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Advil

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Active ingredient
Ibuprofen 200 mg
Other brand names
Drug class
Nonsteroidal Anti-inflammatory Drug
Dosage form
Tablet, Coated
Route
Oral
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 1984
Label revision date
March 12, 2026
Active ingredient
Ibuprofen 200 mg
Other brand names
Drug class
Nonsteroidal Anti-inflammatory Drug
Dosage form
Tablet, Coated
Route
Oral
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Marketed in the U.S.
Since 1984
Label revision date
March 12, 2026
Manufacturer
Haleon US Holdings LLC
Registration number
NDA018989
NDC roots
0573-0150, 0573-0151, 0573-0154, 0573-0160, 0573-0161, 0573-0165, 0573-0166, 0573-1711

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Drug Overview

Advil is a medication that contains ibuprofen, which is a type of nonsteroidal anti-inflammatory drug (NSAID). It is commonly used to temporarily relieve minor aches and pains, such as those caused by headaches, toothaches, backaches, menstrual cramps, muscular aches, and even minor arthritis pain. Additionally, Advil can help reduce fever, making it a versatile option for managing discomfort and illness.

Each tablet of Advil contains 200 mg of ibuprofen, and it comes in the form of coated gel caplets, which are designed to be easy to swallow. Whether you're dealing with everyday aches or a mild fever, Advil can provide effective relief to help you feel more comfortable.

Uses

You can use this medication to temporarily relieve minor aches and pains caused by various conditions, including headaches, toothaches, backaches, menstrual cramps, muscular aches, and even minor arthritis pain. It can also help ease discomfort associated with the common cold.

In addition to pain relief, this medication is effective in temporarily reducing fever. It's important to note that there are no reported teratogenic effects (which means it doesn't cause birth defects) associated with this medication.

Dosage and Administration

When you need relief from pain or fever, you can take Advil in different forms, such as tablets, caplets, or gel caplets. For adults and children aged 12 and older, the recommended dose is 1 tablet, caplet, or gel caplet every 4 to 6 hours as needed while symptoms persist. If you find that 1 does not provide enough relief, you can take 2. However, it’s important not to exceed 6 of any form in a 24-hour period unless your doctor advises otherwise.

If you are considering giving Advil to a child under 12 years old, it’s best to consult with a doctor first to ensure it’s safe and appropriate for their age and condition. Always follow these guidelines to use Advil effectively and safely.

What to Avoid

You should avoid using this medication if you have ever had an allergic reaction to any other pain reliever or fever reducer. Additionally, it is important not to use it right before or after heart surgery, as this could pose serious health risks. Always consult with your healthcare provider if you have any concerns or questions about your eligibility to use this medication. Your safety is the top priority.

Side Effects

Ibuprofen can cause serious allergic reactions, particularly in individuals who are allergic to aspirin. Symptoms of a severe allergic reaction may include hives, facial swelling, wheezing (asthma), shock, skin reddening, rash, and blisters. Additionally, this medication carries a risk of severe stomach bleeding, especially for those over 60, individuals with a history of stomach ulcers or bleeding, and those taking blood thinners or other NSAIDs. Drinking three or more alcoholic beverages daily while using ibuprofen can also increase this risk.

There are important warnings regarding heart attack and stroke, as NSAIDs (excluding aspirin) can elevate these risks, particularly if used in higher doses or for extended periods. You should stop using ibuprofen and consult a doctor if you experience symptoms of stomach bleeding (like faintness, vomiting blood, or black stools), signs of heart problems or stroke (such as chest pain or weakness on one side of the body), or if your pain or fever worsens or lasts longer than expected. Always consult a healthcare professional if you have a history of stomach issues, high blood pressure, heart disease, or if you are 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 ibuprofen and seek medical help immediately. Additionally, this medication can lead to severe stomach bleeding, particularly if you are over 60, have a history of stomach ulcers, take blood thinners or steroids, consume three or more alcoholic drinks daily, or use it for longer than directed. There is also an increased risk of heart attack and stroke with ibuprofen, especially if used in higher doses or for extended periods.

Before using ibuprofen, consult your doctor if you have a history of stomach problems, high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or if you are taking diuretics or other medications. If you experience symptoms of stomach bleeding, such as feeling faint, vomiting blood, or having black stools, or if you notice signs of heart problems or stroke, such as chest pain or trouble breathing, stop taking ibuprofen and contact your doctor. In case of an overdose, seek emergency medical help or contact a Poison Control Center right away.

Overdose

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

Don’t wait for symptoms to worsen; acting quickly can make a significant difference in your safety. Always keep emergency contact information handy and be aware of the signs of overdose to ensure you can respond effectively if needed.

