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Chest Congestion Relief

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Active ingredients
  • Guaifenesin 100 mg/5 mL
  • Dextromethorphan Hydrobromide 10 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 2020
Label revision date
December 30, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Guaifenesin 100 mg/5 mL
  • Dextromethorphan Hydrobromide 10 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 2020
Label revision date
December 30, 2025
Manufacturer
RUGBY LABORATORIES
Registration number
M012
NDC root
0536-1313
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

This medication is designed to temporarily relieve cough caused by minor irritation in the throat and bronchial tubes. It works by helping to loosen phlegm (mucus) and thin bronchial secretions, making your coughs more productive. This can be particularly helpful when you're dealing with a cough that is uncomfortable or persistent.

Uses

If you're dealing with a cough caused by minor irritation in your throat or bronchial tubes, this medication can provide temporary relief. It works by soothing your throat and helping to ease the discomfort associated with coughing.

In addition to relieving your cough, this medication also helps loosen phlegm (mucus) in your airways. By thinning out bronchial secretions, it makes your coughs more productive, allowing you to clear out mucus more effectively. This can be especially helpful when you're feeling congested.

Dosage and Administration

When you need relief, you can take this medication every 4 hours as needed, but make sure to follow your doctor's instructions if they provide specific guidance. It's important not to take more than 6 doses in a 24-hour period, so keep track of how many times you've taken it to avoid exceeding the recommended amount.

For adults and children aged 12 years and older, the typical dose is 2 teaspoonsfuls (which is 10 mL). However, if your child is under 12 years old, you should not use this medication for them. Always stick to the recommended dose to ensure your safety and effectiveness of the treatment.

What to Avoid

You can feel reassured that there are no specific contraindications, controlled substance classifications, or concerns regarding abuse, misuse, or dependence associated with this medication. This means that, based on the available information, you do not need to worry about any particular restrictions or risks related to these aspects. Always consult with your healthcare provider if you have any questions or concerns about your treatment.

Side Effects

You should avoid using this medication if you are currently taking a prescription monoamine oxidase inhibitor (MAOI), which is a type of drug used for depression or certain other conditions, or if you have taken an MAOI in the past two weeks. Additionally, do not use this product if you have ever had an allergic reaction to any of its ingredients.

Before using this medication, consult your doctor if you have a cough with excessive mucus or a chronic cough due to smoking, asthma, chronic bronchitis, or emphysema. If your cough lasts more than seven days, returns, or is accompanied by fever, rash, or a persistent headache, stop using the medication and seek medical advice, as these symptoms may indicate a more serious health issue.

Warnings and Precautions

You should not use this product if you are currently taking a prescription monoamine oxidase inhibitor (MAOI), which is a type of medication used for depression or certain psychiatric conditions, or if you have stopped taking an MAOI within the last two weeks. If you're unsure whether your medication contains an MAOI, please consult your doctor or pharmacist. Additionally, avoid this product if you have ever had an allergic reaction to any of its ingredients.

Before using this product, it's important to talk to your doctor if you have a cough that produces a lot of mucus, or if you have a chronic cough due to smoking, asthma, chronic bronchitis, or emphysema. If your cough lasts more than seven days, returns, or is accompanied by a fever, rash, or persistent headache, stop using the product and contact your doctor, as these may be signs of a more serious condition. In the event of an overdose, seek medical help immediately or call the Poison Control Center at 1-800-222-1222.

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 attention.

In case of an emergency, call your local emergency services or go to the nearest hospital. Always keep your medications in their original packaging and follow the prescribed dosage to minimize the risk of an overdose. 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 medication. They can provide guidance on whether it’s safe for you and your baby. Always prioritize your health and the health of your child by seeking expert advice.

Lactation Use

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using any medication. This ensures that you understand any potential risks and can make informed decisions about your health and the health of your baby. Always prioritize open communication with your doctor regarding your breastfeeding journey.

