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Motrin Ib

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This product has been discontinued

Active ingredient
Ibuprofen 200 mg
Other brand names
Dosage form
Tablet, Film Coated
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2019
Label revision date
July 11, 2019
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Ibuprofen 200 mg
Other brand names
Dosage form
Tablet, Film Coated
Route
Oral
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2019
Label revision date
July 11, 2019
Manufacturer
Savings Distributors LLC
Registration number
NDA019012
NDC root
73097-008
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (3 NDCs)
Packaging & NDC Codes (3)

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Drug Overview

MotrinIB is a medication that temporarily relieves minor aches and pains, including headaches, muscular aches, toothaches, backaches, and menstrual cramps. It is also effective for alleviating minor pain associated with arthritis and discomfort from the common cold. In addition to pain relief, MotrinIB helps to temporarily reduce fever, making it a versatile option for managing various mild health issues.

Uses

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

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

Dosage and Administration

If you are an adult or a child aged 12 years and older, you can take 1 caplet every 4 to 6 hours as needed while you have symptoms. If you find that 1 caplet isn’t enough to relieve your pain or fever, you may take 2 caplets instead. However, it’s important not to exceed 6 caplets in a 24-hour period unless your doctor advises otherwise.

For children under 12 years old, it’s best to consult a doctor before giving any medication. This ensures that the treatment is safe and appropriate for their age and condition. Always follow your healthcare provider's instructions for the best results.

What to Avoid

You should avoid using this medication if you have ever had an allergic reaction to any other pain reliever or fever reducer. Additionally, it is important not to use it right before or after heart surgery, as this could pose serious health risks. Always consult with your healthcare provider if you have any questions or concerns about your eligibility to use this medication. Your safety is the top priority.

Side Effects

Ibuprofen can cause serious allergic reactions, particularly in individuals who are allergic to aspirin. Symptoms of a severe allergic reaction may include hives, facial swelling, wheezing (asthma), shock, skin reddening, rash, and blisters. If you experience any of these symptoms, stop using ibuprofen and seek medical help immediately.

Additionally, ibuprofen carries risks of stomach bleeding, heart attack, and stroke. The risk of stomach bleeding is higher for those over 60, with a history of ulcers or bleeding issues, or who consume alcohol regularly. Using ibuprofen for longer than directed can also increase these risks. 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 difficulty breathing, contact your doctor right away. Always consult your doctor before using ibuprofen if you have existing health conditions or are taking other medications.

Warnings and Precautions

Ibuprofen can cause serious allergic reactions, especially if you are allergic to aspirin. Symptoms may include hives, facial swelling, wheezing, shock, skin reddening, rash, or blisters. If you experience any of these symptoms, stop using ibuprofen and seek medical help immediately. Additionally, this medication can lead to severe stomach bleeding, particularly if you are over 60, have a history of stomach ulcers, take blood thinners or steroids, consume alcohol regularly, or use other NSAIDs (nonsteroidal anti-inflammatory drugs). The risk of heart attack and stroke also increases with ibuprofen use, especially if taken in higher doses or for longer than recommended.

Before using ibuprofen, consult your doctor if you have a history of serious side effects from pain relievers, stomach issues, high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma. It's also important to check with your doctor or pharmacist if you are taking aspirin for heart protection, as ibuprofen may reduce its effectiveness. If you suspect an overdose, contact a medical professional or Poison Control Center immediately at 1-800-222-1222.

You should stop taking ibuprofen and call your doctor if you notice signs of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain. Seek medical attention if you have symptoms of heart problems or stroke, including chest pain, difficulty breathing, weakness on one side of the body, slurred speech, or leg swelling. Additionally, if your pain worsens or lasts more than 10 days, or if your fever worsens or lasts more than 3 days, contact your doctor.

Overdose

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

Acting quickly can make a significant difference, so don’t hesitate to reach out for assistance if you notice any concerning symptoms. Your health and safety are the top priority.

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 crucial to ensure the safety of both you and your baby.

Particularly during the last three months of pregnancy, you should avoid using ibuprofen unless your doctor specifically advises you to do so. Using ibuprofen at this stage can lead to potential issues for your unborn child or complications during delivery. Always prioritize open communication with your healthcare provider regarding any medications you may consider.

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 during the last three months of pregnancy, as using ibuprofen at this stage 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 you are considering this medication for your child, it's important to know that you should consult a doctor before using it for children under 12 years old. For those aged 12 and older, the recommended dosage is one caplet every 4 to 6 hours as needed for symptoms. If one caplet does not relieve pain or fever, you may give two caplets, but be sure not to exceed six caplets in a 24-hour period unless directed by a healthcare professional. Always prioritize safety and seek guidance if you have any questions about dosing 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 or older, the risk of severe stomach bleeding increases, so it's crucial to monitor any symptoms and consult your doctor if you have a history of stomach ulcers or bleeding issues. Additionally, using more than the recommended dose or taking medication for longer than advised can raise your chances of experiencing heart attacks, heart failure, or strokes.

