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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
Capsule, Liquid Filled
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2018
Label revision date
December 20, 2023
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Ibuprofen 200 mg
Other brand names
Drug class
Nonsteroidal Anti-inflammatory Drug
Dosage form
Capsule, Liquid Filled
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 2018
Label revision date
December 20, 2023
Manufacturer
The Kroger Co.
Registration number
ANDA206568
NDC root
30142-745
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (6 NDCs)
Packaging & NDC Codes (6)

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

If you are a consumer or patient please visit this version.

Drug Overview

KROGER Ibuprofen 200 mg Capsules contain ibuprofen, which is a type of medication known as a nonsteroidal anti-inflammatory drug (NSAID). This medication is designed to temporarily relieve minor aches and pains, including headaches, muscular aches, toothaches, backaches, and menstrual cramps. It can also help alleviate pain associated with arthritis and the common cold, as well as reduce fever.

By working to decrease inflammation and pain in the body, KROGER Ibuprofen provides a supportive option for managing discomfort in various situations. If you're experiencing any of the mentioned aches or pains, this medication may be a helpful choice for temporary relief.

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.

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

When using this medication, it's important to follow the instructions carefully. You should take the smallest effective dose, which means using the least amount that helps relieve your symptoms. For adults and children aged 12 years and older, you can take 1 capsule every 4 to 6 hours as needed while your symptoms persist. If you find that 1 capsule isn't enough to relieve your pain or fever, you may take 2 capsules. However, make sure not to exceed 6 capsules in a 24-hour period unless your doctor advises otherwise.

If you're considering this medication for a child under 12 years old, it's best to consult with a doctor first. Remember to take the capsules by mouth, and only use them as directed to ensure your safety and effectiveness of the treatment.

What to Avoid

You should avoid using this medication if you have ever had an allergic reaction to any other pain reliever or fever reducer. Additionally, it is important not to use it right before or after heart surgery, as this could pose serious health risks. Always consult with your healthcare provider if you have any concerns or questions about your eligibility to use this medication. Your safety is the top priority.

Side Effects

Ibuprofen can cause serious allergic reactions, particularly in individuals who are allergic to aspirin. Symptoms of such reactions may include hives, facial swelling, asthma (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. The risk of heart attack and stroke is also increased with NSAID use, particularly if taken in higher doses or for extended periods.

You should stop using ibuprofen and consult a doctor if you experience signs of stomach bleeding, such as feeling faint, vomiting blood, or having black stools. Seek medical attention if you notice symptoms of heart problems or stroke, like chest pain or weakness on one side of the body. It's important to talk to your doctor before using ibuprofen if you have a history of stomach issues, high blood pressure, heart disease, or if you are taking other medications.

Warnings and Precautions

Ibuprofen can cause serious allergic reactions, especially if you are allergic to aspirin. Symptoms may include hives, facial swelling, wheezing, shock, skin reddening, rash, or blisters. If you experience any of these symptoms, stop using the medication 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 it for longer than recommended. 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 by contacting a Poison Control Center at 1-800-222-1222. Stop using ibuprofen and consult your doctor if you notice signs of stomach bleeding (like feeling faint, vomiting blood, or having 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. 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.

Don’t wait to see if symptoms improve; getting prompt assistance can be vital for your safety. Always err on the side of caution and reach out for help if you think an overdose has occurred.

Pregnancy 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 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, the recommended dosage is 1 capsule every 4 to 6 hours as needed for symptoms. If one capsule does not relieve pain or fever, you may give 2 capsules, but be careful not to exceed 6 capsules in a 24-hour period unless a doctor advises otherwise. Always follow these guidelines to ensure your child's safety and well-being.

Geriatric Use

As you age, it's important to be aware of certain health risks when taking medications. If you are 60 years or older, there is a higher chance of experiencing severe stomach bleeding. This risk is especially significant if you have conditions like high blood pressure, heart disease, liver cirrhosis (a liver condition), kidney disease, asthma, or if you have previously had a stroke.

Before starting any new medication, it's crucial to consult with your doctor, particularly if any of these warnings apply to you. Your healthcare provider can help ensure that your treatment is safe and appropriate for your specific health needs.

Renal Impairment

If you have kidney problems, it's important to consult your doctor before using this medication. Inform them about any other health conditions you may have, such as high blood pressure, heart disease, liver cirrhosis, asthma, or a history of stroke. Your doctor will help determine if this medication is 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 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 a priority, so don't hesitate to ask questions or express any concerns you may have.

