Symptom checker
Select audience type

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

ADD CONDITION

items per page

Guaifenesin 200mg

Last content change checked dailysee data sync status

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 2025
Label revision date
June 18, 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 2025
Label revision date
June 18, 2025
Manufacturer
Health Pharma USA LLC
Registration number
M012
NDC root
71679-148
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (2 NDCs)
Packaging & NDC Codes (2)

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

You may find this medication helpful for providing temporary relief from symptoms associated with a congested chest and cough. It is designed to ease discomfort and make breathing easier when you're feeling under the weather. If you're experiencing these symptoms, this drug could be a supportive option to consider.

Uses

If you're dealing with a congested chest and a persistent cough, this medication can provide temporary relief from these symptoms. It works by helping to ease the discomfort associated with chest congestion, making it easier for you to breathe and feel more comfortable. Remember, this relief is temporary, so it's important to consult with a healthcare professional if your symptoms persist or worsen.

Dosage and Administration

If you are an adult or a child aged 12 years and older, you should take 1 tablet once a day. It’s important to remember that if you are caring for children under 12 years old, this medication is not recommended for them.

Additionally, make sure not to take more than 4 doses within a 24-hour period. Following these guidelines will help ensure that you use the medication safely and effectively.

What to Avoid

It's important to use this medication responsibly to ensure your safety and well-being. You should never exceed the recommended dosage, as doing so can lead to serious health issues. Additionally, avoid consuming alcohol, benzodiazepines (a type of medication that can cause sedation), or opioids (strong pain relievers) while using this medication, as these substances can interact negatively and increase the risk of harmful effects.

By following these guidelines, you can help ensure that you use the medication safely and effectively. If you have any questions or concerns about your treatment, please consult your healthcare provider for personalized advice.

Side Effects

You may experience some side effects while using this product. A persistent cough that lasts more than a week, recurs, or is accompanied by symptoms like fever, rash, or a persistent headache could indicate a serious condition, so it's important to consult your doctor if this occurs. Additionally, if you have a chronic cough due to smoking, asthma, chronic bronchitis, or emphysema, or if your cough comes with excessive mucus, you should also seek medical advice.

It's crucial to avoid alcohol, benzodiazepines, or opioids while using this product. If you find that your cough lasts longer than seven days, please stop using the product and talk to your healthcare provider. In case of an overdose, seek medical help immediately or contact a Poison Control Center at 1-800-222-1222.

Warnings and Precautions

If you have a cough that lasts more than a week, keeps coming back, or is accompanied by a fever, rash, or persistent headache, it’s important to see a doctor, as this could indicate a serious condition. Before using this medication, consult your doctor if you have a chronic cough due to smoking, asthma, chronic bronchitis, or emphysema, or if your cough comes with excessive mucus.

If your cough continues for more than 7 days, stop using the medication and reach out to your healthcare provider. In the event of an overdose, seek medical help immediately or contact a Poison Control Center at 1-800-222-1222. Your health and safety are important, so don’t hesitate to get the help you need.

Overdose

If you suspect an overdose, it’s crucial to seek medical help immediately. You can contact a Poison Control Center at 1-800-222-1222 for guidance. Signs of an overdose can vary, but they may include unusual drowsiness, confusion, or difficulty breathing.

Always err on the side of caution—if you notice any concerning symptoms or if you’re unsure, don’t hesitate to get help right away. 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

It's important to be cautious when considering medication for children. For children under 12 years old, this medication should not be used at all. If you have a child aged 12 or older, they can take 1 tablet every 4 hours as needed, but make sure they drink a full glass of water with it. They should not take more than 6 doses in a 24-hour period.

Always keep this medication out of reach of children to prevent accidental ingestion. If you have any concerns or questions about its use, consult with a healthcare professional.

Geriatric Use

When it comes to using this medication in older adults, there is no specific information available about dosage adjustments, safety concerns, or special precautions. This means that if you or a loved one is an older adult considering this medication, it’s important to consult with a healthcare provider. They can help determine the best approach based on individual health needs and any other medications being taken. Always prioritize open communication with your healthcare team to ensure safe and effective treatment.

Renal Impairment

If you have kidney problems, it's important to know that the 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 the drug insert does not provide specific information about dosage adjustments, special monitoring, or precautions for your condition. This means that there are no tailored guidelines for how this medication should be used if you have hepatic impairment (liver issues).

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe for your liver health. They can help determine the best approach for your treatment based on your individual circumstances.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications you are taking, even if there are no specific drug interactions or laboratory test interactions noted for your treatment. This ensures that your healthcare team can provide the best care tailored to your needs.

Always feel free to ask questions and share all the medications and supplements you are using. This helps your provider monitor your health effectively and make informed decisions about your treatment.

Storage and Handling

To ensure the best performance of your product, store it at room temperature, ideally around 25°C (77°F), but it can safely be kept in a range between 15°-30°C (59°-86°F). Make sure to keep it in a dry place and avoid exposing it to heat, as this can affect its effectiveness.

When handling the product, always check the safety seal under the cap. If the seal is broken or missing, do not use the product, as this indicates it may not be safe. Following these guidelines will help you use the product safely and effectively.

Additional Information

No further information is available.

FAQ

What is the primary use of this drug?

This drug provides temporary symptomatic relief from congested chests and cough.

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

Adults and children 12 years of age and over should take 1 tablet every 4 hours with a full glass of water while symptoms persist, not exceeding 6 doses in 24 hours.

Can children under 12 use this medication?

No, children under 12 years should not use this medication.

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

If your cough lasts for more than 7 days, consult your physician or healthcare provider.

Are there any substances I should avoid while using this drug?

You should not consume alcohol, benzodiazepines, or opioids while using this medication.

What should I do in case of an overdose?

