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Infants Ibuprofen

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Active ingredient
Ibuprofen 50 mg/1.25 mL
Other brand names
Drug class
Nonsteroidal Anti-inflammatory Drug
Dosage form
Suspension/ Drops
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2024
Label revision date
January 9, 2024
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Ibuprofen 50 mg/1.25 mL
Other brand names
Drug class
Nonsteroidal Anti-inflammatory Drug
Dosage form
Suspension/ Drops
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 2024
Label revision date
January 9, 2024
Manufacturer
Walgreen Company
Registration number
ANDA075217
NDC root
0363-8139
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

Infants’ Ibuprofen is a concentrated liquid medication designed for infants aged 6 to 23 months. It comes in a berry flavor and is used to relieve minor aches and pains, such as those caused by the common cold, flu, sore throat, headaches, and toothaches. Additionally, it helps reduce fever and can provide relief for up to 8 hours.

This medication contains 50 mg of ibuprofen (a type of nonsteroidal anti-inflammatory drug, or NSAID) per 1.25 mL, making it easy to administer with the enclosed syringe. Infants’ Ibuprofen is dye-free and non-staining, ensuring a gentle experience for both you and your child.

Uses

You can use this medication to help reduce fever and relieve minor aches and pains. It’s 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 using this product, it's important to note that it does not come with complete directions or warnings for adult use. Always make sure to follow the recommended dosage and never give more than directed. To prepare the medication, shake the bottle well before use. You can find the right dose by referring to the dosing chart, which is based on your child's weight. If possible, use their weight for dosing; if not, you can use their age instead.

When measuring the dose, use the dosing device that comes with the product, as other devices may not provide accurate measurements. For administration, dispense the liquid slowly into your child's mouth, aiming for the inner cheek. If necessary, you can repeat the dose every 6 to 8 hours, but remember not to exceed four doses in a single day. For infants under 6 months, it's best to consult a doctor before giving this medication. For children weighing between 12 to 17 pounds (6 to 11 months old), the dose is 1.25 mL, and for those weighing 18 to 23 pounds (12 to 23 months old), the dose is 1.875 mL.

What to Avoid

It's important to be cautious when considering this medication for your child. You should not use it if your child has ever had an allergic reaction to ibuprofen or any other pain reliever or fever reducer. Additionally, avoid using this medication right before or after heart surgery, as it can pose serious risks in these situations.

Always prioritize your child's safety by following these guidelines closely. If you have any concerns or questions about using this medication, consult with a healthcare professional for personalized advice.

Side Effects

Ibuprofen can cause serious allergic reactions, particularly in individuals who are allergic to aspirin. Signs of a severe allergic reaction may include hives, facial swelling, wheezing (asthma), shock, skin reddening, rash, or 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 life-threatening, particularly if used in higher doses or for extended periods. If your child experiences symptoms such as faintness, vomiting blood, black stools, chest pain, or weakness on one side of the body, seek medical attention immediately. It's important to consult a doctor if your child has a severe sore throat with high fever or if symptoms worsen or persist beyond a few days. Always discuss any pre-existing health conditions or medications with a healthcare provider before use.

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 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, stop use and contact your doctor right away.

If you or 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 promptly. For any overdose, seek emergency medical help or contact a Poison Control Center at 1-800-222-1222. Always stop use and call your doctor if symptoms worsen or new symptoms appear.

Overdose

If you suspect an overdose, it’s crucial to seek medical help immediately. You can contact a Poison Control Center at 1-800-222-1222 for guidance. Signs of an overdose can vary, but they may include unusual drowsiness, confusion, or difficulty breathing.

Always err on the side of caution—if you notice any concerning symptoms or if you’re unsure, don’t hesitate to get help right away. Your health and safety are the top priority.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that the safety of ibuprofen has not been established. In fact, ibuprofen is not recommended during pregnancy, especially in the third trimester, as it may pose risks to your developing baby, including potential cardiovascular effects.

Before taking ibuprofen, you should consult your healthcare provider to discuss any necessary dosage modifications and to explore safer alternatives. It's best to avoid using ibuprofen unless specifically directed by a healthcare professional. Your health and the health of your baby are the top priority, so always seek guidance when it comes to medication during pregnancy.

