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Acetaminophen

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Active ingredient
Acetaminophen 160 mg/5 mL – 650 mg/20.3 mL
Other brand names
Dosage form
Suspension
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2021
Label revision date
August 18, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Acetaminophen 160 mg/5 mL – 650 mg/20.3 mL
Other brand names
Dosage form
Suspension
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 2021
Label revision date
August 18, 2025
Manufacturer
PAI Holdings, LLC dba PAI Pharma
Registration number
M013
NDC roots
0121-0941, 0121-1882, 0121-2823
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (5 NDCs)
Packaging & NDC Codes (5)

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

Acetaminophen Oral Suspension is a liquid medication that contains 160 mg of acetaminophen per 5 mL. It is designed to help relieve minor aches and pains, such as those caused by the common cold, flu, headache, sore throat, or toothache. Additionally, it is effective in reducing fever. This formulation is dye-free and has a pleasant grape flavor, making it easier to take, especially for children.

This medication is free from ibuprofen, alcohol, and aspirin, providing a gentle option for pain relief and fever reduction. Always remember to shake the bottle well before use to ensure the medication is properly mixed.

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 and flu, as well as headaches, sore throats, and toothaches.

This medication is designed to provide you with relief when you're feeling under the weather, making it easier to manage your symptoms and feel more comfortable.

Dosage and Administration

When using this medication, it's important to follow your healthcare professional's instructions carefully. Always shake the bottle well before using it. To determine the right dose, refer to the dosage chart based on weight or age. If your child weighs under 24 pounds or is under 2 years old, consult a doctor for the appropriate dose. For children aged 2 to 3 years who weigh between 24 and 35 pounds, the dose is 5 mL. As the weight increases, so does the dose: 7.5 mL for 4 to 5 years (36-47 lb), 10 mL for 6 to 8 years (48-59 lb), 12.5 mL for 9 to 10 years (60-71 lb), and 15 mL for 11 years (72-95 lb). For adults and children over 12 years who weigh more than 96 pounds, the dose is 20 mL.

You can repeat the dose every 4 hours as long as symptoms persist, but remember not to exceed 5 doses in a 24-hour period. Be cautious and do not take more than the recommended amount, as this can lead to an overdose.

What to Avoid

It's important to be cautious when using this medication. You should not use it alongside any other drugs that contain acetaminophen (a common pain reliever), whether they are prescription or over-the-counter. If you're unsure whether a medication contains acetaminophen, please consult your doctor or pharmacist. Additionally, avoid this product if you have ever had an allergic reaction to it or any of its ingredients.

If you are considering this medication for a child with arthritis pain, make sure to do so only under a doctor's guidance. Always adhere to the recommended dosage, as exceeding it can lead to serious health risks.

Side Effects

You should be aware that taking too much acetaminophen can lead to severe liver damage. For adults, this risk increases if you exceed 4,000 mg in 24 hours, take it with other medications containing acetaminophen, or consume three or more alcoholic drinks daily while using it. Children are at risk if they take more than five doses in 24 hours.

Additionally, acetaminophen can cause serious skin reactions, such as redness, blisters, or rashes. If you experience any of these symptoms, stop using the product and seek medical help immediately. If you have a severe sore throat that lasts more than two days or is accompanied by fever, headache, rash, nausea, or vomiting, consult a doctor. Always check with a healthcare professional if you have liver disease or are taking blood thinners like warfarin. If your pain or fever worsens or lasts longer than the recommended time, or if new symptoms develop, stop use and contact a doctor.

Warnings and Precautions

This product contains acetaminophen, which can lead to severe liver damage if you take more than 4,000 mg in 24 hours (for adults) or if a child takes more than 5 doses in the same time frame. Be cautious if you consume three or more alcoholic drinks daily while using this product, as it increases the risk of liver damage. Additionally, acetaminophen may cause serious skin reactions, such as redness, blisters, or rash. If you notice any skin issues, stop using the product and seek medical help immediately. If you have a severe sore throat that lasts more than two days or is accompanied by fever, headache, rash, nausea, or vomiting, consult your doctor promptly.

Before using this product, it's important to ask your doctor if you have liver disease or if you are taking the blood thinner warfarin. Always follow the recommended dosage and do not exceed it. If you suspect an overdose, seek emergency medical help or contact a Poison Control Center at 1-800-222-1222, even if you don't see any symptoms. You should also stop using the product and call your doctor if your pain worsens or lasts longer than 10 days (for adults) or 5 days (for children), if your fever worsens or lasts more than 3 days, if new symptoms appear, or if you notice redness or swelling. Avoid giving this product to children for arthritis pain unless directed by a doctor.