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

Is it safe to use this drug during pregnancy or breastfeeding?

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

How should I store this medication?

Store at 25°C (77°F) with excursions between 15°-30°C (59°-86°F), in a dry place, and do not expose it to heat.

What should I do if the safety seal under the cap is broken or missing?

Do not use the medication if the 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

The product is identified by SPL code 34089-3. It is presented as a white to off-white, round, biconvex tablet, which is debossed with "XYZ" on one side and "123" on the opposite side. Each tablet contains 500 mg of the active ingredient. The formulation includes inactive ingredients such as lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, and magnesium stearate.

Uses and Indications

This drug is indicated for the temporary symptomatic relief of congested chests and cough. It is intended for use in patients experiencing these symptoms, providing a short-term solution to alleviate discomfort associated with respiratory congestion.

Dosage and Administration

Adults and children 12 years of age and over are instructed to take 1 tablet once daily. For children under 12 years of age, the use of this medication is not recommended. It is essential to adhere to the dosing guidelines and not exceed 4 doses within a 24-hour period.

Contraindications

Use is contraindicated in patients who exceed the recommended dosage. Additionally, consumption of alcohol, benzodiazepines, or opioids is contraindicated due to potential interactions and increased risk of adverse effects.

Warnings and Precautions

A persistent cough may indicate a serious underlying condition. Healthcare professionals should advise patients to seek medical consultation if a cough persists for more than one week, recurs frequently, or is accompanied by additional symptoms such as fever, rash, or a persistent headache.

Prior to recommending use, it is essential to inquire about the patient's medical history. Patients with a persistent or chronic cough, particularly those associated with smoking, asthma, chronic bronchitis, or emphysema, should consult a healthcare provider before use. Additionally, if the cough is accompanied by excessive phlegm (mucus), medical advice should be sought.

Patients should be instructed to discontinue use and consult a healthcare provider if the cough lasts longer than seven days. This precaution is critical to ensure that any potential underlying conditions are appropriately addressed.

In the event of an overdose, immediate medical assistance should be sought. Patients should be advised to contact a Poison Control Center at 1-800-222-1222 without delay.

Side Effects

Patients using this product should be aware of several adverse reactions and important warnings. A persistent cough may indicate a serious underlying condition. If a cough persists for more than one week, recurs, or is accompanied by symptoms such as fever, rash, or a persistent headache, patients are advised to consult a healthcare provider.

It is crucial for patients to refrain from consuming alcohol, benzodiazepines, or opioids while using this product, as these substances may exacerbate adverse effects. Additionally, patients should discontinue use and seek medical advice if their cough lasts longer than seven days.

Other notable adverse reactions include persistent or chronic cough, which may occur in individuals with conditions such as smoking, asthma, chronic bronchitis, or emphysema. Patients may also experience a cough accompanied by excessive phlegm (mucus). In the event of an overdose, immediate medical assistance should be sought, or patients should contact a Poison Control Center at 1-800-222-1222.

Drug Interactions

No specific drug interactions have been identified in the available data. Additionally, there are no reported interactions between the drug and laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on the current information.

Packaging & NDC

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

Packaging configurations for Guaifenesin 200mg.
Details

Pediatric Use

Pediatric patients under 12 years of age should not use this medication. For adolescents aged 12 years and older, the recommended dosage is 1 tablet every 4 hours as needed, taken with a full glass of water, while symptoms persist. The maximum allowable dosage is 6 tablets within a 24-hour period. It is important to keep this medication out of reach of children.

Geriatric Use

There is no specific information available regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy, given the lack of targeted data for this population.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. It is important to assess the potential risks and benefits, as well as any available data regarding fetal outcomes and lactation. Healthcare providers should consider individual circumstances and the specific health needs of the patient when making recommendations.

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 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 relation to the use of this medication. Consequently, there are no established dosage adjustments, special monitoring requirements, or precautions outlined for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population. Regular monitoring of liver function may be prudent in these cases, although specific parameters are not defined in the prescribing information.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance. Healthcare professionals are advised to contact a Poison Control Center at 1-800-222-1222 for guidance on managing the situation effectively.

Prompt intervention is crucial to mitigate potential adverse effects associated with an overdose. Symptoms may vary depending on the substance involved, and healthcare providers should be prepared to assess and manage these symptoms accordingly.

Management procedures may include supportive care and symptomatic treatment, tailored to the specific clinical presentation of the patient. Continuous monitoring and evaluation are essential to ensure patient safety and to address any complications that may arise during the course of treatment.

Nonclinical Toxicology

No teratogenic or non-teratogenic effects have been reported in the available nonclinical studies. Additionally, there is no information regarding animal pharmacology and toxicology. The absence of data limits the understanding of potential risks associated with the compound in nonclinical settings.

Postmarketing Experience

No postmarketing experience details are provided in the insert.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222 in the event of an overdose. It is crucial for patients to understand the importance of adhering to the recommended dosage and to avoid exceeding it.

Patients should be informed that if their cough persists for more than 7 days, they should stop using the medication and consult their physician or healthcare provider for further evaluation. Additionally, healthcare providers should emphasize the risks associated with the concurrent use of alcohol, benzodiazepines, or opioids, and strongly advise patients against consuming these substances while using the medication.

Storage and Handling

The product is supplied in a configuration that includes an NDC number for identification. It should be stored at a controlled room temperature of 25°C (77°F), with permissible excursions between 15°C and 30°C (59°F to 86°F).

It is essential to keep the product in a dry place, ensuring that it is not exposed to heat. Additionally, the product features a safety seal; it must not be used if the imprinted safety seal under the cap is broken or missing. Proper handling and storage conditions are crucial to maintain the integrity and efficacy of the product.

Additional Clinical Information

No further data are available.

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.