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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 1988
Label revision date
May 10, 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 1988
Label revision date
May 10, 2025
Manufacturer
Wal-Mart Stores Inc
Registration number
ANDA075010
NDC root
49035-912
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (3 NDCs)
Packaging & NDC Codes (3)

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Drug Overview

Equate™ is a pain reliever and fever reducer that contains ibuprofen (a type of medication commonly used to alleviate pain and reduce inflammation). It comes in the form of 200 mg tablets and is designed to temporarily relieve minor aches and pains associated with various conditions, including menstrual cramps, toothaches, headaches, backaches, muscular aches, and minor arthritis pain. Additionally, it helps to lower fever.

This medication is a nonsteroidal anti-inflammatory drug (NSAID), which means it works by reducing inflammation and pain in the body. If you're experiencing discomfort or a mild fever, Equate™ may be a suitable option to help you feel better.

Uses

You can use this medication to temporarily relieve minor aches and pains caused by various conditions, including menstrual cramps, toothaches, the common cold, backaches, headaches, muscular aches, and minor arthritis pain. 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 go about your day with less pain. Always consult with a healthcare professional if you have any questions or concerns about your symptoms or the use of this medication.

Dosage and Administration

It's important to follow the dosage instructions carefully when taking this medication. You should not take more than the recommended amount, and it's best to use the smallest effective dose to manage your symptoms. For adults and children aged 12 years and older, the typical dose is 1 tablet every 4 to 6 hours as needed while symptoms persist. If you find that 1 tablet isn't enough to relieve your pain or fever, you can take 2 tablets. However, make sure not to exceed 6 tablets 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 essential to consult with a doctor first to ensure it's safe and appropriate for their age and condition. Always prioritize safety and follow the guidance provided by healthcare professionals.

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 this medication right before or after heart surgery, as it may pose risks in these situations. Always consult with your healthcare provider if you have any concerns or questions about your specific health conditions before taking this medication.

Side Effects

Ibuprofen can cause serious allergic reactions, particularly in individuals who are allergic to aspirin. Symptoms of such reactions may include skin reddening, wheezing (asthma), rash, facial swelling, shock, blisters, and hives. Additionally, this medication carries a risk of severe stomach bleeding, especially if you take it for longer than recommended, use blood thinners or steroids, are over 60 years old, have a history of stomach ulcers, or consume three or more alcoholic drinks daily while using it.

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 feeling faint, 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 a history of stomach issues, high blood pressure, heart disease, or are taking other medications.

Warnings and Precautions

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

This medication can also lead to severe stomach bleeding, particularly if you take it for longer than recommended, are over 60 years old, or have a history of stomach ulcers or bleeding problems. Additionally, using ibuprofen increases the risk of heart attack and stroke, especially if taken in higher doses or for extended periods. If you have a history of stomach issues, high blood pressure, heart disease, or are taking other medications, consult your doctor before using ibuprofen.

If you notice signs of stomach bleeding, such as feeling faint, having bloody or black stools, or vomiting blood, stop taking ibuprofen and call your doctor right away. Seek emergency medical help if you experience symptoms of a heart attack or stroke, such as chest pain, slurred speech, or trouble breathing. Also, contact your doctor if your pain worsens or lasts more than 10 days, or if your fever persists for more than 3 days.

Overdose

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

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

Pregnancy Use

If you are pregnant or breastfeeding, it’s crucial to consult with a healthcare professional before using any medication, including ibuprofen. This is particularly important if you are 20 weeks pregnant or later, as using ibuprofen during this time can lead to potential issues for your unborn child or complications during delivery. Always 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 lead to potential issues for your unborn child or complications during delivery. Always prioritize your health and the health of your baby by seeking guidance from your doctor.

Pediatric Use

If your child is under 12 years old, it's important to consult a doctor before giving them this medication. For those aged 12 and older, you can administer 1 tablet every 4 to 6 hours as needed for symptoms. If one tablet isn't effective for pain or fever, you may give 2 tablets instead. However, be sure not to exceed 6 tablets in a 24-hour period unless a doctor advises otherwise. Always prioritize safety and seek professional guidance when it comes to treating your child's health.

Geriatric Use

As you age, it's important to be aware of certain health risks associated with medications. If you are 60 years or older, there is a higher chance of experiencing severe stomach bleeding. This risk increases with the use of certain medications, so it's crucial to follow your healthcare provider's instructions carefully.

Additionally, older adults may face an increased risk of heart attack, heart failure, and stroke, especially if medications are taken in higher doses or for longer periods than recommended. Always discuss your medication plan with your doctor to ensure it is safe and appropriate for your age and health status.

