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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 2020
Label revision date
April 3, 2020
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 2020
Label revision date
April 3, 2020
Manufacturer
Rite Aid Corporation
Registration number
ANDA076359
NDC root
11822-1521
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 Chewable Tablets are a pain reliever and fever reducer designed specifically for children aged 2 to 11 years. Each tablet contains 100 mg of ibuprofen, which is a type of medication known as a nonsteroidal anti-inflammatory drug (NSAID). This medication helps reduce fever and relieve minor aches and pains associated with common conditions like colds, flu, sore throats, headaches, and toothaches.

These chewable tablets come in a pleasant grape flavor and are effective for up to 8 hours, making them a convenient option for managing your child's discomfort. Always ensure that the tablets are chewed or crushed completely before swallowing for the best results.

Uses

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

This means that if you're feeling under the weather or dealing with everyday aches, 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, so do not exceed the recommended amount. To find the right dose, refer to the dosing chart based on weight or age. If you’re unsure, it’s best to consult a doctor, especially for children under 2 years old.

For children aged 2 to 3 years who weigh between 24 and 35 pounds, the dose is 1 tablet. If your child is 4 to 5 years old and weighs between 36 and 47 pounds, they should take 1 and a half tablets. For those aged 6 to 8 years weighing 48 to 59 pounds, the dose is 2 tablets, and for children aged 9 to 10 years weighing 60 to 71 pounds, it’s 2 and a half tablets. Finally, for an 11-year-old weighing between 72 and 95 pounds, the dose is 3 tablets. If needed, you can repeat the dose every 6 to 8 hours, but remember not to use this medication more than 4 times a day.

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

Side Effects

Ibuprofen can cause serious allergic reactions, particularly in individuals who are allergic to aspirin. Signs of an allergic reaction may include hives, facial swelling, wheezing (asthma), shock, skin reddening, rash, or blisters. Additionally, this medication carries a risk of severe stomach bleeding, especially if your child has a history of stomach ulcers, is taking blood thinners or steroids, or uses other NSAIDs (nonsteroidal anti-inflammatory drugs) like aspirin or naproxen.

There is also an increased risk of heart attack and stroke associated with NSAIDs, which can be life-threatening, particularly if used in higher doses or for extended periods. If your child experiences symptoms such as faintness, vomiting blood, or has bloody or black stools, you should seek medical attention immediately. It's important 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 giving 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, facial swelling, wheezing, shock, skin reddening, rash, or blisters. If you experience any of these symptoms, stop using ibuprofen and seek medical help immediately.

This medication can also lead to severe stomach bleeding, particularly if you have a history of stomach ulcers or bleeding problems, are taking blood thinners or steroids, or are using other NSAIDs (nonsteroidal anti-inflammatory drugs) like aspirin or naproxen. Additionally, using ibuprofen for longer than directed increases the risk of heart attack and stroke, which can be fatal. If you notice signs of stomach bleeding, such as feeling faint, vomiting blood, or having black stools, or if you experience chest pain, trouble breathing, or weakness, stop using ibuprofen and contact your doctor right away.

For children, do not use ibuprofen for more than two days without a doctor's guidance, especially if they are under three years old. If your child does not feel better within 24 hours, if their fever or pain worsens or lasts more than three days, or if new symptoms appear, consult a doctor. In case of an overdose, seek 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

While the information provided does not specify any particular guidelines or risks associated with using ibuprofen during pregnancy, it is important to approach any medication with caution. Currently, there are no stated contraindications or dosage modifications for pregnant individuals. However, since the insert does not mention any special precautions, it is advisable 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 and health needs.

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, you should carefully consider the benefits of using ibuprofen against any potential risks to your baby. Your healthcare provider can help you make the best decision for you and your child.

Pediatric Use

It's important to be cautious when giving medication to children. You should not use 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 between 24-35 pounds (2-3 years) should take 1 tablet, while those weighing 72-95 pounds (11 years) can take 3 tablets.

