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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
December 27, 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 2019
Label revision date
December 27, 2024
Manufacturer
CVS Pharmacy
Registration number
ANDA076359
NDC root
69842-329
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (2 NDCs)
Packaging & NDC Codes (2)

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Drug Overview

Ibuprofen is a chewable medication designed for children aged 2 to 11, available in 100 mg doses with a pleasant orange flavor. It is a nonsteroidal anti-inflammatory drug (NSAID) that serves as a pain reliever and fever reducer. You can use it to help alleviate minor aches and pains associated with common conditions like the cold, flu, sore throat, headaches, and toothaches.

This medication works by reducing fever and relieving discomfort, providing relief that can last up to 8 hours. It is important to chew or crush the tablets completely before swallowing to ensure proper absorption. Ibuprofen is comparable to the active ingredient found in Children’s Motrin, making it a familiar choice for parents seeking effective relief for their children.

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.

Feel free to take it when you're feeling under the weather to help make you more comfortable.

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 and not exceed the recommended amount. You can find the right dose based on your child's weight or age, but if you're unsure, it's best to consult a doctor, especially for children under 2 years old.

For children weighing under 24 pounds, you should ask a doctor for guidance. If your child weighs between 24 and 35 pounds (ages 2-3 years), give them 1 tablet. For those weighing 36 to 47 pounds (ages 4-5 years), the dose is 1 ½ tablets. If your child weighs between 48 and 59 pounds (ages 6-8 years), they should take 2 tablets. For children weighing 60 to 71 pounds (ages 9-10 years), the dose is 2 ½ tablets, and for those weighing 72 to 95 pounds (age 11 years), 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

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 risks. Always consult with a healthcare professional if you have any concerns about your child's health or medication use.

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, and 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 fatal, particularly if used in higher doses or for longer than recommended. If your child experiences symptoms such as faintness, vomiting blood, or has bloody or black stools, 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 check with a healthcare professional before using ibuprofen if your child has any underlying health conditions or is taking other medications.

Warnings and Precautions

It's important to be aware of some serious warnings when using this medication. If you or your child have a known allergy to aspirin, be cautious, as this product can cause severe allergic reactions, including hives, facial swelling, and difficulty breathing. If any of these symptoms occur, stop using the medication and seek medical help immediately. Additionally, this medication can increase the risk of stomach bleeding, especially if your child has a history of stomach ulcers, is taking blood thinners, or uses other NSAIDs (nonsteroidal anti-inflammatory drugs) like aspirin or ibuprofen.

You should also be mindful of the potential for heart attack and stroke, which can be life-threatening. This risk increases if the medication is used in higher doses or for longer than recommended. If your child has a severe sore throat that lasts more than two days or is accompanied by a high fever, headache, nausea, or vomiting, consult a doctor right away. Always check with a healthcare provider before use if your child has any underlying health conditions, is taking other medications, or has experienced side effects from pain relievers in the past.

In case of an overdose, seek emergency medical help or contact a Poison Control Center immediately at 1-800-222-1222. If your child shows signs of stomach bleeding, such as feeling faint, vomiting blood, or having black stools, stop the medication and call your doctor. Also, reach out to a healthcare professional if your child experiences chest pain, trouble breathing, or weakness on one side of the body, or if symptoms do not improve within 24 hours.

Overdose

If you suspect an overdose, it’s crucial to seek medical help immediately or contact a Poison Control Center at 1-800-222-1222. Signs of an overdose can vary, but they may include unusual drowsiness, confusion, or difficulty breathing.

Don’t wait for symptoms to worsen; getting prompt assistance can be vital. Always prioritize your safety and the safety of others by acting quickly in these situations.

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 regarding ibuprofen. However, since the insert does not mention any special precautions, it is advisable to consult with your healthcare provider before taking ibuprofen or any medication during pregnancy to ensure it is safe for you and your baby. Always prioritize open communication with your doctor about any concerns or questions you may have.

