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Neotuss S/F

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Active ingredients
  • Guaifenesin 200 mg/5 mL
  • Dextromethorphan Hydrobromide 30 mg/5 mL
Other brand names
Drug classes
Expectorant, Sigma-1 Agonist, Uncompetitive N-methyl-D-aspartate Receptor Antagonist
Dosage form
Liquid
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 18, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Guaifenesin 200 mg/5 mL
  • Dextromethorphan Hydrobromide 30 mg/5 mL
Other brand names
Drug classes
Expectorant, Sigma-1 Agonist, Uncompetitive N-methyl-D-aspartate Receptor Antagonist
Dosage form
Liquid
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 18, 2025
Manufacturer
DORAL PHARMAMEDICS INC dba A. G. Marin Pharmaceuticals
Registration number
M012
NDC root
12539-555
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

NeoTuss SF is a medication designed to temporarily relieve coughs caused by minor bronchial irritations, which can occur with the common cold. It works by loosening phlegm (mucus) and thinning bronchial secretions, helping to clear the bronchial passageways of bothersome mucus and making coughs more productive. This can provide you with relief when you're dealing with a cough associated with respiratory discomfort.

Uses

If you're dealing with a cough caused by minor bronchial irritations, such as those that often accompany the common cold, this medication can provide temporary relief. It works by helping to loosen phlegm (mucus) and thin out bronchial secretions. This action makes it easier for your body to clear out bothersome mucus, leading to more productive coughs. By easing these symptoms, you can feel more comfortable as you recover.

Dosage and Administration

For adults and children over 12 years old, you should take one teaspoonful (5 mL) of the medication every 6 to 8 hours, or follow your doctor's instructions. If your child is between 6 and 12 years old, the recommended dose is half a teaspoonful (2.5 mL) every 6 to 8 hours, again following your physician's guidance.

If your child is under 6 years old, it's important to only use this medication if directed by a physician. Always make sure to follow the specific instructions provided by your healthcare provider to ensure safe and effective use.

What to Avoid

You should avoid using this medication if you are currently taking a prescription monoamine oxidase inhibitor (MAOI), which are specific drugs used for depression, psychiatric or emotional conditions, or Parkinson’s disease. Additionally, do not use this medication for at least two weeks after stopping an MAOI.

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using this product to ensure it is safe for you and your baby. Always prioritize your health and safety by following these guidelines.

Side Effects

You should be aware that a persistent cough could indicate a serious health issue. If your cough lasts more than a week, keeps coming back, or is accompanied by symptoms like fever, rash, or a lasting headache, it's important to see a doctor. Additionally, this product should not be used for chronic coughs related to smoking, asthma, or emphysema, especially if there is a lot of mucus, unless directed by a healthcare professional.

It's also crucial to avoid this product if you are currently taking a prescription monoamine oxidase inhibitor (MAOI), which is used for certain mental health conditions, or if you have stopped taking an MAOI within the last two weeks. If you're unsure whether your medication includes an MAOI, please consult a healthcare provider. Lastly, if you are pregnant or breastfeeding, seek advice from a health professional before using this product.

Warnings and Precautions

If you have a cough that lasts more than a week, keeps coming back, or is accompanied by fever, rash, or a persistent headache, it’s important to see a doctor. Avoid using this product for chronic coughs related to smoking, asthma, or emphysema, especially if you have a lot of mucus, unless your doctor advises otherwise.

In case of an accidental overdose, seek immediate help from a health professional or contact a Poison Control Center. If you are currently taking a prescription monoamine oxidase inhibitor (MAOI) for depression, psychiatric conditions, or Parkinson’s disease, do not use this product, and wait at least two weeks after stopping the MAOI before using it. If you’re unsure whether your medication includes an MAOI, consult your healthcare provider. Additionally, if you are pregnant or breastfeeding, please check with a health professional before using this product.

Overdose

It appears that there is no specific information available regarding overdosage for this medication. However, it's important to be aware of the general signs of an overdose, which can include symptoms like extreme drowsiness, confusion, or difficulty breathing. If you suspect an overdose, it is crucial to seek immediate medical help.

In case of an emergency, call your local emergency number or go to the nearest hospital. Always keep medications out of reach of children and follow the prescribed dosage to prevent any potential risks. If you have any concerns or questions about your medication, don’t hesitate to reach out to your healthcare provider for guidance.

Pregnancy Use

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using this product. 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 this product. They can provide guidance on any potential risks and help ensure the safety of both you and your baby. Always prioritize open communication with your doctor regarding any medications or products you consider while nursing.

Pediatric Use

When it comes to giving this medication to children, it's important to follow specific guidelines. For children aged 6 to under 12 years, the recommended dosage is 1/2 teaspoonful (2.5 mL) every 6 to 8 hours, or as your doctor advises. If your child is under 6 years old, you should only use this medication if a physician has specifically directed you to do so.

