Symptom checker
Select audience type

Switch between content for healthcare professionals (PRO) and general audience (GEN).

ADD CONDITION

items per page

Dye Free Childrens Ibuprofen

Last content change checked dailysee data sync status

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 2025
Label revision date
May 1, 2025
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 2025
Label revision date
May 1, 2025
Manufacturer
CVS
Registration number
ANDA210149
NDC root
51316-914
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 is a medication that comes in an oral suspension form, specifically designed for children, with a concentration of 100 mg per 5 mL. It is classified as a nonsteroidal anti-inflammatory drug (NSAID) and is commonly used to relieve minor aches and pains associated with conditions like the common cold, flu, sore throat, headache, and toothache. Additionally, ibuprofen helps reduce fever, providing comfort during illness.

This grape-flavored formulation is dye-free and does not contain added alcohol, making it a suitable option for children. Each dose can provide relief for up to 8 hours, and a dosing cup is included for easy measurement.

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’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 using this product, make sure to shake the bottle well. It's important to follow the dosing instructions carefully. You should find the right dose based on the dosing chart provided, which considers both weight and age. If possible, use your child's weight to determine the dose; if not, you can use their age instead. Always use the enclosed dosing cup to measure the dose accurately—do not use any other device.

You can repeat the dose every 6 to 8 hours if needed, but remember not to exceed 4 doses in a single day. For children under 2 years old or weighing less than 24 pounds, it's best to consult a doctor for the appropriate dose. For children aged 2 to 3 years and weighing between 24 to 35 pounds, the dose is 5 mL. As the weight increases, so does the dose, reaching up to 15 mL for children who are 11 years old and weigh between 72 to 95 pounds. Always ensure you are following these guidelines or any specific instructions given by your doctor.

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, especially in those 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, particularly in children with a history of stomach ulcers or those taking blood thinners or other NSAIDs. 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, or has bloody or black stools, you should seek medical attention immediately. It's important to consult a doctor if your child has a severe sore throat with high fever, or if symptoms worsen or persist beyond a few days. Always talk to a healthcare professional before using ibuprofen if your child has a history of stomach issues, dehydration, or other serious health conditions.

Warnings and Precautions

Ibuprofen can cause serious allergic reactions, especially if you are allergic to aspirin. Symptoms may include hives, wheezing, skin reddening, facial swelling, shock, 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. Additionally, using ibuprofen for longer than directed increases the risk of heart attack and stroke, which can be fatal. If you or your child experience signs of stomach bleeding (such as faintness, vomiting blood, or black stools), or 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 consulting a doctor, especially if they have a severe sore throat with high fever, headache, nausea, or vomiting. If symptoms worsen or new symptoms appear, seek medical advice. In case of an overdose, get emergency medical help or contact a Poison Control Center immediately at 1-800-222-1222.

Overdose

If you suspect an overdose, it's important to be aware that there is no specific information available about the effects of taking too much of this medication. However, if you experience unusual symptoms or feel unwell after taking your medication, you should seek medical attention immediately.

Signs of an overdose can vary, but common symptoms may include extreme drowsiness, confusion, or difficulty breathing. If you notice any of these signs, or if you are unsure about your situation, do not hesitate to contact a healthcare professional or call emergency services for guidance. Your safety is the top priority, so it's always better to err on the side of caution.

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.

While the absence of warnings may seem reassuring, it's always best to consult with your healthcare provider before taking any medication during pregnancy. They can provide personalized advice based on your specific situation and health needs.

Lactation Use

When it comes to breastfeeding, it's important to be aware that there are no specific guidelines or statements regarding nursing mothers or lactation (the process of producing milk). This means that if you are breastfeeding, you may not find detailed information about how certain medications or treatments could affect you or your baby.

If you have concerns about breastfeeding while taking any medication, it's always best to consult with your healthcare provider. They can provide personalized advice based on your situation and help ensure the safety and well-being of both you and your infant.

