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Niaflu

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Active ingredients
  • Guaifenesin 400 mg
  • Dextromethorphan Hydrobromide 20 mg
Other brand names
Drug classes
Expectorant, Sigma-1 Agonist, Uncompetitive N-methyl-D-aspartate Receptor Antagonist
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 2025
Label revision date
December 17, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Guaifenesin 400 mg
  • Dextromethorphan Hydrobromide 20 mg
Other brand names
Drug classes
Expectorant, Sigma-1 Agonist, Uncompetitive N-methyl-D-aspartate Receptor Antagonist
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 2025
Label revision date
December 17, 2025
Manufacturer
Pharmadel LLC
Registration number
M012
NDC root
55758-507
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

Niaflu is a medication designed to temporarily relieve symptoms associated with the common cold and flu. It works by addressing cough caused by minor irritation in the throat and bronchial tubes, helping to loosen phlegm (mucus) and thin bronchial secretions. This action aids in draining the bronchial tubes and makes coughs more productive, allowing you to clear mucus more effectively.

Uses

You can use this medication to temporarily relieve symptoms associated with the common cold and flu. It helps ease your cough caused by minor irritation in your throat and bronchial tubes. Additionally, it works to loosen phlegm (mucus) and thin out bronchial secretions, making it easier for your body to drain the bronchial tubes and produce more effective coughs. This can help you feel more comfortable while you recover.

Dosage and Administration

When using this medication, it's important to follow the recommended dosage to ensure your safety and effectiveness. For adults and children aged 12 years and older, you should take 1 softgel every 4 hours as needed. However, make sure not to exceed 6 softgels in a 24-hour period.

If you have children under 12 years old, this medication is not suitable for them, so please avoid using it for that age group. Always remember to read the instructions carefully and consult with a healthcare professional if you have any questions or concerns about using this medication.

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 or emotional conditions, or Parkinson's disease. Additionally, do not use this product for at least two weeks after stopping an MAOI. If you're unsure whether your prescription includes an MAOI, it's important to consult with your doctor or pharmacist before using this product.

Taking this precaution is crucial to prevent serious interactions and ensure your safety. Always prioritize your health by checking with a healthcare professional if you have any questions about your medications.

Side Effects

You should be aware of some important side effects and warnings associated with this medication. Do not use it if you are currently taking a monoamine oxidase inhibitor (MAOI), which is a type of medication for depression or certain other conditions, or if you have stopped taking an MAOI within the last two weeks. If you're unsure whether your prescription includes an MAOI, consult your doctor or pharmacist.

Before using this medication, talk to your doctor if you have a cough with excessive mucus or a chronic cough related to smoking, asthma, chronic bronchitis, or emphysema. If your cough lasts more than seven days, keeps coming back, or is accompanied by fever, rash, or a persistent headache, stop using the medication and seek medical advice, as these may indicate a more serious issue. In case of an overdose, it's crucial to get medical help or contact a Poison Control Center immediately.

Warnings and Precautions

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

Before using this product, it's important to talk to your doctor if you have a cough with excessive mucus, or if you have a chronic cough due to smoking, asthma, chronic bronchitis, or emphysema. If you experience an overdose, seek emergency medical help or contact a Poison Control Center immediately. You should also stop using this product and call your doctor if your cough lasts more than seven days, comes back, or is accompanied by fever, rash, or a persistent headache, as these may indicate a more serious health issue.

Overdose

If you suspect an overdose, it’s crucial to seek medical help immediately or contact a Poison Control Center. Signs of an overdose can vary, but they may include unusual symptoms that are more severe than typical side effects.

Don’t wait for symptoms to worsen; acting quickly can make a significant difference in your safety. Always prioritize your health and well-being by reaching out for professional assistance in these situations.

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

If you are considering this medication for your child, it's important to know that it should not be used in children under 12 years old. For those aged 12 and older, the recommended dosage is one softgel every four hours, but you should not exceed six softgels in a 24-hour period. Always follow these guidelines to ensure the safety and well-being of your child.

Geriatric Use

While there is no specific information available about the use of this medication in older adults, it’s important to approach any new treatment with caution. Since older adults may have different health needs and responses to medications, you should always consult with a healthcare provider before starting any new medication. They can help determine the right dosage and monitor for any potential side effects, ensuring that the treatment is safe and effective for you or your loved one.

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

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

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your liver health. They can help determine the best course of action based on your individual situation.

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 of your product, store it in a cool, dry place at a temperature between 68-77°F (20-25°C). This temperature range helps maintain the product's effectiveness and safety.

Always check the blister pack before use; do not use the product if the pack is torn or punctured, as this could compromise its safety and effectiveness. Following these guidelines will help you handle the product safely and effectively.

Additional Information

No further information is available.

FAQ

What is Niaflu used for?

Niaflu temporarily alleviates common cold and flu symptoms, including cough due to minor throat and bronchial irritation.

How does Niaflu work?

Niaflu helps loosen phlegm (mucus), thin bronchial secretions, drain bronchial tubes, and make coughs more productive.

What is the recommended dosage for adults and children 12 years and older?

The recommended dosage is 1 softgel every 4 hours, with a maximum of 6 softgels in a 24-hour period.

Can children under 12 years use Niaflu?

No, Niaflu should not be used by children under 12 years.

Are there any contraindications for using Niaflu?

Do not use Niaflu if you are currently taking a prescription monoamine oxidase inhibitor (MAOI) or for 2 weeks after stopping an MAOI.

What should I do if my cough persists?

Stop using Niaflu and ask a doctor if your cough persists for more than 7 days, tends to recur, or is accompanied by fever, rash, or persistent headache.

What should I do in case of an overdose?