Always consult with your child's healthcare provider to ensure the correct dosage and safety for their age and health condition. This will help you make informed decisions about their treatment.

Geriatric Use

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

Renal Impairment

If you have kidney problems, it's important to know that there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the usual recommendations for monitoring or safety considerations related to renal impairment (kidney issues) are not provided.

Always consult your healthcare provider for personalized advice and to ensure that any medications you take are safe and appropriate for your kidney health. They can help you understand how your condition may affect your treatment plan.

Hepatic Impairment

If you have liver problems, it's important to know that there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the standard recommendations apply, and there are no special monitoring requirements or precautions outlined for patients like you.

Always consult your healthcare provider for personalized advice and to ensure that any medications you take are safe and appropriate for your liver health. They can provide guidance 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 feel free to ask questions and share your complete list of medications and any lab tests you may be undergoing. This way, you can receive the best possible care tailored to your needs.

Storage and Handling

Before using the product, make sure to shake it well. It's important to check the seal; do not use the product if the seal is torn, broken, or missing, as this could compromise its safety and effectiveness.

For proper storage, keep the product in a cool, dry place, ideally between 15°-30°C (59°-86°F). If you're a pharmacist, ensure that the product is preserved and dispensed in tight, light-resistant containers, as specified by the United States Pharmacopeia (USP). Following these guidelines will help maintain the product's quality and safety.

Additional Information

No further information is available.

FAQ

What is NeoTuss SF used for?

NeoTuss SF temporarily relieves cough due to minor bronchial irritations, such as those that may occur with the common cold. It helps loosen phlegm (mucus) and thins bronchial secretions to make coughs more productive.

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

The recommended oral dose for adults and children over 12 years is one teaspoonful (5 mL) every 6-8 hours, or as directed by a physician.

What dosage should children aged 6 to under 12 take?

Children aged 6 to under 12 years should take 1/2 teaspoonful (2.5 mL) every 6-8 hours, or as directed by a physician.

Is NeoTuss SF safe for children under 6?

For children under 6 years of age, NeoTuss SF should only be used as directed by a physician.

Are there any contraindications for using NeoTuss SF?

Do not use NeoTuss SF 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?

If your cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache, consult a physician.

Can I use NeoTuss SF if I am pregnant or breastfeeding?

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

What should I do in case of an accidental overdose?

In case of accidental overdose, seek the advice of a health professional or contact a Poison Control Center immediately.

How should I store NeoTuss SF?

Store NeoTuss SF between 15°-30°C (59°-86°F) and shake well before use. Do not use if the seal is torn, broken, or missing.

Packaging Info

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

Packaging configurations for Neotuss S/F.
Details

Drug Information (PDF)

This file contains official product information for Neotuss S/F, 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 relief of cough associated with minor bronchial irritations, which may occur with the common cold. It aids in loosening phlegm (mucus) and thinning bronchial secretions, facilitating the clearance of bothersome mucus from the bronchial passageways and enhancing the productivity of coughs.

Limitations of Use: This medication is intended for symptomatic relief and does not address the underlying causes of cough or bronchial irritation.

Dosage and Administration

For adults and children over 12 years of age, the recommended oral dosage is one teaspoonful (5 mL) every 6 to 8 hours, or as directed by a physician.

For children aged 6 to under 12 years, the appropriate dosage is 1/2 teaspoonful (2.5 mL) every 6 to 8 hours, or as directed by a physician.

In children under 6 years of age, the medication should only be administered as directed by a physician.

Healthcare professionals should ensure that patients are advised on the correct dosing intervals and the importance of adhering to the prescribed regimen.

Contraindications

Use of this product is contraindicated in patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing such medication, due to the risk of serious interactions. Additionally, the product should not be used by individuals who are pregnant or breastfeeding without prior consultation with a healthcare professional.

Warnings and Precautions

A persistent cough may indicate a serious underlying condition. Healthcare professionals should advise patients to seek medical consultation if a cough persists for more than one week, recurs frequently, or is accompanied by symptoms such as fever, rash, or a persistent headache.

This product is not indicated for the treatment of persistent or chronic coughs associated with smoking, asthma, or emphysema. Additionally, it should not be used if the cough is accompanied by excessive phlegm (mucus) unless directed by a physician.

In the event of an accidental overdose, it is imperative to seek immediate advice from a health professional or contact a Poison Control Center.

Patients currently taking a prescription monoamine oxidase inhibitor (MAOI), which includes certain medications for depression, psychiatric or emotional conditions, or Parkinson’s disease, should not use this product. Furthermore, it is essential to refrain from using this product for at least two weeks after discontinuing an MAOI. If there is any uncertainty regarding the presence of an MAOI in a prescription medication, patients should consult a healthcare professional prior to use.

