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Careone Childrens Ibuprofen

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Active ingredient
Ibuprofen 100 mg
Other brand names
Drug class
Nonsteroidal Anti-inflammatory Drug
Dosage form
Tablet, Chewable
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2019
Label revision date
August 30, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Ibuprofen 100 mg
Other brand names
Drug class
Nonsteroidal Anti-inflammatory Drug
Dosage form
Tablet, Chewable
Route
Oral
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2019
Label revision date
August 30, 2025
Manufacturer
American Sales Company
Registration number
ANDA076359
NDC root
41520-740
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info
Packaging & NDC Codes

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Drug Overview

CAREone® is a children's medication designed for kids aged 2 to 11. It comes in the form of chewable tablets that contain 100 mg of ibuprofen, which is a type of nonsteroidal anti-inflammatory drug (NSAID). This medication is used to relieve minor aches and pains, such as those caused by the common cold, flu, sore throat, headaches, and toothaches, while also helping to reduce fever.

The orange-flavored chewables are easy for children to take, and they work for up to 8 hours, providing effective relief when your child needs it most. CAREone® is comparable to the active ingredient found in Children’s Motrin®, making it a reliable option for managing your child's discomfort.

Uses

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

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

Dosage and Administration

When taking this medication, make sure to chew or crush the tablets completely before swallowing them. It's important to follow the dosage instructions carefully, so do not take more than what is directed. To find the right dose for you or your child, refer to the dosing chart based on weight or age. If you need to take another dose, you can do so every 6 to 8 hours, but remember not to exceed four doses in a single day.

For children under 2 years old who weigh less than 24 pounds, it's best to consult a doctor before giving this medication. For children aged 2 to 3 years who weigh between 24 and 35 pounds, the recommended dose is 1 tablet. If your child is 4 to 5 years old and weighs between 36 and 47 pounds, they should take 1 ½ tablets. For those aged 6 to 8 years weighing 48 to 59 pounds, the dose increases to 2 tablets. Children aged 9 to 10 years who weigh between 60 and 71 pounds should take 2 ½ tablets, and for an 11-year-old weighing 72 to 95 pounds, the dose is 3 tablets. Always ensure you are following these guidelines to use the medication safely and effectively.

What to Avoid

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

Be mindful that this medication is classified as a controlled substance, which means it has the potential for abuse or misuse. Always follow the guidance provided by your healthcare professional to prevent any issues related to dependence (a condition where the body becomes reliant on a substance). If you have any concerns or questions, don't hesitate to reach out to your doctor for more information.

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. Additionally, this medication carries a risk of severe stomach bleeding, especially if you have a history of stomach ulcers or bleeding problems, are taking blood thinners or steroids, or use 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 fatal, particularly if used in higher doses or for longer than recommended. If you or your child experience symptoms such as fainting, vomiting blood, bloody or black stools, chest pain, trouble breathing, or weakness on one side of the body, seek medical attention immediately. It's important to consult a doctor if symptoms persist or worsen, or if new symptoms arise.

Warnings and Precautions

You should be aware of some important warnings and precautions when using this medication. First, if you or your child have a known allergy to aspirin, be cautious, as this medication can cause severe allergic reactions. Symptoms may include hives, facial swelling, wheezing, shock, skin reddening, rash, or blisters. If any of these occur, stop using the medication and seek medical help immediately.

This medication can also increase the risk of serious 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. Additionally, using this medication for longer than directed can raise the risk of heart attack and stroke, which can be fatal. If 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 right away.

Before using this medication, consult a doctor if your child has any history of stomach problems, is dehydrated, or has conditions like high blood pressure, heart disease, or asthma. If you suspect an overdose, contact a Poison Control Center immediately at 1-800-222-1222. Stop using the medication and call your doctor if your child experiences symptoms of stomach bleeding, heart problems, or if their condition does not improve within 24 hours.

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 ibuprofen is not recommended, especially during the third trimester. Using nonsteroidal anti-inflammatory drugs (NSAIDs) like ibuprofen during pregnancy can pose risks to your baby, including potential heart problems and kidney issues.

If you need pain relief or anti-inflammatory treatment while pregnant, consult your healthcare provider for safer alternatives and to discuss any necessary dosage adjustments. Always avoid using ibuprofen unless your doctor specifically advises it. Your health and the health of your baby are the top priority.

