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Childrens Advil

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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 1996
Label revision date
February 8, 2024
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 1996
Label revision date
February 8, 2024
Manufacturer
Haleon US Holdings LLC
Registration number
NDA020589
NDC roots
0573-0170, 0573-0171, 0573-0174, 0573-0207, 0573-0232, 0573-0290
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (11 NDCs)
Packaging & NDC Codes (11)

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Drug Overview

Children's Advil is a liquid medication that contains ibuprofen, which is a type of nonsteroidal anti-inflammatory drug (NSAID). It is designed for children aged 2 to 11 years and is commonly used to relieve minor aches and pains, such as those caused by the common cold, flu, sore throat, headaches, and toothaches. Additionally, it helps reduce fever, providing comfort when your child is feeling unwell.

This blue raspberry-flavored oral suspension is easy to take and can provide relief for up to 8 hours. It is alcohol-free, making it a suitable option for young children who need pain and fever management.

Uses

You can use this medication to help reduce fever and relieve minor aches and pains. It’s effective for discomfort caused by common conditions such as the cold, flu, sore throat, headaches, and toothaches.

This means that if you're feeling under the weather or dealing with everyday aches, this medication can provide some relief to help you feel better.

Dosage and Administration

Before using this medication, it's important to know that it doesn't come with specific directions or warnings for adults. Always make sure to follow the dosage instructions carefully and never give more than what is directed. To prepare the medication, shake the bottle well before each use.

To find the right dose for your child, refer to the dosing chart based on their weight or age. For example, if your child weighs between 24 and 35 pounds (or is 2 to 3 years old), the recommended dose is 5 milliliters (mL). You should repeat the dose every 6 to 8 hours if needed, but do not exceed 4 doses in a single day. It's crucial to measure the dose using the dosing cup provided, as it is specifically designed for this medication. Avoid using it with any other products, and remember that the dose lines on the cup account for the thickness of the liquid, ensuring you get the correct amount.

What to Avoid

You should avoid using this medication if your child has ever had an allergic reaction to any other pain reliever or fever reducer, or if they are scheduled to have heart surgery. It's important to stop using the medication and consult a doctor if your child shows any signs of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain.

Additionally, seek medical attention if your child exhibits symptoms of heart problems or stroke, including chest pain, difficulty breathing, weakness on one side of the body, slurred speech, or swelling in the legs. If your child does not experience relief within the first 24 hours, if their fever or pain worsens or lasts more than three days, if there is redness or swelling in the painful area, or if any new symptoms arise, please contact a healthcare professional.

Side Effects

Ibuprofen can cause serious allergic reactions, particularly in individuals who are allergic to aspirin. Symptoms of such reactions may include hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, and blisters. Additionally, this medication carries a risk of severe stomach bleeding, especially if the 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 severe or persistent sore throat, high fever, or symptoms of stomach bleeding (such as faintness, vomiting blood, or black stools), or shows signs of heart problems or stroke (like chest pain or weakness on one side of the body), seek medical attention immediately. Always consult a doctor before use if your child has any underlying health issues or is taking other medications.

Warnings and Precautions

It's important to be aware of some serious warnings when using this medication. If you or your child have a known allergy to aspirin, be cautious, as this product can cause severe allergic reactions, including hives, facial swelling, and difficulty breathing. If any of these symptoms occur, stop using the medication and seek medical help immediately. Additionally, this medication can increase the risk of stomach bleeding, especially if there is a history of stomach ulcers or if other medications that thin the blood are being taken.

You should also be mindful of the potential risks of heart attack and stroke associated with this medication, particularly if used in higher doses or for longer than recommended. If your child has a severe sore throat that lasts more than two days or is accompanied by a high fever, headache, nausea, or vomiting, consult a doctor promptly. Always check with a healthcare provider before use if your child has any serious health conditions or is taking other medications.

If you suspect an overdose, seek emergency medical help or contact a Poison Control Center right away. Stop using the medication and call your doctor if your child experiences symptoms of stomach bleeding, such as feeling faint, vomiting blood, or having black stools. Also, seek medical advice if there are signs of heart problems or if symptoms worsen or do not improve within 24 hours.

Overdose

If you suspect an overdose, it’s crucial to seek medical help immediately or contact a Poison Control Center. Signs of an overdose can vary, but they may include unusual symptoms that are more severe than what you would typically experience with the medication.

