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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
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2014
Label revision date
October 22, 2020
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
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 2014
Label revision date
October 22, 2020
Manufacturer
CVS Pharmacy
Registration number
ANDA074937
NDC root
59779-971
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

Ibuprofen oral suspension is a medication designed for children aged 2 to 11. It serves as a pain reliever and fever reducer, helping to alleviate minor aches and pains associated with conditions like the common cold, flu, sore throat, headache, and toothache. As a nonsteroidal anti-inflammatory drug (NSAID), it works by reducing inflammation and pain in the body.

This oral suspension comes in a grape flavor and is alcohol-free and gluten-free. Each 5 mL (teaspoonful) contains 100 mg of ibuprofen, providing relief that can last up to 8 hours.

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 developmental issues in a fetus if taken during pregnancy.

Dosage and Administration

Before using this medication, make sure to shake the bottle well. It's important to measure the correct dose using the enclosed measuring cup, as this ensures you get the right amount. You can find the appropriate dose by checking the dosing chart based on your child's weight or age. For children under 2 years old, it's best to consult a doctor for the right dosage.

If your child needs another dose, you can repeat it every 6 to 8 hours, but remember not to exceed four doses in a single day. After each use, wash the measuring cup to keep it clean. Finally, always replace the original bottle cap to keep the medication safe from children.

What to Avoid

You should avoid using this medication if your child has ever had an allergic reaction to 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, as this could pose serious health risks. Always consult with a healthcare professional if you have any concerns about your child's health or medication use.

Side Effects

Ibuprofen can cause serious allergic reactions, particularly in individuals who are allergic to aspirin. Signs of an allergic reaction may include hives, facial swelling, wheezing (asthma), shock, skin reddening, rash, or blisters. Additionally, this medication carries a risk of severe stomach bleeding, which is a serious concern.

If your child experiences symptoms such as feeling faint, vomiting blood, having bloody or black stools, or persistent stomach pain, you should stop using ibuprofen and consult a doctor immediately. It's also important to seek medical advice if your child has a severe sore throat accompanied by high fever, headache, nausea, or vomiting, or if symptoms worsen or do not improve within a few days. Always consult a healthcare professional before using ibuprofen if your child has a history of stomach issues, is dehydrated, or has other serious health conditions.

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 problems, are taking blood thinners or steroids, or are using other NSAIDs (nonsteroidal anti-inflammatory drugs) like aspirin or naproxen. Be cautious and do not use ibuprofen for more than two days for a sore throat, especially in children under 3 years old, unless directed by a doctor.

You should stop using ibuprofen and consult your doctor if you notice any signs of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain. Additionally, if your symptoms do not improve within 24 hours, or if fever or pain worsens or lasts more than three days, seek medical advice. In case of an overdose, contact a medical professional or the Poison Control Center at 1-800-222-1222 right away.

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

When considering the use of ibuprofen during pregnancy, it's important to note that the available information does not specify any particular guidelines or risks associated with its use. There are no stated contraindications (conditions that would make the use of a drug inadvisable) or special precautions for pregnant individuals. Additionally, the insert does not provide any recommendations for dosage modifications for those who are pregnant.

As always, it's best to consult with your healthcare provider before taking any medication during pregnancy to ensure it is safe for you and your baby.

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 on nursing infants have not been thoroughly studied. Because of this uncertainty, it’s wise to be cautious.

When thinking about using ibuprofen while breastfeeding, weigh the benefits against any potential risks. Your healthcare provider can help you make an informed decision that prioritizes both your health and the well-being of your baby.

Pediatric Use

It's important to be cautious when giving this medication to children. You should not use it in children under 3 years of age unless a doctor specifically advises you to do so. For children aged 2 years and younger, always consult a doctor before use. The recommended dosages vary by age and weight: for example, a child aged 2-3 years weighing 24-35 lbs can take 1 teaspoon (5 mL), while an 11-year-old weighing 72-95 lbs can take 3 teaspoons (15 mL). Always keep the medication out of reach of children.

Before giving this medication, check with a doctor if your child has had any allergic reactions to pain relievers or fever reducers, or if they have a history of stomach issues, dehydration, or other serious health conditions. If your child experiences any signs of stomach bleeding, does not feel better within 24 hours, or if their symptoms worsen or new symptoms appear, stop using the medication and consult a doctor immediately. It's also a good idea to give the medication with food or milk if it causes stomach upset.

Geriatric Use

When it comes to using Children's Ibuprofen for older adults, there is no specific information available regarding dosage adjustments, safety concerns, or special precautions. This means that if you or a caregiver are considering this medication, it’s important to consult with a healthcare professional to ensure it’s appropriate for your individual health needs.

