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Childrens Ibuprofen

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Active ingredient
Ibuprofen 100 mg
Other brand names
Drug class
Nonsteroidal Anti-inflammatory Drug
Dosage form
Tablet, Chewable
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2019
Label revision date
May 20, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Ibuprofen 100 mg
Other brand names
Drug class
Nonsteroidal Anti-inflammatory Drug
Dosage form
Tablet, Chewable
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 2019
Label revision date
May 20, 2025
Manufacturer
CVS Pharmacy
Registration number
ANDA076359
NDC root
69842-706
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info
Packaging & NDC Codes

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

Drug Overview

Children’s Ibuprofen is a chewable medication designed for children aged 2 to 11. Each tablet contains 100 mg of ibuprofen, which is a type of nonsteroidal anti-inflammatory drug (NSAID). This medication is primarily used to reduce fever and relieve minor aches and pains associated with common conditions like colds, flu, sore throats, headaches, and toothaches.

The chewable tablets come in a pleasant orange flavor and can provide relief for up to 8 hours. It's important to chew or crush the tablets completely before swallowing to ensure effective use.

Uses

You can use this medication to help reduce fever and relieve minor aches and pains. It is effective for discomfort caused by common conditions such as the cold, flu, sore throat, headaches, and toothaches.

This means that if you're feeling under the weather or experiencing mild pain, this medication can provide some relief to help you feel better.

Dosage and Administration

Before taking this medication, make sure to chew or crush the tablets completely before swallowing them. It's important to follow the dosing instructions carefully, as this product does not provide complete warnings for adult use. Always check the dosing chart to find the right amount for you or your child. If possible, use weight to determine the dose; if not, you can use age instead.

For children weighing under 24 pounds or younger than 2 years, it's best to consult a doctor before giving this medication. For those weighing between 24 and 35 pounds (ages 2-3 years), the dose is 1 tablet. If your child weighs between 36 and 47 pounds (ages 4-5 years), they should take 1 ½ tablets. For children weighing 48 to 59 pounds (ages 6-8 years), the dose is 2 tablets, and for those weighing 60 to 71 pounds (ages 9-10 years), it's 2 ½ tablets. Finally, if your child weighs between 72 and 95 pounds (age 11 years), they should take 3 tablets.

You can repeat the dose every 6 to 8 hours if needed, but remember not to exceed 4 doses in a single day. Always ensure you do not give more than the directed amount.

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

Using ibuprofen can lead to some serious side effects, so it's important to be aware of them. You may experience a severe allergic reaction, especially if you are allergic to aspirin. Symptoms can include hives, facial swelling, wheezing, shock, skin reddening, rash, or blisters. Additionally, ibuprofen can increase the risk of severe stomach bleeding, particularly if you have a history of stomach ulcers, are taking blood thinners or steroids, or use other NSAIDs.

There is also a risk of heart attack and stroke associated with NSAIDs, which can be fatal, especially if used in higher doses or for longer than recommended. If you notice signs of stomach bleeding, such as feeling faint, vomiting blood, or having black stools, or if you experience symptoms of heart problems like chest pain or trouble breathing, seek medical attention immediately. Always consult your doctor if you have any underlying health conditions or are taking other medications before using ibuprofen.

Warnings and Precautions

Ibuprofen can cause serious allergic reactions, especially if you are allergic to aspirin. Symptoms may include hives, facial swelling, wheezing, shock, skin reddening, rash, or blisters. If you experience any of these symptoms, stop using the medication and seek medical help immediately.

This medication can also lead to severe stomach bleeding, particularly if you have a history of stomach ulcers or bleeding problems, are taking blood thinners or steroids, or are using other NSAIDs (nonsteroidal anti-inflammatory drugs) like aspirin or naproxen. Additionally, using ibuprofen for longer than directed increases the risk of heart attack and stroke, which can be fatal. If you notice signs of stomach bleeding, such as feeling faint, vomiting blood, or having black stools, stop use 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 have a severe sore throat with high fever, headache, nausea, or vomiting. If your child does not feel better within 24 hours, or if symptoms worsen or 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 get help right away. Your health and safety are 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 contraindications (situations where a drug should not be used) 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 and considering ibuprofen.

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, it's important to talk to your doctor before using this product. There is a possibility that it can pass into your breast milk, and the effects of ibuprofen on nursing infants haven't been thoroughly studied. Because of this uncertainty, it's wise to be cautious.

