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Ibuprofen 200

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Active ingredient
Ibuprofen 200 mg
Other brand names
Drug class
Nonsteroidal Anti-inflammatory Drug
Dosage form
Tablet, Film Coated
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 1999
Label revision date
June 4, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Ibuprofen 200 mg
Other brand names
Drug class
Nonsteroidal Anti-inflammatory Drug
Dosage form
Tablet, Film Coated
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 1999
Label revision date
June 4, 2025
Manufacturer
Walgreen Company
Registration number
ANDA075139
NDC root
0363-0393
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (5 NDCs)
Packaging & NDC Codes (5)

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Drug Overview

Ibuprofen is a medication that belongs to a class of drugs known as nonsteroidal anti-inflammatory drugs (NSAIDs). It is commonly used to temporarily relieve minor aches and pains, including headaches, toothaches, menstrual cramps, and muscle aches. Additionally, ibuprofen can help reduce fever, making it a versatile option for managing discomfort associated with various conditions, such as the common cold and arthritis.

When you take ibuprofen, it works by blocking certain substances in the body that cause inflammation and pain, providing you with relief from discomfort. It's important to use it as directed and consult with a healthcare professional if you have any questions or concerns about its use.

Uses

You can use this medication to temporarily relieve minor aches and pains caused by various conditions, including headaches, the common cold, arthritis, backaches, menstrual cramps, toothaches, and muscular aches. Additionally, it can help reduce fever for a short period.

This medication is designed to provide you with comfort when dealing with these common discomforts, allowing you to feel better and carry on with your daily activities.

Dosage and Administration

It's important to follow the dosage instructions carefully to ensure your safety and the effectiveness of the medication. You should not take more than the recommended amount, and it's best to use the smallest effective dose. For adults and children aged 12 years and older, the typical dose is 1 caplet every 4 to 6 hours as needed while symptoms persist. If you find that 1 caplet isn't enough to relieve your pain or fever, you can take 2 caplets instead.

However, be cautious not to exceed 6 caplets in a 24-hour period unless your doctor advises otherwise. If you have a child under 12 years old, it's essential to consult a doctor before giving them this medication. Always prioritize safety and follow these guidelines to manage your symptoms effectively.

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 could pose serious health risks. Always consult with your healthcare provider if you have any questions or concerns about your medications.

Side Effects

Ibuprofen can cause serious allergic reactions, particularly in individuals who are allergic to aspirin. Symptoms of such reactions may include skin reddening, asthma (wheezing), rash, facial swelling, shock, blisters, and hives. Additionally, this medication carries a risk of severe stomach bleeding, especially if you have a history of stomach ulcers, are taking blood thinners or steroids, consume alcohol regularly, or are over 60 years old.

There is also an increased risk of heart attack and stroke associated with NSAIDs like ibuprofen, particularly if used in higher doses or for extended periods. If you experience symptoms such as faintness, bloody or black stools, chest pain, slurred speech, or persistent stomach pain, you should stop using ibuprofen and consult a doctor immediately. Always talk to your healthcare provider before using ibuprofen if you have a history of stomach issues, heart disease, or are taking other medications.

Warnings and Precautions

Ibuprofen can cause serious allergic reactions, especially if you are allergic to aspirin. Symptoms may include skin reddening, wheezing, rash, facial swelling, shock, blisters, or hives. If you experience any of these symptoms, stop using ibuprofen and seek medical help immediately.

This medication can also lead to severe stomach bleeding, particularly if you have a history of stomach ulcers, are taking blood thinners or steroids, are over 60 years old, consume three or more alcoholic drinks daily, or use it for longer than recommended. Additionally, using ibuprofen increases the risk of heart attack and stroke, especially if taken in higher doses or for extended periods.

You should seek emergency medical help if you suspect an overdose. Stop using ibuprofen and contact your doctor if you notice signs of stomach bleeding (like feeling faint, bloody or black stools, or vomiting blood), symptoms of heart problems or stroke (such as chest pain, slurred speech, or weakness on one side of the body), or if your pain or fever worsens or lasts longer than the recommended time.