Always prioritize open communication with your doctor about any medications you are taking, especially if you have underlying health conditions or are taking other treatments. Your healthcare provider can help determine the best options for managing pain or fever safely.

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, or liver cirrhosis, as these conditions can affect how your body processes the medication. Your healthcare provider will help determine if it's safe for you and may suggest adjustments to your dosage or additional monitoring to ensure your safety. Always prioritize open communication with your doctor regarding your health conditions.

Hepatic Impairment

If you have liver problems, such as liver cirrhosis (a serious condition where the liver becomes severely scarred), it's important to be aware of how this may affect your treatment. Your healthcare provider may need to adjust your medication dosage or closely monitor your liver function tests (tests that check how well your liver is working) to ensure your safety and the effectiveness of your treatment.

Additionally, if you have other health issues like high blood pressure or heart disease, these can also influence how your liver functions and how medications are processed in your body. Always communicate openly with your healthcare team about your liver health and any other conditions you may have, so they can provide the best care tailored to your needs.

Drug Interactions

It's important to be aware of potential interactions when your child is taking ibuprofen. If your child is allergic to aspirin, they may experience severe allergic reactions to ibuprofen. Additionally, if your child is on blood thinners (medications that prevent blood clots) or steroids, the risk of stomach bleeding increases. The same goes for other nonsteroidal anti-inflammatory drugs (NSAIDs), like aspirin or naproxen, which can also heighten this risk.

Moreover, using ibuprofen for longer than recommended or in higher doses can raise the chances of serious issues like heart attack or stroke. Always consult with your healthcare provider if your child is taking any other medications, as they can help ensure safety and effectiveness in their treatment plan.

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). It's important to avoid freezing the product, as this can damage it. Before use, check that the printed neckband is intact; do not use the product if it is broken or missing. Additionally, make sure to look at the bottom panel for the lot number and expiration date to confirm that the product is still safe to use.

By following these simple storage and handling guidelines, you can help maintain the quality and safety of 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. If you experience stomach upset, taking the medication with food or milk may help. Be aware that using more than the recommended dose or for a longer period than directed can increase your risk of heart attack or stroke.

FAQ

What is Ibuprofen Oral Suspension used for?

Ibuprofen Oral Suspension is used to relieve minor aches and pains due to the common cold, flu, sore throat, headache, and toothache, as well as to reduce fever.

What age group can use Ibuprofen Oral Suspension?

This medication is intended for children ages 2 to 11.

How should I dose Ibuprofen Oral Suspension?

You should find the right dose on the dosing chart based on your child's weight or age, and use only the enclosed measuring cup.

What should I do if my child experiences stomach upset?

If stomach upset occurs, give Ibuprofen Oral Suspension with food or milk.

What are the potential side effects of Ibuprofen Oral Suspension?

Possible side effects include severe allergic reactions, stomach bleeding, and signs of a serious sore throat. Consult a doctor if any severe symptoms occur.

Can I use Ibuprofen Oral Suspension if my child has allergies?

Do not use this product if your child has ever had an allergic reaction to any other pain reliever or fever reducer.

Is Ibuprofen Oral Suspension safe during pregnancy?

The provided information does not mention specific risks or contraindications for use during pregnancy, but consult a doctor for personalized advice.

What should I do in case of an overdose?

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

How should I store Ibuprofen Oral Suspension?

Store the medication at 20-25°C (68-77°F) and do not freeze it. Ensure the printed neckband is intact.

What precautions should I take before using Ibuprofen Oral Suspension?

Ask a doctor before use if your child has high blood pressure, heart disease, liver cirrhosis, or kidney disease.

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 Oral Suspension is a nonsteroidal anti-inflammatory drug (NSAID) formulated to provide relief from pain and reduce fever. Each 5 mL (teaspoonful) of the suspension contains 100 mg of ibuprofen. The product is presented in a 4 fluid ounce (120 mL) bottle and is characterized by its grape flavor. This formulation is gluten-free and alcohol-free, ensuring suitability for a wide range of patients. The effects of the medication can last up to 8 hours.

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

This product is intended for use in pediatric patients and does not contain directions or complete warnings for adult use. Healthcare professionals should ensure that the dosage does not exceed the recommended limits.

Prior to administration, the product must be shaken well. The appropriate dose should be determined using the provided dosing chart, with weight being the preferred method for dosing; if weight is not available, age may be used as an alternative. Only the enclosed measuring cup should be utilized for accurate dosing.

The following dosing recommendations are provided based on weight and age:

  • For patients under 2 years of age (weight under 24 lbs), it is advised to consult a physician for appropriate dosing.