Lactation Use

If you are breastfeeding or planning to breastfeed, it's important to talk to your doctor before using this product. There is a possibility that the medication can pass into your breast milk, and the effects on your nursing infant have not been thoroughly studied. Because of this uncertainty, it's best to exercise caution when considering this medication while nursing.

Pediatric Use

When giving medication to children aged 2 to 11, it's important to follow the recommended dosages carefully. You should use the dosing chart to find the right amount based on your child's weight or age. For example, children weighing between 24-35 pounds (ages 2-3) should receive 1 tablet, while those weighing 72-95 pounds (age 11) can take 3 tablets. Make sure not to exceed 4 doses in a day, and if necessary, doses can be repeated every 6-8 hours.

Be cautious if your child has a history of stomach issues, such as ulcers or bleeding problems, or if they are taking other medications like blood thinners or certain pain relievers. Always consult a doctor before use if any of these conditions apply. Additionally, do not use this medication in children under 3 years old unless directed by a healthcare professional. If your child shows any signs of stomach bleeding, does not improve within 24 hours, or experiences worsening symptoms, stop the medication and seek medical advice.

Geriatric Use

When it comes to using this medication in older adults, there is no specific information available about dosage adjustments, safety concerns, or special precautions. This means that if you or a loved one is an older adult considering this medication, it’s important to consult with a healthcare provider. They can help determine the best approach based on individual health needs and any other medications being taken. Always prioritize open communication with your healthcare team to ensure safe and effective treatment.

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 healthcare provider can help determine if this medication is safe for you and whether any adjustments are needed based on your kidney function. Always prioritize your health by discussing any concerns with your doctor.

Hepatic Impairment

If you have liver problems, such as liver cirrhosis (severe scarring of the liver), it's important to be aware of how this may affect your treatment. Your healthcare provider may need to adjust your medication dosage or closely monitor your liver function tests (blood tests that check how well your liver is working) to ensure your safety and the effectiveness of your treatment.

Additionally, if you have other health conditions like high blood pressure, heart disease, or kidney disease, these factors can also influence your care plan. Always communicate openly with your healthcare team about your liver health and any other medical issues you may have.

Drug Interactions

It's important to be aware that ibuprofen can cause serious allergic reactions, particularly in individuals who are allergic to aspirin. If your child is taking blood thinners (medications that help prevent blood clots) or steroids, the risk of severe stomach bleeding increases. Additionally, combining ibuprofen with other nonsteroidal anti-inflammatory drugs (NSAIDs), such as aspirin or naproxen, can also heighten this risk.

Before giving ibuprofen to your child, make sure to consult with a healthcare provider, especially if they are taking any other medications. This conversation is crucial to ensure their safety and to avoid any potentially harmful interactions.

Storage and Handling

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

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

Additional Information

You should chew or crush the tablets completely before swallowing. It's important not to exceed the recommended dosage; you can repeat the dose every 6-8 hours if needed, but do not take more than 4 doses in a day.

Be aware that you might experience a burning sensation in your mouth or throat, so it's a good idea to take the medication with food or water. If you have an upset stomach, taking it with food or milk can help alleviate that discomfort.

FAQ

What is CAREone®?

CAREone® is a children's ibuprofen chewable tablet designed for ages 2 to 11, available in 100 mg doses as a pain reliever and fever reducer.

How should I administer CAREone®?

You should chew or crush the tablets completely before swallowing. Do not exceed the recommended dosage.

What conditions does CAREone® help with?

CAREone® reduces fever and relieves minor aches and pains due to the common cold, flu, sore throat, headaches, and toothaches.

What is the dosing chart for CAREone®?

The dosing chart varies by weight and age. For example, children weighing 24-35 lb (ages 2-3 years) should take 1 tablet.

Are there any contraindications for using CAREone®?

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

What are the potential side effects of CAREone®?

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.

Is CAREone® safe during pregnancy?

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

Can nursing mothers use CAREone®?

Nursing mothers should consult a doctor before using CAREone®, as there is potential for the drug to be excreted in breast milk.

What should I do in case of an overdose?

In case of overdose, seek medical help or contact a Poison Control Center immediately.

How should CAREone® be stored?