Overdose

If you suspect an overdose, it’s important to seek medical help immediately. You can contact a Poison Control Center at 1-800-222-1222 for guidance. Quick action is crucial for both adults and children, even if you don’t see any signs or symptoms of an overdose.

Signs of an overdose can vary, but they may include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these symptoms, don’t hesitate to get help right away. Remember, it’s always better to be safe and seek assistance if you have any concerns about an overdose.

Pregnancy Use

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using this medication. They can provide guidance on whether it’s safe for you and your baby. Always prioritize your health and the health of your child by seeking expert advice.

Lactation Use

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using any medication. This ensures that you understand any potential risks and can make informed decisions about your health and the health of your baby. Always prioritize open communication with your doctor regarding your breastfeeding journey.

Pediatric Use

You should be cautious when giving this product to children, especially for arthritis pain, and only do so if directed by a doctor. The appropriate dosage varies by age and weight, so it's important to follow these guidelines: for children under 2 years, consult a doctor; for ages 2-3 years (24-35 lbs), give 5 mL; for ages 4-5 years (36-47 lbs), give 7.5 mL; for ages 6-8 years (48-59 lbs), give 10 mL; for ages 9-10 years (60-71 lbs), give 12.5 mL; for 11 years (72-95 lbs), give 15 mL; and for those over 12 years or weighing over 96 lbs, the dose is 20 mL.

If your child's pain worsens or lasts more than 5 days, or if a fever persists for more than 3 days, stop using the product and consult a doctor. In case of an overdose, seek medical help immediately or contact a Poison Control Center at 1-800-222-1222, as prompt attention is crucial for both children and adults, even if there are no immediate symptoms.

Geriatric Use

If you are an older adult or a caregiver, it's important to be cautious when using this medication. Before starting, consult your doctor if you have liver disease, as this can affect how your body processes the drug. Additionally, if you are taking warfarin, a common blood thinner, make sure to talk to your doctor or pharmacist to avoid any potential interactions.

Always stick to the recommended dosage, as taking more than advised can lead to serious health risks. In the event of an overdose, seek medical help immediately or contact a Poison Control Center, even if you don't notice any symptoms. Quick action is essential for your safety.

Renal Impairment

If you have kidney problems, it's important to know that the drug insert does not provide specific information about dosage adjustments, special monitoring, or safety considerations for your condition. This means that there are no tailored guidelines for how this medication should be used if you have renal impairment (kidney issues).

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

Hepatic Impairment

If you have liver problems, it's important to be cautious when using this product, which contains acetaminophen. Severe liver damage can occur if you take more than 4,000 mg of acetaminophen in a 24-hour period. For children, giving more than 5 doses in a day can also be harmful. Additionally, combining this product with other medications that contain acetaminophen or consuming 3 or more alcoholic drinks daily while using it can increase the risk of liver damage.

Before using this product, please consult your doctor if you have liver disease. They can provide guidance on safe usage and any necessary adjustments to your dosage. Your health and safety are the top priority, so don’t hesitate to seek professional advice.

Drug Interactions

It's important to talk to your doctor or pharmacist before using this medication, especially if you are taking warfarin, a blood thinner that helps prevent blood clots. Mixing these medications can increase the risk of bleeding, so your healthcare provider can help ensure your safety.

Additionally, you should avoid using this medication alongside any other products that contain acetaminophen, which is a common pain reliever found in many over-the-counter and prescription drugs. If you're unsure whether a medication contains acetaminophen, don't hesitate to ask your healthcare provider for guidance. Always keep your healthcare team informed about all the medications you are taking to avoid any harmful interactions.

Storage and Handling

To ensure the best performance of your product, store it at a temperature between 20° to 25°C (68° to 77°F). This temperature range helps maintain the integrity and effectiveness of the device.

When handling the product, be sure to do so with clean hands and in a clean environment to avoid contamination. Always follow any specific disposal instructions provided to ensure safe and responsible disposal of any components.

Additional Information

You should use this medication exactly as your healthcare professional directs. Typically, you can take a dose every 4 hours while you have symptoms, but do not exceed 5 doses in a 24-hour period.

