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Infants Advil

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Active ingredient
Ibuprofen 50 mg/1.25 mL
Other brand names
Drug class
Nonsteroidal Anti-inflammatory Drug
Dosage form
Suspension/ Drops
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 1998
Label revision date
November 26, 2024
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Ibuprofen 50 mg/1.25 mL
Other brand names
Drug class
Nonsteroidal Anti-inflammatory Drug
Dosage form
Suspension/ Drops
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 1998
Label revision date
November 26, 2024
Manufacturer
Haleon US Holdings LLC
Registration number
NDA020812
NDC root
0573-0191
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (4 NDCs)
Packaging & NDC Codes (4)

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Drug Overview

Infants' Advil® Concentrated Drops is a medication that contains ibuprofen (a type of pain reliever and fever reducer) in a liquid form, specifically designed for infants aged 6 to 23 months. Each 1.25 mL dose provides 50 mg of ibuprofen, which helps to reduce fever and relieve minor aches and pains associated with common conditions like colds, flu, headaches, and toothaches.

This product is alcohol-free and dye-free, making it a gentle option for your little one. The drops come in a pleasant white grape flavor, and the effects can last up to 8 hours, providing relief when your child needs it most.

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, headaches, and toothaches.

Rest assured, this medication does not have any known teratogenic effects, meaning it does not cause developmental issues in a fetus.

Dosage and Administration

Before using this product, it's important to note that it does not 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.

To find the right dose, refer to the dosing chart based on your child's weight. If possible, use their weight for a more accurate dosage; otherwise, you can use their age. For children under 6 months, it's best to consult a doctor before administering. For children weighing between 12-17 pounds (6-11 months old), the dose is 1.25 mL, and for those weighing 18-23 pounds (12-23 months old), the dose is 1.875 mL. You can repeat the dose every 6 to 8 hours if needed, but do not use it more than four times a day. Always measure the dose with the provided dosing device and avoid using any other measuring tools.

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. Symptoms of such reactions may include hives, facial swelling, wheezing (asthma), 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. This risk is heightened if the medication is used in higher doses or for longer than recommended. 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, you should stop use and consult a doctor immediately. It's important to seek medical advice before using ibuprofen if your child has a history of stomach issues, high blood pressure, heart disease, or is taking other medications.

Warnings and Precautions

Ibuprofen can cause serious allergic reactions, especially in those who are allergic to aspirin. If you notice symptoms like hives, facial swelling, wheezing, or skin rash, stop using the medication and seek medical help immediately. Additionally, ibuprofen is a type of nonsteroidal anti-inflammatory drug (NSAID) that may lead to severe stomach bleeding, particularly if your child has a history of stomach ulcers, is taking blood thinners or steroids, or uses other NSAIDs. The risk of heart attack, heart failure, and stroke is also increased with NSAID use, especially if taken in higher doses or for longer than recommended.

Before giving ibuprofen to your child, consult a doctor if they have had any allergic reactions to pain relievers, are scheduled for heart surgery, or have conditions like high blood pressure, heart disease, or kidney issues. It's also important to check with a healthcare provider if your child is taking other medications or has been dehydrated due to vomiting or diarrhea.

If you suspect an overdose, contact a Poison Control Center or seek medical help right away. You should also stop using ibuprofen and call your doctor if your child experiences symptoms of stomach bleeding (like faintness or vomiting blood), signs of heart problems or stroke (such as chest pain or weakness), or if their symptoms do not improve within 24 hours. If fever or pain worsens or lasts more than three days, or if new symptoms arise, reach out to a healthcare professional.

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 typical side effects.

Always err on the side of caution—if you notice anything concerning, don’t hesitate to reach out for professional 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 during pregnancy has not been established. In fact, ibuprofen is not recommended, especially during the third trimester, as it may pose risks to your developing baby, including potential cardiovascular effects.

Before taking ibuprofen, you should always consult your healthcare provider. They can provide guidance on whether you need to adjust your dosage or consider alternative pain relief options that are safer during pregnancy. Your health and the health of your baby are the top priority, so make sure to discuss any medications 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 on your nursing infant have not been thoroughly studied. Because of this uncertainty, it's wise to be cautious.

If you do take ibuprofen while breastfeeding, keep an eye on your baby for any unusual reactions or side effects. Monitoring your infant can help ensure their safety while you manage your own health needs.

Pediatric Use

When giving this medication to your child, it's important to follow the dosing guidelines based on their weight and age. For infants under 6 months, you should consult a doctor before use. For children aged 6 to 23 months, the recommended doses are 1.25 mL for those weighing 12-17 pounds and 1.875 mL for those weighing 18-23 pounds. Always use the dosing device provided to ensure accuracy, and if your child experiences any stomach upset, you can give the medication with food or milk.

