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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 2022
Label revision date
June 30, 2025
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 2022
Label revision date
June 30, 2025
Manufacturer
Chain Drug Consortium, LLC
Registration number
ANDA206568
NDC root
68016-813
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info
Packaging & NDC Codes

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

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

Drug Overview

PREMIER VALUE Ibuprofen 200 mg Softgels contain ibuprofen, which is 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 discomfort associated with the common cold and reduce fever.

By working to decrease inflammation and pain in the body, ibuprofen provides a supportive option for managing everyday discomfort. If you're experiencing any of the mentioned aches or a mild fever, this medication may be a helpful choice for you.

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, making it easier to go about your daily activities. Always remember to follow the recommended guidelines for use to ensure safety and effectiveness.

Dosage and Administration

When using this medication, it's important to follow the directions carefully. You should take 1 capsule by mouth every 4 to 6 hours as long as you are experiencing symptoms. If you find that 1 capsule isn't enough to relieve your pain or fever, you can take 2 capsules instead. However, make sure not to exceed 6 capsules in a 24-hour period unless your doctor advises otherwise.

For children under 12 years old, it's best to consult a doctor before giving them this medication. Always aim to use the smallest effective dose to manage your symptoms safely. Remember, never take more than directed to ensure your well-being.

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

Side Effects

Using ibuprofen can lead to some serious side effects that you should be aware of. There is a risk of severe allergic reactions, especially if you are allergic to aspirin. Symptoms may include hives, facial swelling, wheezing, shock, skin reddening, rash, or blisters. Additionally, ibuprofen can cause severe stomach bleeding, particularly if you are over 60, have a history of stomach ulcers, or are taking certain medications like blood thinners or other NSAIDs.

It's important to note that using ibuprofen may also increase your risk of heart attack, heart failure, and stroke, especially if taken in higher doses or for longer than recommended. If you experience symptoms such as faintness, vomiting blood, black stools, chest pain, or weakness on one side of your body, you should stop using ibuprofen and consult a doctor immediately. 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 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.

You should seek emergency medical help 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 (such as feeling faint, vomiting blood, or having black stools), symptoms of heart problems or stroke (like chest pain or slurred speech), 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. You can contact a Poison Control Center at 1-800-222-1222 for guidance. Signs of an overdose can vary, but they may include unusual drowsiness, confusion, or difficulty breathing.

Always err on the side of caution—if you notice any concerning symptoms or if you’re unsure, don’t hesitate to get help right away. 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, the recommended dosage is one capsule every 4 to 6 hours as needed for symptoms. If one capsule does not relieve pain or fever, you may give two capsules, but be careful not to exceed six capsules in a 24-hour period unless directed by a doctor. Always follow these guidelines to ensure your child's safety and well-being.

Geriatric Use

If you are 60 years or older, it's important to be aware of certain risks when using this medication. The chance of severe stomach bleeding increases with age, so you should consult your doctor before starting the medication, especially if you have any concerns about stomach bleeding.

Additionally, using more than the recommended dose or taking the medication for longer than advised can raise the risk of heart attack and stroke, particularly in older adults. Always follow your healthcare provider's instructions closely 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 about any other health conditions you may have, such as high blood pressure, heart disease, liver cirrhosis, asthma, or a history of stroke. Your doctor will help determine if this medication is safe for you and may suggest adjustments to your dosage or additional monitoring to ensure your safety. Always prioritize open communication with your healthcare provider regarding your kidney health and any medications you are considering.

Hepatic Impairment

If you have liver problems, such as liver cirrhosis (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.

Always inform your doctor about any existing health issues, including high blood pressure, heart disease, kidney disease, asthma, or a history of stroke, as these can affect your treatment plan. Taking these precautions helps ensure your safety and the effectiveness of your medication.

Drug Interactions

It's important to talk to your healthcare provider about any medications you are taking, especially if you are using ibuprofen. For instance, if you take aspirin for heart attack or stroke, using ibuprofen may reduce the benefits of aspirin. Additionally, ibuprofen can interact with blood thinners, which may increase the risk of stomach bleeding. This risk is even higher if you are taking other nonsteroidal anti-inflammatory drugs (NSAIDs), like aspirin or naproxen.

Certain health conditions, such as high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or a history of stroke, can also affect how ibuprofen works in your body. Always consult your healthcare provider to ensure that your medications are safe and effective for your specific health needs.

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 damage the product. Additionally, keep it protected from light to maintain its effectiveness.

When handling the product, always do so with clean hands and in a clean environment to prevent contamination. Following these guidelines will help ensure the product remains safe and effective for your use.

Additional Information

No further information is available.

FAQ

What is PREMIER VALUE Ibuprofen 200 mg Softgels used for?

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

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

You 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 symptoms?

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

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, especially if used more than directed or for longer than directed.

Can I take ibuprofen if I am pregnant or breastfeeding?

You should ask a health professional before use, especially if you are pregnant or breastfeeding. It is particularly important not to use ibuprofen at 20 weeks or later in pregnancy unless directed by a doctor.

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

You should ask a doctor before using ibuprofen, especially if you have had serious side effects from pain relievers or fever reducers.

How should I store ibuprofen?

Store it between 20° to 25°C (68° to 77°F) and protect it from light. 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

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

Patients should adhere to the prescribed dosage and not exceed the recommended 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 taken orally 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, the total daily dosage must 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 physician before administration.

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 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 carries a risk of severe stomach bleeding. The likelihood of experiencing this adverse effect 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.

