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Ibuprofen, Caseys, 50ct, Ibuprofen, Circle K, 50ct, Ibuprofen, Lil Drug Store...

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Active ingredient
Ibuprofen 200 mg
Other brand names
Drug class
Nonsteroidal Anti-inflammatory Drug
Dosage form
Tablet, Coated
Route
Oral
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2024
Label revision date
June 12, 2024
Active ingredient
Ibuprofen 200 mg
Other brand names
Drug class
Nonsteroidal Anti-inflammatory Drug
Dosage form
Tablet, Coated
Route
Oral
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Marketed in the U.S.
Since 2024
Label revision date
June 12, 2024
Manufacturer
Lil' Drug Store Products, Inc.
Registration number
ANDA079129
NDC roots
66715-5607, 66715-6407, 66715-6720, 66715-6739

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Drug Overview

Ibuprofen is a nonsteroidal anti-inflammatory drug (NSAID) that comes in 200 mg tablets. It is commonly used to temporarily relieve minor aches and pains, including headaches, muscular aches, toothaches, backaches, and menstrual cramps. Additionally, ibuprofen can help reduce fever and alleviate discomfort associated with the common cold.

This medication works by blocking certain substances in the body that cause inflammation and pain, making it an effective option for managing various types of discomfort. If you're looking for relief from minor pain or fever, ibuprofen 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 headaches, muscular aches, arthritis pain, toothaches, backaches, the common cold, and menstrual cramps. Additionally, it can help reduce fever for a short period.

This medication is designed to provide you with quick relief from discomfort, making it easier to go about your daily activities. Always remember to follow the recommended guidelines for use to ensure safety and effectiveness.

Dosage and Administration

When using this medication, it's important to follow the directions carefully. You should take the smallest effective dose to manage your symptoms. For adults and children aged 12 years and older, the recommended dosage is to take 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, make sure not to exceed 6 tablets in a 24-hour period unless your doctor advises otherwise.

If you are considering this medication for a child under 12 years old, it's best to consult with a doctor first to ensure it's safe and appropriate for them. Always remember to take the medication as directed to avoid any potential risks.

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 undergoing 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.

Side Effects

Ibuprofen can cause serious allergic reactions, particularly in individuals who are allergic to aspirin. Symptoms of such reactions may include hives, facial swelling, wheezing, shock, skin reddening, rash, and blisters. Additionally, this medication carries a risk of severe stomach bleeding, especially for those over 60, individuals with a history of stomach ulcers or bleeding, and those taking blood thinners or other NSAIDs. Drinking three or more alcoholic beverages daily while using ibuprofen can also increase this risk.

There are important warnings regarding heart health as well; using ibuprofen may elevate the risk of heart attack, heart failure, and stroke, particularly if taken in higher doses or for extended periods. If you experience symptoms like bloody or black stools, chest pain, slurred speech, or any new concerning symptoms, you should stop using ibuprofen and consult a doctor immediately. Always talk to your healthcare provider before using ibuprofen if you have existing health issues or are taking other medications.

Warnings and Precautions

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

This medication can also lead to severe stomach bleeding, particularly if you are over 60, have a history of stomach ulcers or bleeding, take blood thinners or steroids, consume three or more alcoholic drinks daily, or use other NSAIDs (nonsteroidal anti-inflammatory drugs) like aspirin or naproxen. Additionally, using ibuprofen for longer than directed increases the risk of heart attack and stroke, which can be fatal.

You should seek emergency medical help if you suspect an overdose or contact a Poison Control Center at 1-800-222-1222. Stop using ibuprofen and consult your doctor if you notice any signs of stomach bleeding (like bloody or black stools, faintness, or vomiting blood), symptoms of heart problems or stroke (such as chest pain, slurred speech, or weakness on one side of the body), if your pain worsens or lasts more than 10 days, if your fever worsens or lasts more than 3 days, or if you see any new symptoms.

Overdose

If you suspect an overdose, it’s crucial to seek medical help immediately. You can contact a Poison Control Center at 1-800-222-1222 for guidance. Signs of an overdose can vary, but they may include unusual drowsiness, confusion, or difficulty breathing.

Always err on the side of caution—if you notice any concerning symptoms or if you’re unsure, don’t hesitate to get help right away. Your safety is the top priority.

