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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
October 25, 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
October 25, 2023
Manufacturer
Chain Drug Marketing Association Inc.
Registration number
ANDA210149
NDC root
83324-012
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 designed for children aged 2 to 11 years. This oral suspension contains 100 mg of ibuprofen (a type of medication that helps alleviate pain and reduce fever) per 5 mL and is available in a pleasant mixed berry 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 lower fever. The effects can last for up to 8 hours, providing comfort when your child needs it most.

Uses

You can use this medication to help relieve minor aches and pains that may come from common conditions like the cold, flu, sore throat, headache, or 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 enclosed dosing cup to measure your dose; avoid using any other measuring devices to ensure accuracy. To find the right dose for you or your child, refer to the dosing chart based on weight or age. If you can, use weight for a more precise dosage.

You can repeat the dose every 6 to 8 hours if needed, but remember not to exceed four doses in a single day. For children under 2 years old who weigh less than 24 pounds, it's best to consult a doctor before administering any dose. For children aged 2 to 3 years who weigh between 24 and 35 pounds, the dose is 5 mL. As the weight increases, so does the dose, reaching up to 15 mL for children who are 11 years old and weigh between 72 and 95 pounds. Always follow the dosing chart or your doctor's instructions for the best results.

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 side effects, including severe allergic reactions, especially in those allergic to aspirin. Symptoms of an allergic reaction may include hives, wheezing, skin reddening, facial swelling, shock, rash, and blisters. Additionally, this medication can lead to severe stomach bleeding, particularly in children with a history of stomach ulcers or those taking blood thinners or other NSAIDs. There is also an increased risk of heart attack and stroke associated with NSAIDs, which can be fatal if used improperly.

You should stop using ibuprofen and consult a doctor if your child experiences signs of stomach bleeding, such as fainting, vomiting blood, or having black stools. Other concerning symptoms include chest pain, difficulty breathing, weakness on one side of the body, or slurred speech. If your child does not find relief within 24 hours, or if fever or pain worsens or lasts more than three days, seek medical advice. Always consult a doctor before use if your child has a history of stomach problems, is dehydrated, or has any serious health conditions.

Warnings and Precautions

Ibuprofen can cause serious allergic reactions, especially in those who are allergic to aspirin. If you notice symptoms like hives, wheezing, facial swelling, or blisters, stop using the medication and seek medical help immediately. Additionally, be aware that ibuprofen can lead to severe stomach bleeding, particularly if your child has a history of stomach ulcers, is taking blood thinners or steroids, or is using other NSAIDs (nonsteroidal anti-inflammatory drugs) like aspirin or naproxen.

There is also an increased risk of heart attack and stroke associated with NSAIDs, especially if used in higher doses or for longer than recommended. If your child has a severe or persistent sore throat, especially with high fever, headache, nausea, or vomiting, consult a doctor right away. It’s important not to use ibuprofen for more than two days in these cases or for children under three years old unless directed by a healthcare professional.

If you suspect an overdose, contact a Poison Control Center or seek emergency medical help immediately. You should also stop using ibuprofen and consult your doctor if your child experiences signs of stomach bleeding (like fainting, vomiting blood, or black stools), symptoms of heart problems or stroke (such as chest pain or weakness on one side of the body), or if their condition does not improve within 24 hours. If fever or pain worsens or lasts more than three days, or if new symptoms appear, reach out to your doctor for guidance.

Overdose

If you suspect an overdose, it's important to be aware that there may not be specific information available about the effects or treatment for this situation. However, you should always take any signs of overdose seriously. Common signs can include unusual drowsiness, confusion, or difficulty breathing (respiratory depression).

If you notice any of these symptoms or have concerns about an overdose, seek immediate medical help. It's better to be cautious and get professional assistance to ensure your safety. Always keep emergency contact numbers handy and don’t hesitate to reach out if you feel something is wrong.