Lactation Use

If you are breastfeeding, you can feel reassured that there are no specific warnings or recommendations regarding the use of ibuprofen while nursing. The information available does not indicate any concerns about ibuprofen being passed into breast milk or posing any risk to your infant. Always consult with your healthcare provider if you have any questions or concerns about medications while breastfeeding.

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 between 24-35 pounds (2-3 years) can take 1 tablet, while those weighing 72-95 pounds (11 years) can take 3 tablets. It's important not to use this medication for more than 2 days without consulting a doctor.

If your child has been dehydrated from vomiting or diarrhea, or if they show any concerning symptoms—like stomach pain, chest pain, or worsening fever—contact a doctor immediately. Always keep this medication out of reach of children, and in case of an overdose, seek medical help or contact a Poison Control Center right away.

Geriatric Use

While the drug insert for Children's Ibuprofen does not provide specific information about its use in older adults, it is important to approach any medication with caution. Since there are no guidelines on dosage adjustments or safety concerns for elderly patients, you should consult with a healthcare professional before using this medication. This is especially crucial if you or your loved one has any underlying health conditions or is taking other medications, as these factors can influence how the drug works in older adults. Always prioritize safety and seek personalized advice to ensure the best care.

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 can help determine if this medication is safe for you and whether any adjustments to your dosage or monitoring are necessary. Always prioritize your health and communicate openly with your healthcare provider about your medical history.

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 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 the 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.

Drug Interactions

It's important to be aware of potential interactions when taking ibuprofen. If you or your child are allergic to aspirin, using ibuprofen could lead to a severe allergic reaction. Additionally, the risk of stomach bleeding increases if ibuprofen is taken alongside blood thinners (medications that prevent blood clots) or steroids, as well as other nonsteroidal anti-inflammatory drugs (NSAIDs) like aspirin or naproxen.

If your child is on a diuretic (a medication that helps remove excess fluid from the body) or has conditions such as high blood pressure, heart disease, liver cirrhosis, kidney disease, or a history of stroke, it's crucial to consult a healthcare provider before using ibuprofen. Always discuss any medications or health conditions with your doctor to ensure safe and effective 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 temperature range helps maintain its effectiveness.

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 compromise its safety and effectiveness. Always prioritize these guidelines to ensure safe and proper use.

Additional Information

No further information is available.

FAQ

What is Ibuprofen?

Ibuprofen is a chewable pain reliever and fever reducer available in 100 mg tablets, designed for children ages 2-11.

How does Ibuprofen work?

Ibuprofen works as a nonsteroidal anti-inflammatory drug (NSAID) that reduces fever and relieves minor aches and pains from conditions like the common cold, flu, and headaches.

What is the recommended dosage for children?

Dosage varies by weight: for children weighing 24-35 lb (2-3 years), give 1 tablet; for 36-47 lb (4-5 years), give 1 ½ tablets; and for 48-59 lb (6-8 years), give 2 tablets.

Are there any contraindications for using Ibuprofen?

Do not use Ibuprofen if the child has had an allergic reaction to it 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 give Ibuprofen to my child if they have asthma?

Consult a doctor before use if your child has asthma or any other serious health conditions.

Is there a risk of allergic reactions with Ibuprofen?

Yes, Ibuprofen may cause severe allergic reactions, especially in those allergic to aspirin. Symptoms can include hives, swelling, and difficulty breathing.

How should I administer Ibuprofen to my child?

Chew or crush the tablets completely before swallowing, and do not exceed the recommended dosage.

What should I do in case of an overdose?

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

Is it safe to use Ibuprofen during pregnancy or while nursing?

The provided information does not specify safety concerns regarding the use of Ibuprofen during pregnancy or nursing.

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

Ibuprofen is presented in a dosage form of chewable tablets, each containing 100 mg of the active ingredient. The formulation is dye-free and features an orange flavor. It serves as a nonsteroidal anti-inflammatory drug (NSAID) indicated for pain relief and fever reduction in children aged 2 to 11 years. The tablets are designed to be chewed or crushed completely before swallowing. The product is packaged in a twin pack, consisting of two bottles, each containing 24 tablets, for a total of 48 tablets. The effects of the medication can last up to 8 hours. This formulation is comparable to the active ingredient found in Children’s Motrin and is marketed under the CVS Health brand.

