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Junior Strength Advil

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Active ingredient
Ibuprofen 100 mg
Other brand names
Drug class
Nonsteroidal Anti-inflammatory Drug
Dosage form
Tablet, Chewable
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2011
Label revision date
June 27, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Ibuprofen 100 mg
Other brand names
Drug class
Nonsteroidal Anti-inflammatory Drug
Dosage form
Tablet, Chewable
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 2011
Label revision date
June 27, 2025
Manufacturer
Haleon US Holdings LLC
Registration number
NDA020944
NDC root
0573-0179
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

Advil® is a medication that contains ibuprofen (a type of nonsteroidal anti-inflammatory drug, or NSAID) and is designed for children ages 2 to 11. It is available in a chewable tablet form with a pleasant grape flavor. This medication is primarily used to relieve minor aches and pains, such as those caused by the common cold, flu, sore throat, headaches, and toothaches. Additionally, Advil® helps reduce fever and provides relief that can last up to 8 hours.

With its junior strength formulation, Advil® offers a convenient option for parents looking to manage their child's discomfort effectively.

Uses

You can use this medication to help reduce fever and relieve minor aches and pains. It is 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 experiencing mild pain, this medication can provide some relief to help you feel better. Always consult with a healthcare professional if you have any questions or concerns about your symptoms or treatment options.

Dosage and Administration

When using this medication, it's important to follow the dosing guidelines carefully. First, check the dosing chart to find the right dose based on your child's weight or age. If your child weighs less than 24 pounds or is under 2 years old, you should consult a doctor for the appropriate dosage. For children weighing between 24 and 35 pounds (ages 2-3 years), the dose is 1 tablet. If your child weighs between 36 and 47 pounds (ages 4-5 years), they should take 1 ½ tablets. For those weighing 48 to 59 pounds (ages 6-8 years), the dose is 2 tablets, and for children weighing 60 to 71 pounds (ages 9-10 years), it's 2 ½ tablets. Finally, if your child weighs between 72 and 95 pounds (age 11 years), they should take 3 tablets.

You can repeat the dose every 6 to 8 hours if needed, but make sure not to exceed 4 doses in a single day. Always remember to give the medication exactly as directed and avoid giving more than the recommended 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. Additionally, it is important not to use this medication right before or after your child has undergone heart surgery. Following these guidelines will help ensure your child's safety and well-being.

Side Effects

Ibuprofen can cause serious allergic reactions, particularly in individuals who are allergic to aspirin. Signs of an allergic reaction may include hives, facial swelling, wheezing (asthma), shock, skin reddening, rash, or blisters. Additionally, this medication carries a risk of severe stomach bleeding, especially if 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 your child does not feel better within 24 hours, or if their fever or pain worsens or lasts more than three days, seek medical advice. In case of an overdose, get emergency 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 not typical for you.

Always err on the side of caution—if you think you or someone else may have taken too much of a medication, don’t wait. Getting prompt assistance can make a significant difference in ensuring safety and health.

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 with your healthcare provider. They can help you understand the safest options for managing pain or discomfort during your pregnancy.

Lactation Use

When it comes to breastfeeding, it's important to be aware that there are no specific guidelines or statements regarding nursing mothers or lactation (the process of producing milk). This means that if you are breastfeeding, you may not find detailed information about how certain medications or treatments could affect you or your baby.

If you have concerns about breastfeeding while taking any medication, it's always a good idea to consult with your healthcare provider. They can help you understand any potential risks and provide personalized advice to ensure the health and safety of both you and your infant.

Pediatric Use

When giving medication to your child, it's important to follow the dosing guidelines based on their weight and age. For children under 2 years old who weigh less than 24 pounds, you should consult a doctor before administering any medication. For those aged 2-3 years and weighing 24-35 pounds, the recommended dose is 1 tablet. As your child grows, the dosage increases: 1½ tablets for ages 4-5 years (36-47 pounds), 2 tablets for ages 6-8 years (48-59 pounds), 2½ tablets for ages 9-10 years (60-71 pounds), and 3 tablets for 11-year-olds (72-95 pounds).