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 contraindications (conditions that would prevent its use) mentioned, and no dosage adjustments are recommended for pregnant individuals. Additionally, the text does not highlight any special precautions you should take if you are pregnant.

While this information suggests that ibuprofen may not pose specific risks during pregnancy, it's always best to consult with your healthcare provider before taking any medication. They can provide personalized advice based on your health and pregnancy status.

Lactation Use

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

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

Pediatric Use

If you are considering using this medication for your child, it's important to know the recommended guidelines. For children under 2 years old, you should consult a doctor before use. For those aged 2 to 11 years, the dosage varies based on weight. For example, a child weighing 24-35 lbs (ages 2-3) should receive 5 mL, while a child weighing 72-95 lbs (age 11) can take 15 mL. Always aim to base the dosage on your child's weight, but if that's not possible, you can use their age instead.

Be cautious with this medication: do not use it for more than 2 days without a doctor's guidance, especially for children under 3 years old. Watch for signs of stomach bleeding, such as vomiting blood or having black stools, and consult a doctor if your child has a history of stomach issues or other serious health conditions. If your child does not feel better within 24 hours, or if their fever or pain worsens or lasts more than 3 days, seek medical advice.

Geriatric Use

While there is no specific information about the use of this medication in older adults, it’s important to approach any new treatment with caution. Since the insert mainly discusses pediatric use, you should consult your healthcare provider for personalized advice. They can help determine if this medication is appropriate for you or your loved one, considering any unique health needs or potential risks.

Always discuss any existing health conditions or medications with your doctor, as they can provide guidance on safety and effectiveness tailored to older adults. Your healthcare provider may also suggest monitoring for any side effects or changes in health while using this medication.

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 or dosage adjustments mentioned for your condition in the available information. This means that the standard recommendations apply, but you should always consult your healthcare provider for personalized advice. They can help determine the best approach for your treatment and monitor your liver function as needed.

Make sure to keep your doctor informed about your liver health, as they may want to conduct regular liver function tests (which check how well your liver is working) to ensure your safety while using any medication.

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 at a temperature between 20-25°C (68-77°F). This helps maintain its quality. Before using the product, check that the carton is unopened and that the inner seal, which says "SEALED for YOUR PROTECTION," is intact. If the carton is opened or the seal is broken or missing, do not use the product, as this may compromise its safety.

By following these simple storage and handling guidelines, you can help ensure that the product remains safe and effective for your use.

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. If you experience stomach upset, it's advisable to take the medication with food or milk.

In the event of an overdose, seek medical assistance immediately or contact a Poison Control Center at 1-800-222-1222 for help.

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 use more than 4 times a day.

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 your 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 consult a doctor before using Children's Ibuprofen for children under 2 years of age.

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

If your child experiences symptoms like vomiting blood or has bloody or black stools, stop use and consult a doctor immediately.

Is Children's Ibuprofen safe to use during pregnancy or while nursing?

The provided information does not specify any risks or recommendations regarding the use of ibuprofen during pregnancy or lactation.

How should I store Children's Ibuprofen?

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

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 as a nonsteroidal anti-inflammatory drug (NSAID) for the relief of pain and reduction of fever in pediatric patients aged 2 to 11 years. Each 5 mL dose contains 100 mg of ibuprofen. The product is alcohol-free and features a mixed berry flavor to enhance palatability. It is packaged in a 4 fluid ounce (120 mL) bottle and provides relief that lasts up to 8 hours. This formulation is comparable to the active ingredient in Children's Motrin®. The National Drug Code (NDC) for this product is 83324-012-04.

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 based on the patient's weight or, if weight is not available, their age.

For patients weighing under 24 lbs or under 2 years of age, it is advised to consult a physician for dosing recommendations. 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 administered 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 appropriate dose is 15 mL.

If necessary, doses may be repeated every 6-8 hours, but it is crucial not to exceed a total of 4 doses in a 24-hour period.