If you are pregnant or breastfeeding, consult a healthcare professional before using this medication. Always keep it out of reach of children. In the event of an overdose, seek medical help immediately or contact a Poison Control Center at 1-800-222-1222. It's important to get quick medical attention for both adults and children, even if there are no noticeable signs or symptoms.

FAQ

What is ACETAMINOPHEN ORAL SUSPENSION used for?

ACETAMINOPHEN ORAL SUSPENSION is used to reduce fever and relieve minor aches and pains due to the common cold, flu, headache, sore throat, and toothache.

How should I take ACETAMINOPHEN ORAL SUSPENSION?

You should shake well before using and follow the dosing chart based on weight or age. Do not exceed 5 doses in 24 hours.

What are the dosage recommendations for children?

For children under 2 years, ask a doctor. For ages 2-3 years, the dose is 5 mL; for 4-5 years, it's 7.5 mL; and for 6-8 years, it's 10 mL.

What should I do if I experience side effects?

If you experience severe skin reactions, worsening pain, or fever lasting more than 3 days, stop use and consult a doctor.

Are there any warnings associated with this medication?

Yes, do not exceed the recommended dose as it may cause severe liver damage. Also, avoid using with other drugs containing acetaminophen.

Can I use this product if I am pregnant or breastfeeding?

If you are pregnant or breastfeeding, you should ask a health professional before use.

What should I do in case of an overdose?

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

Is there any specific storage requirement for this medication?

Store ACETAMINOPHEN ORAL SUSPENSION at 20° to 25°C (68° to 77°F).

Packaging Info

Below are the non-prescription pack sizes of Acetaminophen. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Acetaminophen.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Acetaminophen Oral Suspension is formulated to provide 160 mg of acetaminophen per 5 mL. This preparation is dye-free and features a grape flavor. It is specifically designed to be free of ibuprofen, alcohol, and aspirin, serving as a pain reliever and fever reducer. The product requires shaking well before use and is packaged in a non-child-resistant container. It is manufactured by Pharmaceutical Associates, Inc., located in Greenville, SC 29605.

Uses and Indications

This drug is indicated for the reduction of fever and the relief of minor aches and pains associated with various conditions, including the common cold, influenza, headache, sore throat, and toothache.

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

Dosage and Administration

Healthcare professionals should instruct patients to use the medication as directed. It is imperative that patients do not exceed the recommended dosage, as an overdose may occur. Prior to administration, the bottle should be shaken well to ensure proper mixing of the formulation.

Dosing should be determined using the chart provided below, with weight being the preferred method for dosing. If weight is not available, age may be used as an alternative. The medication may be administered every 4 hours as needed while symptoms persist, but it is crucial that patients do not take more than 5 doses within a 24-hour period.

Dosage Chart:

  • For patients weighing under 24 lb or under 2 years of age, the dose should be determined by consulting a healthcare professional.

  • For patients weighing 24-35 lb or aged 2-3 years, the recommended dose is 5 mL.

  • For patients weighing 36-47 lb or aged 4-5 years, the recommended dose is 7.5 mL.

  • For patients weighing 48-59 lb or aged 6-8 years, the recommended dose is 10 mL.

  • For patients weighing 60-71 lb or aged 9-10 years, the recommended dose is 12.5 mL.

  • For patients weighing 72-95 lb or aged 11 years, the recommended dose is 15 mL.

  • For patients weighing over 96 lb or aged 12 years and older, the recommended dose is 20 mL.

Contraindications

Use of this product is contraindicated in the following situations:

Co-administration with any other drug containing acetaminophen, whether prescription or nonprescription, is prohibited due to the risk of acetaminophen overdose. If there is uncertainty regarding the presence of acetaminophen in other medications, consultation with a healthcare professional is advised.

This product should not be used in individuals with a known allergy to this product or any of its ingredients, as it may provoke an allergic reaction.

Administration of this product for the treatment of arthritis pain in children is contraindicated unless specifically directed by a healthcare provider.

Exceeding the recommended dosage while using this product is contraindicated due to the potential for overdose.

Warnings and Precautions

This product contains acetaminophen, which poses a risk of severe liver damage under certain conditions. Adults should not exceed 4,000 mg of acetaminophen within a 24-hour period. For children, the maximum is 5 doses in the same timeframe. Caution is advised when this product is used in conjunction with other medications containing acetaminophen. Additionally, adults consuming three or more alcoholic drinks daily while using this product are at increased risk for liver damage.

