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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)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2025
Label revision date
September 18, 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
September 18, 2025
Manufacturer
FSA Store Inc. (Caring Mill)
Registration number
ANDA210602
NDC root
81522-311
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info
Packaging & NDC Codes

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

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

Drug Overview

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

This medication comes in a pleasant original berry flavor and is both dye-free and alcohol-free, making it suitable for young children. It can provide relief for up to 8 hours, helping to keep your child feeling better throughout the day.

Uses

You can use this medication to help relieve minor aches and pains 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 using this product, it's important to know that it doesn't come with specific directions or warnings for adults. Always make sure to follow the recommended dosage and never exceed the amount directed. To prepare the medication, shake the bottle well before each use. You should find the right dose by referring to the dosing chart, which considers both weight and age. If possible, use your child's weight to determine the dose; if not, you can use their age.

Make sure to use only the enclosed dosing cup for measuring the medication, as other devices may not provide accurate measurements. If necessary, you can repeat the dose every 6 to 8 hours, but do not use it more than four times a day. After using the product, remember to securely replace the original bottle cap to keep it child-resistant. If your child weighs under 24 pounds or is under 2 years old, consult a doctor for the appropriate dose. For children weighing between 24 to 95 pounds, the dosing chart provides specific amounts based on their weight and age.

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, so it's important to be aware of them. You may experience a severe allergic reaction, especially if you are allergic to aspirin. Symptoms can include hives, facial swelling, wheezing, shock, skin reddening, rash, or blisters. Additionally, this medication can lead to severe stomach bleeding, particularly if you have a history of stomach ulcers, are taking blood thinners or steroids, or use other NSAIDs (nonsteroidal anti-inflammatory drugs) like aspirin or naproxen.

There is also an increased risk of heart attack and stroke associated with NSAIDs, which can be fatal, especially if used in higher doses or for longer than recommended. If you notice signs of stomach bleeding, such as feeling faint, vomiting blood, or having black stools, or if you experience symptoms of heart problems or stroke, such as chest pain or trouble breathing, seek medical attention immediately. It's also important to consult a doctor if your symptoms do not improve within 24 hours or if you have a sore throat with a high fever, headache, nausea, or vomiting.

Warnings and Precautions

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

This medication may also lead to severe stomach bleeding, particularly if you or your child have a history of stomach ulcers or bleeding issues, are taking blood thinners or steroids, or are using other NSAIDs (nonsteroidal anti-inflammatory drugs) like aspirin or naproxen. Additionally, using ibuprofen for longer than directed can increase the risk of heart attack and stroke, which can be fatal. If you experience symptoms like chest pain, trouble breathing, or weakness on one side of the body, seek emergency medical assistance right away.

It's important to consult a doctor if your child has a severe sore throat with high fever, headache, nausea, or vomiting, or if symptoms persist beyond two days. You should also stop using ibuprofen and call a doctor if your child shows signs of stomach bleeding (like faintness, vomiting blood, or black stools), does not feel better within 24 hours, or if any new symptoms arise. In case of an overdose, contact a Poison Control Center immediately at 1-800-222-1222.

Overdose

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

Always take overdosing seriously. If you notice any of these symptoms or have concerns about your health, don’t hesitate to reach out for help right away. Your safety is the top priority.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that there is no specific information available about the use of Children's Ibuprofen Oral Suspension during pregnancy. The insert does not mention any risks or contraindications associated with taking ibuprofen while pregnant, nor does it provide any dosage modifications for pregnant individuals. Additionally, there are no special precautions outlined for using this medication during pregnancy.

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

Lactation Use

If you are breastfeeding or planning to breastfeed, it's important to consult your doctor before using this product. There is a possibility that the ingredients may pass into your breast milk, which could pose risks to your infant. Therefore, exercise caution when considering this product while nursing, as it may affect both your milk production and your baby's health. Always prioritize open communication with your healthcare provider to ensure the best outcomes for you and your child.

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 older, the dosage varies based on their weight and age. For example, if your child weighs under 24 pounds and is under 2 years old, you should consult a doctor before giving it to them. For children aged 2 to 3 years who weigh between 24 and 35 pounds, the recommended dose is 5 mL. As your child grows, the dosage increases: 7.5 mL for ages 4 to 5 years (36-47 lbs), 10 mL for ages 6 to 8 years (48-59 lbs), 12.5 mL for ages 9 to 10 years (60-71 lbs), and 15 mL for 11-year-olds (72-95 lbs).

It's important to consult a doctor if your child has a history of stomach issues, is taking other medications, or has serious health conditions. Always ensure that this product is used appropriately for children.

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 problems, it's important to consult your doctor before using this medication. Your healthcare provider needs to know about any existing conditions, such as high blood pressure, heart disease, liver cirrhosis, or a history of stroke, as these can affect how the medication works for you. Always prioritize open communication with your doctor to ensure your safety and the effectiveness of your treatment.

