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Childrens Ibuprofen 100

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Active ingredient
Ibuprofen 100 mg/5 mL
Other brand names
Drug class
Nonsteroidal Anti-inflammatory Drug
Dosage form
Suspension
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2014
Label revision date
June 6, 2023
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Ibuprofen 100 mg/5 mL
Other brand names
Drug class
Nonsteroidal Anti-inflammatory Drug
Dosage form
Suspension
Route
Oral
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2014
Label revision date
June 6, 2023
Manufacturer
Walgreen Company
Registration number
ANDA074937
NDC root
0363-0806
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (3 NDCs)
Packaging & NDC Codes (3)

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Drug Overview

Children’s Ibuprofen is an oral suspension medication designed for children ages 2 to 11 years. It serves as a pain reliever and fever reducer, helping to alleviate minor aches and pains associated with common conditions like the cold, flu, sore throat, headache, and toothache. This dye-free, non-staining, and alcohol-free formula comes in a pleasant berry flavor and can provide relief for up to 8 hours.

As a nonsteroidal anti-inflammatory drug (NSAID), Children’s Ibuprofen works by reducing inflammation and lowering fever, making it a trusted choice for parents seeking to comfort their children during illness.

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 instead.

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 each use, wash the dosing cup to keep it clean. Finally, remember to replace the original bottle cap to maintain its child-resistant feature, ensuring safety in your home.

What to Avoid

You should avoid using this medication if your child has ever had an allergic reaction to ibuprofen or any other pain reliever or fever reducer. Additionally, it is important not to use this medication right before or after your child has undergone heart surgery. Following these guidelines will help ensure your child's safety and well-being.

Side Effects

Ibuprofen can cause serious allergic reactions, particularly in individuals who are allergic to aspirin. Signs of an allergic reaction may include hives, facial swelling, wheezing (asthma), shock, skin reddening, rash, or blisters. Additionally, this medication carries a risk of severe stomach bleeding, especially if your child has a history of stomach ulcers, is taking blood thinners or steroids, or uses other NSAIDs (nonsteroidal anti-inflammatory drugs) like aspirin or naproxen.

There is also an increased risk of heart attack and stroke associated with NSAIDs, which can be life-threatening, particularly if used in higher doses or for extended periods. If your child experiences symptoms such as faintness, vomiting blood, or black stools, or shows signs of heart problems like chest pain or difficulty breathing, seek medical attention immediately. It's important to consult a doctor if your child has a history of stomach issues, is dehydrated, or is taking other medications.

Warnings and Precautions

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

This medication can also lead to severe stomach bleeding, particularly if you have a history of stomach ulcers or bleeding 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 notice signs of stomach bleeding, such as feeling faint, vomiting blood, or having black stools, or if you experience chest pain, trouble breathing, or weakness, stop using ibuprofen and contact your doctor right away.

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

Overdose

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

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

Pregnancy Use

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, ibuprofen is not recommended during pregnancy, especially in the third trimester, as it may pose risks to your developing baby. These risks can include potential heart problems and kidney issues for the fetus.

Before considering the use of ibuprofen, you should always consult your healthcare provider. It's crucial to avoid using this medication unless it has been specifically prescribed or recommended by a medical professional. Your health and the health of your baby are the top priority, so make sure to discuss any pain relief options with your doctor.

Lactation Use

If you are breastfeeding and considering using this product, it’s important to consult your doctor first. There is a possibility that the medication can pass into your breast milk, and the effects of ibuprofen on nursing infants have not been thoroughly studied. Because of this uncertainty, it’s wise to be cautious.

If you do take ibuprofen while nursing, keep an eye on your baby for any unusual reactions or side effects. Your healthcare provider can help guide you on the best practices to ensure both your health and your infant's well-being.

Pediatric Use

It's important to be cautious when giving medication to children. You should not use this medication in children under 3 years of age unless directed by a doctor. For children aged 2 to 10 years, the dosage depends on their weight. For example, if your child weighs under 24 lbs and is under 2 years old, consult a doctor first. For those weighing 24-35 lbs (ages 2-3), the dose is 5 mL, and it increases with weight and age up to 15 mL for an 11-year-old weighing 72-95 lbs. Always use the enclosed dosing cup and never exceed 4 doses in a day.