To ensure your safety, always aim to use the smallest effective dose of any medication. This is especially important for older adults, as your body may process medications differently. If you have any concerns or questions about your medications, don't hesitate to reach out to your healthcare provider for guidance.

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, or liver cirrhosis, as these conditions can affect how your body processes the medication. Your healthcare provider will help determine if it's safe for you and may suggest adjustments to your dosage or additional monitoring to ensure your safety. Always prioritize open communication with your doctor 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 assess your overall health and may need to adjust your dosage or monitor your condition more closely. This is crucial to ensure your safety and the effectiveness of the treatment. Always keep your doctor informed about any existing health issues, including high blood pressure, heart disease, or kidney disease, as these can also affect your treatment plan.

Drug Interactions

It's important to be aware of how certain medications can interact with each other. For instance, if you take ibuprofen, it may reduce the effectiveness of aspirin when used for preventing heart attacks or strokes. Additionally, if you are on blood thinners (medications that help prevent blood clots) or steroids, using ibuprofen can increase your risk of stomach bleeding.

Moreover, using nonsteroidal anti-inflammatory drugs (NSAIDs) like ibuprofen for extended periods or in higher doses than recommended can raise your chances of experiencing serious heart issues, such as heart attack or stroke. Always discuss your current medications and any potential interactions with your healthcare provider to ensure your safety and well-being.

Storage and Handling

To ensure the best performance of your product, store it in a cool, dry place at a temperature between 20-25ºC (68-77ºF). It's important to keep it away from high temperatures and excessive heat, which can exceed 40ºC (104ºF), as this may compromise its effectiveness.

When handling the product, always check the pouch for any tears or damage before use. If the pouch is compromised, do not use the product, as this could affect safety and performance. Following these guidelines will help you use the product safely and effectively.

Additional Information

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

FAQ

What is the drug used for?

The drug temporarily relieves minor aches and pains due to headaches, muscular aches, minor arthritis pain, toothaches, backaches, the common cold, and menstrual cramps. It also temporarily reduces fever.

What should adults and children 12 years and older do for dosing?

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

What should children under 12 years do?

Children under 12 years should ask a doctor before use.

What are the warnings associated with this drug?

This drug may cause severe allergic reactions, stomach bleeding, and increase the risk of heart attack and stroke. You should stop use and seek medical help if you experience symptoms like faintness, vomiting blood, or chest pain.

What should I do if I experience an allergic reaction?

If you experience symptoms of a severe allergic reaction, such as hives or difficulty breathing, stop use and seek medical help immediately.

Can I use this drug if I have high blood pressure or heart disease?

You should ask a doctor before use if you have high blood pressure, heart disease, liver cirrhosis, or kidney disease.

Is it safe to use this drug during pregnancy?

If you are pregnant or breastfeeding, ask a health professional before use. It is especially important not to use this drug during the last 3 months of pregnancy unless directed by a doctor.

What should I do in case of overdose?

In case of overdose, get medical help or contact a Poison Control Center right away.

How should I store this drug?

Store the drug between 20-25ºC (68-77ºF) and avoid high temperatures above 40ºC (104ºF). Do not use if the pouch is torn or damaged.

Packaging Info

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

Packaging configurations for Motrin Ib.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

The product is a nonsteroidal anti-inflammatory drug (NSAID) containing ibuprofen as the active ingredient. Each tablet contains 200 mg of ibuprofen. The inactive ingredients include anhydrous lactose, corn starch, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate, titanium dioxide, FD&C red #40, FD&C blue #1, and FD&C yellow #6. The tablets are round, biconvex, and pink in color.

Uses and Indications

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

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

Dosage and Administration

Adults and children aged 12 years and older are advised to take 1 caplet every 4 to 6 hours as needed while symptoms persist. In cases where pain or fever does not adequately respond to 1 caplet, a dosage of 2 caplets may be administered. It is imperative that the total daily dosage does not exceed 6 caplets within a 24-hour period, unless otherwise directed by a healthcare professional.

For children under 12 years of age, it is recommended to consult a doctor for appropriate dosing guidance.

Contraindications

Use of this product is contraindicated in patients with a history of allergic reactions to any other pain reliever or fever reducer. Additionally, administration is contraindicated immediately before or after heart surgery due to potential complications associated with surgical recovery.

Warnings and Precautions

Ibuprofen is associated with several significant warnings and precautions that healthcare professionals must consider to ensure patient safety.

Allergy Alert Ibuprofen may induce 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.