Pregnancy Use

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

Lactation Use

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using 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 you have a child under 12 years old, it's important to consult with a doctor before using this medication. For children aged 12 and older, the recommended dosage is 1 tablet every 4 to 6 hours as needed for symptoms. If one tablet does not relieve pain or fever, you may give 2 tablets. However, be sure not to exceed 6 tablets in a 24-hour period unless your doctor advises otherwise. Always prioritize safety and seek guidance if you're unsure about the appropriate use for your child.

Geriatric Use

If you are an older adult or caring for one, it's important to be aware of certain risks when using this medication, which contains a type of pain reliever known as an NSAID (nonsteroidal anti-inflammatory drug). This medication can increase the chance of severe stomach bleeding, especially if you are 60 years or older. Additionally, using NSAIDs can raise the risk of heart attack and stroke, particularly if you take more than the recommended dose or use it for an extended period.

Before starting this medication, consult with a doctor if you have a history of stomach bleeding, high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or if you've had a stroke. To help prevent stomach upset, consider taking the medication with food or milk. If you notice any signs of stomach bleeding or symptoms related to heart problems or stroke, stop using the product and seek medical advice immediately.

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 closely to ensure your safety.

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. Your well-being 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 of your product, store it at a temperature between 20°-25°C (68°-77°F). This temperature range helps maintain the integrity and effectiveness of the device.

When handling the product, be sure to do so with clean hands and in a clean environment to avoid contamination. Proper storage and careful handling are essential for your safety and the product's reliability.

Additional Information

For adults and children aged 12 and older, you can take 1 tablet every 4 to 6 hours as needed for pain or fever. If one tablet isn't enough, you may take 2 tablets, but do not exceed 6 tablets in a 24-hour period unless your doctor advises otherwise. If you are giving this medication to a child under 12, consult a doctor first.

If you are pregnant or breastfeeding, it's important to talk to a healthcare professional before using this medication. Avoid using ibuprofen after 20 weeks of pregnancy unless specifically directed by a doctor, as it can pose risks to the unborn child or lead to complications during delivery. Always keep this medication out of reach of children, and in case of an overdose, seek medical help or contact a Poison Control Center immediately at 1-800-222-1222.

FAQ

What is ibuprofen?

Ibuprofen is a nonsteroidal anti-inflammatory drug (NSAID) that temporarily relieves minor aches and pains and reduces fever.

What conditions can ibuprofen help relieve?

Ibuprofen can temporarily relieve minor aches and pains due to headaches, muscular aches, arthritis, toothaches, backaches, the common cold, and menstrual cramps.

What is the recommended dosage for adults and children 12 years and older?

Adults and children 12 years and older 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.

Can children under 12 years take ibuprofen?

Children under 12 years should ask a doctor before use.

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

Stop use and ask a doctor if you have bloody or black stools, feel faint, vomit blood, or have stomach pain that does not get better.

What are the warnings associated with ibuprofen?

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

Is it safe to use ibuprofen during pregnancy?

If pregnant or breastfeeding, ask a health professional before use. It is especially important not to use ibuprofen at 20 weeks or later in pregnancy unless directed by a doctor.

What should I do in case of an overdose?

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

How should ibuprofen be taken to avoid stomach upset?

Take ibuprofen with food or milk if stomach upset occurs.

What should I do if I have a history of allergic reactions to pain relievers?

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

Packaging Info

Below are the non-prescription pack sizes of Ibuprofen, Caseys, 50ct, Ibuprofen, Circle K, 50ct, Ibuprofen, Lil Drug Store, 24ct, Ibuprofen, Lil Drug Store, 50ct (ibuprofen). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Ibuprofen, Caseys, 50ct, Ibuprofen, Circle K, 50ct, Ibuprofen, Lil Drug Store, 24ct, Ibuprofen, Lil Drug Store, 50ct.
Details

Drug Information (PDF)

This file contains official product information for Ibuprofen, Caseys, 50ct, Ibuprofen, Circle K, 50ct, Ibuprofen, Lil Drug Store, 24ct, Ibuprofen, Lil Drug Store, 50ct, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

Ibuprofen, Circle K™, is a nonsteroidal anti-inflammatory drug (NSAID) indicated for the relief of pain and reduction of fever. Each tablet contains 200 mg of ibuprofen and is formulated as a coated tablet. The product is available in a package containing 50 coated tablets.

