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Ibuprofen

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Active ingredient
Ibuprofen 200 mg
Other brand names
Drug class
Nonsteroidal Anti-inflammatory Drug
Dosage form
Capsule
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2022
Label revision date
July 18, 2022
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Ibuprofen 200 mg
Other brand names
Drug class
Nonsteroidal Anti-inflammatory Drug
Dosage form
Capsule
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 2022
Label revision date
July 18, 2022
Manufacturer
Aurohealth LLC
Registration number
ANDA207753
NDC root
58602-852
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (2 NDCs)
Packaging & NDC Codes (2)

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Drug Overview

Ibuprofen capsules (200 mg) are a type of medication known as a nonsteroidal anti-inflammatory drug (NSAID), which is commonly used to relieve pain and reduce fever. You can take ibuprofen to temporarily alleviate minor aches and pains caused by headaches, toothaches, backaches, menstrual cramps, muscular aches, the common cold, and even minor arthritis pain.

In addition to pain relief, ibuprofen is effective in lowering fever, making it a versatile option for managing discomfort and illness. It works by blocking certain substances in the body that cause inflammation and pain, helping you feel better when you're not at your best.

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 discomfort from the common cold. It can also help with minor pain associated with arthritis.

In addition to pain relief, this medication is effective in temporarily reducing fever, helping you feel more comfortable when you're not feeling well.

Dosage and Administration

It's important to follow the dosage instructions carefully to ensure your safety and effectiveness of the medication. You should not take more than the directed amount, and it's best to use the smallest effective dose. For adults and children aged 12 years and older, the recommended dose is to take 1 capsule every 4 to 6 hours as needed while symptoms persist.

If you find that 1 capsule isn't enough to relieve your pain or fever, you can take 2 capsules. However, make sure not to exceed 6 capsules in a 24-hour period unless your doctor has advised you otherwise. If you are considering giving this medication to a child under 12 years old, it's essential to consult with a doctor first.

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, do not take it right before or after heart surgery, as this can pose serious risks.

If you are pregnant or breastfeeding, it's crucial to consult a healthcare professional before using this medication. Specifically, avoid using ibuprofen after 20 weeks of pregnancy unless your doctor has explicitly instructed you to do so, as it may lead to complications for both the unborn child and during delivery.

Side Effects

Ibuprofen can cause serious allergic reactions, particularly in individuals who are allergic to aspirin. Symptoms of such reactions may include hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, and blisters. Additionally, this medication carries a risk of severe stomach bleeding, especially for those over 60, individuals with a history of stomach ulcers or bleeding issues, 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 also 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. If you are pregnant or breastfeeding, it's crucial to consult a healthcare professional before using ibuprofen, especially after 20 weeks of pregnancy, due to potential risks to the unborn child.

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 immediately and seek medical help.

This medication can also lead to severe stomach bleeding, particularly if you are over 60, have a history of stomach ulcers or bleeding, take blood thinners or steroids, consume three or more alcoholic drinks daily, or use 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 bloody or black stools, stop using ibuprofen and contact your doctor. Seek immediate medical attention if you experience chest pain, trouble breathing, weakness on one side of your body, slurred speech, or leg swelling. Also, consult your doctor if your pain worsens or lasts more than 10 days, your fever persists for more than 3 days, or if you notice any new symptoms. In case of an overdose, contact a Poison Control Center at 1-800-222-1222 or seek medical help right away.

Overdose

Taking too much ibuprofen can lead to serious health issues. If you or someone you know has taken an overdose, you might notice symptoms such as nausea, vomiting, stomach pain, drowsiness, headache, or confusion. In more severe cases, an overdose can cause kidney failure, liver damage, and gastrointestinal bleeding.

If you suspect an overdose, it’s crucial to seek emergency medical attention right away. Don’t wait for symptoms to worsen; getting help quickly can make a significant difference in treatment outcomes. Always keep medications out of reach and follow the recommended dosages to avoid these risks.

Pregnancy Use

If you are pregnant or breastfeeding, it’s crucial to consult with a healthcare professional before using ibuprofen. This is particularly important 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 prioritize your health and the health of your baby by seeking medical advice before taking any medication.