Be aware of specific warnings: do not use this medication if your child has had an allergic reaction to pain relievers or fever reducers. If your child has a history of stomach ulcers, bleeding issues, or is taking certain medications (like blood thinners or other NSAIDs), consult a doctor first. Additionally, if your child shows signs of stomach bleeding, heart problems, or does not find relief within 24 hours, stop use and seek medical advice. Always check with a healthcare professional if your child has any serious health conditions or is dehydrated.

Geriatric Use

While the drug insert for Infants' Advil (ibuprofen suspension/drops) does not provide specific information about its use in older adults, it is important to approach any medication with caution. Since there are no recommended age considerations, dosage adjustments, or safety concerns outlined for elderly patients, you should consult with a healthcare professional before using this medication. This ensures that any potential risks or individual health needs are properly addressed, especially if you or your loved one has existing health conditions or is taking other medications. Always prioritize safety and seek guidance tailored to your specific situation.

Renal Impairment

If your child has kidney issues, it's important to be aware of certain health conditions that can affect their treatment. Conditions such as high blood pressure, heart disease, liver cirrhosis, and asthma, as well as a history of stroke, can complicate their care. Additionally, if your child is not drinking enough fluids or has lost a significant amount of fluid due to vomiting or diarrhea, this can further impact their kidney function.

If your child is taking a diuretic (a medication that helps remove excess fluid from the body), it’s crucial to monitor their fluid intake closely. Ensuring they stay hydrated can help support their kidney health. Always consult with your healthcare provider for personalized advice and to determine the best course of action for your child's specific situation.

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.

Drug Interactions

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

Using NSAIDs, except for aspirin, can raise the chances of serious heart issues, including heart attack and stroke, especially if taken in higher doses or for longer than recommended. Always consult with a healthcare provider or pharmacist before starting ibuprofen or any new medication, particularly if other drugs are being used. This ensures safe and effective treatment tailored to your needs.

Storage and Handling

To ensure the best performance of your product, store it in a cool, dry place at a temperature between 20-25°C (68-77°F). It's important to check the bottom of the box for the lot number and expiration date, as this information helps you confirm the product's safety and effectiveness.

When handling the product, always do so with clean hands and in a clean environment to maintain its integrity. Following these guidelines will help you use the product safely and effectively.

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 best to take the medication with food or milk. Always use the dosing device provided to measure your dose accurately; avoid using any other measuring devices.

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

FAQ

What is Infants' Advil® Concentrated Drops used for?

Infants' Advil® Concentrated Drops is used to reduce fever and relieve minor aches and pains due to the common cold, flu, headaches, and toothaches.

What is the dosage for Infants' Advil® Concentrated Drops?

For infants aged 6-11 months weighing 12-17 lb, the dose is 1.25 mL. For those aged 12-23 months weighing 18-23 lb, the dose is 1.875 mL.

How often can I give Infants' Advil® Concentrated Drops?

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

Are there any warnings associated with Infants' Advil® Concentrated Drops?

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 Infants' Advil® Concentrated Drops if my child has had an allergic reaction to pain relievers?

No, do not use it if your child has ever had an allergic reaction to any other pain reliever or fever reducer.

Is it safe to use Infants' Advil® Concentrated Drops 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 if my child experiences signs of stomach bleeding?

Stop use and seek medical help if your child feels faint, vomits blood, has bloody or black stools, or has stomach pain that does not improve.

How should I store Infants' Advil® Concentrated Drops?

Store it at 20-25°C (68-77°F) and check the box for the lot number and expiration date.

Can nursing mothers use Infants' Advil® Concentrated Drops?

Nursing mothers should consult a doctor before using this product, as ibuprofen may be excreted in breast milk.

Packaging Info

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

Packaging configurations for Infants Advil.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Infants' Advil® Concentrated Drops is an ibuprofen oral suspension formulated as a pain reliever and fever reducer, classified as a nonsteroidal anti-inflammatory drug (NSAID). Each 1.25 mL dose contains 50 mg of ibuprofen. This product is designed to alleviate fever and relieve aches and pains, providing effects that last up to 8 hours. The formulation is dye-free and features a white grape flavor, making it suitable for infants aged 6 to 23 months. The product is packaged in a 1/2 FL OZ (15 mL) bottle and is alcohol-free.

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, headaches, and toothaches.

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

Dosage and Administration

This product is intended for use in pediatric patients, and healthcare professionals should refer to the dosing chart to determine the appropriate dosage based on the patient's weight or age. It is essential to shake the product well before each use.

