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Guaifenesin 200mg

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Active ingredient
Guaifenesin 200 mg
Other brand names
Drug class
Expectorant
Dosage form
Tablet
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
November 13, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Guaifenesin 200 mg
Other brand names
Drug class
Expectorant
Dosage form
Tablet
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
November 13, 2025
Manufacturer
Marlex Pharmaceuticals Inc
Registration number
M012
NDC root
10135-789
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 is a medication that helps loosen phlegm (mucus) and thin bronchial secretions. By doing so, it aids in clearing the bronchial passageway of bothersome mucus, making coughs more productive. This can be particularly helpful when you're dealing with respiratory conditions that involve congestion.

Typically available in 200 mg tablets, guaifenesin is used to relieve symptoms associated with colds, allergies, or other respiratory illnesses. If you're experiencing a cough due to mucus buildup, guaifenesin may be a supportive option to consider.

Uses

This medication is designed to help you breathe easier by loosening phlegm (a type of 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 respiratory issues that involve excess mucus.

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 concerned about such risks.

Dosage and Administration

When using this medication, it's important to follow the recommended dosage to ensure your safety. For adults and children aged 12 years and older, you can take 1 to 2 tablets every 4 hours as needed. However, make sure not to exceed 6 doses within a 24-hour period.

If you have children under 12 years of age, please do not use this product for them, as it is not intended for that age group. Always remember to read the instructions carefully and consult with a healthcare professional if you have any questions or concerns about using this medication.

What to Avoid

It's important to be aware of certain precautions when using this product. First and foremost, do not use it if the safety seal under the cap is broken or missing, as this indicates that the product may have been tampered with.

While there are no specific contraindications, controlled substance classifications, or noted risks of abuse, misuse, or dependence associated with this product, always prioritize your safety by following these guidelines. If you have any concerns or questions, consult with a healthcare professional for personalized advice.

Side Effects

You should be aware of some important side effects and warnings associated with this medication. If you have a persistent or chronic cough—like those caused by smoking, asthma, chronic bronchitis, or emphysema—or if your cough is accompanied by excessive mucus, it's essential to consult your doctor before using this product.

Additionally, you should stop using the medication and seek medical advice if your cough lasts more than 7 days, returns, or is accompanied by symptoms such as fever, rash, or a persistent headache, as these could indicate a more serious condition. In the event of an overdose, it's crucial to get medical help or contact a Poison Control Center immediately.

Warnings and Precautions

Before using this medication, it's important to consult your doctor if you have a persistent or chronic cough, especially if it's related to smoking, asthma, chronic bronchitis, or emphysema. Additionally, if your cough produces a lot of phlegm (mucus), you should also seek medical advice.

You should stop using the medication and contact your doctor if your cough lasts more than 7 days, returns after improvement, or is accompanied by symptoms like fever, rash, or a persistent headache, as these may indicate a more serious condition. Always check that the safety seal under the cap is intact before use; do not use the product if it is broken or missing. In the event of an overdose, 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 make a significant difference in your health. Always prioritize your safety and well-being by reaching out for professional assistance in these situations.

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

This product is not suitable for children under 12 years of age. If your child is 12 years or older, you can give them 1 to 2 tablets every 4 hours as needed. However, it’s important to avoid using this medication for children younger than 12, as it may not be safe for them. Always consult with a healthcare professional if you have any questions or concerns about using this product for your child.

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, it’s important to consult with a healthcare provider before starting the medication. 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 information provided does not include specific guidelines for dosage adjustments, special monitoring, or safety considerations related to renal impairment (kidney issues). This means that there are no tailored recommendations for how your treatment may need to change based on your kidney function.

Always consult your healthcare provider for personalized advice and to ensure that your treatment plan is safe and effective for your specific situation. They can help monitor your kidney health and make any necessary adjustments to your medications.

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 provided information. This means that the standard recommendations apply, and there are no special monitoring or precautions outlined for patients with liver impairment.

Always consult your healthcare provider for personalized advice and to ensure that any medications you take are safe for your liver health. They can provide guidance tailored to your specific situation.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications or tests you may be taking. While there are no specific drug interactions or laboratory test interactions noted for this medication, your healthcare provider can help ensure that everything you are taking works well together and is safe for you. Always share your complete list of medications and any recent lab tests to avoid any potential issues. Your health and safety are the top priority, so don't hesitate to ask questions or express any concerns.

Storage and Handling

To ensure the best performance of your product, store it in a cool, dry place at a temperature between 15°C and 30°C (59°F and 86°F). This temperature range helps maintain the product's effectiveness and safety.

When handling the product, be sure to do so with clean hands and in a sterile field (a clean area free from germs) to prevent contamination. Always follow any specific disposal instructions provided to ensure safe and responsible disposal of any components.

Additional Information

It's important to store your medication properly to ensure its effectiveness. Keep it at a temperature between 15°C and 30°C (59°F and 86°F). This helps maintain the quality of the drug and ensures it works as intended.