Lactation 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 prioritize your health and the health of your baby by seeking guidance from your doctor.

Pediatric Use

If your child is under 12 years old, it's important to consult a doctor before giving them this medication. For those aged 12 and older, the recommended dosage is 1 capsule every 4 to 6 hours as needed for symptoms. If one capsule does not relieve pain or fever, you may give 2 capsules, but be careful not to exceed 6 capsules in a 24-hour period unless a doctor advises otherwise. Always follow these guidelines to ensure your child's safety and well-being.

Geriatric Use

As you age, it's important to be aware that the risk of severe stomach bleeding increases if you are 60 years or older. This warning is especially relevant if you have a history of stomach ulcers or bleeding issues, are taking blood thinners (medications that prevent blood clots), steroids, or other nonsteroidal anti-inflammatory drugs (NSAIDs), or if you consume three or more alcoholic drinks daily while using this product.

To help protect your health, make sure to follow dosage instructions carefully and avoid taking this medication for longer than recommended. Always consult with your healthcare provider about your specific situation, especially if you have any of the mentioned risk factors.

Renal Impairment

If you have kidney problems, it's important to know that there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the standard recommendations for the medication do not include special monitoring or safety considerations tailored for patients with renal impairment (kidney issues).

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your kidney health. They can provide guidance based on your individual situation and any other health factors you may have.

Hepatic Impairment

If you have liver problems, it's important to know that there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the standard recommendations for the medication do not change based on liver function. However, it’s always a good idea to discuss your liver health with your healthcare provider before starting any new medication. They can help ensure that your treatment is safe and effective for you.

Make sure to keep your doctor informed about any liver issues you may have, as they may want to monitor your liver function regularly while you are on medication. Your health and safety are the top priority, so don’t hesitate to ask questions or express any concerns you might have.

Drug Interactions

It's important to be aware that certain medications can interact with each other, which may affect how well they work or increase the risk of side effects. For example, if you take ibuprofen, it may reduce the protective benefits of aspirin when used for heart attack or stroke prevention. Additionally, using blood thinners (medications that help prevent blood clots) or steroids alongside ibuprofen can raise the risk of stomach bleeding.

If you are taking other nonsteroidal anti-inflammatory drugs (NSAIDs) like aspirin or naproxen, this can also increase the chance of stomach bleeding. Always talk to your healthcare provider or pharmacist before starting any new medication, including over-the-counter drugs, to ensure your safety and the effectiveness of your treatment.

Storage and Handling

To ensure the best performance of your product, store it in a cool, dry place at a temperature between 20° to 25°C (68° to 77°F). It's important to avoid exposing it to excessive heat, particularly temperatures above 40°C (104°F), as this can compromise its effectiveness.

When handling the product, make sure to do so with clean hands and in a safe environment to maintain its integrity. Always follow any specific disposal instructions provided to ensure safety and compliance.

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 Ibuprofen Capsules 200 mg used for?

Ibuprofen Capsules 200 mg is a pain reliever and fever reducer that temporarily relieves minor aches and pains from headaches, toothaches, backaches, menstrual cramps, muscular aches, the common cold, and minor arthritis pain.

How should I take Ibuprofen Capsules?

Adults and children 12 years and over should take 1 capsule every 4 to 6 hours while symptoms persist. If pain or fever does not respond to 1 capsule, you may take 2 capsules, but do not exceed 6 capsules in 24 hours unless directed by a doctor.

What should I do if I experience stomach bleeding?

Stop using ibuprofen and seek medical help if you experience symptoms of stomach bleeding, such as feeling faint, vomiting blood, or having bloody or black stools.

Can I take Ibuprofen if I am pregnant or breastfeeding?

If you are pregnant or breastfeeding, consult a health professional before using ibuprofen. It is especially important not to use it at 20 weeks or later in pregnancy unless directed by a doctor.

What are the allergy warnings associated with Ibuprofen?

Ibuprofen may cause a severe allergic reaction, especially in individuals allergic to aspirin. Symptoms can include hives, facial swelling, asthma, and skin rash. If an allergic reaction occurs, stop use and seek medical help immediately.

