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Childrens Ibuprofen

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Active ingredient
Ibuprofen 100 mg/5 mL
Other brand names
Drug class
Nonsteroidal Anti-inflammatory Drug
Dosage form
Suspension/ Drops
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2018
Label revision date
September 7, 2018
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Ibuprofen 100 mg/5 mL
Other brand names
Drug class
Nonsteroidal Anti-inflammatory Drug
Dosage form
Suspension/ Drops
Route
Oral
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2018
Label revision date
September 7, 2018
Manufacturer
Guardian Drug Company
Registration number
ANDA210149
NDC root
53041-634
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info
Packaging & NDC Codes

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

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

Drug Overview

Children's Ibuprofen is an oral suspension medication designed for children aged 2 to 11 years. It is a nonsteroidal anti-inflammatory drug (NSAID) that helps relieve minor aches and pains caused by common conditions such as the cold, flu, sore throat, headache, and toothache. Additionally, it effectively reduces fever, providing comfort when your child is feeling unwell.

This medication comes in a pleasant mixed berry flavor and is alcohol-free, making it suitable for young children. Each 5 mL dose contains 100 mg of ibuprofen, and its effects can last for up to 8 hours, helping to keep your child feeling better throughout the day.

Uses

You can use this medication to help relieve minor aches and pains that may come from common conditions like the cold, flu, sore throat, headache, or toothache. It’s also effective in reducing fever, making it a helpful option when you're feeling unwell.

Rest assured, this medication does not have any teratogenic effects, meaning it does not cause birth defects. This makes it a safer choice for those who may be concerned about such risks.

Dosage and Administration

Before you use the medication, make sure to shake the bottle well. It's important to use only the enclosed dosing cup to measure your dose; avoid using any other measuring devices to ensure accuracy. To find the right dose, refer to the dosing chart based on your child's weight or age. If you’re unsure, it’s best to consult with a doctor, especially for children under 2 years old.

Once you have the correct dose, you can repeat it every 6 to 8 hours if necessary, but remember not to exceed four doses in a single day. This helps ensure that the medication is effective while minimizing the risk of side effects. Always follow the guidelines provided or your doctor's instructions for the best results.

What to Avoid

You should avoid using this medication if your child has ever had an allergic reaction to ibuprofen or any other pain reliever or fever reducer. Additionally, it is important not to use this medication right before or after your child has undergone heart surgery. Following these guidelines will help ensure your child's safety and well-being.

Side Effects

Ibuprofen can cause serious side effects, including severe allergic reactions, particularly in those who are allergic to aspirin. Symptoms of an allergic reaction may include hives, wheezing (asthma), skin reddening, facial swelling, shock, rash, and blisters. Additionally, this medication can lead to 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 if used improperly.

If your child experiences symptoms such as fainting, vomiting blood, black or bloody stools, persistent stomach pain, or signs of heart problems (like chest pain or trouble breathing), you should seek medical attention immediately. It's important to consult a doctor before using ibuprofen if your child has a history of stomach issues, is dehydrated, or has other serious health conditions. Always monitor your child closely and stop use if symptoms worsen or new symptoms appear.

Warnings and Precautions

Ibuprofen can cause serious allergic reactions, especially if you are allergic to aspirin. Symptoms may include hives, wheezing, skin redness, facial swelling, and even shock. If you notice any of these signs, stop using the medication and seek medical help immediately.

This medication can also lead to severe stomach bleeding, particularly if your child has a history of stomach ulcers, is taking blood thinners or steroids, or is using other NSAIDs (nonsteroidal anti-inflammatory drugs) like aspirin or naproxen. Additionally, using ibuprofen for longer than recommended increases the risk of heart attack and stroke, which can be life-threatening. If your child has a severe sore throat, especially with a high fever or other concerning symptoms, consult a doctor right away.

Be alert for signs of stomach bleeding, such as faintness, vomiting blood, or black stools, and contact your doctor if these occur. If your child experiences chest pain, trouble breathing, weakness, slurred speech, or swelling in the legs, seek emergency medical help. Always call your doctor if your child does not feel better within 24 hours, if symptoms worsen, or if new symptoms appear. In case of overdose, contact a Poison Control Center immediately at 1-800-222-1222.