For patients under 6 months of age, it is advised to consult a physician for appropriate dosing recommendations. For patients weighing between 12 to 17 pounds (6 to 11 months of age), the recommended dose is 1.25 mL. For those weighing between 18 to 23 pounds (12 to 23 months of age), the recommended dose is 1.875 mL.

Doses may be repeated every 6 to 8 hours as needed, but should not exceed 4 doses in a 24-hour period. It is crucial to measure the dose using the dosing device provided with the product; the use of any other measuring device is not recommended. Healthcare professionals should ensure that patients do not exceed the directed dosage.

Contraindications

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

Warnings and Precautions

Ibuprofen may induce severe allergic reactions, particularly in individuals with a known allergy to aspirin. Symptoms indicative of such reactions 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.

As a nonsteroidal anti-inflammatory drug (NSAID), ibuprofen carries the risk of severe gastrointestinal bleeding. This risk is notably elevated in pediatric patients with a history of stomach ulcers or bleeding disorders, those concurrently using anticoagulants or steroid medications, individuals taking other NSAIDs (including aspirin, ibuprofen, or naproxen), or those exceeding the recommended dosage or duration of treatment. Furthermore, NSAIDs, excluding aspirin, are associated with an increased risk of cardiovascular events, including heart attack, heart failure, and stroke, which can be fatal. This risk is amplified when the medication is used in excess of the recommended guidelines or for prolonged periods.

General precautions should be observed prior to administration. Ibuprofen should not be used in children with a history of allergic reactions to any pain reliever or fever reducer. It is contraindicated for use immediately before or after cardiac surgery. Healthcare professionals should be consulted before use 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, or has pre-existing conditions including high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or a history of stroke. Additionally, caution is advised if the child has not been adequately hydrated or has experienced significant fluid loss due to vomiting or diarrhea, or if they are taking diuretics. Consultation with a doctor or pharmacist is also 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.

Healthcare professionals should instruct caregivers to discontinue ibuprofen and seek medical advice if the child exhibits any signs of gastrointestinal bleeding, such as feeling faint, vomiting blood, passing bloody or black stools, or experiencing persistent stomach pain. Additionally, symptoms suggestive of cardiovascular issues or stroke, including chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling, warrant immediate medical evaluation. If the child does not achieve relief within the first 24 hours of treatment, or if fever or pain worsens or persists beyond three days, or if redness or swelling occurs in the affected area, 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, as a nonsteroidal anti-inflammatory drug (NSAID), carries a significant risk of severe stomach bleeding. This risk is heightened in patients with a history of stomach ulcers or bleeding problems, those taking anticoagulants or steroid medications, and individuals using other NSAIDs, 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 be aware that NSAIDs, excluding aspirin, are associated with an increased risk of heart attack, heart failure, and stroke, which can be fatal. This risk is particularly pronounced when the medication is used in excess of the recommended dosage or duration.

Patients are advised to discontinue use and consult a healthcare professional if they experience any 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 a patient does not achieve relief within the first 24 hours of treatment, or if fever or pain worsens or persists beyond three days, they should seek medical advice. The presence of redness or swelling in the affected area or the emergence of any new symptoms should also prompt consultation with a healthcare provider.

Prior to 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, as well as those taking diuretics, should seek medical advice before use.

It is also 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 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 gastrointestinal bleeding. This risk is further elevated 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 increased risk of cardiovascular events, including heart attack, heart failure, and stroke. This risk is particularly pronounced when NSAIDs are used in higher doses or for extended periods. It is recommended that healthcare providers evaluate the necessity of NSAID therapy and consider alternative pain management strategies when appropriate.

General Recommendations Prior to initiating ibuprofen therapy, it is advisable for caregivers to consult with a healthcare professional if the child is currently taking any other medications. This precaution helps to mitigate potential interactions and ensures safe and effective use of ibuprofen.

Packaging & NDC

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

Packaging configurations for Infants Advil.
Details

Pediatric Use

Pediatric patients under 6 months of age should consult a doctor before use. For those aged 6 to 23 months, dosing is based on weight: infants weighing 12-17 lb (6-11 months) should receive 1.25 mL, while those weighing 18-23 lb (12-23 months) should receive 1.875 mL.

Caution is advised in pediatric patients with a history of allergic reactions to pain relievers or fever reducers. The risk of stomach bleeding is heightened in children with a history of stomach ulcers or bleeding problems, those taking anticoagulants or steroid medications, and those using other NSAIDs, including aspirin, ibuprofen, or naproxen. Prior to administration, healthcare professionals should be consulted if the child has high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or a history of stroke. Additionally, if the child has not been adequately hydrated due to vomiting or diarrhea, or is on a diuretic or under care for a serious condition, a doctor should be consulted.

