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Childrens Ibuprofen Oral Suspension, Dye Free

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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)
Marketed in the U.S.
Since 2025
Label revision date
January 20, 2025
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
Marketed in the U.S.
Since 2025
Label revision date
January 20, 2025
Manufacturer
Best Choice
Registration number
ANDA210602
NDC root
63941-128

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Drug Overview

Best Choice® Children's Ibuprofen Oral Suspension is a medication that contains ibuprofen, which is a type of nonsteroidal anti-inflammatory drug (NSAID). This oral suspension is designed for children aged 2 to 11 years and comes in a pleasant original berry flavor. It is primarily used to relieve minor aches and pains associated with common conditions like the cold, flu, sore throat, headache, and toothache, as well as to reduce fever. The effects of this medication can last for up to 8 hours, providing effective relief for your child when they need it most.

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 developmental issues in a fetus. This makes it a safer choice for those who may be pregnant or planning to become pregnant.

Dosage and Administration

Before you use this medication, make sure to shake the bottle well. It's important to use only the dosing cup that comes with the medication; other devices may not provide the correct amount. To find the right dose for you or your child, refer to the dosing chart based on weight. If you can't use weight, you can use age instead.

For children weighing under 24 pounds (less than 2 years old), it's best to consult a doctor before giving any dose. 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), it's 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 remember not to exceed 4 doses in a single day. Always follow your doctor's instructions if they provide specific guidance.

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, facial swelling, wheezing, shock, skin reddening, rash, and blisters. If you notice any of these signs, stop using the medication and seek medical help immediately.

Additionally, ibuprofen can increase the risk of stomach bleeding, heart attack, and stroke, particularly if used in higher doses or for longer than recommended. Be alert for signs of stomach bleeding, such as feeling faint, vomiting blood, or having black stools. If your child experiences chest pain, trouble breathing, or weakness on one side of the body, seek medical attention right away. Always consult a doctor if your child has a history of stomach issues, is dehydrated, or has other serious health conditions before using ibuprofen.

Warnings and Precautions

Ibuprofen can cause serious allergic reactions, especially in individuals who are allergic to aspirin. If you notice symptoms like hives, facial swelling, wheezing, or any skin rash, stop using the medication immediately and seek medical help. Additionally, be aware that ibuprofen, which is a type of nonsteroidal anti-inflammatory drug (NSAID), can lead to severe stomach bleeding, particularly if your child has a history of stomach ulcers, is taking blood thinners or steroids, or is using other NSAIDs.

There is also an increased risk of heart attack and stroke associated with NSAIDs, especially if used in higher doses or for longer than recommended. If your child experiences a severe sore throat, especially with high fever, headache, nausea, or vomiting, consult a doctor right away. You should not use ibuprofen for more than two days in these cases or give it to children under three years old without a doctor's guidance.

If you suspect an overdose, contact a Poison Control Center or seek emergency medical help immediately. You should also stop using ibuprofen and consult a doctor if your child shows signs of stomach bleeding (like fainting, vomiting blood, or having black stools), symptoms of heart problems or stroke (such as chest pain or trouble breathing), or if their condition does not improve within 24 hours. Additionally, if fever or pain worsens after three days, or if new symptoms appear, it’s important to seek medical advice.

Overdose

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

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

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that the safety of ibuprofen has not been established. In fact, using ibuprofen during pregnancy, especially in the third trimester, is not recommended because it can pose risks to your baby. These risks include potential miscarriage and issues with fetal kidney development, among other adverse effects.

Before taking ibuprofen, you should always consult your healthcare provider, particularly if you are in the later stages of your pregnancy. They can help you understand the safest options for managing any discomfort you may experience.

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 a good idea 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

You should avoid using this medication in children under 3 years of age unless a doctor specifically advises it. For children who are 2 years and older, the dosage depends on their weight. For example, if your child weighs under 24 lbs, consult a doctor before giving any medication. If they weigh between 24-35 lbs, the recommended dose is 5 mL; for 36-47 lbs, it's 7.5 mL; for 48-59 lbs, it's 10 mL; for 60-71 lbs, it's 12.5 mL; and for 72-95 lbs, the dose is 15 mL.

