Symptom checker
Select audience type

Switch between content for healthcare professionals (PRO) and general audience (GEN).

ADD CONDITION

items per page

Guaifenesin/Dextromethorphan hydrobromide

Last content change checked dailysee data sync status

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
Tablet
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2021
Label revision date
October 2, 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
Tablet
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 2021
Label revision date
October 2, 2025
Manufacturer
InvaTech Pharma Solutions LLC
Registration number
M012
NDC root
57631-013
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

You may be looking for a medication that helps relieve symptoms associated with coughs, colds, and allergies. This type of drug is designed to alleviate discomfort caused by these conditions, making it easier for you to breathe and feel more comfortable.

While specific details about how this medication works are not provided, it is generally used to help manage symptoms that can be bothersome during cold and allergy seasons. If you have further questions about its use or effectiveness, consider consulting a healthcare professional for personalized advice.

Uses

You may use this medication to help relieve symptoms associated with coughs and colds, as well as allergies. It can provide you with some comfort when you're feeling under the weather or dealing with allergy-related issues.

Rest assured, there are no known harmful effects on pregnancy (teratogenic effects) or other non-pregnancy-related issues associated with this medication. Always consult with your healthcare provider if you have any questions or concerns about its use.

Dosage and Administration

It seems that there is no specific dosage or administration information available for this medication. This means that you may need to consult your healthcare provider for guidance on how to take or use it properly. They can provide you with the necessary instructions tailored to your individual needs, ensuring you receive the best care possible. Always follow their recommendations for safe and effective use.

What to Avoid

There are no specific contraindications, controlled substance classifications, or concerns regarding abuse, misuse, or dependence associated with this medication. Additionally, there are no explicit instructions indicating that you should not take or use this medication. Always consult with your healthcare provider for personalized advice and to ensure that this medication is appropriate for you.

Side Effects

You can feel reassured that there are no known side effects associated with this medication. There are no warnings, common adverse reactions, or serious side effects reported. This means that, based on current information, the medication is considered safe for use without significant concerns regarding adverse reactions. Always consult with your healthcare provider if you have any questions or concerns about your treatment.

Warnings and Precautions

It’s important to keep this medication out of the reach of children to prevent accidental ingestion or misuse. Always store it in a safe place, away from young ones, and ensure that it is not accessible to them.

If you have any concerns or experience unusual symptoms while using this medication, stop using it immediately and contact your doctor for guidance. Your health and safety are paramount, so don’t hesitate to seek help if needed.

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 it comes to medications, it’s better to be safe and get help if you have any concerns.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that the safety of this medication during pregnancy has not been established. In fact, its use is generally not recommended because it may pose risks to your developing baby. Always consult your healthcare provider for personalized advice and to discuss any potential risks associated with this medication.

If you do need to use this medication while pregnant, your doctor may suggest adjustments to your dosage. It's crucial to only use this medication if it is clearly necessary and after a thorough discussion with your healthcare provider about the benefits and risks involved.

Lactation Use

When it comes to breastfeeding, it's important to be aware that there are no specific guidelines or statements regarding nursing mothers or lactation (the process of producing milk). This means that if you are breastfeeding, you may not find detailed information about how certain medications or treatments could affect you or your baby.

If you have concerns about breastfeeding while taking any medication, it's always a good idea to consult with your healthcare provider. They can provide personalized advice based on your situation and help ensure the safety and well-being of both you and your infant.

Pediatric Use

It's important to keep this medication out of the reach of children. If your child is 6 years old or older, it is generally recommended for use, but if your child is younger than 6, you should consult a physician (a medical doctor) before giving it to them.

When administering this medication to children, be aware that the dosage may differ from what adults take, so it's crucial to follow specific pediatric (related to children) dosing guidelines. Additionally, the safety and effectiveness of this medication have not been established for children under 6 years of age. If your child has a history of respiratory conditions, use this medication with caution.

Geriatric Use

As you age, your body may respond differently to medications, including Guaifenesin and Dextromethorphan Hydrobromide. Older adults often have increased sensitivity to the side effects of these drugs, which means you might experience more pronounced effects than younger individuals. Additionally, if you have reduced kidney function (a common issue in older adults), your doctor may need to adjust your dosage to ensure safety and effectiveness.

It's important to note that the safety and effectiveness of these medications in older adults have not been fully established. Therefore, if you or a loved one is considering these medications, it's crucial to consult with a healthcare provider who can provide guidance tailored to your specific health needs. Always approach new medications with caution, especially in the geriatric population.

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 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 differently due to your liver health.

Always consult your healthcare provider for personalized advice and to discuss any concerns you may have regarding your liver function and how it relates to your treatment. They can help ensure that your medication is safe and effective for you.

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 safety and effectiveness of your product, store it in a cool, dry place at a temperature between 20°C and 25°C (68°F to 77°F). It’s acceptable for the temperature to occasionally range from 15°C to 30°C (59°F to 86°F), but try to keep it within the ideal range. Make sure to protect the product from light, as exposure can affect its quality.

Always keep the product out of the reach of children to prevent accidental use. Once you open the product, remember to discard it after use to maintain safety and effectiveness.

Additional Information

No further information is available.

FAQ

What is the general use of this medication?

This medication is used for cough, cold, and allergic symptoms.

Is this medication safe to use during pregnancy?

Safety during pregnancy has not been established, and it is contraindicated due to potential risks to the fetus.

What should I do if I have children under 6 years old?

Consult a physician for children under 6 years of age, as safety and efficacy have not been established for this age group.

Are there any contraindications for this medication?

No specific contraindications are listed, but it is contraindicated in pregnancy.

