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Severe Tussin Cf

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Active ingredients
  • Acetaminophen 650 mg/20 mL
  • Guaifenesin 400 mg/20 mL
  • Dextromethorphan Hydrobromide 20 mg/20 mL
  • Phenylephrine Hydrochloride 10 mg/20 mL
Other brand names
Drug classes
Expectorant, Sigma-1 Agonist, Uncompetitive N-methyl-D-aspartate Receptor Antagonist, alpha-1 Adrenergic Agonist
Dosage form
Solution
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2023
Label revision date
October 13, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Acetaminophen 650 mg/20 mL
  • Guaifenesin 400 mg/20 mL
  • Dextromethorphan Hydrobromide 20 mg/20 mL
  • Phenylephrine Hydrochloride 10 mg/20 mL
Other brand names
Drug classes
Expectorant, Sigma-1 Agonist, Uncompetitive N-methyl-D-aspartate Receptor Antagonist, alpha-1 Adrenergic Agonist
Dosage form
Solution
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 2023
Label revision date
October 13, 2025
Manufacturer
CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
Registration number
M012
NDC root
51316-323
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (2 NDCs)
Packaging & NDC Codes (2)

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Drug Overview

Severe Tussin CF is a maximum strength, non-drowsy medication designed to temporarily relieve symptoms associated with colds and flu. It contains several active ingredients: acetaminophen (a pain reliever and fever reducer), dextromethorphan HBr (a cough suppressant), guaifenesin (an expectorant that helps loosen mucus), and phenylephrine HCl (a nasal decongestant).

This combination works to alleviate a range of symptoms, including cough, sore throat, body aches, nasal and chest congestion, and fever. It helps soothe minor throat and bronchial irritation, reduces sinus pressure, and makes coughs more productive by thinning bronchial secretions. Severe Tussin CF is suitable for individuals aged 12 years and older.

Uses

This medication is designed to help you feel better when you're dealing with the discomfort of a cold or flu. It can temporarily relieve a variety of symptoms, including cough caused by minor throat and bronchial irritation, nasal and sinus congestion, and pressure. If you're experiencing minor aches and pains, a sore throat, or a headache, this medication can also provide relief. Additionally, it helps to temporarily reduce fever and works to loosen phlegm (mucus) and thin bronchial secretions, making it easier to cough and clear your airways.

By addressing these common symptoms, this medication aims to make you feel more comfortable while you recover.

Dosage and Administration

When using this medication, it's important to follow the recommended dosage carefully to ensure your safety. For adults and children aged 12 years and older, you should take 20 milliliters (mL) every 4 hours, but make sure not to exceed 5 doses within a 24-hour period. This means you can take it up to 5 times in one day, but taking more than the recommended amount can lead to serious liver damage.

To measure your dose accurately, always use the dosing cup that comes with the product. It's essential to keep this cup with the medication to avoid any confusion. Please remember that this product is not suitable for children under 12 years of age, so do not use it for younger kids. By following these guidelines, you can use the medication safely and effectively.

What to Avoid

You should avoid using this product if you are currently taking a prescription monoamine oxidase inhibitor (MAOI), which is a type of medication used for depression, psychiatric conditions, or Parkinson’s disease. Additionally, do not use it for at least two weeks after stopping an MAOI. If you're unsure whether your medication contains an MAOI, please consult your doctor or pharmacist.

It's also important not to take this product with any other medications that contain acetaminophen, whether they are prescription or over-the-counter. If you have a history of allergic reactions to this product or any of its ingredients, you should not use it. Always check with a healthcare professional if you have any questions or concerns about your medications.

Side Effects

Taking this medication can lead to some serious side effects, so it's important to be aware of them. You should avoid exceeding 4,000 mg of acetaminophen in a 24-hour period, taking it with other acetaminophen-containing products, or consuming three or more alcoholic drinks daily, as these can cause severe liver damage. Additionally, be cautious of potential severe skin reactions, which may include symptoms like skin reddening, blisters, or rash. If you experience any of these, stop using the medication and seek medical help immediately.