Drug Interactions

It's important to be aware that taking ibuprofen can affect how well aspirin works, especially if you're using aspirin to prevent heart attacks or strokes. Additionally, if you're on blood thinners (medications that help prevent blood clots) or steroids, using ibuprofen can increase your risk of stomach bleeding. This risk is even greater if you're also taking other nonsteroidal anti-inflammatory drugs (NSAIDs), like aspirin or naproxen.

To ensure your safety, always discuss any medications you are taking with your healthcare provider. They can help you understand potential interactions and adjust your treatment plan as needed.

Storage and Handling

To ensure the best performance of your product, store it in a cool, dry place at a temperature between 20° to 25°C (68° to 77°F). It's important to avoid exposing it to excessive heat, particularly temperatures above 40°C (104°F), as this can damage the product. Additionally, keep it protected from light to maintain its effectiveness.

When handling the product, always do so with clean hands and in a clean environment to prevent contamination. Following these guidelines will help ensure the product remains safe and effective for your use.

Additional Information

No further information is available.

FAQ

What is KROGER Ibuprofen?

KROGER Ibuprofen is a nonsteroidal anti-inflammatory drug (NSAID) that contains 200 mg of ibuprofen, which helps relieve minor aches and pains.

What conditions does KROGER Ibuprofen temporarily relieve?

It temporarily relieves minor aches and pains due to headaches, muscular aches, minor arthritis pain, toothaches, backaches, the common cold, and menstrual cramps. 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 capsule every 4 to 6 hours while symptoms persist, with a maximum of 6 capsules in 24 hours unless directed by a doctor.

What should I do if I experience stomach bleeding symptoms?

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

Are there any contraindications for using KROGER Ibuprofen?

Do not use KROGER Ibuprofen if you have ever had an allergic reaction to any pain reliever or fever reducer, or if you are using it right before or after heart surgery.

What should I do if I am pregnant or breastfeeding?

If you are pregnant or breastfeeding, ask a health professional before use, especially after 20 weeks of pregnancy, as it may cause complications.

What are the allergy alerts associated with KROGER Ibuprofen?

Ibuprofen may cause severe allergic reactions, especially in those allergic to aspirin. Symptoms can include hives, facial swelling, and difficulty breathing.

What storage conditions are recommended for KROGER Ibuprofen?

Store KROGER Ibuprofen between 20° to 25°C (68° to 77°F) and protect it from excessive heat and light.

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

Solubilized ibuprofen is formulated to deliver an equivalent of 200 mg of ibuprofen, a nonsteroidal anti-inflammatory drug (NSAID). This formulation includes both the free acid and potassium salt forms of ibuprofen, ensuring effective solubility and bioavailability.

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 orally, with capsules taken every 4 to 6 hours as needed while symptoms persist. For adults and children aged 12 years and older, the recommended dosage is 1 capsule per administration. If pain or fever does not adequately respond to 1 capsule, a maximum of 2 capsules may be taken. It is imperative that the total dosage does not exceed 6 capsules 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. The smallest effective dose should always be utilized, and patients should not exceed the recommended dosage.

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 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 a risk of severe stomach bleeding. The likelihood of experiencing this adverse effect 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, excluding aspirin, are also linked to an increased risk of heart attack, heart failure, and stroke, which can be fatal. The risk is particularly elevated in patients who use these medications in excess of the recommended dosage or for prolonged periods.

In cases of overdose, immediate medical attention is required. Healthcare professionals should advise patients to contact a Poison Control Center (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: 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 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.

Side Effects

Patients may experience a range of adverse reactions associated with the use of this product, which contains ibuprofen, a nonsteroidal anti-inflammatory drug (NSAID).

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

The use of this NSAID is also associated with an increased risk of severe stomach bleeding. This risk is heightened 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 while using this product, or exceed the recommended dosage or duration of use.

Additionally, NSAIDs, excluding aspirin, have been 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 the medication in excess of the recommended dosage or for prolonged periods.

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 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 their pain worsens or persists beyond 10 days, if fever intensifies or lasts more than 3 days, if redness or swelling occurs in the painful area, or if any new symptoms arise.

Before using this product, patients should consult a healthcare provider if they have a history of stomach problems, such as heartburn, or if the stomach bleeding warning applies to them. Those 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 for patients to inform their healthcare provider if they are under treatment for any serious condition, are taking aspirin for heart attack or stroke (as ibuprofen may diminish the cardioprotective effects of aspirin), or are using any other medications.

