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Equate Health Non Drowsy Day Cold and Flu Plus and Nighttime Cold and Flu Plus

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Active ingredients
  • Acetaminophen 325 mg
  • Dextromethorphan Hydrobromide 10 mg
  • Phenylephrine Hydrochloride 5 mg
Other brand names
Dosage form
Capsule, Liquid Filled
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2022
Label revision date
January 26, 2026
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Acetaminophen 325 mg
  • Dextromethorphan Hydrobromide 10 mg
  • Phenylephrine Hydrochloride 5 mg
Other brand names
Dosage form
Capsule, Liquid Filled
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 2022
Label revision date
January 26, 2026
Manufacturer
Wal-Mart Stores Inc
Registration number
M012
NDC root
79903-133
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info
Packaging & NDC Codes

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

DAY COLD & FLU FORMULA is designed to temporarily relieve symptoms associated with colds and the flu, such as minor aches and pains, headaches, coughs, sore throats, nasal and sinus congestion, and fever. It contains active ingredients like acetaminophen (a pain reliever and fever reducer), dextromethorphan HBr (a cough suppressant), and phenylephrine HCl (a nasal decongestant) to help alleviate these discomforts.

NIGHT COLD & FLU FORMULA serves a similar purpose but is specifically formulated to help you rest at night. It includes the same pain reliever and cough suppressant as the daytime formula, along with doxylamine succinate (an antihistamine) to help with sleep and additional relief from nasal congestion and runny nose. Both formulas aim to make you feel more comfortable while you recover from cold or flu symptoms.

Uses

If you're dealing with the discomfort of a cold or flu, the DAY COLD & FLU FORMULA can help temporarily relieve several bothersome symptoms. This formula is designed to ease minor aches and pains, headaches, coughs, sore throats, and nasal and sinus congestion. It also helps to temporarily reduce fever, making you feel more comfortable as you recover.

For nighttime relief, the NIGHT COLD & FLU FORMULA offers a combination of benefits. It includes a pain reliever and fever reducer, a cough suppressant, an antihistamine (which helps with allergy symptoms), and a nasal decongestant to help you breathe easier while you rest.

Dosage and Administration

For the Day Cold & Flu Formula, if you are an adult or a child aged 12 years and older, you should take 2 softgels with a glass of water every 4 hours. However, make sure not to take more than 10 softgels in a 24-hour period unless your doctor advises otherwise. If you are caring for a child under 12, this product is not suitable for them.

Similarly, for the Nighttime Cold & Flu Formula, adults and children aged 12 and older should also take 2 softgels with water every 4 hours, with the same limit of 10 softgels in 24 hours unless directed by a healthcare professional. Again, this formula is not intended for children under 12. Always follow these guidelines to ensure safe and effective use of the medication.

What to Avoid

You should avoid using DAY COLD & FLU FORMULA or NIGHTTIME COLD & FLU FORMULA if you are currently taking any other medications that contain acetaminophen (a common pain reliever) or if you are on a prescription monoamine oxidase inhibitor (MAOI), which is used for certain mental health conditions. It's also important not to use these formulas if you have had an allergic reaction to them or their ingredients, or if you are under 12 years of age.

When using these products, make sure to follow the recommended dosage and avoid consuming alcoholic drinks with NIGHTTIME COLD & FLU FORMULA, as alcohol can increase drowsiness. If you have any questions about your medications or whether these formulas are safe for you, please consult your doctor or pharmacist.

Side Effects

Taking this product can lead to some serious side effects, particularly concerning your liver. You should avoid taking more than 10 softgels in a 24-hour period, using it with other medications that contain acetaminophen, or consuming three or more alcoholic drinks daily while using this product, as these can increase the risk of severe liver damage.

Be aware that acetaminophen may also cause severe skin reactions, which can include symptoms like skin reddening, blisters, or rash. If you experience any of these, stop using the product and seek medical help immediately. Additionally, if you have a sore throat that is severe, lasts more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, consult a doctor promptly. While using the nighttime formula, you may feel very drowsy, so it's best to avoid alcohol and be cautious when driving or operating machinery. If you notice any worsening symptoms or new issues, it's important to contact your healthcare provider.