Don’t wait for symptoms to worsen; acting quickly can be vital. Always keep emergency contact information handy, and remember that your health and safety are the top priority.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to be cautious with any medications you take. The information available does not specify whether this product is safe to use during pregnancy. Additionally, there are no clear warnings or contraindications regarding the use of ibuprofen during this time.

To ensure the best outcomes for you and your baby, it's always a good idea to consult with your healthcare provider before taking any medication while pregnant. They can provide personalized advice based on your specific situation.

Lactation Use

If you are breastfeeding, you can feel reassured that there are no specific warnings or recommendations against using ibuprofen while nursing. The information available does not indicate any concerns about ibuprofen being passed into breast milk or posing any risk to your infant.

As always, it's a good idea to consult with your healthcare provider if you have any questions or concerns about medications while breastfeeding.

Pediatric Use

It's important to be cautious when using this medication in children. You should not give it to children under 3 years of age unless a doctor specifically advises you to do so. For children aged 2 to 11 years, the dosage depends on their weight and age, so it's essential to follow the dosing chart carefully. For example, a child weighing 24-35 pounds (2-3 years old) should receive 5 mL, while a child weighing 72-95 pounds (11 years old) should receive 15 mL.

Be aware of potential risks, especially if your child has a history of stomach issues, is taking other medications, or has certain health conditions like high blood pressure or asthma. If your child experiences severe sore throat, high fever, or any signs of stomach bleeding—such as feeling faint, vomiting blood, or having black stools—stop use immediately and consult a doctor. Always keep this medication out of reach of children, and in case of an overdose, seek medical help or contact a Poison Control Center right away.

Geriatric Use

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

Always ensure that any medication is appropriate for your health needs, especially if there are concerns about age-related changes in health or medication tolerance. Your healthcare provider can help determine the right dosage and monitor for any potential side effects.

Renal Impairment

If you have kidney problems, it's important to consult your doctor before using this medication. This is especially crucial if you also have high blood pressure, heart disease, liver cirrhosis (a severe liver condition), asthma, or a history of stroke. Your doctor will help determine if this medication is safe for you and may suggest specific guidelines or adjustments based on your kidney health. Always prioritize open communication with your healthcare provider to ensure your safety and well-being.

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, kidney disease, or asthma, make sure to discuss these with your doctor. They will consider all your health issues when determining the best treatment plan for you. Always follow your healthcare provider's advice and report any new symptoms or concerns promptly.

Drug Interactions

It's important to be aware of potential interactions when taking ibuprofen, especially if you or your child have allergies or are on other medications. If you are allergic to aspirin, using ibuprofen could lead to a severe allergic reaction. Additionally, if your child is taking blood thinners or steroids, the risk of serious stomach bleeding increases. This risk also applies if they are using other nonsteroidal anti-inflammatory drugs (NSAIDs), such as aspirin or naproxen.

Using NSAIDs, except for aspirin, can raise the chances of heart attack, heart failure, and stroke, particularly if taken in higher doses or for longer than recommended. Always consult with a healthcare provider before starting ibuprofen or any new medication, especially if your child is already taking other drugs. This ensures safe and effective use while minimizing risks.

Storage and Handling

To ensure the best results with your product, store it at a temperature between 20-25°C (68-77°F). Before using, make sure to shake the container well. When measuring your dose, always use the dosing cup provided, as it is specifically designed for Children's Advil Suspension and should not be used with any other products.

Additionally, check the bottom of the box for important information, including the lot number and expiration date, to ensure the product is safe and effective for use. Following these guidelines will help you handle the product safely and effectively.

Additional Information

If you experience stomach upset while taking this medication, it's best to take it with food or milk. You can repeat the dose every 6 to 8 hours as needed, but make sure not to exceed four doses in a day.

It's important to keep this medication out of reach of children. If you suspect an overdose, seek medical help immediately or contact a Poison Control Center.

FAQ

What is Children's Advil?

Children's Advil is an ibuprofen oral suspension that acts as a pain reliever and fever reducer, available in a blue raspberry-flavored liquid.

What age group is Children's Advil suitable for?

Children's Advil is intended for children aged 2 to 11 years.

How long does the effect of Children's Advil last?

The effects of Children's Advil can last up to 8 hours.

What should I do if my child has a stomach upset while taking Children's Advil?

If your child experiences a stomach upset, you can give Children's Advil with food or milk.

How should I measure the dose of Children's Advil?

You should measure the dose using the dosing cup provided, which is specifically for Children's Advil Suspension.

