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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
ARMY AND AIR FORCE EXCHANGE SERVICE
Registration number
ANDA075010
NDC root
55301-292
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (2 NDCs)
Packaging & NDC Codes (2)

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Drug Overview

✓select™ is a type of medication known as ibuprofen, which comes in 200 mg tablets. It is classified as a nonsteroidal anti-inflammatory drug (NSAID) and is commonly used to temporarily relieve minor aches and pains. You can use it for various discomforts, including backaches, muscular aches, toothaches, menstrual cramps, headaches, and minor arthritis pain. Additionally, ✓select™ helps to temporarily reduce fever.

This product is similar to the active ingredient found in Advil® Caplets, but it is manufactured for military exchanges and distributed by LNK International, Inc. If you're looking for a reliable option to manage pain or fever, ✓select™ may be a suitable choice for you.

Uses

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

In addition to pain relief, this medication is effective in temporarily reducing fever, helping you feel more comfortable when you're not feeling well.

Dosage and Administration

It's important to follow the dosage instructions carefully to ensure your safety and effectiveness of the medication. For adults and children aged 12 years and older, you should take 1 caplet every 4 to 6 hours as needed while you have symptoms. 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 are giving this medication to a child under 12 years old, it's best to consult with a doctor first to determine the appropriate dosage. Always remember to use the smallest effective dose to manage your symptoms safely.

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 concerns or questions about your medical history and the use of this medication.

Side Effects

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

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 symptoms such as faintness, vomiting blood, bloody or black stools, chest pain, slurred speech, or weakness on one side of your body, you should stop using ibuprofen and consult a doctor immediately. Always talk to your healthcare provider before using ibuprofen if you have a history of stomach problems, heart disease, or are taking other medications.

Warnings and Precautions

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

This medication can also lead to severe stomach bleeding, particularly if you take it for longer than recommended, use blood thinners or steroids, consume alcohol heavily, 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.

You should seek emergency medical assistance if you suspect an overdose. Stop using ibuprofen and contact your doctor if you notice signs of stomach bleeding (like faintness, vomiting blood, or black stools), symptoms of heart problems or stroke (such as chest pain or slurred speech), or if your pain or fever worsens or lasts longer than expected.

Overdose

If you suspect an overdose, it’s crucial to seek medical help immediately or contact a Poison Control Center. Signs of an overdose can vary, but they may include unusual symptoms that are more severe than what you would typically experience with the medication.

Don’t wait for symptoms to worsen; acting quickly can make a significant difference in your safety. Always keep emergency contact information handy, and remember that it’s better to be cautious and seek help if you have any concerns about an overdose.

Pregnancy Use

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

Lactation Use

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using any medication, including ibuprofen. This is particularly crucial if you are 20 weeks pregnant or later, as using ibuprofen during this time can 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 for symptoms. If one caplet doesn't relieve pain or fever, you may give 2 caplets instead. However, be sure not to exceed 6 caplets 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 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 especially crucial if you also have other health issues like high blood pressure, heart disease, kidney disease, asthma, or a history of stroke. Always prioritize open communication with your doctor to ensure your safety and the effectiveness of your treatment.

Drug Interactions

It's important to be aware of how certain 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. Additionally, combining ibuprofen with blood thinners (medications that help prevent blood clots) or steroids can increase the risk of stomach bleeding.

If you are using other nonsteroidal anti-inflammatory drugs (NSAIDs), like aspirin or naproxen, alongside ibuprofen, this can also heighten the risk of stomach bleeding. Always discuss any medications you are taking, including over-the-counter drugs, with your healthcare provider to ensure your safety and the effectiveness of your treatments.

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.

Additionally, please check the end flap of the packaging for the expiration date and lot number, which are important for tracking the product's safety and quality. Always handle the product with care to maintain its integrity and safety.

Additional Information

If you are pregnant or breastfeeding, it's important to consult with a healthcare professional before using this medication. 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 ✓select™?

✓select™ is an ibuprofen tablet (200 mg) used as a pain reliever and fever reducer.

What types of pain does ✓select™ relieve?

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

How should I take ✓select™?

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.

What should I do if I experience stomach bleeding?

Stop use and ask a doctor if you experience symptoms like feeling faint, vomiting blood, or having bloody or black stools.

Are there any warnings associated with taking ✓select™?

Yes, ibuprofen may cause severe allergic reactions and increase the risk of stomach bleeding, heart attack, and stroke, especially if used more than directed.

Can I use ✓select™ if I am pregnant or breastfeeding?

If pregnant or breastfeeding, ask a health professional before use, especially after 20 weeks of pregnancy.

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

Ask a doctor before using ✓select™ if you have a history of stomach problems, high blood pressure, heart disease, or other serious conditions.

What is the storage requirement for ✓select™?

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

What should I do in case of an overdose?

In case of overdose, get 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

Ibuprofen is presented in the form of IBUPROFEN Tablets USP, each containing 200 mg of the active ingredient. This nonsteroidal anti-inflammatory drug (NSAID) serves as a pain reliever and fever reducer. The product is packaged as 100 coated caplets, designed for oral administration. Each container is equipped with a tamper-evident feature, and it is advised not to use the product if the imprinted safety seal under the cap is broken or missing. The tablets are manufactured for military exchanges and distributed by LNK International, Inc., located in Hauppauge, NY 11788. For inquiries, a contact number is provided: 1-800-426-9391.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with various conditions, including backache, muscular aches, toothache, menstrual cramps, headache, the common cold, 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 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 is contraindicated in patients with a history of allergic reactions to 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 shock, facial swelling, blisters, rash, hives, skin reddening, 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 under certain conditions, including prolonged use beyond the recommended duration, concurrent use of anticoagulants or steroid medications, co-administration with other NSAIDs (such as aspirin, ibuprofen, or naproxen), being aged 60 years or older, having a history of stomach ulcers or bleeding disorders, or consuming 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, vomiting blood, passing bloody or black stools, or experiencing persistent stomach pain. Additionally, symptoms suggestive of heart problems or stroke, such as chest pain, slurred speech, leg swelling, difficulty breathing, or unilateral weakness, warrant immediate medical evaluation.