Uses and Indications

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

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

Dosage and Administration

The medication should be administered according to the following guidelines to ensure safe and effective use.

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. In cases where pain or fever does not adequately respond to 1 tablet, a dose of 2 tablets may be taken. However, it is imperative that the total daily dosage does not exceed 6 tablets within a 24-hour period, unless otherwise directed by a healthcare professional.

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

Healthcare professionals should emphasize the importance of using the smallest effective dose and adhering strictly to the prescribed dosage to avoid potential adverse effects.

Contraindications

Use is contraindicated in patients with a history of allergic reactions to any other 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 induce severe allergic reactions, particularly in individuals with a known allergy to aspirin. Symptoms indicative of an allergic response may include hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, and blisters. In the event of an allergic reaction, it is imperative to discontinue use immediately and seek medical assistance.

This product contains a nonsteroidal anti-inflammatory drug (NSAID), which is associated with an increased risk of severe stomach bleeding. The likelihood of such an event is heightened in patients who are 60 years of age or older, have a history of stomach ulcers or bleeding disorders, are concurrently using anticoagulants or steroid medications, are taking other NSAIDs (including aspirin, ibuprofen, or naproxen), consume three or more alcoholic beverages daily while using this product, or exceed the recommended dosage or duration of use.

NSAIDs, with the exception of aspirin, are also linked to an elevated 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.

In cases of overdose, immediate medical attention is required. Healthcare professionals should advise patients to contact a Poison Control Center at 1-800-222-1222 without delay.

Patients should be instructed to discontinue use and consult a healthcare provider if they experience any of the following symptoms indicative of stomach bleeding: bloody or black stools, faintness, vomiting blood, or 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.

Side Effects

Patients may experience a range of adverse reactions associated with the use of this product, which contains an NSAID. Serious adverse reactions include severe allergic reactions, which may manifest as hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, or blisters, particularly in individuals with a known allergy to aspirin.

The use of this NSAID is also associated with an increased risk of severe stomach bleeding, especially in patients who are 60 years of age or older, have a history of stomach ulcers or bleeding problems, are taking anticoagulants or steroid medications, consume three or more alcoholic drinks daily, or use other NSAIDs concurrently. Symptoms indicative of stomach bleeding include bloody or black stools, faintness, vomiting blood, and persistent stomach pain.

Additionally, there is a warning regarding the increased risk of heart attack, heart failure, and stroke associated with NSAID use, which can be fatal. This risk is heightened when the medication is used in excess of the recommended dosage or for prolonged periods.

Patients are advised to discontinue use and consult a healthcare professional if they experience any signs of stomach bleeding or symptoms suggestive of heart problems or stroke, such as chest pain, slurred speech, leg swelling, difficulty breathing, or unilateral weakness. Other reasons to seek medical advice include worsening pain lasting more than 10 days, fever persisting beyond 3 days, redness or swelling in the affected area, or the emergence of any new symptoms.

Before initiating treatment, patients should consult a healthcare provider if they have a history of adverse reactions to pain relievers or fever reducers, if the stomach bleeding warning applies to them, or if they have conditions such as high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or a history of stroke. It is also important to discuss the use of this product with a healthcare professional if the patient is taking aspirin for cardiovascular protection, as ibuprofen may diminish the cardioprotective effects of aspirin.

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, Caseys, 50ct, Ibuprofen, Circle K, 50ct, Ibuprofen, Lil Drug Store, 24ct, Ibuprofen, Lil Drug Store, 50ct (ibuprofen). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Ibuprofen, Caseys, 50ct, Ibuprofen, Circle K, 50ct, Ibuprofen, Lil Drug Store, 24ct, Ibuprofen, Lil Drug Store, 50ct.
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 for symptom relief. If pain or fever does not adequately respond to 1 tablet, a dose of 2 tablets may be administered. It is important not to exceed 6 tablets within a 24-hour period unless directed by a healthcare provider.

Geriatric Use

Elderly patients, particularly those aged 60 and older, are at an increased risk for severe stomach bleeding when using this product, which contains a nonsteroidal anti-inflammatory drug (NSAID). The likelihood of experiencing such adverse effects is heightened in this age group.

Additionally, NSAIDs, with the exception of aspirin, are associated with an elevated risk of heart attack, heart failure, and stroke. This risk is further amplified if the medication is used in excess of the recommended dosage or for an extended duration.

