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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
April 16, 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
April 16, 2025
Manufacturer
COSTCO WHOLESALE CORPORATION
Registration number
ANDA075010
NDC root
63981-291
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (2 NDCs)
Packaging & NDC Codes (2)

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Drug Overview

KIRKLAND Signature IBUPROFEN is a type of medication known as a nonsteroidal anti-inflammatory drug (NSAID) that comes in 200 mg tablets. It is primarily used to temporarily relieve minor aches and pains, including those caused by backaches, menstrual cramps, toothaches, headaches, muscular aches, and minor arthritis pain. Additionally, it helps to reduce fever.

This medication works by blocking certain substances in the body that cause inflammation and pain, providing you with relief when you need it most. If you're looking for a way to manage discomfort or fever, KIRKLAND Signature IBUPROFEN may be a suitable option for you.

Uses

You can use this medication to temporarily relieve minor aches and pains caused by various conditions, including backaches, menstrual cramps, toothaches, headaches, muscular aches, and even minor arthritis pain. It can also help alleviate discomfort associated with the common cold.

In addition to pain relief, this medication is effective in temporarily reducing fever. 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 to ensure your safety and effectiveness of the medication. You should not take more than the directed amount, and it's best to use the smallest effective dose. For adults and children aged 12 years and older, the recommended 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 instead.

However, be cautious not to exceed 6 tablets in a 24-hour period unless your doctor has advised you otherwise. If you have a child under 12 years old, it's essential to consult a doctor before giving them this medication. Always prioritize safety and consult with a healthcare professional if you have any questions or concerns.

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 to your health in these situations. Always consult with your healthcare provider if you have any concerns or questions about your specific circumstances.

Side Effects

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

There is also an increased risk of heart attack, heart failure, and stroke associated with NSAIDs like ibuprofen, particularly if used in higher doses or for extended periods. If you experience symptoms such as chest pain, slurred speech, leg swelling, or trouble breathing, you should seek medical attention immediately. It's important to consult your doctor if you have a history of stomach issues, high blood pressure, heart disease, or if you are taking other medications, especially aspirin, as ibuprofen may interfere with its effectiveness.

Warnings and Precautions

Ibuprofen can cause serious allergic reactions, especially if you are allergic to aspirin. Signs of an allergic reaction include facial swelling, shock, asthma (wheezing), skin reddening, hives, blisters, and rash. If you experience any of these symptoms, stop using ibuprofen and seek medical help immediately.

This medication may also lead to severe stomach bleeding, particularly if you take it for longer than recommended, are over 60 years old, take blood thinners or steroids, have a history of stomach ulcers or bleeding, or consume three or more alcoholic drinks daily while using it. Additionally, using ibuprofen can increase your risk of heart attack and stroke, especially if taken in higher doses or for extended periods.

You should get emergency medical help if you suspect an overdose. Stop using ibuprofen and contact your doctor if you notice signs of stomach bleeding (like feeling faint, bloody or black stools, or vomiting blood), symptoms of heart problems or stroke (such as chest pain, slurred speech, or weakness on one side of your body), or if your pain or fever worsens or lasts longer than expected.

Overdose

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

Don’t wait for symptoms to worsen; acting quickly can make a significant difference in your safety. Always prioritize your health and well-being by reaching out for professional assistance in these situations.

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 enough to relieve pain or fever, you may give 2 tablets. However, be sure not to exceed 6 tablets in a 24-hour period unless a doctor advises otherwise. Always prioritize safety and seek guidance if you're unsure about the appropriate dosage for your child.

Geriatric Use

As you age, particularly if you are 60 or older, it's important to be aware that the risk of severe stomach bleeding increases. This is especially relevant if you are taking nonsteroidal anti-inflammatory drugs (NSAIDs), which are commonly used for pain relief. Because of this heightened risk, special precautions should be taken when using these medications.

If you or a loved one is an older adult considering NSAIDs, it's crucial to discuss this with your healthcare provider. They can help determine the safest options and monitor for any potential side effects, ensuring that you receive the best care while managing pain effectively.