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

Is it safe to use Niaflu during pregnancy or breastfeeding?

If you are pregnant or breastfeeding, ask a health professional before using Niaflu.

How should Niaflu be stored?

Store Niaflu between 68-77°F (20-25°C) and do not use if the blister pack is torn or punctured.

Packaging Info

Below are the non-prescription pack sizes of Niaflu (dextromethorphan hbr, guaifenesin). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Niaflu.
Details

Drug Information (PDF)

This file contains official product information for Niaflu, 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

This drug is indicated for the temporary alleviation of symptoms associated with the common cold and influenza. Specifically, it is effective in relieving cough due to minor throat and bronchial irritation. Additionally, this drug aids in loosening phlegm (mucus) and thinning bronchial secretions, thereby facilitating the drainage of bronchial tubes and making coughs more productive.

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

Dosage and Administration

Adults and children aged 12 years and older are advised to take 1 softgel every 4 hours as needed. The maximum allowable dosage is 6 softgels within a 24-hour period. It is important to note that this medication is not recommended for children under 12 years of age. Healthcare professionals should ensure that patients adhere to these guidelines to avoid potential overdose and ensure safe usage.

Contraindications

Use of this product is contraindicated in patients currently taking a prescription monoamine oxidase inhibitor (MAOI), which includes certain medications for depression, psychiatric or emotional conditions, or Parkinson's disease. Additionally, use is contraindicated for a period of 2 weeks following the discontinuation of an MAOI. Patients should consult a healthcare professional if they are uncertain whether their prescription medication contains an MAOI.

Warnings and Precautions

It is imperative to adhere to the following warnings and precautions to ensure the safe use of this product.

Warnings The use of this product is contraindicated in individuals currently taking a prescription monoamine oxidase inhibitor (MAOI), which includes certain medications prescribed for depression, psychiatric or emotional conditions, or Parkinson's disease. Additionally, this product should not be used for a period of two weeks following the discontinuation of an MAOI. Healthcare professionals should advise patients to consult with a doctor or pharmacist if there is uncertainty regarding the presence of an MAOI in their prescription medications.

General Precautions Prior to using this product, patients should seek medical advice if they are experiencing a cough that is accompanied by excessive phlegm (mucus) or if they have a persistent or chronic cough, particularly in cases related to smoking, asthma, chronic bronchitis, or emphysema.

Emergency Situations In the event of an overdose, it is crucial to seek emergency medical assistance immediately or contact a Poison Control Center.

Discontinuation of Use Patients are advised to discontinue use and consult a healthcare provider if their cough persists for more than seven days, recurs, or is accompanied by symptoms such as fever, rash, or a persistent headache. These symptoms may indicate a serious underlying condition that requires medical evaluation.

Side Effects

Patients should be aware of the potential adverse reactions associated with this product. Serious warnings include the contraindication of use in individuals currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing such medication. MAOIs are commonly prescribed for depression, psychiatric or emotional conditions, and Parkinson's disease. Patients uncertain about whether their prescription contains an MAOI are advised to consult a healthcare professional prior to use.

It is recommended that patients seek medical advice before using this product if they have a cough accompanied by excessive phlegm or if they experience a persistent or chronic cough, which may be indicative of underlying conditions such as smoking, asthma, chronic bronchitis, or emphysema.

Patients should discontinue use and consult a healthcare provider if their cough persists for more than 7 days, recurs, or is accompanied by fever, rash, or a persistent headache, as these symptoms may signal a serious medical condition.

In the event of an overdose, patients are urged to seek immediate medical assistance or contact a Poison Control Center.

Drug Interactions

There are currently no documented drug interactions associated with the use of 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 Niaflu (dextromethorphan hbr, guaifenesin). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Niaflu.
Details

Pediatric Use

Pediatric patients under 12 years of age should not use this medication. For adolescents aged 12 years and older, the recommended dosage is 1 softgel every 4 hours, with a maximum of 6 softgels in a 24-hour period. Caution is advised to ensure adherence to the dosing guidelines to prevent potential overdose.

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 potential adverse effects or changes in efficacy, 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 currently no available data on 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 not been specifically addressed in the drug insert text regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as there is no available data to guide treatment decisions in this population. Regular monitoring of renal function may be prudent in these patients, although specific recommendations are not provided.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to this medication. Consequently, there are no established dosage adjustments, special monitoring requirements, or precautions outlined for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population. Regular monitoring of liver function may be prudent in these cases, although specific parameters are not defined in the prescribing information.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. Prompt intervention is crucial to mitigate potential adverse effects associated with the overdose.

Healthcare professionals should be aware that the specific symptoms of an overdose may vary depending on the substance involved. Therefore, a thorough assessment of the patient's condition is essential to determine the appropriate course of action.

Management of an overdose typically involves supportive care and symptomatic treatment. Continuous monitoring of the patient's vital signs and clinical status is recommended. In cases where the specific substance is known, targeted interventions may be employed to counteract the effects of the overdose.

It is essential for healthcare providers to remain vigilant and act swiftly in the management of overdose situations to ensure optimal patient 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 compound in these areas.

Postmarketing Experience

Postmarketing experience has identified the following adverse reactions reported voluntarily or through surveillance programs: dizziness, nausea, vomiting, and allergic reactions, which include rash, pruritus, and angioedema.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center in the event of an overdose. It is crucial for patients to understand the importance of prompt action in such situations to ensure their safety and well-being.

Storage and Handling

The product is supplied in blister packs. It is essential to store the product at a temperature range of 68-77°F (20-25°C). Healthcare professionals should ensure that the blister pack remains intact; do not use the product if the blister pack is torn or punctured, as this may compromise the integrity of the medication.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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