Warnings and Precautions

It's important to be aware of some key warnings when using this product. It contains acetaminophen, which can cause severe liver damage if you take more than 10 softgels in 24 hours, use it with other acetaminophen-containing medications, or consume three or more alcoholic drinks daily while using it. If you experience a severe sore throat that lasts more than two days or is accompanied by fever, headache, rash, nausea, or vomiting, consult your doctor promptly. Additionally, be cautious of potential severe skin reactions, such as reddening, blisters, or rash. If you notice any of these symptoms, stop using the product and seek medical help immediately.

For your safety, do not use this product to sedate children. While there are no specific laboratory tests required for safe use, you should stop taking the product and call your doctor if your pain, cough, or nasal congestion worsens or lasts more than seven days, if your fever worsens or lasts more than three days, or if you notice any redness, swelling, or new symptoms. Also, seek medical advice if you experience nervousness, dizziness, or sleeplessness.

Overdose

Taking more than 10 softgels of this product in a 24-hour period can lead to severe liver damage. It's also important to be cautious if you are using other medications that contain acetaminophen, as combining them with this product can increase the risk of liver damage. Additionally, consuming three or more alcoholic drinks daily while using this product can also pose a serious risk to your liver.

If you suspect an overdose, look out for signs such as nausea, vomiting, loss of appetite, confusion, or jaundice (yellowing of the skin or eyes). If you experience any of these symptoms or believe you have taken too much, seek immediate medical help. Always prioritize your health and safety by following the recommended dosage guidelines.

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 and any medications you may consider.

Pediatric Use

It’s important to be cautious when considering this medication for children. You should not use it to sedate children, and it is not recommended for anyone under 12 years of age. For those 12 years and older, the dosage is 2 softgels taken with water every 4 hours, but you should not exceed 10 softgels in a 24-hour period unless directed by a doctor.

If your child is under 12, please avoid using this medication altogether. Always consult with a healthcare professional if you have any questions or concerns about treating your child.

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, it’s important to consult with a healthcare provider before starting the medication. 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 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 health situation. They can help you understand how to manage your treatment effectively while considering your kidney health.

Hepatic Impairment

It's important to be cautious if you have liver problems and are considering using products that contain acetaminophen. Taking more than 10 softgels in a 24-hour period, using other medications that also contain acetaminophen, or consuming three or more alcoholic drinks daily while using this product can lead to severe liver damage. Always consult your doctor before using this product if you have liver disease.

While using this product, make sure to follow the recommended dosage and avoid alcohol. If your pain, cough, or nasal congestion worsens or lasts more than 7 days, or if your fever worsens or lasts more than 3 days, stop using the product and consult your doctor. Additionally, seek medical advice if you notice any redness or swelling, experience new symptoms, or if your cough returns with a rash or headache that lasts.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications or tests you may be taking. While there are no specific drug interactions or laboratory test interactions noted for this medication, your healthcare provider can help ensure that everything you are taking works well together and is safe for you. Always share your complete list of medications and any recent lab tests to avoid any potential issues. Your health and safety should always come first.

Storage and Handling

To ensure the best performance and safety of your product, store it at room temperature. It's important to keep it away from excessive heat, as high temperatures can affect its effectiveness.

When handling the product, always do so with care to maintain its integrity. Following these simple storage and handling guidelines will help you use the product safely and effectively.

Additional Information

You should take 2 softgels with water every 4 hours if you are an adult or a child aged 12 years and older. However, do not exceed 10 softgels in a 24-hour period unless directed by your doctor. If you are pregnant or breastfeeding, it's important to consult a healthcare professional before using this medication.

FAQ

What is the DAY COLD & FLU FORMULA used for?

The DAY COLD & FLU FORMULA temporarily relieves symptoms due to a cold or flu, including minor aches and pains, headache, cough, sore throat, nasal and sinus congestion, and it temporarily reduces fever.

