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Good Sense 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 1991
Label revision date
July 12, 2023
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 1991
Label revision date
July 12, 2023
Manufacturer
L. Perrigo Company
Registration number
ANDA072096
NDC root
0113-0647
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (5 NDCs)
Packaging & NDC Codes (5)

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

GOODSENSE® Ibuprofen Tablets are a type of medication known as a nonsteroidal anti-inflammatory drug (NSAID) that helps relieve pain and reduce fever. You can use these tablets to temporarily alleviate minor aches and pains caused by headaches, muscular aches, arthritis, toothaches, backaches, the common cold, and menstrual cramps.

In addition to pain relief, GOODSENSE® Ibuprofen also works to lower fever, making it a versatile option for managing discomfort and illness. Each tablet contains 200 mg of ibuprofen, which is the same active ingredient found in Advil® Ibuprofen Caplets.

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 you're experiencing these common discomforts, allowing you to feel better and get back to your daily activities.

Dosage and Administration

If you are an adult or a child aged 12 years and older, you can take 1 caplet every 4 to 6 hours as needed while you have symptoms. If your pain or fever doesn’t improve with just 1 caplet, you may take 2 caplets instead. However, it’s important not to exceed 6 caplets in a 24-hour period unless your doctor advises otherwise.

For children under 12 years old, it’s best to consult a doctor before giving any medication. This ensures that the treatment is safe and appropriate for their age and condition. Always follow your healthcare provider's instructions for the best results.

What to Avoid

You should avoid using this medication if you have ever had an allergic reaction to ibuprofen or any other pain reliever or fever reducer. Additionally, it is important not to take this medication right before or after heart surgery, as it may pose serious risks in these situations.

Be mindful that this medication is classified as a controlled substance, which means it has the potential for abuse or misuse. Dependence (a condition where you rely on a substance to function normally) can also occur, so it's crucial to use it only as directed and to discuss any concerns with your healthcare provider.

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, with a history of stomach ulcers or bleeding, or who consume alcohol regularly. The risk of heart attack and stroke is also increased with ibuprofen 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, especially aspirin.

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 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.

If you notice signs of stomach bleeding, such as feeling faint, vomiting blood, or having bloody or black stools, stop using ibuprofen and contact your doctor. Seek medical attention if you experience chest pain, trouble breathing, weakness on one side of your body, slurred speech, or leg swelling. Also, consult your doctor if your pain worsens or lasts more than 10 days, your fever persists for more than three days, or if you notice any new symptoms. In case of an overdose, get emergency medical help or contact a Poison Control Center at 1-800-222-1222.

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 take overdosing seriously. If you notice any of these symptoms or have concerns about your health, don’t hesitate to reach out for 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 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 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 one caplet every 4 to 6 hours as needed for symptoms. If one caplet does not relieve pain or fever, you may give two caplets. However, be sure not to exceed six caplets 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

As you age, it's important to be aware of certain risks associated with medications, especially nonsteroidal anti-inflammatory drugs (NSAIDs), which are commonly used for pain relief. If you are 60 years or older, you have a higher chance of experiencing severe stomach bleeding when taking these medications. Additionally, NSAIDs (excluding aspirin) can increase the risk of serious heart issues, such as heart attacks, heart failure, and strokes. This risk becomes greater if you take more than the recommended dose or use them for an extended period.

To stay safe, always follow your healthcare provider's instructions regarding dosage and duration of use. If you have any concerns or experience unusual symptoms while taking these medications, be sure to discuss them with your doctor. Your health and well-being are the top priority, and understanding these risks can help you make informed decisions about your treatment.

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), asthma, or have experienced a stroke. 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 open communication with your doctor regarding your health conditions.

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 if you are taking ibuprofen, it may reduce the effectiveness of aspirin, especially if you are using aspirin to help prevent heart attacks or strokes. This means that the protective benefits of aspirin could be lessened when combined with ibuprofen.

Before starting any new medication, including over-the-counter drugs like ibuprofen, you should always consult with your healthcare provider or pharmacist, especially if you are already taking other medications. This helps ensure that all your treatments work well together and keeps you safe.

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 keep it away from high humidity and avoid exposing it to excessive heat, which can be anything above 40°C (104°F).

Before using the product, check the end panel for the lot number and expiration date to confirm its safety and effectiveness. Proper storage and handling will help maintain the quality of the product, so please follow these guidelines closely.