Overdose

If you suspect an overdose, it’s crucial to seek medical help immediately or contact a Poison Control Center. Signs of an overdose can vary, but they may include unusual symptoms that are more severe than typical side effects.

Always err on the side of caution—if you notice anything concerning, don’t hesitate to reach out for assistance. Your health and safety are the top priority.

Pregnancy Use

If you are pregnant or breastfeeding, it’s crucial to consult with a healthcare professional before using any medication, including 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 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 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, you can administer 1 caplet every 4 to 6 hours as needed while symptoms persist. If one caplet does not relieve pain or fever, you may give 2 caplets instead. However, be sure not to exceed 6 caplets in a 24-hour period unless a doctor advises otherwise. Always prioritize safety and seek professional guidance when it comes to treating your child's symptoms.

Geriatric Use

As you age, it's important to be aware of certain health risks associated with medications. If you are 60 years or older, you have a higher chance of experiencing severe stomach bleeding when taking nonsteroidal anti-inflammatory drugs (NSAIDs), which are commonly used for pain relief. Additionally, using NSAIDs—except for aspirin—can increase your risk of heart attack, heart failure, and stroke, especially if you take more than the recommended dose or use them for an extended period.

To stay safe, always follow your healthcare provider's instructions regarding dosage and duration of use. If you have any concerns about your medications or how they may affect your health, be sure to discuss them with your doctor or pharmacist. Your well-being is important, and they can help you make informed choices.

Renal Impairment

If you have kidney problems, it's important to consult your doctor before using this medication. Your healthcare provider will want to know about any other conditions you may have, such as high blood pressure, heart disease, liver cirrhosis, asthma, or a history of stroke. This information helps ensure that the treatment is safe and appropriate for you. Always prioritize open communication with your doctor regarding your health status and any medications you are considering.

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 may need to adjust your dosage or monitor your condition more closely. This is crucial to ensure your safety and the effectiveness of the treatment.

Always inform your doctor about any other health issues you may have, including high blood pressure, heart disease, kidney disease, asthma, or a history of stroke, as these can also affect your treatment plan.

Drug Interactions

It's important to be aware of how certain medications can interact with each other. For instance, if you take ibuprofen, it may reduce the effectiveness of aspirin when used for heart attack or stroke prevention. Additionally, if you're on blood thinners (medications that help prevent blood clots) or steroids, combining these with ibuprofen can increase your risk of stomach bleeding.

You should also be cautious if you're taking other nonsteroidal anti-inflammatory drugs (NSAIDs), like aspirin or naproxen, alongside ibuprofen, as this can further heighten the risk of stomach issues. If you're using diuretics (medications that help remove excess fluid from the body), it's best to discuss this with your healthcare provider to ensure safe use. Always talk to your healthcare provider about all the medications and supplements you are taking to avoid potential interactions and ensure your safety.

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 avoid exposing it to excessive heat, which can reach up to 40°C (104°F), as this may compromise its effectiveness. Always check the expiration date on the package and use the product before that date to ensure safety and reliability.

Handling the product with care is essential. Make sure to keep it in a sterile environment (a clean area free from germs) to maintain its integrity. Following these guidelines will help you use the product safely and effectively.

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 used for?

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

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

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

Can children under 12 take Ibuprofen?

Children under 12 years should ask a doctor before use.

What should I do if I experience signs of stomach bleeding?

Stop use and ask a doctor if you feel faint, have bloody or black stools, vomit blood, or have stomach pain that does not get better.

What are the allergy alerts for Ibuprofen?

Ibuprofen may cause a severe allergic reaction, especially in those allergic to aspirin. Symptoms can include skin reddening, asthma, rash, facial swelling, and hives.

Is there a risk of heart attack or stroke with Ibuprofen?

Yes, NSAIDs like Ibuprofen increase the risk of heart attack, heart failure, and stroke, especially if used more than directed or for longer than directed.

What should I do if I am pregnant or breastfeeding?

