Symptom checker
Select audience type

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

ADD CONDITION

items per page

Guaifenesin

Last content change checked dailysee data sync status

Active ingredient
Guaifenesin 100 mg/5 mL – 300 mg/15 mL
Other brand names
Drug class
Expectorant
Dosage form
Solution
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2002
Label revision date
June 14, 2022
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Guaifenesin 100 mg/5 mL – 300 mg/15 mL
Other brand names
Drug class
Expectorant
Dosage form
Solution
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 2002
Label revision date
June 14, 2022
Manufacturer
PAI Holdings, LLC dba PAI Pharma
Registration number
M012
NDC roots
0121-0744, 0121-1488, 0121-1744, 0121-2232
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (6 NDCs)
Packaging & NDC Codes (6)

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 USP is an expectorant, which means it helps to loosen and relieve chest congestion. This medication works by thinning mucus (phlegm) and bronchial secretions, making it easier for you to cough up and clear your airways. It is sugar-free and alcohol-free, providing a gentle option for those looking to alleviate their cough and congestion symptoms.

Typically, Guaifenesin is comparable to the active ingredient found in Robitussin®, and it comes in a convenient liquid form, allowing for easy dosing. If you're dealing with a cough due to congestion, this solution may help make your coughs more productive and provide relief.

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 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 reported teratogenic effects (which means it doesn't cause birth defects) or nonteratogenic effects associated with it.

Dosage and Administration

When taking this medication, it's important to follow the dosage guidelines or your doctor's instructions. You should not exceed 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, taken 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 (½ to 1 teaspoonful) every 4 hours. If your child is under 2 years old, it's best to consult a physician for the appropriate dosage. Always ensure you measure the medication accurately for the best results.

What to Avoid

If you are hypersensitive (allergic) to any of the ingredients in this medication, you should not use it. Additionally, it’s important to stop using the medication and consult your doctor if your cough lasts more than 7 days, returns, or is accompanied by symptoms like fever, rash, or a persistent headache. These could indicate a more serious health issue that requires medical attention.

Please remember that this medication may have potential for misuse or dependence (a condition where you feel a strong need to use a substance), so it’s crucial to follow these guidelines closely for your safety.

Side Effects

If you experience a cough that lasts more than 7 days, returns, or is accompanied by a fever, rash, or a persistent headache, it's important to stop using the medication and consult a doctor. These symptoms could indicate a more serious condition. Additionally, if you know you are hypersensitive (having an extreme reaction) to any of the ingredients in the medication, you should also stop use and 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, which can happen with conditions like smoking, asthma, chronic bronchitis, or emphysema.

You should stop using the medication and contact your doctor if your cough lasts more than 7 days, returns, or is accompanied by symptoms like fever, rash, or a persistent headache, as these may indicate a more serious issue. Additionally, if you know you are hypersensitive (allergic) to any of the ingredients, you should also stop use and seek medical advice.

If you suspect an overdose, it’s crucial to get emergency medical help or contact a Poison Control Center immediately. If you are pregnant or breastfeeding, please consult a healthcare professional before using this medication. There are no specific lab tests required for safe use.

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 assistance. Quick action can make a significant difference in ensuring your safety and well-being.

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 this 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 ½ to 1 teaspoonful) every 4 hours.

If your child is under 2 years old, you should consult a physician (doctor) before administering this medication, as special guidance is necessary for this age group. Always ensure you are measuring the doses accurately to keep your child safe.

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 wise to discuss any potential risks or benefits with a healthcare provider. They can help determine the best approach based on individual health needs and any other medications being taken.

Always keep in mind that older adults may have different responses to medications, so regular check-ins with your healthcare team are essential to ensure safety and effectiveness.

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 should be used if you have renal impairment (kidney issues).

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 determine the best course of action based on your individual needs.

Hepatic Impairment

If you have liver problems, it's important to know that the provided drug insert does not include specific information about dosage adjustments, special monitoring, or precautions for your condition. This means that there are no established guidelines for how this medication may affect you 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 talk to your healthcare provider about any medications you are taking, including guaifenesin. This medication can affect certain lab tests, specifically those measuring 5-hydroxyindoleacetic acid (5-HIAA) and vanillylmandelic acid (VMA). If you have these tests scheduled, let your doctor know that you are using guaifenesin, as it may interfere with the results.

Always keep your healthcare provider informed about all the medications and supplements you are using. This helps ensure that your treatment is safe and effective, and that any necessary lab tests provide accurate information.

Storage and Handling

To ensure the safety and effectiveness of your product, it’s important to store it properly. Keep the container tightly closed and store it at a controlled room temperature between 20°-25°C (68°-77°F). Additionally, make sure to protect it from light to maintain its quality.

When handling the product, always do so with care to avoid contamination. Following these storage and handling guidelines will help ensure that the product remains safe and effective for your use.

Additional Information

Guaifenesin may affect certain laboratory tests, specifically causing color interference with the measurement of 5-hydroxyindoleacetic acid (5-HIAA) and vanillylmandelic acid (VMA). If you are undergoing tests that involve these substances, it's important to inform your healthcare provider that you are taking guaifenesin, as it could impact the results.

Currently, there is no additional information available regarding abuse potential, administration methods, or patient counseling for guaifenesin.

FAQ

What is Guaifenesin Oral Solution USP?

