Symptom checker
Select audience type

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

ADD CONDITION

items per page

Childrens Advil

Last content change checked dailysee data sync status

Active ingredient
Ibuprofen 100 mg/5 mL
Other brand names
Drug class
Nonsteroidal Anti-inflammatory Drug
Dosage form
Suspension
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 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 root
0573-1174
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 Advil is a liquid medication that contains ibuprofen, which is a type of pain reliever and fever reducer known as a nonsteroidal anti-inflammatory drug (NSAID). It is designed for children aged 2 to 11 years and comes in a pleasant blue raspberry flavor. This medication helps reduce fever and relieve minor aches and pains associated with common conditions like colds, flu, sore throats, headaches, and toothaches.

Children's Advil works effectively for up to 8 hours, providing relief when your child needs it most. It is also dye-free and alcohol-free, making it a suitable option for young children.

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 like 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 note that it does not 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 use. You should measure the dose using the dosing cup that comes with Children's Advil Suspension, as this cup is specifically designed for this product. It's crucial not to use this cup with any other medications. The dose lines on the cup take into account the thickness of the suspension, ensuring you get the right amount.

To find the correct dose, refer to the dosing chart based on your child's weight. If you can, use their weight for the most accurate dosing; otherwise, you can use their age. You can repeat the dose every 6 to 8 hours if needed, but remember not to exceed four doses in a single day. For children weighing under 24 pounds (under 2 years), consult a doctor before administering. For those weighing between 24 and 35 pounds (ages 2-3), the dose is 5 mL; for 36 to 47 pounds (ages 4-5), it's 7.5 mL; for 48 to 59 pounds (ages 6-8), it's 10 mL; for 60 to 71 pounds (ages 9-10), it's 12.5 mL; and for 72 to 95 pounds (age 11), the dose is 15 mL.

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. 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 a severe 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 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 symptoms such as faintness, vomiting blood, black or bloody stools, chest pain, difficulty breathing, or weakness on one side of the body, seek medical attention immediately. It's important to consult a doctor before use if your child has any history of stomach issues, heart disease, 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 consulting a doctor, 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, seek medical advice. In case of an overdose, get medical help or contact a Poison Control Center immediately.

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.

Always err on the side of caution—if you notice anything concerning, don’t hesitate to reach out for assistance. 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 taking ibuprofen or any medication, you should always consult your healthcare provider. They can help you understand the safest options for managing pain or discomfort during your pregnancy.

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 any risks to your infant associated with its use during lactation. Always consult with your healthcare provider if you have any questions or concerns about medications while breastfeeding.

Pediatric Use

This product is suitable for children aged 2 to 11 years. It's important to follow the dosing guidelines based on your child's weight and age. For example, children weighing between 24-35 pounds (ages 2-3 years) should receive 5 mL, while those weighing 72-95 pounds (age 11 years) can take 15 mL. If your child is under 2 years old or weighs less than 24 pounds, you should consult a doctor before use.

Be cautious if your child has a history of stomach ulcers or bleeding issues, as this can increase the risk of stomach bleeding. If your child experiences severe sore throat symptoms, especially with a high fever, headache, nausea, or vomiting, seek medical advice right away. Additionally, if your child does not feel better within 24 hours or if symptoms worsen or last more than 3 days, it's important to consult a doctor. Always stop use and talk to a doctor if your child has any serious side effects from pain relievers or fever reducers.

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 for adult use. This means that if you or a loved one is an older adult, you should consult with a healthcare professional for tailored advice and guidance.

Always ensure that any medication is appropriate for your individual health needs, especially since older adults may have different responses to medications compared to younger individuals. 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 other health issues such as high blood pressure, heart disease, liver cirrhosis, asthma, or a history of stroke. Your doctor can help determine if this medication is safe for you and may suggest adjustments to your dosage or additional monitoring to ensure your safety. Always prioritize open communication with your healthcare provider regarding your kidney health and any medications you are considering.

Hepatic Impairment

If you have liver problems, such as liver cirrhosis (a serious condition where the liver becomes severely scarred), 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 (tests that check how well your liver is working) to ensure your safety and the effectiveness of your treatment.

Additionally, if you have other health issues like high blood pressure, heart disease, kidney disease, or asthma, make sure to discuss these with your doctor. They will consider all your conditions when determining the best approach for your care. Always follow your healthcare provider's recommendations and report any new symptoms or concerns promptly.

Drug Interactions

It's important to be aware of potential interactions when your child is taking ibuprofen. For instance, if your child is allergic to aspirin, they may experience a severe allergic reaction to ibuprofen. Additionally, the risk of serious stomach bleeding increases if your child is also taking blood thinners (medications that prevent blood clots) or steroids, as well as other nonsteroidal anti-inflammatory drugs (NSAIDs) like aspirin or naproxen.

Before giving ibuprofen, make sure to discuss your child's health conditions with a healthcare provider, especially if they have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or have had a stroke. It's also crucial to consult a doctor if your child is on a diuretic (a medication that helps remove excess fluid) or is under care for any serious health issue. Always check with a healthcare professional before combining ibuprofen with any other medications.