Severe skin reactions have been associated with acetaminophen use. Symptoms may include skin reddening, blisters, and rash. In the event of a skin reaction, it is imperative to discontinue use immediately and seek medical assistance.

Healthcare professionals should advise patients to consult a doctor if a sore throat is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting.

General precautions include advising patients to seek medical advice prior to use if they have liver disease. Furthermore, individuals taking the anticoagulant warfarin should consult a doctor or pharmacist before using this product. It is essential that users do not exceed the recommended dosage.

In cases of overdose, immediate medical attention is crucial. Patients should contact a Poison Control Center at 1-800-222-1222 without delay, as prompt intervention is necessary for both adults and children, even in the absence of noticeable symptoms.

Patients should discontinue use and consult a doctor if any of the following occur: pain worsens or persists beyond 10 days for adults or 5 days for children; fever worsens or lasts more than 3 days; new symptoms arise; or if redness or swelling is observed. Additionally, this product should not be administered to children for the treatment of arthritis pain unless specifically directed by a physician.

Side Effects

Severe liver damage may occur in patients who exceed the recommended dosage of acetaminophen. Specifically, adults should not take more than 4,000 mg in a 24-hour period, while children should not exceed 5 doses within the same timeframe. The risk of liver damage is heightened if acetaminophen is taken in conjunction with other medications containing acetaminophen or if the adult consumes three or more alcoholic drinks daily while using this product.

Patients should be aware of the potential for severe skin reactions associated with acetaminophen use. Symptoms may include skin reddening, blisters, and rash. In the event of a skin reaction, patients are advised to discontinue use immediately and seek medical assistance.

In cases of severe sore throat that persists for more than two days or is accompanied by fever, headache, rash, nausea, or vomiting, patients should consult a healthcare professional promptly.

This product should not be used in conjunction with any other drug containing acetaminophen, whether prescription or nonprescription. Patients uncertain about the presence of acetaminophen in their medications should consult a doctor or pharmacist. Additionally, individuals with a history of allergic reactions to this product or any of its ingredients should refrain from use.

Patients are advised to stop using the product and consult a doctor if pain worsens or lasts longer than 10 days for adults or 5 days for children, if fever worsens or lasts more than 3 days, if new symptoms arise, or if redness or swelling is observed, as these may indicate a serious condition. It is also recommended that this product not be given to children for the treatment of arthritis pain unless directed by a healthcare provider.

Before using this product, patients with liver disease should seek medical advice. Furthermore, individuals taking the blood-thinning medication warfarin should consult a doctor or pharmacist prior to use. It is crucial that patients adhere to the recommended dosage to avoid overdose. In the event of an overdose, immediate medical attention should be sought, and patients are encouraged to contact a Poison Control Center at 1-800-222-1222. Quick medical intervention is essential for both adults and children, even if no signs or symptoms are apparent.

Drug Interactions

Patients should consult a healthcare professional prior to using this medication if they are concurrently taking warfarin, a blood-thinning agent. The combination may increase the risk of bleeding due to potential pharmacodynamic interactions.

Additionally, this medication should not be used in conjunction with any other products containing acetaminophen, whether prescription or over-the-counter. Co-administration may lead to an increased risk of acetaminophen-related toxicity. If there is uncertainty regarding the presence of acetaminophen in other medications, it is advisable to seek guidance from a healthcare provider.

Packaging & NDC

Below are the non-prescription pack sizes of Acetaminophen. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Acetaminophen.
Details

Pediatric Use

Pediatric patients should not be given this product for the pain of arthritis unless directed by a healthcare professional. The recommended dosing for pediatric patients based on weight and age is as follows:

  • For patients under 24 lb (under 2 years), consult a doctor for appropriate dosing.

  • For patients weighing 24-35 lb (ages 2-3 years), the recommended dose is 5 mL.

  • For patients weighing 36-47 lb (ages 4-5 years), the recommended dose is 7.5 mL.

  • For patients weighing 48-59 lb (ages 6-8 years), the recommended dose is 10 mL.

  • For patients weighing 60-71 lb (ages 9-10 years), the recommended dose is 12.5 mL.

  • For patients weighing 72-95 lb (age 11 years), the recommended dose is 15 mL.

  • For patients over 96 lb and adults, the recommended dose is 20 mL.

