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Equate Ibuprofen

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Active ingredient
Ibuprofen 100 mg
Other brand names
Drug class
Nonsteroidal Anti-inflammatory Drug
Dosage form
Tablet, Chewable
Route
Oral
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2011
Label revision date
August 21, 2025
Active ingredient
Ibuprofen 100 mg
Other brand names
Drug class
Nonsteroidal Anti-inflammatory Drug
Dosage form
Tablet, Chewable
Route
Oral
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Marketed in the U.S.
Since 2011
Label revision date
August 21, 2025
Manufacturer
Wal-Mart Stores Inc
Registration number
ANDA076359
NDC root
49035-521

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Drug Overview

Equate™ is a chewable medication that contains ibuprofen, which is a type of nonsteroidal anti-inflammatory drug (NSAID). It is designed for children ages 2 to 11 years and comes in a grape flavor. This medication is used to reduce fever and relieve minor aches and pains associated with common conditions like colds, flu, sore throats, headaches, and toothaches. Each chewable tablet contains 100 mg of ibuprofen and can provide relief for up to 8 hours.

When using Equate™, it's important to chew or crush the tablets completely before swallowing to ensure proper absorption. This product is available in a pack of 24 chewable tablets, making it convenient for parents to manage their child's discomfort.

Uses

You can use this medication to help reduce fever and relieve minor aches and pains. It is effective for discomfort caused by common conditions such as the cold, flu, sore throat, headaches, and toothaches.

This means that if you're feeling under the weather or dealing with everyday aches, this medication can provide some relief to help you feel better.

Dosage and Administration

Before taking this medication, make sure to chew or crush the tablets completely before swallowing them. It's important to follow the dosing instructions carefully, so do not exceed the recommended amount. You can find the right dose based on your child's weight or age, but if your child weighs less than 24 pounds or is under 2 years old, it's best to consult a doctor first.

For children weighing between 24 and 35 pounds (or ages 2-3 years), the dose is 1 tablet. If your child weighs between 36 and 47 pounds (ages 4-5 years), they should take 1 ½ tablets. For those weighing 48 to 59 pounds (ages 6-8 years), the dose is 2 tablets, and for children weighing 60 to 71 pounds (ages 9-10 years), it's 2 ½ tablets. Finally, if your child weighs between 72 and 95 pounds (age 11 years), they can take 3 tablets. If needed, you can repeat the dose every 6 to 8 hours, but remember not to use this medication more than 4 times a day.

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 this medication right before or after your child has 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. Signs of a severe allergy may include hives, facial swelling, wheezing (asthma), shock, skin reddening, rash, or blisters. Additionally, this medication can lead to severe stomach bleeding, especially if you have a history of stomach ulcers or bleeding issues, are taking blood thinners or steroids, or use other NSAIDs (nonsteroidal anti-inflammatory drugs) like aspirin or naproxen.

There are also risks associated with heart attack and stroke when using NSAIDs, excluding aspirin, particularly if taken in higher doses or for extended periods. If you or your child experience symptoms such as faintness, vomiting blood, bloody or black stools, chest pain, difficulty breathing, or weakness on one side of the body, seek medical attention immediately. It's important to consult a doctor if symptoms persist or worsen, or if new symptoms arise. For mild side effects like mouth or throat burning, taking ibuprofen with food or water may help.

Warnings and Precautions

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

This medication can also lead to severe stomach bleeding, particularly if you have a history of stomach ulcers or bleeding problems, are taking blood thinners or steroids, or are using 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 black stools, or if you experience symptoms of heart problems like chest pain or trouble breathing, stop using ibuprofen and contact your doctor right away.

For children, do not use ibuprofen for more than two days without a doctor's guidance, especially if they are under three years old. If your child does not feel better within 24 hours, or if their fever or pain worsens or lasts more than three days, consult a doctor. In case of an overdose, seek 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 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 safety is the top priority.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that ibuprofen is not recommended, especially during the third trimester. Using nonsteroidal anti-inflammatory drugs (NSAIDs) like ibuprofen during pregnancy can pose risks to your baby, including potential heart problems and kidney issues.

Always consult your healthcare provider for safe alternatives and any necessary dosage adjustments if you need pain relief during pregnancy. It's best to avoid ibuprofen unless your doctor specifically advises you to use it. Your health and the health of your baby are the top priority, so make sure to discuss any concerns with your healthcare professional.

Lactation Use

If you are breastfeeding or planning to breastfeed, it's important to be aware that there is no specific information available regarding the effects of this medication on nursing mothers or lactation (the process of producing breast milk). Since the insert does not provide guidance on these topics, it may be wise to consult your healthcare provider for personalized advice. They can help you understand any potential risks and make informed decisions about your health and your baby's well-being.