Drug Interactions

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

Pharmacodynamic 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. This interaction may reduce the overall efficacy of aspirin in these critical situations.

Additionally, the concomitant use of ibuprofen with anticoagulants or steroid medications significantly increases the risk of gastrointestinal bleeding. This risk is further amplified when ibuprofen is taken alongside other nonsteroidal anti-inflammatory drugs (NSAIDs), including prescription and nonprescription options such as aspirin and naproxen.

Recommendations

It is advisable for patients to consult a healthcare professional before initiating ibuprofen if they are currently taking any other medications, particularly anticoagulants, steroids, or other NSAIDs. Monitoring for signs of gastrointestinal bleeding is recommended in patients who are prescribed ibuprofen in conjunction with these medications.

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 capsule every 4 to 6 hours as needed while symptoms persist. In cases where pain or fever does not adequately respond to 1 capsule, 2 capsules may be administered. It is important to note that the maximum dosage should not exceed 6 capsules within a 24-hour period unless otherwise directed by a healthcare provider.

Geriatric Use

Elderly patients, particularly those aged 60 and older, are at an increased risk for severe stomach bleeding. It is essential for healthcare providers to exercise caution when prescribing this medication to geriatric patients, especially in the presence of risk factors such as high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or a history of stroke.

Before initiating treatment, healthcare providers should inquire about the presence of these conditions and consider the potential implications for the patient's safety. Close monitoring for signs of gastrointestinal bleeding is advised in this population, and dosage adjustments may be necessary based on individual patient assessments and overall health status.

Pregnancy

Pregnant patients and women of childbearing potential should consult a healthcare professional before using this medication. The use of ibuprofen is particularly cautioned against after 20 weeks of gestation unless explicitly directed by a physician. Administration during this period may pose risks to the developing fetus and could lead to complications during delivery. Therefore, careful consideration and professional guidance are essential for pregnant patients considering the use of this medication.

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 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 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. Healthcare professionals are advised to contact a Poison Control Center at 1-800-222-1222 for guidance on managing the situation effectively.

Prompt intervention is crucial to mitigate potential adverse effects associated with overdose. Symptoms may vary depending on the substance involved, and healthcare providers should be prepared to assess and manage these symptoms accordingly.

Management procedures may include supportive care and symptomatic treatment, tailored to the specific clinical presentation of the patient. Continuous monitoring and evaluation are essential to ensure patient safety and to address any complications that may arise during the course of treatment.

Nonclinical Toxicology

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

Postmarketing Experience

Postmarketing experience has identified several adverse reactions associated with the use of the product. Reports include gastrointestinal bleeding, renal impairment, and cardiovascular events. Serious skin reactions, such as Stevens-Johnson syndrome and toxic epidermal necrolysis, have also been documented. Additionally, cases of liver enzyme elevations and liver failure have been reported.

Anaphylactic reactions, including angioedema and bronchospasm, have been noted, along with serious allergic reactions characterized by hives and facial swelling. Furthermore, postmarketing data indicate an increased risk of heart attack and stroke associated with prolonged use of NSAIDs, including ibuprofen.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222 in the event of an overdose. It is crucial to inform patients that they should not use this medication if they have a history of allergic reactions to any other pain reliever or fever reducer. Additionally, patients should be cautioned against using the product immediately before or after heart surgery.

Patients must be instructed to stop using the medication and consult a doctor if they experience any signs of stomach bleeding, which may include feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain. They should also be made aware of the 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, and advised to seek medical attention if these occur.

Healthcare providers should emphasize that patients need to stop using the medication and consult a doctor 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. It is important for healthcare providers to encourage patients to consult a doctor before use if the stomach bleeding warning is applicable to them or if they have experienced serious side effects from pain relievers or fever reducers in the past.

Patients with a history of stomach problems, such as heartburn, or those with high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or a history of stroke should be advised to seek medical guidance before using this medication. Furthermore, patients taking diuretics or any other medications should be encouraged to consult a doctor or pharmacist prior to use. Lastly, patients should be informed that if they are taking aspirin for heart attack or stroke prevention, they should discuss this with their healthcare provider, as ibuprofen may diminish the effectiveness of aspirin.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It should be stored at a temperature range of 20° to 25°C (68° to 77°F). Care must be taken to avoid exposure to excessive heat, specifically temperatures exceeding 40°C (104°F). Additionally, the product must be protected from light to maintain its integrity and efficacy.

Additional Clinical Information

No further data are available.

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.

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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.