Pediatric Use

When considering this medication for your child, it's important to follow specific guidelines to ensure their safety. You should not use it for more than 2 days or give it to children under 3 years old unless directed by a doctor. For children aged 2 years and older, the dosage depends 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 use the dosing cup that comes with the medication, as other devices may not provide the correct amount. If your child weighs less than 24 pounds or is under 2 years old, consult your doctor for advice before administering the medication.

Geriatric Use

When it comes to using this medication in older adults, there is no specific information available about dosage adjustments, safety concerns, or special precautions. This means that if you or a loved one is an older adult, it’s important to consult with a healthcare provider for personalized advice. They can help determine the best approach based on individual health needs and any other medications being taken. Always prioritize open communication with your healthcare team to ensure safe and effective treatment.

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 standard recommendations for the medication do not include special monitoring or safety considerations tailored for patients with renal impairment (kidney issues).

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your kidney health. They can provide guidance based on your individual situation and any other health factors you may have.

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 apply, but you should always consult your healthcare provider for personalized advice. They can help determine the best approach for your treatment and monitor your liver function as needed.

Make sure to keep your doctor informed about your liver health, as they may want to conduct regular tests to ensure your safety while using any medication. Your well-being is a priority, and your healthcare team is there to support you.

Drug Interactions

It's important to be aware that this product contains a type of medication called an NSAID (nonsteroidal anti-inflammatory drug), which can increase the risk of severe stomach bleeding, especially if your child is also taking blood thinners (medications that prevent blood clots) or steroids. Additionally, if your child is using other NSAIDs, such as aspirin, ibuprofen, or naproxen, the risk may be even higher.

Always discuss any medications your child is taking with a healthcare provider to ensure their safety and avoid potential interactions. While there are no specific laboratory test interactions noted, it's still a good practice to keep your healthcare team informed about all medications and treatments.

Storage and Handling

To ensure the safety and effectiveness of your product, store it in a cool, dry place at a temperature between 20-25°C (68-77°F). It's important to keep the product in its original carton and only use it if the carton is unopened and the inner seal marked "SEALED for YOUR PROTECTION" is intact. If you find that the carton has been opened or the seal is broken, do not use the product, as this may compromise its safety and effectiveness.

By following these simple storage and handling guidelines, you can help maintain the quality of the product and ensure it works as intended.

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. If you experience stomach upset, it's advisable to take the medication with food or milk.

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 ibuprofen used for?

Ibuprofen 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.

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 and age. Do not exceed the recommended dose.

What should I do if my child experiences stomach pain or other severe symptoms?

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

Can ibuprofen be given to children under 2 years old?

You should ask a doctor before giving ibuprofen to children under 2 years old.

What precautions should I take when using ibuprofen?

Do not use ibuprofen if your child has had an allergic reaction to it or any other pain reliever, and avoid using it right before or after heart surgery.

What are the potential side effects of ibuprofen?

Ibuprofen may cause severe allergic reactions, stomach bleeding, and increase the risk of heart attack or stroke. Monitor your child for any unusual symptoms.

How should ibuprofen be stored?

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

Is there any information about ibuprofen use during pregnancy or breastfeeding?

The provided information does not specify any risks or recommendations regarding ibuprofen use during pregnancy or breastfeeding.

Packaging Info

Below are the non-prescription pack sizes of Dye Free Childrens Ibuprofen (ibuprofen). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Dye Free Childrens Ibuprofen.
Details

Drug Information (PDF)

This file contains official product information for Dye Free 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 of ibuprofen, a nonsteroidal anti-inflammatory drug (NSAID), formulated for pediatric use. Each 5 mL dose contains 100 mg of ibuprofen. The product is presented in a 4 FL OZ (120 mL) bottle and is available in a grape flavor. It is designed as a pain reliever and fever reducer, with effects lasting up to 8 hours. The formulation is dye-free and contains no added alcohol. A dosing cup is included for accurate administration. The product is comparable to the active ingredients found in Children's Motrin®. The National Drug Code (NDC) for this formulation is 51316-914-03.