Keep the medication out of reach of children, and in case of an overdose, seek medical help immediately. It's also wise to consult a doctor if your child has a history of stomach issues, dehydration, or any serious health conditions like high blood pressure or asthma, or if they are taking other medications.

Geriatric Use

When considering this medication for older adults, it's important to note that the product does not provide specific directions or complete warnings tailored for adult use. This means that if you or a loved one is an older adult, you should consult with a healthcare professional to ensure safe and effective use.

Always discuss any existing health conditions or medications with your doctor, as they can help determine the right dosage and monitor for any potential side effects. Your safety and well-being are the top priority, so don't hesitate to ask questions or seek clarification about the medication.

Renal Impairment

If you have kidney problems, it's important to consult your doctor before using this medication. Your healthcare provider will want to know about any other health issues you may have, such as high blood pressure, heart disease, liver cirrhosis, or a history of stroke. This information helps ensure that the treatment is safe and appropriate for you. Always prioritize open communication with your doctor regarding your kidney health and any medications you are considering.

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 may 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 be aware of potential interactions when taking ibuprofen. If you or your child are allergic to aspirin, using ibuprofen could lead to a severe allergic reaction. Additionally, combining ibuprofen with blood thinners (medications that prevent blood clots) or steroids can significantly increase the risk of serious stomach bleeding. The risk is also heightened if other nonsteroidal anti-inflammatory drugs (NSAIDs), like aspirin or naproxen, are being used.

Using ibuprofen for extended periods or in higher doses than recommended can raise the chances of heart-related issues, such as heart attack or stroke. If your child is on a diuretic (a medication that helps remove excess fluid), it's crucial to consult a healthcare provider before using ibuprofen. Always discuss any medications or tests with your healthcare provider to ensure safety and effectiveness.

Storage and Handling

To ensure the safety and effectiveness of your product, store it at a temperature between 20-25°C (68-77°F). It's important to avoid freezing the product, as this can damage it. Before use, check the printed neckband; do not use the product if it is broken or missing, as this could indicate a safety issue.

By following these simple storage and handling guidelines, you can help maintain the quality and reliability of your product.

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.

Make sure to keep this medication out of reach of children. In the event of an overdose, seek medical assistance immediately or contact a Poison Control Center at 1-800-222-1222.

FAQ

What is Children's Ibuprofen?

Children's Ibuprofen is an oral suspension pain reliever and fever reducer, available in a berry flavor, and is recommended for children aged 2 to 11 years.

How does Children's Ibuprofen work?

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

What is the recommended dosage for Children's Ibuprofen?

Dosage varies by weight and age; for example, children weighing 24-35 lbs (ages 2-3 years) should take 5 mL, while those weighing 72-95 lbs (age 11 years) should take 15 mL.

Are there any warnings associated with Children's Ibuprofen?

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

Can I use Children's Ibuprofen if my child is pregnant or breastfeeding?

Consult a healthcare provider before using ibuprofen during pregnancy, as its safety has not been established. Nursing mothers should also consult a doctor due to potential effects on the infant.

What should I do in case of an overdose?

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

How should I store Children's Ibuprofen?

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

What should I do if my child experiences side effects?

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

Packaging Info

Below are the non-prescription pack sizes of Childrens Ibuprofen 100 (ibuprofen). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Childrens Ibuprofen 100.
Details

Drug Information (PDF)

This file contains official product information for Childrens Ibuprofen 100, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

Walgreens Children's Ibuprofen is an oral suspension formulation containing ibuprofen as the active ingredient, providing 100 mg of ibuprofen per 5 mL. This non-steroidal anti-inflammatory drug (NSAID) serves as a pain reliever and fever reducer. The product is designed for children aged 2 to 11 years and is available in a 4 FL OZ (118 mL) bottle. It features a berry flavor and is free from dyes and alcohol, ensuring a non-staining and palatable option for pediatric use. The effects of the medication can last up to 8 hours.

