days in these cases or for children under three years without a doctor's guidance.

If you suspect an overdose, contact a Poison Control Center or seek emergency medical help immediately. You should also stop using ibuprofen and call your doctor if you notice signs of stomach bleeding (like faintness, vomiting blood, or black stools), symptoms of heart problems or stroke (such as chest pain or trouble breathing), or if there is no relief within 24 hours. Additionally, seek help if fever or pain worsens after three days, if there is redness or swelling in the painful area, or if any new symptoms appear.

Overdose

If you suspect an overdose, it's important to be aware that there is no specific information available about the effects of taking too much of this medication. However, if you experience unusual symptoms or feel unwell after taking your medication, you should seek medical help immediately.

Signs of an overdose can vary, but they may include severe drowsiness, confusion, or difficulty breathing. If you notice any of these symptoms, or if you are unsure about your situation, do not hesitate to contact a healthcare professional or call emergency services for assistance. Your safety is the top priority, so it's always better to err on the side of caution.

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 (conditions that would make the use of a drug inadvisable) or dosage modifications for pregnant individuals. However, since the insert does not mention any special precautions, it is always best to consult with your healthcare provider before taking ibuprofen or any other medication during pregnancy. They can provide personalized advice based on your specific situation.

Lactation Use

If you are breastfeeding, it's important to talk to your doctor before using this product. There is a possibility that it can pass into your breast milk, which means it could affect your nursing infant. Since the effects of ibuprofen on babies who are breastfed haven't been thoroughly studied, it's best to exercise caution. Always prioritize your health and your baby's well-being by seeking professional advice.

Pediatric Use

When considering medication for your child, it's important to follow specific guidelines based on their age and weight. For children under 2 years old who weigh less than 24 pounds, you should consult a doctor before use. For those aged 2 to 3 years and weighing between 24-35 pounds, the recommended dose is 5 mL. As your child grows, the dosage increases: 7.5 mL for ages 4-5 years (36-47 lbs), 10 mL for ages 6-8 years (48-59 lbs), 12.5 mL for ages 9-10 years (60-71 lbs), and 15 mL for 11-year-olds (72-95 lbs). Remember, do not give this medication to children under 3 years without a doctor's advice.

It's also crucial to be aware of safety concerns. Avoid using this medication if your child has a history of stomach issues, is on other medications, or has certain health conditions like high blood pressure or asthma. Watch for severe allergic reactions, especially if your child is allergic to aspirin, and be cautious of stomach bleeding risks. If your child has a severe sore throat, especially with a high fever or other concerning symptoms, consult a doctor. Always use weight to determine the dose, limit to 4 doses in 24 hours, and consider giving the medication with food or milk to prevent stomach upset.

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 know that there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the usual recommendations for monitoring or safety considerations related to renal impairment (kidney issues) are not provided.

Always consult your healthcare provider for personalized advice and to ensure that any medications you take are safe and appropriate for your kidney health. They can help you understand how your condition may affect your treatment plan.

Hepatic Impairment

If you have liver problems, it's important to know that there are no specific guidelines, dosage adjustments, or special monitoring instructions provided for your condition in the available information. This means that the medication may not have been studied in depth for its effects on individuals with liver impairment.

Always consult your healthcare provider for personalized advice and to discuss any concerns you may have regarding your liver health and medication use. They can help ensure that your treatment is safe and effective based on your individual health needs.

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 or your child are taking ibuprofen, combining it with blood thinners (medications that help prevent blood clots) or steroids can increase the risk of stomach bleeding. This risk is even greater if other nonsteroidal anti-inflammatory drugs (NSAIDs), like aspirin or naproxen, are also being used.

Always discuss any medications you or your child are taking with your healthcare provider. They can help you understand the risks and ensure that your treatment plan is safe and effective.

Storage and Handling

To ensure the safety and effectiveness of your product, store it in a cool, dry place at a temperature between 20-25°C (68-77°F). This helps maintain its quality and performance.

