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Good Sense Ibuprofen

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Active ingredient
Ibuprofen 100 mg/5 mL
Other brand names
Drug class
Nonsteroidal Anti-inflammatory Drug
Dosage form
Suspension
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2011
Label revision date
April 18, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Ibuprofen 100 mg/5 mL
Other brand names
Drug class
Nonsteroidal Anti-inflammatory Drug
Dosage form
Suspension
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 2011
Label revision date
April 18, 2025
Manufacturer
L. Perrigo Company
Registration number
ANDA074937
NDC root
0113-0685
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (2 NDCs)
Packaging & NDC Codes (2)

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Drug Overview

GOODSENSE® Children's Ibuprofen is an oral suspension designed for children aged 2 to 11 years. This medication contains 100 mg of ibuprofen (a type of nonsteroidal anti-inflammatory drug, or NSAID) per 5 mL and is used to relieve minor aches and pains associated with common conditions like the cold, flu, sore throat, headache, and toothache. Additionally, it helps reduce fever and provides relief that can last up to 8 hours.

This dye-free, non-staining formula comes in a pleasant berry flavor and is alcohol-free, making it a suitable option for children. With a total volume of 8 FL OZ (240 mL), it offers a convenient way to help manage your child's discomfort during illness.

Uses

You can use this medication to help relieve minor aches and pains caused by common conditions like the cold, flu, sore throat, headache, and toothache. It is also effective in reducing fever, making it a helpful option when you're feeling unwell.

Rest assured, this medication does not have any teratogenic effects, meaning it does not cause developmental issues in a fetus.

Dosage and Administration

Before using this medication, it's important to know that it doesn't come with specific directions or warnings for adults. Always make sure to follow the dosage instructions carefully and never exceed the recommended amount. Start by shaking the bottle well before each use. To find the right dose, refer to the dosing chart provided. If possible, use your child's weight to determine the dose; if you don't have that information, you can use their age instead.

Make sure to use only the enclosed dosing cup for measuring the medication, as other devices may not provide accurate measurements. If necessary, you can repeat the dose every 6 to 8 hours, but remember not to use it more than four times a day. After each use, wash the dosing cup to keep it clean, and always replace the original bottle cap to ensure it remains child-resistant. For children weighing under 24 pounds (under 2 years), consult a doctor before administering any dose. For those weighing between 24 and 95 pounds, follow the specific dosing amounts based on their weight as outlined in the chart.

What to Avoid

You should avoid using this medication if your child has ever had an allergic reaction to ibuprofen or 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. Always consult with a healthcare professional if you have any concerns about your child's health or medication use.

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 (asthma), shock, skin reddening, rashes, and blisters. Additionally, this medication carries a risk of severe stomach bleeding, especially if your child has a history of stomach ulcers, is taking blood thinners or steroids, or uses other NSAIDs (nonsteroidal anti-inflammatory drugs) like aspirin or naproxen.

There is also an increased risk of heart attack and stroke associated with NSAIDs, which can be fatal, particularly if used in higher doses or for extended periods. If your child experiences severe or persistent sore throat, high fever, or symptoms of stomach bleeding (such as faintness, vomiting blood, or black stools), seek medical attention immediately. Always consult a doctor if your child has a history of stomach issues, is dehydrated, or has other serious health conditions before using ibuprofen.

Warnings and Precautions

It's important to be aware of some serious warnings when using ibuprofen. If you or your child have a known allergy to aspirin, be cautious, as ibuprofen can cause severe allergic reactions. Symptoms may include hives, facial swelling, asthma (wheezing), and skin issues like rash or blisters. If any of these occur, stop using the medication and seek medical help immediately. Additionally, ibuprofen can lead to stomach bleeding, especially if your child has a history of stomach ulcers, is taking blood thinners, or uses other NSAIDs (nonsteroidal anti-inflammatory drugs) like aspirin or naproxen.

You should also be mindful of the risk of heart attack and stroke associated with NSAIDs, particularly if used in higher doses or for longer than recommended. If your child has a severe sore throat that lasts more than two days or is accompanied by high fever, headache, nausea, or vomiting, consult a doctor right away. Before using ibuprofen, check with a healthcare provider if your child has any history of stomach issues, dehydration, high blood pressure, or is taking other medications.

If you suspect an overdose, contact a Poison Control Center or seek medical help immediately. Stop using ibuprofen and call your doctor if your child experiences symptoms of stomach bleeding (like faintness, vomiting blood, or black stools), signs of heart problems or stroke (such as chest pain or weakness), or if their condition does not improve within 24 hours. Always be vigilant for any new symptoms or worsening of fever or pain.

