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Guaifenesin

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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 2023
Label revision date
March 28, 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 2023
Label revision date
March 28, 2025
Manufacturer
KESIN PHARMA CORPORATION
Registration number
M012
NDC root
81033-102
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (2 NDCs)
Packaging & NDC Codes (2)

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

Guaifenesin Oral Solution is a medication designed to help loosen phlegm (mucus) and thin bronchial secretions, making coughs more productive. This means that if you're dealing with a cough due to mucus buildup, this solution can assist your body in clearing it out more effectively.

By improving the flow of mucus in your airways, Guaifenesin can help you breathe easier and feel more comfortable when you're experiencing respiratory issues.

Uses

This medication is designed to help you breathe easier by loosening phlegm (mucus) and thinning bronchial secretions. By doing so, it makes your coughs more productive, allowing you to clear your airways more effectively.

Additionally, there are no teratogenic effects (harmful effects on fetal development) or nonteratogenic effects noted, which means it is considered safe in those aspects.

Dosage and Administration

When taking this medication, it's important to follow the dosage instructions carefully or use as directed by your doctor. You should not take more than 6 doses within a 24-hour period to ensure your safety.

For adults and children aged 12 years and older, the recommended dose is between 10 to 20 mL, which is equivalent to 2 to 4 teaspoonfuls, every 4 hours. If your child is between 6 and 12 years old, they should take 5 to 10 mL (1 to 2 teaspoonfuls) every 4 hours. For younger children aged 2 to under 6 years, the dose is 2.5 to 5 mL (1/2 to 1 teaspoonful) every 4 hours. If your child is under 2 years old, please consult a physician for the appropriate dosage. Always ensure you measure the doses accurately for the best results.

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.

Currently, there are no specific contraindications, risks of abuse or misuse, or concerns regarding dependence associated with this medication. However, always use it responsibly and as directed.

Side Effects

If you experience a cough that lasts more than 7 days, returns, or is accompanied by a fever, rash, or persistent headache, it’s important to stop using the medication and consult your doctor. These symptoms could indicate a more serious condition. Additionally, if you know you are hypersensitive (allergic) to any of the ingredients in the medication, you should also seek medical advice.

Warnings and Precautions

Before using this medication, it's important to consult your doctor if you have a cough that produces a lot of mucus or if your cough is chronic, such as from 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 medication and contact your doctor, as these could indicate a more serious condition. Additionally, if you are pregnant or breastfeeding, please seek advice from a healthcare professional before use.

Be aware that this medication can interfere with certain lab tests, specifically those measuring 5-hydroxyindoleacetic acid (5-HIAA) and vanillylmandelic acid (VMA). If you suspect an overdose, seek emergency medical help or contact a Poison Control Center immediately. Always check for any hypersensitivity to the ingredients before taking the medication.

Overdose

If you suspect an overdose, it's important to stay calm and take immediate action. While the specific signs of an overdose are not detailed, common symptoms can include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these signs, or if you are unsure, seek medical help right away.

In case of an overdose, contact your local emergency services or go to the nearest hospital. It's crucial to provide them with as much information as possible about the substance taken and the amount, if known. Remember, acting quickly can make a significant difference in your health and safety.

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 giving medication to children, it's important to follow the recommended dosages based on their age. For children aged 6 years to under 12 years, the typical dose is 5 to 10 mL (which is about 1 to 2 teaspoonfuls) every 4 hours. For younger children, specifically those aged 2 to under 6 years, the dose is reduced to 2.5 to 5 mL (or 1/2 to 1 teaspoonful) every 4 hours.

If your child is under 2 years old, it's crucial to consult a physician (a medical doctor) before administering any medication. Always ensure you are following these guidelines to keep your child safe and healthy.

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. If you or a loved one is an older adult, it’s always wise to discuss any medications with a healthcare provider, especially considering potential changes in health or how the body processes drugs as we age.

Since there are no dosage adjustments or special precautions mentioned for elderly patients, your healthcare provider can help determine the best approach based on individual health needs and any other medications being taken. Always prioritize open communication with your doctor 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 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, 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 safety while using any medication. Your well-being is a 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 you are taking. In this case, there are no specific drug interactions or laboratory test interactions noted, which means that the medication is generally considered safe to use with other drugs and tests. However, every individual is different, and your healthcare provider can help ensure that your treatment plan is safe and effective for you.

Always discuss any changes in your medications or upcoming lab tests with your healthcare provider to avoid any potential issues and to get the best care possible.

Storage and Handling

To ensure the safety and effectiveness of your product, always keep it tightly closed when not in use. Store it at a controlled room temperature between 20°C to 25°C (68°F to 77°F) to maintain its quality. Additionally, make sure to protect it from light, as exposure can affect its performance. Following these simple storage guidelines will help you use the product safely and effectively.

Additional Information

You will take this medication orally. There are no additional details available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experiences. If you have any questions or concerns about your treatment, be sure to discuss them with your healthcare provider.

FAQ

What is Guaifenesin Oral Solution used for?

Guaifenesin Oral Solution helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive.

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

Adults and children 12 years and over should take 10 to 20 mL (2 to 4 teaspoonfuls) every 4 hours.

What should children under 2 years of age do?

Children under 2 years of age should consult a physician before use.

Are there any contraindications for Guaifenesin?

No contraindications are listed for Guaifenesin Oral Solution.

What should I do in case of an overdose?

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

What precautions should I take if I am pregnant or breastfeeding?

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

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

Stop taking the medication and ask a doctor if your cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache.

How should Guaifenesin Oral Solution be stored?