It's important to consult a doctor if your child has any history of stomach issues, has not been drinking fluids, or has lost a lot of fluids from vomiting or diarrhea. Additionally, if your child has high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or is taking a diuretic (a medication that helps remove excess fluid), you should also seek medical advice. Remember not to exceed 4 doses in a day, and if necessary, doses can be repeated every 6-8 hours.

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 considering this medication, it’s important to consult with a healthcare provider. 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 issues, 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 there are no special monitoring requirements or safety considerations outlined for patients with renal impairment (kidney problems).

Always consult your healthcare provider for personalized advice and to ensure that any medications you take are safe and appropriate for your kidney health. They can provide guidance tailored to your specific situation.

Hepatic Impairment

If you have liver problems, it's important to know that the drug insert does not provide specific information about dosage adjustments, special monitoring, or precautions for your condition. This means that there are no tailored guidelines for how this medication may affect you differently due to your liver health.

Always consult your healthcare provider for personalized advice and to discuss any concerns you may have regarding your liver function and how it relates to your treatment. They can help ensure that your medication is safe and effective for you.

Drug Interactions

It's important to be aware that certain medications can interact with each other, potentially leading to serious side effects. For instance, if you or your child are taking ibuprofen, combining it with blood thinners (medications that help prevent blood clots) or steroids can increase the risk of stomach bleeding. Additionally, using ibuprofen alongside other nonsteroidal anti-inflammatory drugs (NSAIDs) like aspirin or naproxen can further elevate this risk.

Always discuss any medications you or your child are taking with your healthcare provider. They can help you understand the potential interactions and ensure that your treatment plan is safe and effective. Remember, being informed and proactive about your health is key to avoiding complications.

Storage and Handling

To ensure the best performance and safety of your product, store it at a temperature between 20-25°C (68-77°F). This temperature range helps maintain its effectiveness. Additionally, always check the printed neckband before use; do not use the product if the neckband is broken or missing, as this could indicate that the product is compromised.

Handling the product with care is essential. Make sure to keep it in a clean environment to avoid contamination. If you have any questions about disposal or further safety measures, please consult the product guidelines or your healthcare provider.

Additional Information

No further information is available.

FAQ

What is Best Choice® Children's Ibuprofen Oral Suspension used for?

It 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 is the recommended dosage for children?

The dosage varies by weight: for children weighing 24-35 lbs (2-3 years), it's 5 mL; for 36-47 lbs (4-5 years), it's 7.5 mL; and so on, up to 15 mL for those weighing 72-95 lbs (11 years).

How often can I give this medication?

You can repeat the dose every 6-8 hours, but do not use more than 4 times a day.

Are there any contraindications for using this medication?

Do not use if the child has ever had an allergic reaction to ibuprofen or any other pain reliever/fever reducer, or if they are about to undergo heart surgery.

What should I do if my child experiences an allergic reaction?

If an allergic reaction occurs, stop use and seek medical help right away.

Can this medication cause stomach bleeding?

Yes, ibuprofen may cause severe stomach bleeding, especially if the child has had stomach ulcers or is taking blood thinners or other NSAIDs.

Is it safe to use ibuprofen during pregnancy?

The safety of ibuprofen during pregnancy has not been established, and it is contraindicated, especially in the third trimester due to potential risks to the fetus.

What should I do if my child does not get relief from pain or fever?

If your child does not get any relief within the first 24 hours of treatment, or if fever or pain worsens or lasts more than 3 days, consult a doctor.

How should I store this medication?

Store between 20-25° C (68-77° F) and do not use if the printed neckband is broken or missing.

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

Consult a doctor before using ibuprofen if your child has a history of stomach problems, such as heartburn.

