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Dover Addaprin, Medi-First Ibuprofen, Medi-First Plus Ibuprofen, Medique Ipri...

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Active ingredient
Ibuprofen 200 mg
Other brand names
Drug class
Nonsteroidal Anti-inflammatory Drug
Dosage form
Tablet, 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 2014
Label revision date
September 9, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Ibuprofen 200 mg
Other brand names
Drug class
Nonsteroidal Anti-inflammatory Drug
Dosage form
Tablet, 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 2014
Label revision date
September 9, 2025
Manufacturer
Unifirst First Aid Corporation
Registration number
ANDA079174
NDC roots
47682-700, 47682-702, 47682-709, 47682-714, 47682-718
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (15 NDCs)
Packaging & NDC Codes (15)

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

Medi-First® Ibuprofen is a medication that contains 200 mg of ibuprofen, which is a type of nonsteroidal anti-inflammatory drug (NSAID). It is designed to temporarily relieve minor aches and pains, such as headaches, toothaches, backaches, menstrual cramps, muscular aches, and pain associated with the common cold. Additionally, it helps to reduce fever.

This medication works by blocking certain substances in the body that cause inflammation and pain, making it effective for various everyday discomforts. If you're looking for a way to manage mild pain or fever, Medi-First® Ibuprofen may be a suitable option for you.

Uses

You can use this medication to temporarily relieve minor aches and pains from various conditions, including headaches, toothaches, backaches, menstrual cramps, muscular aches, and even pain associated with the common cold or minor arthritis. 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 tablet every 4 to 6 hours as needed while you have symptoms. If you find that one tablet isn’t enough to relieve your pain or fever, you may take 2 tablets instead. However, it’s important not to exceed 6 tablets in a 24-hour period unless your doctor advises you to do so.

For children under 12 years old, it’s best to consult a doctor before giving them this medication. Remember to take the tablets by mouth, and only use them as directed to ensure your safety and effectiveness of the treatment.

What to Avoid

You should avoid using this medication if you have ever had an allergic reaction to any other pain reliever or fever reducer, or if you are about to undergo heart surgery or have just had one. It's important to be aware of potential serious side effects. If you notice any signs of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain, stop using the medication and consult your doctor immediately.

Additionally, seek medical attention if you experience symptoms of heart problems or stroke, including chest pain, difficulty breathing, weakness on one side of your body, slurred speech, or swelling in your legs. You should also stop using the medication if your pain worsens or lasts longer than 10 days, if your fever intensifies or lasts more than 3 days, if you see redness or swelling in the painful area, or if you develop any new or unexpected symptoms.

Side Effects

Using ibuprofen can lead to some serious side effects that you should be aware of. There is a risk of severe allergic reactions, especially if you are allergic to aspirin. Symptoms may include hives, skin reddening, asthma (wheezing), facial swelling, rash, shock, or blisters. Additionally, ibuprofen can cause severe stomach bleeding, particularly if you are over 60, have a history of stomach ulcers, or are taking certain medications like blood thinners or other NSAIDs.

There is also an increased risk of heart attack and stroke associated with NSAIDs, including ibuprofen, especially if used in higher doses or for longer than recommended. If you experience symptoms such as chest pain, trouble breathing, weakness on one side of your body, or any signs of stomach bleeding (like vomiting blood or having black stools), you should stop using ibuprofen and consult a doctor immediately. Always talk to your healthcare provider before using ibuprofen if you have any underlying health conditions or are taking other medications.

Warnings and Precautions

You should be aware that ibuprofen can cause serious allergic reactions, especially if you are allergic to aspirin. Symptoms of an allergic reaction may include hives, skin reddening, asthma (wheezing), facial swelling, rash, shock, 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 taking ibuprofen and call your doctor right away. You should also seek medical attention if you experience chest pain, trouble breathing, weakness on one side of your body, slurred speech, or leg swelling. If your pain worsens or lasts more than 10 days, or if you have a fever that lasts more than 3 days, contact your doctor. Always get emergency help in case of an overdose.

Overdose

It appears that there is no specific information available regarding overdosage for this medication. However, it's always important to be aware of the potential risks associated with taking any medication. If you suspect that you or someone else may have taken too much of a medication, look out for unusual symptoms such as extreme drowsiness, confusion, or difficulty breathing.

In the event of an overdose, it is crucial to seek immediate medical help. You can do this by calling your local emergency number or going to the nearest hospital. Always keep the medication packaging on hand to provide healthcare professionals with important information about what was taken. Remember, it's better to be safe and get checked out if you have any concerns.