What are the active ingredients in the NON-DROWSY DAY Cold & Flu Formula?

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

How should adults take the NIGHTTIME COLD & FLU FORMULA?

Adults and children 12 years and over should take 2 softgels with water every 4 hours, not exceeding 10 softgels in 24 hours or as directed by a doctor.

What should I do if I experience severe skin reactions while using these products?

If you notice symptoms like skin reddening, blisters, or rash, stop use immediately and seek medical help.

Are there any warnings associated with the use of these cold and flu formulas?

Yes, severe liver damage may occur if you exceed the recommended dosage or consume alcohol while using these products. Consult a doctor if symptoms worsen or persist.

Can children under 12 years use these products?

No, both the DAY COLD & FLU FORMULA and NIGHTTIME COLD & FLU FORMULA should not be used in children under 12 years of age.

What should I do if my sore throat is severe or lasts more than 2 days?

Consult a doctor promptly if your sore throat is severe, persists for more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting.

Is it safe to use these products while pregnant or breastfeeding?

If you are pregnant or breastfeeding, you should ask a health professional before using these products.

Packaging Info

Below are the non-prescription pack sizes of Equate Health Non Drowsy Day Cold and Flu Plus and Nighttime Cold and Flu Plus (acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Equate Health Non Drowsy Day Cold and Flu Plus and Nighttime Cold and Flu Plus packaging includes kits with multiple components.
Details

Drug Information (PDF)

This file contains official product information for Equate Health Non Drowsy Day Cold and Flu Plus and Nighttime Cold and Flu Plus, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

No description information is available for the specified drug.

Uses and Indications

DAY COLD & FLU FORMULA is indicated for the temporary relief of symptoms associated with the common cold or influenza, including minor aches and pains, headache, cough, sore throat, nasal and sinus congestion, and the temporary reduction of fever.

NIGHT COLD & FLU FORMULA is indicated for the relief of cold and flu symptoms and includes a pain reliever/fever reducer, cough suppressant, antihistamine, and nasal decongestant.

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

Dosage and Administration

For the Day Cold & Flu Formula, adults and children aged 12 years and older are instructed to take 2 softgels with water every 4 hours. The maximum dosage should not exceed 10 softgels within a 24-hour period, unless otherwise directed by a healthcare professional. This formulation is not recommended for children under 12 years of age.

For the Nighttime Cold & Flu Formula, the dosing regimen is identical; adults and children aged 12 years and older should take 2 softgels with water every 4 hours, with a maximum limit of 10 softgels in a 24-hour period, unless otherwise advised by a healthcare provider. This product is also contraindicated for use in children under 12 years.

Contraindications

DAY COLD & FLU FORMULA is contraindicated in the following situations:

  • Concurrent use with any other drug containing acetaminophen (prescription or nonprescription) due to the risk of acetaminophen overdose.

  • Patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing such medication, as this may lead to serious interactions.

  • Individuals with a history of allergic reactions to this product or any of its ingredients.

  • Children under 12 years of age.

NIGHTTIME COLD & FLU FORMULA is contraindicated in the following situations:

  • Concurrent use with any other drug containing acetaminophen (prescription or nonprescription) due to the risk of acetaminophen overdose.

  • Patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing such medication, as this may lead to serious interactions.

  • Individuals with a history of allergic reactions to this product or any of its ingredients.

  • Children under 12 years of age.

Warnings and Precautions

Severe liver damage may occur with the use of this product containing acetaminophen. Healthcare professionals should advise patients to adhere strictly to the maximum daily dosage of 10 softgels within a 24-hour period. Caution is warranted if the patient is concurrently using other medications that contain acetaminophen or if they consume three or more alcoholic drinks daily while using this product.

In cases of severe sore throat that persists for more than two days, or if it is accompanied by fever, headache, rash, nausea, or vomiting, patients should be instructed to consult a physician promptly.

Acetaminophen may also lead to severe skin reactions. Symptoms indicative of such reactions include skin reddening, blisters, and rash. Should any of these symptoms occur, patients must discontinue use immediately and seek medical assistance.