If your child does not feel better within 24 hours, or if their fever or pain worsens or lasts more than 3 days, you should consult a doctor. Always keep the medication out of reach of children, and in case of an overdose, seek medical help or contact a Poison Control Center immediately.

Geriatric Use

When it comes to using Children's Ibuprofen, there are no specific guidelines or dosage adjustments for older adults mentioned in the drug insert. This means that, generally, elderly patients can use this medication without special considerations or safety concerns related to their age.

However, as with any medication, it's always a good idea for you or your caregivers to consult with a healthcare professional before starting any new treatment, especially if there are existing health conditions or other medications involved. This ensures that the use of Children's Ibuprofen is safe and appropriate for your individual health needs.

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 doctor will help determine if this medication is safe for you and may suggest adjustments to your dosage or additional monitoring to ensure your health and safety. Always prioritize open communication with your healthcare provider regarding your kidney health and any other medical conditions you may have.

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

Drug Interactions

It's important to be aware that ibuprofen can interact with certain medications, particularly blood thinners (anticoagulants) and steroid drugs. If you are taking any of these medications, it's crucial to discuss this with your healthcare provider to avoid potential complications. Additionally, ibuprofen may also interact with other nonsteroidal anti-inflammatory drugs (NSAIDs), such as aspirin or naproxen, whether they are prescription or over-the-counter.

While there are no specific laboratory test interactions noted, always inform your healthcare provider about all the medications you are taking. This ensures they can provide you with the safest and most effective care tailored to your needs.

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, always 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. Following these simple storage and handling guidelines will help you use the product safely and effectively.

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 ensure safety, keep this medication out of reach of children.

If you suspect an overdose, seek medical help immediately or contact a Poison Control Center at 1-800-222-1222. Some users may experience a burning sensation in the mouth or throat; taking the medication with food or water can help. If you experience stomach upset, consider taking it with food or milk.

FAQ

What is Children's Ibuprofen Chewable Tablets used for?

Children's Ibuprofen Chewable Tablets are used to reduce fever and relieve minor aches and pains due to the common cold, flu, sore throat, headaches, and toothaches.

What is the recommended dosage for Children's Ibuprofen?

The dosage depends on the child's weight and age. For example, children aged 2-3 years weighing 24-35 lb should take 1 tablet.

How should I administer the chewable tablets?

You should chew or crush the tablets completely before swallowing. It is also recommended to give them with food or water to avoid mouth or throat burning.

What should I do if my child experiences stomach bleeding?

If your child shows signs of stomach bleeding, such as feeling faint, vomiting blood, or having bloody or black stools, stop use and consult a doctor immediately.

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 for children under 3 years of age?

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

What should I do in case of an overdose?

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

Is it safe to use Children's Ibuprofen while breastfeeding?

Nursing mothers should consult a doctor before using this product, as ibuprofen may be excreted in breast milk and its effects on a nursing infant are not well studied.

How should I store Children's Ibuprofen?

Store Children's Ibuprofen between 20-25°C (68-77°F) and do not use if the printed seal under the cap is broken or missing.

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 Chewable Tablets contain 100 mg of ibuprofen, a nonsteroidal anti-inflammatory drug (NSAID) indicated for the relief of pain and reduction of fever. The dosage form is chewable tablets, which are available in a grape flavor. Each bottle contains 24 tablets. It is recommended that the tablets be chewed or crushed completely before swallowing to ensure proper administration.

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

Patients should chew or crush the tablets completely before swallowing to ensure proper administration. This product does not include specific directions or complete warnings for adult use. Healthcare professionals are advised to adhere strictly to the recommended dosing guidelines and not exceed the directed dosage.

Dosing should be determined using the chart provided below, prioritizing weight for dosing whenever possible; if weight is not available, age may be used as a secondary measure. If necessary, doses may be repeated every 6 to 8 hours, but it is imperative not to exceed a total of 4 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 or aged 2-3 years, administer 1 tablet.

  • For patients weighing 36-47 lb or aged 4-5 years, administer 1 ½ tablets.

  • For patients weighing 48-59 lb or aged 6-8 years, administer 2 tablets.