Additional Information

You should take this medication as follows: for adults and children aged 12 years and older, take 1 caplet every 4 to 6 hours while symptoms persist. If one caplet does not relieve pain or fever, you may take 2 caplets, but do not exceed 6 caplets in a 24-hour period unless directed by a doctor. For children under 12 years, consult a doctor before use.

Before taking this medication, make sure to read all warnings and directions. If you are pregnant or breastfeeding, it’s important to consult a healthcare professional first, especially if you are 20 weeks pregnant or later, as it may pose risks to the unborn child or cause 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 GOODSENSE® Ibuprofen Tablets used for?

GOODSENSE® Ibuprofen Tablets are used to temporarily relieve minor aches and pains due to 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 12 years and older?

Adults and children 12 years and older should take 1 caplet every 4 to 6 hours while symptoms persist. If pain or fever does not respond to 1 caplet, 2 caplets may be used, but do not exceed 6 caplets in 24 hours unless directed by a doctor.

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

Stop using the product and ask a doctor if you experience symptoms such as feeling faint, vomiting blood, having bloody or black stools, or stomach pain that does not get better.

Are there any contraindications for using this medication?

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

Can I take this medication if I am pregnant or breastfeeding?

If you are 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.

What are the storage conditions for this medication?

Store GOODSENSE® Ibuprofen between 20-25°C (68-77°F) and avoid high humidity and excessive heat above 40°C (104°F).

What are the potential risks associated with taking NSAIDs like ibuprofen?

NSAIDs, including ibuprofen, may increase the risk of heart attack, heart failure, and stroke, especially if used more than directed or for longer than directed.

Packaging Info

Below are the non-prescription pack sizes of Good Sense Ibuprofen (ibuprofen). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Good Sense Ibuprofen.
Details

Drug Information (PDF)

This file contains official product information for Good Sense Ibuprofen, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

GOODSENSE® TWIN PACK contains 100 coated caplets of ibuprofen, each delivering 200 mg of the active ingredient. These capsule-shaped tablets function as a nonsteroidal anti-inflammatory drug (NSAID), serving as a pain reliever and fever reducer. The product is designed for comparison with the active ingredient found in Advil® Ibuprofen Caplets.

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

Adults and children aged 12 years and older are advised to take 1 caplet every 4 to 6 hours as needed while symptoms persist. In cases where pain or fever does not adequately respond to 1 caplet, a dosage of 2 caplets may be administered. It is imperative that the total daily dosage does 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 recommended to consult a doctor for appropriate dosing guidance.

Contraindications

Use is contraindicated in patients with a history of allergic reactions to ibuprofen or any other pain reliever or fever reducer, due to the risk of severe hypersensitivity reactions. Additionally, the product should not be administered immediately before or after heart surgery, as it may interfere with postoperative recovery and increase the risk of complications.

Warnings and Precautions

Ibuprofen may elicit 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.

The use of ibuprofen, an NSAID, carries a significant risk of severe stomach bleeding. This risk is notably elevated 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.

Additionally, 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 heightened with the use of higher than recommended doses or prolonged use.

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 physician 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. Furthermore, symptoms suggestive of heart problems or stroke, such as chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling, 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 there is redness or swelling in the affected area, or if any new symptoms arise. Regular monitoring and assessment of these parameters are essential for the safe use of ibuprofen.

Side Effects

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

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 ibuprofen, as a nonsteroidal anti-inflammatory drug (NSAID), carries a significant 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, or exceed the recommended dosage or duration of use.

Additionally, NSAIDs, excluding aspirin, are associated with an increased 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 guidelines.

Patients are advised to 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, difficulty breathing, unilateral weakness, slurred speech, or leg swelling, also warrant immediate medical attention. Furthermore, if pain persists beyond 10 days, fever worsens or lasts more than three days, redness or swelling occurs in the painful area, or any new symptoms arise, patients should seek medical advice.

Before initiating treatment with ibuprofen, patients should consult a healthcare provider if they have a history of serious side effects from pain relievers or fever reducers, if the stomach bleeding warning applies to them, or if they have a history of stomach issues such as heartburn. Those with high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or a history of stroke should also seek medical guidance. It is important for patients taking aspirin for cardiovascular protection to discuss their use of ibuprofen with a healthcare professional, as it may diminish the effectiveness of aspirin. Additionally, patients under medical care for serious conditions or those taking other medications should consult their doctor or pharmacist prior to use.