What precautions should I take if I am over 60 years old?

If you are age 60 or older, you have a higher risk of severe stomach bleeding when using ibuprofen. Consult your doctor before use, especially if you have a history of stomach ulcers or bleeding problems.

What should I do in case of an overdose?

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

How should I store Ibuprofen Capsules?

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

Packaging Info

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

Packaging configurations for Ibuprofen.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

HealthyLiving™ Ibuprofen Capsules are formulated as a pain reliever and fever reducer, classified as a nonsteroidal anti-inflammatory drug (NSAID). Each capsule contains 200 mg of ibuprofen, the active ingredient comparable to that found in Advil®. The product is presented in a liquid-filled capsule form, specifically LIQUI-GELS®, and is available in a total of 300 capsules per package.

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, muscular aches, the common cold, 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

Patients should adhere strictly to the recommended dosage and not exceed the directed amount. The smallest effective dose should be utilized to manage symptoms effectively.

For adults and children aged 12 years and older, the recommended dosage is 1 capsule every 4 to 6 hours as needed while symptoms persist. If pain or fever does not adequately respond to 1 capsule, a maximum of 2 capsules may be administered. However, it is imperative not to exceed 6 capsules within a 24-hour period unless specifically directed by a healthcare professional.

For children under 12 years of age, it is advised to consult a doctor for appropriate dosing recommendations.

Contraindications

Use is contraindicated in patients with a history of allergic reactions to any other pain reliever or fever reducer. Additionally, administration is not recommended immediately before or after heart surgery due to potential complications.

In pregnant or breastfeeding individuals, consultation with a healthcare professional is advised prior to use. Specifically, ibuprofen should not be used at 20 weeks of gestation or later unless explicitly directed by a physician, as it may pose risks to the fetus or lead to complications during delivery.

Warnings and Precautions

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

The use of ibuprofen, an NSAID, carries a significant risk of severe stomach bleeding. This risk is notably elevated 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.

Additionally, NSAIDs, excluding aspirin, are associated with an increased risk of heart attack, heart failure, and stroke, which can be fatal. The likelihood of these adverse events is heightened with the use of higher than recommended doses or prolonged use.

In cases of overdose, immediate medical attention is required. Healthcare professionals should advise patients to contact a Poison Control Center (1-800-222-1222) without delay.

Patients should be instructed to discontinue use and consult a physician if they experience any signs of stomach bleeding, which may manifest as feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain. Furthermore, symptoms suggestive of heart problems or stroke, such as chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling, warrant immediate medical evaluation.

Patients should also seek medical advice if pain worsens or persists beyond 10 days, if fever intensifies or lasts more than 3 days, if there is redness or swelling in the affected area, or if any new symptoms arise. Regular monitoring and assessment of these parameters are essential for the safe use of ibuprofen.

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 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 the product, or exceed the recommended dosage or duration of use.

Additionally, 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 in patients who use ibuprofen in higher doses or for extended periods.

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 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 attention. Furthermore, patients should seek medical advice if pain worsens or persists beyond 10 days, if fever intensifies or lasts more than 3 days, if redness or swelling occurs in the painful area, or if any new symptoms arise.

For pregnant or breastfeeding individuals, it is crucial to consult a healthcare professional before using ibuprofen. The use of this medication is particularly discouraged 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 Interactions

Ibuprofen may diminish the cardioprotective effects of aspirin when used for the prevention of heart attack or stroke. This interaction is particularly relevant for patients relying on aspirin for its antiplatelet properties.

The concomitant use of ibuprofen with anticoagulants or steroid medications significantly elevates the risk of gastrointestinal bleeding. Clinicians should exercise caution and consider monitoring patients for signs of bleeding when these medications are prescribed together.

Additionally, the use of ibuprofen alongside other nonsteroidal anti-inflammatory drugs (NSAIDs), including both prescription and over-the-counter options such as aspirin and naproxen, further increases the risk of stomach bleeding. It is advisable for patients to consult with a healthcare professional before initiating ibuprofen if they are currently taking any other medications, particularly NSAIDs or anticoagulants.

