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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, Liquid Filled
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2018
Label revision date
November 29, 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, Liquid Filled
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 2018
Label revision date
November 29, 2022
Manufacturer
Walgreens
Registration number
ANDA206568
NDC root
0363-0945
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (5 NDCs)
Packaging & NDC Codes (5)

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If you are a consumer or patient please visit this version.

Drug Overview

WALGREENS Ibuprofen 200 mg Softgels contain ibuprofen, which is a type of medication known as a nonsteroidal anti-inflammatory drug (NSAID). This medication is designed to temporarily relieve minor aches and pains, including headaches, muscular aches, toothaches, backaches, and menstrual cramps. It can also help alleviate pain associated with arthritis and the common cold, as well as reduce fever.

By working to decrease inflammation and pain in the body, ibuprofen provides relief when you need it most. Whether you're dealing with everyday discomfort or a specific pain, this softgel formulation offers a convenient option for managing your symptoms.

Uses

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

This medication is designed to provide you with quick relief from discomfort, allowing you to feel more comfortable during everyday activities. Always consult with a healthcare professional if you have any questions or concerns about its use.

Dosage and Administration

It's important to follow the dosage instructions carefully to ensure your safety and effectiveness of the medication. For adults and children aged 12 years and older, you should take 1 capsule every 4 to 6 hours as needed while your 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 advises otherwise.

If you are considering giving this medication to a child under 12 years old, it's best to consult with a doctor first. Always remember to use the smallest effective dose to manage your symptoms and never take more than directed.

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 side effects, including severe allergic reactions, particularly in individuals allergic to aspirin. Symptoms of an allergic reaction may include hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, and blisters. Additionally, this medication can lead to severe stomach bleeding, especially 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 it for longer than recommended.

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 signs of stomach bleeding (such as faintness, bloody or black stools, or vomiting blood), symptoms of heart problems or stroke (like chest pain or slurred speech), or if your pain or fever worsens or lasts longer than expected, you should stop using ibuprofen and consult a doctor. Always talk to your healthcare provider before using ibuprofen if you have any underlying health conditions or 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 the product and seek medical help immediately.

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 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 assistance if you suspect an overdose by contacting a Poison Control Center at 1-800-222-1222. Stop using ibuprofen and consult your doctor if you notice signs of stomach bleeding (like faintness, bloody or black stools, or vomiting blood), symptoms of heart problems or stroke (such as chest pain, slurred speech, or difficulty breathing), or if your pain or fever worsens or lasts longer than expected.

Overdose

If you suspect an overdose, it’s crucial to seek medical help immediately or contact a Poison Control Center at 1-800-222-1222. Signs of an overdose can vary, but they may include unusual drowsiness, confusion, or difficulty breathing.

Always take overdosing seriously. If you notice any of these symptoms or have concerns about your health, don’t hesitate to reach out for professional assistance. Your safety is the top priority.

Pregnancy Use

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using any medication, including ibuprofen. During the last three months of pregnancy, you should avoid ibuprofen unless your doctor specifically advises you to take it, as it 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 professional guidance.

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 during the last three months of pregnancy, as using ibuprofen at this stage can lead to potential issues for your unborn child or complications during delivery. Always prioritize your health and your baby's well-being by seeking professional advice.

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 of certain health risks associated with medications. If you are 60 or older, there is a higher chance of experiencing severe stomach bleeding. It's crucial to consult your doctor before using any medication if this warning applies to you.

Additionally, be cautious about the dosage and duration of use. Taking more than the recommended amount or using a medication for longer than directed can increase the risk of heart attack and stroke, especially in older adults. Always follow your healthcare provider's advice to ensure your safety and well-being.

Renal Impairment

If you have kidney problems, it's important to consult your doctor before using this medication. Inform them if you also have high blood pressure, heart disease, liver cirrhosis (a severe liver condition), asthma, or if you've had a stroke. Your doctor will help determine if this medication is safe for you and may adjust your dosage or monitor your condition closely to ensure your safety. Always prioritize open communication with your healthcare provider regarding your kidney health and any other medical conditions you may have.

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 closely to ensure your safety.

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. Your well-being is the priority, so open communication with your healthcare team is essential.