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

The safety of ibuprofen during pregnancy has not been established, and it is generally not recommended, especially in the third trimester (the final three months of pregnancy). Using ibuprofen may pose risks to your developing baby, including potential cardiovascular effects.

If you are pregnant or planning to become pregnant, it is important to consult your healthcare provider before taking ibuprofen or any medication. They can help you understand the risks and suggest safer alternatives for managing pain or inflammation during this time.

Lactation Use

If you are breastfeeding or planning to breastfeed, it's important to consult your doctor before using this product. There is a possibility that the medication can pass into your breast milk, which may pose risks to your infant. Therefore, caution is advised when considering this medication while nursing. Always prioritize your health and your baby's safety by discussing any concerns with your healthcare provider.

Pediatric Use

When using this medication for children aged 2 to 11 years, it's important to follow specific dosing guidelines based on their weight. For children under 2 years who weigh less than 24 lbs, you should consult a doctor before use. For those aged 2-3 years weighing 24-35 lbs, the recommended dose is 5 mL, while children aged 4-5 years weighing 36-47 lbs should receive 7.5 mL. As the child's weight increases, so does the dosage, reaching up to 15 mL for an 11-year-old weighing 72-95 lbs.

Be cautious not to use this medication for more than 2 days without a doctor's advice, especially for children under 3 years. If you need to repeat a dose, do so every 6-8 hours, but do not exceed 4 doses in a day. Always use the enclosed dosing cup for accuracy. Watch for any signs of stomach bleeding, such as faintness or bloody stools, and consult a doctor if your child has a history of stomach issues, high blood pressure, or other serious health conditions. If your child does not feel better within 24 hours or if symptoms worsen, seek medical advice.

Geriatric Use

As you care for older adults, it's important to be aware that they may be more sensitive to the side effects of medications. This means that their dosages might need to be adjusted, especially if they have any kidney issues or other health concerns. If you or your loved one has a history of stomach problems, such as heartburn, or has experienced serious side effects from pain relievers or fever reducers, it's crucial to consult a doctor before starting any new medication.

Additionally, if there are existing conditions like high blood pressure, heart disease, liver cirrhosis, or a history of stroke, special precautions should be taken. Be particularly cautious if there have been past issues with stomach ulcers or bleeding, as these can increase the risk of stomach bleeding when taking certain medications, especially those that are blood thinners or nonsteroidal anti-inflammatory drugs (NSAIDs) like aspirin or ibuprofen. Always discuss any concerns with a healthcare professional to ensure safe and effective 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), or if you've had a stroke. Your healthcare provider can help determine if this medication is safe for you and whether any adjustments are needed based on your kidney health. Always prioritize open communication with your doctor regarding your medical history and current health conditions.

Hepatic Impairment

If you have liver problems, such as liver cirrhosis (severe scarring of the liver), it's important to be aware of how this may affect your treatment. Your healthcare provider may need to adjust your medication dosage or closely monitor your liver function tests (tests that check how well your liver is working) to ensure your safety and the effectiveness of the treatment.

Additionally, if you have other health issues like high blood pressure, heart disease, or kidney disease, these conditions can also influence your treatment plan. Always communicate openly with your healthcare team about your liver health and any other medical conditions you have, so they can provide the best care tailored to your needs.

Drug Interactions

It's important to be aware that ibuprofen can cause serious allergic reactions, particularly in individuals who are allergic to aspirin. Additionally, if your child is taking blood thinners (medications that help prevent blood clots) or steroids, the risk of stomach bleeding increases. This risk is also heightened if your child is using other nonsteroidal anti-inflammatory drugs (NSAIDs), such as aspirin or naproxen.

To ensure your child's safety, always consult with a healthcare provider before starting ibuprofen or any other medication. Discussing all medications your child is taking, including over-the-counter drugs, is crucial to avoid potential interactions and complications.

Storage and Handling

To ensure the safety and effectiveness of your product, store it at a temperature between 20-25°C (68-77°F). It's important to avoid freezing the product, as this can damage it. Before use, check the printed neckband; do not use the product if it is broken or missing, as this could indicate a safety issue.

By following these simple storage and handling guidelines, you can help maintain the quality and reliability of your product.

Additional Information

You should take this medication orally, and if necessary, you can repeat the dose every 6 to 8 hours, but do not exceed four doses in a day. To help prevent stomach upset, consider taking it with food or milk. Always use the enclosed dosing cup for accurate measurement, and make sure to wash it after each use.