Pediatric Use

It’s important to be cautious when considering medication for your child. For children under 12 years old, this medication should not be used. Always consult with your child's healthcare provider for guidance on safe treatment options that are appropriate for their age and health needs.

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, it’s important to consult with a healthcare provider before starting the medication. 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, but you should always consult your healthcare provider for personalized advice. They can help determine the best approach for your treatment and monitor your liver function as needed.

Make sure to keep your doctor informed about your liver health, as they may want to conduct regular tests to ensure your liver is functioning well while you are on medication. Your safety and well-being are the top priority, so don’t hesitate to ask questions or express any concerns you may have.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications or tests you may be taking. While there are no specific drug interactions or laboratory test interactions noted for this medication, your healthcare provider can help ensure that everything you are taking works well together and is safe for you. Always share your complete list of medications and any recent lab tests to avoid any potential issues. Your health and safety should always come first.

Storage and Handling

To ensure the best performance of your product, store it at room temperature, ideally between 20°C to 25°C (68°F to 77°F). It's important to keep the container tightly closed to protect the contents from light and maintain their effectiveness. Once you open the container, please remember to discard it after use to ensure safety and prevent contamination. Following these guidelines will help you handle the product safely and effectively.

Additional Information

You should take this medication orally, every 4 hours as needed, or as directed by your doctor. It's important not to exceed 6 doses in a 24-hour period and to stick to the recommended dose to avoid potential risks. If you have any questions or concerns about your dosage, be sure to consult with your healthcare provider.

FAQ

What does this drug do?

This drug temporarily relieves cough due to minor throat and bronchial irritation, helps loosen phlegm (mucus), and thins bronchial secretions to make coughs more productive.

How should I take this drug?

You should take this drug every 4 hours as needed, or as directed by a doctor. Do not take more than 6 doses in 24 hours.

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

The recommended dosage for adults and children 12 years and over is 2 teaspoonsfuls (10 mL).

Can children under 12 use this drug?

No, children under 12 years should not use this drug.

Are there any warnings I should be aware of?

Do not use this drug if you are taking a prescription monoamine oxidase inhibitor (MAOI) or if you have had an allergic reaction to any of its ingredients.

What should I do if my cough lasts more than 7 days?

You should stop using the drug and ask a doctor if your cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or headache that lasts.

What should I do in case of overdose?

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

What should I do if I am pregnant or breastfeeding?

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

How should I store this drug?

Store the drug at room temperature, between 20°C to 25°C (68°F to 77°F), protect it from light, and keep the container tightly closed.

Packaging Info

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

Packaging configurations for Chest Congestion Relief.
Details

Drug Information (PDF)

This file contains official product information for Chest Congestion Relief, 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 throat and bronchial irritation. It assists in loosening phlegm (mucus) and thinning bronchial secretions, thereby facilitating more productive coughs.

Dosage and Administration

The recommended dosage for adults and children aged 12 years and older is 2 teaspoonsfuls (10 mL) every 4 hours as needed, or as directed by a healthcare professional. It is imperative that patients do not exceed 6 doses within a 24-hour period.

For children under 12 years of age, the use of this medication is not advised. Healthcare professionals should ensure that patients are informed about the importance of adhering to the recommended dosage and frequency to avoid exceeding the maximum allowable dose.

Contraindications

There are no contraindications associated with the use of this product. It is not classified as a controlled substance, and there are no known risks of abuse, misuse, or dependence. Additionally, there are no specific instructions indicating that the product should not be taken or used under any circumstances.

Warnings and Precautions

Patients should not use this product concurrently with prescription monoamine oxidase inhibitors (MAOIs), which are medications prescribed for depression, psychiatric or emotional conditions, or Parkinson's disease. Additionally, use of this product is contraindicated for a period of two weeks following the discontinuation of an MAOI. If there is uncertainty regarding the presence of an MAOI in a prescription medication, it is imperative to consult a healthcare professional, such as a doctor or pharmacist, prior to use.