Drug Interactions

Ibuprofen may diminish the cardioprotective effects of aspirin when used concurrently for the prevention of heart attack or stroke. It is advisable for patients to consult with a healthcare professional, such as a doctor or pharmacist, prior to using ibuprofen in conjunction with any other medications. This precaution is essential to ensure safe and effective use of these drugs and to mitigate potential interactions.

Packaging & NDC

Below are the non-prescription pack sizes of Good Sense Ibuprofen (ibuprofen). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Good Sense 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 for symptom relief. If pain or fever does not adequately respond to 1 caplet, 2 caplets may be administered. It is important not to exceed 6 caplets within a 24-hour period unless otherwise directed by a healthcare provider.

Geriatric Use

Elderly patients, particularly those aged 60 and older, may experience an increased risk of severe stomach bleeding when using this medication. It is essential for healthcare providers to consider this heightened risk when prescribing and monitoring treatment in this population.

Additionally, nonsteroidal anti-inflammatory drugs (NSAIDs), with the exception of aspirin, are associated with an elevated risk of cardiovascular events, including heart attack, heart failure, and stroke. This risk is further amplified in elderly patients who exceed the recommended dosage or duration of use. Therefore, careful assessment of the benefits and risks, along with appropriate dose adjustments and close monitoring, is advised for geriatric patients receiving NSAIDs.

Pregnancy

Pregnant patients should consult a healthcare professional before using this medication, particularly if they are in the later stages of pregnancy or breastfeeding. It is crucial 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 health professional before using this medication. 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 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 a history of kidney disease. It is essential to assess the patient's overall health status, including any comorbid conditions such as high blood pressure, heart disease, liver cirrhosis, asthma, or a history of stroke, as these factors may influence the management of their renal function and the appropriateness of treatment. Monitoring and potential dosing adjustments may be necessary based on the patient's renal status to ensure safety and efficacy.

Hepatic Impairment

Patients with hepatic impairment should consult a healthcare professional prior to use, particularly if they have a history of liver cirrhosis. It is essential for these patients to receive appropriate medical guidance to assess the potential risks associated with their liver function. Monitoring of liver function may be necessary to ensure safety and efficacy during treatment. Adjustments to dosage or treatment regimens may be required based on the severity of hepatic impairment, and healthcare providers should evaluate the individual patient's condition to determine the most suitable approach.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. The national Poison Control Center can be reached at 1-800-222-1222.

Healthcare professionals should be aware that timely 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.

Management procedures may include supportive care and symptomatic treatment, tailored to the specific symptoms presented. It is recommended that healthcare providers remain vigilant and prepared to implement appropriate 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 regarding nonclinical toxicology or animal pharmacology and toxicology provided in the current information.

Postmarketing Experience

Postmarketing experience has identified the following adverse reactions reported voluntarily or through surveillance programs: hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, and blisters. These events have been documented in the context of ongoing safety monitoring.

Patient Counseling

Patients should be advised to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222 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 experienced problems or serious side effects from pain relievers or fever reducers in the past. Additionally, patients should be informed to ask a doctor before use if they have a history of stomach issues, such as heartburn, or if the stomach bleeding warning applies to them.

Patients with high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or a history of stroke should also be advised to consult a doctor prior to use. Furthermore, it is important for patients to discuss their use of diuretics with their healthcare provider before starting this medication.

Patients taking aspirin for the prevention of heart attack or stroke should be informed that ibuprofen may reduce the effectiveness of aspirin, and they should consult a doctor or pharmacist before use. Lastly, patients under a doctor’s care for any serious condition or those taking any other medications should be encouraged to seek advice from their healthcare provider or pharmacist prior to using this medication.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for reference. It is essential to store the product at a temperature range of 20-25°C (68-77°F) to maintain its efficacy. Care should be taken to avoid exposure to high humidity and excessive heat, particularly temperatures exceeding 40°C (104°F). For quality assurance, the lot number and expiration date can be found on the end panel of the packaging. Proper handling and storage conditions are crucial to ensure the integrity of the product throughout its shelf life.

Additional Clinical Information

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

Patients should be counseled to read all warnings and directions prior to use. Pregnant or breastfeeding individuals should seek advice from a healthcare professional before use, particularly noting that ibuprofen should not be used after 20 weeks of pregnancy unless specifically directed by a doctor due to potential risks to the unborn child or complications during delivery. It is crucial to keep the medication out of reach of children, and in the event of an overdose, medical assistance should be sought immediately or contact a Poison Control Center at 1-800-222-1222.

Drug Information (PDF)

This file contains official product information for Good Sense 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 Good Sense 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.