  • For patients weighing 24-35 lbs (ages 2-3 years), the recommended dose is 1 teaspoonful (5 mL).

  • For patients weighing 36-47 lbs (ages 4-5 years), the recommended dose is 1 ½ teaspoonfuls (7.5 mL).

  • For patients weighing 48-59 lbs (ages 6-8 years), the recommended dose is 2 teaspoonfuls (10 mL).

  • For patients weighing 60-71 lbs (ages 9-10 years), the recommended dose is 2 ½ teaspoonfuls (12.5 mL).

  • For patients weighing 72-95 lbs (age 11 years), the recommended dose is 3 teaspoonfuls (15 mL).

If necessary, doses may be repeated every 6 to 8 hours, but the total daily administration should not exceed 4 doses. After each use, the dosage cup should be washed to maintain hygiene. To ensure child safety, the original bottle cap should be replaced securely after each use.

Contraindications

Use is contraindicated in patients with a history of allergic reactions to 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, wheezing, shock, skin reddening, rash, and blisters. In the event of an allergic reaction, it is imperative to discontinue use immediately and seek medical assistance.

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

Healthcare professionals should be vigilant regarding the potential for severe or persistent sore throat in patients, particularly when accompanied by high fever, headache, nausea, or vomiting, as these symptoms may indicate a serious condition. It is advised to consult a physician promptly in such cases. 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.

Patients and caregivers should be instructed to discontinue use and consult a physician if any of the following signs of stomach bleeding occur: faintness, vomiting of blood, presence of bloody or black stools, persistent stomach pain, lack of relief within the first 24 hours of treatment, worsening fever or pain lasting more than three days, redness or swelling in the affected area, or the emergence of any new symptoms.

In the event of an overdose, immediate medical attention is required. Contact a Poison Control Center or seek emergency medical help without delay (1-800-222-1222).

Side Effects

Patients using ibuprofen should be aware of the potential for serious adverse reactions. Notably, 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.

Additionally, as an NSAID, ibuprofen carries a warning for the risk of severe stomach bleeding. Patients should be vigilant for signs of stomach bleeding, which may manifest as faintness, vomiting blood, bloody or black stools, or persistent stomach pain that does not improve. In children, it is crucial to consult a healthcare provider if any of these symptoms occur, or if the child does not experience relief within the first 24 hours of treatment. Furthermore, if fever or pain worsens or lasts more than three days, or if redness or swelling is present in the painful area, medical advice should be sought.

Severe or persistent sore throat, especially when accompanied by high fever, headache, nausea, and vomiting, may also indicate a serious condition requiring prompt medical attention. The use of ibuprofen should not exceed two days in such cases, and it is not recommended for children under three years of age unless directed by a physician.

Before administering ibuprofen, it is advisable to consult a healthcare provider if the child has a history of stomach problems, such as heartburn, or has experienced serious side effects from pain relievers or fever reducers. Additional caution is warranted for children who have not been adequately hydrated, have lost significant fluids due to vomiting or diarrhea, or have pre-existing conditions such as high blood pressure, heart disease, liver cirrhosis, or kidney disease. Children with asthma or those taking diuretics should also seek medical advice prior to use.

Patients are encouraged to discuss any ongoing serious conditions or concurrent medications with their healthcare provider or pharmacist before using ibuprofen.

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 further elevated when ibuprofen is taken alongside other nonsteroidal anti-inflammatory drugs (NSAIDs), including prescription and nonprescription options such as aspirin and naproxen. Monitoring for signs of gastrointestinal distress is advised in patients receiving these combinations.

Cardiovascular Risks There is an increased risk of heart attack or stroke associated with the use of ibuprofen, particularly when used in higher doses or for extended periods beyond the recommended duration. It is advisable to adhere strictly to dosing guidelines and to evaluate the necessity of continued therapy regularly.

Consultation Recommendation Healthcare providers should be consulted if the patient is taking any other medications, as potential interactions may necessitate dosage adjustments or enhanced monitoring.

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 product unless directed by a doctor. For dosing, the following guidelines apply: children under 2 years should consult a doctor; for those weighing 24-35 lbs (2-3 years), the recommended dose is 1 teaspoon (5 mL); for 36-47 lbs (4-5 years), 1 ½ teaspoons (7.5 mL); for 48-59 lbs (6-8 years), 2 teaspoons (10 mL); for 60-71 lbs (9-10 years), 2 ½ teaspoons (12.5 mL); and for 72-95 lbs (11 years), 3 teaspoons (15 mL).