Overdose

Taking too much ibuprofen can lead to serious health issues. If you or someone you know has taken an overdose, it's important to be aware of the symptoms, which may include nausea (feeling sick), vomiting, stomach pain, drowsiness (extreme tiredness), and headache.

If you suspect an overdose, seek immediate medical help or contact a Poison Control Center right away. Acting quickly can make a significant difference in ensuring safety and health.

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 the use of any medication with caution. Currently, there are no stated contraindications (conditions that would prevent use) 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, you can feel reassured that there are no specific warnings or recommendations regarding nursing mothers or lactation in the information provided. This means that, based on the available data, there are no known risks associated with breastfeeding while using this medication. However, it's always a good idea to consult with your healthcare provider if you have any concerns or questions about your specific situation.

Pediatric Use

When giving medication to your child, it's important to follow the correct dosage based on their weight and age. For children under 24 pounds or under 2 years old, you should consult a doctor before use. For those aged 2-3 years weighing 24-35 pounds, the recommended dose is 5 mL. As your child grows, the dosage increases: 7.5 mL for ages 4-5 years (36-47 lbs), 10 mL for ages 6-8 years (48-59 lbs), 12.5 mL for ages 9-10 years (60-71 lbs), and 15 mL for 11-year-olds (72-95 lbs). Always follow your doctor’s instructions if they provide specific guidance.

Be cautious when using this medication for children. It should not be given for more than 2 days or to children under 3 years without a doctor's advice. If your child has a history of stomach issues, is dehydrated, or has certain health conditions like high blood pressure or asthma, consult a doctor before use. Additionally, keep the medication out of reach of children, and in case of an overdose, seek medical help immediately or contact a Poison Control Center at 1-800-222-1222.

Geriatric Use

While there is no specific information about the use of this medication in older adults, it’s important to approach any new treatment with caution. Since the insert mainly discusses pediatric use, you should consult your healthcare provider for personalized advice, especially if you or a loved one is an older adult. They can help determine if any dosage adjustments or special precautions are necessary based on individual health needs.

Always keep in mind that older adults may have different responses to medications, so discussing any concerns with a healthcare professional is essential for ensuring safety and effectiveness.

Renal Impairment

If you have kidney problems, it's important to know that there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the usual recommendations for monitoring or safety considerations related to renal impairment (kidney issues) are not provided.

Always consult your healthcare provider for personalized advice and to ensure that any medications you take are safe and appropriate for your kidney health. They can help you understand how your condition may affect your treatment plan.

Hepatic Impairment

If you have liver problems, it's important to know that there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the standard recommendations for the medication do not change based on liver impairment. However, it’s always a good idea to discuss your liver health with your healthcare provider, as they can offer personalized advice and monitor your condition effectively.

Make sure to keep your doctor informed about any liver issues you may have, as they can help ensure that your treatment is safe and appropriate for you.

Drug Interactions

It's important to be aware of how certain medications can interact with each other. For instance, if you take ibuprofen, it can lead to severe stomach bleeding, especially when combined with blood thinners (medications that prevent blood clots) or steroids. Additionally, using nonsteroidal anti-inflammatory drugs (NSAIDs) like ibuprofen for longer than recommended can increase your risk of heart attack and stroke. If you are taking other NSAIDs, such as aspirin or naproxen, this risk of stomach bleeding may also rise.

Always discuss any medications you are taking with your healthcare provider. They can help you understand the potential risks and ensure that your treatment plan is safe and effective for you.

Storage and Handling

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

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

Additional Information

You should take this medication orally, and if necessary, you can repeat the dose every 6 to 8 hours. However, do not exceed four doses in a single day. It's important to 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 for help.

FAQ

What is Children's Ibuprofen?

Children's Ibuprofen is an oral suspension (NSAID) that provides relief from minor aches and pains and reduces fever.

What age group is Children's Ibuprofen suitable for?