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

Packaging Info

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

Packaging configurations for Careone Childrens Ibuprofen.
Details

Drug Information (PDF)

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

View product document (PDF)

Uses and Indications

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

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

Dosage and Administration

Tablets should be chewed or crushed completely before swallowing. Healthcare professionals are advised to ensure that patients do not exceed the recommended dosage. The appropriate dose can be determined using the dosing chart provided below; when possible, weight should be used for dosing, otherwise age may be utilized.

Dosing may be repeated every 6 to 8 hours as necessary, but it is important to note that the medication should not be administered more than four times in a 24-hour period.

Dosing Chart:

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

  • For patients weighing 24-35 lb (ages 2-3 years), the recommended dose is 1 tablet.

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

  • For patients weighing 48-59 lb (ages 6-8 years), the recommended dose is 2 tablets.

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

  • For patients weighing 72-95 lb (age 11 years), the recommended dose is 3 tablets.

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 immediately before or after heart surgery due to potential complications associated with surgical recovery.

Warnings and Precautions

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

This product contains a nonsteroidal anti-inflammatory drug (NSAID), which is associated with a risk of severe stomach bleeding. The likelihood of this adverse effect is heightened in children who have a history of stomach ulcers or bleeding problems, are taking anticoagulants or steroid medications, are using other NSAIDs (including aspirin, ibuprofen, or naproxen), or are exceeding the recommended dosage or duration of treatment.

Additionally, NSAIDs, excluding aspirin, are linked to an increased risk of heart attack, heart failure, and stroke, which can be fatal. This risk escalates with higher doses or prolonged use beyond the recommended guidelines.

Severe or persistent sore throat, particularly when accompanied by high fever, headache, nausea, or vomiting, may indicate a serious condition. In such cases, it is essential to consult a healthcare provider promptly. The use of this medication should not exceed two days, nor should it be administered to children under three years of age unless directed by a physician.

Before administering ibuprofen, it is advisable to consult a healthcare professional if any of the following conditions apply: the child has a history of stomach problems (such as heartburn), has experienced serious side effects from pain relievers or fever reducers, has not been adequately hydrated, has lost significant fluids due to vomiting or diarrhea, has high blood pressure, heart disease, liver cirrhosis, kidney disease, or a history of stroke, has asthma, or is taking a diuretic. Furthermore, consultation with a doctor or pharmacist is recommended if the child is under medical care for any serious condition or is taking other medications.

In the event of an overdose, immediate medical attention should be sought, or the Poison Control Center should be contacted at 1-800-222-1222.

Parents and caregivers should discontinue use and contact a healthcare provider 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, symptoms indicative of heart problems or stroke, including chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling, warrant immediate medical evaluation. If the child does not experience relief within the first 24 hours of treatment, if fever or pain worsens or persists beyond three days, if redness or swelling occurs in the affected area, or if any new symptoms arise, medical advice should be sought without delay.

Side Effects

Patients may experience a range of adverse reactions while using this product. Serious adverse reactions include severe allergic reactions, which may manifest as hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, 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 with a history of stomach ulcers or bleeding problems, those taking anticoagulants or steroid medications, and individuals using other NSAIDs, including aspirin and naproxen. Additionally, the risk of heart attack, heart failure, and stroke is increased with NSAID use, particularly when used in excess or for prolonged periods.

Patients should be vigilant for signs of serious conditions, such as severe or persistent sore throat, especially when accompanied by high fever, headache, nausea, or vomiting, and should seek medical attention promptly. It is advised not to use the product for more than two days or in children under three years of age without a doctor's guidance.

Parents should discontinue use and consult a healthcare professional if their child exhibits any signs of stomach bleeding, including 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 attention. Furthermore, if the child does not achieve relief 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 provider.

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

Drug Interactions

Ibuprofen has the potential to induce severe allergic reactions, particularly in individuals with a known allergy to aspirin. This risk necessitates careful consideration when prescribing ibuprofen to patients with such allergies.

In terms of pharmacodynamic interactions, the concomitant use of ibuprofen with anticoagulants or steroid medications significantly increases the risk of severe gastrointestinal bleeding. This risk is further compounded when ibuprofen is taken alongside other nonsteroidal anti-inflammatory drugs (NSAIDs), including both prescription and over-the-counter options such as aspirin and naproxen.

Given these interactions, it is imperative that healthcare providers consult with a physician prior to administering ibuprofen to patients who are currently taking any other medications. Monitoring for signs of gastrointestinal bleeding is advised in patients receiving ibuprofen in conjunction with these high-risk medications.

