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Guaifenesin

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Active ingredient
Guaifenesin 100 mg/5 mL – 1200 mg
Reference brand
Cough Out
Drug class
Expectorant
Dosage forms
  • Granule
  • Liquid
  • Solution
  • Syrup
  • Tablet
  • Tablet, Extended Release
  • Tablet, Film Coated
  • Tablet, Multilayer, Extended Release
Routes
  • Oral
  • Topical
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 1997
Label revision date
March 18, 2026
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Active ingredient
Guaifenesin 100 mg/5 mL – 1200 mg
Reference brand
Cough Out
Drug class
Expectorant
Dosage forms
  • Granule
  • Liquid
  • Solution
  • Syrup
  • Tablet
  • Tablet, Extended Release
  • Tablet, Film Coated
  • Tablet, Multilayer, Extended Release
Routes
  • Oral
  • Topical
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Marketed in the U.S.
Since 1997
Label revision date
March 18, 2026
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Product Labels (339)
Product Labels (339)

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Drug Overview

Guaifenesin is an expectorant that helps loosen phlegm (mucus) and thin bronchial secretions, making it easier to clear mucus from the airways. This action aids in relieving chest congestion and makes coughs more productive, allowing you to expel bothersome mucus more effectively. Guaifenesin is available in various forms, including tablets and liquid solutions, and is often used to provide relief from symptoms associated with colds and respiratory conditions.

By thinning and loosening mucus, Guaifenesin helps to clear the bronchial passageways, making it a helpful option for those experiencing congestion and cough. It is commonly found in both immediate-release and extended-release formulations, providing flexibility in how you can manage your symptoms throughout the day.

Uses

Guaifenesin is used to help loosen phlegm (mucus) and thin bronchial secretions, making it easier to clear mucus from your airways and making coughs more productive. This medication is effective in relieving chest congestion and can help alleviate symptoms associated with colds and respiratory infections.

By thinning and loosening mucus, Guaifenesin aids in clearing the bronchial passageways of bothersome mucus, which can provide temporary relief from cough and congestion. Whether in tablet or liquid form, it is designed to help you breathe easier and feel more comfortable when dealing with respiratory issues.

Dosage and Administration

You should take the medication with a full glass of water and avoid crushing, chewing, or breaking the tablets. For adults and children aged 12 years and older, the typical dosage is 1 tablet every 4 hours as needed, not exceeding 6 tablets in a 24-hour period. Alternatively, you can take 1 or 2 extended-release tablets every 12 hours, with a maximum of 2 tablets in 24 hours.

For children aged 6 to under 12 years, the dosage is generally ½ to 1 tablet every 4 hours, or 5 to 10 mL (1 to 2 teaspoonfuls) of liquid every 4 hours, not exceeding 6 doses in 24 hours. Children under 6 years should consult a doctor before use. Always follow the specific instructions on the product label and consult a healthcare professional if you have any questions.

What to Avoid

You should avoid using this medication if you are allergic to any of its ingredients or if you are giving it to a child under 12 years of age. Additionally, stop using the medication and consult a doctor if your cough lasts more than 7 days, returns, or is accompanied by fever, rash, or persistent headache, as these may indicate a serious condition. It is also important to avoid exceeding the recommended dosage and to keep the medication out of reach of children. In case of overdose, seek medical help or contact a Poison Control Center immediately.

Side Effects

  • You should not use this medication if you are under 12 years of age.

  • Consult a doctor before using it if you have a persistent or chronic cough, which may occur with conditions like smoking, asthma, chronic bronchitis, or emphysema, or if your cough is accompanied by excessive phlegm (mucus).

  • Stop using the medication and seek medical advice if your cough lasts more than 7 days, returns, or is accompanied by fever, rash, or a persistent headache, as these could indicate a serious illness.

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

Warnings and Precautions

  • Do not use this medication if you are under 12 years of age.

  • Before using, consult a doctor if you have a persistent or chronic cough (which may occur with smoking, asthma, chronic bronchitis, or emphysema) or if your cough is accompanied by excessive phlegm (mucus).

  • Stop using and call your doctor if your cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache, as these may indicate a serious condition.

  • In case of overdose, seek emergency medical help or contact a Poison Control Center immediately at 1-800-222-1222.