Before using the product, check that the carton is unopened and that the inner seal, which should say "SEALED for YOUR PROTECTION," is intact. If the seal is broken or missing, do not use the product, as this may compromise its safety. Always handle the product with care to avoid any contamination or damage.

Additional Information

You should take this medication orally, and if necessary, you can repeat the dose every 6 to 8 hours. However, do not exceed four doses in a single day. It's important to be cautious; if you suspect an overdose, seek medical help immediately or contact a Poison Control Center at 1-800-222-1222 for assistance.

FAQ

What is Children's Ibuprofen used for?

Children's Ibuprofen is a pain reliever and fever reducer that helps relieve minor aches and pains due to the common cold, flu, sore throat, headache, and toothache.

What is the recommended dosage for Children's Ibuprofen?

The dosage varies by weight and age. For example, children aged 2-3 years weighing 24-35 lbs should take 5 mL, while those aged 11 years weighing 72-95 lbs should take 15 mL.

How often can I give Children's Ibuprofen?

You can repeat the dose every 6-8 hours, but do not exceed 4 doses in a 24-hour period.

Are there any warnings associated with Children's Ibuprofen?

Yes, it may cause severe allergic reactions, stomach bleeding, and increase the risk of heart attack and stroke. Consult a doctor if the child has a history of stomach problems or is taking other medications.

Can I use Children's Ibuprofen if my child is under 2 years old?

You should ask a doctor before using Children's Ibuprofen for children under 2 years old, especially if they weigh under 24 lbs.

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

The provided information does not mention specific risks or contraindications for using ibuprofen during pregnancy, but it is advisable to consult a doctor.

What should I do in case of an overdose?

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

How should I store Children's Ibuprofen?

Store Children's Ibuprofen between 20-25°C (68-77°F) and do not use it if the carton is opened or the inner seal is broken.

What flavor does Children's Ibuprofen come in?

Children's Ibuprofen is available in a bubble gum flavor.

Can I give Children's Ibuprofen with food?

Yes, you can take it 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

NDC 83324-013-04. QUALITY CHOICE Children's Ibuprofen is an oral suspension formulated as a nonsteroidal anti-inflammatory drug (NSAID) for the relief of pain and reduction of fever. Each 5 mL dose contains 100 mg of ibuprofen and is suitable for children aged 2 to 11 years. The product is alcohol-free and features a bubble gum flavor. The suspension is packaged in a 4 FL OZ (120 mL) bottle and provides relief that lasts up to 8 hours. This formulation is comparable to the active ingredient in Children's Motrin®.

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

The medication should be shaken well before use. It is imperative to utilize only the enclosed dosing cup for administration; other dosing devices are not recommended. Healthcare professionals should refer to the dosing chart to determine the appropriate dose, prioritizing weight for dosing whenever possible. If weight is not available, age may be used as a secondary reference.

The recommended dosing intervals are every 6 to 8 hours as needed, with a maximum frequency of administration not to exceed four times per day.

Dosing Chart:

  • For patients weighing under 24 lbs or under 2 years of age, consultation with a doctor is advised.

  • For patients weighing 24-35 lbs or aged 2-3 years, the recommended dose is 5 mL.

  • For patients weighing 36-47 lbs or aged 4-5 years, the recommended dose is 7.5 mL.

  • For patients weighing 48-59 lbs or aged 6-8 years, the recommended dose is 10 mL.

  • For patients weighing 60-71 lbs or aged 9-10 years, the recommended dose is 12.5 mL.

  • For patients weighing 72-95 lbs or aged 11 years, the recommended dose is 15 mL.

Dosing may be adjusted as directed by a healthcare professional.

Contraindications

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

Warnings and Precautions

Ibuprofen may induce severe allergic reactions, particularly in individuals with a known allergy to aspirin. Symptoms indicative of an allergic response may include hives, asthma (wheezing), skin reddening, facial swelling, shock, 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 carries 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, or naproxen). Additionally, exceeding the recommended dosage or duration of treatment increases the risk 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 extended 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 such symptoms occur. The use of ibuprofen should not exceed two days, nor should it be administered to children under three years of age without a physician's directive.