Storage and Handling

To ensure the best results and safety when using this product, store it at room temperature between 20-25°C (68-77°F). Before each use, make sure to shake the bottle well. Always measure the dosage using the dosing cup provided, as this cup is specifically designed for Children's Advil Suspension and should not be used with any other products.

When checking the product, look at the bottom of the box for the lot number and expiration date to confirm its validity. Additionally, the bottle comes with a Tamper-Evident cap, which means you should not use it if the breakable ring is separated or missing, as this indicates that the product may have been tampered with. Following these guidelines will help ensure your safety and the effectiveness of the medication.

Additional Information

You should take this medication orally, repeating the dose every 6 to 8 hours as needed, but do not exceed four doses in a day. If you experience stomach upset, it's advisable to take the medication with food or milk. Always keep this medication out of reach of children. In the event of an overdose, seek medical help immediately or contact a Poison Control Center for assistance.

FAQ

What is Children's Advil?

Children's Advil is an ibuprofen oral suspension, a pain reliever and fever reducer, available in a blue raspberry-flavored liquid for children ages 2-11 years.

How does Children's Advil work?

Children's Advil reduces fever and relieves minor aches and pains associated with the common cold, flu, sore throat, headaches, and toothaches.

What is the recommended dosage for Children's Advil?

The dosage varies by weight: for children weighing 24-35 lb (2-3 years), the dose is 5 mL; for 36-47 lb (4-5 years), it's 7.5 mL; and so on. Always consult the dosing chart for specific recommendations.

What should I do if my child has a severe sore throat?

Consult a doctor promptly if your child has a severe or persistent sore throat, especially if accompanied by high fever, headache, nausea, or vomiting.

Are there any warnings associated with Children's Advil?

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 give Children's Advil to my child if they have had an allergic reaction to other pain relievers?

No, do not use 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?

The safety of ibuprofen during pregnancy has not been established, and it is contraindicated, especially during the third trimester.

What should I do in case of an overdose?

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

How should I store Children's Advil?

Store Children's Advil at 20-25°C (68-77°F) and keep it out of reach of children.

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 oral suspension formulation containing ibuprofen as the active ingredient, with a strength of 100 mg per 5 mL. This nonsteroidal anti-inflammatory drug (NSAID) is classified as a pain reliever and fever reducer, indicated for the management of fever, aches, and pains. The product is designed for pediatric use in children aged 2 to 11 years and is presented in a blue raspberry-flavored liquid form. The suspension is dye-free and alcohol-free, ensuring a suitable option for young patients. Each bottle contains 4 FL OZ (120 mL) of the suspension, which provides relief lasting up to 8 hours. The National Drug Code (NDC) for this product is 0573-1174-12.

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 healthcare professionals should ensure that the appropriate dosing guidelines are followed. Prior to administration, the product must be shaken well to ensure proper mixing.

Dosing should be measured exclusively with the dosing cup provided, which is specifically designed for use with Children's Advil Suspension. It is imperative that this dosing cup is not used with any other products, as the dose lines are calibrated to account for the viscosity of the suspension, which may affect the volume remaining in the cup.

The recommended dosing is based on the child's weight; however, if weight is not available, age may be used as a secondary guide. The following dosing chart should be referenced:

  • For children weighing under 24 lb (under 2 years), consult a physician before administration.

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

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

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

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

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

Doses may be repeated every 6 to 8 hours as needed, but it is crucial not to exceed 4 doses in a 24-hour period. Healthcare professionals should advise caregivers to adhere strictly to these guidelines to ensure safe and effective use of the product.

Contraindications

Use is contraindicated in the following situations:

  • In patients with a history of allergic reactions to any other pain reliever or 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 carries a risk of severe stomach bleeding. The likelihood of such an event is heightened in children 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 use increases this risk.

NSAIDs, excluding aspirin, are associated with an elevated risk of heart attack, heart failure, and stroke, which can be fatal. This risk is particularly pronounced when the medication is used 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. Healthcare professionals should be consulted promptly in such cases. The use of this medication should not exceed two days, nor should it be administered to children under three years of age unless specifically directed by a physician.

Healthcare providers should advise patients to discontinue use and seek medical attention 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.

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

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, exceeding the recommended dosage or duration of use increases the likelihood of stomach bleeding.

There is also a significant risk associated with the use of NSAIDs, excluding aspirin, for heart attack, heart failure, and stroke, which can be fatal. This risk escalates with prolonged use or higher than directed dosages.

Patients should be vigilant for severe or persistent sore throat symptoms, especially when accompanied by high fever, headache, nausea, or vomiting, as these may indicate a serious condition requiring prompt medical consultation. It is advised not to use ibuprofen for more than two days or in children under three years of age without a doctor's guidance.

Patients are instructed to discontinue use and seek medical advice 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 attention. Furthermore, if relief is not achieved within the first 24 hours of treatment, or if fever or pain worsens or persists beyond three days, patients should consult a healthcare professional. The presence of redness or swelling in the painful area or any new symptoms should also prompt a medical evaluation.