Packaging Info

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

Packaging configurations for Childrens Ibuprofen Oral Suspension, Dye Free.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Best Choice® Children's Ibuprofen Oral Suspension is a nonsteroidal anti-inflammatory drug (NSAID) formulated for pediatric use. Each 5 mL dose contains 100 mg of ibuprofen, serving as an effective pain reliever and fever reducer. This dye-free oral suspension is designed for children aged 2 to 11 years and is available in an original berry flavor. The product is packaged in a 4 FL OZ (118 mL) bottle and provides relief that lasts up to 8 hours. It is comparable to the active ingredient found in Children's Motrin®.

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; other dosing devices are not recommended.

Dosing should be determined primarily by the patient's weight; however, if weight is not available, age may be used as a secondary guide. The following dosing chart provides the recommended volumes based on weight:

  • For patients weighing under 24 lbs (under 2 years), consultation with a physician 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.

Dosing may be repeated every 6 to 8 hours as necessary, but should not exceed four doses in a 24-hour period. Administration should be conducted as directed by a healthcare professional.

Contraindications

Use is contraindicated in children with a history of allergic reactions to Ibuprofen or any other pain reliever or fever reducer, 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 elicit 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.

The use of ibuprofen, as a nonsteroidal anti-inflammatory drug (NSAID), carries a significant risk of severe stomach bleeding. This risk is notably elevated in pediatric patients with a history of stomach ulcers or bleeding disorders, those concurrently using anticoagulants or steroid medications, and individuals 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 likelihood of gastrointestinal complications.

Healthcare professionals should be aware that the use of NSAIDs, excluding aspirin, is associated with an increased 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.

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

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

Healthcare providers should instruct caregivers to discontinue ibuprofen and consult a physician if the child exhibits any signs of stomach bleeding, such as feeling faint, vomiting blood, passing bloody or black stools, or experiencing persistent stomach pain. Additionally, symptoms suggestive 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 that arise during treatment should also prompt consultation with a healthcare professional.

Side Effects

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

Severe allergic reactions may occur, particularly in individuals with a known allergy to aspirin. Symptoms of such reactions can include hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, and blisters. In the event of an allergic reaction, it is imperative to discontinue use and seek immediate medical assistance.

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

Additionally, ibuprofen is associated with an increased 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 longer than directed.

Patients should be vigilant for signs of serious conditions, such as severe or persistent sore throat, especially when accompanied by high fever, headache, nausea, or vomiting, and should consult a healthcare provider promptly. It is advised not to use ibuprofen for more than two days or to administer it to children under three years of age without medical guidance.

Patients should discontinue use and consult a doctor if they experience any signs of stomach bleeding, including feeling faint, vomiting blood, having bloody or black stools, or persistent stomach pain. Symptoms indicative of heart problems or stroke, such as chest pain, difficulty breathing, weakness on one side of the body, slurred speech, or leg swelling, also warrant immediate medical attention. Furthermore, if there is no relief within the first 24 hours of treatment, or if fever or pain worsens or persists beyond three days, medical advice should be sought.

Before using ibuprofen, it is essential to consult a healthcare provider if the patient has a history of stomach issues, has experienced serious side effects from pain relievers or fever reducers, is dehydrated, or has conditions such as high blood pressure, heart disease, liver cirrhosis, kidney disease, or a history of stroke. Patients with asthma or those taking diuretics should also seek medical advice prior to use.

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

Drug Interactions

Ibuprofen has been associated with an increased risk of gastrointestinal bleeding when co-administered with anticoagulants or corticosteroids. This interaction necessitates careful monitoring of patients who are prescribed these medications concurrently. It is advisable to consider dosage adjustments or alternative therapies to mitigate this risk.

Additionally, the risk of gastrointestinal bleeding is further elevated in pediatric patients who are taking ibuprofen alongside other nonsteroidal anti-inflammatory drugs (NSAIDs), including aspirin and naproxen. Clinicians should exercise caution and evaluate the necessity of concurrent NSAID therapy in these cases to prevent potential adverse effects.