Lactation Use

If you are breastfeeding and considering using this product, it's important to consult your doctor first. There is a possibility that the medication can pass into your breast milk, and the effects of ibuprofen on nursing infants have not been thoroughly studied. Because of this uncertainty, it's wise to be cautious.

If you do take ibuprofen while nursing, keep an eye on your baby for any unusual reactions or side effects. Your healthcare provider can help you weigh the benefits and risks to ensure both you and your infant stay healthy.

Pediatric Use

It's important to be cautious when giving this medication to children. You should not use it in children under 3 years of age unless a doctor specifically advises you to do so. For children between 6 months and 2 years, the dosage varies based on their weight, so it's best to consult a doctor for guidance if your child is under 6 months old.

If your child has a history of stomach issues, such as heartburn, or if they have not been drinking fluids due to vomiting or diarrhea, you should also consult a doctor. Additionally, if your child has conditions like high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or is taking a diuretic, it's essential to seek medical advice before administering this medication. Always follow the recommended dosage and do not exceed four doses in a day. If your child does not feel better within 24 hours, contact your healthcare provider.

Geriatric Use

When considering the use of Infants' Ibuprofen for older adults, it's important to note that the drug insert does not provide specific information about how it should be used in this age group. This means there are no special dosage adjustments, safety concerns, or precautions outlined for elderly patients.

If you are caring for an older adult, it's always best to consult with a healthcare professional before starting any new medication, including over-the-counter options like Infants' Ibuprofen. They can provide guidance tailored to individual health needs and ensure safe use.

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 can 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 medications you are considering.

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 certain medications can interact with each other, potentially leading to serious side effects. For instance, if you or your child are taking ibuprofen, combining it with blood thinners (medications that help prevent blood clots) or steroids can increase the risk of stomach bleeding. This risk is even greater if other nonsteroidal anti-inflammatory drugs (NSAIDs), like aspirin or naproxen, are also being used.

Always discuss any medications you or your child are taking with your healthcare provider. They can help you understand the risks and ensure that your treatment plan is safe and effective.

Storage and Handling

To ensure the best performance of your product, store it at a temperature between 20-25°C (68-77°F). It's important to keep it away from freezing temperatures, as freezing can damage the product.

When handling the product, check the printed neckband before use; do not use it if the neckband is broken or missing, as this could compromise safety. Following these guidelines will help you use the product effectively and safely.

Additional Information

You should take this medication orally. If you experience an upset stomach, it's recommended to take it with food or milk to help alleviate discomfort. In the event of an overdose, seek medical assistance immediately or contact a Poison Control Center at 1-800-222-1222 for guidance.

FAQ

What is Infants' Ibuprofen used for?

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

What is the recommended age for using Infants' Ibuprofen?

Infants' Ibuprofen is recommended for children aged 6 to 23 months.

How should I measure the dose of Infants' Ibuprofen?

Use the enclosed syringe to measure the dose. Do not use any other device.

What should I do if my child experiences stomach bleeding?

If your child shows signs of stomach bleeding, such as feeling faint, vomiting blood, or having bloody or black stools, stop use and consult a doctor immediately.

Can I give Infants' Ibuprofen to my child if they have had an allergic reaction to ibuprofen before?

No, do not use Infants' Ibuprofen if your child has ever had an allergic reaction to ibuprofen or any other pain reliever/fever reducer.

What should I do if my child does not get relief from pain or fever?

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

Is it safe to use Infants' Ibuprofen during pregnancy?

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

What are the side effects of Infants' Ibuprofen?

Possible side effects include severe allergic reactions, stomach bleeding, and increased risk of heart attack or stroke. Consult a doctor if any severe symptoms occur.

How should I store Infants' Ibuprofen?

Store Infants' Ibuprofen at 20-25°C (68-77°F) and do not freeze. Ensure the printed neckband is intact before use.

Can nursing mothers use Infants' Ibuprofen?

Nursing mothers should consult a doctor before using Infants' Ibuprofen, as it may be excreted in breast milk.

What should I do in case of an overdose?