Contraindications

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

Warnings and Precautions

Ibuprofen may cause severe allergic reactions, 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. 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 an increased risk of severe stomach bleeding. The likelihood of this adverse effect is heightened in children who have a history of stomach ulcers or bleeding disorders, are concurrently taking anticoagulants or steroid medications, are using other NSAIDs (including aspirin, ibuprofen, or naproxen), or exceed the recommended dosage or duration of treatment.

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

In cases of severe or persistent sore throat, especially when accompanied by high fever, headache, nausea, or vomiting, immediate consultation with a healthcare provider is advised. 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 physician.

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

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 indicative of heart problems or stroke, including chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling, warrant immediate medical evaluation. If the child does not experience relief within the first 24 hours of treatment, or if fever or pain worsens or persists beyond three days, or if redness or swelling occurs in the affected area, medical advice should be sought. Any new or unusual symptoms should also prompt consultation with a healthcare professional.

Side Effects

Patients using ibuprofen may experience a range of adverse reactions, which can be categorized by seriousness and frequency.

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

The use of ibuprofen is associated with an increased risk of severe stomach bleeding, particularly 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. The risk of stomach bleeding is heightened if the medication is taken in higher doses or for extended periods beyond the recommended duration.

Additionally, ibuprofen carries warnings regarding the potential for serious cardiovascular events, including heart attack, heart failure, and stroke, which can be fatal. The likelihood of these events increases with the use of higher doses or prolonged treatment.

Patients should be advised 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 attention. 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, they should seek medical advice. Redness or swelling in the painful area or the emergence of any new symptoms should also prompt consultation with a healthcare professional.

Before using ibuprofen, it is advisable for patients to consult a doctor if they have a history of stomach issues, such as heartburn, or if they have experienced serious side effects from pain relievers or fever reducers. Patients who have not been adequately hydrated, have lost significant fluids due to vomiting or diarrhea, or have pre-existing conditions such as high blood pressure, heart disease, liver cirrhosis, kidney disease, or a history of stroke should also seek medical guidance. Additionally, patients with asthma or those taking diuretics should consult a healthcare provider prior to use.

In summary, while ibuprofen can be effective for pain relief and fever reduction, it is essential for patients to be aware of the potential for serious adverse reactions and to seek medical advice when necessary.

Drug Interactions

Ibuprofen has been associated with an increased risk of gastrointestinal bleeding when co-administered with anticoagulants or corticosteroids. This risk is further elevated 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 medication regimen.

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

For children under 2 years of age, consultation with a doctor is recommended prior to use. The dosing chart for pediatric patients aged 2 to 11 years is as follows: for those weighing 24-35 lbs (2-3 years), the recommended dose is 5 mL; for 36-47 lbs (4-5 years), 7.5 mL; for 48-59 lbs (6-8 years), 10 mL; for 60-71 lbs (9-10 years), 12.5 mL; and for 72-95 lbs (11 years), 15 mL. Dosing should ideally be based on weight; if weight is not available, age may be used as a guide.

Safety concerns include a recommendation against use for more than 2 days and a caution against administration to children under 3 years of age unless directed by a doctor. There is a warning regarding the risk of stomach bleeding, particularly in children with a history of stomach ulcers or bleeding problems, or those taking other NSAIDs. It is advised to consult a doctor if the child has a history of stomach issues, is dehydrated, or has serious health conditions such as high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma.

Special precautions should be taken if the child exhibits symptoms of stomach bleeding, such as vomiting blood, passing bloody or black stools, or experiencing stomach pain; in such cases, use should be discontinued and a doctor consulted. Additionally, if the child does not achieve relief within the first 24 hours of treatment, or if fever or pain worsens or persists beyond 3 days, a doctor should be consulted.

Geriatric Use

There is no specific information regarding the use of this medication in geriatric patients. The prescribing information primarily emphasizes pediatric use and does not provide any recommended age considerations, dosage adjustments, safety concerns, or special precautions for elderly patients.