Renal Impairment

If you have kidney problems, it's important to consult your doctor before using this medication. Your healthcare provider will want to know about any other conditions you may have, such as high blood pressure, heart disease, liver cirrhosis, asthma, or a history of stroke. This information helps ensure that the treatment is safe and appropriate for you. Always prioritize open communication with your doctor regarding your health status 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 other health issues you may have, including high blood pressure, heart disease, kidney disease, asthma, or a history of stroke, as these can affect your treatment plan. Your safety is the priority, so open communication with your healthcare team is essential.

Drug Interactions

It's important to be aware that taking ibuprofen can reduce the effectiveness of aspirin, especially if you're using aspirin to prevent heart attacks or strokes. This means that if you are prescribed aspirin for these serious health issues, you should discuss any use of ibuprofen with your healthcare provider.

Always talk to your doctor or pharmacist about all the medications you are taking, including over-the-counter drugs like ibuprofen. This way, you can ensure that your treatments work effectively and safely together.

Storage and Handling

To ensure the best performance and safety of your product, always check the expiration date on the package before use. Store the product 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 is anything above 40°C (104°F), as this can compromise its effectiveness.

When handling the product, make sure to do so with clean hands and in a safe 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 KIRKLAND Signature IBUPROFEN used for?

KIRKLAND Signature IBUPROFEN is used to temporarily relieve minor aches and pains from conditions like backache, menstrual cramps, toothache, headache, the common cold, muscular aches, and minor arthritis pain. 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 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 KIRKLAND Signature IBUPROFEN?

Yes, this product may cause severe stomach bleeding, especially if taken for longer than directed, if you are over 60, or if you consume alcohol. It also increases the risk of heart attack and stroke.

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

If you experience symptoms like feeling faint, bloody or black stools, or vomit blood, stop using the product and seek medical help immediately.

Can I take KIRKLAND Signature IBUPROFEN if I am pregnant or breastfeeding?

If you are pregnant or breastfeeding, consult a health professional before use. 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 allergic reactions to pain relievers?

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

How should I store KIRKLAND Signature IBUPROFEN?

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

What is the active ingredient in KIRKLAND Signature IBUPROFEN?

The active ingredient in KIRKLAND Signature IBUPROFEN is ibuprofen, which is a nonsteroidal anti-inflammatory drug (NSAID) that acts as a pain reliever and fever reducer.

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

KIRKLAND Signature is a nonsteroidal anti-inflammatory drug (NSAID) containing ibuprofen as its active ingredient. Each tablet is formulated to deliver 200 mg of ibuprofen. The product is presented in a dosage form of tablets USP and is indicated for the relief of pain and reduction of fever. KIRKLAND Signature is packaged in a container of 500 tablets and is identified by the National Drug Code (NDC) 63981-291-14.

This product is manufactured by LNK INTERNATIONAL, INC., located at 60 Arkay Drive, Hauppauge, NY 11788, USA, and is distributed for Costco Wholesale Corporation, P.O. Box 34535, Seattle, WA 98124-1535, USA. For inquiries, contact 1-800-774-2678 or visit www.costco.com. The product features a tamper-evident warning stating, "DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING." KIRKLAND Signature is made in the USA and is not manufactured or distributed by PF Consumer Healthcare 1 LLC, the owner of the registered trademark Advil.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with various conditions, including backache, menstrual cramps, toothache, headache, the common cold, 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, it is imperative not to 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 before administration.

Contraindications

Use is contraindicated in patients with a history of allergic reactions to any other pain reliever or fever reducer, due to the potential for severe hypersensitivity reactions. Additionally, the product should not be administered immediately before or after heart surgery, as it may pose risks to surgical outcomes and patient safety.

Warnings and Precautions

Ibuprofen may induce severe allergic reactions, particularly in individuals with a known allergy to aspirin. Symptoms indicative of such reactions may include facial swelling, shock, wheezing, skin reddening, hives, blisters, and rash. 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 under certain conditions, including prolonged use beyond the recommended duration, age 60 or older, concurrent use of anticoagulants or steroid medications, use of other NSAIDs (whether prescription or over-the-counter, such as aspirin, ibuprofen, or naproxen), a history of stomach ulcers or bleeding disorders, and consumption of three or more alcoholic beverages daily while using this product.