Pregnancy Use

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using any medication, including ibuprofen. This is particularly crucial 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 any medication, including ibuprofen. This is particularly crucial 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 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 using this medication. For those aged 12 and older, the recommended dosage is 1 tablet every 4 to 6 hours as needed for symptoms. If one tablet does not relieve pain or fever, you may give 2 tablets. However, be sure not to exceed 6 tablets in a 24-hour period unless directed by a healthcare professional. Always prioritize safety and seek guidance if you're unsure about the appropriate use for your child.

Geriatric Use

As you age, it's important to be aware of certain health risks associated with medications. If you are 60 years or older, there is a higher chance of experiencing severe stomach bleeding. This means you should be cautious about the medications you take and discuss any concerns with your healthcare provider.

Additionally, using medications beyond the recommended dosage or for longer than advised can increase your risk of serious heart issues, such as heart attacks, heart failure, and strokes. Always follow your doctor's instructions carefully to help protect your health as you age.

Renal Impairment

If you have kidney problems, it's important to know that there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the usual recommendations for monitoring or safety considerations related to renal impairment (kidney issues) are not provided.

Always consult your healthcare provider for personalized advice and to ensure that any medications you take are safe and appropriate for your kidney health. They can help you understand how your condition may affect your treatment plan.

Hepatic Impairment

If you have liver problems, it's important to know that the drug insert does not provide specific information about dosage adjustments, special monitoring, or precautions for your condition. This means that there are no tailored guidelines for how this medication may affect you differently due to your liver health.

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your situation. They can help monitor your liver function and make any necessary adjustments to your treatment plan.

Drug Interactions

It's important to talk to your healthcare provider before using this medication, especially if you are taking aspirin to prevent heart attacks or strokes. Ibuprofen can reduce the effectiveness of aspirin, which may affect your heart health.

Always keep your doctor informed about all the medications you are taking to ensure your treatment is safe and effective. This way, you can avoid any potential interactions and get the best care possible.

Storage and Handling

To ensure the safety and effectiveness of your product, store it in a cool, dry place at a temperature between 68-77°F (20-25°C). It's important to avoid exposing it to excessive heat, which can occur at temperatures above 104°F (40°C). Always use the tamper-evident sealed packets provided, as these help ensure the product's integrity. If you find any packets that are opened or torn, do not use them, as this could compromise safety and effectiveness.

Additional Information

No further information is available.

FAQ

What is Medi-First® Ibuprofen used for?

Medi-First® Ibuprofen is used to temporarily relieve minor aches and pains associated with headaches, toothaches, backaches, menstrual cramps, common colds, muscular aches, and minor arthritis pain, as well as to reduce fever.

What is the recommended dosage for adults and children over 12?

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

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

If you experience signs of stomach bleeding such as feeling faint, vomiting blood, having bloody or black stools, or stomach pain that does not get better, stop use and ask a doctor immediately.

Are there any warnings associated with taking Medi-First® Ibuprofen?

Yes, you should be aware of allergy alerts, stomach bleeding warnings, and the increased risk of heart attack or stroke, especially if you are over 60, have a history of stomach problems, or take other NSAIDs.

Can I use Medi-First® Ibuprofen if I am pregnant or breastfeeding?

If you are pregnant or breastfeeding, you should ask a health professional before use. It is especially important not to use ibuprofen at 20 weeks or later in pregnancy unless directed by a doctor.

What should I do if I have an allergic reaction to ibuprofen?

If you experience a severe allergic reaction, such as hives, skin reddening, or difficulty breathing, stop use and seek medical help right away.

How should I store Medi-First® Ibuprofen?

Store Medi-First® Ibuprofen at 68-77°F (20-25°C) and avoid excessive heat above 104°F (40°C). Use tamper-evident sealed packets and do not use any opened or torn packets.

Packaging Info

Below are the non-prescription pack sizes of Dover Addaprin, Medi-First Ibuprofen, Medi-First Plus Ibuprofen, Medique Iprin, Otis Clapp Ultraprin (ibuprofen). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Dover Addaprin, Medi-First Ibuprofen, Medi-First Plus Ibuprofen, Medique Iprin, Otis Clapp Ultraprin.
Details

Drug Information (PDF)

This file contains official product information for Dover Addaprin, Medi-First Ibuprofen, Medi-First Plus Ibuprofen, Medique Iprin, Otis Clapp Ultraprin, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

No description information is available for the specified drug.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with headache, toothache, backache, menstrual cramps, common cold, muscular aches, and minor arthritis pain. Additionally, it is indicated for the temporary reduction of fever.

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

Dosage and Administration

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

Contraindications

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

Patients should discontinue use and consult a healthcare professional if they experience signs of stomach bleeding, including feeling faint, vomiting blood, having bloody or black stools, or 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 attention. Furthermore, if pain worsens or persists beyond 10 days, fever intensifies or lasts more than 3 days, redness or swelling occurs in the affected area, or any new or unexpected symptoms arise, medical advice should be sought.