NSAIDs, excluding aspirin, are associated with an increased risk of heart attack, heart failure, and stroke, which can be fatal. This risk is amplified when the medication is used in excess of the recommended dosage or for prolonged periods.

In cases of overdose, immediate medical attention is required. Healthcare professionals should advise patients to contact a Poison Control Center at 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. Additionally, symptoms suggestive of heart problems or stroke, such as chest pain, slurred speech, leg swelling, difficulty breathing, 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 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 hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, and blisters.

The use of ibuprofen, as a nonsteroidal anti-inflammatory drug (NSAID), 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 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 the medication beyond the directed dosage or duration.

Patients should discontinue use and consult a healthcare professional if they experience signs of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain. Symptoms indicative of heart problems or stroke, including chest pain, slurred speech, leg swelling, difficulty breathing, or weakness on one side of the body, also warrant immediate medical attention. Furthermore, 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, patients should seek medical advice.

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 prior to use. It is important for patients to inform their healthcare provider if they are under care for any serious condition, are taking aspirin for heart attack or stroke (as ibuprofen may diminish the cardioprotective effects of aspirin), or are using any other medications.

Drug Interactions

The concomitant use of ibuprofen with aspirin, particularly in the context of cardiovascular events such as heart attack or stroke, may diminish the therapeutic efficacy of aspirin. This interaction necessitates careful consideration of the timing and dosage of these medications to optimize their benefits.

Ibuprofen has the potential to interact with anticoagulant medications, which may elevate the risk of gastrointestinal bleeding. Clinicians should monitor patients closely for signs of bleeding, especially in those who are concurrently using other nonsteroidal anti-inflammatory drugs (NSAIDs), including both prescription and over-the-counter options such as aspirin and naproxen. The risk of stomach bleeding is significantly heightened in these scenarios.

Furthermore, the use of ibuprofen may be contraindicated or require dosage adjustments in patients with pre-existing conditions such as high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or a history of stroke. It is advisable to evaluate the patient's overall health status and medication regimen before initiating ibuprofen therapy to mitigate potential adverse effects. Regular monitoring and assessment of the patient's response to treatment are recommended to ensure safety and efficacy.

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, a dose of 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 and women of childbearing potential should consult a healthcare professional before using this medication. The use of ibuprofen is particularly cautioned against after 20 weeks of pregnancy, as it may pose risks to the developing fetus and lead to complications during delivery. Healthcare providers should carefully evaluate the necessity of ibuprofen in these patients and consider alternative treatments when appropriate.

Lactation

Lactating mothers are advised to consult a healthcare 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 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 receive appropriate medical guidance to assess the potential risks associated with their liver function status. Monitoring of liver function may be necessary to ensure safety and efficacy during treatment. Adjustments to dosage or treatment regimens may be required based on the severity of hepatic impairment, and healthcare providers should evaluate the individual patient's condition to determine the most suitable approach.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance. Healthcare professionals are advised to contact a Poison Control Center at 1-800-222-1222 for guidance on managing the situation effectively.

Prompt intervention is crucial, as symptoms of overdose may vary depending on the substance involved. Therefore, a thorough assessment of the patient's condition is essential to determine the appropriate course of action.

Management procedures may include supportive care and symptomatic treatment, tailored to the specific symptoms presented by the patient. Continuous monitoring of vital signs and clinical status is recommended to ensure patient safety and to facilitate timely interventions as needed.

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 current information.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions associated with the use of the product. Reports have included 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 liver failure have been reported.

Anaphylactic reactions, including angioedema and bronchospasm, have been noted in the postmarketing data. There have been instances of hypertension and exacerbation of heart failure linked to ibuprofen use. Furthermore, postmarketing surveillance has indicated an increased risk of thrombotic events, including myocardial infarction and stroke, particularly in patients with pre-existing cardiovascular risk factors.

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 crucial to inform patients that they should not use this medication if they have a history of allergic reactions to any other pain reliever or fever reducer. Additionally, patients must be cautioned against using this product right before or after undergoing heart surgery.

Healthcare providers should instruct patients to discontinue use and consult a doctor if they experience any signs of stomach bleeding, which may include feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain. Patients should also be made aware of the symptoms indicative of heart problems or stroke, such as chest pain, slurred speech, leg swelling, difficulty breathing, or weakness on one side of the body, and should be advised to stop use and seek medical attention if these occur.

Patients should be informed that if their pain worsens or persists for more than 10 days, or if their fever worsens or lasts more than 3 days, they should stop using the product and consult a doctor. They should also be advised to seek medical advice if they notice any redness or swelling in the painful area or if any new symptoms arise.

When using this medication, patients should be counseled to take it with food or milk if they experience stomach upset. It is important for patients to consult a doctor before use if the warning regarding stomach bleeding applies to them, or if they have experienced serious side effects from pain relievers or fever reducers in the past.

Patients with a history of stomach problems, such as heartburn, or those with high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or a history of stroke should be advised to consult a doctor prior to use. Furthermore, patients taking diuretics or any other medications should also seek medical advice before using this product. It is essential to inform patients that if they are under a doctor's care for any serious condition or are taking aspirin for heart attack or stroke, they should consult a doctor or pharmacist before use, as ibuprofen may diminish the benefits of aspirin.

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 temperature range 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). Additionally, the product must be protected from light to maintain its integrity and efficacy. Proper handling and storage conditions are crucial to ensure the product's quality and effectiveness.

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.