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Leader Ibuprofen

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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 2016
Label revision date
February 25, 2026
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 2016
Label revision date
February 25, 2026
Manufacturer
Cardinal Health 110, LLC. dba Leader
Registration number
ANDA072096
NDC root
70000-0175
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (9 NDCs)
Packaging & NDC Codes (9)

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

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

In addition to pain relief, ibuprofen is effective in lowering fever. This makes it a versatile option for managing discomfort and helping you feel better when you're unwell.

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 comfort when you're experiencing these common discomforts, allowing you to feel better and get back to your daily activities.

Dosage and Administration

If you are an adult or a child aged 12 years and older, you can take 1 tablet every 4 to 6 hours as needed while you have symptoms. If you find that 1 tablet isn’t enough to relieve your pain or fever, you may take 2 tablets instead. However, it’s important not to exceed 6 tablets in a 24-hour period unless your doctor advises you otherwise.

For children under 12 years old, it’s best to consult with a doctor before giving them this medication. Always follow your healthcare provider's instructions to ensure safe and effective use.

What to Avoid

You should avoid using this medication if you have ever had an allergic reaction to ibuprofen or 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.

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, with a history of stomach ulcers or bleeding issues, or who consume alcohol regularly while using it.

There is also an increased risk of heart attack and stroke associated with NSAIDs like ibuprofen, particularly if taken in higher doses or for extended periods. If you experience signs of stomach bleeding (such as feeling faint, vomiting blood, or having black stools) or symptoms of heart problems (like chest pain or trouble breathing), you should stop using ibuprofen and consult a doctor immediately. Always talk to your healthcare provider before using ibuprofen if you have existing 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, asthma (wheezing), shock, skin reddening, rash, or blisters. 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 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.

Be alert for signs of stomach bleeding, such as feeling faint, vomiting blood, or having black stools, and contact your doctor if you notice these symptoms. Seek medical attention if you experience chest pain, trouble breathing, weakness on one side of your body, slurred speech, or swelling in your legs. If your pain worsens or lasts more than 10 days, or if your fever persists for more than 3 days, consult your doctor. In case of an overdose, get emergency medical help or contact a Poison Control Center right away at 1-800-222-1222.

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 take overdosing seriously. If you notice any of these symptoms or have concerns about your health, don’t hesitate to reach out for help right away. Your safety is 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 ibuprofen. This is particularly crucial if you are 20 weeks pregnant or later, as using ibuprofen during this time can potentially lead to issues for your unborn child or complications during delivery. Always prioritize your health and the health of your baby by seeking guidance from your doctor.

Pediatric Use

If you have a child under 12 years old, it's important to consult with a doctor before using this medication. For children aged 12 and older, the recommended dosage is 1 tablet every 4 to 6 hours as needed for symptoms. If one tablet does not relieve pain or fever, you may give 2 tablets, but be careful not to exceed 6 tablets in a 24-hour period unless your 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. To help protect your health, your healthcare provider may recommend monitoring for any signs of stomach bleeding, such as unusual bruising or blood in your stool. They might also suggest using the smallest effective dose of medication to minimize risks.

Additionally, older adults often experience increased sensitivity to side effects from medications. This means that careful adjustments to your dosage may be necessary, along with regular check-ins with your healthcare provider to ensure your safety and well-being. Always communicate openly about any concerns or changes you notice.

Renal Impairment

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

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 have open conversations with your healthcare provider about any medications or tests you may be taking. While there are no specific drug interactions or laboratory test interactions noted for this medication, your healthcare provider can help ensure that everything you are taking works well together and is safe for you. Always share your complete list of medications and any recent lab tests to avoid any potential issues. Your health and safety should always come first.

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 keep it away from high humidity and avoid exposing it to excessive heat, which can be anything above 40°C (104°F).

Before using the product, check the end panel for the lot number and expiration date to confirm its safety and effectiveness. Proper storage and handling will help maintain the quality of the product, ensuring it works as intended when you need it.

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, muscular aches, arthritis, toothaches, backaches, the common cold, and menstrual cramps.

How should I take Ibuprofen?

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

Are there any warnings associated with Ibuprofen?

Yes, Ibuprofen may cause severe allergic reactions, stomach bleeding, and increase the risk of heart attack and stroke. You should stop use and seek medical help if you experience symptoms like fainting, vomiting blood, or chest pain.

Can I use Ibuprofen if I am pregnant or breastfeeding?

If you are pregnant or breastfeeding, you should ask 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 should I do if I experience 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 should I do if I have a history of stomach problems?

If you have a history of stomach problems, such as ulcers or bleeding, you should ask a doctor before using Ibuprofen, as it may increase the risk of stomach bleeding.

Is there a specific storage requirement for Ibuprofen?

Yes, store Ibuprofen between 20-25°C (68-77°F) and avoid high humidity and excessive heat above 40°C (104°F).

What should I do if I overdose on Ibuprofen?

In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222.

Packaging Info

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

Packaging configurations for Leader Ibuprofen.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

No description information is available for the specified drug.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with various conditions, including headache, 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

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

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

Contraindications

Use is contraindicated in patients with a history of allergic reactions to ibuprofen or any other pain reliever or fever reducer. Additionally, the product should not be administered 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 an increased risk of severe stomach bleeding. The likelihood of 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.