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 healthcare professionals should refer to the dosing chart to determine the appropriate dosage based on the patient's weight or age. It is essential to shake the product well before each use. The enclosed dosing cup must be utilized for accurate measurement; no other dosing devices should be employed.

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

Dosing may be repeated every 6 to 8 hours as needed, but it is crucial not to exceed 4 doses in a 24-hour period. Healthcare professionals should ensure that patients do not receive more than the directed amount.

Contraindications

Use of this product is contraindicated in the following situations:

Patients with a history of allergic reactions to ibuprofen or any other pain reliever/fever reducer should not use this product due to the risk of severe allergic reactions. Additionally, the product should not be administered immediately before or after heart surgery, as it may interfere with postoperative recovery and increase the risk of complications.

Warnings and Precautions

Ibuprofen may cause severe allergic reactions, particularly in individuals with a known allergy to aspirin. Symptoms of such reactions can include hives, 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.

This product contains a nonsteroidal anti-inflammatory drug (NSAID), which is associated with an increased risk of severe stomach bleeding. The likelihood of this adverse effect is heightened in children who have a history of stomach ulcers or bleeding disorders, are concurrently taking anticoagulants or steroid medications, are using other NSAIDs (including aspirin, ibuprofen, or naproxen), or exceed the recommended dosage or duration of treatment.

Healthcare professionals should be aware that NSAIDs, excluding aspirin, elevate the risk of heart attack, heart failure, and stroke, which can be fatal. This risk is particularly pronounced when the medication is used in excess of the recommended dosage or for prolonged periods.

In cases of severe or persistent sore throat, especially when accompanied by high fever, headache, nausea, or vomiting, immediate consultation with a healthcare provider is advised. 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 physician.

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

Healthcare providers should instruct caregivers to discontinue use 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 heart problems or stroke, including chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling, warrant immediate medical evaluation. If the child does not experience relief within the first 24 hours of treatment, 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 or unusual symptoms should also prompt consultation with a healthcare professional.

Side Effects

Patients using ibuprofen should be aware of the potential for serious adverse reactions, including severe allergic reactions, which may manifest as hives, asthma (wheezing), skin reddening, facial swelling, shock, rash, or blisters. Individuals with a known allergy to aspirin are particularly at risk.

The use of ibuprofen, as a nonsteroidal anti-inflammatory drug (NSAID), carries a warning for the possibility 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, and individuals using other NSAIDs, including aspirin and naproxen. Patients are advised to adhere strictly to dosing instructions, as exceeding the recommended dosage or duration of use increases the likelihood of adverse effects.

Additionally, NSAIDs, excluding aspirin, are associated with an elevated risk of heart attack, heart failure, and stroke, which can be fatal. This risk is particularly pronounced when the medication is used inappropriately, such as taking more than directed or for an extended period.

Patients should seek medical attention if they experience signs of stomach bleeding, such as feeling faint, vomiting blood, passing 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 consultation. Furthermore, if a patient does not achieve relief within the first 24 hours of treatment, or if fever or pain worsens or persists beyond three days, they should contact a healthcare provider. Redness or swelling in the painful area or the emergence of new symptoms should also prompt a consultation.

Before using ibuprofen, it is advisable for patients to consult a healthcare professional if they have a history of stomach issues, such as heartburn, or if they have experienced serious side effects from pain relievers or fever reducers. Patients 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, kidney disease, or a history of stroke should also seek medical advice. Additionally, patients with asthma or those taking diuretics should consult a doctor prior to use.

In summary, while ibuprofen can be effective for pain and fever relief, it is essential for patients to be vigilant regarding potential adverse reactions and to seek medical guidance when necessary.

Drug Interactions

The product contains a nonsteroidal anti-inflammatory drug (NSAID), which is associated with an increased risk of severe gastrointestinal bleeding. This risk is particularly heightened in patients who are concurrently using anticoagulants or steroid medications. Additionally, the risk of adverse effects may be amplified if the patient is taking other NSAIDs, whether prescription or over-the-counter, such as aspirin, ibuprofen, or naproxen.