Parents and caregivers should monitor for signs of stomach bleeding, such as faintness, vomiting blood, black or bloody stools, or persistent stomach pain. Symptoms indicating potential heart problems or stroke, including chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling, warrant immediate cessation of use. If the child does not experience relief within 24 hours of treatment, discontinuation and consultation with a healthcare provider are recommended.

For administration, the medication should be taken with food or milk if stomach upset occurs. It is essential to use the dosing device provided and not to substitute it with any other measuring device. Doses may be repeated every 6-8 hours as needed, but should not exceed four doses in a 24-hour period.

Geriatric Use

There is no specific information regarding the use of Infants' Advil (ibuprofen suspension/drops) in geriatric patients. The prescribing information does not provide recommended age considerations, dosage adjustments, safety concerns, or special precautions for elderly patients. Therefore, healthcare providers should exercise caution when considering the use of this medication in the geriatric population, as the absence of data necessitates careful evaluation of individual patient needs and potential risks. Monitoring for adverse effects and therapeutic efficacy is advised when administering this medication to elderly 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 ibuprofen during pregnancy may pose risks, including potential cardiovascular effects on the developing fetus.

Dosage modifications may be necessary, and pregnant women are advised to consult their healthcare provider for guidance before using ibuprofen. It is essential for healthcare professionals to consider these factors when prescribing ibuprofen to pregnant patients or women of childbearing potential.

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 may require careful consideration regarding dosing adjustments and monitoring. In particular, those with reduced kidney function, such as children with kidney disease, may be at increased risk for complications. It is essential to assess hydration status, as patients who have not been drinking fluids or have experienced significant fluid loss due to vomiting or diarrhea may further complicate their renal status. Additionally, the use of diuretics in these patients necessitates close monitoring, as it can exacerbate fluid loss and impact renal function. Healthcare professionals should remain vigilant in evaluating these factors to ensure safe and effective treatment in patients with renal impairment.

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, including alanine aminotransferase (ALT), aspartate aminotransferase (AST), and bilirubin levels, is recommended throughout the treatment course.

Additionally, patients with hepatic impairment should be evaluated for the presence of comorbid conditions such as high blood pressure, heart disease, kidney disease, and asthma, as these may influence the management of their treatment regimen.

Healthcare providers should exercise caution and consider the overall clinical picture when prescribing this medication to patients with compromised liver function.

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 alert to the signs of overdose and to act swiftly to ensure patient safety and optimal outcomes.

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 reported voluntarily or through surveillance programs. These include allergic reactions such as hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, and blisters. Additionally, cases of stomach bleeding have been noted, particularly in patients with a history of stomach ulcers or bleeding problems, as well as in those taking anticoagulants or other nonsteroidal anti-inflammatory drugs (NSAIDs). There is also an increased risk of heart attack, heart failure, and stroke associated with prolonged use or higher than directed doses.

Patient Counseling

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

Patients should be informed that if they experience stomach upset, the medication can be taken with food or milk to alleviate discomfort. It is important for healthcare providers to recommend that patients consult a doctor before use if the child has a history of stomach bleeding or has experienced serious side effects from pain relievers or fever reducers.

Additionally, patients should be encouraged to discuss any history of stomach problems, such as heartburn, with their healthcare provider prior to use. It is crucial to ask a doctor before administering this medication if the child has high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or has previously suffered a stroke.

Patients should also be advised to consult a healthcare professional if the child has not been drinking fluids or has lost a significant amount of fluid due to vomiting or diarrhea. Furthermore, it is essential to seek medical advice before use if the child is taking a diuretic or is under a doctor's care for any serious condition. Lastly, patients should be reminded to inform their healthcare provider or pharmacist about any other medications the child is currently taking to avoid potential interactions.

Storage and Handling

The product is supplied in packaging that includes a lot number and expiration date, which can be found on the bottom of the box. It is essential to store the product at a temperature range of 20-25°C (68-77°F) to ensure its stability and efficacy. Proper handling and storage conditions must be adhered to in order to maintain the integrity of the product.

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. Clinicians should advise patients to take the medication with food or milk if gastrointestinal upset occurs.

Patient counseling should emphasize the importance of keeping the medication out of reach of children and instructing patients to seek immediate medical assistance or contact a Poison Control Center in the event of an overdose. Additionally, patients should be instructed to use the dosing device provided for accurate measurement and to avoid using any other measuring device.

Drug Information (PDF)

This file contains official product information for Infants 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 Infants 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.

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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.