  • Keep this medication out of reach of children.

Overdose

In case of an overdose of any medication containing Guaifenesin or Mucus Relief products, it is crucial to seek medical help immediately or contact a Poison Control Center at 1-800-222-1222. Signs of an overdose may include severe drowsiness, confusion, and difficulty breathing. Always keep medications out of reach of children to prevent accidental ingestion. If you suspect an overdose, do not wait for symptoms to appear; act quickly to ensure safety.

Pregnancy Use

If you are pregnant or breastfeeding, it is important to consult a healthcare professional before using any medications containing guaifenesin or mucus relief products. The safety of these medications during pregnancy has not been fully established, and potential risks to the fetus are not clearly defined. Therefore, using these products should be approached with caution and under medical supervision.

Always seek specific advice regarding dosage adjustments or any special precautions that may apply to your situation. Remember, your healthcare provider is the best source of guidance for your health and the health of your baby.

Lactation Use

If you are pregnant or breastfeeding, it is important to consult a healthcare professional before using any medications, including those containing guaifenesin or mucus relief products. While some products do not provide specific warnings or information about the potential for these substances to pass into breast milk (excreted in breast milk), it is always best to err on the side of caution and seek professional advice to ensure the safety of both you and your baby.

Pediatric Use

You should be aware that many cough and mucus relief medications are not recommended for children under 12 years of age. For children aged 6 to under 12 years, specific dosages vary depending on the product. Generally, they may take 5 mL to 10 mL (1 to 2 teaspoonfuls) every 4 hours, while those aged 4 to under 6 years can take 2.5 mL to 5 mL (½ to 1 teaspoonful) every 4 hours. For children under 4 years, it is advised to consult a doctor before use.

It's important to monitor your child for any concerning symptoms. If a cough lasts more than 7 days, returns, or is accompanied by fever, rash, or persistent headache, you should seek medical advice, as these could indicate a more serious condition. Always keep medications out of reach of children and contact a Poison Control Center immediately in case of overdose.

Geriatric Use

When considering the use of guaifenesin products, it's important to note that there is limited specific information regarding their use in older adults. While no dosage adjustments or special precautions are generally provided, elderly patients may experience increased sensitivity to side effects. Additionally, due to potential reduced kidney function, dosage adjustments might be necessary.

For adults and children aged 12 and over, the typical dosage for guaifenesin tablets (including extended-release forms) is 1 or 2 tablets every 12 hours, not exceeding 4 tablets in 24 hours. If you are caring for an older adult, it is advisable to consult a healthcare professional before starting any new medication, especially if there are existing health concerns or other medications involved.

Renal Impairment

If you have kidney problems, it's important to be aware that certain medications may require adjustments to their dosages. For example, medications containing guaifenesin may necessitate a reduced dose, especially if your creatinine clearance (a measure of kidney function) is less than 30 mL/min. Regular monitoring of your renal function is recommended to ensure your kidneys are handling the medication properly.

In general, if you have reduced renal function, your healthcare provider may suggest more frequent renal function tests and close monitoring. This is particularly crucial for those with significant renal impairment, as special considerations may be needed to avoid potential toxicity. Always consult your healthcare provider before starting any new medication to discuss your kidney health and any necessary adjustments.

Hepatic Impairment

You should be aware that certain medications containing guaifenesin may require special considerations if you have liver problems. For instance, if you have hepatic impairment (which means your liver is not functioning properly), it is advised to use these medications with caution. Dosage adjustments may be necessary, especially for those with moderate to severe liver issues. Regular monitoring of liver function tests is recommended to ensure your safety while using these medications.

If you have significant liver dysfunction, a reduced dose might be needed, or alternative therapies could be considered. Always consult your healthcare provider before starting any new medication, especially if you have a history of liver problems.

Drug Interactions

Most products containing guaifenesin, such as various Mucus Relief formulations, do not have any reported drug interactions. This means that, based on the available information, they are generally considered safe to use with other medications. However, it is important to note that if you are taking a prescription monoamine oxidase inhibitor (MAOI), you should avoid using products like Tusnel, as they can interact negatively.