Pediatric Use

When giving medication to children aged 2 to 11 years, it's important to follow the recommended dosages carefully. You should use the dosing chart to find the right amount based on your child's weight or age. For example, a child weighing 24-35 pounds (ages 2-3 years) should receive 1 tablet, while a child weighing 72-95 pounds (age 11 years) can take 3 tablets. Make sure not to exceed the maximum of 4 doses in a day, and do not use the medication for more than 2 days without consulting a doctor, especially for children under 3 years old.

Be cautious if your child has a history of stomach issues, is taking other medications, or has certain health conditions like high blood pressure or asthma. If your child shows any signs of stomach bleeding, does not feel better within 24 hours, or if symptoms worsen, stop the medication and consult a doctor immediately. Always ask a healthcare professional if you have any concerns or questions before giving medication to your child.

Geriatric Use

When considering this product for older adults, it's important to consult with a doctor first, especially if you or your loved one has any existing health conditions. This includes high blood pressure, heart disease, liver cirrhosis (a serious liver condition), kidney disease, or a history of stroke. These conditions can affect how the product works and may require special attention or adjustments in dosage.

Please note that the product does not provide specific directions or warnings for adult use, so professional guidance is essential to ensure safety and effectiveness. Always prioritize open communication with healthcare providers to address any concerns or questions.

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 doctor will help determine if this medication is safe for you and may suggest adjustments to your dosage or additional monitoring to ensure your health and safety. Always prioritize open communication with your healthcare provider regarding your kidney health and any other medical conditions you may have.

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 need to assess your overall health, including any other conditions you may have, like high blood pressure, heart disease, or kidney disease. This ensures that the treatment is safe and appropriate for you. Always prioritize open communication with your doctor about your liver health and any concerns you may have.

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 severe 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 potentially dangerous interactions.

Storage and Handling

To ensure the safety and effectiveness of your product, store it at a temperature between 20-25°C (68-77°F). This temperature range helps maintain the product's integrity. Before using, always check that the printed seal under the cap is intact; do not use the product if the seal is broken or missing, as this could indicate contamination or that the product is no longer safe to use.

By following these simple storage and handling guidelines, you can help ensure that the product remains safe and effective for your needs.

Additional Information

You may experience some burning in your mouth or throat when taking this medication. To help reduce this sensation, it's best to take it with food or water. If you find that your stomach feels upset, consider taking the medication with food or milk to ease any discomfort.

FAQ

What is equate™ used for?

Equate™ is used to reduce fever and relieve minor aches and pains due to the common cold, flu, sore throat, headaches, and toothaches.

What age group can use equate™?

Equate™ is intended for children ages 2 to 11 years.

How should I administer equate™?

You should chew or crush the tablets completely before swallowing. It is recommended to take them with food or water to avoid mouth or throat burning.

What is the maximum dosage for equate™?

Do not use more than 4 times a day and do not exceed the recommended dose based on your child's weight or age.

What should I do if my child experiences side effects?

If your child experiences signs of stomach bleeding, such as feeling faint or vomiting blood, or symptoms of heart problems, stop use and consult a doctor immediately.

Are there any contraindications for using equate™?

Do not use equate™ if your child has had an allergic reaction to ibuprofen or any other pain reliever/fever reducer, or if they are about to undergo heart surgery.

Can equate™ be used during pregnancy?

Ibuprofen is contraindicated in pregnancy, especially during the third trimester, due to potential risks to the fetus.

What should I do if my child does not get relief from equate™?

If your child does not experience relief within the first 24 hours of treatment, or if fever or pain worsens or lasts more than 3 days, consult a doctor.

What are the storage instructions for equate™?

Store equate™ between 20-25°C (68-77°F) and do not use if the printed seal under the cap is broken or missing.

Packaging Info

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

Packaging configurations for Equate Ibuprofen.
Details

Drug Information (PDF)

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

View product document (PDF)

Uses and Indications

This drug is indicated for the reduction of fever and the relief of minor aches and pains associated with conditions such as the common cold, influenza, sore throat, headaches, and toothaches.

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

Dosage and Administration

Tablets should be chewed or crushed completely before swallowing. This product does not contain directions or complete warnings for adult use. Healthcare professionals are advised to ensure that patients do not exceed the recommended dosage. The appropriate dose can be determined using the following chart, which prioritizes weight for dosing; if weight is not available, age may be used as a secondary measure.

Dosing may be repeated every 6 to 8 hours as needed, but should not exceed four doses in a 24-hour period.

Dosing Chart:

  • For patients weighing under 24 lb or under 2 years of age, consultation with a physician is recommended.

  • For patients weighing 24-35 lb or aged 2-3 years, the recommended dose is 1 tablet.

  • For patients weighing 36-47 lb or aged 4-5 years, the recommended dose is 1 ½ tablets.

