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Childrens Ibuprofen

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This product has been discontinued

Active ingredient
Ibuprofen 100 mg/5 mL
Other brand names
Dosage form
Suspension
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2017
Label revision date
December 7, 2020
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Ibuprofen 100 mg/5 mL
Other brand names
Dosage form
Suspension
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 2017
Label revision date
December 7, 2020
Manufacturer
TARGET Corporation
Registration number
ANDA209207
NDC root
11673-349
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (2 NDCs)
Packaging & NDC Codes (2)

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Drug Overview

Ibuprofen is a medication that comes in an oral suspension form, specifically designed for children aged 2 to 11 years. It is a pain reliever and fever reducer, classified as a nonsteroidal anti-inflammatory drug (NSAID). This dye-free and alcohol-free formulation has a pleasant berry flavor, making it easier for children to take.

Ibuprofen works by relieving minor aches and pains associated with common conditions like the cold, flu, sore throat, headache, and toothache. Additionally, it helps to reduce fever, providing comfort when your child is feeling unwell. Each dose contains 100 mg of ibuprofen per 5 mL, and the effects can last for up to 8 hours.

Uses

You can use this medication to help relieve minor aches and pains caused by common conditions like the cold, flu, sore throat, headache, and toothache. It is 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 developmental issues in a fetus.

Dosage and Administration

Before using the medication, make sure to shake the bottle well. It's important to use only the dosing cup that comes with the medication, as other devices may not provide the correct amount. To find the right dose, refer to the dosing chart provided. If possible, base the dose on your child's weight; if you don't have that information, you can use their age instead.

For children weighing under 24 pounds (younger than 2 years), it's best to consult a doctor before administering the medication. For those weighing between 24 and 35 pounds (ages 2-3), the dose is 5 mL. If your child weighs between 36 and 47 pounds (ages 4-5), the dose increases to 7.5 mL. For children weighing 48 to 59 pounds (ages 6-8), the dose is 10 mL, and for those weighing 60 to 71 pounds (ages 9-10), the dose is 12.5 mL. Finally, if your child weighs 72 to 95 pounds (11 years old), the dose is 15 mL. You can repeat the dose every 6 to 8 hours if needed, but do not exceed 4 doses in a single 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 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 allergic reactions, particularly in individuals who are allergic to aspirin. Symptoms of such reactions 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 are also warnings regarding heart attack and stroke risks associated with NSAIDs, which can be fatal, particularly if used in higher doses or for extended periods. If your child experiences severe sore throat symptoms, stomach bleeding signs (like faintness, vomiting blood, or black stools), or symptoms of heart problems (such as chest pain or trouble breathing), seek medical attention immediately. Always consult a doctor if your child has a history of stomach issues, is dehydrated, or is taking other medications.

Warnings and Precautions

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

This medication can also lead to severe stomach bleeding, particularly if you have a history of stomach ulcers or bleeding issues, 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 symptoms of heart problems like chest pain or trouble breathing, stop using ibuprofen and contact your doctor right away.

For children, do not use ibuprofen for more than two days without a doctor's guidance, especially if they are under three years old. If your child does not feel better within 24 hours, if their fever or pain worsens or lasts more than three days, or if any new symptoms appear, consult a doctor. In case of an overdose, seek emergency medical help or contact a Poison Control Center immediately at 1-800-222-1222.

Overdose

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

Always err on the side of caution—if you notice any concerning symptoms or if you’re unsure, don’t hesitate to get help right away. Your health and safety are the top priority.

Pregnancy Use

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 (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 medication during pregnancy to ensure it is safe for you and your baby. Always prioritize open communication with your doctor regarding any concerns or questions you may have.

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 advisable to be cautious.

If you do take ibuprofen while breastfeeding, 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 the safety of both you and your child.

Pediatric Use

It's important to be cautious when using this medication in children. You should avoid giving it to children under 3 years of age unless a doctor specifically advises you to do so. For children aged 2 years and older, the dosage varies based on their weight. For example, if your child weighs between 24-35 pounds, the recommended dose is 5 mL, while a child weighing 72-95 pounds should receive 15 mL.

Always consult a doctor if your child has a history of stomach issues, is taking other medications, or has experienced significant fluid loss from vomiting or diarrhea. If your child does not feel better within 24 hours, or if their fever or pain worsens or lasts more than 3 days, you should stop using the medication and seek medical advice.