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

Packaging Info

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

Packaging configurations for Infants Ibuprofen.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Infants’ Ibuprofen is a concentrated oral suspension formulated to provide pain relief and reduce fever. Each 1.25 mL dose contains 50 mg of ibuprofen, a nonsteroidal anti-inflammatory drug (NSAID). The product is dye-free and non-staining, ensuring a clean administration. It is available in a 1 FL OZ (30 mL) bottle and is designed to last up to 8 hours. The formulation features a berry flavor for palatability. Administration should be conducted using the enclosed syringe only.

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

This product is intended for pediatric use only and does not contain directions or complete warnings for adult use. Healthcare professionals should ensure that the dosage administered does not exceed the recommended limits.

Prior to administration, the product must be shaken well. The appropriate dose can be determined using the dosing chart provided below. When possible, dosing should be based on the child's weight; if weight is not available, age may be used as a guide.

The dosing device provided with the product must be used for measurement; other devices should not be utilized to ensure accurate dosing. The liquid should be dispensed slowly into the child’s mouth, directed toward the inner cheek to facilitate swallowing.

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 children under 6 months of age (weight under 12 lbs): Consult a doctor.

  • For children weighing 12-17 lbs (ages 6-11 months): Administer 1.25 mL.

  • For children weighing 18-23 lbs (ages 12-23 months): Administer 1.875 mL.

Contraindications

Use is contraindicated in patients with a history of allergic reactions to ibuprofen or any other pain reliever or fever reducer. Additionally, administration is contraindicated in the perioperative period surrounding heart surgery due to potential complications.

Warnings and Precautions

Ibuprofen may cause severe allergic reactions, particularly in individuals with a known allergy to aspirin. Symptoms indicative of an allergic reaction 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.

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.

Healthcare professionals should be aware that NSAIDs, excluding aspirin, 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 recommended dosage or for extended periods.

In cases of severe or persistent sore throat, especially when accompanied by high fever, headache, nausea, or vomiting, immediate medical consultation is advised. The use of ibuprofen should not exceed two days, and it should not be administered to children under three years of age unless specifically directed by a physician.

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

Healthcare providers should instruct caregivers to discontinue use and seek medical advice 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, if symptoms indicative of heart problems or stroke arise—such as chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling—medical attention should be sought without delay.

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 develop, it is essential to consult a healthcare professional.

Side Effects

Patients using ibuprofen may experience 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 potential severe stomach bleeding. The risk of this adverse reaction 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, exceeding the recommended dosage or duration of use increases the likelihood of stomach bleeding.

There is also a significant risk associated with the use of NSAIDs, excluding aspirin, for heart attack, heart failure, and stroke, which can be fatal. This risk escalates with prolonged use or higher than recommended dosages.

Patients should be vigilant for severe or persistent sore throat symptoms, especially when accompanied by high fever, headache, nausea, or vomiting, as these may indicate a serious condition requiring prompt medical attention. It is advised not to use ibuprofen for more than two days or to administer it to children under three years of age without a doctor's guidance.

In the event of specific symptoms, patients should discontinue use and consult a healthcare provider. Signs of stomach bleeding include feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain. Symptoms indicative of heart problems or stroke, such as chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling, also warrant immediate medical evaluation. Furthermore, if relief is not achieved within the first 24 hours of treatment, or if fever or pain worsens or persists beyond three days, medical advice should be sought. Redness or swelling in the painful area or the emergence of any new symptoms should also prompt consultation with a healthcare professional.

Before using ibuprofen, it is essential for patients to consult a doctor if they have a history of stomach issues, are experiencing dehydration, or have conditions such as high blood pressure, heart disease, liver cirrhosis, kidney disease, or a history of stroke. Additionally, patients with asthma or those taking diuretics should seek medical advice prior to use. It is also recommended to consult a healthcare provider if the patient is under care for any serious condition or is taking other medications.

Drug Interactions

Ibuprofen has been identified to interact with certain classes of medications, particularly anticoagulants and steroids. When administered concurrently with blood-thinning agents or steroid drugs, ibuprofen may elevate the risk of gastrointestinal bleeding. This risk is further compounded in pediatric patients who are concurrently taking other nonsteroidal anti-inflammatory drugs (NSAIDs), including but not limited to aspirin and naproxen.