  • For patients weighing 48-59 lb or aged 6-8 years, the recommended dose is 2 tablets.

  • For patients weighing 60-71 lb or aged 9-10 years, the recommended dose is 2 ½ tablets.

  • For patients weighing 72-95 lb or aged 11 years, the recommended dose is 3 tablets.

Contraindications

Use 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 severe allergic responses. Additionally, the product should not be administered immediately before or after heart surgery due to potential complications associated with surgical recovery and medication interactions.

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 is associated with an increased risk of severe stomach bleeding. The likelihood of this adverse effect is heightened in children who have a history of stomach ulcers or bleeding disorders, are concurrently taking anticoagulants or steroid medications, are using other NSAIDs (including aspirin, ibuprofen, or naproxen), or exceed the recommended dosage or duration of treatment.

NSAIDs, excluding aspirin, are also linked to an elevated risk of heart attack, heart failure, and stroke, which can be fatal. This risk is particularly pronounced when the medication is used in excess of the recommended dosage or for prolonged periods.

Healthcare professionals should be vigilant for signs of severe or persistent sore throat, especially when accompanied by high fever, headache, nausea, or vomiting, as these symptoms may indicate a serious condition. It is advised to consult a physician promptly in such cases. Additionally, ibuprofen should not be used for more than two days or administered to children under three years of age unless specifically directed by a healthcare provider.

Healthcare providers should instruct caregivers to discontinue use and seek medical advice if the child exhibits any of the following signs indicative of stomach bleeding: feeling faint, vomiting blood, passing bloody or black stools, or experiencing persistent stomach pain. Symptoms suggestive of heart problems or stroke, such as chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling, also warrant immediate medical consultation. Furthermore, 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.

In cases of overdose, it is crucial to obtain emergency medical help or contact a Poison Control Center immediately at 1-800-222-1222.

Side Effects

Ibuprofen may cause a range of adverse reactions, some of which can be serious.

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 warning for the potential 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. Additionally, the risk increases if the medication is taken in higher doses or for extended periods beyond the recommended guidelines.

Patients should be aware that NSAIDs, excluding aspirin, may elevate the risk of heart attack, heart failure, and stroke, which can be fatal. This risk is particularly pronounced when the medication is used in excess of the directed dosage or for longer than advised.

Severe or persistent sore throat, especially when accompanied by high fever, headache, nausea, and vomiting, may indicate a serious condition. Patients are advised to consult a healthcare provider promptly in such cases and to avoid using ibuprofen for more than two days or administering it to children under three years of age unless directed by a physician.

Patients should discontinue use and seek medical advice if they experience any signs of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain. Symptoms indicative of heart problems or stroke, including chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling, also warrant immediate medical attention. Furthermore, if a patient does not achieve relief within the first 24 hours of treatment, or if fever or pain worsens or persists beyond three days, they should consult a healthcare professional. Redness or swelling in the painful area or the emergence of any new symptoms should also prompt a medical evaluation.

Additional adverse reactions may include mouth or throat burning, which can be mitigated by administering the medication with food or water. If stomach upset occurs, it is recommended to take ibuprofen with food or milk.

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 pediatric patients, the concomitant use of ibuprofen with anticoagulants or steroid medications significantly increases the risk of severe gastrointestinal bleeding. Therefore, it is imperative to monitor these patients closely and consider alternative pain management strategies if they are on these medications.

Additionally, the risk of severe stomach bleeding is elevated when ibuprofen is used alongside other nonsteroidal anti-inflammatory drugs (NSAIDs), including both prescription and over-the-counter options such as aspirin and naproxen. Healthcare providers should advise parents or guardians to consult a physician before administering ibuprofen if the child is taking any other medications, particularly those that may interact adversely.

Packaging & NDC

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

Packaging configurations for Equate Ibuprofen.
Details

Pediatric Use

Pediatric patients aged 2 to 11 years may receive this medication, with dosing determined primarily by weight. The following dosing chart should be utilized:

  • Weight under 24 lb: Age under 2 years: Ask a doctor.

  • Weight 24-35 lb: Age 2-3 years: 1 tablet.

  • Weight 36-47 lb: Age 4-5 years: 1 ½ tablets.

  • Weight 48-59 lb: Age 6-8 years: 2 tablets.

  • Weight 60-71 lb: Age 9-10 years: 2 ½ tablets.

  • Weight 72-95 lb: Age 11 years: 3 tablets.

Doses may be repeated every 6-8 hours as needed, but should not exceed 4 doses in a 24-hour period. The medication should not be used for more than 2 days or administered to children under 3 years of age unless directed by a doctor.