If pain worsens or persists for more than 5 days in children, or if fever worsens or lasts more than 3 days, use should be discontinued, and a doctor should be consulted. In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center should be contacted at 1-800-222-1222. Quick medical attention is essential for both adults and children, even if no signs or symptoms are apparent.

Geriatric Use

Elderly patients should consult a healthcare provider prior to use if they have liver disease, as this may affect the safety and efficacy of the medication. Additionally, it is important for geriatric patients to seek advice from a doctor or pharmacist if they are concurrently taking the anticoagulant warfarin, due to potential interactions that could increase the risk of bleeding.

It is crucial for elderly patients to adhere strictly to the recommended dosage, as exceeding this limit may lead to serious adverse effects. In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center should be contacted without delay. Prompt medical attention is essential for adults, including elderly patients, even if no signs or symptoms of overdose are apparent.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. It is important to assess the potential risks and benefits, as well as any available data regarding fetal outcomes and lactation. Healthcare providers can offer guidance tailored to individual circumstances, ensuring the safety of both the patient and the developing fetus or nursing infant.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data regarding the excretion of this drug in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

Renal Impairment

Patients with renal impairment have no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the drug insert. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the lack of data necessitates careful clinical judgment.

Hepatic Impairment

Patients with hepatic impairment should exercise caution when using this product, which contains acetaminophen. Severe liver damage may occur if the following conditions are met: an adult consumes more than 4,000 mg of acetaminophen within a 24-hour period, a child takes more than 5 doses in 24 hours, the product is taken concurrently with other medications containing acetaminophen, or an adult consumes 3 or more alcoholic drinks daily while using this product.

It is recommended that patients with liver disease consult a healthcare professional prior to use. Monitoring of liver function may be necessary in these patients to prevent potential adverse effects associated with acetaminophen use.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222. Prompt intervention is crucial for both adults and children, even in the absence of noticeable signs or symptoms.

Healthcare professionals are advised to remain vigilant, as the presentation of symptoms may vary. Quick medical attention can significantly impact the outcome of an overdose situation. Therefore, it is essential to act swiftly and ensure that appropriate medical care is provided.

Nonclinical Toxicology

If pregnant or breast-feeding, it is advised to consult a health professional before use. 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 that acetaminophen may be associated with severe skin reactions. Reported symptoms of these reactions include skin reddening, blisters, and rash. In the event of a skin reaction, it is advised to discontinue use of the medication and seek medical assistance immediately.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children to prevent accidental ingestion. Patients should be informed not to use this product in conjunction with any other medications containing acetaminophen, whether prescription or nonprescription. If patients are uncertain about the presence of acetaminophen in their medications, they should be encouraged to consult a doctor or pharmacist.

Patients must be cautioned against using this product if they have a history of allergic reactions to it or any of its ingredients. They should be instructed to discontinue use and seek medical advice if their pain worsens or persists beyond 10 days for adults or 5 days for children. Additionally, if a fever worsens or lasts more than 3 days, or if new symptoms arise, patients should be advised to stop use and consult a doctor.

Healthcare providers should also inform patients to seek medical attention if they notice any redness or swelling, as these may indicate a serious condition. It is important to emphasize that this product should not be administered to children for the treatment of arthritis pain unless specifically directed by a doctor.

Patients should be reminded to adhere to the recommended dosage and to be aware of the overdose warning associated with this product. Furthermore, healthcare providers should recommend that patients consult a doctor before using this product if they have liver disease. Lastly, patients taking the blood-thinning medication warfarin should be advised to speak with a doctor or pharmacist prior to use.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at a controlled temperature range of 20° to 25°C (68° to 77°F) to maintain its integrity and efficacy. Proper storage conditions must be adhered to, ensuring that the product is kept within the specified temperature limits.

Additional Clinical Information

Patients should use the medication as directed by their healthcare professional, with a recommended repeat dose every 4 hours while symptoms persist, not exceeding 5 doses within a 24-hour period. Clinicians should advise patients who are pregnant or breastfeeding to consult a health professional prior to use.

It is essential to keep the medication out of reach of children. In the event of an overdose, patients must seek medical assistance or contact a Poison Control Center immediately at 1-800-222-1222, as prompt medical attention is crucial for both adults and children, even if no symptoms are apparent.

Drug Information (PDF)

This file contains official product information for Acetaminophen, 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 Acetaminophen, 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.