Guaifenesin Oral Solution USP is an expectorant that helps loosen and relieve chest congestion. It is sugar-free and alcohol-free, available in a concentration of 100 mg/5 mL.

How does Guaifenesin work?

Guaifenesin helps loosen phlegm (mucus) and thin bronchial secretions, making coughs more productive.

What are the dosage recommendations for adults?

Adults and children 12 years and over should take 10 to 20 mL (2 to 4 teaspoonfuls) every 4 hours, not exceeding 6 doses in 24 hours.

What should I do if I have a cough that 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.

Are there any contraindications for using Guaifenesin?

You should not use Guaifenesin if you are hypersensitive to any of its ingredients.

Is Guaifenesin safe to use during pregnancy or breastfeeding?

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

What should I do in case of an overdose?

In case of overdose, seek medical help or contact a Poison Control Center immediately.

What are the dosage recommendations for children?

For children 6 years to under 12 years, the dosage is 5 to 10 mL (1 to 2 teaspoonfuls) every 4 hours. For children 2 to under 6 years, it is 2.5 to 5 mL (½ to 1 teaspoonful) every 4 hours. Consult a physician for children under 2 years.

What precautions should I take when using Guaifenesin?

Ask a doctor before use if you have a cough with too much phlegm, or if your cough is chronic due to smoking, asthma, chronic bronchitis, or emphysema.

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 loosen and relieve chest congestion. Each 5 mL of the solution contains 100 mg of guaifenesin. The product is sugar-free and alcohol-free, making it suitable for a variety of patients. It is packaged in a 16 fl oz (473 mL) bottle. The National Drug Code (NDC) for this formulation is 0121-0744-16. This product is manufactured by Pharmaceutical Associates, Inc., located in Greenville, SC 29605.

Uses and Indications

This drug is indicated for the facilitation of mucus clearance in patients by loosening phlegm and thinning bronchial secretions, thereby enhancing the productivity of coughs.

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

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 (½ 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 of this product is contraindicated in individuals with hypersensitivity to any of its ingredients.

Additionally, if a cough persists for more than 7 days, recurs, or is accompanied by fever, rash, or a persistent headache, the product should be discontinued, and a healthcare professional should be consulted, as these symptoms may indicate a serious underlying condition.

Warnings and Precautions

Healthcare professionals should be aware of the following warnings and precautions associated with the use of this medication.

Patients should be advised to 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, particularly in cases related to smoking, asthma, chronic bronchitis, or emphysema. These conditions may necessitate further evaluation and management.

It is imperative to discontinue use and seek medical advice if the 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 medical attention. Additionally, individuals with known hypersensitivity to any of the ingredients in the formulation should refrain from use and consult a healthcare provider.

In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center should be contacted without delay to ensure appropriate management.

For patients who are pregnant or breastfeeding, it is essential to consult a healthcare professional before initiating use of this medication to ensure safety for both the mother and child.

Currently, there are no specific laboratory tests recommended for the safe use of this medication. However, ongoing monitoring of patient symptoms and response to treatment is advised to ensure optimal therapeutic outcomes.

Side Effects

Patients should discontinue use and consult a healthcare professional if they experience a cough that lasts 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 also seek medical advice.

Drug Interactions

Guaifenesin may interfere with certain clinical laboratory determinations, specifically affecting the measurement of 5-hydroxyindoleacetic acid (5-HIAA) and vanillylmandelic acid (VMA). This interference can lead to inaccurate laboratory results, which may impact clinical decision-making.

It is advisable for healthcare professionals to consider this potential interaction when interpreting laboratory tests involving 5-HIAA and VMA in patients receiving guaifenesin. Monitoring and alternative testing methods should be considered to ensure accurate assessment of these metabolites.

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 (½ to 1 teaspoonful) every 4 hours. In children under 2 years of age, it is advised to consult a physician 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 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 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 regarding the excretion of this medication 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 drug insert regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients to ensure safety and efficacy.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to 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 absence of data regarding its safety and efficacy in this population.

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 vigilant for symptoms that may arise from an overdose, although specific symptoms are not detailed in the provided information. The management of an overdose typically involves supportive care and symptomatic treatment, tailored to the individual patient's needs.

It is essential for healthcare providers to remain alert and prepared to implement appropriate management strategies in response to an overdose situation, ensuring the safety and well-being of the patient.

Nonclinical Toxicology

No teratogenic effects were observed in animal studies, and there was no increase in fetal malformations noted. Animal studies did not demonstrate any adverse developmental outcomes.

Guaifenesin has been shown to produce a color interference with certain clinical laboratory determinations of 5-hydroxyindoleacetic acid (5-HIAA) and vanillylmandelic acid (VMA).

Postmarketing Experience

No specific postmarketing experience details are available in the insert text. As such, there are no additional adverse events or rare case reports to summarize.

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°-25°C (68°-77°F). Additionally, it is essential to protect the product from light to maintain its efficacy and stability.

Additional Clinical Information

Guaifenesin has been shown to produce a color interference with certain clinical laboratory determinations, specifically affecting the measurement of 5-hydroxyindoleacetic acid (5-HIAA) and vanillylmandelic acid (VMA). Clinicians should be aware of this potential interference when interpreting laboratory results in patients receiving guaifenesin.

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.