  • For patients weighing 60-71 lb or aged 9-10 years, administer 2 ½ tablets.

  • For patients weighing 72-95 lb or aged 11 years, administer 3 tablets.

It is essential to follow these guidelines to ensure safe and effective use of the product.

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 cause severe allergic reactions, particularly in individuals with a known allergy to aspirin. Symptoms indicative of an allergic reaction can include hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, and blisters. In the event of an allergic reaction, it is imperative to discontinue use immediately and seek medical assistance.

This product contains a nonsteroidal anti-inflammatory drug (NSAID), which 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 taking anticoagulants or steroid medications, or those concurrently using other NSAIDs, including aspirin, ibuprofen, or naproxen. Additionally, exceeding the recommended dosage or duration of use increases the risk of stomach bleeding.

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 prolonged 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 symptoms persist beyond two days or if the patient is under three years of age unless otherwise directed by a healthcare provider.

Patients should be instructed to discontinue use and consult a physician if any of the following occur: signs of stomach bleeding such as feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain; symptoms suggestive 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; presence of redness or swelling in the affected area; or the emergence of any new symptoms.

In the event of an overdose, immediate medical attention should be sought, or contact with a Poison Control Center is recommended (1-800-222-1222).

Side Effects

Patients using ibuprofen may experience a range of adverse reactions, some of which can be serious.

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

The use of ibuprofen, as a nonsteroidal anti-inflammatory drug (NSAID), carries a warning for potential severe stomach bleeding. The risk of this adverse reaction is heightened in patients with a history of stomach ulcers or bleeding problems, those taking anticoagulants or steroid medications, and individuals using other NSAIDs, including aspirin and naproxen. Additionally, the risk increases if the medication is taken in higher doses or for extended periods beyond the recommended guidelines.

Patients should also be aware of the increased risk of heart attack, heart failure, and stroke associated with NSAID use, excluding aspirin. These cardiovascular events can be fatal, particularly when the medication is used in excess or for longer durations than directed.

In clinical settings, patients presenting with severe or persistent sore throat, especially when accompanied by high fever, headache, nausea, or vomiting, should seek medical attention promptly. It is advised not to use ibuprofen for more than two days in such cases or to administer it to children under three years of age without a doctor's guidance.

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

Before using ibuprofen, it is crucial for patients to consult a healthcare provider 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. Additional caution is advised for patients with dehydration, high blood pressure, heart disease, liver cirrhosis, kidney disease, or a history of stroke, as well as those with asthma or those taking diuretics. It is also recommended to seek guidance from a doctor or pharmacist if the patient is under care for any serious condition or is taking other medications.

Drug Interactions

Ibuprofen has the potential to interact with various classes of medications, particularly anticoagulants and corticosteroids. The concomitant use of ibuprofen with blood-thinning agents may enhance the risk of bleeding due to the additive effects on platelet function and gastrointestinal mucosa. Therefore, careful monitoring of patients receiving both ibuprofen and anticoagulants or steroids is advised. Dosage adjustments may be necessary based on the clinical scenario and the patient's response.

Additionally, ibuprofen may interact with other nonsteroidal anti-inflammatory drugs (NSAIDs), including prescription and over-the-counter options such as aspirin and naproxen. The use of multiple NSAIDs concurrently can increase the risk of adverse effects, particularly gastrointestinal complications. It is recommended that patients avoid the simultaneous use of ibuprofen with other NSAIDs unless specifically directed by a healthcare professional.

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

Packaging & NDC

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

Packaging configurations for Childrens Ibuprofen.
Details

Pediatric Use

Pediatric patients under 3 years of age should not use this medication unless directed by a doctor. For children aged 2 to 11 years, dosing is based on weight and age, as outlined in the following chart:

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

  • 24-35 lb / 2-3 years: 1 tablet

  • 36-47 lb / 4-5 years: 1 ½ tablets

  • 48-59 lb / 6-8 years: 2 tablets

  • 60-71 lb / 9-10 years: 2 ½ tablets

  • 72-95 lb / 11 years: 3 tablets

If a child does not experience relief within the first 24 hours of treatment, or if fever or pain worsens or persists beyond 3 days, a doctor should be consulted. It is important to keep this medication out of reach of children. In the event of an overdose, immediate medical assistance or contact with a Poison Control Center is necessary.