It is imperative to note that this product should not be used to sedate children.

Patients should be advised to stop taking the product and contact their healthcare provider if any of the following occur: pain, cough, or nasal congestion worsens or persists beyond seven days; fever worsens or lasts more than three days; redness or swelling is observed; new symptoms develop; cough recurs or is accompanied by a rash or headache that lasts; or if they experience nervousness, dizziness, or sleeplessness.

No specific laboratory tests are recommended for the safe use of this product. However, healthcare professionals should remain vigilant for the aforementioned symptoms and reactions to ensure patient safety.

Side Effects

Severe liver damage may occur in patients who exceed the maximum daily dosage of 10 softgels within a 24-hour period, take the product in conjunction with other medications containing acetaminophen, 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 using the Nighttime Cold & Flu Formula may experience marked drowsiness. It is advised to avoid alcoholic beverages, as well as sedatives and tranquilizers, which may exacerbate drowsiness. Caution is recommended when driving or operating machinery. Additionally, excitability may occur, particularly in children.

For the Daytime Cold & Flu Formula, patients should consult a healthcare professional 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 is observed, if new symptoms arise, or if a cough recurs alongside a rash or headache that persists. Symptoms such as nervousness, dizziness, or sleeplessness should also prompt a consultation with a doctor.

Similar advisories apply to the Nighttime Cold & Flu Formula, where patients should seek medical advice under the same conditions as outlined for the Daytime formulation.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there is no information available regarding interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Equate Health Non Drowsy Day Cold and Flu Plus and Nighttime Cold and Flu Plus (acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Equate Health Non Drowsy Day Cold and Flu Plus and Nighttime Cold and Flu Plus packaging includes kits with multiple components.
Details

Pediatric Use

Pediatric patients should not be administered this medication for sedation purposes. The use of this product is contraindicated in children under 12 years of age. For patients aged 12 years and older, the recommended dosage is 2 softgels taken with water every 4 hours, with a maximum of 10 softgels in a 24-hour period, unless otherwise directed by a healthcare professional.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any adverse effects or changes in therapeutic response, given the lack of targeted data for this population.

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 weighed, as the effects on fetal outcomes and lactation are not fully established. It is essential for women of childbearing potential to seek medical advice to ensure safe use during pregnancy and lactation.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is no specific data available regarding the excretion of this medication in breast milk or its effects on breastfed infants. Therefore, caution is recommended when 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. Regular monitoring of renal function may be advisable in these patients to ensure safety and efficacy.

Hepatic Impairment

Patients with hepatic impairment should exercise caution when using this product, as it contains acetaminophen, which is associated with the risk of severe liver damage. It is critical that patients do not exceed the maximum daily dosage of 10 softgels within a 24-hour period. Additionally, patients should avoid concomitant use of other medications containing acetaminophen and limit alcohol consumption to fewer than three alcoholic drinks per day while using this product.

Before initiating treatment, patients with a history of liver disease are advised to consult a healthcare professional. During the course of treatment, it is essential for patients to adhere strictly to the recommended dosage and to refrain from consuming alcoholic beverages.

Patients should discontinue use and seek medical advice if any of the following occur: worsening pain, cough, or nasal congestion lasting more than 7 days; fever that worsens or persists for more than 3 days; the presence of redness or swelling; the emergence of new symptoms; or if a cough recurs or is accompanied by a rash or headache that lasts. Regular monitoring of liver function may be warranted in patients with pre-existing hepatic impairment to ensure safety and efficacy during treatment.

Overdosage

In cases of overdosage, significant health risks are associated with the consumption of this product beyond the recommended limits.

Risk of Severe Liver Damage Taking more than 10 softgels within a 24-hour period, which is the maximum daily dosage for this product, can lead to severe liver damage. Healthcare professionals should be vigilant in assessing patients who may have exceeded this dosage.

Additionally, the concomitant use of this product with other medications containing acetaminophen poses a further risk of severe liver damage. It is crucial for healthcare providers to inquire about all medications a patient is taking to prevent potential interactions that could exacerbate liver toxicity.