Be cautious if your child has a sore throat; do not use the medication for more than 2 days or give it to children under 3 years without a doctor's guidance. Additionally, consult a doctor before use if your child has had allergic reactions to pain relievers, has a history of stomach issues, or has any serious health conditions like high blood pressure or kidney disease. It's also important to be aware that certain medications can increase the risk of stomach bleeding, especially if your child is taking other drugs or has a history of stomach ulcers. Always ensure your child is well-hydrated, especially if they have been vomiting or have diarrhea.

Geriatric Use

If you are caring for an older adult, it's important to be aware of specific precautions when using this product. Always consult a doctor before use if the individual has any serious health conditions, such as high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or a history of stroke. Additionally, if they have experienced stomach issues like heartburn, be cautious, as there is a risk of stomach bleeding.

For older adults, the risk of heart attack and stroke may increase if the product is used more than directed or for an extended period. To help prevent stomach upset, which can be more common in older individuals, consider taking the medication with food or milk. Always prioritize safety and seek medical advice when necessary.

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 (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 instructions and attend regular check-ups to manage your health effectively.

Drug Interactions

It's important to be aware of potential interactions when taking medications. For instance, if you or your child are allergic to aspirin, taking 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 serious stomach bleeding increases. This risk is also heightened if they are taking other nonsteroidal anti-inflammatory drugs (NSAIDs), such as aspirin or naproxen.

Moreover, using NSAIDs, except for aspirin, can raise the chances of heart-related issues, including heart attack, heart failure, and stroke. Always discuss any medications or tests with your healthcare provider to ensure safety and avoid these serious interactions.

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 side 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 have phenylketonuria (a condition that affects how your body processes phenylalanine), be aware that each tablet contains 4.2 mg of phenylalanine.

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

FAQ

What is Advil®?

Advil® is a Junior Strength, Chewable Ibuprofen Tablet that contains 100 mg of ibuprofen, a pain reliever and fever reducer.

What age group is Advil® suitable for?

Advil® is suitable for children ages 2 to 11.

How long does the effect of Advil® last?

The effects of Advil® can last up to 8 hours.

What are the indications for using Advil®?

Advil® is used to reduce fever and relieve minor aches and pains due to the common cold, flu, sore throat, headaches, and toothaches.

What should I do if my child has an allergic reaction to Advil®?

If your child experiences symptoms of a severe allergic reaction, such as hives or difficulty breathing, stop use and seek medical help immediately.

What are the dosing instructions for Advil®?

Dosing is based on weight and age. For example, children weighing 24-35 lb (ages 2-3 years) should take 1 tablet, while those weighing 72-95 lb (age 11 years) should take 3 tablets.

How often can I give Advil® to my child?

You can repeat the dose every 6-8 hours if needed, but do not exceed 4 doses in a day.

What precautions should I take when using Advil®?

Consult a doctor before use if your child has a history of stomach problems, high blood pressure, heart disease, or is taking other medications.

What should I do if my child experiences stomach bleeding symptoms?

If your child shows signs of stomach bleeding, such as vomiting blood or having black stools, stop use and contact a doctor immediately.

Is it safe to use Advil® during pregnancy?

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

How should I store Advil®?

Store 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 Junior Strength Advil (ibuprofen). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Junior Strength Advil.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Junior Strength Advil® is a chewable formulation of ibuprofen, providing 100 mg per tablet. This nonsteroidal anti-inflammatory drug (NSAID) serves as a pain reliever and fever reducer, specifically indicated for pediatric patients aged 2 to 11 years. The tablets are flavored with grape and are packaged in a bottle containing 24 chewable tablets. Each dose offers relief that lasts up to 8 hours.

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 use in pediatric patients, and healthcare professionals should refer to the dosing chart to determine the appropriate dosage based on the patient's weight and age. It is essential to adhere to the recommended dosing guidelines and not exceed the maximum dosage.

For patients weighing under 24 lb (under 2 years of age), it is advised to consult a physician for the appropriate dosage. For those weighing between 24-35 lb (ages 2-3 years), the recommended dose is 1 tablet. Patients weighing 36-47 lb (ages 4-5 years) should receive 1 ½ tablets. For patients weighing 48-59 lb (ages 6-8 years), the dosage is 2 tablets. For those weighing 60-71 lb (ages 9-10 years), the recommended dose is 2 ½ tablets. Finally, for patients weighing 72-95 lb (age 11 years), the dosage is 3 tablets.

