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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
March 5, 2024
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
March 5, 2024
Manufacturer
Rite Aid Corporation
Registration number
ANDA076359
NDC root
11822-4461
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 specifically designed for children aged 2 to 11 years. These chewable tablets contain 100 mg of ibuprofen, which is a type of medication known as a nonsteroidal anti-inflammatory drug (NSAID). They work by reducing fever and alleviating minor aches and pains associated with common conditions like colds, flu, sore throats, headaches, and toothaches.

The tablets come in a pleasant orange flavor and are formulated to last up to 8 hours, providing effective relief when your child needs it. It's important to ensure that the tablets are chewed or crushed completely before swallowing for optimal effectiveness.

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 such as 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, 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 under 24 pounds or under 2 years old, it's best to consult a doctor before giving this medication. For those weighing between 24 to 35 pounds (ages 2-3 years), the recommended dose is 1 tablet. If your child weighs between 36 to 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 72 to 95 pounds (age 11 years), they can take 3 tablets.

If you need to give another dose, you can repeat it every 6 to 8 hours, but remember not to exceed 4 doses in a single day. Always ensure you do not give more than the recommended amount.

What to Avoid

You should avoid using this medication if your child has ever had an allergic reaction to ibuprofen or any other pain reliever or fever reducer. Additionally, it is important not to use it right before or after heart surgery, as this could pose serious health risks. Always consult with a healthcare professional if you have any concerns about your child's health or medication use.

Side Effects

You should be aware of some potential side effects when using this medication. There is a risk of severe allergic reactions, especially if you are allergic to aspirin. Symptoms can include hives, facial swelling, wheezing, shock, skin reddening, rash, and blisters. Additionally, severe stomach bleeding is a concern, particularly if you have a history of stomach ulcers or bleeding problems, or if you are taking blood thinners or other nonsteroidal anti-inflammatory drugs (NSAIDs) like aspirin or ibuprofen.

There is also an increased risk of heart attack, heart failure, and stroke, which can be serious or even fatal, especially if the medication is used longer or in higher doses than recommended. If you experience severe or persistent sore throat, especially with high fever, headache, nausea, or vomiting, consult your doctor immediately. It's important to stop using the medication and seek medical advice if you notice symptoms of stomach bleeding, heart problems, or if your condition does not improve within 24 hours.

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 symptoms do not improve within 24 hours, or if fever or pain worsens or lasts more than three days, 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 safety is the top priority.

Pregnancy Use

When considering the use of ibuprofen during pregnancy, it's important to note that the available information does not specify any particular guidelines or risks associated with its use. There are no 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 and considering using this product, it's important to consult your doctor first. There is a possibility that the medication can pass into your breast milk, and the effects of ibuprofen on nursing infants have not 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

It's important to be cautious when using this medication for children. You should not give it to children under 3 years of age unless a doctor specifically advises you to do so. For children aged 2 to 11 years, the dosage depends on their weight and age. For example, if your child weighs between 24-35 pounds and is 2-3 years old, they can take 1 tablet. Always refer to the dosing chart for the correct amount based on your child's weight.

If your child needs another dose, you can repeat it every 6 to 8 hours, but do not exceed 4 doses in a day. If your child does not feel better within 24 hours or if their fever or pain worsens or lasts more than 3 days, it's important to consult a doctor. Always prioritize your child's health and safety by following these guidelines.

Geriatric Use

When it comes to using Children's Ibuprofen for older adults, there is no specific information available about dosage adjustments, safety concerns, or special precautions. This means that the drug insert does not provide guidelines tailored for elderly patients.

If you are considering this medication for an older adult, it's important to consult with a healthcare professional to ensure it is appropriate for their individual health needs. Always prioritize safety and seek advice if there are any concerns about using this medication.

Renal Impairment

If you have kidney problems, it's important to consult your doctor before using this medication. Your healthcare provider needs to know about any existing conditions, such as high blood pressure, heart disease, liver cirrhosis, or a history of stroke, as these can affect how the medication works for you. Always prioritize open communication with your doctor to ensure your safety and the effectiveness of your treatment.

Hepatic Impairment

If you have liver problems, such as liver cirrhosis (severe scarring of the liver), it's important to be aware of how this may affect your treatment. Your healthcare provider will need to monitor your liver function closely, which involves checking specific tests that measure how well your liver is working. Depending on the severity of your liver condition, they may adjust your medication dosage to ensure it's safe and effective for you.

Additionally, if you have other health issues like high blood pressure, heart disease, or kidney disease, these 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 how ibuprofen can interact with other medications you may be taking. For instance, if you are using blood thinners (medications that help prevent blood clots) or steroids, taking ibuprofen could increase your risk of stomach bleeding. Additionally, using ibuprofen or other nonsteroidal anti-inflammatory drugs (NSAIDs) for longer than recommended may raise your chances of serious heart issues, such as heart attack or stroke.

