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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
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
April 22, 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
April 22, 2025
Manufacturer
Meijer Distribution Inc
Registration number
ANDA075139
NDC root
41250-993
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (3 NDCs)
Packaging & NDC Codes (3)

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Drug Overview

Meijer® is a medication that contains ibuprofen, which is a type of pain reliever and fever reducer classified as a nonsteroidal anti-inflammatory drug (NSAID). It comes in the form of 200 mg tablets and is designed to temporarily relieve minor aches and pains, including headaches, muscular aches, menstrual cramps, minor arthritis pain, backaches, toothaches, and discomfort associated with the common cold. Additionally, it helps to temporarily reduce fever.

If you're looking for a way to manage these types of pain or reduce fever, Meijer® may be a suitable option for you. Always ensure to follow the recommended guidelines for use.

Uses

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

It's important to note that there are no reported teratogenic effects (which means it does not cause birth defects) associated with this medication.

Dosage and Administration

It's important to follow the dosage instructions carefully when taking this medication. You should not take more than what is directed, and it's best to use the smallest effective dose to manage your symptoms. For adults and children aged 12 years and older, the recommended 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, make sure not to exceed 6 caplets in a 24-hour period unless your doctor advises otherwise.

If you have children under 12 years old, it's essential to consult a doctor before giving them this medication. Always prioritize safety and follow the guidance provided to ensure effective treatment.

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 questions or concerns about your eligibility to use this medication. Your safety is the top priority.

Side Effects

Ibuprofen can cause serious allergic reactions, particularly in individuals who are allergic to aspirin. Symptoms of such reactions may include rash, blisters, hives, facial swelling, and difficulty breathing (asthma). Additionally, this medication carries a risk of severe stomach bleeding, especially for those over 60, those taking blood thinners or steroids, and individuals with a history of stomach ulcers or bleeding problems. The risk of heart attack and stroke is also increased with ibuprofen use, particularly if taken in higher doses or for extended periods.

You should stop using ibuprofen and consult a doctor if you experience signs of stomach bleeding, such as faintness, bloody or black stools, or persistent stomach pain. Seek medical attention if you notice symptoms of heart problems or stroke, including chest pain, slurred speech, or weakness on one side of the body. Always talk to your doctor before using ibuprofen if you have existing health conditions like high blood pressure, heart disease, or asthma, or if you are taking other medications.

Warnings and Precautions

Ibuprofen can cause serious allergic reactions, especially if you are allergic to aspirin. Symptoms may include rash, hives, facial swelling, or difficulty breathing. If you experience any of these signs, stop using ibuprofen and seek medical help immediately. Additionally, ibuprofen can lead to severe stomach bleeding, particularly if you are over 60, take blood thinners or steroids, consume alcohol regularly, or have a history of stomach ulcers. It’s important to be cautious and consult your doctor if you have high blood pressure, heart disease, or other serious health conditions before using ibuprofen.

You should also be aware that using ibuprofen may increase your risk of heart attack and stroke, especially if taken in higher doses or for longer than recommended. If you notice any signs of stomach bleeding, such as faintness, bloody stools, or persistent stomach pain, stop taking ibuprofen and contact your doctor. Seek immediate medical attention if you experience chest pain, slurred speech, or difficulty breathing, as these could indicate serious heart problems or a stroke. Always consult your healthcare provider 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. 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 think you or someone else may have taken too much of a medication, don’t wait for symptoms to appear. Getting prompt assistance can be vital for safety and recovery.

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

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 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 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 directed by a healthcare professional.

Always keep this medication out of reach of children to ensure their safety.

Geriatric Use

As you age, it's important to be aware of certain health risks associated with medications. If you are 60 or older, the risk of severe stomach bleeding increases, so it's crucial to monitor any unusual symptoms. Additionally, using more than the recommended dose or taking medication for longer than advised can raise your chances of heart attack, heart failure, and stroke.

To help minimize stomach upset, consider taking your medication with food or milk, especially if you have a sensitive stomach. Always aim to use the smallest effective dose, as older adults may be more sensitive to side effects. Staying informed and cautious can help you manage your health safely.

Renal Impairment

If you have kidney disease, it's important to consult your doctor before using this medication. Your healthcare provider can help determine if it's safe for you and if any adjustments to your dosage are necessary. Always prioritize your kidney health and follow your doctor's guidance closely.