Healthcare providers should advise elderly patients to consult a physician prior to using this product if they have a history of conditions such as high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or prior stroke, as these factors may increase the risk of serious complications.

To mitigate gastrointestinal discomfort, it is recommended that elderly patients take this product with food or milk. Furthermore, patients should be instructed to discontinue use and seek medical attention immediately if they experience any signs of stomach bleeding or symptoms indicative of heart problems or stroke. Regular monitoring and careful consideration of the patient's overall health status are essential when prescribing this medication to geriatric patients.

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 evaluate the potential benefits and risks when considering the use of this medication in pregnant patients.

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 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 therapy in individuals with reduced kidney function. Monitoring and appropriate dosing adjustments may be necessary to ensure safety and efficacy in this population.

Hepatic Impairment

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

Overdosage

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

Prompt intervention is crucial in managing overdose situations. Symptoms of overdose may vary depending on the substance involved and the individual’s health status. Therefore, a thorough assessment and monitoring of the patient are essential to determine the appropriate course of action.

Management procedures may include supportive care and symptomatic treatment, tailored to the specific symptoms presented. It is vital for healthcare providers to remain vigilant and prepared to implement necessary interventions based on the clinical presentation 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 have been identified in the available data. Additionally, there are no details provided regarding nonclinical toxicology or animal pharmacology and toxicology.

Postmarketing Experience

No specific postmarketing experience details are available in the extracted data. As such, there are no reported adverse events or case reports to summarize.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. In the event of an overdose, patients should be instructed to seek medical help immediately or contact a Poison Control Center at 1-800-222-1222.

Patients must be cautioned against using this medication if they have a history of allergic reactions to any other pain reliever or fever reducer. Additionally, it should not be used right before or after heart surgery.

Patients should be informed to stop using the medication and consult a doctor if they experience any signs of stomach bleeding, which may include bloody or black stools, faintness, vomiting blood, or persistent stomach pain. They should also seek medical advice if they exhibit 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.

It is important to instruct patients to discontinue use and consult a healthcare professional if their pain worsens or persists for more than 10 days, if their fever worsens or lasts more than 3 days, if there is redness or swelling in the painful area, or if any new symptoms arise.

When using this product, patients should be advised to take it with food or milk if they experience stomach upset. Healthcare providers should encourage patients to consult a doctor before use if they have experienced problems or serious side effects from pain relievers or fever reducers in the past.

Patients should also be advised to seek medical guidance if the warning regarding stomach bleeding applies to them, or if they have a history of stomach issues such as heartburn. Furthermore, patients with high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or a history of stroke should consult a doctor before using this medication.

Patients taking diuretics or aspirin for heart attack or stroke should be advised to speak with a doctor or pharmacist before use, as ibuprofen may diminish the effectiveness of aspirin. Lastly, patients under a doctor's care for any serious condition or those taking any other medications should also consult a healthcare professional prior to use.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It should be stored at a controlled room temperature of 20° to 25°C (68° to 77°F). Care should be taken to ensure that the product is kept within this temperature range to maintain its integrity and efficacy.

Additional Clinical Information

Patients aged 12 years and older are advised to take 1 tablet every 4 to 6 hours while symptoms persist. If pain or fever does not respond to 1 tablet, 2 tablets may be used, but the total should not exceed 6 tablets in a 24-hour period unless directed by a healthcare professional. For children under 12 years, consultation with a doctor is recommended prior to administration.

Clinicians should counsel patients who are pregnant or breastfeeding to seek advice from a health professional before use. It is particularly important to avoid ibuprofen after 20 weeks of pregnancy unless specifically directed by a doctor, as it may pose risks to the unborn child or lead to complications during delivery. Additionally, patients should be reminded to keep the medication out of reach of children and to seek immediate medical assistance or contact a Poison Control Center (1-800-222-1222) in the event of an overdose.

Drug Information (PDF)

This file contains official product information for Ibuprofen, Caseys, 50ct, Ibuprofen, Circle K, 50ct, Ibuprofen, Lil Drug Store, 24ct, Ibuprofen, Lil Drug Store, 50ct, 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, Caseys, 50ct, Ibuprofen, Circle K, 50ct, Ibuprofen, Lil Drug Store, 24ct, Ibuprofen, Lil Drug Store, 50ct, 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.

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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.