Store Guaifenesin Oral Solution at a controlled room temperature of 20°C to 25°C (68°F to 77°F) and keep tightly closed.

Packaging Info

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

Packaging configurations for Guaifenesin.
Details

Drug Information (PDF)

This file contains official product information for Guaifenesin, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

Guaifenesin Oral Solution, USP is formulated to deliver 100 mg of guaifenesin per 5 mL. The product is packaged in individual unit dose cups, with a total of 100 cups per case. It is recommended to store the solution at a temperature range of 68°F to 77°F (20°C to 25°C). The National Drug Code (NDC) for this product is 81033-102-51.

Uses and Indications

This drug is indicated for the management of conditions associated with excessive mucus production in the respiratory tract. It helps to loosen phlegm (mucus) and thin bronchial secretions, thereby facilitating more productive coughs.

There are no teratogenic effects associated with this drug, and no nonteratogenic effects have been reported.

Dosage and Administration

The recommended dosage for the medication should be followed as outlined or as directed by a physician. It is imperative that no more than 6 doses are administered within a 24-hour period.

For adults and children aged 12 years and older, the dosage is 10 to 20 mL (equivalent to 2 to 4 teaspoonfuls) every 4 hours. For children aged 6 years to under 12 years, the dosage is 5 to 10 mL (1 to 2 teaspoonfuls) every 4 hours. In children aged 2 to under 6 years, the recommended dosage is 2.5 to 5 mL (1/2 to 1 teaspoonful) every 4 hours. For children under 2 years of age, it is advised to consult a physician for appropriate dosing guidance.

Healthcare professionals should ensure that the administration technique is appropriate for the age group and that the dosing intervals are strictly adhered to in order to maintain safety and efficacy.

Contraindications

Use is contraindicated in children due to the risk of accidental ingestion. In the event of an overdose, immediate medical assistance should be sought or contact with a Poison Control Center is advised.

Warnings and Precautions

Patients should consult a healthcare professional prior to use if they have a cough associated with excessive phlegm (mucus) or if the cough is chronic, as seen in conditions such as smoking, asthma, chronic bronchitis, or emphysema.

In the event that a cough persists for more than 7 days, recurs, or is accompanied by fever, rash, or a persistent headache, it is imperative to discontinue use and seek medical advice, as these symptoms may indicate a serious underlying condition. Additionally, individuals with known hypersensitivity to any of the product's ingredients should refrain from use and consult a healthcare provider.

For pregnant or breastfeeding individuals, it is essential to seek guidance from a health professional before using this product.

Guaifenesin may interfere with certain clinical laboratory tests, specifically those measuring 5-hydroxyindoleacetic acid (5-HIAA) and vanillylmandelic acid (VMA). Healthcare professionals should be aware of this potential interference when interpreting laboratory results.

In cases of overdose, immediate medical assistance should be sought, or contact with a Poison Control Center is recommended.

Patients are advised to stop taking the medication and consult their doctor if the cough lasts more than 7 days, returns, or is accompanied by fever, rash, or persistent headache.

Side Effects

Patients should be advised to discontinue use and consult a healthcare professional if they experience a cough that persists for more than 7 days, recurs, or is accompanied by fever, rash, or a persistent headache, as these symptoms may indicate a serious underlying condition. Additionally, individuals who are hypersensitive to any of the ingredients should refrain from using the product and seek medical advice.

No specific adverse reactions were reported in clinical trials or postmarketing experiences beyond the aforementioned warnings. It is essential for patients to remain vigilant and report any unusual or severe symptoms to their healthcare provider promptly.

Drug Interactions

No specific drug interactions have been identified in the available data. Additionally, there are no reported interactions between the drug and laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on the current information.

Packaging & NDC

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

Packaging configurations for Guaifenesin.
Details

Pediatric Use

Pediatric patients aged 6 years to under 12 years may receive a dosage of 5 to 10 mL (1 to 2 teaspoonfuls) every 4 hours. For children aged 2 to under 6 years, the recommended dosage is 2.5 to 5 mL (1/2 to 1 teaspoonful) every 4 hours.

For infants and children under 2 years of age, it is advised to consult a physician before administration.

Geriatric Use

There is no specific information 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 they may have altered pharmacokinetics and pharmacodynamics. Close monitoring is recommended to ensure safety and efficacy in this population.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. It is essential to evaluate the potential risks and benefits associated with its use during pregnancy and lactation. The safety of this medication in pregnant women has not been established, and caution is advised to ensure the well-being of both the mother and the fetus.

Lactation

Lactating mothers are advised to consult a health 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 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 indicated 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 information regarding overdosage, healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdose.

It is essential to monitor the patient closely for any potential symptoms that may arise from an overdose. Symptoms can vary widely depending on the substance involved and the individual patient's response.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should implement supportive care measures, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

Additionally, it is recommended to consult local poison control centers or relevant toxicology resources for guidance on specific management protocols and antidotes, if applicable.

Documentation of the incident, including the amount and timing of the substance taken, is crucial for effective treatment and follow-up care.

Nonclinical Toxicology

No teratogenic effects were reported in the studies conducted. Additionally, there was no increase in fetal malformations observed, indicating a lack of non-teratogenic effects.

Information regarding nonclinical toxicology and animal pharmacology and toxicology was not provided in the insert.

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 tightly closed container to ensure integrity. It should be stored at a controlled room temperature, specifically between 20°C to 25°C (68°F to 77°F). Additionally, it is essential to protect the product from light to maintain its efficacy.

Additional Clinical Information

The medication is administered orally. There are no additional details available regarding laboratory tests, abuse information, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Guaifenesin, 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, 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.