Doses may be repeated every 6-8 hours as needed, but should not exceed 4 doses in a 24-hour period. It is crucial to ensure that the total daily dosage does not exceed the specified limits.

Contraindications

Use is contraindicated in the following situations:

Patients with a history of allergic reactions to any pain reliever or fever reducer should not use this product, as it may trigger a similar response. Additionally, the product is contraindicated for use 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 an allergic reaction can include hives, facial swelling, wheezing, shock, skin reddening, rash, and blisters. Should any of these symptoms manifest, 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, whether prescription or over-the-counter (e.g., aspirin, ibuprofen, 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.

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

It is crucial to advise patients to discontinue use and consult a physician if any of the following occur: signs of stomach bleeding such as feeling faint, vomiting blood, passing bloody or black stools, or experiencing persistent stomach pain; symptoms suggestive of heart problems or stroke, including chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling; lack of relief within the first 24 hours of treatment; worsening fever or pain lasting more than three days; presence of redness or swelling in the affected area; or the emergence of any new symptoms.

In the event of an overdose, immediate medical attention is required. Patients should be instructed to contact a Poison Control Center or seek emergency medical help without delay.

Side Effects

Patients may experience a range of adverse reactions associated with the use of this product, which contains an NSAID. Serious adverse reactions include severe allergic reactions, which may manifest as hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, or blisters, particularly in individuals with a known allergy to aspirin.

The use of this NSAID is also associated with an increased risk of severe stomach bleeding, especially in patients with a history of stomach ulcers or bleeding problems, those taking anticoagulants or steroid medications, or those using other NSAIDs, including aspirin and naproxen. The risk of stomach bleeding is heightened if the medication is taken in higher doses or for extended periods beyond the recommended duration.

Additionally, there is a warning regarding the potential for heart attack, heart failure, and stroke, which can be fatal. This risk is particularly pronounced when the medication is used in excess of the directed dosage or for longer than recommended.

Common adverse reactions may include severe or persistent sore throat, especially when accompanied by high fever, headache, nausea, or vomiting. Patients are advised to consult a healthcare provider promptly under these circumstances and to avoid use for more than two days or in children under three years of age unless directed by a physician.

Patients should discontinue use and seek medical attention if they experience signs of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or experiencing 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 consultation. 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 painful area or the emergence of any new symptoms should also prompt a consultation with a healthcare provider.

Before using this product, patients should consult a doctor 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. It is also advisable to seek medical advice if the patient has not been adequately hydrated or has lost significant fluids due to vomiting or diarrhea, or if they are taking diuretics. Additionally, patients under a doctor's care for any serious condition or those taking other medications should consult a healthcare professional prior to use.

Drug Interactions

Ibuprofen has the potential to induce severe allergic reactions, particularly in individuals with a known allergy to aspirin.

In pediatric patients, the concomitant use of ibuprofen with anticoagulants or steroid medications significantly elevates the risk of severe gastrointestinal bleeding. This risk is further compounded when ibuprofen is administered alongside other nonsteroidal anti-inflammatory drugs (NSAIDs), whether prescription or over-the-counter, such as aspirin or naproxen.

It is important to note that the use of NSAIDs, excluding aspirin, is associated with an increased risk of cardiovascular events, including heart attack, heart failure, and stroke. Monitoring for these adverse effects is advised when prescribing ibuprofen, especially in patients with pre-existing cardiovascular conditions.

Packaging & NDC

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

Packaging configurations for Junior Strength Advil.
Details

Pediatric Use

Pediatric patients require careful consideration when using this medication. Dosing is based on weight and age, as outlined in the following chart:

  • For patients under 24 lb (under 2 years), consultation with a doctor is advised before use.

  • For those weighing 24-35 lb (ages 2-3 years), the recommended dose is 1 tablet.

  • Patients weighing 36-47 lb (ages 4-5 years) should receive 1 ½ tablets.