Caution is advised due to the risk of stomach bleeding, which may be heightened in children with a history of stomach ulcers or bleeding problems, those taking anticoagulants or steroids, or those using other NSAIDs. Parents should consult a doctor before use if any of the following apply: the child has a history of stomach issues, has experienced serious side effects from pain relievers, is dehydrated, or has underlying health conditions such as high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma.

Healthcare professionals should be alerted if the child is under a doctor's care for any serious condition or is taking other medications. Parents should discontinue use and seek medical advice if the child shows signs of stomach bleeding, does not achieve relief within 24 hours, experiences worsening symptoms, or develops new symptoms.

Geriatric Use

Elderly patients should exercise caution when considering the use of this product, as it does not contain specific directions or complete warnings for adult use. It is imperative for healthcare providers to assess the individual health status of geriatric patients prior to administration.

Particular attention should be given to patients aged 65 and older who may have underlying health conditions. It is advisable to consult a physician before use if the elderly patient has a history of high blood pressure, heart disease, liver cirrhosis, kidney disease, or has previously experienced a stroke. These conditions may necessitate careful monitoring and potential dose adjustments to ensure safety and efficacy in this population.

Pregnancy

The use of ibuprofen during pregnancy is contraindicated, particularly in the third trimester. The administration of nonsteroidal anti-inflammatory drugs (NSAIDs), including ibuprofen, may pose risks to the fetus, such as potential cardiovascular complications and renal impairment.

Pregnant patients are advised to avoid the use of ibuprofen unless specifically directed by a healthcare professional. It is essential for healthcare providers to consult with patients regarding appropriate alternatives and necessary dosage adjustments during pregnancy to mitigate any potential risks to fetal outcomes.

Lactation

There is no specific information available regarding the use of this medication in nursing mothers or its effects during lactation. Healthcare professionals should consider the absence of data when advising lactating mothers about the use of this medication. The potential risks and benefits should be carefully weighed in the context of the individual patient's situation.

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 should consult a healthcare professional prior to use, particularly if they have a history of liver cirrhosis. It is essential to assess liver function and consider any potential risks associated with the use of this medication in individuals with compromised liver function. Monitoring of liver parameters may be warranted to ensure safety and efficacy in this patient population.

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 teratogenic effects were reported in the conducted studies. Additionally, there was no increase in fetal malformations observed in animal studies. In terms of animal pharmacology and toxicology, ibuprofen did not result in adverse developmental outcomes in the evaluated animal models.

Postmarketing Experience

No specific postmarketing experience details have been provided in the insert text. As such, there are no additional adverse events or rare case reports to summarize at this time.

Patient Counseling

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

Patients should be instructed to discontinue use and consult a doctor if the child exhibits any signs of stomach bleeding, which may include feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain. Furthermore, they should stop use and seek medical advice if the child shows symptoms indicative of heart problems or stroke, such as chest pain, difficulty breathing, weakness on one side of the body, slurred speech, or swelling in the legs.

Healthcare providers should emphasize that if the child does not experience relief within the first 24 hours of treatment, or if fever or pain worsens or persists beyond three days, a doctor should be consulted. Patients should also be advised to seek medical attention if there is any redness or swelling in the painful area or if new symptoms arise.

When using this product, patients may experience mouth or throat burning; therefore, it is recommended to administer it with food or water. If stomach upset occurs, taking the medication with food or milk may help alleviate discomfort.

Providers should encourage patients to consult a doctor before use if the stomach bleeding warning is applicable to their child, or if the child has a history of stomach issues such as heartburn. It is also important to discuss any previous serious side effects from pain relievers or fever reducers, as well as any concerns regarding fluid intake, particularly if the child has lost a significant amount of fluid due to vomiting or diarrhea.

Patients should be advised to consult a doctor before use if the child has high blood pressure, heart disease, liver cirrhosis, kidney disease, or a history of stroke. Additionally, if the child has asthma or is taking a diuretic, a doctor should be consulted prior to use. Lastly, patients should be encouraged to speak with a doctor or pharmacist if the child is under care for any serious condition or is taking any other medications.

Storage and Handling

The product is supplied in a configuration that includes an NDC number for identification. It should be stored at a temperature range of 20-25°C (68-77°F) to ensure its stability and efficacy.

Healthcare professionals are advised to inspect the product prior to use; it should not be utilized if the printed seal under the cap is broken or missing, as this may indicate potential tampering or compromise of the product's integrity. Proper handling and storage conditions are essential to maintain the quality of the product.

Additional Clinical Information

Patients may experience mouth or throat burning when taking the medication; it is advisable to administer it with food or water to mitigate this effect. If stomach upset occurs, clinicians should recommend taking the medication with food or milk to alleviate discomfort. No further information is available regarding laboratory tests, abuse potential, route, method, or frequency of administration, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Equate 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 Equate 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.