To ensure your safety, always discuss any medications you are taking with your healthcare provider. This includes over-the-counter drugs like ibuprofen, especially if you are already on other NSAIDs, such as aspirin or naproxen. Your healthcare provider can help you understand the risks and make informed decisions about your treatment.

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.

When handling the product, be sure to 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 prioritize these storage and handling guidelines to ensure your safety and the product's reliability.

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 burning sensation in your mouth or throat, consider taking it with food or water. If you experience stomach upset, taking it with food or milk may help.

Always keep this medication out of reach of children. In the event of an overdose, seek medical assistance immediately or contact a Poison Control Center at 1-800-222-1222.

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 age group is Children's Ibuprofen Chewable Tablets indicated for?

This medication is indicated for children aged 2 to 11 years.

How should I administer Children's Ibuprofen Chewable Tablets?

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

What is the maximum dosage for Children's Ibuprofen Chewable Tablets?

Do not use more than 4 times a day, and if needed, you can repeat the dose every 6-8 hours.

Are there any warnings associated with Children's Ibuprofen Chewable Tablets?

Yes, there are warnings for severe allergic reactions, stomach bleeding, and increased risk of heart attack and stroke. Consult a doctor if your child experiences any severe symptoms.

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

If your child experiences symptoms like hives, facial swelling, or difficulty breathing, stop use immediately and seek medical help.

Can I give Children's Ibuprofen Chewable Tablets to a child under 2 years?

You should ask a doctor before giving this medication to a child under 2 years of age.

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

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

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

The provided information does not specify any risks or contraindications for use during pregnancy, but it is advisable to consult a doctor.

What should nursing mothers know about using Children's Ibuprofen?

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

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 are formulated as chewable dosage forms containing 100 mg of ibuprofen, a nonsteroidal anti-inflammatory drug (NSAID) indicated for the relief of pain and reduction of fever in children aged 2 to 11 years. Each tablet is designed to provide effective relief lasting up to 8 hours. The tablets are orange-flavored and should be chewed or crushed completely before swallowing. The product is packaged in a container containing 24 tablets.

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.

Dosing should be determined using the chart provided below, with weight being the preferred method for dosing; if weight is not available, age may be used as an alternative. If necessary, doses may be repeated every 6 to 8 hours, but it is important 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, consult a doctor.

  • 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.

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

This product contains a nonsteroidal anti-inflammatory drug (NSAID), which is associated with a risk of severe stomach bleeding. The likelihood of this adverse effect is heightened in pediatric patients with a history of stomach ulcers or bleeding disorders, those concurrently using anticoagulants or steroid medications, or those taking other NSAIDs (including aspirin, ibuprofen, naproxen, or similar agents). Additionally, exceeding the recommended dosage or duration of treatment increases this risk.

NSAIDs, excluding aspirin, are linked to an elevated risk of heart attack, heart failure, and stroke, which can be fatal. This risk is particularly pronounced when the medication is used in excess of the recommended dosage or for extended periods.

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 promptly. The use of ibuprofen should not exceed two days for sore throat relief, nor should it be administered to children under three years of age unless specifically directed by a healthcare provider.

It is crucial to advise caregivers to discontinue use and consult a physician if the child exhibits any of the following symptoms indicative of stomach bleeding: feeling faint, vomiting blood, passing bloody or black stools, or experiencing persistent stomach pain. Additionally, signs of heart problems or stroke, such as chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling, warrant immediate medical evaluation. If the child does not experience relief within the first 24 hours of treatment, or if fever or pain worsens or persists beyond three days, or if redness or swelling occurs in the affected area, medical advice should be sought. Any new symptoms that arise should also prompt consultation with a healthcare professional.

In cases of overdose, immediate medical attention is necessary. Caregivers should contact a Poison Control Center or seek emergency medical help without delay (1-800-222-1222).

Side Effects

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

There is also a significant risk of severe stomach bleeding, especially in patients with a history of stomach ulcers or bleeding problems, those taking anticoagulants or steroid medications, or those using other nonsteroidal anti-inflammatory drugs (NSAIDs) such as aspirin, ibuprofen, or naproxen. The likelihood of stomach bleeding increases with prolonged use or higher than recommended dosages.

Additionally, patients may face an increased risk of heart attack, heart failure, and stroke, which can be fatal. This risk is heightened when the medication is used beyond the directed duration or dosage.