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

How should I store Ibuprofen?

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

What should I do in case of an overdose?

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

Packaging Info

Below are the non-prescription pack sizes of Ibuprofen 200 (ibuprofen). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Ibuprofen 200.
Details

Drug Information (PDF)

This file contains official product information for Ibuprofen 200, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

Ibuprofen 200 is presented in the form of Ibuprofen Tablets USP, each containing 200 mg of ibuprofen, a nonsteroidal anti-inflammatory drug (NSAID) indicated for pain relief and fever reduction. The product is packaged in a container of 225 caplets. It features a tamper-evident design, and users are advised not to use the product if the imprinted safety seal under the cap is broken or missing. This medication is distributed by Walgreen Co., located at 200 Wilmot Rd., Deerfield, IL 60015.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with various conditions, including headache, the common cold, minor pain of arthritis, backache, menstrual cramps, toothache, and muscular aches. 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 administration guidelines. 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 caplet every 4 to 6 hours as needed while symptoms persist. If pain or fever does not adequately respond to 1 caplet, a maximum of 2 caplets may be administered. However, it is imperative not to exceed 6 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 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 contraindicated immediately before or after heart surgery due to potential complications associated with surgical recovery.

Warnings and Precautions

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

This product contains a nonsteroidal anti-inflammatory drug (NSAID), which is associated with a risk of severe stomach bleeding. The likelihood of experiencing such adverse effects is heightened in patients with a history of stomach ulcers or bleeding disorders, those concurrently using anticoagulants or steroid medications, individuals taking other NSAIDs (including aspirin, ibuprofen, or naproxen), patients aged 60 years or older, those consuming three or more alcoholic beverages daily while using this product, and individuals who exceed the recommended dosage or duration of use.

NSAIDs, with the exception of aspirin, are known to elevate the 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 extended periods.

In cases of suspected overdose, immediate medical attention should be sought, or contact with a Poison Control Center is advised.

Healthcare professionals should instruct patients to discontinue use and consult a physician if any of the following symptoms occur: signs of stomach bleeding such as feeling faint, experiencing bloody or black stools, vomiting blood, or persistent stomach pain; symptoms indicative of heart problems or stroke, including chest pain, slurred speech, leg swelling, difficulty breathing, or weakness on one side of the body; worsening pain that persists beyond 10 days; fever that worsens or lasts more than 3 days; visible redness or swelling in the affected area; or the emergence of any new symptoms.

Side Effects

Patients using ibuprofen should be aware of potential adverse reactions, which can range from serious to common.

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

The use of ibuprofen, as a nonsteroidal anti-inflammatory drug (NSAID), carries a risk of severe stomach bleeding. This risk is heightened in patients with a history of stomach ulcers or bleeding problems, those taking blood thinners or steroid medications, individuals using other NSAIDs (including aspirin, ibuprofen, or naproxen), patients aged 60 or older, those consuming three or more alcoholic drinks daily while using the product, and individuals who 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 the medication in excess of the recommended dosage 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, having bloody or black stools, vomiting blood, or experiencing persistent stomach pain. Symptoms indicative of heart problems or stroke, including chest pain, slurred speech, leg swelling, difficulty breathing, or weakness on one side of the body, 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 three days, if redness or swelling occurs in the painful area, or if any new symptoms arise.

Before using ibuprofen, patients should consult a healthcare provider if they have a history of stomach issues, high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or a history of stroke. It is also important for patients taking diuretics or those who have experienced serious side effects from pain relievers or fever reducers to seek medical advice prior to use. Additionally, individuals under a doctor's care for serious conditions or those taking aspirin for heart attack or stroke should consult a healthcare professional, as ibuprofen may diminish the cardioprotective effects of aspirin.

Drug Interactions

Ibuprofen may diminish the cardioprotective effects of aspirin when used for the prevention of heart attack or stroke. Therefore, concurrent use of these medications should be carefully considered, particularly in patients requiring aspirin for cardiovascular protection.