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:

  • Are aged 60 years or older

  • Have a history of stomach ulcers or bleeding disorders

  • Are concurrently using anticoagulants or steroid medications

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

  • Consume three or more alcoholic beverages daily while using this product

  • Exceed the recommended dosage or duration of use

Heart Attack and 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 amplified when the medication is used in excess of the recommended dosage or for prolonged periods.

General Precautions Healthcare providers should advise patients to consult a physician prior to using ibuprofen if they have:

  • Experienced problems or serious side effects from pain relievers or fever reducers

  • Conditions that align with the stomach bleeding warning

  • A history of gastrointestinal issues, such as heartburn

  • High blood pressure, heart disease, liver cirrhosis, or kidney disease

  • Asthma

  • Current use of diuretics

Additionally, patients should be cautioned to seek guidance from a doctor or pharmacist if they are:

  • Taking aspirin for the prevention of heart attack or stroke, as ibuprofen may diminish the cardioprotective effects of aspirin

  • Under medical supervision for any serious health condition

  • Using any other medications

Emergency Medical Help Instructions In the event of an overdose, immediate medical attention is required. Patients should contact a Poison Control Center or seek emergency medical help without delay (1-800-222-1222).

Stop Taking and Call Your Doctor Instructions Patients should discontinue use and consult a physician if they experience any of the following:

  • 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

  • Worsening pain that persists beyond 10 days

  • Fever that worsens or lasts more than 3 days

  • Redness or swelling in the affected area

  • Any new or unusual symptoms

These warnings and precautions are critical for the safe administration of ibuprofen and should be communicated effectively to patients.

Side Effects

Patients using ibuprofen may experience a range of adverse reactions, which can vary in severity.

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. In the event of an allergic reaction, patients are advised to discontinue use and seek immediate medical assistance.

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 who are 60 years of age or older, have a history of stomach ulcers or bleeding problems, are taking anticoagulants or steroid medications, consume three or more alcoholic drinks daily while using the product, or exceed the recommended dosage or duration of use.

Additionally, NSAIDs, excluding aspirin, are associated with an increased risk of heart attack, heart failure, and stroke, which can be fatal. This risk is particularly pronounced in patients who use the medication in excess of the recommended dosage or for prolonged periods.

Patients should discontinue use and consult a healthcare provider 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, patients should seek medical advice if pain worsens or persists beyond 10 days, if fever intensifies or lasts more than three days, if redness or swelling occurs in the affected area, or if any new symptoms arise.

Before using ibuprofen, patients should consult a healthcare professional if they have a history of serious side effects from pain relievers or fever reducers, if the stomach bleeding warning applies to them, or if they have conditions such as heartburn, high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma. It is also advisable for patients taking diuretics to seek medical advice prior to use.

Patients taking aspirin for the prevention of heart attack or stroke should be aware that ibuprofen may diminish the cardioprotective effects of aspirin. Additionally, those under a physician's care for serious conditions or those taking other medications should consult a doctor or pharmacist before using ibuprofen.

Drug Interactions

The use of ibuprofen in conjunction with other medications may lead to significant drug interactions that warrant careful consideration.

Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) and Aspirin Ibuprofen may diminish the cardioprotective effects of aspirin when both are administered for the prevention of heart attack or stroke. It is advisable to avoid concurrent use of ibuprofen and aspirin for this purpose to ensure optimal therapeutic outcomes.

Anticoagulants and Steroids Co-administration of ibuprofen with anticoagulants or steroid medications heightens the risk of gastrointestinal bleeding. Clinicians should monitor patients closely for signs of bleeding and consider dosage adjustments or alternative therapies as necessary.

Cardiovascular Risks with NSAIDs The use of NSAIDs, including ibuprofen, is associated with an increased risk of cardiovascular events such as heart attack, heart failure, and stroke. This risk is particularly pronounced when these medications are used in higher doses or for extended periods. It is recommended that healthcare providers evaluate the necessity of ibuprofen therapy and consider the lowest effective dose for the shortest duration possible to mitigate these risks.

Packaging & NDC

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

Packaging configurations for Motrin Ib.
Details

Pediatric Use

Pediatric patients under 12 years of age should consult a healthcare professional before use. For adolescents aged 12 years and older, the recommended dosage is 1 caplet every 4 to 6 hours as needed for symptom relief. If pain or fever does not adequately respond to 1 caplet, 2 caplets may be administered. It is important not to exceed 6 caplets within 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 risk necessitates careful consideration when prescribing medications that may exacerbate this condition. Additionally, the likelihood of experiencing serious cardiovascular events, such as heart attack, heart failure, and stroke, is heightened in older adults, especially when medications are used in excess or for prolonged periods beyond the recommended duration.