Geriatric Use

While the drug insert for Children's Ibuprofen does not provide specific information about its use in older adults, it's important to approach any medication with caution. Since there are no recommended age considerations, dosage adjustments, or safety concerns outlined for elderly patients, you should consult with a healthcare professional before using this medication. This ensures that any unique health needs or conditions are taken into account, helping to keep you or your loved ones safe and healthy. Always prioritize open communication with your doctor about any medications being considered.

Renal Impairment

If you have kidney problems, it's important to consult your doctor before using this medication. This is especially crucial if you also have high blood pressure, heart disease, liver cirrhosis (a severe liver condition), or if you've had a stroke. Your healthcare provider can help determine if this medication is safe for you and may suggest adjustments to your dosage or additional monitoring based on your specific health needs. Always prioritize open communication with your doctor regarding your kidney health and any other medical conditions you may have.

Hepatic Impairment

If you have liver problems, such as liver cirrhosis (a serious condition where the liver is damaged and scarred), 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 regular tests to check 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 potential interactions when taking medications. For instance, if you or your child is allergic to aspirin, using ibuprofen could lead to a severe allergic reaction. Additionally, if your child is on blood thinners (medications that prevent blood clots) or steroids, the risk of stomach bleeding increases. This risk is also heightened if they are taking other nonsteroidal anti-inflammatory drugs (NSAIDs), such as aspirin or naproxen.

If your child is prescribed a diuretic (a medication that helps remove excess fluid from the body), it's crucial to consult with a healthcare provider. Always discuss any medications or tests with your doctor to ensure safety and avoid serious complications.

Storage and Handling

To ensure the safety and effectiveness of your product, store it in a cool, dry place at a temperature between 20° to 25°C (68° to 77°F). This range is considered a controlled room temperature, which helps maintain the product's quality. Always check the carton before use; do not use the product if the carton is opened or if the bottle wrap marked "SEALED FOR SAFETY" is broken or missing.

Additionally, make sure to look at the bottom panel of the carton for the lot number and expiration date, as this information is important for tracking the product's safety and effectiveness. Proper handling and storage are key to ensuring you get the best results from your product.

Additional Information

You should take this medication orally. It's important to keep it out of reach of children to prevent accidental ingestion. If you suspect an overdose, seek medical help immediately or contact a Poison Control Center at 1-800-222-1222 for assistance.

FAQ

What is ibuprofen?

Ibuprofen is a dye-free, alcohol-free oral suspension used as a pain reliever and fever reducer for children aged 2 to 11 years.

What conditions does ibuprofen relieve?

Ibuprofen relieves minor aches and pains due to the common cold, flu, sore throat, headache, and toothache, and it also reduces fever.

How should I dose ibuprofen for my child?

Use the enclosed dosing cup and refer to the dosing chart based on your child's weight. If possible, use weight to determine the dose; otherwise, use age.

What are the dosing recommendations for ibuprofen?

For children weighing 24-35 lbs (2-3 years), the dose is 5 mL; for 36-47 lbs (4-5 years), it's 7.5 mL; and for 48-59 lbs (6-8 years), it's 10 mL, with specific doses for other weight ranges.

What should I do if my child experiences side effects?

Stop using ibuprofen and consult a doctor if your child shows signs of stomach bleeding, heart problems, or does not get relief within 24 hours.

Are there any warnings associated with ibuprofen?

Yes, ibuprofen may cause severe allergic reactions, stomach bleeding, and increase the risk of heart attack and stroke. Consult a doctor if your child has a history of stomach problems or is taking other medications.

Can ibuprofen be used during pregnancy?

The provided information does not specify any contraindications or risks associated with ibuprofen use during pregnancy.

Is ibuprofen safe for nursing mothers?

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

How should ibuprofen be stored?

Store ibuprofen at 20° to 25°C (68° to 77°F) and do not use if the carton is opened or if the safety seal is broken.

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

This product is an oral suspension formulation of ibuprofen, specifically designed for children aged 2 to 11 years. It contains 100 mg of ibuprofen per 5 mL and is classified as a nonsteroidal anti-inflammatory drug (NSAID) that serves as a pain reliever and fever reducer. The product is alcohol-free and dye-free, featuring a berry flavor to enhance palatability. Each package contains 4 fluid ounces (120 mL) of the suspension, and a dosage cup is included for accurate measurement. The effects of the medication can last up to 8 hours. The National Drug Code (NDC) for this product is 11673-349-08, and it is comparable to the active ingredient found in Children's Motrin® Dye-Free.