What are the dosing recommendations for Children's Advil?

Dosing varies by weight and age; for example, children weighing 24-35 lb (ages 2-3 years) should take 5 mL.

What should I do if my child experiences signs of stomach bleeding?

If your child feels faint, vomits blood, has bloody or black stools, or has persistent stomach pain, stop use and consult a doctor immediately.

Can I give Children's Advil to a child who has had an allergic reaction to other pain relievers?

No, do not give Children's Advil if your child has ever had an allergic reaction to any other pain reliever or fever reducer.

Is it safe to use Children's Advil during pregnancy or while nursing?

The product does not contain specific information regarding its use during pregnancy or nursing mothers.

What should I do in case of an overdose?

In case of overdose, seek medical help or contact a Poison Control Center immediately.

Packaging Info

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

Packaging configurations for Childrens Advil.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Children's Advil® Suspension is an ibuprofen oral suspension formulated as a blue raspberry-flavored liquid. Each 5 mL dose contains 100 mg of ibuprofen, a nonsteroidal anti-inflammatory drug (NSAID) indicated for the relief of fever and minor aches and pains. The product is designed for use in children aged 2 to 11 years and is presented in a 4 FL OZ (120 mL) bottle. This formulation is alcohol-free and provides relief that lasts up to 8 hours. The National Drug Code (NDC) for this product is 0573-0174-30.

Uses and Indications

This drug is indicated for the reduction of fever and the relief of minor aches and pains associated with conditions such as the common cold, influenza, sore throat, headaches, and toothaches.

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

Dosage and Administration

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

Prior to administration, the suspension must be shaken well. The appropriate dose should be determined using the dosing chart provided below, with weight being the preferred method for dosing; if weight is not available, age may be used as an alternative. Doses may be repeated every 6 to 8 hours as needed, but should not exceed four doses in a 24-hour period.

Dosing should be measured exclusively with the dosing cup provided, which is specifically designed for use with Children's Advil Suspension. It is important to note that the dosing cup should not be used with any other products. The dose lines on the cup account for the product remaining in the cup due to the thickness of the suspension.

Dosing Chart:

  • For children weighing under 24 lb or under 2 years of age, consult a doctor for the appropriate dose.

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

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

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

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

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

Contraindications

Use of this product is contraindicated in children with a history of allergic reactions to any other pain reliever or fever reducer. Additionally, administration is contraindicated immediately before or after heart surgery due to potential complications.

If a child exhibits signs of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain, discontinue use and consult a physician. Similarly, if symptoms indicative of heart problems or stroke arise, including chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling, medical advice should be sought immediately.

Discontinue use if the child does not achieve relief within the first 24 hours of treatment, if fever or pain worsens or persists beyond three days, if redness or swelling occurs in the affected area, or if any new symptoms develop.

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

Furthermore, NSAIDs, excluding aspirin, are linked to 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 healthcare provider promptly. The use of this medication should not exceed two days, nor should it be administered to children under three years of age unless directed by a physician.

General precautions should be observed prior to administration. Healthcare professionals should advise caregivers to consult a physician if any of the following conditions apply: the child has a history of stomach bleeding, has experienced adverse effects from pain relievers or fever reducers, has a history of gastrointestinal issues such as heartburn, has high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma, has experienced a stroke, has not been adequately hydrated, has lost significant fluids due to vomiting or diarrhea, or is taking a diuretic. Additionally, consultation with a doctor or pharmacist is recommended if the child is under medical care for any serious condition or is taking other medications.

In the event of an overdose, immediate medical attention should be sought, or contact with a Poison Control Center is advised.

Caregivers should be instructed to discontinue use and consult a healthcare provider 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. Symptoms indicative of heart problems or stroke, including chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling, warrant immediate medical evaluation. If the child does not experience relief within the first 24 hours of treatment, if fever or pain worsens or persists beyond three days, if redness or swelling occurs in the affected area, or if any new symptoms arise, medical consultation is necessary.

Side Effects

Patients using ibuprofen may experience a range of adverse reactions, which can be categorized by seriousness and frequency.

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 carries a warning for potential severe stomach bleeding, especially in patients with a history of stomach ulcers or bleeding problems. The risk is heightened in those taking anticoagulants, steroid medications, or other NSAIDs, as well as in patients who exceed the recommended dosage or duration of use. Signs of stomach bleeding may include faintness, vomiting blood, bloody or black stools, and persistent stomach pain.

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 guidelines.