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

Packaging & NDC

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

Packaging configurations for Childrens Ibuprofen Oral Suspension, Dye Free.
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 based on weight and age:

  • For patients weighing under 24 lbs and under 2 years of age, consultation with a doctor is required.

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

Healthcare professionals should advise parents or guardians to consult a doctor if the child has a history of stomach problems, such as heartburn, or if the child has not been drinking fluids or has experienced significant fluid loss due to vomiting or diarrhea. Additionally, consultation is necessary if the child has high blood pressure, heart disease, liver cirrhosis, kidney disease, a history of stroke, or asthma. If the child is taking a diuretic, a doctor should also be consulted.

The medication should not be used more than four times a day, and if needed, doses may be repeated every 6-8 hours.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, 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 or changes in efficacy, given the lack of targeted data for this population.

Pregnancy

The safety of ibuprofen during pregnancy has not been established. Ibuprofen is contraindicated in pregnancy, particularly during the third trimester, due to the risk of fetal harm. The use of nonsteroidal anti-inflammatory drugs (NSAIDs), including ibuprofen, during pregnancy may be associated with an increased risk of miscarriage, fetal renal impairment, and other adverse effects.

Pregnant women are advised to consult a healthcare provider before using ibuprofen, especially if they are in the later stages of pregnancy. It is essential for healthcare professionals to weigh the potential risks to the fetus against the benefits of treatment when considering the use of ibuprofen in pregnant patients.

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 prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

Hepatic Impairment

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

Overdosage

Overdosage of ibuprofen can lead to significant health risks and serious harm. Healthcare professionals should be aware of the potential symptoms associated with an overdose, which may include nausea, vomiting, stomach pain, drowsiness, and headache.

In the event of an overdose, it is imperative to seek immediate medical attention. Healthcare providers should advise patients or caregivers to contact a Poison Control Center for further guidance and management. Prompt intervention is crucial to mitigate the effects of ibuprofen overdosage and ensure patient safety.

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 available regarding animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has indicated that various adverse reactions have been reported voluntarily or through surveillance programs. These include allergic reactions such as hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, and blisters. Additionally, instances of stomach bleeding have been documented, particularly in patients with a history of stomach ulcers or bleeding disorders, as well as those concurrently using blood thinners or other nonsteroidal anti-inflammatory drugs (NSAIDs).

Serious cardiovascular events, including heart attack, heart failure, and stroke, have also been reported, especially among patients who exceed the recommended dosage or duration of use. Furthermore, reports of severe or persistent sore throat, or sore throat accompanied by high fever, headache, nausea, and vomiting, have been noted as serious conditions that necessitate prompt medical consultation.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. In the event of an overdose, patients should be instructed to seek medical help or contact a Poison Control Center immediately at 1-800-222-1222.

Patients should be informed 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 is important to emphasize that this medication should not be administered right before or after heart surgery.

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

Patients should also be informed 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.

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

Patients should be encouraged 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 significant fluid due to vomiting or diarrhea. Additionally, healthcare providers should advise patients to consult a doctor before use if the child has high blood pressure, heart disease, liver cirrhosis, kidney disease, a history of stroke, or asthma.

Lastly, patients should be reminded to discuss with a doctor or pharmacist before use if the child is taking a diuretic or is under medical care for any serious condition, as well as if the child is taking any other medications.

Storage and Handling

The product is supplied in configurations that include specific NDC numbers. It should be stored at a temperature range of 20-25° C (68-77° F) to ensure optimal stability and efficacy.

Healthcare professionals are advised to inspect the product prior to use; it should not be utilized if the printed neckband is broken or missing, as this may indicate compromised integrity. Proper handling and storage conditions are essential to maintain the quality of the product.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Childrens Ibuprofen Oral Suspension, Dye Free, 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 Oral Suspension, Dye Free, 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.