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 2024
Label revision date
October 17, 2024
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 2024
Label revision date
October 17, 2024
Manufacturer
American Health Packaging
Registration number
M012
NDC roots
60687-852, 60687-863, 60687-874
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (3 NDCs)
Packaging & NDC Codes (3)

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 is an oral solution that acts as an expectorant, which means it helps to loosen phlegm (mucus) and thin bronchial secretions. This action makes coughs more productive, allowing you to clear mucus from your airways more effectively.

This medication is sugar-free and alcohol-free, and it comes in a pleasant raspberry flavor, making it easier to take. Guaifenesin is typically used to relieve symptoms associated with respiratory conditions where mucus buildup is a concern.

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, which can make your coughs more productive. This means that you may find it easier to clear mucus from your airways, helping you breathe better.

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

When using this medication, it's important to follow the dosage instructions carefully or use as directed by your doctor. For adults and children aged 12 years and older, you should take 10 to 20 ml (which is about 2 to 4 teaspoonfuls) every 4 hours. If you're giving this medication to children aged 6 to under 12 years, the dose is 5 to 10 ml (1 to 2 teaspoonfuls) every 4 hours. For younger children, those aged 2 to under 6 years, the recommended dose is 2.5 to 5 ml (1/2 to 1 teaspoonful) every 4 hours.

If your child is under 2 years old, it's crucial to consult a physician before administering the medication. Remember, you should not take more than 6 doses in any 24-hour period to ensure safety and effectiveness. Always measure the doses accurately to avoid any potential issues.

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. Always prioritize your health and safety by following these guidelines.

Side Effects

If you experience a cough that lasts more than 7 days, returns, or is accompanied by fever, rash, or a persistent headache, it's important to stop using the medication and consult a doctor, as these could indicate a serious condition. Additionally, if you are hypersensitive to any of the ingredients, you should also discontinue use and seek medical advice.

Before using this medication, talk to your doctor if you have a cough that produces a lot of phlegm (mucus) or if your cough is chronic, which can occur with conditions like smoking, asthma, chronic bronchitis, or emphysema.

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 health issue. Additionally, if you know you are sensitive to any of the ingredients, it's best to avoid this medication.

Always keep this product out of reach of children. If an overdose occurs, seek 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 what you would typically experience with the medication.

Don’t wait for symptoms to worsen; acting quickly can be vital. Always keep emergency contact information handy, and remember that 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

If you have a child under 2 years old, it's important to consult a physician before giving them this medication. For children aged 2 to under 6 years, the recommended dosage is 2.5 to 5 mL (which is about 1/2 to 1 teaspoonful) every 4 hours. For those between 6 and 12 years old, the dosage increases to 5 to 10 mL (1 to 2 teaspoonfuls) every 4 hours.

Regardless of age, make sure not to exceed 6 doses in a 24-hour period. Always follow these guidelines to ensure your child's safety and well-being.

Geriatric Use

When it comes to using Guaifenesin Oral Solution, there is no specific information available about how it should be used by older adults. This means that there are no special dosage adjustments, safety concerns, or precautions outlined for elderly patients.

If you are caring for an older adult who may need this medication, it’s always a good idea to consult with a healthcare professional. They can provide personalized advice and ensure that the medication is appropriate for their specific health needs.

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 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 health situation. They can help monitor your kidney function and make any necessary adjustments to 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 monitor your liver function and determine the best course of action for your treatment.

Make sure to keep your doctor informed about your liver health, as they may need 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 be aware that guaifenesin, a common medication used to relieve coughs and chest congestion, can affect certain lab tests. Specifically, it may interfere with the measurement of 5-hydroxyindoleacetic acid (5-HIAA) and vanillylmandelic acid (VMA), which are substances tested in urine to help diagnose certain medical conditions.

Because of this potential interaction, you should always discuss any medications you are taking, including over-the-counter ones like guaifenesin, with your healthcare provider. This ensures that your lab results are accurate and that you receive the best possible care.

Storage and Handling

To ensure the safety and effectiveness of your product, store it at a controlled room temperature between 20° to 25°C (68° to 77°F). It's important to keep the product protected from light to maintain its quality. Always check the seal before use; if the seal is broken, do not use the product, as this could compromise its safety.

By following these simple storage and handling guidelines, you can help ensure that the product remains safe and effective for your needs.

Additional Information

No further information is available.

FAQ

What is Guaifenesin?

Guaifenesin is an oral solution expectorant that helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive.

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

The usual dosage for adults and children 12 years and over is 10 to 20 mL (2 to 4 teaspoonfuls) every 4 hours, not exceeding 6 doses in any 24-hour period.

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.

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 are the storage instructions for Guaifenesin?

Store Guaifenesin at a controlled room temperature between 20° to 25°C (68° to 77°F) and protect it from light.

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 flavors does Guaifenesin come in?

Guaifenesin is available in a sugar-free and alcohol-free raspberry flavor.

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 is an expectorant formulated as an oral solution USP. Each 5 mL dose contains 100 mg of guaifenesin. This preparation is sugar-free and alcohol-free, with a raspberry flavor for palatability. It is recommended to store the solution at a temperature range of 20° to 25°C (68° to 77°F) and to protect it from light. This product is intended for institutional use only.