For individuals who are pregnant or breastfeeding, it is crucial to seek guidance from a health professional before using this product.

Side Effects

Patients may experience a range of adverse reactions associated with the use of this product. A persistent cough may indicate a serious underlying condition; therefore, if a cough persists for more than one week, recurs, or is accompanied by fever, rash, or a persistent headache, patients are advised to consult a physician promptly.

It is important to note that this product should not be used for a persistent or chronic cough, such as those associated with smoking, asthma, or emphysema, unless directed by a physician. Additionally, patients should refrain from using this product if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have stopped taking an MAOI within the past two weeks. MAOIs are commonly prescribed for depression, psychiatric or emotional conditions, or Parkinson’s disease. If patients are uncertain whether their prescription medication contains an MAOI, they should seek guidance from a health professional before using this product.

For pregnant or breastfeeding individuals, it is recommended to consult a health professional prior to use to ensure safety for both the patient and the child.

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 Neotuss S/F (guaifenesin, dextromethorphan hbr). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Neotuss S/F.
Details

Pediatric Use

Pediatric patients aged 6 to under 12 years may be administered 1/2 teaspoonful (2.5 mL) every 6-8 hours, or as directed by a physician. For children under 6 years of age, the medication should only be used as directed by a physician. Caution is advised when prescribing to this younger age group, and dosing should be carefully managed to ensure safety and efficacy.

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 product. The potential risks and benefits must be carefully considered, 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 the safety of both the mother and the developing fetus.

Lactation

Lactating mothers are advised to consult a health professional prior to using this product. There is no specific data available regarding the excretion of this product in breast milk or its effects on breastfed infants. Therefore, caution is recommended when considering its use during lactation.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

Hepatic Impairment

There is no information available regarding hepatic impairment, including dosage adjustments, special monitoring, or precautions for patients with compromised liver function. Therefore, no specific recommendations can be made for the use of this medication in patients with hepatic impairment. It is advised that healthcare professionals exercise caution and consider individual patient circumstances when prescribing this medication to patients with liver problems.

Overdosage

In the absence of specific overdosage information, it is essential for healthcare professionals to remain vigilant and prepared for potential scenarios involving overdose.

Healthcare providers should be aware that the clinical presentation of an overdose may vary significantly depending on the substance involved and the individual patient’s characteristics. Symptoms of overdose can range from mild to severe and may include altered mental status, cardiovascular instability, respiratory distress, and gastrointestinal disturbances.

In the event of suspected overdosage, immediate medical evaluation is recommended. Healthcare professionals should assess the patient's vital signs and conduct a thorough clinical examination. Supportive care should be initiated as necessary, which may include airway management, intravenous fluids, and monitoring of vital parameters.

If specific antidotes or treatments are available for the substance involved, they should be administered according to established protocols. Consultation with a poison control center or a medical toxicologist may also be beneficial in managing the case effectively.

It is crucial to document all findings and interventions in the patient's medical record to ensure continuity of care and facilitate further management.

Nonclinical Toxicology

If pregnant or breastfeeding, it is advised to consult a health professional prior to using this product due to potential teratogenic effects. No information regarding non-teratogenic effects is available in the insert. Additionally, there is no data provided concerning nonclinical toxicology or animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions reported voluntarily or through surveillance programs. These include dizziness, nausea, vomiting, rash, and allergic reactions, which encompass anaphylaxis. Additionally, cases of hallucinations, confusion, agitation, somnolence, respiratory depression, and serotonin syndrome have also been documented. It is important to note that these reactions were reported during the postmarketing experience and may not be directly related to the use of the product.

Patient Counseling

Patients should be advised to seek immediate medical attention or contact a Poison Control Center in the event of an accidental overdose. It is crucial to inform patients that they should not use this product if they are currently taking a prescription monoamine oxidase inhibitor (MAOI), which includes certain medications for depression, psychiatric or emotional conditions, or Parkinson’s disease. Additionally, patients should be cautioned against using this product for at least two weeks after discontinuing an MAOI.

Healthcare providers should encourage patients to consult with them if they are uncertain whether their prescription medication contains an MAOI prior to using this product. Furthermore, it is important to discuss the use of this product with patients who are pregnant or breastfeeding, advising them to seek guidance from a health professional before proceeding with its use.

Storage and Handling

This product is supplied in tight, light-resistant containers as defined in the USP. It is essential to shake well before use. The product should not be used if the seal is torn, broken, or missing.

For optimal storage, maintain the product at a temperature range of 15°-30°C (59°-86°F). Proper handling and storage conditions are crucial to ensure the integrity and efficacy of the product.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Neotuss S/F, 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 Neotuss S/F, 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.