Uses and Indications

This drug is indicated for the relief of minor aches and pains associated with the common cold, influenza, sore throat, headache, and toothache. Additionally, it is utilized to reduce fever.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

This product is intended for use in pediatric patients, and specific dosing instructions must be followed. Healthcare professionals should ensure that the product is shaken well before each use. The appropriate dose should be determined using the dosing chart provided, prioritizing weight for dosing when possible; if weight is not available, age may be used as a secondary reference.

Dosing should be administered using only the enclosed dosing cup, as other dosing devices may lead to inaccuracies. The recommended dosing intervals are every 6 to 8 hours as needed, with a maximum of 4 doses per day.

The dosing chart is as follows:

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

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

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

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

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

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

After each use, the dosing cup should be washed thoroughly to maintain hygiene. It is essential to replace the original bottle cap after use to ensure child resistance and prevent accidental ingestion. Healthcare professionals should advise caregivers to adhere strictly to the dosing recommendations and not exceed the directed amount.

Contraindications

Use of this product is contraindicated in the following situations:

  • In patients with a history of allergic reactions to ibuprofen or any other pain reliever/fever reducer, due to the risk of severe allergic reactions.

  • In patients undergoing heart surgery, as use immediately before or after such procedures may pose significant risks.

Warnings and Precautions

Ibuprofen may induce severe allergic reactions, particularly in individuals with a known allergy to aspirin. Symptoms indicative of an allergic response may include hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, and blisters. In the event of an allergic reaction, it is imperative to discontinue use immediately and seek medical assistance.

This product contains a nonsteroidal anti-inflammatory drug (NSAID), which is associated with an increased risk of severe stomach bleeding. The likelihood of such an event is heightened in pediatric patients with a history of stomach ulcers or bleeding disorders, those concurrently using anticoagulants or steroid medications, or those taking other NSAIDs (including aspirin, ibuprofen, or naproxen). Additionally, exceeding the recommended dosage or duration of treatment may further elevate this risk.

NSAIDs, excluding aspirin, are linked to an increased risk of serious cardiovascular events, including heart attack, heart failure, and stroke, which can be fatal. The risk is particularly pronounced when the medication is used in excess of the recommended dosage or for prolonged periods.

Healthcare professionals should be vigilant for signs of severe or persistent sore throat, especially when accompanied by high fever, headache, nausea, or vomiting, as these symptoms may indicate a serious condition. Consultation with a physician is advised if symptoms persist beyond two days or if the patient is under three years of age unless otherwise directed by a healthcare provider.

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 suggestive 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.

In cases of overdose, immediate medical attention is required. Patients or caregivers should contact a Poison Control Center or seek emergency medical help without delay (1-800-222-1222).

Side Effects

Patients using ibuprofen may experience a range of adverse reactions, some of which can be serious.

Severe allergic reactions have been reported, particularly in individuals with a known allergy to aspirin. Symptoms of such reactions may 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 warning for potential severe stomach bleeding. The risk of this adverse reaction 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. Additionally, the risk increases if the medication is taken in higher doses or for extended periods beyond the recommended guidelines.

Patients should also be aware of the increased risk of heart attack, heart failure, and stroke associated with NSAID use, excluding aspirin. These cardiovascular events can be fatal, particularly when the medication is used in excess or for prolonged durations.

In clinical settings, severe or persistent sore throat, especially when accompanied by high fever, headache, nausea, and vomiting, has been noted as a serious condition requiring prompt medical consultation. It is advised that ibuprofen not be used for more than two days in such cases or in children under three years of age unless directed by a healthcare provider.

Patients are advised to discontinue use and seek medical attention if they experience signs of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or 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 evaluation. 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, medical advice should be sought. Redness or swelling in the painful area or the emergence of any new symptoms should also prompt consultation with a healthcare professional.

Before using ibuprofen, it is essential for patients to consult a doctor if they have a history of stomach issues, have experienced serious side effects from pain relievers or fever reducers, are dehydrated, or have 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. Additionally, individuals under a doctor's care for any serious condition or those taking other medications should consult with a healthcare provider or pharmacist before using ibuprofen.

