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Desgen

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Active ingredients
  • Guaifenesin 50 mg/1 mL
  • Dextromethorphan Hydrobromide 5 mg/1 mL
  • Phenylephrine Hydrochloride 2.5 mg/1 mL
Other brand names
Drug classes
Expectorant, Sigma-1 Agonist, Uncompetitive N-methyl-D-aspartate Receptor Antagonist, alpha-1 Adrenergic Agonist
Dosage form
Solution/ Drops
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2014
Label revision date
December 4, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Guaifenesin 50 mg/1 mL
  • Dextromethorphan Hydrobromide 5 mg/1 mL
  • Phenylephrine Hydrochloride 2.5 mg/1 mL
Other brand names
Drug classes
Expectorant, Sigma-1 Agonist, Uncompetitive N-methyl-D-aspartate Receptor Antagonist, alpha-1 Adrenergic Agonist
Dosage form
Solution/ Drops
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 2014
Label revision date
December 4, 2025
Manufacturer
Kramer Novis
Registration number
M012
NDC root
52083-641
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

Desgen is a medication designed to help loosen phlegm (mucus) and thin bronchial secretions, making it easier for you to drain your bronchial tubes and have more productive coughs. It is commonly used to temporarily relieve nasal congestion caused by hay fever or other upper respiratory allergies (known as allergic rhinitis), as well as to alleviate coughs resulting from minor throat and bronchial irritation, which can occur with the common cold.

Uses

This medication is designed to help you breathe easier by loosening phlegm (mucus) and thinning bronchial secretions. This action helps drain your bronchial tubes, making your coughs more productive, which can be especially helpful when you're dealing with respiratory issues.

Additionally, it provides temporary relief from nasal congestion caused by hay fever or other upper respiratory allergies (known as allergic rhinitis). If you're experiencing a cough due to minor throat and bronchial irritation, such as what might happen with a common cold, this medication can also help alleviate that discomfort.

Dosage and Administration

When taking this medication, it's important to follow the dosing instructions carefully to ensure safety and effectiveness. You should not take more than 6 doses within a 24-hour period, and you can repeat the dose every 4 hours as needed. To measure your dose accurately, use the dosage device that comes with the medication; avoid using any other measuring tools to ensure you get the correct amount.

For children aged 2 to under 6 years, the recommended dose is 1 mL. If you have a child under 2 years of age, it's crucial to consult a doctor before administering this medication. Always prioritize safety by adhering to these guidelines.

What to Avoid

It's important to keep this medication out of reach of children to ensure their safety. If you suspect an overdose, seek medical help immediately or contact a Poison Control Center for assistance.

While there are no specific contraindications, risks of abuse, misuse, or dependence associated with this medication, always use it responsibly and as directed. Your health and safety are paramount, so please follow these guidelines closely.

Side Effects

It's important to be aware of potential side effects when using this medication. You should not give it to a child who is currently taking a monoamine oxidase inhibitor (MAOI) or has stopped taking one within the last two weeks. Before using this medication, consult a doctor if your child has any of the following conditions: heart disease, thyroid disease, high blood pressure, diabetes, or a cough that produces a lot of mucus or lasts a long time, such as with asthma.

If your child experiences nervousness, dizziness, or trouble sleeping, you should stop using the medication and consult a doctor. Additionally, if symptoms do not improve within seven days or are accompanied by a fever, or if a cough lasts more than seven days, returns, or is accompanied by a fever, rash, or persistent headache, seek medical advice as these could indicate a more serious issue.

Warnings and Precautions

It's important to be cautious when using this medication for your child. Do not give it to a child who is currently taking a monoamine oxidase inhibitor (MAOI), which is a type of medication used for depression or certain other conditions, or for two weeks after stopping an MAOI. If you're unsure whether your child's prescription includes an MAOI, please consult a doctor or pharmacist. Additionally, check with a doctor before use if your child has any of the following: heart disease, thyroid disease, high blood pressure, diabetes, a cough with excessive mucus, or a chronic cough like asthma. Always follow the dosing instructions carefully.

If your child experiences nervousness, dizziness, or sleeplessness, or if their symptoms do not improve within seven days or are accompanied by a fever, stop using the medication and call your doctor. A cough that lasts more than seven days, returns, or is accompanied by fever, rash, or a persistent headache may indicate a more serious issue, so it's important to seek medical advice in those cases.

In the event of an overdose, seek emergency medical help or contact a Poison Control Center immediately. Your child's safety is the top priority, so please take these precautions seriously.

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.

Always err on the side of caution—if you notice anything concerning, don’t hesitate to reach out for assistance. Your health and safety are the top priority.

Pregnancy Use

When it comes to using this product during pregnancy, there is no specific information available about its safety, dosage adjustments, or any special precautions you should take. This means that if you are pregnant or planning to become pregnant, it’s important to consult with your healthcare provider before using this product. They can help you understand any potential risks and make informed decisions about your health and the health of your baby. Always prioritize open communication with your doctor regarding any medications or treatments during pregnancy.