Pregnancy Use

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using any medication, including ibuprofen. This is particularly crucial if you are 20 weeks pregnant or later, as using ibuprofen during this time can lead to potential issues for your unborn child or complications during delivery. Always seek guidance from your doctor to ensure the safety of both you and your baby.

Lactation Use

If you are pregnant or breastfeeding, it's important to consult with a healthcare professional before using ibuprofen. This is particularly crucial if you are 20 weeks pregnant or later, as using ibuprofen during this time can potentially lead to issues for your unborn child or complications during delivery. Always prioritize your health and your baby's well-being by seeking guidance from your doctor.

Pediatric Use

When considering Advil for your child, it's important to know that it is not recommended for children under 12 years old without consulting a doctor first. For children aged 12 and older, the typical dosage is one tablet, caplet, or gel caplet every 4 to 6 hours as needed for pain or fever. If one does not provide relief, you may give two, but be careful not to exceed six in a 24-hour period unless directed by a healthcare professional. Always prioritize your child's safety by following these guidelines and seeking medical advice when necessary.

Geriatric Use

As you age, it's important to be aware of certain risks associated with medications, especially those containing NSAIDs (nonsteroidal anti-inflammatory drugs). If you are 60 or older, you should know that these medications can increase the chance of severe stomach bleeding. This risk is even higher if you have a history of stomach ulcers or bleeding problems, or if you are taking blood thinners or steroid medications.

To stay safe, always consult your doctor before using these products. It's also crucial to use the smallest effective dose for the shortest time possible to minimize the risk of heart attack and stroke, which can be heightened in older adults when medications are used improperly. Your health and safety should always come first, so don’t hesitate to ask questions and seek guidance from your healthcare provider.

Renal Impairment

If you have kidney problems, it's important to consult your doctor before using this medication. This is especially crucial if you also have high blood pressure, heart disease, liver cirrhosis (a severe liver condition), asthma, or a history of stroke. Your doctor can help determine if this medication is safe for you and whether any adjustments to your dosage or monitoring are necessary. Always prioritize your health by discussing your medical history with your healthcare provider.

Hepatic Impairment

If you have liver problems, such as liver cirrhosis (a severe scarring of the liver), it's important to consult your doctor before using this medication. Your healthcare provider will assess your overall health and any other conditions you may have, including high blood pressure, heart disease, kidney disease, asthma, or a history of stroke. This ensures that the medication is safe and appropriate for you.

Always prioritize open communication with your doctor about your liver health and any concerns you may have. They can provide guidance on the best course of action tailored to your specific needs.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications or tests you may be taking. Currently, there are no specific drug interactions or laboratory test interactions noted for this medication. However, every individual’s health situation is unique, and your provider can help ensure that your treatment plan is safe and effective for you. Always feel free to ask questions and share all the medications and supplements you are using to avoid any potential issues.

Storage and Handling

To ensure the safety and effectiveness of your product, store it at a temperature between 20-25°C (68-77°F). It's important to avoid exposing it to excessive heat, which can occur if temperatures exceed 40°C (104°F). Before using the product, check that the seal under the bottle cap marked “SEALED for YOUR PROTECTION” is intact; do not use it if this seal is broken or missing.

Additionally, keep the original carton as it contains important warnings and information that you may need. Proper storage and handling are essential for maintaining the quality and safety of the product.

Additional Information

You should take this medication orally. If you are pregnant or breastfeeding, it's important to consult with a healthcare professional before using it. Specifically, avoid using ibuprofen after 20 weeks of pregnancy unless your doctor has specifically instructed you to do so, as it may pose risks to your unborn child or lead to complications during delivery.

FAQ

What is Advil?

Advil is an ibuprofen tablet formulation, available in 200 mg doses, used as a pain reliever and fever reducer.

What conditions does Advil temporarily relieve?

Advil temporarily relieves minor aches and pains due to headaches, toothaches, backaches, menstrual cramps, the common cold, muscular aches, and minor arthritis pain.

What is the recommended dosage for adults and children over 12?

Adults and children 12 years and over should take 1 tablet, caplet, or gel caplet every 4 to 6 hours while symptoms persist, not exceeding 6 in 24 hours unless directed by a doctor.

What should I do if I experience stomach bleeding symptoms?

Stop use and ask a doctor if you experience symptoms like feeling faint, vomiting blood, or having bloody or black stools.

Are there any warnings associated with taking Advil?

Yes, Advil may cause severe allergic reactions, stomach bleeding, and increase the risk of heart attack and stroke, especially if used more than directed.

Can I take Advil if I am pregnant or breastfeeding?

If you are pregnant or breastfeeding, ask a health professional before use, especially not to use it at 20 weeks or later in pregnancy unless directed by a doctor.

What should I do if I have a history of stomach problems?

Ask a doctor before using Advil if you have a history of stomach problems, high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or if you have had a stroke.

How should I store Advil?