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, or liver cirrhosis, as these conditions can affect how your body processes the medication. Your doctor will help determine if it's 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 (severe liver scarring), it's important to consult your doctor before using this medication. Your healthcare provider will assess your overall health and may need to adjust your dosage or monitor your condition more closely. This is crucial to ensure your safety and the effectiveness of the treatment.

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

Drug Interactions

It's important to be aware of how different medications can interact with each other. For instance, if you take ibuprofen, it may reduce the effectiveness of aspirin when used for preventing heart attacks or strokes. This means that if you're relying on aspirin for heart health, you should be cautious about using ibuprofen alongside it.

Additionally, if you are taking a diuretic (a type of medication that helps remove excess fluid from the body), it's essential to consult with your healthcare provider before using ibuprofen. Always discuss any medications or tests with your doctor to ensure your safety and the effectiveness of your treatment.

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, particularly temperatures above 40°C (104°F), as this can affect its effectiveness.

Before using the product, check the end flap for the expiration date and lot number to confirm its safety and quality. Proper storage and handling are essential for maintaining the integrity of the device, so please follow these guidelines closely.

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 equate™?

Equate™ is a pain reliever and fever reducer that contains the active ingredient ibuprofen.

What conditions does equate™ temporarily relieve?

Equate™ temporarily relieves minor aches and pains due to menstrual cramps, toothache, the common cold, backache, headache, muscular aches, and minor pain of arthritis.

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

Adults and children 12 years and over should take 1 tablet every 4 to 6 hours while symptoms persist, with a maximum of 6 tablets in 24 hours unless directed by a doctor.

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

If you feel faint, have bloody or black stools, vomit blood, or have stomach pain that does not get better, stop use and call your doctor immediately.

Can I use equate™ if I am pregnant or breastfeeding?

If you are pregnant or breastfeeding, ask a health professional before use, especially if you are 20 weeks or later in pregnancy.

What are the allergy alerts associated with equate™?

Ibuprofen may cause a severe allergic reaction, especially in those allergic to aspirin, with symptoms including skin reddening, rash, and difficulty breathing.

What should I avoid while taking equate™?

Avoid taking more than directed, using it right before or after heart surgery, and consuming 3 or more alcoholic drinks daily while using this product.

What should I do if pain or fever persists?

If pain worsens or lasts more than 10 days, or if fever lasts more than 3 days, stop use and consult your doctor.

Is equate™ safe for children under 12?

Children under 12 years should ask a doctor before use.

How should I store equate™?

Store equate™ between 20°-25°C (68°-77°F) and 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

NDC 49035-912-15. This product, equate™, contains ibuprofen as its active ingredient, formulated as 200 mg tablets USP. It serves as a pain reliever and fever reducer, classified as a nonsteroidal anti-inflammatory drug (NSAID). Each bottle contains 50 tablets, with each tablet delivering 200 mg of ibuprofen. The product is tamper evident; do not use if the imprinted safety seal under the cap is broken or missing. Distributed by Wal-Mart Stores, Inc., Bentonville, AR 72716. This product is not manufactured or distributed by PF Consumer Healthcare 1 LLC, the owner of the registered trademark Advil® Tablets.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with various conditions, including menstrual cramps, toothache, the common cold, backache, headache, muscular aches, and minor pain of arthritis. 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 tablet every 4 to 6 hours as needed while symptoms persist. If pain or fever does not adequately respond to 1 tablet, a maximum of 2 tablets may be taken. However, the total dosage must 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 advised to consult a doctor for appropriate dosing recommendations.

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 cause severe allergic reactions, particularly in individuals with a known allergy to aspirin. Symptoms of such reactions can include skin reddening, asthma (wheezing), rash, facial swelling, shock, blisters, and hives. 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 this adverse effect increases under certain conditions, including prolonged use beyond the recommended duration, concurrent use of anticoagulants or steroid medications, being aged 60 years or older, taking other NSAIDs (whether prescription or over-the-counter), having a history of stomach ulcers or bleeding disorders, or consuming three or more alcoholic beverages daily while using this product.

Additionally, NSAIDs, excluding aspirin, are associated with an elevated risk of heart attack, heart failure, and stroke, which can be fatal. This risk is heightened when the medication is used in excess of the recommended dosage or for an extended period.

Healthcare professionals should advise patients to consult a physician prior to using ibuprofen if they have a history of gastrointestinal issues, such as heartburn, are on diuretics, or have conditions such as high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or a history of stroke. Patients should also be cautioned if the stomach bleeding warning applies to them or if they have experienced significant side effects from pain relievers or fever reducers in the past.

It is also advisable for patients to seek guidance from a healthcare provider or pharmacist before using ibuprofen if they are under medical care for any serious condition, are taking aspirin for cardiovascular protection (as ibuprofen may diminish the efficacy of aspirin), or are using any other medications.

