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Sound Body Ibuprofen

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This product has been discontinued

Active ingredient
Ibuprofen 200 mg
Other brand names
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 2015
Label revision date
October 12, 2023
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Ibuprofen 200 mg
Other brand names
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 2015
Label revision date
October 12, 2023
Manufacturer
Big Lots Stores, Inc.
Registration number
ANDA077349
NDC root
50594-005
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info
Packaging & NDC Codes

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

Ibuprofen is a type of medication known as a nonsteroidal anti-inflammatory drug (NSAID) that comes in tablet form, typically at a strength of 200 mg. It is commonly used to temporarily relieve minor aches and pains, including headaches, muscular aches, toothaches, backaches, and menstrual cramps. Additionally, ibuprofen can help reduce fever and alleviate minor pain associated with arthritis and the common cold.

This medication works by blocking certain substances in the body that cause inflammation and pain, making it effective for a variety of everyday discomforts. If you're looking for relief from these types of symptoms, ibuprofen may be a suitable option for you.

Uses

You can use this medication to temporarily relieve minor aches and pains caused by various conditions, including headaches, muscular aches, arthritis pain, toothaches, backaches, the common cold, and menstrual cramps. Additionally, it can help reduce fever for a short period.

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

Dosage and Administration

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 you find that one caplet isn’t enough to relieve your pain or fever, you may take 2 caplets instead. However, it’s important not to exceed 6 caplets in a 24-hour period unless your doctor advises you 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 use this medication right before or after heart surgery, as it may pose serious risks in these situations. Always consult with your healthcare provider if you have any concerns or questions about your health and 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, asthma (wheezing), shock, skin reddening, rash, and blisters. Additionally, this medication carries a risk of severe stomach bleeding, especially for those over 60, those with a history of stomach ulcers or bleeding, and those taking blood thinners or other NSAIDs. The risk of heart attack and stroke is also increased with NSAID use, particularly if taken in higher doses or for extended periods.

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

Warnings and Precautions

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

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

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 3 days, or if you notice any new symptoms. In case of an overdose, get emergency medical help or contact a Poison Control Center immediately 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 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 one caplet every 4 to 6 hours as needed for symptoms. If one caplet isn't effective, you can give two, but be sure not to exceed six caplets in a 24-hour period unless a doctor advises otherwise.

Always keep this medication out of reach of children. In the event of an overdose, seek medical help immediately or contact a Poison Control Center at 1-800-222-1222.

Geriatric Use

If you are 60 years or older, there are important considerations to keep in mind when using certain pain relievers or fever reducers, such as ibuprofen. You should be cautious if you have a history of stomach ulcers or bleeding problems, as well as if you take blood thinners (medications that prevent blood clots) or steroids. It's also essential to avoid using other nonsteroidal anti-inflammatory drugs (NSAIDs), like aspirin or naproxen, while taking ibuprofen, as this can increase the risk of side effects.

Additionally, if you consume three or more alcoholic drinks daily, take medications for high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or have had a stroke, you should consult your doctor before using ibuprofen. Be mindful of any serious side effects you've experienced from pain relievers in the past, and always follow the recommended dosage. If you are under a doctor's care for any serious condition or taking other medications, it's crucial to discuss your options with your healthcare provider to ensure your safety.

Renal Impairment

If you have kidney problems, it's important to consult your doctor before using this medication. Your healthcare provider will want to know about any other conditions you may have, such as high blood pressure, heart disease, liver cirrhosis, asthma, or a history of stroke. This information helps ensure that the treatment is safe and appropriate for you. Always prioritize open communication with your doctor regarding your health status and any medications you are considering.

Hepatic Impairment

If you have liver problems, such as liver cirrhosis (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 monitor your liver function closely. This is to ensure that the medication is safe and effective for you, considering your liver's ability to process it.

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

Drug Interactions

It's important to be aware that certain medications can interact with each other, which may affect how well they work. For instance, if you take ibuprofen, it might reduce the effectiveness of aspirin when used for heart attack or stroke prevention. Additionally, if you are on blood thinners (medications that help prevent blood clots) or steroids, it's crucial to consult with your doctor or pharmacist before using ibuprofen.