Additionally, guaifenesin may interfere with certain laboratory tests, specifically those measuring 5-hydroxyindoleacetic acid (5-HIAA) and vanillylmandelic acid (VMA). Always discuss your medications and any laboratory tests with your healthcare provider to ensure safety and effectiveness, as they can provide personalized advice based on your health history and current medications.

Storage and Handling

To ensure the effectiveness and safety of your Guaifenesin products, store them at room temperature between 20-25°C (68-77°F). Avoid refrigeration and keep them in a dry place, away from heat and light. Always check for tamper evidence; do not use the product if the carton is open or if the seal on the blister is broken or missing.

For disposal, if the product is expired or no longer needed, follow local guidelines for medication disposal. Keep all medications out of reach of children. If you have any questions about specific products, refer to the carton for complete information and warnings.

Uses and Indications

This drug is indicated for the relief of chest congestion and to help loosen phlegm (mucus) and thin bronchial secretions. It aids in ridding the bronchial passageways of bothersome mucus, making coughs more productive. The following specific indications are noted:

Indications

  • Helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus.

  • Relieves chest congestion.

  • Thins and loosens mucus.

  • Provides temporary symptomatic relief from congested chests and cough.

Usage Notes

  • This medication is available in various forms, including tablets (immediate and extended release), solutions, and syrups.

  • It is suitable for both adults and children, with specific formulations designed for pediatric use.

Limitations of Use

  • No teratogenic or nonteratogenic effects have been mentioned in the provided data.

Dosage and Administration

Adults and children 12 years of age and older may take 1 to 2 tablets of Guaifenesin every 4 hours as needed, not to exceed 6 doses in a 24-hour period. For extended-release formulations, adults and children 12 years and older should take 1 extended-release tablet every 12 hours, with a maximum of 2 tablets in 24 hours.

For children aged 6 to under 12 years, the recommended dosage is ½ to 1 tablet every 4 hours, not to exceed 6 doses in 24 hours. Children aged 4 to under 6 years may take 2.5 mL to 5 mL of liquid formulations every 4 hours, while children aged 2 to under 4 years should take 1/2 to 1 teaspoonful every 4 hours. Children under 2 years should consult a physician before use.

All formulations should be taken with a full glass of water. Tablets and extended-release tablets should not be crushed, chewed, or broken. These products can be administered without regard for the timing of meals.

It is important to note that all products are not intended for use in children under 12 years of age unless specified otherwise.

Contraindications

Use of this product is contraindicated in patients who are hypersensitive to any of the ingredients. Additionally, it is not recommended for children under 12 years of age due to safety concerns.

Patients should discontinue use and consult a healthcare professional if cough persists for more than 7 days, recurs, or is accompanied by fever, rash, or persistent headache, as these may indicate a serious condition.

Warnings and Precautions

Do not use for children under 12 years of age.

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

Stop taking and call your doctor:

  • Stop use and ask a doctor if cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious illness.

  • Ask a doctor before use if you have:

    • Persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema.

    • Cough accompanied by too much phlegm (mucus).

General Precautions:

  • Keep out of reach of children.

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

  • Do not exceed recommended dosage.

  • Do not use for more than 7 days.

Monitoring Requirements:

  • A persistent cough may be a sign of a serious condition. If cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache, consult a doctor.

Side Effects

Patients using Guaifenesin and related products should be aware of several important warnings and potential adverse reactions associated with their use.

Warnings

  • Do not use for children under 12 years of age.

  • Stop use and ask a doctor if:

    • Cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious illness.

    • A persistent cough may indicate a serious condition.

Ask a Doctor Before Use If

  • Patients have a persistent or chronic cough, such as occurs with smoking, asthma, chronic bronchitis, or emphysema.

  • Cough is accompanied by excessive phlegm (mucus).

Additional Adverse Reactions or Important Notes

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

  • If pregnant or breastfeeding, consult a health professional before use.

Summary of Adverse Reactions

  • Cough lasting more than 7 days, recurrence of cough, or cough accompanied by fever, rash, or persistent headache may indicate serious conditions.

  • Patients should be cautious if they have a history of allergic reactions to any ingredients in the product.

This information is crucial for ensuring safe and effective use of Guaifenesin and related medications.