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 imperative to utilize only the enclosed dosing cup for administration; the use of any other dosing device is not recommended.

Healthcare professionals should refer to the dosing chart to determine the appropriate dose. When possible, dosing should be based on the patient's weight; if weight is not available, age may be used as a secondary guide. The following dosing recommendations apply:

  • For patients weighing under 24 lbs (under 2 years), consultation with a physician is advised prior to administration.

  • For patients weighing 24-35 lbs (2-3 years), the recommended dose is 5 mL.

  • For patients weighing 36-47 lbs (4-5 years), the recommended dose is 7.5 mL.

  • For patients weighing 48-59 lbs (6-8 years), the recommended dose is 10 mL.

  • For patients weighing 60-71 lbs (9-10 years), the recommended dose is 12.5 mL.

  • For patients weighing 72-95 lbs (11 years), the recommended dose is 15 mL.

If necessary, the dose may be repeated every 6 to 8 hours, but it is important not to exceed 4 doses in a 24-hour period.

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 carries a risk of severe stomach bleeding. The likelihood of such an event 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 use increases this risk.

NSAIDs, excluding aspirin, are associated with an elevated risk of heart attack, heart failure, and stroke, which can be fatal. This risk is amplified when the medication is used in excess of the recommended dosage or for prolonged periods.

Healthcare professionals should be vigilant for signs of severe or persistent sore throat, particularly 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, nor should it be administered to children under three years of age unless specifically directed by a healthcare provider.

It is crucial 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 attention. 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, it is essential to seek emergency medical assistance or contact a Poison Control Center immediately at 1-800-222-1222.

Side Effects

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.

As a nonsteroidal anti-inflammatory drug (NSAID), ibuprofen carries a warning for the potential risk of severe stomach bleeding. This risk is heightened in patients with a history of stomach ulcers or bleeding problems, those taking anticoagulants or steroid medications, individuals using other NSAIDs (including aspirin, ibuprofen, or naproxen), and those who exceed 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. The likelihood of these serious cardiovascular events is greater when the medication is used in excess of the recommended dosage or for prolonged periods.

Patients should be vigilant for severe or persistent sore throat symptoms, especially when accompanied by high fever, headache, nausea, or vomiting, as these may indicate a serious condition requiring prompt medical consultation. It is advised not to use ibuprofen for more than two days or to administer it to children under three years of age without a doctor's guidance.

Parents should discontinue use and seek medical advice if their child exhibits signs of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain. Symptoms indicative of heart problems or stroke, including chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling, also warrant immediate medical attention. Furthermore, 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, medical consultation is recommended. Redness or swelling in the painful area or the emergence of any new symptoms should also prompt a discussion with a healthcare provider.

It is contraindicated to use ibuprofen in children with a history of allergic reactions to ibuprofen or other pain relievers/fever reducers, and it should not be administered immediately before or after heart surgery. Prior to use, consultation with a healthcare professional is advised if the child has a history of stomach issues, has experienced serious side effects from pain relievers, is dehydrated, or has underlying 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 be evaluated by a doctor before using ibuprofen. Parents should also consult a healthcare provider if their child is under medical care for any serious condition or is taking other medications.

Drug Interactions

Ibuprofen has the potential to induce severe allergic reactions, particularly in individuals with a known allergy to aspirin.

When considering the concomitant use of ibuprofen with anticoagulants or steroid medications, there is an increased risk of gastrointestinal bleeding. This risk is also elevated when ibuprofen is taken alongside other nonsteroidal anti-inflammatory drugs (NSAIDs), including both prescription and over-the-counter options such as aspirin and naproxen.

In pediatric patients, it is advisable to consult a healthcare professional if the child is concurrently taking a diuretic, as this may necessitate careful monitoring or dosage adjustments.

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 healthcare professional. For dosing, the following guidelines apply:

  • For patients under 24 lbs (under 2 years): Consult a doctor.

  • For patients weighing 24-35 lbs (2-3 years): Administer 5 mL.

  • For patients weighing 36-47 lbs (4-5 years): Administer 7.5 mL.