Geriatric Use

Elderly patients do not have specific geriatric use considerations, dosage adjustments, or safety concerns noted in the prescribing information for Children's Ibuprofen. Therefore, healthcare providers may not need to implement any special precautions or modifications when prescribing this medication to geriatric patients. However, as with any medication, it is advisable to monitor elderly patients for any potential adverse effects or interactions, given the variability in pharmacokinetics and pharmacodynamics that may occur with aging.

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 pregnancy. Healthcare professionals should consider the absence of 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 weigh the benefits against the potential risks when considering the use of ibuprofen while breastfeeding.

Renal Impairment

Patients with renal impairment should consult a healthcare professional prior to use, particularly if they have a history of kidney disease. It is essential to assess the patient's overall health status, including any comorbid conditions such as high blood pressure, heart disease, liver cirrhosis, or a history of stroke, as these factors may influence the management of 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 drug 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 liver function is crucial, particularly in those with concurrent conditions such as high blood pressure, heart disease, or kidney disease, which may further complicate their clinical management.

Healthcare providers should exercise caution and consider alternative therapies in patients with severe hepatic impairment, as the risk of adverse effects may be heightened.

Overdosage

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

Prompt intervention is crucial in managing overdose situations, as timely medical support can significantly influence outcomes. Symptoms of overdose may vary depending on the substance involved, and healthcare providers should be prepared to assess and manage these symptoms accordingly.

Management procedures may include supportive care, monitoring of vital signs, and symptomatic treatment as necessary. It is essential for healthcare professionals to remain vigilant and act swiftly to mitigate potential complications associated with overdose.

Nonclinical Toxicology

No information is available regarding teratogenic effects. Similarly, there is no information provided concerning non-teratogenic effects. The insert does not contain any details related to nonclinical toxicology. Additionally, there is no information available regarding animal pharmacology and 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 ongoing safety monitoring.

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.

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, 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, they should stop use and seek medical advice.

It is important to inform patients that if the child does not experience relief within the first 24 hours of treatment, they should stop use and consult a doctor. Furthermore, if fever or pain worsens or persists beyond three days, or if there is any redness or swelling in the affected area, medical consultation is necessary. Patients should also be advised to seek medical attention if any new symptoms arise.

When using this product, patients should be made aware that mouth or throat burning may occur; therefore, it is recommended to administer the medication with food or water. If stomach upset occurs, taking the product with food or milk may help alleviate discomfort.

Patients should be encouraged to consult a doctor before use if the child has a history of stomach problems, such as heartburn, or if the stomach bleeding warning applies. Additionally, it is crucial to discuss any previous serious side effects from pain relievers or fever reducers, as well as any issues related to fluid intake, particularly if the child has not been drinking fluids or has lost significant fluid due to vomiting or diarrhea.

Healthcare providers should also inquire about the child's medical history, including high blood pressure, heart disease, liver cirrhosis, kidney disease, or a history of stroke. If the child has asthma or is taking a diuretic, a consultation with a doctor is advised prior to use. Lastly, patients should be reminded to inform their healthcare provider 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.

Learn more in our Editorial Policy

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Primary FDA sources:

Orange Book data shown on this page are limited to Regulatory Status (Rx), Established Pharmacologic Class (EPC), and Mechanism of Action (MoA).

Regulatory data notice: Information on this page is reproduced verbatim from FDA public databases (NSDE, Orange Book, Purple Book, DailyMed SPL). NDA/ANDA drugs are FDA-approved, BLA biologics are FDA-licensed. Inclusion alone does not guarantee current market availability or imply FDA endorsement.

Medical disclaimer: This AI-generated content is provided for educational purposes only and does not constitute medical advice. Always consult a licensed healthcare professional for diagnosis or treatment decisions.