You should also check with your healthcare provider if you are taking other nonsteroidal anti-inflammatory drugs (NSAIDs), like aspirin or naproxen, as combining these can lead to complications. Always discuss any medications you are taking 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 20-25°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, ensuring it works as intended when you need it.

Additional Information

You should take this medication orally. If you are pregnant or breastfeeding, it's important to consult a healthcare professional before using it. Specifically, avoid using ibuprofen after 20 weeks of pregnancy unless your doctor has specifically instructed you to do so, as it can lead to issues for the unborn child or complications during delivery.

Always keep this medication out of reach of children. In the event of an overdose, seek medical assistance immediately or contact a Poison Control Center at 1-800-222-1222.

FAQ

What is ibuprofen used for?

Ibuprofen is used to temporarily relieve minor aches and pains from headaches, muscular aches, arthritis, toothaches, backaches, the common cold, and menstrual cramps. It also temporarily reduces fever.

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

You should take 1 caplet every 4 to 6 hours while symptoms persist. If pain or fever does not respond to 1 caplet, you may take 2 caplets, 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 ibuprofen and seek medical help if you feel faint, vomit blood, have bloody or black stools, or have stomach pain that does not improve.

Are there any contraindications for using ibuprofen?

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

Can ibuprofen be used during pregnancy?

If you are pregnant or breastfeeding, consult 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 immediately at 1-800-222-1222.

What are the potential allergic reactions to ibuprofen?

Ibuprofen may cause severe allergic reactions, especially in those allergic to aspirin. Symptoms can include hives, facial swelling, asthma, shock, skin reddening, rash, and blisters.

What storage conditions are recommended for ibuprofen?

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

Packaging Info

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

Packaging configurations for Sound Body Ibuprofen.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Ibuprofen is a nonsteroidal anti-inflammatory drug (NSAID) indicated for the relief of pain and reduction of fever. Each tablet contains 200 mg of ibuprofen. The product is presented in the form of capsule-shaped tablets, with a total of 100 caplets per package. The actual size of the tablets is designed for ease of administration.

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 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 of this product is contraindicated in patients with a history of allergic reactions to ibuprofen or any other pain reliever or fever reducer. Additionally, it should not be administered immediately before or after heart surgery due to potential complications associated with surgical recovery.

Warnings and Precautions

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

The use of ibuprofen, an NSAID, carries a significant risk of severe stomach bleeding. This risk is notably elevated in patients who are aged 60 years 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 or seek emergency medical help without delay (1-800-222-1222).

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. Additionally, 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 redness or swelling occurs in the affected area, or if any new symptoms arise.

Side Effects

Patients using ibuprofen may experience a range of adverse reactions, which can vary in 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 ibuprofen in higher doses or for extended periods.

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, patients should seek medical advice if pain worsens or persists beyond 10 days, if fever intensifies or lasts more than three days, if redness or swelling occurs in the painful area, or if any new symptoms arise.

Before using ibuprofen, patients should consult a healthcare provider if they have experienced 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 advice prior to use. It is important for patients taking aspirin for heart attack or stroke to discuss their use of ibuprofen with a healthcare professional, as it may diminish the cardioprotective effects of aspirin. Additionally, patients under a doctor's care for serious conditions or those taking other medications should consult their healthcare provider or pharmacist before using ibuprofen.

Drug Interactions

Ibuprofen may diminish the cardioprotective effects of aspirin when used for the prevention of heart attack or stroke. Therefore, patients should be advised to avoid concurrent use of ibuprofen with aspirin for these indications.

When considering the use of ibuprofen in patients who are on anticoagulants or steroid medications, it is essential to consult a healthcare professional. This precaution is necessary due to the potential for increased risk of bleeding or other adverse effects associated with the combination of these drug classes.

Additionally, patients should seek guidance from a healthcare provider before using ibuprofen if they are currently taking other nonsteroidal anti-inflammatory drugs (NSAIDs), including both prescription and over-the-counter options such as aspirin or naproxen. This is important to prevent the risk of cumulative NSAID-related side effects.