It is imperative for healthcare providers to advise geriatric patients to consult with a physician prior to initiating treatment if they have a history of stomach ulcers or bleeding problems. In managing treatment for elderly patients, the smallest effective dose should be employed to minimize potential adverse effects and ensure safety. Regular monitoring and reassessment of therapy may be warranted to address any emerging concerns related to the unique pharmacokinetic and pharmacodynamic changes that occur with aging.

Pregnancy

Pregnant patients should consult a healthcare professional before using this medication, particularly if they are in the later stages of pregnancy or breastfeeding. It is especially important to avoid the use of ibuprofen during the last trimester unless specifically directed by a physician, as it may pose risks to the developing fetus and lead to complications during delivery. Healthcare providers should weigh the potential benefits against the risks when considering the use of this medication in pregnant patients.

Lactation

Lactating mothers are advised to consult a health professional before using this medication. It is particularly important to avoid the use of ibuprofen during the last three months of pregnancy unless explicitly directed by a physician, as it may pose risks to the unborn child or lead to complications during delivery. There is no specific data available regarding the excretion of this medication in breast milk or its effects on breastfed infants. Therefore, caution is recommended when considering its use in lactating individuals.

Renal Impairment

Patients with renal impairment should consult a healthcare professional prior to use, particularly if they have conditions such as high blood pressure, heart disease, liver cirrhosis, or kidney disease. It is essential to assess renal function and consider potential dosing adjustments or monitoring requirements based on the severity of renal impairment.

Hepatic Impairment

Patients with hepatic impairment should consult a healthcare professional prior to use, particularly if they have conditions such as liver cirrhosis. It is essential for these patients to receive appropriate evaluation and monitoring of their liver function to ensure safe use of the medication. Adjustments to dosage or specific monitoring parameters may be necessary based on the severity of hepatic impairment. Therefore, healthcare providers should assess the individual patient's liver function and overall health status before initiating treatment.

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 effectively. 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 to determine the appropriate course of action.

Management procedures may include supportive care, symptomatic treatment, and specific antidotes if applicable. Healthcare providers should remain vigilant and prepared to implement emergency protocols as necessary to ensure patient safety and optimal outcomes.

Nonclinical Toxicology

It is especially important not to use ibuprofen during the last three months of pregnancy unless specifically directed by a healthcare professional, as it may lead to complications for the unborn child or during delivery. No specific non-teratogenic effects have been identified in the available data. Additionally, there are no detailed findings regarding nonclinical toxicology or animal pharmacology and toxicology provided in the current information.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions associated with the use of the product. These include gastrointestinal bleeding, renal impairment, and elevations in liver enzymes. Additionally, reports have included allergic reactions, skin reactions, and cardiovascular events. The frequency of these adverse reactions is not known.

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. Patients should be informed that taking the medication with food or milk may help alleviate any stomach upset that occurs.

It is important for healthcare providers to encourage patients to consult a doctor before using the medication if they have experienced problems or serious side effects from pain relievers or fever reducers in the past. Patients should also be made aware of the stomach bleeding warning and discuss their medical history, particularly if they have a history of stomach issues such as heartburn, or if they have conditions such as high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma. Additionally, patients taking diuretics should be advised to seek medical guidance prior to use.

Patients should be instructed to ask a doctor or pharmacist before using the medication if they are currently taking aspirin for heart attack or stroke, as ibuprofen may reduce the effectiveness of aspirin. They should also consult a healthcare professional if they are under medical care for any serious condition or if they are taking any other medications.

Healthcare providers should inform patients to 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. Patients should also be advised to watch for symptoms of heart problems or stroke, including chest pain, difficulty breathing, weakness on one side of the body, slurred speech, or leg swelling. Furthermore, if pain worsens or persists for more than 10 days, if fever worsens or lasts more than 3 days, if redness or swelling occurs in the painful area, or if any new symptoms arise, patients should be instructed to contact their healthcare provider.

Storage and Handling

The product is supplied in pouches that must be stored at a temperature range of 20-25ºC (68-77ºF). It is essential to avoid exposure to high temperatures and excessive heat, specifically temperatures exceeding 40ºC (104ºF). Healthcare professionals should ensure that the pouches are not used if they are torn or damaged, as this may compromise the integrity of the product. Proper handling and storage conditions are crucial to maintain the quality and efficacy of the product.

Additional Clinical Information

The route of administration for the medication is oral. Clinicians should advise patients who are pregnant or breastfeeding to consult a health professional prior to use. It is particularly crucial to avoid ibuprofen during the last trimester of pregnancy unless specifically directed by a physician, as it may pose risks to the unborn child or lead to complications during delivery.

Drug Information (PDF)

This file contains official product information for Motrin Ib, 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 Motrin Ib, 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.