It's important to keep this medication out of reach of children. In case of an overdose, seek medical help immediately or contact a Poison Control Center at 1-800-222-1222.

FAQ

What is GOODSENSE® Children's Ibuprofen used for?

It is used to relieve minor aches and pains due to the common cold, flu, sore throat, headache, and toothache, as well as to reduce fever.

What age group is GOODSENSE® Children's Ibuprofen indicated for?

This product is indicated for children aged 2 to 11 years.

How should I administer GOODSENSE® Children's Ibuprofen?

You should use the enclosed dosing cup and follow the dosing chart based on your child's weight or age. Shake well before using.

What are the dosing recommendations for GOODSENSE® Children's Ibuprofen?

For children weighing 24-35 lbs (2-3 years), the dose is 5 mL; for 36-47 lbs (4-5 years), it's 7.5 mL; and so on, up to 15 mL for children weighing 72-95 lbs (11 years).

What precautions should I take when using this medication?

Do not use if your child has had an allergic reaction to ibuprofen or any other pain reliever. Consult a doctor if your child has a history of stomach problems, high blood pressure, or is taking other medications.

What should I do if my child experiences side effects?

Stop use and consult a doctor if your child shows signs of stomach bleeding, heart problems, or if symptoms worsen or do not improve within 24 hours.

Can I give GOODSENSE® Children's Ibuprofen with food?

Yes, it is recommended to give it with food or milk if stomach upset occurs.

Is there a risk of allergic reactions with this medication?

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

What should I do in case of an overdose?

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

Is it safe to use GOODSENSE® Children's Ibuprofen during pregnancy?

The safety of ibuprofen during pregnancy has not been established, and it is contraindicated, especially during the third trimester.

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® is an oral suspension formulation of Children's Ibuprofen, indicated for use in children aged 2 to 11 years. Each 5 mL dose contains 100 mg of ibuprofen, serving as a non-steroidal anti-inflammatory drug (NSAID) for pain relief and fever reduction. The product is designed to be dye-free and non-staining, ensuring a clean administration experience. It is alcohol-free and features a berry flavor for palatability. The suspension provides relief that lasts up to 8 hours and is available in an 8 FL OZ (240 mL) bottle. This formulation is comparable to the active ingredient found in Children’s Motrin® Dye-Free.

Uses and Indications

This drug is indicated for the relief of minor aches and pains associated with the common cold, influenza, sore throat, headache, and toothache. Additionally, it is utilized to reduce fever.

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

Dosage and Administration

This product is intended for use in pediatric patients, and healthcare professionals should refer to the dosing chart to determine the appropriate dosage based on the patient's weight or age. It is essential to shake the product well before each use. The enclosed dosing cup must be utilized for accurate measurement; no other dosing devices should be employed.

For patients weighing under 24 lbs (under 2 years), consultation with a physician is required prior to administration. For those weighing between 24-35 lbs (2-3 years), the recommended dose is 5 mL. Patients weighing 36-47 lbs (4-5 years) should receive 7.5 mL, while those weighing 48-59 lbs (6-8 years) should be administered 10 mL. For patients weighing 60-71 lbs (9-10 years), the dose is 12.5 mL, and for those weighing 72-95 lbs (11 years), the recommended dose is 15 mL.

Dosing may be repeated every 6-8 hours as necessary, but should not exceed four doses in a 24-hour period. After each use, the dosing cup should be washed thoroughly to ensure hygiene. It is crucial to replace the original bottle cap after use to maintain child resistance and prevent accidental ingestion. Healthcare professionals should advise caregivers to adhere strictly to the dosing recommendations and not exceed the directed amount.

Contraindications

Use of this product is contraindicated in the following situations:

Patients with a history of allergic reactions to ibuprofen or any other pain reliever or fever reducer should not use this product, as it may trigger a severe allergic response. Additionally, the product should not be administered immediately before or after heart surgery due to potential complications associated with its use in this context.

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 heightened in children who have a history of stomach ulcers or bleeding problems, are taking anticoagulants or steroid medications, are using other NSAIDs (including aspirin, ibuprofen, or naproxen), 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 escalates with higher doses or prolonged use beyond the recommended guidelines.

Severe or persistent sore throat, particularly when accompanied by high fever, headache, nausea, or vomiting, may indicate a serious condition. In such cases, it is essential to consult a healthcare provider promptly. The use of ibuprofen should not exceed two days, nor should it be administered to children under three years of age unless directed by a physician.