Lastly, it is advisable for patients to consult a healthcare professional before initiating ibuprofen if they are taking any other medications, to ensure safe and effective use.

Packaging & NDC

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

Packaging configurations for Sound Body 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 while symptoms persist. If pain or fever does not adequately respond to 1 caplet, 2 caplets may be administered. It is important not to exceed 6 caplets in a 24-hour period unless directed by a healthcare provider.

Healthcare professionals should advise caregivers to keep the medication out of reach of children. In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center should be contacted at 1-800-222-1222.

Geriatric Use

Elderly patients, defined as those aged 60 years or older, may be at an increased risk for adverse effects when using this product. Special caution is warranted for geriatric patients with a history of stomach ulcers or bleeding problems, as well as those who are concurrently taking blood thinners (anticoagulants) or steroid medications. The concomitant use of this product with other drugs containing prescription or nonprescription nonsteroidal anti-inflammatory drugs (NSAIDs), such as aspirin, ibuprofen, or naproxen, should be avoided due to the potential for increased gastrointestinal bleeding.

Geriatric patients who consume three or more alcoholic drinks daily while using this product should be closely monitored, as this may exacerbate the risk of stomach bleeding. Additionally, those who take more of the product or for a longer duration than directed should be advised against such practices to minimize the risk of serious side effects.

Patients with a history of allergic reactions to ibuprofen or other pain relievers/fever reducers should not use this product. Furthermore, individuals who have undergone heart surgery or have experienced serious side effects from pain relievers or fever reducers should exercise caution. The warning regarding stomach bleeding is particularly relevant for elderly patients with a history of stomach problems, such as heartburn.

Elderly patients with comorbid conditions, including high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or a history of stroke, should be carefully evaluated before using this product. Those taking diuretics or aspirin for the prevention of heart attacks or strokes should also be aware that ibuprofen may diminish the cardioprotective effects of aspirin.

Finally, geriatric patients under a physician's care for any serious condition or those taking any other medications should consult their healthcare provider prior to using this product to ensure safe and effective use. Regular monitoring and appropriate dose adjustments may be necessary to mitigate potential risks in this population.

Pregnancy

Pregnant patients and women of childbearing potential should consult a healthcare professional before using this medication. The use of ibuprofen is particularly cautioned against after 20 weeks of pregnancy, as it may pose risks to the developing fetus and lead to complications during delivery. Healthcare providers should carefully evaluate the necessity of ibuprofen in these patients and consider alternative treatments when appropriate.

Lactation

Lactating mothers are advised to consult a healthcare 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 available regarding the excretion of ibuprofen in breast milk or its effects on breastfed infants. Therefore, caution is recommended when considering the use of this medication during lactation.

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 may experience altered pharmacokinetics of the medication. 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 due to impaired drug metabolism. 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.

Patients with significant hepatic impairment should be evaluated for potential contraindications, particularly if they also have comorbid conditions such as high blood pressure, heart disease, kidney disease, asthma, or a history of stroke. It is crucial to tailor treatment plans based on the severity of liver dysfunction and the overall health status of the patient.

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

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 text.

Postmarketing Experience

Postmarketing experience has identified several events reported voluntarily or through surveillance programs.

Leg swelling has been noted among patients. Additionally, instances of pain worsening or persisting for more than 10 days have been documented. Reports also indicate that fever may worsen or last beyond 3 days. Redness or swelling in the area of pain has been observed, along with the emergence of any new symptoms.

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 heart attack or stroke should be cautioned to speak with a doctor or pharmacist, as ibuprofen may reduce the effectiveness of aspirin in these situations. Lastly, patients under a doctor's care for any serious condition or those taking any other medications should be encouraged to consult their healthcare provider or pharmacist before 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). 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 maintain the integrity of the product.

Additional Clinical Information

The medication is administered orally. Clinicians should counsel patients who are pregnant or breastfeeding to consult a health professional prior to use, particularly emphasizing the importance of avoiding ibuprofen after 20 weeks of pregnancy unless specifically directed by a physician, due to potential risks to the unborn child and complications during delivery.

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

Drug Information (PDF)

This file contains official product information for Sound Body 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 Sound Body 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.