Before using ibuprofen, patients should consult a doctor if they have a history of stomach bleeding, serious side effects from pain relievers or fever reducers, or any significant medical conditions such as high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or a history of stroke. Additionally, patients who have not been adequately hydrated or have experienced significant fluid loss due to vomiting or diarrhea, or those taking diuretics, should seek medical advice prior to use.

Lastly, it is recommended that patients under a doctor's care for any serious condition or those taking other medications consult with a healthcare professional or pharmacist before using ibuprofen.

Drug Interactions

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

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

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 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.

Patient-Specific Considerations In pediatric patients, it is essential to consult a healthcare provider if the child has underlying conditions such as high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or a history of stroke. Additionally, if the child is on a diuretic or is under medical supervision for any serious condition, a thorough evaluation by a healthcare professional is recommended prior to ibuprofen use.

General Recommendations Before initiating ibuprofen therapy, it is advisable for patients to consult with a healthcare provider or pharmacist if they are taking any other medications. This ensures that potential interactions are identified and managed appropriately.

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

This product is intended for use in pediatric patients aged 2 to 11 years. The dosing recommendations are as follows:

  • For children weighing under 24 lb and under 2 years of age, consultation with a doctor is advised before use.

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

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

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

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

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

Caution is advised for children under 3 years of age, as use should only occur if directed by a doctor. Healthcare professionals should be alerted if a child experiences severe or persistent sore throat, especially if accompanied by high fever, headache, nausea, or vomiting.

In pediatric patients, the risk of stomach bleeding may be increased in those with a history of stomach ulcers or bleeding disorders, or in those taking anticoagulants, steroids, or other NSAIDs, including aspirin. Parents and caregivers should discontinue use and consult a doctor if the child experiences any serious side effects from pain relievers or fever reducers. If the child does not achieve relief within the first 24 hours of treatment, or if fever or pain worsens or persists beyond 3 days, a doctor should be consulted promptly.

Geriatric Use

Elderly patients may not receive adequate guidance regarding the use of this product, as it does not contain directions or complete warnings specifically for adult use. Healthcare providers should exercise caution when prescribing this product to geriatric patients, considering the potential for inadequate information on safety and efficacy in this population.

It is essential for healthcare providers to monitor elderly patients closely for any adverse effects and to consider the need for dose adjustments based on individual patient factors, including comorbidities and concurrent medications. Given the lack of specific guidance, careful clinical judgment is advised when determining the appropriateness of this product for 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 are advised to consult a healthcare provider before using ibuprofen to discuss potential risks and alternative treatment options.

Lactation

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

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, asthma, 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 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 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 significant hepatic impairment should be evaluated for the risk of adverse effects, particularly if they have concurrent conditions such as high blood pressure, heart disease, kidney disease, asthma, or a history of stroke.

Healthcare providers should consider these factors when determining the appropriate therapeutic regimen and monitoring parameters for patients with hepatic impairment.

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 vigilant for symptoms that may arise from an overdose, although specific symptoms are not detailed in the provided information. The management of an overdose typically involves supportive care and symptomatic treatment, tailored to the individual patient's needs.

It is essential for healthcare providers to remain informed about the appropriate protocols for managing overdose situations, ensuring that patients receive timely and effective care.

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 potential effects in nonclinical settings.

Postmarketing Experience

Postmarketing experience has identified the following adverse reactions reported voluntarily or through surveillance programs: hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, trouble breathing, weakness in one part or side of the body, slurred speech, and leg swelling.

Additionally, it has been noted that if a child does not experience relief within the first 24 hours of treatment, or if fever or pain worsens or persists for more than three days, further evaluation may be warranted. The presence of redness or swelling in the painful area, as well as the emergence of any new symptoms, should also be considered for further assessment.

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 discontinue use and consult a doctor if the child exhibits any signs of stomach bleeding, which may include feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain. Furthermore, healthcare providers should emphasize the importance of stopping 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 swelling in the legs.

Patients should also be informed to stop use and consult a doctor if the child does not experience relief within the first 24 hours of treatment, if fever or pain worsens or persists beyond three days, if there is redness or swelling in the affected area, or if any new symptoms arise.

When administering this product, it is advisable to take it with food or milk to mitigate potential stomach upset. 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.

Additionally, patients should be advised to seek medical guidance before use if the child has high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or a history of stroke. It is also important to consult a doctor if the child has not been adequately hydrated or has lost significant fluids due to vomiting or diarrhea. Patients should be reminded to ask a doctor before use if the child is taking a diuretic or if they are under a doctor's care for any serious condition. Lastly, healthcare providers should recommend that patients consult a doctor or pharmacist before use if the child is taking any other medications.

Storage and Handling

The product is supplied in a tamper-evident bottle, which should not be used if the breakable ring is separated or missing. It is essential to store the product at a temperature range of 20-25°C (68-77°F). Prior to use, the bottle must be shaken well to ensure proper mixing of the contents.

For accurate dosing, only the dosing cup provided with Children's Advil Suspension should be utilized. This dosing cup is specifically designed for this product and should not be used with any other medications. Users are advised to check the bottom of the box for the lot number and expiration date to ensure product integrity and safety.

Additional Clinical Information

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

Clinicians should counsel 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.