It is suitable for children aged 2 to 11 years.

How long does the effect of Children's Ibuprofen last?

The effects can last up to 8 hours.

How should I dose Children's Ibuprofen?

Use the enclosed dosing cup and refer to the dosing chart based on your child's weight or age. Repeat doses every 6-8 hours, not exceeding 4 times a day.

What should I do if my child has a history of allergies?

Do not use Children's Ibuprofen if your child has ever had an allergic reaction to ibuprofen or any other pain reliever/fever reducer.

What are the warnings associated with Children's Ibuprofen?

Warnings include the risk of severe allergic reactions, stomach bleeding, and increased risk of heart attack and stroke, especially if used more than directed.

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

Stop use and call your doctor if your child experiences symptoms like vomiting blood, bloody stools, or severe stomach pain.

Can I use Children's Ibuprofen if my child has a sore throat?

Consult a doctor if your child has a severe or persistent sore throat, especially if accompanied by high fever or other symptoms.

How should I store Children's Ibuprofen?

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

Is there any specific information regarding use during pregnancy or nursing?

The provided information does not include specific warnings or recommendations for use 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

NDC 53041-634-03, GUARDIAN is a children's ibuprofen oral suspension, USP, indicated for use in children aged 2 to 11 years. Each 5 mL dose contains 100 mg of ibuprofen, functioning as a nonsteroidal anti-inflammatory drug (NSAID) for the relief of pain and reduction of fever. The formulation is designed to provide relief lasting up to 8 hours. This product is alcohol-free and contains no artificial sweeteners, featuring a mixed berry flavor for palatability. The total volume of the product is 4 FL OZ (120 mL).

Uses and Indications

This drug is indicated for the relief of minor aches and pains associated with the common cold, influenza, sore throat, headache, and toothache. Additionally, it is utilized to reduce fever.

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

Dosage and Administration

The medication should be shaken well before use. It is essential to utilize only the enclosed dosing cup for administration; other dosing devices are not recommended. Healthcare professionals should refer to the dosing chart to determine the appropriate dose based on the patient's weight or age, as applicable.

For patients weighing under 24 pounds or under 2 years of age, it is advised to consult a doctor for the appropriate dosage. For those weighing between 24 to 35 pounds or aged 2 to 3 years, the recommended dose is 5 mL. Patients weighing 36 to 47 pounds or aged 4 to 5 years should receive 7.5 mL. For individuals weighing 48 to 59 pounds or aged 6 to 8 years, the dose is 10 mL. Patients weighing 60 to 71 pounds or aged 9 to 10 years should be administered 12.5 mL, while those weighing 72 to 95 pounds or aged 11 years should receive 15 mL.

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 should always be conducted in accordance with the guidance of a healthcare professional.

Contraindications

Use of this product is contraindicated in the following situations:

  • In patients with a history of allergic reactions to ibuprofen or any other pain reliever or fever reducer, due to the risk of severe allergic reactions.

  • In patients undergoing heart surgery, as use immediately before or after such procedures may pose significant risks.

Warnings and Precautions

Patients should be closely monitored for potential allergic reactions when administering ibuprofen, particularly in individuals with a known allergy to aspirin. Symptoms indicative of a severe allergic reaction may include hives, asthma (wheezing), skin reddening, facial swelling, shock, rash, and blisters. In the event of an allergic reaction, it is imperative to discontinue use immediately and seek medical assistance.

The use of ibuprofen carries a significant risk of severe stomach bleeding, particularly in pediatric patients with a history of stomach ulcers or bleeding disorders. The risk is further elevated in patients concurrently taking anticoagulants, steroid medications, or other nonsteroidal anti-inflammatory drugs (NSAIDs) such as aspirin or naproxen. It is crucial to adhere strictly to the recommended dosage and duration of treatment to mitigate this risk.

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

In cases of severe or persistent sore throat, particularly when accompanied by high fever, headache, nausea, or vomiting, immediate medical consultation is advised. Ibuprofen should not be used for more than two days in such instances, nor should it be administered to children under three years of age unless specifically directed by a healthcare provider.