In the case of an overdose, immediate medical attention should be sought, or the Poison Control Center should be contacted without delay.

Patients should be instructed to discontinue ibuprofen and contact their healthcare provider if they experience any signs of stomach bleeding, such as feeling faint, having bloody or black stools, vomiting blood, or experiencing persistent stomach pain. Symptoms indicative of heart problems or stroke, including chest pain, slurred speech, leg swelling, difficulty breathing, or weakness on one side of the body, warrant immediate medical evaluation. Furthermore, 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 skin reddening, asthma (wheezing), rash, facial swelling, shock, blisters, and hives.

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 take higher doses or use the medication for extended periods, those who are 60 years of age or older, individuals taking anticoagulants or steroid medications, and patients with a history of stomach ulcers or bleeding problems. Additionally, the risk increases for those consuming three or more alcoholic drinks daily while using this product.

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 in those who exceed the recommended dosage or duration of use.

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, vomiting blood, or experiencing persistent stomach pain. Symptoms indicative of heart problems or stroke, including chest pain, slurred speech, leg swelling, difficulty breathing, or weakness on one side of the body, also warrant immediate medical attention. Furthermore, patients should seek medical advice if pain worsens or persists beyond 10 days, if fever intensifies or lasts more than three days, if redness or swelling occurs in the painful area, or if any new symptoms arise.

Before using ibuprofen, patients with a history of stomach issues, such as heartburn, or those taking diuretics, should consult a healthcare professional. Individuals 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 to note that ibuprofen may diminish the cardioprotective effects of aspirin in patients taking it for heart attack or stroke prevention.

Drug Interactions

Ibuprofen has the potential to diminish the cardioprotective effects of aspirin when both medications are used concurrently for the prevention of heart attack or stroke. It is advisable for patients to consult with a healthcare professional prior to initiating ibuprofen therapy if they are currently prescribed aspirin for these indications.

Additionally, caution is warranted when ibuprofen is used in conjunction with diuretics. Patients should seek medical advice before using ibuprofen if they are taking a diuretic, as this combination may require careful monitoring or dosage adjustments to mitigate potential adverse effects.

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 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 may have an increased risk of severe stomach bleeding, particularly those aged 60 years and older. It is essential for healthcare providers to monitor these patients closely for any signs of gastrointestinal bleeding, especially when prescribing medications that may exacerbate this risk.

Additionally, the risk of heart attack, heart failure, and stroke is heightened in geriatric patients who exceed the recommended dosage or duration of treatment. Therefore, careful consideration of dosing and adherence to prescribed treatment regimens is crucial in this population. Regular assessment and monitoring of cardiovascular health are advised to mitigate these risks effectively.

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 gestation 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 risks and benefits when prescribing this medication to pregnant patients.

Lactation

Lactating mothers are advised to consult a health 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, healthcare providers should weigh the potential benefits against the risks when considering this medication for lactating mothers.

Renal Impairment

Patients with renal impairment should consult a healthcare professional prior to use, particularly if they have underlying conditions such as high blood pressure, heart disease, liver cirrhosis, or kidney disease. It is essential to assess renal function and consider potential dosing adjustments or monitoring requirements based on the severity of renal impairment.

Hepatic Impairment

Patients with hepatic impairment should consult a healthcare professional prior to use, particularly if they have liver cirrhosis. It is essential for these patients to discuss their liver function status, as compromised liver function may influence the safety and efficacy of the treatment. Monitoring of liver function may be necessary to ensure appropriate management and to mitigate potential risks associated with the use of this medication in individuals with hepatic impairment.

Overdosage

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

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

It is essential for healthcare providers to remain informed about the appropriate protocols for managing overdose situations, ensuring that patients receive timely and effective care.

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 or additional nonclinical toxicology details are available in the provided data. Furthermore, there are no specific findings related to animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions associated with the use of ibuprofen. Reports have included gastrointestinal bleeding, renal impairment, and elevations in liver enzymes. Serious skin reactions, such as Stevens-Johnson syndrome and toxic epidermal necrolysis, have also been documented.

Additionally, cases of cardiovascular events, including myocardial infarction and stroke, have been reported. Hypersensitivity reactions, such as anaphylaxis and angioedema, have been noted, along with instances of elevated blood pressure in patients. Other adverse reactions reported include dizziness and headache. Furthermore, liver-related adverse events, including hepatitis and jaundice, have been observed in the postmarketing setting.

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 configurations that include specific NDC numbers, which can be found on the packaging. 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). For proper tracking and quality assurance, the expiration date and lot number are located on the end flap of the packaging.

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.