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

The recommended dosage for the medication should be adhered to as outlined or as directed by a physician.

For adults and children aged 12 years and older, the dosage is 10 to 20 ml (2 to 4 teaspoonfuls) administered 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. For children aged 2 years to under 6 years, the dosage is 2.5 to 5 ml (1/2 to 1 teaspoonful) every 4 hours.

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

It is important to note that no more than 6 doses should be taken within any 24-hour period.

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 are advised to exercise caution when recommending this product. Prior to use, it is imperative to consult a physician if the patient presents with a cough that is associated with excessive phlegm (mucus) or if the cough is chronic, particularly in individuals with a history of smoking, asthma, chronic bronchitis, or emphysema.

Patients should be instructed 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 further evaluation.

Additionally, it is crucial to assess for any hypersensitivity to the ingredients contained in the formulation. In the event of an overdose, immediate medical assistance should be sought, or the patient should contact a Poison Control Center without delay.

To ensure safety, this product must be kept out of reach of children at all times.

Side Effects

Patients should be aware of the potential adverse reactions associated with the use of this medication. Serious adverse reactions may necessitate immediate medical attention. Patients are advised to stop use and consult a healthcare professional if they experience a cough that lasts more than 7 days, if the cough returns, or if it is accompanied by fever, rash, or persistent headache, as these symptoms could indicate a serious underlying condition.

Additionally, individuals who are hypersensitive to any of the ingredients should discontinue use and seek medical advice.

Before using this medication, patients should consult a healthcare provider if they have a cough that occurs with excessive phlegm (mucus) or if they have a chronic cough associated with conditions such as smoking, asthma, chronic bronchitis, or emphysema. These considerations are important to ensure the safe and effective use of the medication.

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 and to inform laboratory personnel of the patient's guaifenesin use to mitigate the risk of misinterpretation. No specific dosage adjustments are indicated; however, close monitoring of laboratory results is recommended in patients undergoing testing for these substances while on guaifenesin therapy.

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 under 2 years of age should consult a physician before use. For children aged 2 years to under 6 years, the recommended dosage is 2.5 to 5 mL (1/2 to 1 teaspoonful) every 4 hours. In children aged 6 years to under 12 years, the dosage increases to 5 to 10 mL (1 to 2 teaspoonfuls) every 4 hours.

For adolescents and adults aged 12 years and over, the dosage is 10 to 20 mL (2 to 4 teaspoonfuls) every 4 hours. It is important to note that no more than 6 doses should be taken in any 24-hour period to ensure safety.

Geriatric Use

There is no specific information regarding the use of Guaifenesin Oral Solution in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as the absence of data necessitates careful consideration of individual patient factors and potential risks. Monitoring for efficacy and adverse effects is recommended in this population, given the lack of established guidelines for geriatric use.

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 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 drug insert text 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 lack of data necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients, although specific recommendations are not provided.

Hepatic Impairment

There is no information available regarding the use of this medication in patients with hepatic impairment. Consequently, there are no dosage adjustments, special monitoring requirements, or precautions specified for individuals with compromised liver function. Healthcare professionals should exercise clinical judgment when considering the use of this medication in patients with liver problems, as the absence of data does not preclude the need for careful evaluation and monitoring 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 aware that the specific symptoms of an overdose may vary depending on the 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. Continuous monitoring of the patient's vital signs and clinical status is recommended. In cases where the substance is known, specific antidotes or treatments may be indicated, and healthcare providers should refer to established guidelines for the management of the particular overdose scenario.

It is vital for healthcare professionals to remain vigilant and act swiftly in the event of an overdose to ensure the best possible outcomes for affected individuals.

Nonclinical Toxicology

If pregnant or breast-feeding, it is advised to consult a health professional before use. There are no specific non-teratogenic effects or nonclinical toxicology details available. Additionally, no specific information regarding animal pharmacology and toxicology has been provided.

Postmarketing Experience

No specific postmarketing experience details are available. As such, there are no additional adverse events or rare case reports to summarize at this time.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center in the event of an overdose. It is important for patients to be aware of the signs that may indicate a serious condition; therefore, they should be instructed to stop use and consult a doctor if their cough persists for more than 7 days, returns after resolution, or is accompanied by symptoms such as fever, rash, or a persistent headache.

Patients should also be informed to discontinue use and consult a healthcare professional if they experience hypersensitivity to any of the product's ingredients. Additionally, it is essential for patients to ask their doctor before using the medication if they have a cough that is associated with excessive phlegm (mucus). Furthermore, patients should be encouraged to seek medical advice prior to use if they have a chronic cough, particularly one related to smoking, asthma, chronic bronchitis, or emphysema.

Storage and Handling

The product is supplied in a configuration that includes specific NDC numbers, which should be referenced for accurate identification. It is essential to store the product at a controlled room temperature, maintaining a range between 20° to 25°C (68° to 77°F) as per USP guidelines.

To ensure the integrity of the product, it must be protected from light exposure. Additionally, it is critical to note that the product should not be used if the seal is broken, as this may compromise its safety and efficacy. Proper handling and storage conditions are vital to maintain the quality of the product throughout its shelf life.

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.