Store Advil at 20-25°C (68-77°F) and avoid excessive heat above 40°C (104°F).

Packaging Info

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

Packaging configurations for Advil.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

No description information is available for the specified drug.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with various conditions, including headache, toothache, backache, menstrual cramps, the common cold, muscular aches, and minor pain of arthritis. Additionally, it is indicated for the temporary reduction of fever.

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

Dosage and Administration

Adults and children aged 12 years and older are advised to take 1 tablet, caplet, or gel caplet of Advil every 4 to 6 hours as needed while symptoms persist. In cases where pain or fever does not adequately respond to 1 unit, a dosage of 2 units may be administered. It is imperative that the total daily dosage does not exceed 6 units within a 24-hour period, unless otherwise directed by a healthcare professional.

For children under 12 years of age, it is recommended to consult a doctor prior to administration.

Contraindications

Use of this product is contraindicated in patients with a history of allergic reactions to any other pain reliever or fever reducer, due to the potential for severe hypersensitivity reactions. Additionally, the product should not be administered immediately before or after heart surgery, as it may pose risks to surgical outcomes and patient safety.

Warnings and Precautions

Ibuprofen is associated with several significant warnings and precautions that healthcare professionals must consider to ensure patient safety.

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

Stomach Bleeding Warning As a nonsteroidal anti-inflammatory drug (NSAID), ibuprofen carries a risk of severe stomach bleeding. This risk is heightened in patients who are 60 years of age or older, have a history of stomach ulcers or bleeding disorders, are concurrently using anticoagulants or steroid medications, are taking other NSAIDs (including aspirin, ibuprofen, or naproxen), consume three or more alcoholic beverages daily while using this product, or exceed the recommended dosage or duration of use.

Heart Attack and Stroke Warning The use of NSAIDs, excluding aspirin, is associated with an increased risk of heart attack, heart failure, and stroke, which can be fatal. This risk is particularly pronounced in patients who use ibuprofen in excess of the recommended dosage or for extended periods.

General Precautions Healthcare professionals should advise patients to consult a physician prior to using ibuprofen if any of the following conditions apply:

  • The patient has a history of stomach bleeding or related issues.

  • The patient has experienced serious side effects from pain relievers or fever reducers.

  • The patient has a history of gastrointestinal problems, such as heartburn.

  • The patient has high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or a history of stroke.

  • The patient is taking diuretics.

Additionally, patients should be counseled to seek advice from a doctor or pharmacist if they are:

  • Under medical care for any serious condition.

  • Taking aspirin for the prevention of heart attack or stroke, as ibuprofen may diminish the cardioprotective effects of aspirin.

  • Using any other medications.

Emergency Medical Help Instructions In the event of an overdose, immediate medical attention should be sought, or the Poison Control Center should be contacted without delay.

Stop Taking and Call Your Doctor Instructions Patients should be instructed to discontinue use and consult a physician if they experience any of the following:

  • 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.

  • Worsening pain that persists beyond 10 days.

  • Fever that worsens or lasts more than 3 days.

  • Redness or swelling in the affected area.

  • Any new or unusual symptoms.

These precautions are essential for the safe administration of ibuprofen and should be communicated clearly to patients.

Side Effects

Patients may experience a range of adverse reactions associated with the use of this product, which contains ibuprofen, a nonsteroidal anti-inflammatory drug (NSAID).

Severe allergic reactions may occur, particularly in individuals with a known allergy to aspirin. Symptoms of such reactions can include hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, and blisters.

The use of this NSAID is also associated with a risk of severe stomach bleeding, which is heightened in patients who are 60 years of age or older, have a history of stomach ulcers or bleeding problems, are taking anticoagulants or steroid medications, consume three or more alcoholic drinks daily while using this product, or exceed the recommended dosage or duration of use. Signs of stomach bleeding that warrant immediate medical attention include feeling faint, vomiting blood, having bloody or black stools, and experiencing persistent stomach pain.

Additionally, NSAIDs, excluding aspirin, have been linked to an increased risk of heart attack, heart failure, and stroke, which can be fatal. This risk is particularly pronounced in patients who use the medication in excess of the recommended dosage or for prolonged periods.

Patients are advised to discontinue use and consult a healthcare professional if they experience any symptoms indicative of stomach bleeding or heart problems, such as chest pain, difficulty breathing, weakness on one side of the body, slurred speech, or leg swelling. Furthermore, if pain persists beyond 10 days, fever worsens or lasts more than three days, redness or swelling occurs in the painful area, or any new symptoms arise, medical advice should be sought.