Healthcare professionals should exercise caution when prescribing ibuprofen alongside these medications and consider monitoring for signs of gastrointestinal bleeding. Dosage adjustments may be warranted based on the clinical scenario and the patient's overall medication regimen.

No specific interactions with laboratory tests have been reported in the available data.

Packaging & NDC

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

Packaging configurations for Infants Ibuprofen.
Details

Pediatric Use

Pediatric patients under 3 years of age should not use this medication unless directed by a healthcare professional. For dosing, the following guidelines apply based on weight and age: infants under 6 months should consult a doctor before use; for children weighing 12-17 lbs (6-11 months), the recommended dose is 1.25 mL; and for those weighing 18-23 lbs (12-23 months), the dose is 1.875 mL.

Healthcare professionals should advise parents or guardians to consult a doctor if the child has a history of stomach problems, such as heartburn, or if the child has not been drinking fluids or has experienced significant fluid loss due to vomiting or diarrhea. Additional caution is warranted for children with high blood pressure, heart disease, liver cirrhosis, kidney disease, a history of stroke, or asthma. If the child is taking a diuretic or is under medical care for any serious condition, a doctor should be consulted prior to use.

Dosing should not exceed the recommended amount, and if necessary, doses may be repeated every 6-8 hours, with a maximum of 4 doses in a 24-hour period. If the child does not experience relief within the first 24 hours of treatment, a healthcare professional should be consulted.

Geriatric Use

There is no specific information regarding the use of Infants' Ibuprofen in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when considering the administration of this medication to elderly patients, as the absence of data necessitates careful monitoring and individualized assessment of potential risks and benefits.

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 pregnancy may pose risks, including potential cardiovascular effects on the developing fetus.

Pregnant patients and women of childbearing potential should consult a healthcare provider before using ibuprofen, especially if they are pregnant or planning to become pregnant. It is recommended that pregnant women avoid using ibuprofen unless directed by a healthcare professional.

Lactation

Nursing mothers should consult a doctor before using this product. There is a potential for excretion in breast milk, and the effects of ibuprofen on a nursing infant are not well studied; therefore, caution is advised. It is recommended to monitor the infant for any adverse effects if the nursing mother takes ibuprofen.

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, or liver cirrhosis, as these 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 the patient's overall health status, including any coexisting conditions such as high blood pressure, heart disease, or kidney disease, as these may influence the management of their hepatic condition. Monitoring of liver function may be warranted in patients with compromised liver function to ensure safety and efficacy during treatment. Adjustments to dosage or treatment regimens may be necessary based on the severity of hepatic impairment and the patient's individual response to 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 the individual’s health status. Therefore, a thorough assessment and monitoring of the patient are essential.

Management procedures may include supportive care, symptomatic treatment, and specific antidotes if applicable. Healthcare providers should remain vigilant and prepared to implement appropriate interventions based on the clinical presentation of the patient.

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

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

Patient Counseling

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 recommended to administer the medication with food or milk if the patient experiences stomach upset.

Providers should encourage patients to consult a doctor prior to use if the child has a history of stomach problems, such as heartburn, or if there is a concern regarding stomach bleeding. Additionally, it is important to ask a doctor before use if the child has experienced serious side effects from pain relievers or fever reducers, has not been adequately hydrated, or has lost significant fluids due to vomiting or diarrhea.

Patients should also be advised to consult a healthcare professional if the child has pre-existing conditions such as high blood pressure, heart disease, liver cirrhosis, kidney disease, or a history of stroke. If the child has asthma or is taking a diuretic, a discussion with a doctor is warranted before use.

Furthermore, healthcare providers should recommend that patients speak with a doctor or pharmacist if the child is under medical care for any serious condition or is currently taking any other medications. This ensures safe and effective use of the medication.

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. Clinicians should advise patients to take the medication with food or milk if they experience stomach upset. In the event of an overdose, patients are instructed to seek medical assistance or contact a Poison Control Center immediately at 1-800-222-1222. No further information is available regarding laboratory tests, abuse potential, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Infants 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 Infants 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.