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, prioritizing weight for dosing when possible; if weight is not available, age may be used as a secondary reference. If necessary, doses may be repeated every 6 to 8 hours, but it is important not to exceed a maximum 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 (ages 2-3 years), the recommended dose is 1 tablet.

  • For patients weighing 36-47 lb (ages 4-5 years), the recommended dose is 1 ½ tablets.

  • For patients weighing 48-59 lb (ages 6-8 years), the recommended dose is 2 tablets.

  • For patients weighing 60-71 lb (ages 9-10 years), the recommended dose is 2 ½ tablets.

  • For patients weighing 72-95 lb (age 11 years), the recommended dose is 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 cause severe allergic reactions, particularly in individuals with a known allergy to aspirin. Symptoms of such reactions 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 children who have a history of stomach ulcers or bleeding problems, are taking anticoagulants or steroid medications, are using other NSAIDs (including aspirin, ibuprofen, or naproxen), or are exceeding the recommended dosage or duration of use.

Additionally, NSAIDs, excluding aspirin, are associated with an increased risk of heart attack, heart failure, and stroke, which can be fatal. This risk escalates with prolonged use or higher than recommended dosages.

Severe or persistent sore throat, particularly when accompanied by high fever, headache, nausea, or vomiting, may indicate a serious condition. In such cases, it is essential to consult a healthcare provider promptly. The use of ibuprofen should not exceed two days, nor should it be administered to children under three years of age unless directed by a physician.

Healthcare professionals should advise caregivers to consult a doctor prior to use if any of the following conditions apply: the child has a history of stomach problems (such as heartburn), has experienced serious side effects from pain relievers or fever reducers, has not been adequately hydrated, has lost significant fluids due to vomiting or diarrhea, has high blood pressure, heart disease, liver cirrhosis, kidney disease, or a history of stroke, has asthma, or is taking a diuretic. Furthermore, it is advisable to consult a doctor or pharmacist if the child is under medical care for any serious condition or is taking other medications.

In the event of an overdose, immediate medical attention should be sought, or contact the Poison Control Center at 1-800-222-1222.

Caregivers should be instructed to discontinue use and consult a healthcare provider if the child exhibits any signs of stomach bleeding, such as feeling faint, vomiting blood, passing bloody or black stools, or experiencing persistent stomach pain. Additionally, symptoms indicative of heart problems or stroke, including chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling, warrant immediate medical evaluation. If the child does not experience relief within the first 24 hours of treatment, if fever or pain worsens or persists beyond three days, if redness or swelling occurs in the affected area, or if any new symptoms arise, medical advice should be sought without delay.

Side Effects

Patients using ibuprofen may experience a range of adverse reactions, which can vary in severity.

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 is associated with an increased risk of severe stomach bleeding, particularly in patients with a history of stomach ulcers or bleeding problems, those taking anticoagulants or steroid medications, or those using other NSAIDs (including aspirin and naproxen). The risk of stomach bleeding is heightened if the medication is taken in higher doses or for extended periods beyond the recommended guidelines.

Additionally, ibuprofen, like other nonsteroidal anti-inflammatory drugs (NSAIDs) excluding aspirin, may elevate the risk of heart attack, heart failure, and stroke, which can be fatal. This risk is particularly pronounced when the medication is used in excess of the directed dosage or for longer than advised.

Patients should be vigilant for signs of serious conditions. If a child experiences symptoms indicative of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or persistent stomach pain, medical consultation is advised. Symptoms suggestive of heart problems or stroke, including chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling, also warrant immediate medical attention. Furthermore, if a child does not achieve relief within the first 24 hours of treatment, or if fever or pain worsens or persists beyond three days, a healthcare provider should be consulted. Redness or swelling in the painful area or the emergence of new symptoms should also prompt a discussion with a healthcare professional.