Patients should be vigilant for severe or persistent sore throat symptoms, especially when accompanied by high fever, headache, nausea, or vomiting, and should seek medical advice promptly. It is advised not to use ibuprofen for more than two days or in children under three years of age without a doctor's direction.

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 consultation is recommended. Additional symptoms warranting medical attention include redness or swelling in the painful area and the emergence of any new symptoms.

Before using ibuprofen, patients should consult a healthcare provider if they have a history of stomach problems, high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or if they have experienced serious side effects from pain relievers or fever reducers. Special caution is advised for those who have not been adequately hydrated or have lost significant fluids due to vomiting or diarrhea, as well as for patients taking diuretics.

Patients under a doctor's care for serious conditions or those taking other medications should also seek advice prior to using ibuprofen.

Drug Interactions

Ibuprofen is associated with several significant drug interactions that warrant careful consideration, particularly in pediatric populations.

Allergic Reactions Ibuprofen may induce severe allergic reactions in individuals with a known allergy to aspirin. It is crucial to assess the patient's allergy history prior to administration.

Gastrointestinal Risks The concomitant use of ibuprofen with anticoagulants or steroid medications increases the risk of severe gastrointestinal bleeding. This risk is further amplified when ibuprofen is taken alongside other nonsteroidal anti-inflammatory drugs (NSAIDs), including both prescription and over-the-counter options such as aspirin and naproxen. Monitoring for signs of gastrointestinal distress is advised in patients receiving these combinations.

Cardiovascular Risks The use of NSAIDs, excluding aspirin, has been linked to an elevated risk of cardiovascular events, including heart attack, heart failure, and stroke. This risk is particularly pronounced when NSAIDs are used in dosages exceeding the recommended levels or for durations longer than prescribed. It is advisable to adhere strictly to dosing guidelines and to evaluate the necessity of continued NSAID therapy regularly.

Consultation Recommendations Prior to initiating ibuprofen therapy, it is recommended that healthcare providers consult with a physician if the patient is currently taking any other medications. This ensures a comprehensive assessment of potential interactions and the implementation of appropriate monitoring strategies.

Packaging & NDC

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

Packaging configurations for Childrens Advil.
Details

Pediatric Use

Pediatric patients under 3 years of age should not use this medication unless directed by a doctor. For children aged 2 to 10 years, dosing is weight-based as follows: for those under 24 lb (under 2 years), consult a doctor; for 24-35 lb (2-3 years), the dose is 5 mL; for 36-47 lb (4-5 years), the dose is 7.5 mL; for 48-59 lb (6-8 years), the dose is 10 mL; for 60-71 lb (9-10 years), the dose is 12.5 mL; and for 72-95 lb (11 years), the dose is 15 mL.

Healthcare professionals should be aware of the increased risk of stomach bleeding in pediatric patients with a history of stomach ulcers or bleeding problems, those taking anticoagulants or steroids, and those using other NSAIDs, including aspirin, ibuprofen, or naproxen. Parents or caregivers should be advised to consult a doctor promptly if the child experiences severe or persistent sore throat, especially if accompanied by high fever, headache, nausea, or vomiting. The medication should not be used for more than 2 days in children under 3 years of age without medical guidance.

Before administering this medication, it is essential to ask a doctor if the child is under care for any serious condition, taking other medications, has experienced serious side effects from pain relievers or fever reducers, has a history of stomach issues, high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or has had a stroke. Additionally, caution is warranted if the child has not been adequately hydrated or is taking a diuretic.

Parents or caregivers should be instructed to stop use and seek medical advice if the child exhibits signs of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain. It is crucial to keep this medication out of reach of children, and in the event of an overdose, immediate medical assistance or contact with a Poison Control Center is necessary.

Geriatric Use

Elderly patients may require special consideration when using this product, as it does not contain directions or complete warnings for adult use. Healthcare providers should exercise caution and closely monitor geriatric patients for any adverse effects or complications that may arise due to the lack of specific guidance. It is advisable to evaluate the individual needs and health status of elderly patients before prescribing this product, as the absence of comprehensive information may necessitate dose adjustments or alternative therapeutic options.

Pregnancy

The product does not contain specific information regarding its use during pregnancy. Currently, there are no explicit statements about contraindications or risks associated with the use of ibuprofen during pregnancy in the provided text. Healthcare professionals should consider the lack of data when advising pregnant patients and weigh the potential benefits against any unknown risks. It is advisable to exercise caution and to discuss the use of this product with women of childbearing potential who are pregnant or planning to become pregnant.