Hepatic Impairment

If you have liver problems, such as liver cirrhosis (severe scarring of the liver), 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 (blood tests that check how well your liver is working). This is crucial to ensure that the medication is safe and effective for you.

Additionally, if you have other health conditions like high blood pressure, heart disease, or kidney disease, these factors can also influence your treatment plan. Always communicate openly with your healthcare team about your liver health and any other medical issues you may have to receive the best care possible.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications or tests you may be taking. While there are no specific drug interactions or laboratory test interactions noted for this medication, your healthcare provider can help ensure that everything you are taking works well together and is safe for you.

Always feel free to ask questions and share your complete list of medications and any tests you might be undergoing. This way, you can avoid any potential issues and receive the best care possible.

Storage and Handling

To ensure the best performance and safety of your product, store it in a cool, dry place at a temperature between 20º to 25ºC (68º to 77ºF). This temperature range helps maintain the integrity of the device.

Before using the product, check that the printed neckband is intact. If it is broken or missing, do not use the device, as this could compromise its safety and effectiveness. Always handle the product with care to ensure it remains in good condition.

Additional Information

No further information is available.

FAQ

What is Children's Ibuprofen?

Children's Ibuprofen is an oral suspension (NSAID) that contains 100 mg of ibuprofen per 5 mL, designed to relieve minor aches and pains in children.

What conditions does Children's Ibuprofen treat?

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

What age group is Children's Ibuprofen intended for?

This product is intended for use in children ages 2 to 11 years.

How should I dose Children's Ibuprofen?

Use the enclosed dosing cup and refer to the dosing chart based on your child's weight and age. Do not exceed 4 doses in a day.

What should I do if my child experiences stomach bleeding?

If your child shows signs of stomach bleeding, such as feeling faint or vomiting blood, stop use and seek medical help immediately.

Are there any allergies associated with Children's Ibuprofen?

Yes, ibuprofen may cause severe allergic reactions, especially in those allergic to aspirin. Symptoms can include hives, swelling, and difficulty breathing.

Can I use Children's Ibuprofen if my child has had heart surgery?

No, do not use this product right before or after heart surgery.

Is it safe to use Children's Ibuprofen during pregnancy?

The insert does not provide specific information regarding the use of Children's Ibuprofen during pregnancy.

What precautions should nursing mothers take?

Nursing mothers should consult a doctor before using this product due to the potential for ibuprofen to be excreted in breast milk.

How should I store Children's Ibuprofen?

Store the product between 20º to 25ºC (68º to 77ºF) and do not use if the printed neckband is broken or missing.

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

No description information is available.

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 specific dosing instructions must be followed. Healthcare professionals should ensure that the patient does not exceed the recommended dosage.

Prior to administration, the product must be shaken well. The appropriate dose should be determined using the provided dosing chart, which considers both weight and age. If possible, weight should be used to ascertain the correct dosage; otherwise, age may be utilized.

The dosing cup enclosed with the product should be the only device used for measuring the dose. The following dosing recommendations are provided:

  • For patients weighing under 24 lb or under 2 years of age, the dose should be determined by consulting a physician.

  • For patients weighing 24-35 lb or aged 2-3 years, the recommended dose is 5 mL.

  • For patients weighing 36-47 lb or aged 4-5 years, the recommended dose is 7.5 mL.

  • For patients weighing 48-59 lb or aged 6-8 years, the recommended dose is 10 mL.

  • For patients weighing 60-71 lb or aged 9-10 years, the recommended dose is 12.5 mL.

  • For patients weighing 72-95 lb or aged 11 years, the recommended dose is 15 mL.

Doses may be repeated every 6-8 hours as needed, but should not exceed four doses in a 24-hour period. After use, the original bottle cap must be replaced to maintain child resistance.

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 pose risks related to surgical recovery and cardiovascular stability.

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, facial swelling, asthma (wheezing), shock, skin reddening, rash, and blisters. In the event of an allergic reaction, it is imperative to discontinue use immediately and seek medical assistance.

This product contains a nonsteroidal anti-inflammatory drug (NSAID), which carries a risk of severe stomach bleeding. The likelihood of this adverse effect is increased 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 the use of NSAIDs, excluding aspirin, is 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 in excess of the recommended dosage or for extended periods.

Severe or persistent sore throat, especially when accompanied by high fever, headache, nausea, or vomiting, may indicate a serious condition. In such cases, it is essential to consult a physician promptly. The use of ibuprofen should not exceed two days, nor should it be administered to children under three years of age unless specifically directed by a healthcare provider.

In the event of an overdose, immediate medical attention is required. Healthcare professionals should advise patients to contact a Poison Control Center at 1-800-222-1222 without delay.