You should also consult a doctor if you have a sore throat that is severe, lasts more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting. Other reasons to stop using the medication and seek medical advice include feeling nervous, dizzy, or sleepless, if your pain or cough worsens or lasts more than seven days, or if you notice any new symptoms. If you have certain health conditions, such as liver disease, heart disease, or diabetes, or if you are taking blood thinners like warfarin, it's best to talk to your doctor before using this medication. In case of overdose, seek medical help immediately, even if you don't notice any symptoms.

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, use it with other medications containing acetaminophen, or consume three or more alcoholic drinks daily while using it. Be aware that acetaminophen may also cause serious skin reactions, such as redness, blisters, or rashes. If you experience any skin reactions, 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, talk to your doctor if you have any of the following conditions: liver disease, heart disease, high blood pressure, thyroid disease, diabetes, trouble urinating due to an enlarged prostate, or a persistent cough. If you are taking the blood thinner warfarin, consult your doctor or pharmacist before use. If you suspect an overdose, seek emergency medical help or contact a Poison Control Center right away at 1-800-222-1222, even if you do not notice any symptoms.

You should stop taking this product and call your doctor if you feel nervous, dizzy, or unable to sleep; if your pain, cough, or nasal congestion worsens or lasts more than seven days; if your fever worsens or lasts more than three days; if you notice redness or swelling; if new symptoms develop; or if your cough returns with a rash or headache that lasts. These could indicate a more serious condition.

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. This 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, acting quickly can make a significant difference in the outcome.

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

This product is specifically designed for adults and should not be used in children under 12 years of age. If you have a child who is younger than 12, it is important to avoid using this medication for their safety. Always consult with a healthcare professional if you have questions about appropriate treatments for your child.

Geriatric Use

If you are an older adult or caring for one, it's important to know that this medication is not suitable for children under 12 years old. Before using it, you should consult with a doctor if you have any existing health conditions, such as liver disease, heart disease, high blood pressure, thyroid issues, diabetes, or difficulty urinating due to an enlarged prostate. Additionally, if you are taking the blood thinner warfarin, it's essential to check with your doctor or pharmacist first.

When using this product, make sure to follow the dosage instructions carefully and do not exceed the recommended amount. If you experience any nervousness, dizziness, or sleeplessness, or if your pain, cough, or nasal congestion worsens or lasts longer than seven days, stop using the product and consult your doctor. Your health and safety are the top priority, so always seek guidance when in doubt.

Renal Impairment

If you have kidney problems, it's important to consult your doctor before using this medication, especially if you experience difficulty urinating due to an enlarged prostate gland. Your healthcare provider can help determine if this medication is safe for you and may suggest adjustments to your dosage or monitoring based on your kidney function. Always prioritize open communication with your doctor regarding any concerns related to your kidney health.

Hepatic Impairment

If you have liver problems, it's important to be cautious when using products that contain acetaminophen. Taking more than 4,000 mg of acetaminophen in a 24-hour period can lead to severe liver damage. This risk increases if you are also taking other medications that contain acetaminophen or if you consume three or more alcoholic drinks each day while using this product.

Before using this product, you should consult with your doctor, especially 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 acetaminophen if you are taking warfarin, a medication that helps prevent blood clots. This is because acetaminophen can interact with warfarin, potentially affecting how well it works and increasing the risk of bleeding.

Always keep your healthcare provider informed about all the medications you are taking, including over-the-counter drugs, to ensure your safety and the effectiveness of your treatments.

Storage and Handling

To ensure the best performance of your product, store it at room temperature between 20-25°C (68-77°F). It's important not to refrigerate the product, as this could affect its effectiveness.

When handling the product, make sure to do so in a clean environment to maintain its integrity. Always follow any additional safety instructions provided to ensure safe and effective use.

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. Always keep this medication 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. Quick medical attention is crucial for both adults and children, even if there are no noticeable signs or symptoms.

FAQ

What is Severe Tussin CF used for?

Severe Tussin CF temporarily relieves symptoms of cold or flu, including cough, nasal congestion, sore throat, minor aches and pains, and fever.

What are the active ingredients in Severe Tussin CF?

The active ingredients are acetaminophen (pain reliever/fever reducer), dextromethorphan HBr (cough suppressant), guaifenesin (expectorant), and phenylephrine HCl (nasal decongestant).