Healthcare providers should exercise caution when prescribing this medication to geriatric patients, given the absence of data on its safety and efficacy in this population. Monitoring for potential adverse effects may be warranted, as elderly patients often have altered pharmacokinetics and may be more susceptible to medication-related complications.

Pregnancy

There are no specific statements regarding the use of ibuprofen during pregnancy in the provided information. The prescribing information 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 this period. Healthcare professionals should consider the absence of specific data when advising pregnant patients and weigh the potential benefits against any unknown risks.

Lactation

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

Renal Impairment

Patients with renal impairment have no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the text. Therefore, healthcare professionals should exercise caution and consider individual patient factors when prescribing to patients with reduced kidney function. Regular monitoring of renal function may be warranted in these patients, although specific guidelines are not outlined.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there are no established dosage adjustments, special monitoring requirements, or precautions for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population. Regular monitoring of liver function may be prudent in these cases, although specific parameters are not defined in the available information.

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.

Healthcare providers should monitor patients closely for any potential symptoms that may arise from an overdose. Symptoms can vary widely depending on the substance involved and the individual patient's response.

In the event of an overdosage, it is recommended that healthcare professionals initiate supportive care, which may include the following steps:

  1. Assessment: Conduct a thorough assessment of the patient's clinical status, including vital signs and level of consciousness.

  2. Supportive Care: Provide symptomatic treatment as necessary, which may involve intravenous fluids, oxygen supplementation, or other interventions based on the patient's needs.

  3. Consultation: Engage with a poison control center or toxicology expert for guidance on specific management strategies tailored to the substance involved.

It is essential for healthcare professionals to remain vigilant and prepared to address any complications that may arise from an overdosage scenario.

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. These include gastrointestinal bleeding, renal impairment, and hypersensitivity reactions, which encompass anaphylaxis and various skin reactions. Additionally, cases of serious skin reactions, such as Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported.

Cardiovascular events, including heart attack and stroke, have also been documented in association with the use of NSAIDs. Furthermore, instances of liver enzyme elevations and liver failure have been noted. Reports of asthma exacerbations in patients with pre-existing asthma have been observed as well.

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 child experiences stomach upset.

Patients should be instructed to discontinue use and consult a doctor if the child exhibits any signs of stomach bleeding, which may include feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain. Additionally, healthcare providers should inform patients to stop 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.

Patients should be counseled to monitor the child’s response to treatment. If the child does not experience relief within the first 24 hours, or if fever or pain worsens or persists beyond three days, they should contact a healthcare professional. Redness or swelling in the painful area or the appearance of any new symptoms should also prompt a consultation with a doctor.

Before initiating treatment, healthcare providers should encourage patients to discuss the following with their doctor: if the stomach bleeding warning applies to the child, if the child has a history of stomach issues such as heartburn, if there have been any serious side effects from pain relievers or fever reducers, if the child has not been adequately hydrated, or if there has been significant fluid loss due to vomiting or diarrhea. It is also important to mention any existing conditions such as high blood pressure, heart disease, liver cirrhosis, kidney disease, a history of stroke, or asthma, as well as if the child is taking a diuretic.

Lastly, healthcare providers should recommend that patients consult a doctor or pharmacist before use if the child is under medical care for any serious condition or is taking any other medications.

Storage and Handling

The product is supplied in a carton that must remain unopened until use. It is essential to verify that the printed inner seal, marked "SEALED for YOUR PROTECTION," is intact before administration.

Storage conditions require the product to be maintained at a temperature between 20-25°C (68-77°F). Proper adherence to these storage guidelines is crucial to ensure the integrity and efficacy of the product.

Additional Clinical Information

The medication is administered orally, with a recommended dosing frequency of every 6-8 hours as needed, not to exceed four doses per day. Patients are advised to take the medication with food or milk if they experience stomach upset. In the event of an overdose, it is crucial for patients to seek medical assistance immediately or contact a Poison Control Center at 1-800-222-1222.

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.

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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.