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 keep your doctor informed about any existing health issues, 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 that certain medications can interact with each other, which may affect their effectiveness or increase the risk of side effects. For instance, if you take ibuprofen, it may reduce the protective benefits of aspirin when used for heart attack or stroke prevention. Additionally, using other nonsteroidal anti-inflammatory drugs (NSAIDs), like aspirin or naproxen, alongside ibuprofen can raise your chances of experiencing stomach bleeding. This risk is even greater if you are also taking blood thinners (medications that prevent blood clots) or steroids.

To ensure your safety and the effectiveness of your medications, always discuss any prescriptions or over-the-counter drugs you are taking with your healthcare provider. They can help you understand potential interactions and adjust your treatment plan as needed.

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 occur at temperatures above 40°C (104°F). Always check the expiration date on the package and use the product before that date to ensure its safety and effectiveness.

When handling the product, make sure to do so with clean hands and in a clean environment 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 Meijer® and what is its active ingredient?

Meijer® is a pain reliever and fever reducer that contains ibuprofen as its active ingredient.

What are the indications for using Meijer®?

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

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.

Are there any warnings associated with Meijer®?

Yes, Meijer® may cause severe allergic reactions, stomach bleeding, and increase the risk of heart attack and stroke. Consult a doctor if you have certain health conditions or experience specific symptoms.

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

If you feel faint, have bloody or black stools, stomach pain that does not improve, or vomit blood, stop taking Meijer® and call your doctor immediately.

Can I use Meijer® if I am pregnant or breastfeeding?

If you are pregnant or breastfeeding, consult a health professional before using Meijer®. It is especially 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 allergic reactions to pain relievers?

Do not use Meijer® if you have ever had an allergic reaction to any other pain reliever or fever reducer.

How should Meijer® be stored?

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

What should I do if I take too much Meijer®?

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

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

Meijer Ibuprofen Tablets USP contain 200 mg of ibuprofen as the active ingredient. This dosage form is presented as tablets, specifically designed for use as a pain reliever and fever reducer, classified as a nonsteroidal anti-inflammatory drug (NSAID). Each package contains 100 caplets, and the product is identified by the National Drug Code (NDC) 41250-993-20.

The product is comparable to Motrin® IB Caplets. It features a tamper-evident safety seal, and users are advised not to use the product if the seal under the cap is broken or missing. Meijer Ibuprofen Tablets are distributed by Meijer Distribution, Inc., located in Grand Rapids, MI 49544. Additional information can be found on the website www.meijer.com.

Uses and Indications

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

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

Dosage and Administration

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

For adults and children aged 12 years and older, the recommended dosage is 1 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, the total daily dosage must not 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 physician for appropriate dosing recommendations.

Contraindications

Use of this product is contraindicated in patients with a history of allergic reactions to any other pain reliever or fever reducer. Additionally, it should not be administered immediately before or after heart surgery due to potential complications associated with surgical recovery.

Warnings and Precautions

Ibuprofen may cause severe allergic reactions, particularly in individuals with a known allergy to aspirin. Symptoms of such reactions can include rash, blisters, shock, hives, skin reddening, facial swelling, and asthma (wheezing). 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 this adverse effect is heightened in patients who are 60 years of age or older, those taking anticoagulants or steroid medications, individuals consuming three or more alcoholic beverages daily while using this product, and patients who exceed the recommended dosage or duration of use. Additionally, those with a history of stomach ulcers or bleeding disorders are at increased risk.

NSAIDs, excluding 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 higher doses or extend the duration of treatment beyond the recommended guidelines.

Healthcare professionals should advise patients to consult a physician prior to using ibuprofen if they have a history of high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or prior strokes. Patients taking diuretics or those with a history of gastrointestinal issues, such as heartburn, should also seek medical advice. Furthermore, individuals under a physician's care for serious conditions or those taking aspirin for cardiovascular protection should be cautioned, as ibuprofen may diminish the cardioprotective effects of aspirin.

In the event of an overdose, immediate medical attention should be sought, or the Poison Control Center should be contacted.

Patients should be instructed to discontinue ibuprofen and contact their healthcare provider if they experience any signs of stomach bleeding, including feeling faint, having bloody or black stools, persistent stomach pain, or vomiting blood. 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, warrant immediate medical evaluation. Additionally, if pain worsens or persists beyond 10 days, fever intensifies or lasts more than 3 days, redness or swelling occurs in the affected area, or any new symptoms arise, patients should seek medical advice promptly.

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 rash, blisters, shock, hives, skin reddening, facial swelling, and asthma (wheezing).

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, those taking anticoagulants or steroid medications, individuals consuming three or more alcoholic drinks daily while using ibuprofen, and patients with a history of stomach ulcers or bleeding problems. Additionally, prolonged use or exceeding the recommended dosage increases the likelihood of this adverse reaction.