Drug Interactions

Ibuprofen is associated with several significant drug interactions that warrant careful consideration.

Allergic Reactions Ibuprofen may induce severe allergic reactions, particularly in individuals with a known allergy to aspirin. It is essential to assess the patient's allergy history before prescribing ibuprofen.

Gastrointestinal Risks The concomitant use of ibuprofen with anticoagulants or steroid medications increases the risk of severe gastrointestinal bleeding. This risk is also heightened when ibuprofen is taken alongside other nonsteroidal anti-inflammatory drugs (NSAIDs), including aspirin and naproxen. Monitoring for gastrointestinal symptoms is advised in patients receiving these combinations.

Cardiovascular Risks The use of ibuprofen may elevate the risk of serious cardiovascular events, such as heart attack, heart failure, and stroke. This risk is particularly pronounced when ibuprofen is used in excess of the recommended dosage or for extended periods. Patients should be counseled on the importance of adhering to prescribed dosages and durations.

Diuretics Patients taking diuretics should consult a healthcare provider prior to initiating ibuprofen therapy. The interaction between these medications may necessitate dosage adjustments or increased monitoring to ensure patient safety.

Packaging & NDC

Below are the non-prescription pack sizes of Childrens Ibuprofen 100 (ibuprofen). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Childrens Ibuprofen 100.
Details

Pediatric Use

Pediatric patients under 3 years of age should not use this medication unless directed by a doctor. For dosing, the following guidelines apply:

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

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

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

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

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

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

It is essential to use only the enclosed dosing cup and not any other dosing device. Doses may be repeated every 6-8 hours as needed, but should not exceed 4 doses in a 24-hour period.

Healthcare professionals should advise caregivers to keep the medication out of reach of children. In the event of an overdose, immediate medical assistance or contact with a Poison Control Center is necessary.

Consultation with a doctor is recommended if the pediatric patient has a history of stomach problems (e.g., heartburn), has experienced an allergic reaction to ibuprofen or other pain relievers/fever reducers, has not been adequately hydrated, or has lost significant fluids due to vomiting or diarrhea. Additionally, a doctor should be consulted if the child has high blood pressure, heart disease, liver cirrhosis, kidney disease, a history of stroke, asthma, or is taking a diuretic. Caregivers should also seek medical advice if the child is under treatment for any serious condition or is taking other medications.

Geriatric Use

Elderly patients may not receive comprehensive directions or warnings regarding the use of this product. Therefore, healthcare providers should exercise caution when prescribing this product to geriatric patients. It is essential to consider the unique physiological changes and potential comorbidities that may affect the safety and efficacy of the treatment in this population.

Healthcare providers are advised to closely monitor elderly patients for any adverse effects and to adjust dosages as necessary based on individual patient needs and responses. Given the lack of specific guidance for adult use, careful evaluation and clinical judgment are paramount when managing treatment in geriatric patients.

Pregnancy

The safety of ibuprofen during pregnancy has not been established. Ibuprofen is contraindicated in pregnancy, particularly during the third trimester, due to potential risks to the fetus. The use of nonsteroidal anti-inflammatory drugs (NSAIDs), including ibuprofen, during pregnancy may be associated with adverse fetal outcomes, such as cardiovascular effects and renal impairment.

Pregnant women should avoid using ibuprofen unless specifically directed by a healthcare professional. It is essential for healthcare providers to consult with patients regarding dosage modifications and to assess the risks versus benefits of ibuprofen use during pregnancy.

Lactation

Nursing mothers should consult a doctor before using this product. There is a potential for excretion in breast milk, and the effects of ibuprofen on a nursing infant are not well studied; therefore, caution is advised. It is recommended to monitor the infant for any adverse effects if the nursing mother takes ibuprofen.

Renal Impairment

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

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. Additionally, patients with a history of significant liver disease, such as cirrhosis, should be evaluated for any contraindications related to their hepatic condition.