Healthcare professionals should advise caregivers to consult a doctor prior to use if any of the following conditions apply: the child has a history of stomach problems (such as heartburn), has experienced serious side effects from pain relievers or fever reducers, has not been adequately hydrated, has lost significant fluids due to vomiting or diarrhea, has high blood pressure, heart disease, liver cirrhosis, kidney disease, or a history of stroke, has asthma, or is taking a diuretic. Furthermore, it is advisable to consult a doctor or pharmacist if the child is under medical care for any serious condition or is taking other medications.

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

Caregivers should discontinue use and consult a healthcare provider if the child exhibits any signs of stomach bleeding, such as feeling faint, vomiting blood, passing bloody or black stools, or experiencing persistent stomach pain. Additionally, symptoms indicative of heart problems or stroke, including chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling, warrant immediate medical evaluation. If the child does not experience relief within the first 24 hours of treatment, if fever or pain worsens or persists beyond three days, if redness or swelling occurs in the affected area, or if any new symptoms arise, medical advice should be sought without delay.

Side Effects

Patients may experience a range of adverse reactions associated with the use of this product. 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 product, which contains a nonsteroidal anti-inflammatory drug (NSAID), carries a risk of severe stomach bleeding. This risk is heightened in patients with a history of stomach ulcers or bleeding problems, those taking anticoagulants or steroid medications, and individuals using other NSAIDs, including aspirin and naproxen. Patients should be monitored for signs of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain.

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 greater when the medication is used in excess of the recommended dosage or for prolonged periods.

Patients should be advised to seek medical attention if they experience severe or persistent sore throat, especially when accompanied by high fever, headache, nausea, or vomiting, as these symptoms may indicate a serious condition.

Common adverse reactions may include gastrointestinal discomfort, and patients should be instructed to discontinue use and consult a healthcare provider if symptoms do not improve within 24 hours, if fever or pain worsens or persists beyond three days, or if any new symptoms arise.

Before using this product, it is essential for patients to consult a healthcare provider if they have a history of stomach problems, are experiencing dehydration, or have pre-existing conditions such as high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma. Special caution is advised for patients under a doctor's care for serious conditions or those taking other medications.

Drug Interactions

Ibuprofen has the potential to induce severe allergic reactions, particularly in individuals with a known allergy to aspirin. This risk necessitates careful consideration when prescribing ibuprofen to patients with such allergies.

In terms of pharmacodynamic interactions, the concomitant use of ibuprofen with anticoagulants or steroid medications significantly increases the risk of gastrointestinal bleeding. This risk is further compounded when ibuprofen is taken alongside other nonsteroidal anti-inflammatory drugs (NSAIDs), including both prescription and over-the-counter options such as aspirin and naproxen.

Given these interactions, it is advisable for healthcare providers to closely monitor patients who are prescribed ibuprofen, especially those who are concurrently taking anticoagulants, steroids, or other NSAIDs. Consultation with a physician is recommended if the patient is on any additional medications to ensure safe and effective use of ibuprofen.

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 aged 2 to 11 years may receive this medication with specific dosing guidelines based on weight. For children weighing under 24 lbs, consultation with a doctor is advised for those under 2 years of age. The recommended dosages for children aged 2 to 11 years are as follows: 5 mL for those weighing 24-35 lbs (ages 2-3 years), 7.5 mL for those weighing 36-47 lbs (ages 4-5 years), 10 mL for those weighing 48-59 lbs (ages 6-8 years), 12.5 mL for those weighing 60-71 lbs (ages 9-10 years), and 15 mL for those weighing 72-95 lbs (age 11 years).

Administration precautions include a maximum treatment duration of 2 days without a doctor's direction for children under 3 years. Doses may be repeated every 6-8 hours, not exceeding 4 doses in a 24-hour period. Only the enclosed dosing cup should be used for administration.

Warnings for pediatric use include the risk of stomach bleeding, particularly in children with a history of stomach issues such as heartburn. Healthcare professionals should be consulted if the child experiences any serious side effects from pain relievers or fever reducers, has not been adequately hydrated, or has lost significant fluids due to vomiting or diarrhea. Additional consultation is necessary for children with high blood pressure, heart disease, liver cirrhosis, kidney disease, a history of stroke, asthma, or those taking diuretics. It is also important to consult a doctor if the child is under care for any serious condition or is taking other medications.

Signs of potential complications include symptoms of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or persistent stomach pain. Symptoms indicating heart problems or stroke, such as chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling, should also prompt immediate medical consultation. If the child does not experience relief within 24 hours, or if fever or pain worsens or persists beyond 3 days, a doctor should be consulted.