It is essential to keep this product out of reach of children. In the event of an overdose, immediate medical assistance or contact with a Poison Control Center is necessary. Prior to use, a doctor should be consulted if the child has a history of allergic reactions to pain relievers or fever reducers, stomach bleeding, or any of the following conditions: stomach problems (e.g., heartburn), dehydration from vomiting or diarrhea, high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or if they are taking a diuretic or any other medication.

When administering this product, it is advisable to give it with food or milk if stomach upset occurs. Parents or caregivers should discontinue use and consult a doctor if the child shows signs of stomach bleeding, does not experience relief within 24 hours, if fever or pain worsens or persists beyond 3 days, if redness or swelling occurs in the painful area, or if any new symptoms arise.

Geriatric Use

Elderly patients may not have specific information regarding the use of Children's Ibuprofen, including dosage adjustments, safety concerns, or special precautions. As such, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any potential adverse effects, given the lack of targeted data for this population.

Pregnancy

There are no specific statements regarding the use of ibuprofen during pregnancy in the provided information. The 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 text does not include any special precautions regarding the use of ibuprofen during pregnancy. Healthcare professionals should consider these factors when advising pregnant patients or women of childbearing potential.

Lactation

Lactating mothers should consult a doctor before using this product. There is a potential for excretion in breast milk, and the effects on nursing infants are not well studied; therefore, caution is advised. It is recommended to weigh the benefits against the potential risks when considering the use of ibuprofen while breastfeeding.

Renal Impairment

Patients with renal impairment should consult a healthcare professional prior to use, particularly if they have comorbid conditions such as high blood pressure, heart disease, liver cirrhosis, or kidney disease. It is essential to assess renal function and consider potential dosing adjustments or monitoring requirements based on the patient's overall health status and renal function.

Hepatic Impairment

Patients with hepatic impairment may experience altered pharmacokinetics of the drug due to compromised liver function. It is essential to assess the severity of liver impairment before initiating treatment.

In patients with liver cirrhosis, dosage adjustments may be necessary to avoid potential toxicity. Close monitoring of liver function tests, including alanine aminotransferase (ALT), aspartate aminotransferase (AST), and bilirubin levels, is recommended throughout the treatment course.

Additionally, patients with significant hepatic impairment should be evaluated for the presence of comorbid conditions such as high blood pressure, heart disease, or kidney disease, as these may further complicate management and necessitate additional monitoring or dosage modifications.

Healthcare providers should exercise caution and consider the overall clinical picture when prescribing this medication to patients with 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 timely medical help 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 these contexts.

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 crucial to inform patients that this medication should not be used if the child has a history of allergic reactions to any other pain reliever or fever reducer. Additionally, patients should be cautioned against using this product right before or after heart surgery.

Patients must be instructed to stop use and consult a doctor if the child exhibits any signs of stomach bleeding, which include feeling faint, vomiting blood, having bloody or black stools, experiencing persistent stomach pain, not achieving relief within the first 24 hours of treatment, or if fever or pain worsens or lasts more than three days. They should also be aware that redness or swelling in the painful area or the appearance of any new symptoms warrants medical consultation.

When administering this product, healthcare providers should recommend giving it with food or milk to mitigate potential stomach upset. It is important to communicate that the risk of heart attack or stroke may increase if the medication is used in excess of the directed dosage or for a duration longer than recommended.

Patients should be advised to consult a doctor before use if any of the following apply: the child has a history of stomach bleeding, has experienced stomach problems such as heartburn, has had serious side effects from pain relievers or fever reducers, has not been adequately hydrated, has lost significant fluids due to vomiting or diarrhea, or has pre-existing conditions such as high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma. Furthermore, it is essential to recommend consulting a doctor or pharmacist 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 configurations that include specific NDC numbers, which can be referenced for identification. It is essential to store the product at a temperature range of 20-25°C (68-77°F) to maintain its integrity. Freezing the product is strictly prohibited, as it may compromise its effectiveness.

Healthcare professionals should ensure that the product is not used if the printed neckband is broken or missing, as this may indicate tampering or compromise of the product. For traceability, the lot number and expiration date can be found on the bottom panel of the packaging. Proper handling and adherence to these storage conditions are crucial for ensuring the product's safety and efficacy.

Additional Clinical Information

The medication is administered orally. Clinicians should counsel patients to keep the medication out of reach of children and to seek medical assistance or contact a Poison Control Center (1-800-222-1222) immediately in the event of an overdose. Patients are advised to take the medication with food or milk if they experience stomach upset. It is important to note that using more than the directed dose or extending the duration of use may increase the risk of heart attack or stroke.

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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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.