  • For children weighing 48-59 lb (ages 6-8 years), the dose is 2 tablets.

  • Those weighing 60-71 lb (ages 9-10 years) should take 2 ½ tablets.

  • For patients weighing 72-95 lb (age 11 years), the recommended dose is 3 tablets.

It is important to note that the medication should not be used for more than 2 days for sore throat relief, and it is contraindicated for children under 3 years of age unless directed by a physician.

Caution is warranted in pediatric patients with a history of stomach ulcers or bleeding problems, as the risk of stomach bleeding may be increased, particularly if the child is taking anticoagulants, steroids, or other NSAIDs.

Healthcare professionals should advise parents to consult a doctor prior to use if the child has a history of allergic reactions to pain relievers or fever reducers, has experienced serious side effects from such medications, or has any of the following conditions: heartburn, high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or a history of stroke. Additionally, consultation is necessary if the child has not been adequately hydrated or is taking diuretics or other medications.

Geriatric Use

Elderly patients may have specific considerations when using this product. It is important to consult a healthcare provider before use, particularly if the patient has a history of high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or has previously experienced a stroke.

The risk of serious adverse events, such as heart attack and stroke, may be heightened in elderly patients, especially if the product is used in excess of the recommended dosage or for an extended duration. Additionally, elderly patients with a history of stomach problems, including heartburn, should be aware that warnings regarding stomach bleeding are applicable.

For those experiencing stomach upset, it is advisable to take the product with food or milk, as this may help mitigate gastrointestinal discomfort, which can be more pronounced in geriatric patients.

Overall, careful monitoring and consultation with a healthcare provider are recommended for elderly patients to ensure safe and effective use of this product.

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 statements regarding the use of this medication in lactating mothers or its effects on breastfed infants. Healthcare professionals should consider the absence of data when advising lactating mothers about the use of this medication.

Renal Impairment

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

Hepatic Impairment

Patients with hepatic impairment may experience altered pharmacokinetics of the medication due to compromised liver function. It is essential to assess the severity of liver impairment prior to initiating treatment.

In patients with liver cirrhosis, dosage adjustments may be necessary to avoid potential toxicity. Close monitoring of liver function tests is recommended throughout the treatment course to ensure safety and efficacy.

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

Overdosage

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

Healthcare professionals should be aware that the symptoms of overdose may vary depending on the specific 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. This may include monitoring vital signs, providing respiratory support if necessary, and administering specific antidotes when applicable. The healthcare provider should follow established protocols and guidelines for the management of overdose cases to ensure optimal patient outcomes.

In summary, timely medical intervention and appropriate management strategies are vital in addressing overdose situations effectively.

Nonclinical Toxicology

No teratogenic or non-teratogenic effects have been reported in the available nonclinical studies. Additionally, there is no information regarding animal pharmacology and toxicology. The absence of data limits the assessment of potential risks associated with the compound in these areas.

Postmarketing Experience

No specific postmarketing experience details are provided in the insert text.

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 to take the medication with food or milk if they experience stomach upset. It is essential for healthcare providers to encourage patients to consult a doctor before use if the child has a warning for stomach bleeding or has experienced problems or serious side effects from pain relievers or fever reducers in the past.

Additionally, patients should be advised to seek medical advice if the child has a history of stomach issues, such as heartburn, or if there are pre-existing conditions such as high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or a history of stroke.

Healthcare providers should also recommend that patients consult a doctor before use if the child has not been adequately hydrated or has lost significant fluids due to vomiting or diarrhea. It is important to discuss the use of this medication with a healthcare professional if the child is taking a diuretic or is under a doctor's care for any serious condition. Lastly, patients should be encouraged to speak with a doctor or pharmacist before use if the child is currently taking any other medications.

Storage and Handling

The product is supplied in packaging that includes a lot number and expiration date, which can be found on the side 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 counsel patients that each tablet contains 4.2 mg of phenylalanine, which is relevant for individuals with phenylketonuria. It is essential to keep the medication out of reach of children, and in the event of an overdose, patients should seek medical assistance or contact a Poison Control Center immediately.

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

Drug Information (PDF)

This file contains official product information for Junior Strength 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 Junior Strength 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

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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.