Packaging & NDC

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

Packaging configurations for Careone Childrens Ibuprofen.
Details

Pediatric Use

Pediatric patients aged 2 to 11 years may receive this medication according to the following dosing guidelines, which should be determined primarily by weight when possible. The maximum dosage should not exceed the recommended limits, and doses may be repeated every 6 to 8 hours, with a maximum of four doses per day.

For dosing based on weight:

  • For children weighing under 24 lb (under 2 years of age), consultation with a doctor is advised.

  • For children weighing 24-35 lb (ages 2-3 years), the recommended dose is 1 tablet.

  • For children weighing 36-47 lb (ages 4-5 years), the recommended dose is 1 ½ tablets.

  • For children weighing 48-59 lb (ages 6-8 years), the recommended dose is 2 tablets.

  • For children weighing 60-71 lb (ages 9-10 years), the recommended dose is 2 ½ tablets.

  • For children weighing 72-95 lb (age 11 years), the recommended dose is 3 tablets.

Caution is advised when administering this medication to children under 3 years of age unless directed by a healthcare professional. There is an increased risk of stomach bleeding in pediatric patients with a history of stomach ulcers or bleeding problems, those taking anticoagulants or steroids, or those using other NSAIDs. Parents should consult a doctor before use if any of the following apply: a history of stomach issues, dehydration, high blood pressure, heart disease, liver cirrhosis, kidney disease, stroke, asthma, or if the child is on diuretics.

Parents should discontinue use and seek medical advice if the child shows signs of stomach bleeding, does not experience relief within 24 hours, if fever or pain worsens or persists beyond 3 days, or if any new symptoms arise. Additionally, the medication should not be used in children with a known allergy to ibuprofen or other pain relievers/fever reducers.

Geriatric Use

There is no specific information regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population.

Pregnancy

The use of ibuprofen during pregnancy is contraindicated, particularly in the third trimester. Nonsteroidal anti-inflammatory drugs (NSAIDs), including ibuprofen, may pose risks to the fetus, such as potential cardiovascular complications and renal impairment. Pregnant patients are advised to avoid ibuprofen unless specifically directed by a healthcare professional. If the use of ibuprofen is deemed necessary, it is essential to consult a healthcare provider for appropriate alternatives and dosage adjustments to ensure maternal and fetal safety.

Lactation

Lactating mothers should consult a doctor before using this product. There is a potential for excretion in breast milk, and the effects on a nursing infant are not well studied. Therefore, caution is advised when administering this medication to nursing mothers.

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 may experience altered pharmacokinetics of the medication due to compromised liver function. It is essential to assess the severity of liver impairment before initiating treatment.

In patients with liver cirrhosis, dosage adjustments may be necessary to avoid potential toxicity. Close monitoring of liver function tests is recommended throughout the treatment course to ensure safety and efficacy.

Additionally, patients with a history of significant cardiovascular conditions, such as high blood pressure or heart disease, as well as those with kidney disease or a history of stroke, should be evaluated carefully, as these factors may further complicate the management of their hepatic impairment.

Overall, a thorough assessment of the patient's overall health status, including liver function, is critical in determining the appropriate therapeutic approach.

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 teratogenic effects were reported in the conducted studies. Additionally, there was no increase in fetal malformations observed in animal studies. Animal studies have demonstrated that ibuprofen does not lead to adverse developmental outcomes.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

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 they may experience burning sensations in the mouth or throat when taking the medication. To mitigate this, it is recommended that the medication be taken with food or water. Additionally, if patients experience stomach upset, they should take the medication with food or milk to help alleviate discomfort.

Storage and Handling

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

Healthcare professionals are advised to inspect the product prior to use; it should not be utilized if the printed seal under the cap is broken or missing, as this may indicate potential tampering or contamination. Proper handling and storage conditions are essential to ensure the product remains safe and effective for patient use.

Additional Clinical Information

Patients should chew or crush the tablets completely before swallowing and adhere strictly to the directed dosage. If necessary, doses may be repeated every 6-8 hours, but should not exceed four doses in a 24-hour period.

Clinicians should counsel patients that mouth or throat burning may occur, and it is advisable to take the medication with food or water to mitigate this effect. Additionally, if stomach upset occurs, taking the medication with food or milk may help alleviate discomfort.

Drug Information (PDF)

This file contains official product information for Careone Childrens 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 Careone Childrens 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.