Healthcare providers should consider the overall health status of patients, including any coexisting conditions such as high blood pressure, heart disease, kidney disease, or a history of stroke, as these may further complicate the management of therapy in the context of hepatic impairment. Regular follow-up and reassessment of liver function are advised to ensure patient safety and therapeutic efficacy.

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 potential overdose situations. Symptoms of overdose may vary depending on the substance involved and the individual’s health status. Therefore, a thorough assessment and monitoring of the patient are essential.

Management procedures may include supportive care, symptomatic treatment, and specific interventions as dictated by the clinical scenario. It is vital for healthcare providers to remain vigilant and prepared to implement appropriate measures based on the patient's presentation and the substance involved in the 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 limits the assessment of potential risks associated with the compound in these areas.

Postmarketing Experience

Allergic reactions have been reported, including manifestations such as hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, and blisters. Additionally, cases of stomach bleeding have been documented in patients using nonsteroidal anti-inflammatory drugs (NSAIDs), including ibuprofen. Furthermore, occurrences of heart attack and stroke have been noted in patients taking NSAIDs, including ibuprofen. These events were reported voluntarily or identified through surveillance programs.

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 to administer the medication with food or milk if the child 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 persistent stomach pain. Additionally, healthcare providers should inform patients 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 be made aware that 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, they should consult a doctor. Redness or swelling in the painful area or the appearance of any new symptoms should also prompt a discussion with a healthcare professional.

Before initiating treatment, healthcare providers should encourage patients to consult a doctor if any of the following conditions apply: the child has a history of stomach problems, such as heartburn; has experienced serious side effects from pain relievers or fever reducers; has not been adequately hydrated; has lost significant fluids due to vomiting or diarrhea; has high blood pressure, heart disease, liver cirrhosis, kidney disease, or a history of stroke; has asthma; or is taking a diuretic.

Furthermore, patients should be advised to consult a doctor or pharmacist prior to use if the child is currently under medical care for any serious condition or is taking any other medications.

Storage and Handling

The product is supplied in a configuration that includes specific NDC numbers, which should be referenced for accurate identification. It is essential to store the product at a temperature range of 20-25°C (68-77°F) to maintain its integrity and efficacy. Freezing the product is strictly prohibited, as it may compromise its quality.

Healthcare professionals should ensure that the product is not utilized if the printed neckband is broken or missing, as this may indicate tampering or compromise of the product's safety. Proper handling and adherence to these storage conditions are crucial for optimal product performance.

Additional Clinical Information

The medication is administered orally, with a recommended repeat dose every 6-8 hours as needed, not to exceed four doses in a 24-hour period. Clinicians should advise patients to take the medication with food or milk if they experience stomach upset.

It is crucial to keep the medication out of reach of children. In the event of an overdose, patients should seek medical assistance immediately or contact a Poison Control Center at 1-800-222-1222. No additional information is available regarding laboratory tests, abuse potential, or postmarketing experiences.

Drug Information (PDF)

This file contains official product information for Childrens Ibuprofen 100, 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 100, retrieved by a validated AI data-extraction workflow.

All FDA-listed dosage forms and strengths are shown in the Packaging & NDC Codes section above. Regulatory status appears in the Summary Information panel above and was verified in the FDA National Drug Code directory and the NSDE NDC Directory daily file.

Note: an automated daemon monitors NSDE checksums; when the record for this NDC changes, the new file is pulled instantly and this page is refreshed.

No human clinician has reviewed this version.

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Primary FDA sources:

Orange Book data shown on this page are limited to Regulatory Status (Rx), Established Pharmacologic Class (EPC), and Mechanism of Action (MoA).

Regulatory data notice: Information on this page is reproduced verbatim from FDA public databases (NSDE, Orange Book, Purple Book, DailyMed SPL). NDA/ANDA drugs are FDA-approved, BLA biologics are FDA-licensed. Inclusion alone does not guarantee current market availability or imply FDA endorsement.

Medical disclaimer: This AI-generated content is provided for educational purposes only and does not constitute medical advice. Always consult a licensed healthcare professional for diagnosis or treatment decisions.