Who can use Severe Tussin CF?

This product is intended for adults and children aged 12 years and over. It should not be used in children under 12 years of age.

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

The recommended dosage is 20 mL every 4 hours, and you should not take more than 5 doses in a 24-hour period.

What should I do if I experience an overdose?

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

Are there any contraindications for using Severe Tussin CF?

Do not use if you are taking a prescription monoamine oxidase inhibitor (MAOI), have had an allergic reaction to this product, or are using another drug containing acetaminophen.

What are the potential side effects of Severe Tussin CF?

Possible side effects include severe skin reactions, nervousness, dizziness, or sleeplessness. If you experience any severe symptoms, stop use and consult a doctor.

Is it safe to use Severe Tussin CF while pregnant or breastfeeding?

If you are pregnant or breastfeeding, consult a health professional before using this product.

What should I do if my symptoms persist?

If your pain, cough, or nasal congestion worsens or lasts more than 7 days, or if fever lasts more than 3 days, consult a doctor.

How should I store Severe Tussin CF?

Store at 20-25°C (68-77°F) and do not refrigerate.

Packaging Info

Below are the non-prescription pack sizes of Severe Tussin Cf (acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Severe Tussin Cf.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

No description information is available for the drug.

Uses and Indications

This drug is indicated for the temporary relief of symptoms associated with the common cold or influenza. Specifically, it alleviates cough due to minor throat and bronchial irritation, nasal congestion, sinus congestion and pressure, minor aches and pains, sore throat, and headache. Additionally, it temporarily reduces fever and assists in loosening phlegm (mucus) and thinning bronchial secretions, thereby facilitating more productive coughs.

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 20 mL every 4 hours as needed. It is imperative that no more than 5 doses are administered within a 24-hour period. Healthcare professionals should emphasize the importance of adhering to the recommended dosage, as exceeding this may result in serious liver damage.

The dosing cup provided with the product must be used for accurate measurement; it is essential to keep the dosing cup with the product at all times to ensure proper dosing. This product is not intended for use in children under 12 years of age.

Contraindications

Use of this product is contraindicated in the following situations:

Patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or those who have discontinued MAOI therapy within the past two weeks. This is due to the potential for serious interactions. If there is uncertainty regarding the presence of an MAOI in a prescription, consultation with a healthcare professional is advised.

Concurrent use with any other drug containing acetaminophen, whether prescription or nonprescription, is contraindicated to prevent the risk of acetaminophen overdose. If there is doubt about the acetaminophen content of a medication, a healthcare professional should be consulted.

This product should not be used by individuals with a known history of allergic reactions to it or any of its ingredients, as this may lead to severe allergic responses.

Warnings and Precautions

This product contains acetaminophen, which carries significant risks that healthcare professionals must communicate to patients.

Liver Warning Severe liver damage may occur if the patient exceeds 4,000 mg of acetaminophen within a 24-hour period, uses other medications containing acetaminophen concurrently, or consumes three or more alcoholic drinks daily while using this product. It is imperative to monitor patients for signs of liver dysfunction, particularly in those with pre-existing liver conditions.

Allergy Alert Acetaminophen may induce severe skin reactions, which can manifest as skin reddening, blisters, or rash. Should any of these symptoms occur, patients must be advised to discontinue use immediately and seek medical assistance.

Sore Throat Warning Patients experiencing a severe sore throat that persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, should be instructed to consult a physician without delay.

General Precautions Healthcare professionals should advise patients to consult a doctor prior to use if they have any of the following conditions: liver disease, heart disease, high blood pressure, thyroid disease, diabetes, difficulty urinating due to an enlarged prostate gland, or a cough associated with excessive phlegm. Additionally, patients with persistent or chronic coughs, such as those related to smoking, asthma, chronic bronchitis, or emphysema, should also seek medical advice before use. It is crucial to inquire about concurrent use of warfarin, a blood-thinning medication, as it may interact adversely with acetaminophen.

Emergency Medical Help In the event of an overdose, immediate medical attention is essential. Patients should be instructed to contact a Poison Control Center at 1-800-222-1222 or seek emergency medical help right away, regardless of the presence of symptoms.