FAQ

What is Guaifenesin used for?

Guaifenesin 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 1 to 2 tablets every 4 hours, not exceeding 6 doses in a 24-hour period.

Is Guaifenesin safe for children under 12?

No, this product is not intended for use in children under 12 years of age.

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

You should stop using Guaifenesin 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 warnings before using Guaifenesin?

Yes, ask a doctor before use if you have a persistent or chronic cough, or if your cough is accompanied by too much phlegm (mucus).

What should I do in case of an overdose?

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

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 Guaifenesin be stored?

Store Guaifenesin at 15°C-30°C (59°F-86°F).

What should I check before using Guaifenesin?

Do not use Guaifenesin if the imprinted safety seal under the cap is broken or missing.

Packaging Info

Below are the non-prescription pack sizes of Guaifenesin 200mg (guaifenesin). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Guaifenesin 200mg.
Details

Drug Information (PDF)

This file contains official product information for Guaifenesin 200mg, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

No description information is available for the drug.

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 passageway.

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

Dosage and Administration

The recommended dosage for adults and children aged 12 years and older is 1 to 2 tablets every 4 hours, as needed. It is important to note that no more than 6 doses should be taken within a 24-hour period. This product is contraindicated for use in children under 12 years of age; therefore, it should not be administered to this population.

Contraindications

Use is contraindicated if the tamper-evident safety seal under the cap is broken or missing. This precaution is necessary to ensure the integrity and safety of the product.

Warnings and Precautions

Patients should consult a healthcare professional prior to use if they have a persistent or chronic cough, particularly if it is associated with smoking, asthma, chronic bronchitis, or emphysema. Additionally, individuals experiencing a cough that is accompanied by excessive phlegm (mucus) should seek medical advice before using this product.

Use of this product should be discontinued and a healthcare provider should be contacted if the cough persists for more than 7 days, recurs, or is accompanied by symptoms such as fever, rash, or a persistent headache. These symptoms may indicate the presence of a serious underlying condition that requires medical evaluation.

It is imperative to note that the product is tamper-evident. Therefore, it should not be used if the imprinted safety seal under the cap is broken or missing, as this may compromise the integrity of the product.

In the event of an overdose, immediate medical assistance should be sought, or the individual should contact a Poison Control Center without delay.

Side Effects

Patients should be aware of the potential adverse reactions associated with the use of this medication. Serious adverse reactions may occur, and it is advised that patients consult a healthcare professional before use if they have a persistent or chronic cough, such as that which occurs with smoking, asthma, chronic bronchitis, or emphysema. Additionally, patients experiencing a cough accompanied by excessive phlegm (mucus) should seek medical advice prior to use.

Patients are instructed to discontinue use and consult a healthcare provider if their cough persists for more than 7 days, recurs, or is accompanied by symptoms such as fever, rash, or a persistent headache, as these may indicate a serious underlying condition.

In the event of an overdose, it is crucial for patients to seek immediate medical assistance or contact a Poison Control Center.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there is no information available regarding interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Guaifenesin 200mg (guaifenesin). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Guaifenesin 200mg.
Details

Pediatric Use

This product is not intended for use in pediatric patients under 12 years of age. For adolescents aged 12 years and older, the recommended dosage is 1 to 2 tablets every 4 hours as needed. There are no established safety or efficacy data for children under 12 years, and therefore, use in this population is contraindicated.

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 the safety of both the mother and the developing fetus.

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 available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in clinical trials for this medication. Consequently, there is no information available regarding 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, as the lack of data may impact the safety and efficacy of treatment 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 informed about the appropriate protocols for managing overdose situations, ensuring that patients receive timely and effective care.

Nonclinical Toxicology

If pregnant or breast-feeding, it is advised to consult a health professional before use. No specific non-teratogenic effects have been identified in the available data. Additionally, there are no detailed findings regarding nonclinical toxicology or animal pharmacology and toxicology provided in the current information.

Postmarketing Experience

No postmarketing experience details are available in the insert.

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 warrant discontinuation of the medication; they should 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, as these may indicate a serious underlying condition.

Additionally, healthcare providers should emphasize the importance of product integrity by instructing patients to check the tamper-evident seal. Patients should be informed that the product should not be used if the safety seal under the cap is broken or missing, as this may compromise the safety and efficacy of the medication.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at a temperature range of 15°C to 30°C (59°F to 86°F) to maintain its efficacy and stability. Proper storage conditions must be adhered to, ensuring that the product is kept within the specified temperature limits to prevent degradation.

Additional Clinical Information

Patients should store the medication at a temperature range of 15°C to 30°C (59°F to 86°F) to ensure its efficacy and stability. Clinicians should advise patients to adhere to these storage conditions.

Drug Information (PDF)

This file contains official product information for Guaifenesin 200mg, 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 200mg, 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.