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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 2013
Label revision date
August 12, 2025
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 2013
Label revision date
August 12, 2025
Manufacturer
Good Sense (Geiss, Destin & Dunn, Inc.)
Registration number
ANDA078682
NDC root
50804-199
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (2 NDCs)
Packaging & NDC Codes (2)

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

GOOD SENSE Ibuprofen Capsules contain solubilized ibuprofen, a type of 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, GOOD SENSE Ibuprofen Capsules provide a supportive option for managing discomfort in various situations. If you're experiencing minor pain or fever, this medication may be a helpful 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 comfort when dealing with these common discomforts, allowing you to go about your day with less pain. Always remember to follow the recommended guidelines for use.

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 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 can take 2 capsules. However, make sure not to exceed 6 capsules 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 and never take more than directed.

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 risks to your health.

Be cautious about the dosage; using more than directed or for longer than recommended can increase your risk of heart attack or stroke. Always follow the instructions provided to ensure your safety and well-being.

Side Effects

Ibuprofen can cause serious allergic reactions, particularly in individuals who are allergic to aspirin. Signs of a severe allergic reaction may include hives, facial swelling, wheezing (asthma), shock, skin reddening, rash, and blisters. Additionally, this medication carries a risk of severe stomach bleeding, especially for those over 60, with a history of stomach ulcers or bleeding, or who consume alcohol regularly. If you experience symptoms such as feeling faint, vomiting blood, having bloody or black stools, or persistent stomach pain, you should stop using ibuprofen and consult a doctor immediately.

It's important to be aware of other potential side effects, including symptoms of heart problems or stroke, such as chest pain, slurred speech, difficulty breathing, leg swelling, or weakness on one side of the body. If your pain worsens or lasts more than 10 days, or if your fever persists for more than 3 days, seek medical advice. Always consult a healthcare professional before using ibuprofen if you have any underlying health conditions 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 ibuprofen immediately and seek medical help. Additionally, ibuprofen can lead to severe stomach bleeding, particularly if you are over 60, have a history of stomach ulcers, take blood thinners or steroids, consume three or more alcoholic drinks daily, or use it for longer than directed.

Before using ibuprofen, consult your doctor if you have a history of stomach problems, high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma. It's also important to check with your doctor if you are taking aspirin for heart issues, as ibuprofen may reduce its effectiveness. If you experience signs of stomach bleeding, such as feeling faint, vomiting blood, or having black stools, or if you notice symptoms of a heart problem or stroke, stop taking ibuprofen and call your doctor right away. For any overdose, seek emergency medical help or contact a Poison Control Center immediately.

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 health and safety are the top priority.

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 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, 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 directed by a doctor. 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 relevant if you have conditions like high blood pressure, heart disease, liver cirrhosis (a liver condition), kidney disease, or asthma.

Before starting any new medication, it's wise to consult with your doctor to ensure it's safe for you, particularly if any of these warnings apply to your health situation. Your doctor can help you understand the best options for your needs and monitor any potential side effects.

Renal Impairment

If you have kidney problems, it's important to consult your doctor before using this medication. This is especially crucial if you also have high blood pressure, heart disease, liver cirrhosis (a severe liver condition), or asthma. Your healthcare provider can help determine if this medication is safe for you and may suggest necessary adjustments to your dosage or monitoring based on your kidney function. Always prioritize your health by discussing any concerns with your doctor.

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, or asthma. Always prioritize open communication with your doctor to ensure safe and effective treatment.

Drug Interactions

It's important to be aware of how certain medications can interact with each other. For instance, if you take aspirin to prevent heart attacks or strokes, using it alongside ibuprofen may reduce the effectiveness of aspirin. Additionally, if you have an allergy to aspirin, taking ibuprofen could lead to severe allergic reactions.

You should also know that combining ibuprofen with blood thinners (medications that prevent blood clots) or steroids can increase the risk of stomach bleeding. Furthermore, using ibuprofen for longer than recommended can raise your chances of having a heart attack or stroke. Always discuss your medications and any lab tests with your healthcare provider to ensure your safety and the effectiveness of your treatment.

Storage and Handling

To ensure the best performance of your product, store it in a cool, dry place at a temperature between 20° 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. If you have any specific disposal instructions, be sure to follow them carefully to ensure safety and compliance.

Additional Information

No further information is available.

FAQ

What is GOOD SENSE Ibuprofen Capsules used for?

GOOD SENSE Ibuprofen Capsules are used to temporarily relieve minor aches and pains from headaches, muscular aches, arthritis, toothaches, backaches, the common cold, and menstrual cramps. They also temporarily reduce 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. If pain or fever does not respond to 1 capsule, you may take 2 capsules, but do not exceed 6 capsules in 24 hours unless directed by a doctor.

Are there any warnings associated with ibuprofen?

Yes, ibuprofen may cause severe allergic reactions, especially in those allergic to aspirin. It can also increase the risk of stomach bleeding, particularly in individuals over 60 or those with certain medical conditions.

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

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

Can I take ibuprofen if I am pregnant or breastfeeding?

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

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

If you have a history of stomach problems, such as ulcers or bleeding, or if the stomach bleeding warning applies to you, ask a doctor before using ibuprofen.

How should I store GOOD SENSE Ibuprofen Capsules?

