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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 2025
Label revision date
April 1, 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 2025
Label revision date
April 1, 2025
Manufacturer
KESIN PHARMA CORPORATION
Registration number
M012
NDC root
81033-102
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

Guaifenesin Oral Solution is an expectorant, which means it helps to loosen phlegm (mucus) and thin bronchial secretions. This action makes it easier for you to clear mucus from your airways, leading to more productive coughs. The solution comes in a grape flavor and is available in a 16 fl oz (473 mL) bottle, with a concentration of 100 mg of guaifenesin per 5 mL.

By helping to clear mucus from your bronchial passageways, guaifenesin can provide relief when you're dealing with congestion due to colds or other respiratory conditions.

Uses

This medication is designed to help you breathe easier by loosening phlegm (mucus) and thinning bronchial secretions. By doing so, it helps clear out bothersome mucus from your bronchial passageways, making your coughs more productive. This can be particularly helpful if you're dealing with a cough that feels unproductive or if you're experiencing congestion.

Rest assured, there are no known teratogenic effects (which means it doesn't cause birth defects) associated with this medication, making it a safer option for those who may be concerned about such risks.

Dosage and Administration

You can take this medication every 4 hours as needed, or as your doctor directs. However, it's important not to exceed 6 doses in a 24-hour period, so be mindful of how often you take it. Always stick to the recommended dose to ensure your safety.

For adults and children aged 12 years and older, the typical dose is 2 to 4 teaspoonfuls every 4 hours. If your child is between 6 and 12 years old, they should take 1 to 2 teaspoonfuls every 4 hours. For younger children aged 2 to under 6 years, the dose is 1/2 to 1 teaspoonful every 4 hours. If your child is under 2 years old, it's best to consult a doctor before giving them this medication.

What to Avoid

You should not use this product if you have ever had an allergic reaction to any of its ingredients. It's important to prioritize your safety, so please avoid using it under these circumstances. If you have any concerns or questions about your allergies or the ingredients, consult with a healthcare professional before using the product.

Side Effects

You should avoid using 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, such as from smoking, asthma, chronic bronchitis, or emphysema.

If your cough lasts more than 7 days, returns, or is accompanied by symptoms like 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, such as from smoking, asthma, chronic bronchitis, or emphysema.

If your cough lasts more than 7 days, returns, or is accompanied by a fever, rash, or persistent headache, stop using the product and contact your doctor, as these may indicate a more serious condition. In the event of an overdose, seek emergency medical help or contact a Poison Control Center immediately.

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 professional assistance. Your health and safety are the top priority.

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 your child, it's important to follow the recommended dosages based on their age. For children aged 6 years to under 12 years, you can administer 1 to 2 teaspoonfuls every 4 hours. If your child is between 2 years and under 6 years, the dosage is reduced to 1/2 to 1 teaspoonful every 4 hours.

For children under 2 years old, it's crucial to consult with a doctor before giving any medication. Always ensure you are following these guidelines to keep your child safe and healthy.

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 drug insert does not provide specific information about dosage adjustments, special monitoring, or safety considerations for your condition. This means that there are no tailored guidelines for how this medication may affect you if your kidneys are not functioning properly.

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your kidney health. They can help monitor your condition and make any necessary adjustments to 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 should be used if you have hepatic impairment (liver issues).

Before starting any new medication, including this one, you should discuss your liver health with your healthcare provider. They can help determine the best approach for your treatment and ensure your safety.

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 health status with your healthcare provider to avoid any potential issues and to get the best care possible.

Storage and Handling

To ensure the best performance of your product, store it in a cool, dry place at a temperature between 20ºC to 25ºC (68ºF to 77ºF) and keep it protected from light. It's important not to refrigerate the product, as this can affect its effectiveness.

Before using, always check that the printed inner seal is intact; do not use the product if the seal is broken or missing, as this could compromise safety and quality. Following these guidelines will help you use the product safely and effectively.

Additional Information

No further information is available.

FAQ

What is Guaifenesin Oral Solution used for?

Guaifenesin Oral Solution is an expectorant that helps loosen phlegm (mucus) and thin bronchial secretions, making coughs more productive.

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

Adults and children 12 years and over should take 2 to 4 teaspoonfuls every 4 hours, as needed.

What should I do if I have a cough with too much phlegm?

You should ask a doctor before using Guaifenesin if you have a cough that occurs with too much phlegm or if it lasts or is chronic.

Are there any contraindications for using this product?

Do not use Guaifenesin 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?

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

Can I use Guaifenesin if I am pregnant or breastfeeding?

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

How should I store Guaifenesin Oral Solution?

Store Guaifenesin at 20ºC to 25ºC (68ºF to 77ºF) and protect it from light. Do not refrigerate.

What is the maximum number of doses I can take in 24 hours?