If you do take ibuprofen while nursing, 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

You should avoid using this medication in children under 3 years of age unless a doctor specifically advises it. For children aged 2 to 11 years, the dosage depends on their weight and age. For example, children weighing under 24 pounds or under 2 years should consult a doctor, while those weighing 24-35 pounds (ages 2-3) can take 1 tablet, and the dosage increases with weight and age up to 3 tablets for an 11-year-old weighing 72-95 pounds.

It's important to consult a doctor if your child has not been drinking fluids or has lost a lot of fluids due to vomiting or diarrhea. You should also stop using the medication and seek medical advice if your child shows signs of stomach bleeding (like feeling faint or vomiting blood), has symptoms of heart problems or stroke (such as chest pain or trouble breathing), does not feel better within 24 hours, or if fever or pain worsens or lasts more than 3 days. Additionally, watch for any redness or swelling in the painful area or the appearance of new symptoms.

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, it’s important to consult with a healthcare provider for personalized advice. 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. This is especially crucial if you also have high blood pressure, heart disease, liver cirrhosis (a severe liver condition), or if you've had a stroke. Your healthcare provider can help determine if this medication is safe for you and whether any adjustments are needed based on your kidney function. Always prioritize open communication with your doctor regarding your health conditions.

Hepatic Impairment

If you have liver problems, such as liver cirrhosis (a severe scarring of the liver), it's important to be aware of how this may affect your treatment. Your healthcare provider may need to adjust your medication dosage or closely monitor your liver function tests (tests that check how well your liver is working) to ensure your safety and the effectiveness of your treatment.

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

Drug Interactions

It's important to be aware of potential interactions when your child is taking ibuprofen. If your child is allergic to aspirin, they may experience a severe allergic reaction to ibuprofen. Additionally, if your child is on blood thinners (medications that prevent blood clots) or steroids, the risk of stomach bleeding increases. This risk is also heightened if they are taking other nonsteroidal anti-inflammatory drugs (NSAIDs), such as aspirin or naproxen.

Always consult with your healthcare provider if your child is taking any other medications, especially if they have asthma and are on a diuretic (a medication that helps remove excess fluid from the body). Discussing all medications and health conditions with a doctor ensures your child's safety and helps prevent serious side effects.

Storage and Handling

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

Before using the product, check that the printed seal under the cap is intact. If the seal is broken or missing, do not use the product, as this may indicate that it is no longer safe. Always handle the product with care to ensure your safety and the product's integrity.

Additional Information

You should take this medication orally, making sure to chew or crush the tablets completely before swallowing. If necessary, you can repeat the dose every 6 to 8 hours, but do not exceed four doses in a day. To help prevent any discomfort, consider taking it with food or milk, especially if you experience stomach upset.

It's important to keep this medication out of reach of children. In case of an overdose, seek medical help immediately or contact a Poison Control Center at 1-800-222-1222. You may experience a burning sensation in your mouth or throat, so taking it with food or water can help alleviate this.

FAQ

What is Children's Ibuprofen?

Children's Ibuprofen is a chewable pain reliever and fever reducer available in 100 mg tablets for children aged 2-11.

How does Children's Ibuprofen work?

It reduces fever and relieves minor aches and pains associated with the common cold, flu, sore throat, headaches, and toothaches.

How should I administer Children's Ibuprofen?

You should chew or crush the tablets completely before swallowing. If needed, repeat the dose every 6-8 hours, but do not exceed 4 doses in a day.

What is the dosing chart for Children's Ibuprofen?

The dosing chart is based on weight: Under 24 lb (Ask a doctor), 24-35 lb (1 tablet), 36-47 lb (1 ½ tablets), 48-59 lb (2 tablets), 60-71 lb (2 ½ tablets), 72-95 lb (3 tablets).

Are there any contraindications for using Children's Ibuprofen?

Do not use if the child has had an allergic reaction to ibuprofen or any other pain reliever, or if they are about to undergo heart surgery.

What should I do if my child experiences side effects?

Stop use and consult a doctor if your child shows signs of stomach bleeding, heart problems, or if symptoms worsen or do not improve within 24 hours.

Can I use Children's Ibuprofen for children under 3 years?

Do not use in children under 3 years of age unless directed by a doctor.

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

The provided information does not specify any risks or contraindications for use during pregnancy, but consult a doctor for personalized advice.

What precautions should nursing mothers take?

Nursing mothers should consult a doctor before using this product, as ibuprofen may be excreted in breast milk.

What should I do in case of an overdose?