Warnings and Precautions

Ibuprofen is associated with several significant warnings and precautions that healthcare professionals must consider when prescribing or recommending its use.

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

Stomach Bleeding Warning As a nonsteroidal anti-inflammatory drug (NSAID), ibuprofen carries a risk of severe stomach bleeding. The likelihood of this adverse effect is heightened in patients who meet any of the following criteria:

  • Age 60 or older

  • History of stomach ulcers or bleeding disorders

  • Concurrent use of anticoagulants or steroid medications

  • Use of other NSAIDs, whether prescription or over-the-counter (e.g., aspirin, ibuprofen, naproxen)

  • Consumption of three or more alcoholic beverages daily while using this product

  • Exceeding the recommended dosage or duration of use

Heart Attack or Stroke Warning The use of NSAIDs, excluding aspirin, is associated with an increased risk of heart attack, heart failure, and stroke, which can be fatal. This risk is particularly pronounced in patients who exceed the recommended dosage or duration of treatment.

Emergency Medical Help 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.

Monitoring and Consultation Patients should be instructed to discontinue ibuprofen and consult their healthcare provider if they experience any of the following:

  • 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

  • Worsening pain that persists beyond 10 days

  • Fever that worsens or lasts longer than 3 days

  • Redness or swelling in the affected area

  • Any new or unexpected symptoms

Healthcare professionals should ensure that patients are adequately informed of these warnings and precautions to promote safe use of ibuprofen.

Side Effects

Patients may experience a range of adverse reactions associated with the use of this product. Serious adverse reactions include severe allergic reactions, which may manifest as hives, skin reddening, asthma (wheezing), facial swelling, rash, shock, or blisters, particularly in individuals with a known allergy to aspirin.

The use of this product, which contains a nonsteroidal anti-inflammatory drug (NSAID), carries a risk of severe stomach bleeding. This risk is heightened in patients aged 60 years or older, those with a history of stomach ulcers or bleeding problems, individuals taking anticoagulants or steroid medications, and those consuming three or more alcoholic drinks daily while using this product. Additionally, prolonged use or exceeding the recommended dosage may increase the likelihood of this adverse reaction.

Patients should be aware that 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 when the product is used in higher doses or for extended periods.

Common adverse reactions may include gastrointestinal symptoms, and patients are advised to discontinue use and consult a healthcare professional if they experience 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.

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

Before using this product, patients with a history of serious side effects from pain relievers or fever reducers, those with stomach bleeding concerns, or individuals with conditions such as high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma should consult a healthcare provider. It is also recommended that patients taking aspirin for cardiovascular protection discuss their use of this product with a doctor, as ibuprofen may diminish the cardioprotective effects of aspirin.

Drug Interactions

Patients taking aspirin for the prevention of heart attack or stroke should consult a healthcare professional prior to using ibuprofen. The concomitant use of ibuprofen may diminish the cardioprotective effects of aspirin, potentially reducing its efficacy in these clinical scenarios. Monitoring and dosage adjustments may be necessary based on individual patient circumstances and the specific therapeutic goals.

Packaging & NDC

Below are the non-prescription pack sizes of Dover Addaprin, Medi-First Ibuprofen, Medi-First Plus Ibuprofen, Medique Iprin, Otis Clapp Ultraprin (ibuprofen). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Dover Addaprin, Medi-First Ibuprofen, Medi-First Plus Ibuprofen, Medique Iprin, Otis Clapp Ultraprin.
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 tablet every 4 to 6 hours as needed while symptoms persist. If pain or fever does not adequately respond to 1 tablet, 2 tablets may be administered. It is important not to exceed 6 tablets in a 24-hour period unless directed by a healthcare provider.

Geriatric Use

Elderly patients, particularly those aged 60 and older, are at an increased risk for severe stomach bleeding. This heightened risk necessitates careful consideration when prescribing medications that may contribute to gastrointestinal complications.

Additionally, the risk of heart attack, heart failure, and stroke is elevated in geriatric patients who exceed the recommended dosage or duration of treatment. It is essential for healthcare providers to monitor these patients closely and to adhere strictly to dosing guidelines to mitigate these risks.

Given these safety considerations, healthcare providers should exercise caution when prescribing to elderly patients and ensure appropriate monitoring throughout the treatment course.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional before using this medication. It is particularly important to avoid the use of ibuprofen after 20 weeks of gestation unless specifically directed by a physician, as it may pose risks to the developing fetus and lead to complications during delivery. Healthcare providers should carefully consider the potential risks and benefits when prescribing this medication to pregnant patients.