Furthermore, NSAIDs, excluding aspirin, are linked to an elevated risk of heart attack, heart failure, and stroke, which can be fatal. This risk is particularly pronounced in individuals who use the medication in excess of the recommended dosage or for extended periods.

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, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain. Additionally, symptoms suggestive of heart problems or stroke warrant immediate medical evaluation, including chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling. 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 may experience a range of adverse reactions associated with the use of this product, which contains an NSAID. Serious adverse reactions include severe allergic reactions, which may manifest as hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, or blisters, particularly in individuals with a known allergy to aspirin.

Additionally, the use of this NSAID carries a warning for potential severe stomach bleeding, with an increased risk in patients aged 60 or older, those with a history of stomach ulcers or bleeding problems, individuals taking blood thinners or steroid medications, and those consuming three or more alcoholic drinks daily while using this product. Symptoms indicative of stomach bleeding include feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain.

The risk of heart attack, heart failure, and stroke is also heightened with the use of NSAIDs, excluding aspirin. This risk escalates when the medication is used in higher doses or for extended periods. Patients should be vigilant for symptoms of heart problems or stroke, such as chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling.

Common adverse reactions may include gastrointestinal discomfort, and patients are advised to discontinue use and consult a healthcare provider 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.

Patients with a history of serious side effects from pain relievers or fever reducers, those with pre-existing stomach issues, high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or a history of stroke should seek medical advice before using this product. Furthermore, individuals taking aspirin for cardiovascular protection should consult a healthcare professional, as ibuprofen may diminish the cardioprotective effects of aspirin.

Drug Interactions

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

Packaging & NDC

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

Packaging configurations for Leader 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 tablet every 4 to 6 hours as needed while symptoms persist. If pain or fever does not adequately respond to 1 tablet, 2 tablets may be administered. It is important not to exceed 6 tablets in 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. Therefore, it is essential to monitor these patients closely for any signs of gastrointestinal bleeding.

Recommended precautions for geriatric patients include the consideration of the smallest effective dose to minimize potential adverse effects. Additionally, elderly patients may exhibit increased sensitivity to side effects, which underscores the importance of careful dosage adjustments and vigilant monitoring throughout the treatment process.

Pregnancy

Pregnant patients and women of childbearing potential should 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 developing fetus and lead to complications during delivery. The potential fetal impacts associated with ibuprofen use during late pregnancy warrant careful consideration and professional guidance.

Lactation

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

Renal Impairment

Patients with renal impairment should consult a healthcare professional prior to use, particularly if they have a history of kidney disease. It is essential to assess the patient's overall health status, including any comorbid conditions such as high blood pressure, heart disease, liver cirrhosis, asthma, or a history of stroke, as these factors may influence the management of their renal function and the appropriateness of treatment. Monitoring and potential dosing adjustments may be necessary based on the patient's renal status to ensure safety and efficacy.

Hepatic Impairment

Patients with hepatic impairment should consult a healthcare professional prior to use, particularly if they have a history of liver cirrhosis. It is essential for these patients to disclose any existing conditions such as high blood pressure, heart disease, kidney disease, asthma, or a history of stroke to ensure safe and effective use of the medication. Monitoring of liver function may be warranted in this population to assess any potential impact on drug metabolism and overall safety. Adjustments to dosage or treatment regimens may be necessary based on the severity of hepatic impairment and the patient's overall health status.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. Healthcare professionals should advise patients or caregivers to call the Poison Control Center at 1-800-222-1222 for expert guidance.

Prompt intervention is crucial in managing overdose situations, as timely medical help can significantly influence outcomes. Symptoms of overdose may vary depending on the substance involved, and healthcare providers should be prepared to assess and manage these symptoms accordingly.

Management procedures may include supportive care, monitoring of vital signs, and symptomatic treatment as necessary. It is essential for healthcare professionals to remain vigilant and act swiftly to mitigate potential complications associated with overdose.

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 associated with the use of the product. Reports include gastrointestinal bleeding, renal impairment, and elevations in liver enzymes. Additionally, cases of anaphylaxis and serious skin reactions, such as Stevens-Johnson syndrome and toxic epidermal necrolysis, have been documented.

Cardiovascular events, including heart attack and stroke, have been observed, particularly in patients with pre-existing cardiovascular conditions. Elevated blood pressure and heart failure have also been reported in patients taking ibuprofen. Hepatic reactions, including jaundice and hepatitis, have been noted in the postmarketing data.

Furthermore, there have been instances of hypersensitivity reactions, including asthma exacerbations and allergic reactions, particularly in patients with a history of such conditions.

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

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

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for reference. It is essential to store the product at a temperature range of 20-25°C (68-77°F) to maintain its efficacy. Care should be taken to avoid exposure to high humidity and excessive heat, particularly temperatures exceeding 40°C (104°F). For traceability, the lot number and expiration date can be found on the end panel of the packaging. Proper handling and storage conditions are crucial to ensure the integrity of the product throughout its shelf life.

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 Leader 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 Leader 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.

Learn more in our Editorial Policy

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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.