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

CVS Health® Children’s Ibuprofen is a nonsteroidal anti-inflammatory drug (NSAID) formulated as chewable tablets containing 100 mg of ibuprofen. Designed for children aged 2 to 11, these tablets serve as a pain reliever and fever reducer. Each bottle contains 24 chewable tablets, which are to be chewed or crushed completely before swallowing. The tablets are presented in an orange flavor and are effective for up to 8 hours.

Uses and Indications

This drug is indicated for the reduction of fever and the relief of minor aches and pains associated with conditions such as the common cold, influenza, sore throat, headaches, and toothaches.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

Tablets should be chewed or crushed completely before swallowing. This product does not provide directions or complete warnings for adult use. Healthcare professionals are advised to ensure that patients do not exceed the recommended dosage.

The appropriate dose can be determined using the following chart, which prioritizes weight for dosing; if weight is not available, age may be used as a secondary reference. Dosing may be repeated every 6 to 8 hours as needed, but should not exceed four doses in a 24-hour period.

Dosing Chart:

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

  • For patients weighing 24-35 lb (ages 2-3 years): administer 1 tablet.

  • For patients weighing 36-47 lb (ages 4-5 years): administer 1 ½ tablets.

  • For patients weighing 48-59 lb (ages 6-8 years): administer 2 tablets.

  • For patients weighing 60-71 lb (ages 9-10 years): administer 2 ½ tablets.

  • For patients weighing 72-95 lb (age 11 years): administer 3 tablets.

It is imperative to adhere strictly to the dosing guidelines to ensure safety and efficacy.

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, facial swelling, asthma (wheezing), shock, skin reddening, rash, and blisters. In the event of an allergic reaction, it is imperative to discontinue use immediately and seek medical assistance.

The use of ibuprofen, an NSAID, carries a significant risk of severe stomach bleeding. This risk is notably elevated in pediatric patients with a history of stomach ulcers or bleeding disorders, those concurrently using anticoagulants or steroid medications, and individuals taking other NSAIDs, whether prescription or over-the-counter (e.g., aspirin, ibuprofen, naproxen). Additionally, exceeding the recommended dosage or duration of treatment increases the likelihood of gastrointestinal complications.

Healthcare professionals should be aware that the use of NSAIDs, excluding aspirin, is associated with an increased risk of heart attack, heart failure, and stroke, which can be fatal. This risk is amplified when the medication is used in excess of the recommended dosage or for prolonged periods.

In cases of severe or persistent sore throat, particularly when accompanied by high fever, headache, nausea, or vomiting, immediate 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 without a physician's directive.

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.

Healthcare providers should instruct caregivers to discontinue ibuprofen and seek medical advice 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 consultation is necessary. Any new symptoms that arise should also prompt a discussion with a healthcare professional.

Side Effects

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

The use of this product, which contains a nonsteroidal anti-inflammatory drug (NSAID), carries a risk of severe stomach bleeding. This risk is heightened in patients with a history of stomach ulcers or bleeding problems, those taking anticoagulants or steroid medications, and individuals using other NSAIDs, including aspirin and naproxen. Patients should be monitored for signs of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain.

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

Patients should be advised to seek medical attention if they experience severe or persistent sore throat, especially when accompanied by high fever, headache, nausea, or vomiting. The product should not be used for more than two days in such cases or in children under three years of age unless directed by a physician.

Common adverse reactions may include mouth or throat burning, which can be mitigated by administering the product with food or water. If stomach upset occurs, it is recommended to take the product with food or milk.

Patients should be instructed to discontinue use and consult a healthcare provider if they do not achieve 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 using this product, patients should consult a healthcare provider if they have a history of stomach problems, are experiencing dehydration, or have conditions such as high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma. It is also advisable to seek medical advice if the patient is under a doctor's care for any serious condition or is taking other medications.

Drug Interactions

Ibuprofen is associated with a risk of severe allergic reactions, particularly in individuals with a known allergy to aspirin.

When considering the use of ibuprofen in pediatric patients, it is important to note that the concomitant use of blood thinners (anticoagulants) or steroid medications may significantly increase the risk of gastrointestinal bleeding. Additionally, the risk of stomach bleeding is further elevated if the child is concurrently taking other nonsteroidal anti-inflammatory drugs (NSAIDs), including but not limited to aspirin and naproxen.

In cases where a child is receiving multiple medications, particularly those that may interact with ibuprofen, it is advisable to consult a healthcare professional for guidance.

Furthermore, caution is warranted when ibuprofen is administered to a child with asthma who is also taking a diuretic, as this combination may require careful monitoring and potential dosage adjustments based on the child's overall health status and response to treatment.