In cases of overdose, immediate medical attention is required. Healthcare providers should instruct caregivers to contact a Poison Control Center (1-800-222-1222) without delay.

Healthcare professionals should advise caregivers to discontinue use and consult a physician if the child exhibits any of the following symptoms: signs of stomach bleeding (such as feeling faint, vomiting blood, or passing bloody or black stools), persistent stomach pain, symptoms indicative of heart problems or stroke (including chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling), lack of relief within the first 24 hours of treatment, worsening fever or pain lasting more than three days, redness or swelling in the affected area, or the emergence of any new symptoms.

Side Effects

Patients using ibuprofen should be aware of potential adverse reactions, which can range from serious to common.

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

The use of ibuprofen is associated with a risk of severe stomach bleeding, particularly in patients with a history of stomach ulcers or bleeding problems, those taking anticoagulants or steroid medications, or those using other NSAIDs (including aspirin and naproxen). The risk of stomach bleeding increases with prolonged use or higher doses than recommended.

Additionally, ibuprofen carries warnings regarding cardiovascular risks. The use of NSAIDs, excluding aspirin, has been linked to an increased risk of heart attack, heart failure, and stroke, which can be fatal. This risk is heightened with excessive or prolonged use.

Patients should be vigilant for signs of serious conditions. If a child experiences symptoms indicative of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or persistent stomach pain, medical attention should be sought immediately. Symptoms of heart problems or stroke, including chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling, also warrant urgent medical consultation.

It is advised to discontinue use and consult a healthcare provider 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 redness or swelling occurs in the painful area, or if any new symptoms arise.

Before administering ibuprofen, it is crucial to consult a healthcare professional if the child has a history of stomach issues, has experienced serious side effects from pain relievers or fever reducers, is dehydrated, or has underlying health conditions such as high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma. Additionally, consultation is recommended if the child is taking diuretics or is under a doctor's care for any serious condition.

Drug Interactions

Ibuprofen has been associated with an increased risk of gastrointestinal bleeding when co-administered with anticoagulants or corticosteroids. This risk is particularly pronounced in pediatric patients who are concurrently taking other nonsteroidal anti-inflammatory drugs (NSAIDs), including but not limited to aspirin and naproxen.

Healthcare professionals should exercise caution when prescribing ibuprofen alongside these medications and consider monitoring for signs of gastrointestinal bleeding. Dosage adjustments may be warranted based on the clinical scenario and the patient's overall risk profile.

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 24 lbs should not be treated without consulting a doctor, particularly those under 2 years of age. For children aged 2 to 3 years weighing 24-35 lbs, the recommended dose is 5 mL. For those aged 4 to 5 years weighing 36-47 lbs, the dose increases to 7.5 mL. Children aged 6 to 8 years weighing 48-59 lbs should receive 10 mL, while those aged 9 to 10 years weighing 60-71 lbs should be given 12.5 mL. For children aged 11 years weighing 72-95 lbs, the recommended dose is 15 mL.

Safety concerns include a recommendation against use in children under 3 years of age unless directed by a doctor. It is advised to consult a healthcare professional if the child has a history of stomach problems, is taking other medications, or has specific health conditions such as high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma.

Warnings include the potential for severe allergic reactions, particularly in children with an allergy to aspirin. There is also an increased risk of stomach bleeding, especially in children with a history of stomach ulcers or those taking other NSAIDs. Parents should seek medical advice if a child experiences a severe or persistent sore throat, particularly if accompanied by high fever, headache, nausea, or vomiting.

Dosing instructions emphasize using the child's weight to determine the appropriate dose; if weight is not available, age may be used as a guide. It is important not to exceed 4 doses in a 24-hour period and to administer the medication with food or milk if stomach upset occurs.