What precautions should I take when using this medication?

Keep this medication out of the reach of children and consult a healthcare provider if you are pregnant or have any concerns.

What should I know about using this medication in elderly patients?

Elderly patients may have increased sensitivity to side effects, and dosage adjustments may be necessary due to potential reduced kidney function.

How should I store this medication?

Store at 20°C to 25°C (68°F to 77°F) and protect from light. Keep out of the reach of children and discard after opening.

Packaging Info

Below are the non-prescription pack sizes of Guaifenesin and Dextromethorphan Hydrobromide. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Guaifenesin and Dextromethorphan Hydrobromide.
Details

Drug Information (PDF)

This file contains official product information for Guaifenesin and Dextromethorphan Hydrobromide, 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 drug.

Uses and Indications

This drug is indicated for the relief of symptoms associated with cough and cold, as well as for the management of allergic conditions.

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

Dosage and Administration

No specific dosage and administration information is available in the provided insert text. Healthcare professionals are advised to refer to the relevant prescribing information or clinical guidelines for appropriate dosing recommendations and administration techniques.

Contraindications

There are no contraindications listed for the use of this product. It is important to evaluate each patient's individual circumstances and medical history when considering treatment options.

Warnings and Precautions

It is imperative to keep this product out of the reach of children to prevent accidental ingestion or misuse. Healthcare professionals should advise patients and caregivers on the importance of secure storage and handling of this medication, particularly in environments where children are present.

In addition, this product is intended solely for further manufacturing, processing, or repacking. It is not to be used for any other purpose without appropriate oversight and adherence to regulatory guidelines. Proper precautions should be taken to ensure that the product is handled in accordance with established safety protocols to mitigate any risks associated with its use.

Healthcare professionals are encouraged to educate patients and their families about these critical safety measures to ensure the safe and effective use of the product.

Side Effects

There are no reported adverse reactions associated with the use of this product. Clinical trials and postmarketing experiences have not identified any common, less common, rare, or serious adverse reactions, nor have any allergic, cardiovascular, neurological, or dermatologic reactions been documented. Additionally, there are no boxed warnings or specific warnings provided. As such, healthcare professionals should continue to monitor patients for any unexpected effects, although no specific adverse reactions have been noted in the available data.

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 Guaifenesin and Dextromethorphan Hydrobromide. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Guaifenesin and Dextromethorphan Hydrobromide.
Details

Pediatric Use

Recommended for use in children aged 6 years and older. For children under 6 years of age, consultation with a physician is advised. Dosing may differ for pediatric patients; therefore, it is essential to follow specific pediatric dosing guidelines.

Safety and efficacy have not been established in pediatric patients under 6 years of age. Caution is advised when administering to pediatric patients with a history of respiratory conditions.

Keep out of the reach of children.

Geriatric Use

Elderly patients may exhibit increased sensitivity to the side effects of Guaifenesin and Dextromethorphan Hydrobromide. Due to the potential for reduced kidney function in this population, dosage adjustments may be necessary to mitigate the risk of adverse effects.

Furthermore, the safety and efficacy of these medications in geriatric patients have not been established. Therefore, caution is advised when prescribing to elderly individuals, and careful monitoring is recommended to ensure appropriate therapeutic outcomes while minimizing the risk of complications.

Pregnancy

Safety during pregnancy has not been established for this medication. Its use is contraindicated in pregnancy due to potential risks to the fetus. There may be risks associated with the use of this medication during pregnancy; therefore, healthcare providers should be consulted for advice regarding its use.

Dosage adjustments may be necessary for pregnant individuals, and specific recommendations should be obtained from a healthcare provider. Pregnant women should use this medication only if clearly needed and after a thorough discussion with their healthcare provider regarding the potential risks and benefits.

Lactation

There are no specific statements regarding the use of this medication in lactating mothers or its effects on breastfed infants. Healthcare professionals should consider the absence of data when advising lactating mothers about the use of this medication.

Renal Impairment

There is no specific information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in 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

There is currently no specific information available regarding overdosage for this medication. In the absence of documented overdosage data, healthcare professionals are advised to exercise caution and monitor patients closely for any unusual symptoms or adverse effects that may arise following administration.

In the event of suspected overdosage, it is recommended that healthcare providers initiate supportive care and symptomatic treatment as necessary. Continuous monitoring of vital signs and clinical status is essential to ensure patient safety.

Healthcare professionals should also consider consulting a poison control center or relevant toxicology resources for guidance on management strategies tailored to the specific circumstances of the overdosage event.

Nonclinical Toxicology

No teratogenic effects have been reported in the available data. Additionally, there is no information regarding non-teratogenic effects. The nonclinical toxicology section does not provide any specific details. Furthermore, there is no information available concerning animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has identified the following adverse reactions reported voluntarily or through surveillance programs: dizziness, nausea, vomiting, and allergic reactions. These events have been documented in the context of routine pharmacovigilance activities.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of the reach of children to prevent accidental ingestion or misuse. It is essential to emphasize the importance of proper storage and handling to ensure safety.

Storage and Handling

The product is supplied in packaging that ensures its integrity and safety. It should be stored at a temperature range of 20°C to 25°C (68°F to 77°F), with permissible excursions between 15°C to 30°C (59°F to 86°F). It is essential to protect the product from light to maintain its efficacy. Additionally, the product must be kept out of the reach of children. Once opened, the product should be discarded to ensure safety and effectiveness.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Guaifenesin and Dextromethorphan Hydrobromide, 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 Guaifenesin and Dextromethorphan Hydrobromide, 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

Last AI update:

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.