  • For patients weighing 48-59 lbs (6-8 years): Administer 10 mL.

  • For patients weighing 60-71 lbs (9-10 years): Administer 12.5 mL.

  • For patients weighing 72-95 lbs (11 years): Administer 15 mL.

Healthcare professionals should advise parents or guardians to consult a doctor if the child has a history of stomach problems, is taking other medications, or has experienced significant fluid loss due to vomiting or diarrhea. Additionally, if the child does not experience relief within the first 24 hours of treatment, or if fever or pain worsens or persists beyond 3 days, they should stop use and seek medical advice.

Geriatric Use

There is no specific information regarding the use of Children's Ibuprofen in geriatric patients. The prescribing information does not provide any recommended age considerations, dosage adjustments, safety concerns, or special precautions for elderly patients. Therefore, healthcare providers should exercise caution when considering the use of this medication in the geriatric population, as the absence of data necessitates careful monitoring and individualized assessment of risks and benefits.

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, 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, 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 adjust the dosage as needed.

Additionally, patients with a history of significant comorbidities such as high blood pressure, heart disease, kidney disease, or a history of stroke should be monitored closely, as these conditions may further complicate the management of their hepatic impairment.

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

Management procedures may include supportive care and symptomatic treatment, tailored to the specific symptoms presented. Continuous monitoring of the patient's vital signs and clinical status is recommended to ensure safety and efficacy during the management of an overdose.

Nonclinical Toxicology

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

Postmarketing Experience

Postmarketing experience has identified several adverse reactions associated with the use of the product. Reports of gastrointestinal bleeding have been documented, with some cases resulting in fatal outcomes. Additionally, renal impairment has been observed, particularly in patients with pre-existing renal conditions or those concurrently using medications that may impact renal function. Hypersensitivity reactions, including anaphylaxis, have also been reported, especially in individuals with a history of allergic reactions to nonsteroidal anti-inflammatory drugs (NSAIDs). These events were reported voluntarily or through surveillance programs and do not imply a causal relationship.

Patient Counseling

Advise patients to keep this medication out of reach of children to prevent accidental ingestion. Instruct them that in the event of an overdose, they should seek medical help or contact a Poison Control Center immediately at 1-800-222-1222.

Inform patients that this medication should not be used if the child has a history of allergic reactions to ibuprofen or any other pain reliever or fever reducer. Additionally, it should not be administered right before or after heart surgery.

Patients should be made aware of the signs of potential stomach bleeding. They should stop use and consult a doctor if the child experiences any of the following symptoms: feeling faint, vomiting blood, having bloody or black stools, or experiencing stomach pain that does not improve.

Furthermore, patients should be advised to stop use and seek medical attention if the child exhibits 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 also be instructed to discontinue use and consult a doctor if the child does not experience relief within the first 24 hours of treatment, if fever or pain worsens or persists for more than three days, if there is redness or swelling in the painful area, or if any new symptoms arise.

When using this product, patients should be advised to take it with food or milk if stomach upset occurs. It is important to encourage patients to consult a doctor before use if the stomach bleeding warning applies to their child or if the child has a history of stomach problems, such as heartburn.

Patients should also be reminded to seek medical advice before use if the child has experienced serious side effects from pain relievers or fever reducers, has not been drinking fluids, or has lost a significant amount of fluid due to vomiting or diarrhea.

Additionally, patients should consult a doctor before use if the child has high blood pressure, heart disease, liver cirrhosis, kidney disease, or a history of stroke, as well as if the child has asthma or is taking a diuretic. Lastly, patients should be encouraged to speak with a doctor or pharmacist before use if the child is under medical care for any serious condition or is taking any other medications.

Storage and Handling

The product is supplied in a carton that contains a bottle, which must be stored at a temperature range of 20° to 25°C (68° to 77°F), in accordance with USP Controlled Room Temperature guidelines. It is imperative that the product is not used if the carton has been opened or if the bottle wrap, marked with "SEALED FOR SAFETY," is broken or missing. For reference, the lot number and expiration date can be found on the bottom panel of the carton.

Additional Clinical Information

The medication is administered orally. Clinicians should advise patients to keep the medication out of reach of children. In the event of an overdose, patients are instructed to seek medical assistance or contact a Poison Control Center immediately at 1-800-222-1222. No further 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.

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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.