When to Stop Taking the Product Patients should be advised to discontinue use and contact their healthcare provider if they experience nervousness, dizziness, or sleeplessness. Additionally, they should seek medical advice if pain, cough, or nasal congestion worsens or persists beyond seven days, if fever worsens or lasts more than three days, if redness or swelling occurs, if new symptoms develop, or if a cough recurs with a rash or headache lasting longer than expected. These symptoms may indicate a serious underlying condition that requires further evaluation.

Side Effects

Severe liver damage may occur in patients who exceed 4,000 mg of acetaminophen within a 24-hour period, use other medications containing acetaminophen concurrently, or consume three or more alcoholic drinks daily while using this product.

Patients should be aware of the potential for severe skin reactions associated with acetaminophen, which may manifest as skin reddening, blisters, or rash. In the event of a skin reaction, it is imperative to discontinue use and seek medical assistance immediately.

Participants should consult a healthcare provider if they experience a sore throat that is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting.

Patients are advised to stop use and contact a doctor if they experience nervousness, dizziness, or sleeplessness; if pain, cough, or nasal congestion worsens or lasts longer than seven days; if fever worsens or lasts more than three days; if redness or swelling is present; if new symptoms arise; or if a cough recurs or occurs with a rash or headache that persists, as these may indicate a serious condition.

Before using this product, patients should consult a healthcare professional if they have liver disease, heart disease, high blood pressure, thyroid disease, diabetes, difficulty urinating due to an enlarged prostate gland, or a cough that produces excessive phlegm. Additionally, those with a persistent or chronic cough, such as that associated with smoking, asthma, chronic bronchitis, or emphysema, should seek medical advice prior to use.

Patients taking the blood-thinning medication warfarin should also consult a doctor or pharmacist before using this product.

In the event of an overdose, it is crucial for patients to seek medical help or contact a Poison Control Center immediately at 1-800-222-1222. Prompt medical attention is essential for both adults and children, even if no signs or symptoms are immediately apparent.

Drug Interactions

Patients taking the anticoagulant warfarin should consult a healthcare professional prior to using acetaminophen. The interaction between these two medications may alter the anticoagulant effect of warfarin, potentially increasing the risk of bleeding. Monitoring of INR (International Normalized Ratio) levels is advisable to ensure safe and effective management of anticoagulation therapy. Adjustments to the dosage of warfarin may be necessary based on clinical judgment and INR results.

Packaging & NDC

Below are the non-prescription pack sizes of Severe Tussin Cf (acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Severe Tussin Cf.
Details

Pediatric Use

This product is not intended for use in pediatric patients under 12 years of age. The safety and efficacy of this medication have not been established in children younger than 12, and its use in this population is contraindicated.

Geriatric Use

Elderly patients, particularly those aged 65 and older, should exercise caution when using this product. It is not intended for use in children under 12 years of age. Prior to use, geriatric patients with a history of liver disease, heart disease, high blood pressure, thyroid disease, diabetes, or urinary difficulties due to an enlarged prostate gland should consult a healthcare provider.

Additionally, it is advisable for elderly patients to seek guidance from a doctor or pharmacist if they are concurrently taking the anticoagulant warfarin, as interactions may occur.

When using this product, elderly patients must adhere strictly to the recommended dosage and should not exceed the directed amount. If any adverse effects such as nervousness, dizziness, or sleeplessness occur, or if symptoms such as pain, cough, or nasal congestion worsen or persist beyond 7 days, it is imperative to discontinue use and consult a healthcare professional. Monitoring for these effects is particularly important in the geriatric population due to potential increased sensitivity to medications.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. The potential risks and benefits must be carefully considered in these populations to ensure the safety of both the mother and the fetus or infant.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently 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 the use of this medication during lactation.

Renal Impairment

Patients with renal impairment should consult a healthcare professional prior to use, particularly if they experience difficulty urinating due to an enlarged prostate gland. It is essential to assess renal function and consider potential dosing adjustments or monitoring requirements based on the degree of impairment.