Before administering ibuprofen, it is crucial to consult a doctor if the child has a history of stomach issues, has experienced serious side effects from pain relievers or fever reducers, is dehydrated, or has underlying health conditions such as high blood pressure, heart disease, liver cirrhosis, kidney disease, or a history of stroke. Additionally, children with asthma or those taking diuretics should seek medical advice prior to use.

In summary, while ibuprofen can be effective for pain and fever relief, careful consideration of potential adverse reactions and close monitoring of the patient’s condition are essential to ensure safety.

Drug Interactions

Ibuprofen is associated with several significant drug interactions that warrant careful consideration.

Allergic Reactions Ibuprofen may induce severe allergic reactions, particularly in individuals with a known allergy to aspirin. It is essential to assess the patient's allergy history before prescribing ibuprofen.

Gastrointestinal Risks The concomitant use of ibuprofen with anticoagulants or steroid medications increases the risk of gastrointestinal bleeding. This risk is also heightened when ibuprofen is taken alongside other nonsteroidal anti-inflammatory drugs (NSAIDs), including aspirin and naproxen. Clinicians should monitor patients closely for signs of gastrointestinal distress and consider alternative pain management strategies if necessary.

Diuretics and Comorbid Conditions Patients taking diuretics should be advised to consult a healthcare provider prior to initiating ibuprofen therapy. Additionally, individuals with high blood pressure, heart disease, liver cirrhosis, kidney disease, or a history of stroke should also seek medical advice before using ibuprofen, as these conditions may influence the safety and efficacy of the medication. Monitoring and potential dosage adjustments may be required based on the patient's overall health status and concurrent medications.

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 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

The medication should not be used for more than 2 days in children under 3 years of age unless directed by a doctor. If a child has not been drinking fluids or has experienced significant fluid loss due to vomiting or diarrhea, a doctor should be consulted.

Healthcare professionals should advise parents to stop use and seek medical attention if the child exhibits any of the following symptoms: signs of stomach bleeding (e.g., feeling faint, vomiting blood, having bloody or black stools, persistent stomach pain), symptoms of heart problems or stroke (e.g., chest pain, difficulty breathing, weakness on one side of the body, slurred speech, leg swelling), lack of relief within the first 24 hours of treatment, worsening fever or pain lasting more than 3 days, redness or swelling in the painful area, or the appearance of any new symptoms.

It is essential 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

There is no specific information regarding the use of Children's Ibuprofen in geriatric patients. The prescribing information does not provide recommended age considerations, dosage adjustments, safety concerns, or special precautions for elderly patients. Therefore, healthcare providers should exercise caution and consider individual patient factors when prescribing this medication to geriatric patients, as the absence of specific data necessitates careful clinical judgment. Monitoring for potential adverse effects and therapeutic efficacy is advised in 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 pregnancy. Additionally, no dosage modifications for pregnant individuals are provided. The insert also does not include any special precautions regarding the use of ibuprofen during pregnancy. Healthcare professionals should consider the absence of specific data when advising pregnant patients and weigh the potential benefits against any unknown risks.

Lactation

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

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 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. 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 enzymes and other relevant laboratory values is advised to ensure patient safety and therapeutic efficacy. If any signs of liver dysfunction arise during treatment, appropriate modifications to the therapeutic regimen should be considered.

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 the individual’s health status. Therefore, a thorough assessment and monitoring of the patient are essential.

Management procedures may include supportive care, symptomatic treatment, and specific antidotes if applicable. Healthcare providers should remain vigilant and prepared to implement appropriate interventions based on the clinical presentation of the patient.

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 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. 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 are concerns regarding stomach bleeding.

Additionally, healthcare providers should encourage patients to discuss any history of serious side effects from pain relievers or fever reducers, as well as any issues related to fluid intake. It is crucial to ask about recent fluid loss due to vomiting or diarrhea, and to consult a doctor if the child has high blood pressure, heart disease, liver cirrhosis, kidney disease, or has experienced a stroke.

Patients should also be advised to consult a doctor before use if the child has asthma or is taking a diuretic. Furthermore, it is important to recommend that patients speak with 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

No further data are available.

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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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.