Store the capsules at 20° to 25°C (68° to 77°F) and protect them from excessive heat above 40°C (104°F) 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 provide an equivalent of 200 mg of ibuprofen, a nonsteroidal anti-inflammatory drug (NSAID). The active ingredient is present in both its free acid form and as a potassium salt, facilitating enhanced 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 according to the following guidelines to ensure safety and efficacy.

For adults and children aged 12 years and older, the recommended dosage is 1 capsule every 4 to 6 hours as needed while symptoms persist. 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 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, 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 cause severe allergic reactions, particularly in individuals with a known allergy to aspirin. Symptoms of such reactions can 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 carries a risk of severe stomach bleeding. The likelihood of this adverse effect is increased in patients who are 60 years of age or older, have a history of stomach ulcers or bleeding disorders, are taking anticoagulants or steroid medications, are using 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.

Healthcare professionals should advise patients to consult a physician prior to use if any of the following conditions apply: the patient is at risk for stomach bleeding, has experienced serious side effects from pain relievers or fever reducers, has a history of gastrointestinal issues such as heartburn, has high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma, or is currently taking a diuretic. Additionally, patients should be cautioned to seek guidance from a doctor or pharmacist if they are under medical care for any serious condition, are using aspirin for cardiovascular protection, or are taking any other medications.

In the event of an overdose, immediate medical attention should be sought, or the Poison Control Center (1-800-222-1222) should be contacted.

Patients should be instructed to discontinue use and contact their healthcare provider if they experience any signs of stomach bleeding, which may include feeling faint, vomiting blood, passing bloody or black stools, or experiencing persistent stomach pain. Symptoms indicative of a heart problem or stroke, such as chest pain, slurred speech, difficulty breathing, leg swelling, or weakness on one side of the body, also warrant immediate medical evaluation. Furthermore, if pain worsens or persists beyond 10 days, fever intensifies or lasts more than 3 days, redness or swelling occurs in the affected area, or any new symptoms arise, patients should seek medical advice promptly.

Side Effects

Patients 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.

Additionally, there is a significant risk of severe stomach bleeding associated with the use of this NSAID. The likelihood of experiencing this adverse reaction is increased in patients who are aged 60 years 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.

Patients should be advised to discontinue use and seek medical attention if they experience any signs of stomach bleeding, which may manifest as feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain. Furthermore, symptoms indicative of a heart problem or stroke, such as chest pain, slurred speech, difficulty breathing, leg swelling, or weakness on one side of the body, warrant immediate medical consultation. Patients should also consult a healthcare provider if 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 doctor if they fall into any of the following categories: those for whom the stomach bleeding warning applies, individuals with a history of serious side effects from pain relievers or fever reducers, those with a history of stomach problems such as heartburn, and patients with high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma. Additionally, individuals taking diuretics or under a doctor's care for any serious condition should seek medical advice prior to use. It is also important for patients taking aspirin for heart attack or stroke to consult a healthcare professional, as ibuprofen may diminish the cardioprotective effects of aspirin.

Drug Interactions

The concomitant use of ibuprofen with aspirin, particularly in the context of cardiovascular events such as heart attack or stroke, may diminish the therapeutic efficacy of aspirin. It is advisable to monitor patients closely when these medications are used together, as the intended benefits of aspirin may not be fully realized.

Patients with a known allergy to aspirin should exercise caution when taking ibuprofen, as it may provoke severe allergic reactions in this population.

The co-administration of ibuprofen with anticoagulants or steroid medications significantly elevates the risk of gastrointestinal bleeding. Clinicians should consider dosage adjustments and implement regular monitoring for signs of bleeding in patients receiving these combinations.

Furthermore, prolonged use of ibuprofen beyond the recommended duration may increase the risk of cardiovascular events, including heart attack or stroke. It is essential to adhere to prescribed dosages and treatment durations to mitigate these risks.

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, a dose of 2 capsules may be administered. It is important not to exceed 6 capsules 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. It is essential for healthcare providers to exercise caution when prescribing medications that may exacerbate this risk in this population.

Before initiating treatment, healthcare providers should inquire about the presence of any conditions that may heighten the risk of stomach bleeding, such as high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma. It is advisable for geriatric patients to consult with their healthcare provider prior to use if any of these conditions apply.

Monitoring for signs of gastrointestinal bleeding is recommended in elderly patients, and dosage adjustments may be necessary based on individual health status and concurrent medical conditions.

Pregnancy

Pregnant patients and women of childbearing potential 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 evaluate the potential benefits and risks when considering the use of ibuprofen in 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 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 any risks when considering the use of this medication in lactating mothers.

Renal Impairment

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

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 this 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 in mitigating potential adverse effects associated with an overdose. Symptoms may vary depending on the substance involved, and healthcare providers should be prepared to assess and manage these symptoms as they arise.

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 develop 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 were identified in the available data. Additionally, there are no specific details regarding nonclinical toxicology or animal pharmacology and toxicology provided in the text.

Postmarketing Experience

Postmarketing experience has identified the following adverse reactions reported voluntarily or through surveillance programs: gastrointestinal bleeding, renal impairment, and hypersensitivity reactions. The hypersensitivity reactions include cases of anaphylaxis and angioedema.

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.

Patients should be informed that if they experience stomach upset, it is recommended to take the medication with food or milk to alleviate discomfort.

It is important for healthcare providers to discuss the potential risks associated with the medication, specifically that the risk of heart attack or stroke may increase if patients use more than the directed dosage or for a duration longer than prescribed.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available upon request. 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.

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.