Packaging & NDC

Below are the non-prescription pack sizes of Childrens Ibuprofen (ibuprofen). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Childrens Ibuprofen.
Details

Pediatric Use

Pediatric patients under 3 years of age should not use this medication unless directed by a doctor. For children aged 2 years and older, dosing is based on weight and age as follows:

  • Under 24 lb / Under 2 yr: Consult a doctor

  • 24-35 lb / 2-3 yr: 1 tablet

  • 36-47 lb / 4-5 yr: 1 ½ tablets

  • 48-59 lb / 6-8 yr: 2 tablets

  • 60-71 lb / 9-10 yr: 2 ½ tablets

  • 72-95 lb / 11 yr: 3 tablets

Healthcare professionals should advise parents to consult a doctor if the child has not been drinking fluids or has experienced significant fluid loss due to vomiting or diarrhea.

The use of this medication should be discontinued and a doctor consulted if the child exhibits any signs of stomach bleeding (e.g., feeling faint, vomiting blood, having bloody or black stools, or persistent stomach pain), symptoms of heart problems or stroke (e.g., chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling), or if there is no relief within the first 24 hours of treatment. Additionally, if fever or pain worsens or persists beyond 3 days, if redness or swelling occurs in the painful area, or if any new symptoms arise, medical advice should be sought.

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 information. The prescribing information does not mention any contraindications or risks associated with ibuprofen use during this period. Additionally, no dosage modifications for pregnant individuals are provided, nor are there any special precautions outlined 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 doctor before using this product. There is a potential for excretion in breast milk, and the effects of ibuprofen on a nursing infant are not well studied; therefore, caution is advised. It is recommended to monitor the infant for any adverse effects if the nursing mother takes 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, or liver cirrhosis, as these may influence the management of their renal function and the appropriateness of treatment. Monitoring and potential dosing adjustments may be necessary based on the patient's renal status to ensure safety and efficacy.

Hepatic Impairment

Patients with hepatic impairment may experience altered pharmacokinetics of the medication due to compromised liver function. It is essential to assess the severity of liver impairment before initiating treatment.

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

Additionally, patients with a history of significant liver disease, such as cirrhosis, should be evaluated for any contraindications related to their hepatic condition. Regular assessment of clinical parameters and laboratory values is advised to manage any adverse effects effectively.

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 are advised to call the Poison Control Center at 1-800-222-1222 for guidance on managing the situation effectively.

Prompt intervention is crucial, as symptoms of overdose may vary depending on the substance involved. Therefore, a thorough assessment of the patient's condition is essential to determine the appropriate course of action.

Management procedures may include supportive care and symptomatic treatment, tailored to the specific symptoms presented by the patient. Continuous monitoring and evaluation are recommended to ensure patient safety and to address any complications that may arise during the management of an overdose.

Nonclinical Toxicology

No information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or toxicology.

Postmarketing Experience

Postmarketing experience has identified the following adverse reactions reported voluntarily or through surveillance programs: hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, and blisters. These events have been documented in the context of postmarketing surveillance and should be considered when evaluating the safety profile of the product.

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 important to inform patients that mouth or throat burning may occur, and to recommend administering the medication with food or water to mitigate this effect.

Patients should be instructed to take the medication with food or milk if they experience stomach upset. Healthcare providers should emphasize the necessity of consulting a doctor before use if the child has a history of stomach problems, such as heartburn, or if there is a stomach bleeding warning applicable to the child.

Additionally, patients should be advised to consult a doctor before use if the child has experienced significant fluid loss due to vomiting or diarrhea, or if the child has not been drinking fluids adequately. It is also crucial to recommend that patients seek medical advice if the child has high blood pressure, heart disease, liver cirrhosis, kidney disease, or has had a stroke.

Healthcare providers should encourage patients to discuss any history of asthma, as well as the use of diuretics, with their doctor prior to using the medication. Furthermore, patients should be reminded to consult a doctor or pharmacist if the child is under care for any serious condition or is taking any other medications.

Storage and Handling

The product is supplied in a configuration that includes an NDC number for identification. 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 product prior to use; it should not be utilized if the printed seal under the cap is broken or missing, as this may indicate potential tampering or contamination. 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 tablets required to be chewed or crushed completely before swallowing. Dosing may be repeated every 6-8 hours as needed, but should not exceed four doses in a 24-hour period.

Clinicians should counsel 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. Patients may experience mouth or throat burning, which can be mitigated by taking the medication with food or water. If stomach upset occurs, it is advisable to take the medication with food or milk.

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.