Hepatic Impairment

Patients with hepatic impairment should be advised of the potential risks associated with the use of this product, particularly due to its acetaminophen content. Severe liver damage may occur if the total daily dosage exceeds 4,000 mg of acetaminophen, especially when combined with other medications containing acetaminophen or when consuming three or more alcoholic drinks daily while using this product.

It is recommended that patients with liver disease consult a healthcare professional prior to using this product to assess the appropriateness of treatment and to discuss any necessary dosage adjustments or monitoring requirements.

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 medical attention is crucial for both adults and children, even in the absence of noticeable signs or symptoms.

Healthcare professionals should be aware that the management of an overdose may vary depending on the specific substance involved and the clinical presentation of the patient. Therefore, it is essential to conduct a thorough assessment and provide appropriate interventions based on the patient's condition.

Monitoring for potential symptoms of overdose is critical, as they may not be immediately apparent. Early recognition and intervention can significantly improve outcomes.

Nonclinical Toxicology

No teratogenic or non-teratogenic effects have been reported in the available nonclinical studies. Additionally, there is no information regarding animal pharmacology and toxicology. The absence of data limits the assessment of potential risks associated with the use of the compound in these contexts.

Postmarketing Experience

Postmarketing experience has identified the potential for severe skin reactions associated with acetaminophen use. Reported symptoms of these reactions may include skin reddening, blisters, and rash. In the event of a skin reaction, it is advised to discontinue use and seek medical assistance immediately.

Additionally, users are encouraged to stop use and consult a healthcare professional if they experience symptoms such as nervousness, dizziness, or sleeplessness; if pain, cough, or nasal congestion worsens or persists beyond 7 days; if fever intensifies or lasts more than 3 days; if redness or swelling occurs; if new symptoms develop; or if a cough recurs or is accompanied by a rash or headache that persists. These symptoms may indicate a serious condition requiring medical evaluation.

Furthermore, an overdose warning is included, advising individuals to seek medical help or contact a Poison Control Center (1-800-222-1222) immediately in the event of an overdose. Prompt medical attention is critical for both adults and children, even if no signs or symptoms are apparent.

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, as prompt medical attention is crucial for both adults and children, even if no signs or symptoms are apparent.

Patients should be informed not to use this product if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have taken one within the past two weeks. It is important for patients to consult with their doctor or pharmacist if they are uncertain whether their prescription medication contains an MAOI.

Healthcare providers should emphasize that patients must not use this product in conjunction with any other medication containing acetaminophen, whether prescription or nonprescription. If patients are unsure about the presence of acetaminophen in their medications, they should be encouraged to ask their doctor or pharmacist.

Patients should 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 consult a doctor if they experience symptoms such as nervousness, dizziness, or sleeplessness.

Additionally, patients should be advised to stop using the product and seek medical advice if their pain, cough, or nasal congestion worsens or persists for more than seven days, if their fever worsens or lasts more than three days, or if they notice any redness or swelling. They should also be informed to consult a doctor if new symptoms arise or if a cough returns or occurs alongside a rash or headache that lasts, as these may indicate a serious condition.

When using this product, patients must be reminded to adhere strictly to the recommended dosage and not exceed it. Healthcare providers should encourage patients to consult a doctor before use if they have any of the following conditions: liver disease, heart disease, high blood pressure, thyroid disease, diabetes, or difficulty urinating due to an enlarged prostate gland. Patients with a cough that produces excessive phlegm or those with a persistent or chronic cough, such as that associated with smoking, asthma, chronic bronchitis, or emphysema, should also seek medical advice prior to use.

Lastly, patients taking the blood-thinning medication warfarin should be advised to consult their doctor or pharmacist before using this product.

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 temperature range of 20-25°C (68-77°F). Refrigeration is not recommended, as it may compromise the integrity of the product. Proper storage conditions must be maintained to ensure optimal efficacy and safety.

Additional Clinical Information

The medication is administered orally. Clinicians should advise patients who are pregnant or breastfeeding to consult a healthcare professional prior to use. It is essential to keep the medication out of reach of children. In the event of an overdose, patients should seek immediate medical assistance or contact a Poison Control Center 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 Severe Tussin Cf, 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 Severe Tussin Cf, 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.