Alcohol Consumption Patients who consume three or more alcoholic drinks daily while using this product are also at an increased risk of severe liver damage. Healthcare professionals should advise patients on the dangers of alcohol consumption in conjunction with this medication and recommend moderation or abstinence.

Recommended Actions In the event of suspected overdosage, immediate medical evaluation is warranted. Healthcare providers should monitor liver function tests and consider appropriate interventions based on the severity of the symptoms and the extent of liver damage. Prompt recognition and management are essential to mitigate the risks associated with overdosage.

Nonclinical Toxicology

There is currently no available information regarding teratogenic effects. Additionally, no data has been provided concerning non-teratogenic effects. The nonclinical toxicology section does not contain any relevant information at this time. Furthermore, there is no information available related to animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has identified the potential for severe skin reactions associated with acetaminophen use. Reports indicate that symptoms 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, excitability has been noted as a possible adverse event, particularly in pediatric populations.

Patient Counseling

Patients should be advised to consult a healthcare professional if they are pregnant or breastfeeding before using the product. It is important to inform patients that they should not use DAY COLD & FLU FORMULA or NIGHTTIME COLD & FLU FORMULA in conjunction with any other medication containing acetaminophen, whether prescription or nonprescription. If patients are uncertain whether a drug contains acetaminophen, they should be encouraged to ask their doctor or pharmacist.

Patients should be cautioned against using DAY COLD & FLU FORMULA or NIGHTTIME COLD & FLU FORMULA if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have taken one within the last two weeks. They should be advised to consult their healthcare provider if they are unsure whether their prescription medication contains an MAOI.

It is essential to inform patients that they should not use either formula if they have a history of allergic reactions to the product or any of its ingredients. Additionally, both formulas are not recommended for use in children under 12 years of age.

Patients should be instructed to stop using the product and seek medical advice if their pain, cough, or nasal congestion worsens or persists for more than 7 days, or if their fever worsens or lasts more than 3 days. They should also be advised to consult a doctor if they experience redness or swelling, new symptoms, or if their cough returns with a rash or headache that lasts, as these may indicate a serious condition. Furthermore, if patients experience nervousness, dizziness, or sleeplessness, they should discontinue use and consult a healthcare professional.

When using DAYTIME COLD & FLU FORMULA or NIGHTTIME COLD & FLU FORMULA, patients should be reminded not to exceed the recommended dosage. They should be made aware that NIGHTTIME COLD & FLU FORMULA may cause marked drowsiness and should avoid alcoholic beverages while using this product, as alcohol, sedatives, and tranquilizers can enhance drowsiness. Patients should exercise caution when driving or operating machinery.

Patients should also be advised that excitability may occur, particularly in children. It is important for patients to consult their healthcare provider before use if they have any of the following conditions: liver disease, heart disease, high blood pressure, thyroid disease, diabetes, cough with excessive phlegm, difficulty urinating due to prostate enlargement, persistent or chronic cough (such as that associated with smoking, asthma, or emphysema), glaucoma, or breathing problems such as emphysema or chronic bronchitis. Additionally, patients should seek advice from their doctor or pharmacist if they are taking the blood-thinning medication warfarin or any sedatives or tranquilizers.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers assigned for identification. It is essential to store the product at room temperature, ensuring that it is kept away from excessive heat to maintain its integrity and efficacy. Proper handling should be observed to prevent any degradation of the product.

Additional Clinical Information

Patients aged 12 years and older are advised to take 2 softgels with water every 4 hours, with a maximum of 10 softgels in a 24-hour period unless directed otherwise by a healthcare professional. Clinicians should counsel patients to consult a health professional if they are pregnant or breastfeeding before use. No additional information is available regarding laboratory tests, abuse potential, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Equate Health Non Drowsy Day Cold and Flu Plus and Nighttime Cold and Flu Plus, 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 Equate Health Non Drowsy Day Cold and Flu Plus and Nighttime Cold and Flu Plus, 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.