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

Healthcare providers should instruct caregivers to discontinue ibuprofen and consult a physician if the child exhibits any signs of stomach bleeding, such as feeling faint, vomiting blood, passing bloody or black stools, or experiencing persistent stomach pain. Additionally, symptoms indicative of cardiovascular issues or stroke, including chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling, warrant immediate medical evaluation.

If the child does not experience relief within the first 24 hours of treatment, or if fever or pain worsens or persists beyond three days, or if there is any redness or swelling in the affected area, further medical assessment is necessary. Caregivers should also be vigilant for the emergence of any new symptoms during treatment.

Side Effects

Patients using ibuprofen should be aware of potential adverse reactions, which can range from serious to common.

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

The use of ibuprofen is associated with a 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, ibuprofen, or naproxen). The risk of stomach bleeding increases with prolonged use or higher doses than recommended.

Additionally, ibuprofen carries warnings regarding cardiovascular risks. The use of NSAIDs, excluding aspirin, has been linked to an increased risk of heart attack, heart failure, and stroke, which can be fatal. This risk is heightened with excessive or prolonged use.

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 attention should be sought immediately. Symptoms of heart problems or stroke, including chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling, also warrant prompt consultation with a healthcare provider.

It is advised to discontinue use and consult a doctor if the child does not achieve relief within the first 24 hours of treatment, if fever or pain worsens or persists beyond three days, if redness or swelling occurs in the painful area, or if any new symptoms arise.

Before administering ibuprofen, it is crucial to consult a healthcare professional 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.

Lastly, it is recommended to consult a doctor or pharmacist if the child is under medical care for any serious condition or is taking other medications.

Drug Interactions

Ibuprofen has several notable drug interactions that may impact patient safety and treatment efficacy.

Pharmacodynamic Interactions:

Ibuprofen may significantly increase the risk of severe gastrointestinal bleeding when co-administered with anticoagulants or steroid medications. Clinicians should exercise caution and consider alternative therapies or enhanced monitoring for patients requiring concurrent use of these agents.

Additionally, the use of nonsteroidal anti-inflammatory drugs (NSAIDs), including ibuprofen, is associated with an elevated risk of cardiovascular events such as heart attack and stroke. This risk is particularly pronounced when NSAIDs are used in higher doses or for extended durations. It is advisable to limit the duration of NSAID therapy and to monitor patients closely for any signs of cardiovascular complications.

Pharmacokinetic Interactions:

The concomitant use of ibuprofen with other NSAIDs, whether prescription or over-the-counter (e.g., aspirin, naproxen), may further increase the likelihood of gastrointestinal bleeding. Healthcare providers should assess the necessity of multiple NSAID therapies and consider dosage adjustments or alternative pain management strategies to mitigate this risk.

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 require careful consideration when using this medication. Dosing is based on weight and age, with specific recommendations as follows: for children under 24 lbs or under 2 years, consultation with a doctor is advised; for those weighing 24-35 lbs (2-3 years), the dose is 5 mL; for 36-47 lbs (4-5 years), the dose is 7.5 mL; for 48-59 lbs (6-8 years), the dose is 10 mL; for 60-71 lbs (9-10 years), the dose is 12.5 mL; and for 72-95 lbs (11 years), the dose is 15 mL, or as directed by a doctor.

Warnings specific to pediatric use include a recommendation against use for more than 2 days or in children under 3 years of age unless directed by a doctor. There is an increased risk of stomach bleeding in children with a history of stomach ulcers or bleeding problems, those taking anticoagulants or steroids, or those using other NSAIDs, especially if the medication is taken in excess or for prolonged periods.

Healthcare professionals should advise parents to consult a doctor before use if the child has a history of stomach issues, has experienced serious side effects from pain relievers or fever reducers, has not been adequately hydrated, or has underlying conditions such as high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma. Additionally, caution is warranted if the child is taking a diuretic.