Do not take more than 6 doses of Guaifenesin in a 24-hour period.

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 an expectorant formulated to aid in the relief of chest congestion. Each 5 mL of the solution contains 100 mg of guaifenesin. The product is presented in a 16 fl oz (473 mL) bottle and is flavored with grape. The National Drug Code (NDC) for this formulation is 81033-102-16.

Uses and Indications

This drug is indicated for the facilitation of mucus clearance in patients experiencing excessive bronchial secretions. It helps to loosen phlegm and thin bronchial secretions, thereby enhancing the productivity of coughs and aiding in the clearance of bothersome mucus from the bronchial passageways.

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

Dosage and Administration

The medication is to be administered as follows:

For adults and children aged 12 years and older, the recommended dosage is 2 to 4 teaspoonfuls every 4 hours, as needed or as directed by a healthcare professional. For children aged 6 years to under 12 years, the dosage is 1 to 2 teaspoonfuls every 4 hours. In children aged 2 years to under 6 years, the appropriate dosage is 1/2 to 1 teaspoonful every 4 hours. For infants under 2 years of age, consultation with a healthcare provider is advised prior to administration.

It is imperative that no more than 6 doses are taken within a 24-hour period, and the recommended dosage should not be exceeded.

Contraindications

Use of this product is contraindicated in individuals with a history of allergic reactions to any of its ingredients.

Warnings and Precautions

Patients should not use this product if they have a known allergy to any of its ingredients. An allergic reaction may pose significant health risks.

Healthcare professionals are advised to exercise caution and recommend that patients consult a physician prior to use if they present with a cough that is productive of excessive phlegm (mucus) or if they have a chronic cough associated with conditions such as smoking, asthma, chronic bronchitis, or emphysema. These underlying conditions may necessitate a different therapeutic approach.

Patients should be 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. These symptoms may indicate a more serious underlying condition that requires further evaluation.

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center. Prompt action is essential to mitigate potential adverse effects associated with overdose.

Side Effects

Patients should be aware of the potential adverse reactions associated with this product. Serious adverse reactions may occur, and it is crucial to discontinue use and consult a healthcare professional if the cough persists for more than 7 days, recurs, or is accompanied by fever, rash, or a persistent headache, as these symptoms could indicate a serious underlying condition.

Patients are advised not to use this product if they have a known allergy to any of its ingredients. Additionally, it is recommended that individuals consult a doctor prior to use if they experience a cough that is productive with excessive phlegm (mucus) or if they have a chronic cough, such as that associated with smoking, asthma, chronic bronchitis, or emphysema.

These precautions are essential to ensure the safety and well-being of patients using this product.

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 be administered 1 to 2 teaspoonfuls every 4 hours. For children aged 2 years to under 6 years, the recommended dosage is 1/2 to 1 teaspoonful every 4 hours. For infants and children under 2 years of age, it is advised to consult a doctor before administration.

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 weighed, as the effects on fetal outcomes and lactation are not fully established. It is essential for women of childbearing potential to seek medical advice to ensure safe use during pregnancy and lactation.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data on 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 no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the drug insert. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the lack of data necessitates careful clinical judgment.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to this medication. Consequently, there are no 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 prescribing 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 symptoms of overdose may vary depending on the specific 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. This may include monitoring vital signs, providing respiratory support, and administering activated charcoal if indicated and within the appropriate time frame. In cases where specific antidotes are available, their use should be considered based on the clinical scenario.

It is essential for healthcare providers to remain vigilant and prepared to implement emergency protocols in the event of an overdose, ensuring the safety and well-being of the patient.

Nonclinical Toxicology

There is currently no available information regarding teratogenic or non-teratogenic effects associated with the compound. Additionally, no data has been provided concerning nonclinical toxicology, including animal pharmacology and toxicology. As such, a comprehensive assessment of these aspects cannot be made at this time.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children to prevent accidental ingestion. It is important to inform patients not to use the product if they have ever experienced an allergic reaction to any of its ingredients.

Patients should be instructed to stop using the product and consult a doctor if their cough lasts more than 7 days, returns, or is accompanied by symptoms such as fever, rash, or a persistent headache, as these may indicate a serious condition.

Additionally, healthcare providers should encourage patients to seek medical advice before using the product if they have a cough that occurs with excessive phlegm (mucus) or if they have a chronic cough associated with smoking, asthma, chronic bronchitis, or emphysema.

Storage and Handling

This product is supplied in packaging that includes specific NDC numbers. It should be stored at a temperature range of 20ºC to 25ºC (68ºF to 77ºF) and must be protected from light. Refrigeration is not permitted. Additionally, the product should not be used if the printed inner seal is broken or missing, as this may compromise its integrity.

Additional Clinical Information

No further data are available.

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.