Drug Interactions

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

Using nonsteroidal anti-inflammatory drugs (NSAIDs) like ibuprofen can also raise the chances of serious heart issues, such as heart attack or stroke, especially if taken in higher doses or for extended periods. If you are on diuretics (medications that help remove excess fluid from the body), it's crucial to talk to your healthcare provider before using ibuprofen. Always discuss any medications or tests with your healthcare provider to ensure your safety and well-being.

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, always do so with clean hands and in a clean environment to maintain its integrity. If you have any specific disposal instructions, be sure to follow them carefully to ensure safety and compliance.

Additional Information

No further information is available.

FAQ

What is WALGREENS Ibuprofen 200 mg Softgels used for?

WALGREENS Ibuprofen 200 mg Softgels temporarily relieve minor aches and pains due to headaches, muscular aches, arthritis, toothaches, backaches, the common cold, and menstrual cramps. It also temporarily reduces fever.

What should I do if I experience stomach bleeding symptoms?

If you experience symptoms like feeling faint, bloody or black stools, vomiting blood, or stomach pain that does not improve, stop using the product and ask a doctor immediately.

How should I take WALGREENS Ibuprofen?

Adults and children 12 years and over should take 1 capsule every 4 to 6 hours while symptoms persist. Do not exceed 6 capsules in 24 hours unless directed by a doctor.

Are there any warnings associated with taking ibuprofen?

Yes, ibuprofen may cause severe allergic reactions, stomach bleeding, and increase the risk of heart attack and stroke. Consult a doctor if you have a history of these issues.

Can I take ibuprofen if I am pregnant or breastfeeding?

If you are pregnant or breastfeeding, ask a health professional before use. It is especially important not to use ibuprofen during the last 3 months of pregnancy unless directed by a doctor.

What should I do if I have an allergic reaction to ibuprofen?

If you experience symptoms of a severe allergic reaction, such as hives, facial swelling, or difficulty breathing, stop using ibuprofen and seek medical help immediately.

What are the storage conditions for ibuprofen?

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

Who should not take ibuprofen?

Do not use ibuprofen if you have ever had an allergic reaction to any pain reliever/fever reducer or if you are about to have heart surgery.

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

Solubilized ibuprofen is formulated to provide an equivalent of 200 mg of ibuprofen, a nonsteroidal anti-inflammatory drug (NSAID). The active ingredient is present in both its free acid form and as a potassium salt, facilitating enhanced solubility and bioavailability.

Uses and Indications

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

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

Dosage and Administration

The medication should be administered according to the following guidelines to ensure safety and efficacy.

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 taken. It is imperative that the total dosage does not exceed 6 capsules 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.

Healthcare professionals should emphasize the importance of using the smallest effective dose and adhering strictly to the prescribed dosage to avoid potential adverse effects.

Contraindications

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

Warnings and Precautions

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

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 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.

The use of NSAIDs, excluding aspirin, is linked to an increased risk of heart attack, heart failure, and stroke, which can be fatal. This risk escalates with the use of higher doses or prolonged treatment beyond the recommended guidelines.

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

Patients should be instructed to discontinue use and consult a physician if they experience any of the following symptoms indicative of stomach bleeding: feeling faint, bloody or black stools, vomiting blood, or persistent stomach pain. Additionally, symptoms suggestive of heart problems or stroke, such as chest pain, slurred speech, difficulty breathing, leg swelling, or unilateral weakness, 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 redness or swelling occurs in the affected area, or if any new symptoms arise.

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, having bloody or black stools, vomiting blood, or experiencing persistent stomach pain. Symptoms indicative of heart problems or stroke, including chest pain, slurred speech, difficulty breathing, leg swelling, 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 3 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 problems, such as heartburn, or if the stomach bleeding warning applies to them. Those with high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or a history of stroke should also seek medical advice. It is important for patients taking diuretics or under a doctor's care for any serious condition to consult a healthcare professional prior to use. Additionally, patients taking aspirin for heart attack or stroke should be aware that ibuprofen may diminish the cardioprotective effects of aspirin.

Drug Interactions

Ibuprofen may interact with several classes of medications, leading to significant clinical effects that warrant careful consideration.

Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) and Aspirin Ibuprofen has the potential to diminish the cardioprotective effects of aspirin when both are used concurrently for the prevention of heart attack or stroke. It is advisable for patients to consult their healthcare provider regarding the use of ibuprofen in conjunction with aspirin.

Anticoagulants and Corticosteroids The concomitant use of ibuprofen with anticoagulants or corticosteroids increases the risk of gastrointestinal bleeding. Patients on these medications should be closely monitored for signs of bleeding and may require dosage adjustments or alternative therapies.

Cardiovascular Risks The use of NSAIDs, including ibuprofen, is associated with an elevated risk of cardiovascular events such as heart attack, heart failure, and stroke. This risk is particularly pronounced with prolonged use or higher-than-recommended dosages. Patients should be advised to adhere strictly to dosing guidelines and to discuss any concerns with their healthcare provider.

Diuretics Patients taking diuretics should seek medical advice before initiating ibuprofen therapy. The interaction may necessitate monitoring of renal function and electrolyte levels, as well as potential adjustments in diuretic therapy.

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. If pain or fever does not adequately respond to 1 capsule, 2 capsules may be administered. It is important not to exceed 6 capsules within a 24-hour period unless directed by a healthcare provider.

Geriatric Use

Elderly patients, particularly those aged 60 and older, are at an increased risk for severe stomach bleeding. It is advisable for these patients to consult a healthcare provider before using this medication if they have concerns related to stomach bleeding.

Additionally, the risk of heart attack and stroke is heightened in geriatric patients who exceed the recommended dosage or duration of use. Therefore, careful monitoring and adherence to prescribed guidelines are essential to mitigate these risks in older adults.

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 especially important to avoid the use of ibuprofen during the last trimester unless specifically directed by a physician, as it may pose risks to the developing fetus and lead to complications during delivery. Healthcare providers should weigh the potential benefits against the 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 during the last three months of pregnancy 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 available regarding the excretion of this medication in breast milk or its effects on breastfed infants. Therefore, caution is recommended when considering its use in lactating mothers.

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 and any potential risks associated with the medication. Monitoring of liver function may be necessary to ensure safety and efficacy. Adjustments to dosage or treatment regimens may be required based on the severity of hepatic impairment, and healthcare providers should evaluate the overall health status of patients with compromised liver function before initiating therapy.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. The national Poison Control Center can be reached at 1-800-222-1222.

Healthcare professionals should be aware that timely intervention is crucial in managing overdose situations. Symptoms of overdose may vary depending on the substance involved and the individual’s health status. Therefore, a thorough assessment of the patient is essential to determine the appropriate course of action.

Management of an overdose may include supportive care and symptomatic treatment, tailored to the specific symptoms presented. Continuous monitoring of the patient’s vital signs and clinical status is recommended to ensure prompt identification and management of any complications that may arise.

In summary, immediate medical attention and appropriate management strategies are vital in addressing overdose cases effectively.

Nonclinical Toxicology

It is especially important not to use ibuprofen during the last three months of pregnancy unless specifically directed by a healthcare professional, as it may lead to complications for the unborn child or 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 current information.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions associated with the use of the product. Reports include gastrointestinal bleeding, renal impairment, and cardiovascular events. Serious skin reactions, such as Stevens-Johnson syndrome and toxic epidermal necrolysis, have also been documented. Additionally, cases of liver enzyme elevations and hepatic failure have been reported. Anaphylactic reactions, including angioedema and bronchospasm, have been noted, along with serious allergic reactions, such as hives and facial swelling, associated with ibuprofen use.

Patient Counseling

Patients should be advised to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222 in the event of an overdose. It is recommended that patients take the medication with food or milk if they experience stomach upset.

Healthcare providers should encourage patients to consult with a doctor before using this medication if any of the following apply: they have a history of stomach bleeding, have experienced problems or serious side effects from pain relievers or fever reducers, or have a history of stomach issues such as heartburn. Additionally, patients with high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or a history of stroke should also seek medical advice prior to use. Those taking diuretics should be particularly cautious and consult their healthcare provider.

Furthermore, patients should be instructed to ask a doctor or pharmacist before using this medication if they are under medical care for any serious condition, are taking aspirin for heart attack or stroke (as ibuprofen may reduce the effectiveness of aspirin), or are currently taking any other medications.

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 must 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

No further data are available.

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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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.