It is essential to keep this medication out of reach of children. In the event of an overdose, immediate medical assistance should be sought or contact a Poison Control Center at 1-800-222-1222.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, as the prescribing information primarily emphasizes pediatric use. There are no recommended age considerations, dosage adjustments, safety concerns, or special precautions outlined for geriatric patients.

Healthcare providers should exercise caution when prescribing this medication to elderly patients, given the absence of data on its safety and efficacy in this population. Monitoring for potential adverse effects and therapeutic responses is advisable, as individual patient factors may influence treatment outcomes.

Pregnancy

There are no specific statements regarding the use of ibuprofen during pregnancy in the provided text. The insert does not mention any contraindications or risks associated with ibuprofen use during this period. Additionally, no dosage modifications for pregnant individuals are provided. Furthermore, the insert 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 nursing mothers or lactation in the provided text. Therefore, healthcare professionals should consider the absence of data when advising lactating mothers about the use of this medication. It is advisable to monitor breastfed infants for any potential effects, although no specific concerns have been identified in the available information.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available data regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the lack of information necessitates careful clinical judgment and monitoring of these patients.

Hepatic Impairment

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

Overdosage

Overdosage of ibuprofen can lead to significant health risks and requires prompt medical intervention.

Symptoms of Overdose Healthcare professionals should be aware that symptoms of ibuprofen overdose may manifest as nausea, vomiting, stomach pain, drowsiness, and headache. These symptoms can vary in severity depending on the amount ingested and the individual’s health status.

Recommended Actions In the event of an overdose, it is crucial to seek immediate medical attention. Healthcare providers should advise patients or caregivers to contact a Poison Control Center for guidance on the appropriate steps to take. Timely intervention is essential to mitigate potential complications associated with ibuprofen overdosage.

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 understanding of potential risks associated with the compound in nonclinical settings.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions reported voluntarily or through surveillance programs. These include allergic reactions such as hives, asthma (wheezing), skin reddening, facial swelling, shock, rash, and blisters. Additionally, cases of stomach bleeding have been noted, particularly in patients with a history of stomach ulcers or bleeding problems, as well as those concurrently using anticoagulants or other nonsteroidal anti-inflammatory drugs (NSAIDs). There is also an increased risk of heart attack, heart failure, and stroke associated with the use of NSAIDs. Furthermore, reports of severe or persistent sore throat, or sore throat accompanied by high fever, headache, nausea, and vomiting, may indicate serious underlying conditions.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222 in the event of an overdose. It is recommended that the medication be taken with food or milk if the patient experiences stomach upset.

Patients should be instructed to discontinue use and consult a doctor if the child exhibits any signs of stomach bleeding, which may include feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain. Additionally, healthcare providers should inform patients to stop use and seek medical attention if the child shows symptoms indicative of heart problems or stroke, such as chest pain, difficulty breathing, weakness on one side of the body, slurred speech, or swelling in the legs.

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

Before initiating treatment, healthcare providers should encourage patients to consult a doctor if any of the following 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, patients should be advised to seek guidance from a doctor or pharmacist if the child is currently under medical care for any serious condition or is taking any other medications.

Storage and Handling

The product is supplied in packaging that includes specific NDC numbers. 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 carton prior to use; the product should not be utilized if the carton is opened or if the printed inner seal marked "SEALED for YOUR PROTECTION" is broken or missing. 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 a recommended dosing frequency of every 6-8 hours as needed, not to exceed four doses per day. Clinicians should advise 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.

No additional information is available regarding laboratory tests, abuse potential, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Childrens Ibuprofen, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Data Generation & Sources

This page was automatically generated and is maintained by the AllDrugs AI Data-Science Team. It was built from the FDA Structured Product Label (DailyMed) for Childrens Ibuprofen, retrieved by a validated AI data-extraction workflow.

All FDA-listed dosage forms and strengths are shown in the Packaging & NDC Codes section above. Regulatory status appears in the Summary Information panel above and was verified in the FDA National Drug Code directory and the NSDE NDC Directory daily file.

Note: an automated daemon monitors NSDE checksums; when the record for this NDC changes, the new file is pulled instantly and this page is refreshed.

No human clinician has reviewed this version.

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.