Packaging & NDC

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

Packaging configurations for Ibuprofen.
Details

Pediatric Use

Pediatric patients under 12 years of age should consult a healthcare professional before use. For adolescents aged 12 years and older, the recommended dosage is 1 capsule every 4 to 6 hours as needed while symptoms persist. In cases where pain or fever does not adequately respond to 1 capsule, 2 capsules may be administered. It is important to note that the maximum dosage should not exceed 6 capsules within a 24-hour period, unless otherwise directed by a healthcare provider.

Geriatric Use

Elderly patients, particularly those aged 60 years and older, are at an increased risk of severe stomach bleeding. This risk is further heightened in individuals who have a history of stomach ulcers or bleeding problems, those who are concurrently using blood-thinning medications (anticoagulants) or steroid drugs, and patients taking other nonsteroidal anti-inflammatory drugs (NSAIDs), whether prescription or nonprescription.

Additionally, the risk of stomach bleeding is amplified in geriatric patients who consume three or more alcoholic drinks daily while using this product, or who exceed the recommended dosage or duration of use. Therefore, careful monitoring and consideration of these factors are essential when prescribing this medication to elderly patients. Dose adjustments may be necessary based on individual risk profiles to ensure safety and minimize potential adverse effects.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional before using this medication. It is particularly important 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. Healthcare providers should carefully consider the potential benefits and risks when prescribing this medication to pregnant patients.

Lactation

Lactating mothers are advised to consult a health professional before using this medication while breastfeeding. 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, healthcare providers should weigh the potential benefits against the risks when considering this medication for lactating mothers.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available data regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the lack of information necessitates careful clinical judgment and monitoring.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there are no established dosage adjustments, special monitoring requirements, or precautions for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population. Regular monitoring of liver function may be considered as part of standard clinical practice.

Overdosage

Overdosage of ibuprofen can lead to serious adverse effects that require prompt medical intervention. Healthcare professionals should be aware of the potential symptoms and management strategies associated with ibuprofen overdose.

Symptoms of Overdose Patients experiencing an overdose may present with a range of symptoms, including nausea, vomiting, stomach pain, drowsiness, headache, and confusion. These symptoms can vary in severity depending on the amount ingested and the individual patient's response.

In more severe cases, ibuprofen overdose can result in critical complications such as kidney failure, liver damage, and gastrointestinal bleeding. These conditions necessitate immediate medical evaluation and intervention.

Recommended Actions If an overdose is suspected, it is imperative to seek emergency medical attention without delay. Healthcare providers should conduct a thorough assessment of the patient's condition and consider appropriate diagnostic tests to evaluate organ function and the extent of any potential damage.

Management of ibuprofen overdose may involve supportive care, monitoring of vital signs, and specific interventions to address complications as they arise. It is essential for healthcare professionals to remain vigilant and act swiftly to mitigate the risks associated with ibuprofen overdosage.

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 in the available data. Additionally, there are no details regarding nonclinical toxicology or animal pharmacology and toxicology provided in the text.

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, severe stomach bleeding has been noted, particularly in individuals over 60 years of age, those with a history of stomach ulcers or bleeding problems, and those concurrently using blood thinners or other nonsteroidal anti-inflammatory drugs (NSAIDs). There is also an increased risk of heart attack, heart failure, and stroke associated with NSAID use, especially when used at higher doses or for extended durations beyond those recommended.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222 in the event of an overdose.

Patients who are pregnant or breastfeeding should be encouraged to consult with a healthcare professional prior to use. It is particularly important to inform patients that ibuprofen should not be used 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.

Additionally, healthcare providers should recommend that patients take the medication with food or milk if they experience stomach upset, to help mitigate gastrointestinal discomfort.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It should be stored at a controlled room temperature of 20° to 25°C (68° to 77°F). Care should be taken to avoid exposure to excessive heat, specifically temperatures exceeding 40°C (104°F). Proper storage conditions are essential to maintain the integrity and efficacy of the product.

Additional Clinical Information

The medication is administered orally. 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 Ibuprofen, 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 Ibuprofen, 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.