Patients should be vigilant for signs of serious conditions, such as severe or persistent sore throat, particularly when accompanied by high fever, headache, nausea, or vomiting, and should seek medical advice promptly. It is advised not to use the medication for more than two days or to administer it to children under three years of age without a doctor's guidance.

Patients are instructed to discontinue use and consult a healthcare provider if they experience symptoms indicative of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or persistent stomach pain. Symptoms of heart problems or stroke, including chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling, also warrant immediate medical attention. Furthermore, if there is no relief within the first 24 hours of treatment, or if fever or pain worsens or persists beyond three days, patients 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.

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

Drug Interactions

Ibuprofen may interact with various medications, leading to significant clinical effects.

Pharmacodynamic Interactions:The concomitant use of ibuprofen with anticoagulants or steroid medications may elevate the risk of gastrointestinal bleeding. Healthcare professionals should monitor patients closely for signs of bleeding and consider alternative pain management strategies if necessary.

Additionally, the use of nonsteroidal anti-inflammatory drugs (NSAIDs), including ibuprofen, has been associated with an increased risk of cardiovascular events such as heart attack, heart failure, and stroke. This risk is particularly pronounced when NSAIDs are used in higher doses or for extended periods. It is advisable to limit the duration and dosage of ibuprofen to the lowest effective amount necessary for symptom relief.

Pharmacokinetic Interactions:Ibuprofen should not be administered concurrently with other medications containing NSAIDs, whether prescription or over-the-counter, such as aspirin or naproxen. The combination of these agents may lead to an increased risk of adverse effects without providing additional therapeutic benefit.

No specific laboratory test interactions 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:

  • Weight under 24 lb / Age under 2 years: Ask a doctor

  • Weight 24-35 lb / Age 2-3 years: 1 tablet

  • Weight 36-47 lb / Age 4-5 years: 1 ½ tablets

  • Weight 48-59 lb / Age 6-8 years: 2 tablets

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

  • Weight 72-95 lb / Age 11 years: 3 tablets

Doses may be repeated every 6-8 hours as needed, but should not exceed 4 doses in a 24-hour period. If a child does not experience relief within the first 24 hours of treatment, or if fever or pain worsens or persists for more than 3 days, a doctor should be consulted.

Geriatric Use

Elderly patients may not have specific information regarding the use of Children's Ibuprofen, including dosage adjustments, safety concerns, or special precautions. As such, 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, 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, including those with liver cirrhosis, may require careful consideration when being prescribed this medication. Due to the potential for altered pharmacokinetics in individuals with compromised liver function, dosage adjustments may be necessary.

Monitoring of liver function is recommended for patients with hepatic impairment to ensure safety and efficacy. Clinicians should assess liver enzymes and other relevant parameters regularly to evaluate the patient's response to treatment and to identify any potential adverse effects related to liver function.

In patients with significant hepatic impairment, such as those with a history of liver cirrhosis, the use of this medication may be restricted or contraindicated, depending on the severity of the impairment and the specific clinical scenario. It is essential for healthcare providers to weigh the benefits against the risks when considering treatment options for these patients.

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 effectively. Symptoms of overdose may vary depending on the substance involved, and healthcare providers should be prepared to assess and address any potential complications that may arise.

Management procedures should include a thorough evaluation of the patient's condition, monitoring vital signs, and providing supportive care as necessary. Depending on the specific circumstances of the overdose, additional medical interventions may be required to ensure patient safety and recovery.

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 question.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions reported voluntarily or through surveillance programs. These include hives, facial swelling, asthma characterized by wheezing, shock, skin reddening, rash, and blisters.

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 stomach pain that does not improve. 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 for more than three days, or if there is any redness or swelling in the painful area, medical advice should be sought. Patients should also be aware that any new symptoms that arise warrant a consultation with a healthcare provider.

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

Healthcare providers should encourage patients 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, patients should be advised to seek medical advice if the child has experienced serious side effects from pain relievers or fever reducers, has not been adequately hydrated, or has lost significant fluids due to vomiting or diarrhea.

Patients should also be instructed to consult a doctor before use if the child has high blood pressure, heart disease, liver cirrhosis, kidney disease, or a history of stroke. If the child has asthma, is taking a diuretic, or is under a doctor’s care for any serious condition, it is essential to seek medical advice prior to using this product. Lastly, patients should be reminded to consult a doctor or pharmacist if the child 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 ensure optimal stability 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 compromise of the product's integrity.

Additional Clinical Information

The medication is administered orally, with patients advised to chew or crush the tablets 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 that mouth or throat burning may occur, and it is recommended to take the medication with food or water to mitigate this effect. If stomach upset occurs, taking the medication with food or milk is advisable. Patients should be instructed 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.

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.