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 provided regarding the excretion of this medication in breast milk or its effects on breastfed infants. Therefore, caution is recommended when considering its use during lactation.

Renal Impairment

There is no specific information regarding renal impairment, dosage adjustments, special monitoring, or safety considerations for patients with reduced kidney function. Healthcare professionals should exercise caution and consider individual patient factors when prescribing to patients with renal impairment, as the absence of detailed guidance necessitates careful clinical judgment.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there are no established dosage adjustments, special monitoring requirements, or precautions outlined for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population. Regular monitoring of liver function may be prudent in these cases, although specific parameters are not defined in the available information.

Overdosage

In the absence of specific overdosage information, it is essential for healthcare professionals to remain vigilant and prepared for potential scenarios involving overdose.

Healthcare providers should be aware that the clinical presentation of an overdose may vary significantly depending on the substance involved and the individual patient’s characteristics. Symptoms may include, but are not limited to, altered mental status, cardiovascular instability, respiratory distress, and gastrointestinal disturbances.

In the event of suspected overdosage, immediate assessment of the patient's condition is critical. Recommended actions include:

  1. Assessment: Conduct a thorough evaluation of the patient's vital signs and clinical status.

  2. Supportive Care: Initiate supportive measures as necessary, including airway management, oxygen supplementation, and intravenous fluids.

  3. Decontamination: If appropriate and within a reasonable timeframe, consider gastrointestinal decontamination methods such as activated charcoal, provided the patient is alert and able to protect their airway.

  4. Specific Antidotes: If a specific antidote is available for the substance involved, it should be administered according to established protocols.

Healthcare professionals are encouraged to consult local poison control centers or toxicology experts for guidance on management strategies tailored to the specific circumstances of the overdose. Continuous monitoring and supportive care are paramount until the patient stabilizes or further treatment is determined.

Documentation of the incident, including the substance involved, estimated dose, time of ingestion, and any interventions performed, is crucial for ongoing patient management and future reference.

Nonclinical Toxicology

It is especially important not to use ibuprofen at 20 weeks or later in pregnancy unless specifically directed to do so by a doctor, as it may cause problems in the unborn child or complications during delivery. No specific non-teratogenic effects have been identified in the available data. Additionally, there are no details regarding nonclinical toxicology or animal pharmacology and toxicology provided in the current information.

Postmarketing Experience

No specific postmarketing experience details are available in the extracted data. 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 keep this medication out of reach of children. In the event of an overdose, patients should seek medical help or contact a Poison Control Center immediately.

Patients should be informed not to use this medication if they have ever experienced an allergic reaction to any other pain reliever or fever reducer. Additionally, it is important to counsel patients against using this product right before or after heart surgery.

Patients should be instructed to stop using the medication and consult a doctor if they experience any signs of stomach bleeding, which may include feeling faint, vomiting blood, having bloody or black stools, or experiencing stomach pain that does not improve. They should also be advised to seek medical attention if they exhibit symptoms 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 remind patients to discontinue use and consult a doctor if their pain worsens or persists for more than 10 days, or if their fever worsens or lasts for more than 3 days. Patients should also be advised to seek medical advice if they notice redness or swelling in the painful area or if any new or unexpected symptoms arise.

When using this product, patients should be counseled to take it with food or milk if they experience stomach upset. It is essential for patients to consult a doctor before use if they have a history of problems or serious side effects from pain relievers or fever reducers, or if the stomach bleeding warning applies to them.

Patients should also be advised to seek medical advice before using this medication if they have a history of stomach problems such as heartburn, or if they have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or a history of stroke. Furthermore, patients taking a diuretic should consult a doctor prior to use.

Healthcare providers should inform patients to speak with a doctor or pharmacist before using this medication if they are taking aspirin for heart attack or stroke, as ibuprofen may reduce the effectiveness of aspirin. Lastly, patients under a doctor’s care for any serious condition or those taking any other medications should also consult a healthcare professional before using this product.

Storage and Handling

The product is supplied in tamper-evident sealed packets to ensure integrity and safety. It is essential to store the product at a temperature range of 68-77°F (20-25°C). Care should be taken to avoid exposure to excessive heat, specifically temperatures exceeding 104°F (40°C). Opened or torn packets must not be used to maintain product efficacy and safety.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Dover Addaprin, Medi-First Ibuprofen, Medi-First Plus Ibuprofen, Medique Iprin, Otis Clapp Ultraprin, 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 Dover Addaprin, Medi-First Ibuprofen, Medi-First Plus Ibuprofen, Medique Iprin, Otis Clapp Ultraprin, 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

Last AI update:

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.