Individuals with a known allergy to any of the ingredients in this product should refrain from its use to avoid potential allergic reactions.

Prior to using this product, patients should seek medical advice if they are experiencing a cough that is productive with excessive phlegm (mucus) or if they have a chronic cough associated with conditions such as smoking, asthma, chronic bronchitis, or emphysema.

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

In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center should be contacted at 1-800-222-1222.

Side Effects

Patients should be aware of the potential adverse reactions associated with the use of this product. Serious warnings include the contraindication of use in individuals currently taking a prescription monoamine oxidase inhibitor (MAOI) or within two weeks of discontinuing such medication. Additionally, patients with a known allergy to any of the product's ingredients should refrain from use.

Common adverse reactions may arise in patients who have a cough accompanied by excessive phlegm or those with chronic cough conditions, such as smoking-related cough, asthma, chronic bronchitis, or emphysema. It is advised that patients consult a healthcare professional before using the product under these circumstances.

Patients are also instructed to discontinue use and seek medical advice if their cough persists for more than seven days, recurs, or is accompanied by symptoms such as fever, rash, or a lasting headache. These symptoms may indicate a serious underlying condition that requires further evaluation.

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 Chest Congestion Relief (dextromethorphan hydrobromide, guaifenesin). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Chest Congestion Relief.
Details

Pediatric Use

Pediatric patients under 12 years of age should not use this medication. Safety and efficacy have not been established in this age group, and therefore, it is contraindicated for children in this category. Healthcare professionals are advised to consider alternative treatments for pediatric patients under 12 years.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any potential adverse effects or changes in efficacy, given the lack of targeted data for this population.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. The potential risks and benefits must be carefully considered in these populations to ensure maternal and fetal safety.

Lactation

Lactating mothers are advised to consult a healthcare professional prior to using this medication. There is no specific data available regarding the excretion of this medication in breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

Renal Impairment

Patients with renal impairment have no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the text. Therefore, healthcare professionals should exercise caution and consider individual patient factors when prescribing to patients with reduced kidney function. Regular monitoring of renal function may be warranted in these patients, although specific guidelines are not outlined.

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 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 absence of specific overdosage information, it is essential for healthcare professionals to remain vigilant regarding the potential for overdose with this medication. In cases where an overdose is suspected, immediate medical attention should be sought.

Healthcare providers are advised to monitor patients closely for any signs or symptoms that may indicate an overdose. These may include, but are not limited to, increased severity of known side effects, unusual behavioral changes, or any other atypical clinical manifestations.

Management of an overdose should be guided by the clinical presentation of the patient. Supportive care is paramount, and symptomatic treatment should be initiated as necessary. It is recommended that healthcare professionals consult local poison control centers or relevant toxicology resources for specific guidance on the management of overdose cases.

In summary, while specific overdosage information is not available, healthcare professionals should exercise caution, remain observant for potential overdose symptoms, and implement appropriate management strategies as needed.

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 in these areas limits the understanding of the compound's potential effects in nonclinical settings.

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 at 1-800-222-1222. Patients should be made aware of the potential seriousness of an overdose and the importance of prompt action in such situations.

Storage and Handling

The product is supplied in a container that must be kept tightly closed to maintain its integrity. It should be stored at room temperature, specifically within the range of 20°C to 25°C (68°F to 77°F). It is essential to protect the product from light exposure to ensure its stability. Once opened, the product should be discarded to prevent any potential degradation or contamination.

Additional Clinical Information

The medication is administered orally and should be taken every 4 hours as needed, or as directed by a healthcare professional. Patients are advised not to exceed 6 doses within a 24-hour period and to adhere to the recommended dosage to avoid potential complications.

Drug Information (PDF)

This file contains official product information for Chest Congestion Relief, 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 Chest Congestion Relief, 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.