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 efficacy, 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. The text 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

Lactating mothers should consult a doctor before using this product. There is a potential for excretion in breast milk. The effects of ibuprofen on a nursing infant are not well studied; therefore, caution is advised.

Renal Impairment

There is no specific information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in this patient population.

Hepatic Impairment

There is no information available regarding the use of this medication in patients with hepatic impairment. Consequently, there are no dosage adjustments, special monitoring requirements, or precautions specified for individuals with compromised liver function. Healthcare professionals should exercise caution and consider the lack of data when prescribing this medication to patients with liver problems.

Overdosage

In the absence of specific information regarding overdosage in the provided sections of the Summary of Product Characteristics (SPL), healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdosage.

Recommended Actions In the event of an overdosage, it is essential for healthcare providers to assess the patient's clinical status and initiate appropriate supportive care. Monitoring of vital signs and symptomatic treatment should be implemented as necessary.

Potential Symptoms While specific symptoms of overdosage are not detailed, healthcare professionals should remain vigilant for any unusual or severe reactions that may arise, given the pharmacological profile of the medication.

Management Procedures In the absence of specific antidotes or treatment protocols, healthcare professionals should consider contacting a poison control center for guidance on the management of overdosage. It is crucial to document the incident thoroughly and report any adverse effects to the relevant regulatory authorities as per local guidelines.

Overall, the lack of detailed overdosage information underscores the importance of careful dosing and monitoring of patients receiving this medication.

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, asthma (wheezing), skin reddening, facial swelling, shock, rash, and blisters. Additionally, severe stomach bleeding has been noted, particularly in children with a history of stomach ulcers or bleeding problems, those taking anticoagulants or steroids, or those using 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. Symptoms indicative of heart problems or stroke have been reported, including chest pain, difficulty breathing, weakness in one part or side of the body, slurred speech, and leg swelling.

Patient Counseling

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

Providers should encourage patients to consult a doctor before use if there is a history of stomach bleeding in the child. Additionally, it is important to ask a doctor before use if the child has a history of stomach problems, such as heartburn, or if they have experienced serious side effects from pain relievers or fever reducers.

Patients should be informed to consult a doctor before use if the child has not been adequately hydrated or has lost significant fluids due to vomiting or diarrhea. It is also crucial to seek medical advice if the child has high blood pressure, heart disease, liver cirrhosis, kidney disease, or has had a stroke. Furthermore, patients should be advised to consult a doctor if the child has asthma or is taking a diuretic.

Healthcare providers should recommend that patients speak with a doctor or pharmacist before use if the child is under medical care for any serious condition or is taking any other medications.

Patients should be instructed to discontinue use and consult a doctor if the child exhibits any signs of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain. They should also stop use and seek medical attention if the child shows symptoms of heart problems or stroke, including chest pain, difficulty breathing, weakness on one side of the body, slurred speech, or leg swelling.

Additionally, patients should be advised to stop use and consult a doctor if there is no relief within the first 24 hours of treatment, 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.

Storage and Handling

The product is supplied in packaging that includes specific NDC numbers. It should be stored at a temperature range of 20-25°C (68-77°F) to maintain its integrity and efficacy.

Healthcare professionals are advised to inspect the carton prior to use; the product should not be utilized if the carton is opened or if the printed inner seal marked "SEALED for YOUR PROTECTION" is broken or missing. Proper handling and storage conditions are essential to ensure the product remains safe and effective for patient use.

Additional Clinical Information

The medication is administered orally, with a recommended repeat dose every 6-8 hours as needed, not to exceed four doses in a 24-hour period. Clinicians should advise patients to seek immediate medical assistance or contact a Poison Control Center (1-800-222-1222) in the event of an overdose.

No further information is available regarding laboratory tests, abuse potential, or postmarketing experiences.

Drug Information (PDF)

This file contains official product information for Childrens Ibuprofen, 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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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.