Due to these interactions, it is advisable to monitor patients closely for signs of gastrointestinal bleeding, especially in those who are on anticoagulant or steroid therapy, or who are using multiple NSAIDs. Dosage adjustments may be necessary based on the clinical scenario and the presence of these concomitant medications.

No specific interactions with laboratory tests have been identified in the available data.

Packaging & NDC

Below are the non-prescription pack sizes of Dye Free Childrens Ibuprofen (ibuprofen). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Dye Free Childrens Ibuprofen.
Details

Pediatric Use

Pediatric patients should not use this medication for more than 2 days or be administered to children under 3 years of age unless directed by a healthcare professional.

Dosing recommendations are as follows:

  • For patients weighing under 24 lbs (under 2 years of age), consultation with a doctor is advised.

  • 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.

It is essential to use only the enclosed dosing cup for administration and to avoid using any other dosing device.

Geriatric Use

There is no specific information available regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy.

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 pregnancy. Additionally, no dosage modifications for pregnant individuals are provided. The insert also does not include any special precautions regarding the use of ibuprofen during pregnancy. Healthcare professionals should consider the absence of specific data when advising pregnant patients and weigh the potential benefits against any unknown risks.

Lactation

There are no specific statements regarding the use of this medication in lactating mothers or its effects on breastfed infants. Healthcare professionals should consider the absence of data when advising lactating mothers about the use of this medication.

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.

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

In the absence of specific information regarding overdosage in the provided sections of the Summary of Product Characteristics (SPL), healthcare professionals are advised to exercise caution when administering the medication.

It is essential to monitor patients closely for any signs of adverse effects or symptoms that may arise from excessive dosing. In the event of suspected overdosage, immediate medical attention should be sought.

Healthcare providers should implement standard supportive measures, which may include symptomatic treatment and monitoring of vital signs. Additionally, it is recommended to consult local poison control centers or relevant toxicology resources for guidance on management strategies tailored to the specific circumstances of the overdosage event.

Documentation of the incident and any interventions taken is crucial for ongoing patient care and safety.

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 compound in these areas.

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, there have been reports of severe stomach bleeding, particularly in children with a history of stomach ulcers or bleeding problems, as well as in those taking blood thinners, steroids, or other nonsteroidal anti-inflammatory drugs (NSAIDs).

Furthermore, an increased risk of heart attack, heart failure, and stroke has been associated with the use of NSAIDs. Serious adverse events, including gastrointestinal bleeding, renal impairment, and liver function abnormalities, have also been noted in postmarketing surveillance.

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 stomach pain that does not improve. Additionally, healthcare providers should inform patients to stop use and seek medical advice 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 also be counseled to stop 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 beyond three days, if there is redness or swelling in the painful area, or if any new symptoms arise.

It is important for healthcare providers to remind patients to consult a doctor before use if the stomach bleeding warning is applicable to the child, or if the child has a history of stomach issues, such as heartburn. Patients should also be advised to seek medical advice if the child has experienced serious side effects from pain relievers or fever reducers, has not been drinking fluids, or has lost significant fluid due to vomiting or diarrhea.

Furthermore, healthcare providers should recommend that patients consult a doctor before use if the child has high blood pressure, heart disease, liver cirrhosis, kidney disease, or a history of stroke. Patients with asthma or those taking a diuretic should also be advised to seek medical consultation prior to use. Lastly, it is prudent for patients to discuss with a doctor or pharmacist if the child is under care for any serious condition or is taking any other medications.

Storage and Handling

The product is supplied in 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. Patients are advised to take the medication with food or milk if they experience stomach upset. In the event of an overdose, it is crucial for patients to seek medical assistance immediately or contact a Poison Control Center at 1-800-222-1222.

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

Drug Information (PDF)

This file contains official product information for Dye Free 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 Dye Free 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

Last AI update:

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.