Geriatric Use

Elderly patients may exhibit increased sensitivity to side effects associated with this product, necessitating careful consideration of dosage adjustments based on individual kidney function and overall health status. It is essential for healthcare providers to monitor geriatric patients closely, particularly those aged 65 and older, as they may be at a higher risk for adverse effects.

Special precautions should be taken for elderly patients with comorbid conditions such as high blood pressure, heart disease, liver cirrhosis, or kidney disease. Additionally, those with a history of stroke may require further evaluation before initiating treatment.

Healthcare providers should also be vigilant in assessing any history of gastrointestinal issues, including heartburn or previous stomach ulcers, as these conditions may increase the risk of serious complications such as stomach bleeding. The risk is further elevated in patients who are concurrently taking anticoagulants, steroid medications, or other nonsteroidal anti-inflammatory drugs (NSAIDs), including aspirin, ibuprofen, or naproxen.

In summary, careful monitoring and potential dosage modifications are critical when prescribing this product to elderly patients to ensure their safety and minimize the risk of adverse effects.

Pregnancy

The safety of ibuprofen during pregnancy has not been established. Ibuprofen is contraindicated in pregnancy, particularly during the third trimester, due to potential risks to the fetus. The use of ibuprofen during this period may pose risks, including potential cardiovascular effects on the developing fetus.

Pregnant women are advised to consult a healthcare provider before using ibuprofen to discuss potential risks and alternative treatment options.

Lactation

Nursing mothers are advised to consult a doctor before using this product. There is a potential for excretion in breast milk, and caution is recommended when administering this medication to lactating mothers due to the potential risk to the breastfed infant.

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, 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 may experience altered pharmacokinetics of the medication due to compromised liver function. It is essential to assess liver function prior to initiating treatment and to monitor liver parameters throughout the course of therapy.

In patients with liver cirrhosis, dosage adjustments may be necessary to mitigate the risk of adverse effects. Close monitoring of liver function tests, including alanine aminotransferase (ALT), aspartate aminotransferase (AST), and bilirubin levels, is recommended to ensure patient safety and therapeutic efficacy.

Additionally, patients with a history of significant liver disease, such as cirrhosis, should be evaluated for potential contraindications or the need for alternative therapeutic options. Regular follow-up assessments are advised to monitor for any changes in liver function that may necessitate further dosage modifications or discontinuation of therapy.

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, as timely medical support can significantly influence outcomes. Symptoms of overdose 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, monitoring of vital signs, and symptomatic treatment as necessary. It is essential for healthcare professionals to remain vigilant and act swiftly to mitigate potential complications associated with overdose.

Nonclinical Toxicology

No information is available regarding teratogenic effects. Additionally, there is no information provided concerning non-teratogenic effects. The insert does not contain any details related to nonclinical toxicology. Furthermore, there is no information available regarding animal pharmacology and toxicology.

Postmarketing Experience

Allergic reactions, including hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, and blisters, have been reported in the postmarketing experience. Serious adverse reactions such as headache, nausea, and vomiting may also occur. A warning regarding stomach bleeding is applicable to children with a history of stomach problems, such as heartburn, or those taking blood thinners or other nonsteroidal anti-inflammatory drugs (NSAIDs). Additionally, symptoms indicative of heart problems or stroke have been reported, including chest pain, difficulty breathing, weakness in one part or side of the body, slurred speech, and leg swelling. Reports of severe allergic reactions, including anaphylaxis, have been noted in the postmarketing experience.

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 for patients to understand the importance of prompt action in such situations.

Additionally, healthcare providers should recommend that patients take the medication with food or milk if they experience any stomach upset. This guidance can help mitigate gastrointestinal discomfort and enhance the overall tolerability of the treatment.

Storage and Handling

The product is supplied in configurations that include specific NDC numbers. It should be stored at a temperature range of 20-25°C (68-77°F) to maintain its integrity. Freezing is not permitted, as it may compromise the product's quality. Additionally, the product must not be used if the printed neckband is broken or missing, as this indicates potential tampering or damage. Proper handling and storage conditions are essential to ensure the product remains safe and effective for use.

Additional Clinical Information

The medication is administered orally, with a recommended dosing frequency of every 6-8 hours as needed, not to exceed four doses per day. Clinicians should advise patients to take the medication with food or milk if gastrointestinal upset occurs and to use only the enclosed dosing cup for accurate measurement, ensuring it is washed after each use.

Patients should be counseled to keep the medication out of reach of children and to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222 in the event of an overdose.

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.

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.