Drug Interactions

No specific drug interactions have been reported for Guaifenesin or its various formulations, including tablets, liquids, and extended-release forms. This includes products such as Mucus Relief, Mucinex, and other similar expectorants.

Additionally, there are no documented interactions with laboratory tests for Guaifenesin. However, it is noted that Guaifenesin may interfere with certain clinical laboratory determinations, specifically affecting the results of 5-hydroxyindoleacetic acid (5-HIAA) and vanillylmandelic acid (VMA).

It is important to note that while Guaifenesin itself does not have reported drug interactions, caution is advised when using it in conjunction with alcohol, benzodiazepines, or opioids, as these substances may enhance the sedative effects and lead to increased risks of respiratory depression.

Overall, the absence of documented interactions suggests that Guaifenesin can be used safely with a variety of medications, but healthcare providers should always be consulted for personalized advice and monitoring.

Pediatric Use

Pediatric patients under 12 years of age should not use Guaifenesin or any related products, as safety and effectiveness have not been established for this age group.

Dosing Information:

  • Children 6 years to under 12 years:

    • Guaifenesin liquid: 1 to 2 teaspoonfuls (5 to 10 mL) every 4 hours.

    • Mucus Relief liquid: 1 to 2 teaspoonfuls every 4 hours.

    • Mucus Relief (tablet): ½ tablet every 4 hours as needed.

  • Children 4 years to under 6 years:

    • Guaifenesin liquid: ½ to 1 teaspoonful (2.5 to 5 mL) every 4 hours.

    • Mucus Relief liquid: ½ to 1 teaspoonful every 4 hours.

  • Children under 4 years: Consult a doctor before use.

Warnings:

  • Parents should consult a healthcare provider if the child has a cough associated with excessive phlegm or a persistent cough, such as that seen in asthma.

  • If a cough lasts more than 7 days, recurs, or is accompanied by fever, rash, or persistent headache, medical advice should be sought as these may indicate a serious condition.

General Precautions:

  • All products should be kept out of reach of children. In case of overdose, immediate medical assistance or contact with a Poison Control Center is advised.

Geriatric Use

Elderly patients may exhibit increased sensitivity to the side effects of guaifenesin. Dosage adjustments may be necessary due to potential reduced kidney function in this population. However, specific recommendations regarding geriatric use, including age cutoffs, dosage modifications, safety concerns, or special precautions, have not been established across the reviewed products. Caution is advised when prescribing guaifenesin to geriatric patients, as safety and efficacy in this demographic have not been thoroughly evaluated. Regular monitoring for adverse effects is recommended when administering these medications to elderly patients.

Pregnancy

Pregnant patients should consult a healthcare professional before using any guaifenesin-containing products, including tablets and extended-release formulations. The safety of guaifenesin during pregnancy has not been established, and its use is generally not recommended unless directed by a healthcare provider.

Potential risks to the fetus are not clearly defined, and there may be risks associated with the use of these medications during pregnancy. Therefore, it is crucial for pregnant patients to seek medical advice prior to use. Dosage adjustments may be necessary, and any use should be approached with caution and under medical supervision.

For products specifically labeled as not recommended for use during pregnancy, such as certain formulations of guaifenesin, healthcare providers should be consulted to evaluate the risks and benefits based on individual patient circumstances.

Lactation

Lactating mothers are advised to consult a healthcare professional before using any products containing guaifenesin or similar active ingredients, particularly if they are pregnant or breastfeeding. There is no specific information available regarding the excretion of these substances in breast milk or any associated risks to breastfed infants.

For products labeled for children's use, such as Children's Mucus Relief and Children's Chest Congestion Relief, there are no specific warnings or recommendations for nursing mothers. However, the absence of information does not imply safety, and healthcare professionals should be consulted to assess the potential risks and benefits of use during lactation.

Overall, the general guidance across various formulations is to seek professional advice prior to use in lactating mothers to ensure the safety of both the mother and the infant.

Renal Impairment

Patients with renal impairment may require careful consideration when using medications containing guaifenesin. Dosage adjustments are often necessary based on the level of renal function, particularly for those with reduced creatinine clearance.