Before using this product, patients should consult a healthcare provider if they have a history of stomach problems, high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or a history of stroke. It is also important to discuss use with a doctor if the patient is under care for any serious condition, is taking aspirin for heart attack or stroke (as ibuprofen may diminish the cardioprotective effects of aspirin), or is using any other medications.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there is no information available regarding interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

Packaging & NDC

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

Packaging configurations for Advil.
Details

Pediatric Use

Pediatric patients aged 12 years and older may take 1 Advil tablet, caplet, or gel caplet every 4 to 6 hours as needed for pain or fever. If symptoms do not improve with 1 dosage, 2 may be administered. The maximum recommended dosage is 6 tablets, caplets, or gel caplets within a 24-hour period, unless otherwise directed by a healthcare professional.

For children under 12 years of age, it is advised to consult a doctor before administration.

Geriatric Use

Elderly patients, particularly those aged 60 and older, are at an increased risk for severe stomach bleeding when using this product, which contains a nonsteroidal anti-inflammatory drug (NSAID). This risk is further heightened in individuals with a history of stomach ulcers or bleeding problems. Therefore, it is imperative that healthcare providers exercise caution and consider a thorough evaluation of the patient's medical history prior to prescribing this medication.

Additionally, the risk of heart attack and stroke is elevated in geriatric patients, especially when the medication is used in excess of the recommended dosage or for prolonged periods. It is essential for healthcare providers to monitor elderly patients closely for any signs of cardiovascular complications during treatment.

For optimal safety, the smallest effective dose should be utilized in older adults to minimize potential adverse effects. Healthcare providers are advised to consult with patients aged 60 and older regarding their use of this product, particularly if they are concurrently taking anticoagulants or steroid medications.

Pregnancy

Pregnant patients should consult a healthcare professional before using this medication, particularly if they are in the later stages of pregnancy or breastfeeding. It is crucial to avoid the use of ibuprofen after 20 weeks of gestation unless specifically directed by a physician, as it may pose risks to the developing fetus and lead to complications during delivery. The potential adverse effects on fetal outcomes necessitate careful consideration and professional guidance in these circumstances.

Lactation

Lactating mothers are advised to consult a health professional before using this medication. It is particularly important to avoid the use of ibuprofen at 20 weeks of gestation or later unless specifically directed by a physician, as it may pose risks to the unborn child or lead to complications during delivery. There is no specific data provided regarding the excretion of ibuprofen in breast milk or its effects on breastfed infants. Therefore, caution is recommended when considering the use of this medication 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 to ensure safety and efficacy.

Hepatic Impairment

Patients with hepatic impairment should consult a healthcare professional prior to use, particularly if they have a history of liver cirrhosis. It is essential for these patients to discuss their liver function status, as compromised liver function may influence the safety and efficacy of the treatment. Monitoring of liver function may be warranted in this population to ensure appropriate management and to mitigate potential risks associated with the use of the medication.

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 in monitoring for symptoms that may arise from an overdose. While specific symptoms are not detailed in the provided information, it is essential to remain alert to any unusual or severe reactions in the patient.

Management of an overdose should be guided by established protocols, which may include supportive care and symptomatic treatment as necessary. The healthcare provider should ensure that the patient is stabilized and that any life-threatening conditions are addressed promptly.

In summary, immediate medical attention is essential in cases of overdose, and healthcare professionals should be prepared to implement appropriate management strategies based on the patient's clinical presentation.

Nonclinical Toxicology

It is especially important not to use ibuprofen at 20 weeks or later in pregnancy unless definitely directed to do so by a doctor, as it may cause problems in the unborn child or complications during delivery. No specific non-teratogenic effects have been identified. Additionally, there are no detailed findings regarding nonclinical toxicology or animal pharmacology and toxicology available.

Postmarketing Experience

No specific postmarketing experience details are available. As such, there are no additional adverse events or rare case reports to summarize at this time.

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 for patients to understand the importance of prompt action in such situations.

Additionally, healthcare providers should recommend that patients take the medication with food or milk if they experience any stomach upset. This guidance can help mitigate gastrointestinal discomfort and enhance the overall tolerability of the treatment.

Storage and Handling

The product is supplied in a configuration that includes a protective seal under the bottle cap, which is imprinted with “SEALED for YOUR PROTECTION.” It is imperative that the product is not used if this seal is broken or missing.

For optimal storage, the product should be maintained at a temperature range of 20-25°C (68-77°F). It is essential to avoid exposure to excessive heat, specifically temperatures exceeding 40°C (104°F). Additionally, healthcare professionals are advised to retain the carton for complete warnings and information regarding the product.

Additional Clinical Information

The route of administration for the medication is oral. Clinicians should advise patients who are pregnant or breastfeeding to consult a health professional prior to use. It is particularly crucial to avoid ibuprofen after 20 weeks of pregnancy unless specifically directed by a physician, as it may pose risks to the unborn child or lead to complications during delivery.

Drug Information (PDF)

This file contains official product information for 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 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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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.