The concomitant use of ibuprofen with anticoagulants or steroid medications significantly elevates the risk of gastrointestinal bleeding. Clinicians should monitor patients closely for signs of bleeding and consider alternative pain management strategies when prescribing these medications together.

Additionally, the use of ibuprofen alongside other nonsteroidal anti-inflammatory drugs (NSAIDs), whether prescription or over-the-counter, such as aspirin or naproxen, further increases the risk of stomach bleeding. It is advisable to avoid the simultaneous use of multiple NSAIDs to mitigate this risk.

Caution is also warranted when ibuprofen is used in conjunction with diuretics. The potential for adverse effects necessitates careful monitoring of renal function and blood pressure in patients receiving this combination therapy.

Packaging & NDC

Below are the non-prescription pack sizes of Ibuprofen 200 (ibuprofen). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Ibuprofen 200.
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 caplet every 4 to 6 hours as needed while symptoms persist. If pain or fever does not adequately respond to 1 caplet, 2 caplets may be administered. It is important not to exceed 6 caplets in a 24-hour period unless directed by a healthcare provider.

Geriatric Use

Elderly patients, particularly those aged 60 and older, may have an increased risk of severe stomach bleeding when using this medication. It is essential for healthcare providers to consider this heightened risk when prescribing and monitoring treatment in this population.

Additionally, nonsteroidal anti-inflammatory drugs (NSAIDs), with the exception of aspirin, are associated with an elevated risk of cardiovascular events, including heart attack, heart failure, and stroke. This risk is further amplified in elderly patients who exceed the recommended dosage or duration of use. Therefore, careful assessment of the benefits and risks is crucial when prescribing NSAIDs to geriatric patients, and appropriate monitoring should be implemented to mitigate 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 pregnancy 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 evaluate the potential benefits and risks when considering the use of this medication in pregnant patients.

Lactation

Lactating mothers are advised to consult a healthcare 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 this medication in breast milk or its effects on breastfed infants. Therefore, caution is recommended when considering its use 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 necessary to ensure appropriate management and to mitigate potential risks associated with the use of this medication in individuals with hepatic impairment.

Overdosage

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

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

It is essential for healthcare providers to remain alert and prepared to implement appropriate management strategies in response to an overdose situation, ensuring the safety and well-being of the patient.

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 specific details regarding nonclinical toxicology or animal pharmacology and toxicology provided in the text.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions associated with the use of the product. Reports include gastrointestinal bleeding, renal failure, and liver dysfunction. Serious skin reactions, such as Stevens-Johnson syndrome and toxic epidermal necrolysis, have also been documented. Additionally, cases of cardiovascular events, including heart attack and stroke, have been reported. Hypersensitivity reactions, such as anaphylaxis and angioedema, have been noted as well. Instances of elevated liver enzymes and jaundice have also been observed in the postmarketing data.

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 recommended that patients take the medication with food or milk if they experience stomach upset.

Patients should be encouraged to consult with their healthcare provider before use if they have a history of stomach problems, such as heartburn, or if they are subject to stomach bleeding warnings. Additionally, it is important for patients to discuss their medical history with their healthcare provider, particularly if they have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or if they have previously experienced a stroke.

Patients should also be informed to ask their doctor before use if they are currently taking a diuretic or if they have experienced problems or serious side effects from pain relievers or fever reducers in the past. Furthermore, it is advisable for patients to consult with their doctor or pharmacist if they are under medical care for any serious condition.

Lastly, patients should be made aware that if they are taking aspirin for the prevention of heart attack or stroke, they should discuss this with their healthcare provider, as ibuprofen may reduce the effectiveness of aspirin. It is also prudent for patients to consult their doctor or pharmacist before using this medication if they are taking any other drugs.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at a controlled room temperature, specifically between 20°-25°C (68°-77°F). Care should be taken to avoid exposure to excessive heat, defined as temperatures exceeding 40°C (104°F). Additionally, healthcare professionals are advised to adhere to the expiration date indicated on the package to ensure product efficacy and safety.

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 Ibuprofen 200, 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 200, 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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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.