Furthermore, NSAIDs, excluding aspirin, are linked to an increased risk of heart attack, heart failure, and stroke, which can be fatal. The risk escalates with dosages exceeding the recommended amount or duration of use.

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.

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, having bloody or black stools, vomiting blood, or experiencing persistent stomach pain. Additionally, symptoms suggestive 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.

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. Regular monitoring and assessment of these parameters are essential for the safe use of ibuprofen.

Side Effects

Patients using ibuprofen may experience a range of adverse reactions, which can be categorized by seriousness and frequency.

Serious adverse reactions include severe allergic reactions, particularly in individuals with a known allergy to aspirin. Symptoms of such reactions may manifest as facial swelling, shock, asthma (wheezing), skin reddening, hives, blisters, and rash. Additionally, 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 take more than the recommended dosage, are aged 60 or older, use anticoagulants or steroid medications, consume other NSAIDs, have a history of stomach ulcers or bleeding problems, or consume three or more alcoholic drinks daily while using the product.

Furthermore, NSAIDs, excluding aspirin, are associated with an increased risk of heart attack, heart failure, and stroke, which can be fatal. This risk escalates with prolonged use or higher than directed dosages.

Common adverse reactions may include gastrointestinal symptoms such as stomach pain, which may indicate potential bleeding. Patients are advised to discontinue use and consult a healthcare professional if they experience signs of stomach bleeding, such as feeling faint, having bloody or black stools, vomiting blood, or 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.

Patients should seek medical advice before using ibuprofen if they have a history of stomach problems, high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or a history of stroke. It is also recommended that patients consult a healthcare provider if they are taking diuretics, have experienced serious side effects from pain relievers or fever reducers, or are under medical care for any serious condition. Additionally, those taking aspirin for heart attack or stroke should be aware that ibuprofen may diminish the cardioprotective effects of aspirin.

In clinical trials and postmarketing experiences, it is essential for patients to monitor for any new symptoms or if pain persists beyond 10 days, fever worsens or lasts more than three days, or if redness or swelling occurs in the affected area.

Drug Interactions

Ibuprofen has the potential to diminish the cardioprotective effects of aspirin when both medications are administered concurrently for the prevention of heart attack or stroke. It is advisable to monitor patients closely for any signs of reduced efficacy of aspirin in such scenarios. Consideration should be given to the timing of administration, as taking ibuprofen at least 30 minutes after or 8 hours before aspirin may help mitigate this interaction.

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, particularly those aged 60 and older, are at an increased risk of severe stomach bleeding when using this medication. Therefore, special precautions should be implemented for this population.

Healthcare providers are advised to closely monitor geriatric patients for signs of gastrointestinal complications and other side effects associated with nonsteroidal anti-inflammatory drug (NSAID) use. It is essential to consider these risks when determining the appropriate dosage and treatment regimen for elderly patients, ensuring that the benefits of therapy outweigh the potential hazards.

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 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 healthcare provider, 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 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. Monitoring of liver function may be necessary to ensure safety and efficacy during treatment. Adjustments to dosage or specific restrictions 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 therapeutic approach.

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 alert and prepared to implement appropriate management strategies in response to an overdose situation, ensuring the safety and well-being of the patient.

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 reported voluntarily or through surveillance programs. These include allergic reactions, such as anaphylaxis and serious skin reactions. Gastrointestinal events have been noted, including bleeding, ulceration, and perforation. Cardiovascular events, such as heart attack and stroke, have also been reported.

Renal toxicity, specifically acute kidney injury, has been observed, along with liver toxicity characterized by elevated liver enzymes and hepatitis. Hematologic reactions, including thrombocytopenia and aplastic anemia, have been documented. Additionally, central nervous system effects, such as headache, dizziness, and drowsiness, have been reported.

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 with an expiration date clearly indicated on the package. It should be stored 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). Proper storage conditions are essential to maintain the integrity and efficacy of the product.

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.