Patients should be instructed to discontinue use and consult a physician if any of the following occur: 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; lack of relief within the first 24 hours of treatment; worsening fever or pain lasting more than three days; presence of redness or swelling in the affected area; or the emergence of any new symptoms.

Side Effects

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

The use of ibuprofen, as a nonsteroidal anti-inflammatory drug (NSAID), carries a risk of severe stomach bleeding. This risk is heightened in patients with a history of stomach ulcers or bleeding problems, those taking anticoagulants or steroid medications, and individuals using other NSAIDs, whether prescription or over-the-counter. Additionally, the risk of stomach bleeding increases with prolonged use or higher than recommended dosages.

Patients should also be informed of the increased risk of heart attack, heart failure, and stroke associated with NSAID use, excluding aspirin. These cardiovascular events can be fatal, and the risk is amplified when the medication is used in excess of the recommended duration or dosage.

In the event of a severe or persistent sore throat, particularly when accompanied by high fever, headache, nausea, or vomiting, patients are advised to seek medical attention promptly. It is recommended that ibuprofen not be used for more than two days or administered to children under three years of age without a doctor's guidance.

Patients should discontinue use and consult a healthcare professional if any of the following symptoms occur: signs of stomach bleeding such as feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain; symptoms indicative of heart problems or stroke, including chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling; 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.

Drug Interactions

There are currently no documented drug interactions associated with the use of this medication. Additionally, there is no information available regarding interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

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 product unless directed by a healthcare professional. For dosing, the following guidelines apply:

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

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

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

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

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

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

Healthcare professionals should exercise caution and consult a doctor if the pediatric patient has a history of stomach problems, is taking other medications, or has other serious health conditions. This product is specifically intended for use in children.

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 adverse effects or changes in efficacy, given the lack of targeted data for this population.

Pregnancy

There is no specific information available regarding the use of Children's Ibuprofen Oral Suspension during pregnancy. The prescribing information does not mention any contraindications or risks associated with the use of ibuprofen during this period. Additionally, no dosage modifications for pregnant individuals are specified. The insert also does not include any special precautions regarding the use of this medication during pregnancy. Healthcare professionals should consider the absence of data when advising pregnant patients and weigh the potential benefits against any unknown risks.

Lactation

Nursing mothers should consult a doctor before using this product. There is a potential for excretion in breast milk, and caution is advised when administering this product to nursing mothers due to the potential risk to the infant.

Renal Impairment

Patients with renal impairment should consult a healthcare professional prior to use, particularly if they have a history of kidney disease. It is essential to assess the patient's overall health status, including any comorbid conditions such as high blood pressure, heart disease, liver cirrhosis, or a history of stroke, as these factors may influence the management of their renal function and the appropriateness of treatment. Monitoring and potential dosing adjustments may be necessary based on the patient's renal status to ensure safety and efficacy.

Hepatic Impairment

Patients with hepatic impairment may experience altered pharmacokinetics of the medication 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 is recommended throughout the treatment course to ensure safety and efficacy.

Additionally, patients with a history of significant liver disease, such as cirrhosis, should be evaluated for any contraindications related to their hepatic condition. Regular assessment of clinical parameters and laboratory values is advised to manage any adverse effects that may arise from the medication's use in this population.

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 support can significantly influence outcomes. Symptoms of overdose may vary depending on the substance involved, and healthcare providers should be prepared to assess and manage these symptoms accordingly.

Management procedures may include supportive care, monitoring of vital signs, and symptomatic treatment as necessary. It is essential for healthcare professionals to remain vigilant and act swiftly to mitigate potential complications associated with overdose.

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 in these areas limits the understanding of the compound's safety profile in nonclinical settings.

Postmarketing Experience

Postmarketing experience has identified the following adverse reactions reported voluntarily or through surveillance programs: gastrointestinal bleeding, renal impairment, and hypersensitivity reactions. The hypersensitivity reactions include anaphylaxis and various skin reactions.

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.

Providers should encourage patients to consult a doctor before use if the child has a warning for stomach bleeding or a history of stomach problems, such as heartburn. Additionally, it is important to ask a doctor before use if the child has experienced problems or serious side effects from pain relievers or fever reducers.

Patients should be informed to consult a doctor before use if the child has not been drinking fluids or has lost a significant amount of fluid due to vomiting or diarrhea. Furthermore, healthcare providers should recommend discussing the use of this medication with a doctor if the child has high blood pressure, heart disease, liver cirrhosis, kidney disease, or has had a stroke.

Providers should also advise patients to seek medical advice before use if the child has asthma or is taking a diuretic. It is essential to recommend that patients consult a doctor or pharmacist before use if the child is under a doctor's 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 should be referenced for accurate identification. It is essential to store the product at a controlled temperature range of 20º to 25ºC (68º to 77ºF) to maintain its integrity 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 potential tampering or compromise of the product's safety. Proper handling and storage conditions are crucial to ensure the product remains effective and safe for patient use.

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.