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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 S/F is a medication designed to temporarily relieve coughs caused by minor bronchial irritations, which can occur with the common cold. It works by helping to loosen phlegm (mucus) and thin bronchial secretions, making it easier for you to clear bothersome mucus from your airways. This action helps make your coughs more productive, allowing for better relief from discomfort.

Uses

If you're dealing with a cough caused by minor bronchial irritations, such as those that can happen with a 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 you are giving this medication to a child aged 6 to under 12 years, the appropriate dose is half a teaspoonful (2.5 mL) every 6 to 8 hours, again following your physician's guidance.

If the patient is under 6 years of age, it’s important to only use this medication as directed by a physician. Always ensure you measure the doses accurately to provide the right amount for effective treatment.

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 consult a doctor. Additionally, avoid using this product for chronic coughs related to smoking, asthma, or emphysema, especially if you have excessive mucus, unless directed by a healthcare professional.

It's also crucial not to use this product if you are currently taking a prescription monoamine oxidase inhibitor (MAOI), which are medications for depression or certain psychiatric conditions, or if you have stopped taking an MAOI within the last two weeks. If you are pregnant or breastfeeding, please consult a healthcare provider 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 you to do so.

If you accidentally take too much of this product, seek help from a health professional or contact a Poison Control Center right away. Additionally, do not use this product if you are currently taking a monoamine oxidase inhibitor (MAOI), which is a type of medication for depression or certain other conditions, or for two weeks after stopping an MAOI. If you're unsure whether your prescription includes an MAOI, check with your healthcare provider. Lastly, if you are pregnant or breastfeeding, consult 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 always important to be aware of the signs of an overdose, which can include unusual drowsiness, confusion, or difficulty breathing. If you suspect that you or someone else may have taken too much of a medication, it’s crucial to seek immediate medical help.

In case of an overdose, contact your local emergency services or go to the nearest hospital. Having the medication packaging or information on hand can help medical professionals provide the best care. Always remember that when in doubt, it’s better to err on the side of caution and seek assistance.

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 or effects it may have on you and your baby. Taking this precaution helps ensure the safety and well-being of both you and your child.

Pediatric Use

When 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, unless your doctor advises otherwise. If your child is under 6 years old, you should only use this medication if directed by a physician, as the safety and dosage for younger children need careful consideration.

Always consult with your child's healthcare provider to ensure the correct use and dosage for their age and health needs. This helps ensure their safety and effectiveness of the treatment.

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 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 and what steps to take for your safety.

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 with liver impairment.

Always consult your healthcare provider for personalized advice and to ensure that any medications you take are safe for your liver health. They can provide guidance tailored to your specific 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

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 S/F used for?

NeoTUSS S/F temporarily relieves cough due to minor bronchial irritations, such as those that may occur with the common cold. It helps loosen phlegm (mucus) and makes 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 should take 1/2 teaspoonful (2.5 mL) every 6-8 hours, or as directed by a physician.

Is NeoTUSS S/F safe for children under 6?

For children under 6 years of age, NeoTUSS S/F should only be used as directed by a physician.

Are there any contraindications for using NeoTUSS S/F?

Do not use NeoTUSS S/F 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 S/F if I am pregnant or breastfeeding?

If you are pregnant or breastfeeding, ask a health professional before using NeoTUSS S/F.

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 S/F?

Store NeoTUSS S/F 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), 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 due to the risk of serious interactions.

Pregnant or breastfeeding individuals should consult a healthcare professional prior to using this product.

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 additional symptoms such as fever, rash, or a persistent headache.

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

For individuals who are pregnant or breastfeeding, it is crucial to seek guidance from a health professional before using this product to ensure safety for both the mother and child.

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 persistent or chronic coughs, such as those associated with smoking, asthma, or emphysema, unless directed by a physician. Additionally, patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or who have stopped taking an MAOI within the past two weeks should avoid using this product, as serious interactions may occur.

For pregnant or breastfeeding patients, it is recommended to seek advice from a health professional before using this product 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 for this younger age group, and dosing should be carefully managed to ensure safety and efficacy.

Geriatric Use

There is no specific information available regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy.

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 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 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 the use of this medication in patients with hepatic impairment. Consequently, there are no dosage adjustments, special monitoring requirements, or precautions specified for individuals with compromised liver function. Healthcare professionals should exercise clinical judgment when considering the use of this medication in patients with liver problems, as the absence of specific guidance necessitates careful evaluation of the patient's overall health status and liver function.

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, including airway management, oxygen supplementation, and intravenous fluids.

If the specific agent involved in the overdose is known, appropriate antidotes or specific treatments should be administered as indicated. Continuous monitoring of the patient’s condition is crucial, and healthcare providers should be prepared to manage complications that may arise during the course of treatment.

In all cases of suspected overdose, it is advisable to contact a poison control center or consult relevant clinical guidelines for further management recommendations.

Nonclinical Toxicology

If pregnant or breastfeeding, it is advised to consult a health professional prior to using this product. No specific non-teratogenic effects have been identified in the available data. Additionally, there are no detailed findings regarding nonclinical toxicology or animal pharmacology and toxicology provided in the current information.

Postmarketing Experience

Postmarketing experience has identified 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 implications of pregnancy and breastfeeding, advising patients to seek guidance from a health professional before using this product in these circumstances.

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). Special handling requirements include preserving the integrity of the container to ensure the product's efficacy and safety.

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.