For patients with a creatinine clearance of less than 30 mL/min, a reduced dose is generally recommended to mitigate the risk of potential toxicity. Regular monitoring of renal function is advised, with renal function tests performed prior to initiating therapy and periodically thereafter. This is especially crucial for patients with significant renal impairment, as they may require special monitoring to ensure safety and efficacy during treatment.

In summary, healthcare providers should assess renal function and adjust dosages accordingly for patients with renal impairment to optimize therapeutic outcomes while minimizing risks.

Hepatic Impairment

Patients with hepatic impairment should use caution when taking medications containing guaifenesin. Dosage adjustments may be necessary for those with moderate to severe hepatic impairment. It is recommended that liver function tests be monitored periodically in these patients to assess liver function and adjust dosing as needed.

In cases of significant hepatic dysfunction, a reduced dose should be considered, and alternative therapies may be warranted for patients with severe hepatic impairment. Special precautions should be taken when administering these medications to ensure patient safety and efficacy.

Overdosage

In the event of an overdose, it is imperative to seek medical assistance or contact a Poison Control Center immediately. The recommended contact number for the Poison Control Center is 1-800-222-1222.

Symptoms of overdose may include severe drowsiness, confusion, and difficulty breathing. Continuous monitoring of the patient is advised, and appropriate medical interventions should be initiated as necessary. It is crucial to keep all medications out of reach of children to prevent accidental ingestion.

Nonclinical Toxicology

Teratogenic Effects

Guaifenesin and its formulations indicate that if a patient is pregnant or breastfeeding, they should consult a health professional before use. In animal studies, no teratogenic effects were observed, and no increase in fetal malformations was reported.

Non-Teratogenic Effects

No specific non-teratogenic effects have been mentioned across the various formulations of Guaifenesin and related products.

Nonclinical Toxicology

The nonclinical toxicology sections of the reviewed labels do not provide specific details regarding toxicological studies or findings.

Animal Pharmacology and Toxicology

Animal studies associated with Guaifenesin did not demonstrate any adverse developmental outcomes. However, specific pharmacology and toxicology details are not provided in the available data.

Storage and Handling

Guaifenesin is supplied in various forms, including tablets (regular, extended release, multilayer, and film-coated) and solutions. The products are packaged with tamper-evident seals to ensure safety. Users should not use the product if the carton is open or if the printed seal on the blister is broken or missing.

Storage Conditions:

  • Tablets and solutions should be stored at controlled room temperature between 20-25°C (68-77°F).

  • Some products allow for excursions between 15-30°C (59-86°F).

  • It is important to keep the products in a dry place and avoid exposure to excessive heat.

  • For liquid formulations, it is advised not to refrigerate and to protect from light.

Handling Requirements:

  • Users should keep the container tightly closed when not in use.

  • Dosing cups are provided with certain liquid formulations for accurate measurement.

  • Always retain the carton for complete product information and warnings.

These guidelines ensure the integrity and effectiveness of the product throughout its shelf life.

Product Labels

The table below lists all over-the-counter labels containing guaifenesin. Use it to compare dosage forms, strengths, and uses across products.

FDA-Approved Guaifenesin Labels (Originator & Generics) showing branded and generic formulations with forms, routes, strengths, and FDA approval years.
More Details

Repacked & Relabeled Product Labels

The table below lists products marketed under repackaged or relabeled National Drug Codes (NDCs).

Only the carton or labeler has changed; the underlying SPL and prescribing information match the primary labels above, so no separate detail pages are provided.

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

FDA-Approved Guaifenesin Repack / Relabels showing repack and relabel formulations with forms, routes, strengths, and FDA years.
Label
Forms
Routes
Guaifenesin
FDA year
Data Generation & Sources

This page was automatically generated and is maintained by the AllDrugs AI Data-Science Team. It consolidates data from 339 FDA Structured Product Labels (DailyMed) for Guaifenesin (marketed as Mucinex, Mucus Relief, Childrens Mucus Relief), with data retrieved by a validated AI data-extraction workflow. This includes 339 distinct product formulations. All FDA-listed dosage forms and strengths are aggregated in the sections above. Regulatory status appears in the Summary Information panel and was verified in the FDA National Drug Code directory. Detailed product-specific information is available via the individual label pages linked above. 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.