Lactation

There are no specific warnings or recommendations regarding the use of ibuprofen in lactating mothers. Additionally, there is no information available concerning the potential for excretion of ibuprofen in breast milk or any associated risks to breastfed infants.

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 asthma, as these 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 associated health conditions.

Hepatic Impairment

Patients with hepatic impairment may experience altered pharmacokinetics of the drug due to compromised liver function. It is essential to assess liver function prior to initiating treatment and to monitor liver parameters throughout the course of therapy.

In patients with liver cirrhosis, dosage adjustments may be necessary to mitigate the risk of adverse effects. Close monitoring of liver function tests, including alanine aminotransferase (ALT), aspartate aminotransferase (AST), and bilirubin levels, is recommended to ensure patient safety and therapeutic efficacy.

Patients with significant hepatic impairment should be approached with caution, and the potential benefits of treatment must be weighed against the risks associated with their liver condition.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. Prompt intervention is crucial to mitigate potential adverse effects associated with the overdose.

Healthcare professionals should be aware that the specific symptoms of an overdose may vary depending on the substance involved. Therefore, a thorough assessment of the patient's condition is essential to determine the appropriate course of action.

Management of an overdose typically involves supportive care and symptomatic treatment. Continuous monitoring of the patient's vital signs and clinical status is recommended. In cases where the substance is known, specific antidotes or treatments may be indicated, and healthcare providers should refer to established guidelines for the management of the particular overdose scenario.

It is vital for healthcare professionals to remain vigilant and act swiftly in the event of an overdose to ensure the best possible outcomes for affected individuals.

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 identified several adverse reactions associated with the use of the product, including hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, and blisters. Severe allergic reactions may occur, particularly in individuals with a known allergy to aspirin.

Additionally, the use of nonsteroidal anti-inflammatory drugs (NSAIDs), excluding aspirin, has been associated with an increased risk of serious cardiovascular events, such as heart attack, heart failure, and stroke, especially when used in excess of the recommended duration or dosage.

Reports of stomach bleeding have also been noted, particularly in pediatric patients with a history of stomach ulcers or bleeding disorders, as well as in those concurrently using blood thinners or other NSAIDs.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center in the event of an overdose. It is crucial to inform patients that this medication should not be used if the child has a history of allergic reactions to any other pain reliever or fever reducer. Additionally, patients should be cautioned against using this product right before or after heart surgery.

Patients must be instructed to stop use and consult a doctor if the child exhibits any signs of stomach bleeding, which may include feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain. Furthermore, healthcare providers should emphasize the importance of discontinuing use and seeking medical advice if the child shows symptoms indicative of heart problems or stroke, such as chest pain, difficulty breathing, weakness on one side of the body, slurred speech, or leg swelling.

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 administering this product, patients should be advised to take it with food or milk if stomach upset occurs. Healthcare providers should encourage patients to consult a doctor before use if the child has a history of stomach bleeding, has experienced serious side effects from pain relievers or fever reducers, or has any stomach issues such as heartburn.

It is also important for patients to discuss with their healthcare provider if the child has high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or a history of stroke. Patients should be advised to seek medical advice if the child has not been adequately hydrated, has lost significant fluids due to vomiting or diarrhea, or is taking a diuretic. Lastly, patients should be encouraged to consult a doctor or pharmacist before use if the child is under medical care for any serious condition or is taking any other medications.

Storage and Handling

The product is supplied in a configuration that includes a dosing cup specifically designed for use with Children's Advil Suspension. It is essential to store the product at a temperature range of 20-25°C (68-77°F) to maintain its efficacy. Prior to administration, the product must be shaken well to ensure proper mixing.

For accurate dosing, it is imperative to use only the dosing cup provided with the product; this cup should not be utilized with any other products. Additionally, healthcare professionals should refer to the bottom of the box for the lot number and expiration date to ensure the product's validity and safety.

Additional Clinical Information

Patients should take the medication with food or milk if they experience stomach upset. The recommended dosing frequency is every 6-8 hours as needed, with a maximum of four doses per day. Clinicians should advise patients to keep the medication out of reach of children and to seek immediate medical assistance or contact a Poison Control Center in the event of an overdose.

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

Drug Information (PDF)

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

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

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

No human clinician has reviewed this version.

Learn more in our Editorial Policy

Last AI update:

Primary FDA sources:

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

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

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