Patients should also seek medical advice if pain worsens or persists beyond 10 days, if fever intensifies or lasts more than 3 days, if redness or swelling occurs in the affected area, or if any new symptoms arise. 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, some of which can be serious.

Severe allergic reactions have been reported, particularly in individuals with a known allergy to aspirin. Symptoms of such reactions may include shock, facial swelling, blisters, rash, hives, skin reddening, and asthma (wheezing).

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 higher doses or use the medication for extended periods, as well as those concurrently using blood thinners, steroids, or other NSAIDs (including aspirin, ibuprofen, or naproxen). Additional risk factors include being aged 60 or older, having a history of stomach ulcers or bleeding problems, or consuming three or more alcoholic drinks daily while using this product.

Furthermore, NSAIDs, excluding aspirin, are associated with an increased risk of heart attack, heart failure, and stroke, which can be fatal. The likelihood of these serious cardiovascular events is elevated with prolonged use or higher than recommended dosages.

Patients should discontinue use and consult a healthcare professional if they experience any signs of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, 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. Additionally, 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 should consult a healthcare provider if they have a history of stomach issues, such as heartburn, or if they are taking diuretics, have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or a history of stroke. It is also advisable to seek guidance if experiencing serious side effects from pain relievers or fever reducers, or if under a doctor's care for any serious condition. Patients taking aspirin for heart attack or stroke should be aware that ibuprofen may diminish the cardioprotective effects of aspirin and should consult a healthcare professional before use.

Drug Interactions

Ibuprofen may interact with several classes of medications, leading to significant clinical effects that warrant careful consideration.

Interactions with Antiplatelet Agents 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 to avoid the simultaneous use of ibuprofen and aspirin for this purpose to ensure optimal therapeutic outcomes.

Interactions with Anticoagulants and Corticosteroids The concomitant use of ibuprofen with anticoagulants or corticosteroids may elevate the risk of gastrointestinal bleeding. Clinicians should monitor patients closely for signs of bleeding and consider dosage adjustments or alternative therapies as necessary to mitigate this risk.

Interactions with Other Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) Co-administration of ibuprofen with other NSAIDs, whether prescription or over-the-counter (such as aspirin or naproxen), can further increase the likelihood of gastrointestinal bleeding. It is recommended that patients avoid using multiple NSAIDs simultaneously and that healthcare providers assess the necessity of each medication to minimize 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 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 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 use the medication in excess of the recommended dosage or for an extended duration. Therefore, careful adherence to dosing guidelines is crucial in this population to mitigate these serious cardiovascular risks. Regular assessment and monitoring of elderly patients are advised to ensure their safety while on treatment.

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 ibuprofen 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 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 status, as compromised liver function may influence the safety and efficacy of the treatment. Monitoring of liver function may be warranted in this population to ensure appropriate management and to mitigate potential risks associated with the use of the medication.

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 therapies may be employed as indicated.

It is essential 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 provided regarding nonclinical toxicology or animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has indicated that ibuprofen may lead to severe allergic reactions, particularly in individuals with a known allergy to aspirin. Reported symptoms of such reactions include shock, facial swelling, blisters, rash, hives, skin reddening, and asthma (wheezing).

Additionally, there is a recognized risk of severe stomach bleeding associated with ibuprofen, especially in patients who exceed the recommended dosage, those taking blood thinners or steroids, individuals using other NSAIDs, patients aged 60 years or older, and those with a history of stomach ulcers or bleeding issues. The risk is further amplified in individuals who consume three or more alcoholic drinks daily while using the product.

Furthermore, the use of NSAIDs, including ibuprofen, has been linked to an increased risk of serious cardiovascular events such as heart attack, heart failure, and stroke, which may be fatal. This risk is particularly pronounced with prolonged use or when dosages exceed the recommended levels.

Patient Counseling

Patients should be advised to seek immediate medical assistance or contact a Poison Control Center in the event of an overdose. It is recommended that patients take the medication with food or milk if they experience stomach upset.

Healthcare providers should encourage patients to consult a doctor before using this medication if they have a history of stomach problems, such as heartburn, or if they are subject to a stomach bleeding warning. Additionally, patients should be advised to discuss their medical history with their healthcare provider, particularly if they have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or a history of stroke.

Patients should also be informed to consult a doctor before use if they are taking a diuretic or if they have experienced problems or serious side effects from pain relievers or fever reducers in the past. It is important for patients to communicate with their healthcare provider or pharmacist if they are under care for any serious condition.

Furthermore, patients should be cautioned to ask a doctor or pharmacist before using this medication if they are taking aspirin for heart attack or stroke, as ibuprofen may diminish the effectiveness of aspirin in this context. Lastly, patients should be encouraged to discuss any other medications they are taking with their healthcare provider or pharmacist prior to use.

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

Patients should be advised to consult a healthcare professional if they are pregnant or breastfeeding before using the medication. It is particularly crucial to avoid the use of ibuprofen at 20 weeks of pregnancy or later 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.