Symptom checker
Select audience type

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

ADD CONDITION

items per page

Chest Congestion Relief

Last content change checked dailysee data sync status

Active ingredient
Guaifenesin 100 mg/5 mL
Other brand names
Drug class
Expectorant
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 ingredient
Guaifenesin 100 mg/5 mL
Other brand names
Drug class
Expectorant
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
0536-1314
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 help you breathe easier by loosening phlegm (mucus) and thinning bronchial secretions. By making coughs more productive, it can assist your body in clearing out mucus from your airways, which may help alleviate symptoms associated with respiratory conditions.

Uses

This medication is designed to help you if you're dealing with a cough that produces phlegm (a thick mucus). It works by loosening the phlegm and thinning out the bronchial secretions, making it easier for you to cough up the mucus. This can help make your cough more productive, allowing you to clear your airways more effectively.

You can feel confident using this medication, as there are no known teratogenic effects (which means it doesn't cause birth defects) associated with it.

Dosage and Administration

When taking this medication, adults and children aged 12 years and older should take 2 to 4 teaspoonfuls every 4 hours as needed. However, if you are giving this medication to a child under 12 years old, it’s important to consult a doctor for the appropriate dosage.

To ensure your safety, remember not to exceed 6 doses within a 24-hour period. Always follow the recommended dosage guidelines to avoid any potential risks associated with taking too much.

What to Avoid

It's important to keep this medication out of reach of children to ensure their safety. If you suspect an overdose, please seek medical help immediately or contact a Poison Control Center at 1-800-222-1222. Your health and safety are paramount, so always follow these guidelines closely.

Side Effects

You should not use this product if you have ever had an allergic reaction to any of its ingredients. It's important to consult with a doctor before using it if you have a cough that produces a lot of mucus or if your cough is chronic, which can happen with conditions like smoking, asthma, chronic bronchitis, or emphysema.

If your cough lasts more than 7 days, returns, or is accompanied by symptoms such as fever, rash, or a persistent headache, you should stop using the product and seek medical advice, as these could indicate a more serious health issue.

Warnings and Precautions

You should not use this product if you have ever had an allergic reaction to any of its ingredients. Before using it, consult your doctor if you have a cough that produces a lot of mucus or if your cough is chronic, which can happen with conditions like smoking, asthma, chronic bronchitis, or emphysema.

If your cough lasts more than 7 days, returns, or is accompanied by fever, rash, or a persistent headache, stop using the product and contact your doctor, as these symptoms may indicate a more serious issue. In the event of an overdose, seek emergency 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 always important to be aware of the potential risks associated with taking any medication. If you suspect that you or someone else may have taken too much of a medication, look out for unusual symptoms such as extreme drowsiness, confusion, or difficulty breathing.

In the event of an overdose, it is crucial to seek immediate medical help. You can do this by calling your local emergency number or going to the nearest hospital. Always keep the medication packaging on hand, as it can provide important information to healthcare professionals. Remember, when in doubt, it's better to err on the side of caution and get help.

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

When it comes to giving this medication to children, it's important to follow specific guidelines. For adults and children aged 12 years and older, the recommended dosage is 2 to 4 teaspoonfuls every 4 hours. However, if your child is under 12 years old, you should consult a doctor before administering the medication. This ensures that you receive the appropriate advice tailored to your child's needs and safety. Always prioritize your child's health by seeking professional guidance when it comes to their medication.

Geriatric Use

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

Renal Impairment

If you have kidney problems, it's important to know that 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 there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the standard recommendations for the medication do not change based on liver function. However, it’s always a good idea to discuss your liver health with your healthcare provider before starting any new medication. They can help ensure that your treatment 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 health conditions you have to receive the best care possible.

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 can take this medication orally. For adults and children aged 12 years and older, the recommended dose is 2 to 4 teaspoonfuls every 4 hours. If the patient is under 12 years old, it's important to consult a doctor for the appropriate dosage.

FAQ

What does this drug do?

This drug helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive.

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

The recommended dosage is 2 to 4 teaspoonfuls every 4 hours.

What should I do if my child is under 12 years old?

If your child is under 12 years old, you should ask a doctor for the appropriate dosage.

What is the maximum dosage I can take?

You should not take more than 6 doses in a 24-hour period.

Are there any contraindications for this drug?

There are no contraindications listed for this drug.

What should I do in case of an overdose?

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

Can I use this drug if I have allergies?

Do not use this drug if you have ever had an allergic reaction to any of its ingredients.

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

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

Is this drug safe to use during pregnancy or breastfeeding?

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

How should I store this drug?

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

Packaging Info

Below are the non-prescription pack sizes of Chest Congestion Relief (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 drug.

Uses and Indications

This drug is indicated for the facilitation of mucus clearance in patients with respiratory conditions. It helps to loosen phlegm and thin bronchial secretions, thereby making coughs more productive.

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

Dosage and Administration

For adults and children aged 12 years and over, the recommended dosage is 2 to 4 teaspoonfuls administered every 4 hours as needed. For children under 12 years of age, it is advised to consult a physician for appropriate dosing guidance.

It is imperative that patients do not exceed a maximum of 6 doses within a 24-hour period. Healthcare professionals should emphasize the importance of adhering to the recommended dosage to avoid potential adverse effects.

Contraindications

Use is contraindicated in the following situations:

  • The product should be kept 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 (1-800-222-1222) without delay.

Warnings and Precautions

Patients should not use this product if they have a known allergy to any of its ingredients.

Before initiating treatment, it is advisable for healthcare professionals to consult with a physician if the patient presents with a cough that is productive of excessive phlegm (mucus) or if the cough is chronic, particularly in cases associated with smoking, asthma, chronic bronchitis, or emphysema.

Should the cough persist for more than 7 days, recur, or be accompanied by additional symptoms such as fever, rash, or a persistent headache, it is imperative to discontinue use and seek medical advice. These symptoms may indicate a more serious underlying condition that requires further evaluation.

In the event of an overdose, immediate medical assistance should be sought. Patients or caregivers should contact a Poison Control Center at 1-800-222-1222 without delay.

Side Effects

Patients should be aware of the potential for serious adverse reactions associated with the use of this product. It is contraindicated in individuals who have a history of allergic reactions to any of its ingredients.

In clinical practice, it is advised that patients consult a healthcare professional prior to use if they experience a cough that is productive with excessive phlegm or if they have a chronic cough related to conditions such as smoking, asthma, chronic bronchitis, or emphysema.

Patients are also instructed to discontinue use and seek medical advice if their cough persists for more than 7 days, recurs, or is accompanied by additional symptoms such as fever, rash, or a persistent headache, as these may indicate a serious underlying condition.

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 (guaifenesin). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Chest Congestion Relief.
Details

Pediatric Use

Pediatric patients aged 12 years and older may be administered 2 to 4 teaspoonfuls every 4 hours. For children under 12 years of age, it is advised to consult a healthcare professional for appropriate dosing recommendations.

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 adverse effects or changes in therapeutic response, 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 currently no available data regarding the excretion of this drug in human 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 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 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 data is not available, healthcare professionals should exercise caution, remain observant for potential overdose symptoms, and implement appropriate management strategies in the event of an overdose.

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. For adults and children aged 12 years and older, the recommended dosage is 2 to 4 teaspoonfuls every 4 hours. For children under 12 years of age, it is advised to consult a doctor for appropriate dosing. There is no additional information available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

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.