Lactation Use

If you are breastfeeding, you can feel reassured that there are no specific warnings or recommendations regarding the use of this product while nursing. Additionally, there are no known concerns about the product being passed into breast milk or any associated risks for your infant. Always consult with your healthcare provider if you have any questions or concerns about medications while breastfeeding.

Pediatric Use

When considering medication for your child, it's important to be aware of specific guidelines. If your child is taking a prescription monoamine oxidase inhibitor (MAOI) or has stopped taking one within the last two weeks, do not use this medication. Before giving it to your child, consult a doctor if they have any of the following conditions: heart disease, thyroid disease, high blood pressure, diabetes, or a cough that produces a lot of mucus or lasts a long time, such as with asthma.

For children aged 2 to under 6 years, the recommended dose is 1 mL, and you should not exceed 6 doses in a 24-hour period. Doses can be repeated every 4 hours, but always use the dosage device provided to ensure accuracy—do not use any other measuring device. If your child is under 2 years old, please consult a doctor before use.

Geriatric Use

While there is no specific information about the use of DESGEN PEDIATRIC (a combination of dextromethorphan, guaifenesin, and phenylephrine) in older adults, it's important to approach any medication with caution. If you are caring for an older adult, be aware that their bodies may process medications differently due to age-related changes.

Always consult with a healthcare professional before starting any new medication, especially for older adults who may have other health conditions or take multiple medications. This ensures that the treatment is safe and appropriate for their specific health needs.

Renal Impairment

If you have kidney problems, it's important to know that the information provided does not include specific guidelines for dosage adjustments, special monitoring, or safety considerations related to renal impairment (kidney issues). This means that there are no tailored recommendations for how your treatment may need to change based on your kidney function.

Always consult your healthcare provider for personalized advice and to ensure that your treatment plan is safe and effective for your specific situation. They can help monitor your kidney health and make any necessary adjustments to your medications.

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 may affect you if you have hepatic impairment (liver issues).

Always consult your healthcare provider for personalized advice and to discuss any concerns regarding your liver health and how it may relate to your treatment. They can help ensure that you receive the safest and most effective care.

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

To ensure the safety and effectiveness of your product, always check that the cap seal is intact before use. If the seal is torn, broken, or missing, do not use the product. For optimal storage, keep it at a controlled room temperature between 15-30°C (59-86°F) and protect it from excessive heat and humidity.

By following these guidelines, you can help maintain the quality of the product and ensure it remains safe for use.

Additional Information

You should take this medication orally and can repeat the dose every 4 hours, but do not exceed 6 doses in a 24-hour period. It's important to follow these guidelines to ensure safe and effective use of the medication. If you have any questions or concerns about your treatment, be sure to consult with your healthcare provider.

FAQ

What is Desgen used for?

Desgen helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes, making coughs more productive. It also temporarily relieves nasal congestion due to hay fever or other upper respiratory allergies.

How should I administer Desgen?

You should measure Desgen with the dosage device provided and not use any other device. For children aged 2 to under 6 years, the dosage is 1 mL, and you should not exceed 6 doses in any 24-hour period.

What should I do if my child has a cough that lasts more than 7 days?

You should stop using Desgen and call your doctor if your child's cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache.

Are there any warnings for using Desgen?

Do not use Desgen in a child taking a prescription monoamine oxidase inhibitor (MAOI) or for 2 weeks after stopping an MAOI. Consult a doctor if your child has heart disease, thyroid disease, high blood pressure, diabetes, or a chronic cough.

What should I do in case of an overdose?

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

Is Desgen safe to use during pregnancy or while nursing?

The insert does not provide specific information regarding the use of Desgen during pregnancy or while nursing, so consult your doctor for advice.

What are the storage instructions for Desgen?

Store Desgen at controlled room temperature between 15-30°C (59-86°F) and avoid excessive heat and humidity.

Packaging Info

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

Packaging configurations for Desgen.
Details

Drug Information (PDF)

This file contains official product information for Desgen, 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 relief of symptoms associated with upper respiratory conditions. It helps to loosen phlegm (mucus) and thin bronchial secretions, facilitating drainage of the bronchial tubes and enhancing the productivity of coughs.

This medication temporarily relieves nasal congestion due to hay fever or other upper respiratory allergies (allergic rhinitis) and alleviates cough resulting from minor throat and bronchial irritation, which may occur with the common cold.

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

Dosage and Administration

The maximum recommended dosage is 6 doses within a 24-hour period. Dosing should be repeated every 4 hours as needed. It is essential to measure the dosage using the device provided with the medication; the use of any other measuring device is not advised.

For children aged 2 to under 6 years, the appropriate dosage is 1 mL. For children under 2 years of age, it is imperative to consult a healthcare professional before administration.

Contraindications

There are no specific contraindications listed for this product. However, it is essential to keep the product out of reach of children to prevent accidental ingestion. In the event of an overdose, immediate medical assistance should be sought, or contact a Poison Control Center for guidance.

Warnings and Precautions

The use of this product in pediatric patients requires careful consideration of specific contraindications and precautions.