Patients should be aware that NSAIDs, excluding aspirin, may elevate the risk of heart attack, heart failure, and stroke, which can be fatal. This risk is particularly pronounced when the medication is used in higher doses or for extended periods.

Participants in clinical trials and postmarketing experiences have indicated that patients should discontinue use and consult a healthcare provider if they experience signs of stomach bleeding, such as feeling faint, having bloody or black stools, persistent stomach pain, or vomiting blood. 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 with high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or a history of stroke should consult a healthcare professional. Those taking diuretics or who have experienced serious side effects from pain relievers or fever reducers should also seek medical advice. Additionally, patients under a doctor's care for any serious condition or those taking aspirin for heart attack or stroke should be cautious, 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 ibuprofen with aspirin for these indications is not recommended.

The concomitant use of ibuprofen with other nonsteroidal anti-inflammatory drugs (NSAIDs), including both prescription and nonprescription medications such as aspirin and naproxen, is associated with an increased risk of gastrointestinal bleeding.

Additionally, the risk of stomach bleeding is further elevated in patients who are also taking anticoagulants or steroid medications. It is advisable to monitor patients closely for signs of gastrointestinal complications when these drugs are used together.

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 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 within a 24-hour period unless directed by a healthcare provider. Additionally, this medication should be kept out of reach of children to ensure safety.

Geriatric Use

Elderly patients, particularly those aged 60 and older, are at an increased risk for severe stomach bleeding. This heightened risk necessitates careful consideration when prescribing medications that may contribute to gastrointestinal complications. Additionally, the likelihood of experiencing serious cardiovascular events, such as heart attack, heart failure, and stroke, is elevated in older adults, especially when medications are used in excess or for prolonged periods beyond the recommended duration.

For geriatric patients, it is advisable to administer medications with food or milk to mitigate potential stomach upset, a concern that may be more pronounced in this population due to increased sensitivity. Furthermore, it is essential to utilize the smallest effective dose when treating elderly patients, as they may exhibit a greater susceptibility to adverse effects. Close monitoring and appropriate dose adjustments are recommended to ensure safety and efficacy in this demographic.

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 consider the potential benefits and risks when prescribing this medication to pregnant patients, especially in the later stages of pregnancy.

Lactation

Lactating mothers are advised to consult a healthcare professional before using this medication while breastfeeding. There is a particular concern regarding the use of ibuprofen during pregnancy, especially after 20 weeks, as it may pose risks to the unborn child and lead to complications during delivery. Therefore, careful consideration and professional guidance are essential for lactating mothers considering this treatment.

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 renal function and consider potential dosing adjustments or monitoring requirements based on the degree of impairment.

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 in this population. 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. Prompt intervention is crucial to mitigate potential adverse effects associated with the overdose.

Healthcare professionals should be aware that the specific symptoms of an 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 of an overdose typically involves supportive care and symptomatic treatment. Continuous monitoring of the patient's vital signs and clinical status is recommended. In cases where the specific substance is known, targeted interventions may be employed to counteract the effects of the overdose.

It is vital for healthcare providers to remain vigilant and act swiftly in the management of overdose situations to ensure optimal patient outcomes.

Nonclinical Toxicology

It is especially important not to use ibuprofen at 20 weeks or later in pregnancy unless definitely directed to do so by a doctor, as it may cause problems in the unborn child or complications during delivery. No specific non-teratogenic effects have been identified in the available data. Additionally, there are no details regarding nonclinical toxicology or animal pharmacology and toxicology provided in the text.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions reported voluntarily or through surveillance programs, including rash, blisters, shock, asthma (wheezing), hives, skin reddening, and facial swelling.

Additionally, it has been noted that the risk of severe stomach bleeding is increased in patients with a history of stomach ulcers or bleeding problems, those aged 60 years or older, individuals taking anticoagulants or steroid medications, patients using other prescription or nonprescription NSAIDs, and those consuming three or more alcoholic drinks daily while using this product. Furthermore, the use of nonsteroidal anti-inflammatory drugs (NSAIDs), excluding aspirin, is associated with an elevated risk of heart attack, heart failure, and stroke, which can be fatal. This risk is heightened when these medications are used in excess of the recommended duration or dosage.

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 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 identification. It should be stored at a temperature range of 20° to 25°C (68° to 77°F) to maintain its efficacy. Care should be taken to avoid exposure to excessive heat, specifically temperatures exceeding 40°C (104°F). Additionally, it is essential to adhere to the expiration date indicated on the package to ensure optimal use 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, 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.

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.