Contraindications This product must not be administered to children who are 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. If there is uncertainty regarding the presence of an MAOI in a child's prescription, consultation with a healthcare professional, such as a doctor or pharmacist, is essential prior to administration.

Pre-existing Conditions Prior to use, it is imperative to consult a healthcare provider if the child has any of the following conditions:

  • Heart disease

  • Thyroid disease

  • High blood pressure

  • Diabetes

  • A cough associated with excessive phlegm (mucus)

  • A chronic cough, such as that which occurs with asthma

Dosage and Administration When utilizing this product, it is critical to adhere strictly to the recommended dosage. Exceeding the directed amount can lead to adverse effects.

Monitoring and Discontinuation Parents and caregivers should monitor the child for any of the following symptoms and seek medical advice if they occur:

  • Nervousness, dizziness, or sleeplessness

  • Lack of improvement in symptoms within 7 days, especially if accompanied by fever

  • A cough that persists beyond 7 days, recurs, or is associated with fever, rash, or a persistent headache, as these may indicate a serious underlying condition.

Emergency Situations In the event of an overdose, immediate medical assistance should be sought, or contact with a Poison Control Center is advised without delay.

Side Effects

Patients should be aware of the potential adverse reactions associated with the use of this medication. Serious adverse reactions may occur, particularly in children who are concurrently taking a prescription monoamine oxidase inhibitor (MAOI) or have taken one within the past two weeks. It is crucial to avoid the use of this medication in such cases.

Before administering this medication to a child, it is advisable to consult a healthcare professional if the child has any of the following conditions: heart disease, thyroid disease, high blood pressure, diabetes, or a cough that is productive with excessive phlegm or is chronic, such as that which occurs with asthma.

Patients should discontinue use and seek medical advice if the child experiences nervousness, dizziness, or sleeplessness. Additionally, if symptoms do not improve within seven days or are accompanied by fever, or if a cough persists for more than seven days, recurs, or is associated with fever, rash, or a persistent headache, these may indicate a serious underlying condition that requires medical evaluation.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there are no known 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 Desgen (dextromethorphan hbr, guiafenesin, phenylephrine hcl). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Desgen.
Details

Pediatric Use

Pediatric patients should not use this medication if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing an MAOI. Prior to administration, it is essential to consult a healthcare professional if the child has any of the following conditions: heart disease, thyroid disease, high blood pressure, diabetes, or a cough associated with excessive phlegm or chronic cough, such as that seen in asthma.

For children aged 2 to under 6 years, the recommended dosage is 1 mL, while for those under 2 years of age, consultation with a doctor is advised before use. The medication should not exceed 6 doses within a 24-hour period, with doses repeated every 4 hours as needed. It is important to measure the dosage using the device provided and to avoid using any other measuring device to ensure accurate dosing.

Geriatric Use

There is no specific information regarding the use of DESGEN PEDIATRIC (dextromethorphan hbr, guaifenesin, phenylephrine hcl solution/drops) in geriatric patients. Therefore, healthcare providers should exercise caution when prescribing this medication to elderly patients.

Due to the lack of clinical data in this population, it is advisable to closely monitor geriatric patients for any adverse effects or changes in response to treatment. Additionally, consideration should be given to potential age-related physiological changes that may affect drug metabolism and clearance.

Healthcare providers are encouraged to evaluate the necessity of dosage adjustments on a case-by-case basis, taking into account the overall health status and concurrent medications of elderly patients.

Pregnancy

The available prescribing information does not provide specific data regarding the use of this product during pregnancy. Consequently, there are no established safety concerns, dosage modifications, or special precautions outlined for pregnant patients. Healthcare professionals should exercise caution when considering the use of this product in women of childbearing potential and weigh the potential risks and benefits. It is advisable to monitor for any adverse fetal outcomes in the absence of specific data.

Lactation

There are no specific warnings or recommendations regarding the use of this product in lactating mothers. Additionally, there are no statements concerning the potential for excretion in breast milk or any associated risks to breastfed infants during the use of this product.

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

Patients with hepatic impairment have not been specifically studied in relation to the use of 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 available 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 therapies may be employed as indicated.

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

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. It is crucial to emphasize the importance of safety in the home environment, particularly for households with young children.

In the event of an overdose, healthcare providers should instruct patients to seek medical help immediately or contact a Poison Control Center. Patients should be made aware of the signs of overdose and the urgency of obtaining assistance to ensure their safety and well-being.

Storage and Handling

The product is supplied in a bottle with an imprinted seal around the neck for added protection. It is essential to refrain from using the product if the cap seal is torn, broken, or missing.

For optimal storage, the product should be maintained at a controlled room temperature between 15-30°C (59-86°F). It is important to avoid exposure to excessive heat and humidity to ensure the integrity and efficacy of the product.

Additional Clinical Information

The medication is administered orally, with a recommended frequency of every 4 hours. Clinicians should advise patients not to exceed 6 doses within a 24-hour period. No additional information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experiences.

Drug Information (PDF)

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